CN118019489A

CN118019489A - Wearable device with physiological parameter monitoring

Info

Publication number: CN118019489A
Application number: CN202280061036.3A
Authority: CN
Inventors: A·艾尔-阿里; S·斯克鲁格斯; R·皮瑞德戴尔
Original assignee: Masimo Corp
Current assignee: Masimo Corp
Priority date: 2021-07-13
Filing date: 2022-07-12
Publication date: 2024-05-10

Abstract

The optical physiological sensor may be integrated into the wearable device and may include: a substrate having an optical center; a first emitter group of Light Emitting Diodes (LEDs) positioned adjacent to and spaced apart from the optical center of the substrate by an offset; LEDs of the second emitter group positioned adjacent the optical center of the substrate at an offset from the optical center and spaced apart from the optical center opposite the first emitter group LEDs relative to the optical center at an offset; and a plurality of detectors arranged in a spatial configuration around the first emitter group and the second emitter group. Each detector of the plurality of detectors may be positioned on the substrate at the same distance from the optical center of the substrate.

Description

Wearable device with physiological parameter monitoring

Cross Reference to Related Applications

The present application claims the benefit of U.S. provisional application No.63/252,893 filed on month 10 of 2021 and U.S. provisional application No.63/230,239 filed on month 8 of 2021 and U.S. provisional application No.63/221,385 filed on month 13 of 2021. The entire disclosure of each of the foregoing items is hereby incorporated by reference as if fully set forth herein, and for all purposes and all that they contain.

Technical Field

The present disclosure relates to a wearable health monitoring device incorporating a plurality of sensors worn on the wrist.

Background

Spectroscopy is a common technique for measuring the concentration of organic and some inorganic components of a solution. The theoretical basis of this technique is the beer-lambert law, which states that the concentration of the absorber in the solution, c _i, can be determined from the intensity of the light transmitted through the solution, the known path length, d _λ, the intensity of the incident light, I _0,λ, and the extinction coefficient, ε _i,λ, at a particular wavelength λ.

In broad form, the beer-lambert law is expressed as:

Where mu _α,λ is the bulk absorption coefficient and represents the absorption probability per unit length. The minimum number of discrete wavelengths required to solve equations 1 and 2 is the number of important absorbers present in the solution.

A practical application of this technique is pulse oximetry or plethysmography, which uses non-invasive sensors to measure oxygen saturation and pulse rate, as well as other physiological parameters. Pulse oximetry or plethysmography rely on sensors attached to the outside of a patient (typically at the fingertip, foot, ear, forehead or other measurement site, for example) to output signals indicative of various physiological parameters, such as the patient's blood constituents and/or analytes, including, for example, percent values of arterial oxygen saturation, as well as other physiological parameters. The sensor has at least one emitter that emits one or more wavelengths of optical radiation into the tissue site and at least one detector that is responsive 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 within the tissue site. Based on the response, the processor determines the relative concentrations of oxyhemoglobin (HbO ₂) and deoxyhemoglobin (Hb) in the blood to derive oxygen saturation so that potentially dangerous reductions in the patient's oxygen supply, as well as other physiological parameters, can be detected early.

The patient monitoring device may include a plethysmograph sensor. The plethysmograph sensor may calculate oxygen saturation (SpO ₂), pulse rate, plethysmograph waveform, perfusion Index (PI), volume variation index (PVI), methemoglobin (MetHb), carboxyhemoglobin (CoHb), total hemoglobin (tHb), respiration rate, glucose, and/or other parameters. The parameters measured by the plethysmograph sensor may be displayed on one or more monitors individually, in groups, on trend, as a combination, or as an overall health or other index.

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

Disclosure of Invention

A disadvantage of current pulse oximetry sensors is the need to be located near the body's vital capillary beds, including the fingers, ears, toes, nose and forehead. Outside of medical institutions, such locations are often inconvenient for monitoring users during normal activities. Furthermore, although there are techniques for measuring oxygen saturation by exercise, it is directed to medical institution environments and is not reliable for normal daily activities, including athletic activities or other important daily activities. Accordingly, the present disclosure provides a sensor that allows pulse oximetry to be measured at sparse capillary bed locations including the wrist. The present disclosure also provides algorithms for measuring pulse oximetry by higher intensity daily movements.

The physiological monitoring sensor or module (also referred to herein as a physiological parameter measurement sensor or module, or module) may be integrated into a wearable device, such as a wristwatch or watch, that is secured to a person's ("wearer") wrist. The sensors on the watch may be used to monitor physiological parameters of the wearer. The sensors may detect the pulse rate, oxygen saturation, hydration status, respiration rate, and/or other parameters of the wearer, such as the parameters disclosed herein. The sensor may include a convex protrusion to improve pressure and contact, and thereby improve optical coupling between the skin of the wearer and the physiological parameter measuring sensor. The curvature of the sensor may be designed to balance the pressure desired by the wristwatch against the wearer's wrist and the comfort of the wearer. The sensor may include, among other features, a light blocking layer between the emitter and detector of the module and/or a light diffusing material surrounding the emitter and detector to increase signal strength and reduce noise. The sensor or watch may include a connection port for receiving another sensor, which may be configured to be coupled to the wearer at a different measurement site of the wearer's body than the wrist. The sensor may be configured to measure one or more physiological parameters continuously, at intervals, and/or upon request by the wearer. For example, the sensor may be configured to continuously measure the oxygen saturation and/or pulse rate of the wearer while the wristwatch is worn on the wrist of the wearer.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face tissue of the wearer when the watch is worn by the wearer. The optical physiological sensor may be configured to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a Printed Circuit Board (PCB); a first emitter group comprising a first plurality of Light Emitting Diodes (LEDs) located at a first location on the PCB; a second emitter group comprising a second plurality of LEDs located at a second location on the PCB different from the first location, wherein the second emitter group comprises the same number and type of LEDs as the first emitter group; one or more first light barriers separating the first emitter group from the second emitter group; a light diffusing material configured to diffuse light emitted by each of the first and second plurality of LEDs; a plurality of detectors including six or more photodiodes on the PCB; one or more second light blockers separating each of the plurality of detectors from (i) each of the other of the plurality of detectors and from (ii) the first emitter group and the second emitter group; and a convex surface configured to be positioned between (i) the first and second emitter sets and six or more photodiodes and (ii) tissue of a wearer, the convex surface comprising one or more surface materials.

In some configurations, the first plurality of LEDs may be configured to emit light of at least five wavelengths, and the second plurality of LEDs may be configured to emit light of at least five wavelengths.

In some configurations, the five wavelengths emitted by the first plurality of LEDs may be the same wavelengths as the five wavelengths emitted by the second plurality of LEDs.

In some configurations, the first plurality of LEDs may include LEDs of the same type as LEDs of the second plurality of LEDs.

In some configurations, the LEDs of the first plurality of LEDs may be arranged on the PCB to mirror the arrangement of the LEDs of the second plurality of LEDs on the PCB across the centerline of the sensor.

In some configurations, the first plurality of LEDs may include: a first LED configured to emit light at a first wavelength, a second LED configured to emit light at a second wavelength, a third LED configured to emit light at a third wavelength, a fourth LED configured to emit light at a fourth wavelength, and a fifth LED configured to emit light at a fifth wavelength, and the second plurality of LEDs may include: a sixth LED configured to emit light at a first wavelength, a seventh LED configured to emit light at a second wavelength, an eighth LED configured to emit light at a third wavelength, a ninth LED configured to emit light at a fourth wavelength, and a tenth LED configured to emit light at a fifth wavelength.

In some configurations, the first LED may be located on the PCB at a position that mirrors the position of the sixth LED on the PCB across the centerline of the sensor; the second LED may be located on the PCB at a position that mirrors the position of the seventh LED on the PCB across the centerline of the sensor; the third LED may be located on the PCB at a position that mirrors the position of the eighth LED on the PCB across the centerline of the sensor; the fourth LED may be located on the PCB at a position that mirrors the position of the ninth LED on the PCB across the centerline of the sensor; the fifth LED may be located on the PCB at a position that mirrors the position of the tenth LED on the PCB across the centerline of the sensor; and a centerline of the sensor may bisect at least one detector of the plurality of detectors.

In some configurations, a centerline of the sensor may bisect two detectors of the plurality of detectors, and each of the two detectors may be configured to generate one or more signals for normalizing the physiological parameter measurement of the sensor in response to detecting light emitted from the first and second plurality of emitters.

In some configurations, the first and sixth LEDs may each be located at the same distance from at least one detector of the plurality of detectors; the second and seventh LEDs may each be located at the same distance from at least one of the plurality of detectors; the third and eighth LEDs may each be located at the same distance from at least one of the plurality of detectors; the fourth and ninth LEDs may each be located at the same distance from at least one of the plurality of detectors; and the fifth and tenth LEDs may each be located at the same distance from at least one of the plurality of detectors.

In some configurations, the plurality of detectors may include: a first detector set comprising at least two detectors; a second detector set comprising at least two detectors, and a first emitter set may be proximate to the first detector set and remote from the second detector set, and a second emitter set may be proximate to the second detector set and remote from the first detector set.

In some configurations, the first emitter group and the second emitter group may be located at a central location of the PCB of the sensor.

In some configurations, the plurality of detectors may extend around the circumference of the PCB of the sensor.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face tissue of the wearer when the watch is worn by the wearer. The optical physiological sensor may be configured to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a Printed Circuit Board (PCB); a first emitter group comprising a first plurality of Light Emitting Diodes (LEDs) at a first location on the PCB; a second emitter group comprising a second plurality of LEDs on the PCB at a second location different from the first location, wherein the second emitter group comprises the same number and type of LEDs as the first emitter group; one or more first light barriers separating the first emitter group from the second emitter group; a light diffusing material configured to diffuse light emitted by each of the first and second plurality of LEDs; a plurality of detectors including six or more photodiodes on the PCB; one or more second light blockers separating each of the plurality of detectors from each of the other of the plurality of detectors; and a convex surface configured to be positioned between (i) the first and second emitter sets and six or more photodiodes and (ii) tissue of a wearer, the convex surface comprising one or more surface materials.

In some configurations, the first set of emitters may define a first set of emitters, each emitter of the first set of emitters being located less than 1.0mm from each other emitter of the other emitters of the first set of emitters on the PCB, and wherein the second set of emitters may define a second set of emitters, each emitter of the second set of emitters being located less than 1.0mm from each other emitter of the other emitters of the second set of emitters on the PCB.

In some configurations, the plurality of detectors may include: a first detector set that may include at least two detectors, wherein each of the at least two detectors may be proximate to the first emitter set; a second detector set may include at least two detectors, wherein each of the at least two detectors may be remote from the first emitter set.

In some configurations, at least two detectors of the plurality of detectors may each independently include an intermediate detector for the first emitter group and the second emitter group.

In some configurations, the PCB may include a conductive liquid adhesive.

In some configurations, the PCB may include a reflective surface.

In some configurations, the first plurality of LEDs may be configured to emit light at least four wavelengths, and wherein the second plurality of LEDs may be configured to emit light at least four wavelengths.

In some configurations, the first plurality of LEDs may include: a first LED that may be configured to emit light of a first wavelength; a second LED that may be configured to emit light at a second wavelength; a third LED that may be configured to emit light at a third wavelength; and a fourth LED that may be configured to emit light at a fourth wavelength, and the second plurality of LEDs may include: a fifth LED that may be configured to emit light of a first wavelength, a sixth LED that may be configured to emit light of a second wavelength; a seventh LED that may be configured to emit light of a third wavelength; and an eighth LED that may be configured to emit light of a fourth wavelength.

In some configurations, the sensor may include a sensor processor configured to drive the first plurality of LEDs and the second plurality of LEDs at different intensities.

In some configurations, the sensor processor may be configured to drive intensities of the first and second pluralities of LEDs based at least in part on one or more of an attenuation of the emitted light or temperatures of the first and second pluralities of LEDs.

In some configurations, the sensor may include a sensor processor configured to activate or deactivate some of the plurality of detectors.

In some configurations, the sensor may include an ECG sensor, and the ECG sensor may include a reference electrode, a negative electrode, and a positive electrode, and the reference electrode and the negative electrode may be located on the sensor, and a portion of the housing of the watch may form the positive electrode.

In some configurations, the reference electrode and the negative electrode may be releasably coupled to the PCB of the sensor.

The present disclosure provides a system for monitoring a physiological parameter. The system may include a wearable device that may include one or more physiological sensors configured to monitor one or more physiological parameters of a user. The system may include a computing device external to and in wireless communication with the wearable device. The computing device may be configured to: receiving user input via an interactive user interface; in response to receiving the user input, wirelessly transmitting a first signal to the wearable device to instruct the wearable device to perform a physiological monitoring operation; receive physiological parameter data measured by a physiological monitoring operation from a wearable device; and causing presentation of physiological parameter data in the interactive user interface.

In some configurations, the monitoring operation may include continuous measurement of the physiological parameter.

In some configurations, the monitoring operation may include: measuring a physiological parameter over a predetermined length of time; and stopping measuring the physiological parameter when the predetermined length of time expires.

In some configurations, the wearable device may be configured to: in response to receiving the first signal from the computing device, determining a charge level of a battery of the wearable device; determining whether the charge level is sufficient to perform a monitoring operation; and in response to determining that the charge level is sufficient, performing a monitoring operation.

In some configurations, the wearable device may be configured to: in response to receiving the first signal from the computing device, determining a charge level of a battery of the wearable device; determining whether the charge level is sufficient to perform a monitoring operation; responsive to determining that the charge level is insufficient, determining a modified monitoring operation based at least in part on the charge level; and performs a modified monitoring operation.

In some configurations, the computing device may be further configured to: one or more of graphs, charts, or trends of historical and substantially real-time physiological parameter data are presented in an interactive user interface.

In some configurations, the wearable device may be configured to: determining that one or more physiological parameters exceed respective predetermined thresholds; and in response to determining that the one or more physiological parameters exceeds the respective predetermined thresholds, sending a second signal to the computing device to cause the computing device to generate an alert.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a first emitter group comprising a first plurality of Light Emitting Diodes (LEDs) at a first location; a second emitter group comprising a second plurality of LEDs at a second location different from the first location, wherein the second emitter group may comprise the same number and type of LEDs as the first emitter group; one or more light barriers separating the first emitter group from the second emitter group; 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 a convex surface configured to be positioned between (i) the first and second emitter sets and the four or more photodiodes and (ii) tissue of the wearer, the convex surface comprising one or more surface materials.

In some configurations, the one or more surface materials may include one or more light barriers and at least a portion of a light transmissive material.

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

In some configurations, the first emitter group or the second emitter group may define an immediately positioned emitter group.

In some configurations, the plurality of detectors may be both near and far detectors of each emitter group individually.

In some configurations, the first emitter group and the second emitter group may be located at non-central locations of a Printed Circuit Board (PCB) of the sensor.

In some configurations, one or more light barriers may extend from a surface of the sensor that positions the first plurality of LEDs and the second plurality of LEDs toward tissue of the wearer when the watch is worn.

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

In some configurations, the light diffusing material surrounding the first emitter group may be different than the light diffusing material surrounding the second emitter group.

In some configurations, at least some of the plurality of detectors may extend around the circumference of the sensor.

In some configurations, multiple detectors may be positioned in a grid pattern and/or relative to each other.

In some configurations, the position of the emitter group may be staggered with respect to the plurality of detectors.

In some configurations, at least one detector of the plurality of detectors may be located between the first plurality of LEDs and the second plurality of LEDs, and at least one detector of the plurality of detectors may be located on each of at least two sides of each of the first plurality of LEDs and the second plurality of LEDs.

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

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of emitters configured to emit light of 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 user when the wristwatch is worn on a wrist of a wearer, and output signals to the sensor processor to determine a physiological parameter of the wearer; and a sensor housing, the plurality of emitters and the plurality of detectors enclosed within the housing, wherein the sensor housing may comprise: a convex skin-facing light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being located on a first side of the sensor housing and a Printed Circuit Board (PCB) being located on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being located on a skin-facing side of the PCB; and a plurality of light blocking layers extending from the PCB to the cover, the plurality of light blocking layers configured to form walls of the chambers 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, wherein at least one of the skin facing surface of the cover and the light blocking layers may define a skin facing surface of the sensor, a surface area of the cover extending over the chamber enclosing the one or more detectors being at least 50% of a surface area of the skin facing surface of the sensor.

In some configurations, the surface area of the cover extending over the chamber enclosing the one or more detectors may be at least 100mm ².

In some configurations, the surface area of the cover extending over the chamber enclosing the one or more detectors may be at least 150mm ².

In some configurations, the surface area of the cover extending over the chamber enclosing the one or more detectors may be at least 165mm ².

In some configurations, the surface area of the light-transmissive cover extending over the chamber enclosing the one or more emitters may be at least 25mm ².

In some configurations, the surface area of the light-transmissive cover extending over the chamber enclosing the one or more detectors may be at least 35mm ².

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

In some configurations, more of the plurality of detectors may be positioned along the longer side than along the shorter side.

In some configurations, the plurality of emitters may include a first set of emitters and a second set of emitters, the chamber including a first emitter chamber enclosing the first set and a second emitter chamber enclosing the second set.

In some configurations, the plurality of detectors may include a first ring of detectors surrounding the first set of emitters and a second ring of detectors surrounding the second set of emitters.

In some configurations, at least one detector of the plurality of detectors may be located between the first set of emitters and the second set of emitters and may be shared by a first ring of detectors and a second ring of detectors.

In some configurations, some of the plurality of detectors may be closer to the first set of emitters than the remainder of the plurality of detectors, and some of the plurality of detectors may be closer to the second set of emitters than the remainder of the plurality of detectors.

In some configurations, the plurality of light blocking layers may extend to the skin-facing surface of the cover.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of emitters configured to emit light of 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 user when the wristwatch is worn on a wrist of a wearer, and output signals to the sensor processor to determine a physiological parameter of the wearer; and a sensor housing, the plurality of emitters and the plurality of detectors enclosed within the housing, wherein the sensor housing may comprise: a convex skin-facing light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being located on a first side of the sensor housing and a Printed Circuit Board (PCB) being located on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being located on a skin-facing side of the PCB; and a plurality of light blocking layers extending from the PCB to the cover, the plurality of light blocking layers configured to form walls of the chambers 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, wherein at least one light blocking layer of the plurality of light blocking layers may extend to a skin facing surface of the cover.

In some configurations, all of the plurality of light blocking layers may extend to the skin-facing surface of the cap.

In some configurations, at least one of the skin-facing surface of the cover and the light blocking layer may define a skin-facing surface of the sensor.

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

In some configurations, the cover may be a single lens or cover.

In some configurations, the cover may include individual lenses, each lens or cover covering a single chamber.

In some configurations, the cover may include a lens or cover that covers all of the chambers extending over the one or more detectors.

In some configurations, a lens or cover covering all of the chambers extending over one or more detectors may not cover the chambers extending over one or more emitters.

In some configurations, the plurality of light blocking layers may include colored sapphire glass.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a first emitter comprising a first plurality of Light Emitting Diodes (LEDs) positioned on a surface of a substrate; a first photodiode positioned on a surface of the substrate; a curved surface extending over all of the first plurality of LEDs and the first photodiode; and a first light blocking layer positioned between the first emitter and the first photodiode and extending from the surface of the substrate to the curved surface.

In some configurations, the first light blocking layer may include one or more portions that together extend from the surface of the substrate to the curved surface.

In some configurations, the sensor may further comprise: a second emitter comprising a second plurality of LEDs positioned on a surface of the substrate; a second photodiode positioned on a surface of the substrate; a second light blocking layer positioned between (i) both the first and second emitters and (ii) the second photodiode and extending from the surface of the substrate to a curved surface, wherein the curved surface may extend over all of the second plurality of LEDs and the second photodiode.

In some configurations, the second light blocking layer may include one or more portions that together extend from the surface of the substrate to the curved surface.

In some configurations, the portion of the curved surface positioned over the first and second emitters may comprise at least a first material, the portion of the curved surface positioned over the first and second photodiodes may comprise at least a second material, and the portion of the first and second barrier layers extending to the curved surface may comprise at least a third material different from the first and second materials.

In some configurations, at least the first, second, and third materials may together comprise a curved surface.

In some configurations, the first material and the second material may comprise the same material.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of Light Emitting Diodes (LEDs) configured to emit light toward tissue of a wearer; a wall separating the plurality of LEDs into at least a first group of LEDs and a second group of LEDs, the wall blocking at least some light emitted by 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 tissue attenuation; 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 the convex surface configured to contact tissue.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of emitters configured to emit light of 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 user when the wristwatch is worn on a wrist of a wearer, and output signals to the sensor processor to determine a physiological parameter of the wearer; and a sensor housing, the plurality of emitters and the plurality of detectors enclosed within the housing, wherein the sensor housing may comprise: a convex skin-facing light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being located on a first side of the sensor housing and a Printed Circuit Board (PCB) being located on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being located on a skin-facing side of the PCB; and a plurality of light blocking layers extending from the PCB to the cover, the plurality of light blocking layers configured to form walls of the chambers 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, wherein the plurality of detectors may include a plurality of far detectors that are farther from at least some of the plurality of emitters than a remaining portion of the plurality of detectors.

In some configurations, at least one detector of the plurality of detectors may be located between the first set of emitters and the second set of emitters and shared by a first ring of detectors and a second ring of detectors.

In some configurations, some of the plurality of detectors may be closer to the first set of emitters than the remainder of the plurality of detectors and some of the plurality of detectors may be closer to the second set of emitters than the remainder of the plurality of detectors.

In some configurations, the sensor may further comprise a sensor processor, wherein the sensor processor is configured to determine the hydration state of the user based on signals from the plurality of remote detectors.

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 remainder of the different wavelengths.

In some configurations, the wavelength that is more sensitive to water may be about 970nm.

In some configurations, the sensor processor may be configured to compare signals of reflected light from the plurality of remote detectors at a wavelength that is more sensitive to water and at another wavelength that is less sensitive to water.

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

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of emitters configured to emit light of a plurality of different wavelengths, wherein at least one of the emitters may be configured to emit light of a reference wavelength; a plurality of detectors configured to detect light emitted by the plurality of emitters and attenuated by tissue of the user when the wristwatch is worn on a wrist of a wearer; a sensor processor, wherein the plurality of detectors may be configured to output signals to the sensor processor to determine at least some of the physiological parameters of the wearer based in part on the signals of the reflected light of the reference wavelength; and a sensor housing, the plurality of emitters and the plurality of detectors enclosed within the housing, wherein the sensor housing may comprise: a convex skin-facing light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being located on a first side of the sensor housing and a Printed Circuit Board (PCB) being located on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being located on a skin-facing side of the PCB; and a plurality of light blocking layers extending from the printed circuit board to the cover, the plurality of light blocking layers configured to form walls of the chambers to block light or substantially all light between the chambers, each chamber enclosing one or more emitters without detectors or one or more detectors without emitters.

In some configurations, the reference wavelength may be about 525nm.

In some configurations, the reference wavelength of light may be green or yellow.

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

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.

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

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

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

In some configurations, the one or more physiological parameters may include pulse rate, respiration rate, spO ₂, PVI, PI, RRP, hydration, or a combination thereof.

In some configurations, the sensor may further include a thermistor positioned proximate the plurality of emitters.

In some configurations, the sensor may further include an accelerometer and/or a gyroscope.

Example optical physiological sensors of the present disclosure may be integrated into watches configured to monitor the health of a wearer. The optical physiological sensor may be configured to face a wearer's tissue when the wristwatch is worn by the wearer and to measure a physiological parameter of the wearer using information from the optical physiological sensor. The optical physiological sensor may include: a plurality of emitters configured to emit light of 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 user when the wristwatch is worn on a wrist of a wearer, and output signals to the sensor processor to determine a physiological parameter of the wearer; and a sensor housing, the plurality of emitters and the plurality of detectors enclosed within the housing, wherein the sensor housing may comprise: a convex skin-facing light-transmitting cover extending over the plurality of emitters and the plurality of detectors, the cover being located on a first side of the sensor housing and a Printed Circuit Board (PCB) being located on a second side of the sensor housing opposite the first side, the plurality of emitters and detectors being located on a skin-facing side of the PCB; a plurality of light blocking layers extending from the PCB to the cover, the plurality of light blocking layers configured to form walls of the chambers 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, wherein each chamber enclosing one or more emitters may be filled with a diffusing material such that there is no air gap between the plurality of emitters and the cover.

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

In some configurations, the cover may include glass microspheres.

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

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

In some configurations, the sensor housing may include one or more exhaust openings configured to receive air expelled from the chamber by the flow of light diffusing solution.

In some configurations, each chamber enclosing one or more detectors may be filled with a diffusing material such that there is no air gap between the plurality of detectors and the cover.

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

Example watches of the present disclosure may be configured to monitor physiological parameters of a wearer. The wristwatch may include: any of the optical sensors or physiological parameter measurement sensor configurations 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 the plurality of physiological parameters monitored by the sensor.

In some configurations, the display may be configured to display the SpO ₂ and pulse rate of the wearer monitored by the sensor.

In some configurations, the sensor may be configured to continuously monitor the SpO ₂ and pulse rate of the wearer.

In some configurations, the display may be configured to continuously display the SpO ₂ and pulse rate of the wearer.

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

In some configurations, the ECG sensor can include a reference electrode, a negative electrode, and a positive electrode.

In some configurations, the reference electrode and the negative electrode may be located on the sensor.

In some configurations, a portion of the case of the watch may form a positive electrode.

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

In some configurations, the watch may further include a wireless transmitter such that the watch is configured to wirelessly connect to an external device and/or an external sensor.

In some configurations, the wireless transmitter may be a bluetooth chip.

In some configurations, the external device and/or external sensor may include a bedside monitor, a mobile communication device, a tablet computer, a nurses' station system, or a different medical device.

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

The wearable health monitoring device may be 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 may include: a first emitter group comprising a first plurality of Light Emitting Diodes (LEDs) configured to emit light at one or more wavelengths, wherein the first emitter group may be arranged at a first location spaced apart from an axis extending through a center of the wearable health monitoring device; a second emitter group comprising a second plurality of LEDs configured to emit light at one or more wavelengths, wherein the second emitter group may be arranged at a second location spaced apart from the first location and spaced apart from an axis passing through a center of the wearable health monitoring device; one or more light barriers separating the first emitter group from the second emitter group; a first light diffusing material configured to be positioned between the first emitter group and tissue of the user when the wearable health monitoring device is in use, wherein the first light diffusing material may be configured to spread light emitted from one or more LEDs of the first plurality of LEDs before the emitted light reaches the tissue; a second light diffusing material configured to be positioned between the second emitter group and tissue of the user when the wearable health monitoring device is in use, wherein the second light diffusing material may be configured to spread light emitted from one or more LEDs of the second plurality of LEDs before the emitted light reaches the tissue; 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 user tissue, 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 the one or more signals in response to the one or more signals output by the plurality of photodiodes, and further configured to determine a physiological parameter of the user based on the received and processed one or more signals.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a substrate having an optical center; a first emitter group Light Emitting Diode (LED) positioned adjacent to and spaced apart from the optical center of the substrate by an offset; a second emitter group LED positioned adjacent the optical center of the substrate at an offset from the optical center and spaced from the optical center opposite the first emitter group LED relative to the optical center at an offset; and a plurality of detectors arranged in a spatial configuration around the first emitter group and the second emitter group. Each detector of the plurality of detectors may be positioned on the substrate at the same distance from the optical center of the substrate.

In some configurations, the spatial configuration includes a ring.

In some configurations, the ring has the same optical center as the substrate.

In some configurations, the annulus is concentric with the perimeter of the sensor.

In some configurations, the annulus includes a radius between about 6.2mm and about 6.6 mm.

In some configurations, the annulus includes a radius between about 6.15mm and about 6.45 mm.

In some configurations, the sensor includes a radius between about 15.0mm and about 15.5 mm.

In some configurations, the ratio of the radius of the annulus to the radius of the sensor is between about 40% and about 45%.

In some configurations, the second emitter group is spaced less than 1.5mm from the first emitter group.

In some configurations, the second emitter group is spaced apart from the first emitter group by about 1.28mm.

In some configurations, the second emitter group is spaced apart from the first emitter group by about 1.2mm.

In some configurations, the sensor may further include a light blocking layer construction mounted on the substrate and configured to isolate the first emitter group, the second emitter group, and the plurality of detectors.

In some configurations, the light blocking layer construction is a single integrated unit comprising a plurality of light blocking layers defining one or more chambers.

In some configurations, the light blocking layer construction includes a plurality of light blocking layers configured to isolate the first emitter group and the second emitter group from each of the plurality of detectors.

In some configurations, the light blocking layer construction includes a light blocking layer configured to isolate the first emitter group from the second emitter group.

In some configurations, the light blocking layer includes a width between about 1.25mm and about 1.35mm separating the first emitter group from the second emitter group.

In some configurations, the light blocking layer includes a width between about 1.1mm and about 1.3mm separating the first emitter group from the second emitter group.

In some configurations, the light blocking layer includes a width that is less than a distance from an emitter chamber defined by the light blocking layer construction and housing the first emitter group to a detector chamber defined by the light blocking layer construction and housing a detector bisected by a centerline of the sensor.

In some configurations, the light blocking layer configuration includes a height of between about 2.80mm and about 2.90mm extending away from an optical center of the substrate.

In some configurations, the light blocking layer configuration includes a height of between about 2.55mm and about 2.65mm extending away from an optical center of the substrate.

In some configurations, the light blocking layer construction includes a height of between about 1.25mm and about 1.35mm extending away from the perimeter of the substrate.

In some configurations, the light blocking layer construction includes a height of between about 1.75mm and about 1.85mm extending away from the perimeter of the substrate.

In some configurations, the ratio of the maximum height of the light blocking layer configuration extending away from the substrate to the minimum height of the light blocking layer configuration extending away from the substrate is between about 215% and about 225%.

In some configurations, the ratio of the maximum height of the light blocking layer configuration extending away from the substrate to the minimum height of the light blocking layer configuration extending away from the substrate is between about 145% and about 155%.

In some configurations, the light blocking layer configuration includes a maximum height extending away from the substrate at an optical center of the substrate.

In some configurations, the light blocking layer defines a plurality of chambers including at least a detector chamber housing a detector bisected by a centerline of the sensor; a first emitter chamber housing a first emitter group; and a second emitter chamber housing a second emitter group.

In some configurations, the distance extending from the first emitter chamber to the detector chamber along a length parallel to the centerline of the sensor is the same as the distance extending from the second emitter chamber to the detector chamber along a length parallel to the centerline of the sensor.

In some configurations, the distance extending from the first emitter chamber to the detector chamber along a length parallel to the centerline of the sensor is less than half the width of the first emitter chamber along a length parallel to the centerline of the sensor.

In some configurations, the distance extending from the first emitter chamber to the detector chamber along a length parallel to the centerline of the sensor is greater than half the width of the first emitter chamber along a length parallel to the centerline of the sensor.

In some configurations, the first emitter group comprises two or more LEDs, and wherein the second emitter group comprises two or more LEDs.

In some configurations, the first emitter group comprises three or more LEDs, and wherein the second emitter group comprises three or more LEDs.

In some configurations, the first emitter group comprises four or more LEDs, and wherein the second emitter group comprises four or more LEDs.

In some configurations, the first emitter group comprises five LEDs, and wherein the second emitter group comprises five LEDs.

In some configurations, each LED in the first emitter group emits light of a different wavelength than each of the other LEDs in the first emitter group.

In some configurations, each LED in the second emitter group emits light of a different wavelength than each of the other LEDs in the second emitter group.

In some configurations, the first emitter group is configured to emit the same plurality of light wavelengths as the second emitter group.

In some configurations, the arrangement of the LEDs of the first emitter group on the substrate mirrors the arrangement of the LEDs of the second emitter group on the substrate across a centerline of the sensor bisecting the sensor.

In some configurations, the optical center of the substrate is located on the centerline of the sensor.

In some configurations, a centerline of the sensor bisects at least one detector of the plurality of detectors.

In some configurations, a distance from the first emitter group to at least one detector of the plurality of detectors is substantially similar to a distance from the second emitter group to at least one detector of the plurality of detectors.

In some configurations, the sensor further comprises an ECG sensor, and the ECG sensor comprises a reference electrode, a negative electrode, and a positive electrode, and the reference electrode and the negative electrode are located on the sensor and the positive electrode is located on a housing of the wearable device.

In some configurations, the reference electrode and the negative electrode are releasably coupled to the substrate of the sensor via one or more springs configured to bias the reference electrode and the negative electrode away from the substrate.

In some configurations, the reference electrode extends along the circumference of the sensor on a first side of the sensor, and wherein the negative electrode extends along the circumference of the sensor on a second side of the sensor.

In some configurations, the reference electrode is substantially semi-annular, and wherein the negative electrode is substantially semi-annular.

In some configurations, the reference electrode and the negative electrode surround the plurality of detectors.

In some configurations, the substrate includes a conductive liquid adhesive configured to facilitate a conductive electrical connection between the electrodes of the ECG sensor and the substrate.

In some configurations, the substrate includes a Printed Circuit Board (PCB).

In some configurations, the substrate includes a reflective surface.

In some configurations, the sensor further includes a first temperature sensor positioned on the substrate adjacent the first emitter group LED and a second temperature sensor adjacent the second emitter group LED.

In some configurations, the first emitter group LEDs are configured to emit light of at least four wavelengths, and wherein the second emitter group LEDs are configured to emit light of at least four wavelengths.

In some configurations, the four wavelengths emitted by the first emitter group LEDs are the same as the four wavelengths emitted by the second emitter group LEDs.

In some configurations, the first emitter group LEDs comprise the same type of LEDs as the second emitter group LEDs.

In some configurations, the first emitter group LEDs comprise: a first LED configured to emit light of a first wavelength; a second LED configured to emit light of a second wavelength; a third LED configured to emit light at a third wavelength; and a fourth LED configured to emit light of a fourth wavelength, and the second emitter group LED comprises: a fifth LED configured to emit light of a first wavelength; a sixth LED configured to emit light of a second wavelength; a seventh LED configured to emit light of a third wavelength; and an eighth LED configured to emit light of a fourth wavelength.

In some configurations, the first LED is located on the PCB at a position that mirrors the position of the fifth LED on the PCB across the centerline of the sensor; the second LED is located on the PCB at a position that mirrors the position of the sixth LED on the PCB across the centerline of the sensor; the third LED is located on the PCB at a position that mirrors the position of the seventh LED on the PCB across the centerline of the sensor; and the fourth LED is located on the PCB at a position that mirrors the position of the eighth LED on the PCB across the centerline of the sensor.

In some configurations, the first and fifth LEDs are each located at the same distance from at least one detector of the plurality of detectors; the second and sixth LEDs are each located at the same distance from at least one of the plurality of detectors; the third and seventh LEDs are each located at the same distance from at least one of the plurality of detectors; and the fourth and eighth LEDs are each located at the same distance from at least one of the plurality of detectors.

In some configurations, light emitted from the first emitter group LED travels to a first detector of the plurality of detectors along an optical path that is substantially similar in length to an optical path along which light emitted from the second emitter group LED travels to the first detector.

In some configurations, the plurality of detectors includes a first detector set and a second detector set.

In some configurations, the first detector set includes at least two detectors housed in respective detector chambers, and wherein the second detector set includes at least two detectors housed in respective detector chambers.

In some configurations, the distance between the first emitter group and the first detector group is greater than the distance between the second emitter group and the first detector group.

In some configurations, the distance between the first emitter group and the first detector of the first detector group is substantially similar to the distance between the first emitter group and the second detector of the first detector group.

In some configurations, the distance between the first emitter set and the first detector set is substantially similar to the distance between the second emitter set and the second detector set.

In some configurations, light emitted from the first emitter group travels to the first detector group along a shorter optical path than light emitted from the second emitter group travels to the first detector group.

In some configurations, light emitted from the second emitter set and detected by the first detector set penetrates deeper into the tissue of the wearer than light emitted from the first emitter set and detected by the first detector set.

In some configurations, the sensor further includes a light blocking layer construction mounted on the substrate and configured to isolate the first emitter group, the second emitter group, and the plurality of detectors, wherein the light blocking layer construction includes a plurality of light blocking layers defining one or more chambers.

In some configurations, the one or more chambers include a first emitter chamber configured to house a first emitter group Light Emitting Diode (LED).

In some configurations, the one or more chambers include a second Light Emitting Diode (LED) emitter chamber configured to house a second LED emitter group.

In some configurations, the one or more chambers include a plurality of detector chambers configured to house a plurality of detectors.

In some configurations, the light blocking layer construction is further configured to prevent light from transmitting therethrough.

In some configurations, the sensor further includes a convex surface configured to be positioned between the tissue of the wearer and the emitter and detector chambers, the convex surface including at least a portion of the light blocking layer construction.

In some configurations, the convex surface further comprises one or more lenses defining surfaces of the emitter chamber and the detector chamber, wherein the one or more lenses are further configured to transmit light.

In some configurations, the one or more lenses comprise polycarbonate and are configured to diffuse light.

In some configurations, the emitter and detector chambers enclose a light diffusing material or encapsulant.

In some configurations, the light diffusing material or encapsulant comprises glass beads or microspheres.

In some configurations, the height of the convex surface from the optical center of the substrate is between about 2.80mm and about 2.90 mm.

In some configurations, the height of the convex surface from the optical center of the substrate is between about 2.55mm and about 2.65 mm.

In some configurations, a centerline of the sensor bisects a first detector of the plurality of detectors, and wherein the first detector is configured to generate one or more signals for calibrating or normalizing the physiological parameter measurement of the sensor in response to detecting light emitted from the first emitter group and the second emitter group.

In some configurations, the sensor processor is further configured to calibrate or normalize the physiological parameter measurement of the sensor based at least in part on comparing a first signal generated by the first detector in response to light emitted from the first emitter group with a second signal generated by the first detector in response to light emitted from the second emitter group.

In some configurations, the sensor further includes a sensor processor configured to drive the LEDs of the first emitter group and the second emitter group at different intensities.

In some configurations, the sensor processor is configured to drive the intensities of the LEDs of the first and second emitter groups based at least in part on one or more of an attenuation of the emitted light or a temperature of the LEDs of the first and second emitter groups.

In some configurations, the sensor further comprises a sensor processor configured to activate or deactivate some of the plurality of detectors.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a first emitter group Light Emitting Diode (LED) mounted on the substrate; a second emitter group LED mounted on the substrate and spaced apart from the first emitter group LED, wherein the first emitter group is isolated from the second emitter group; and at least six detectors mounted on the substrate and arranged in a spatial configuration surrounding the first emitter group and the second emitter group and isolated from each other, from the first emitter group and the second emitter group.

In some configurations, the spatial configuration includes a ring.

In some configurations, the ring has the same geometric center as the substrate or sensor.

In some configurations, the first emitter group and the second emitter group are located at a central location of the substrate.

In some configurations, the first emitter group and the second emitter group are positioned adjacent a geometric center of the substrate or a geometric center of the sensor.

In some configurations, the sensor further includes a light blocking layer construction mounted on the substrate and configured to isolate the first emitter group, the second emitter group, and the at least six detectors.

In some configurations, the sensor further comprises an ECG sensor comprising a reference electrode, a negative electrode, and a positive electrode, and the reference electrode and the negative electrode are located on the sensor and the positive electrode is located on the housing of the wearable device.

In some configurations, the reference electrode is substantially semi-annular and the negative electrode is substantially semi-annular.

In some configurations, the substrate includes a Printed Circuit Board (PCB).

In some configurations, the substrate includes a reflective surface.

In some configurations, a centerline of the sensor bisects a first detector of the plurality of detectors, and the first detector is configured to generate one or more signals for calibrating or normalizing the physiological parameter measurement of the sensor in response to detecting light emitted from the first emitter group and the second emitter group.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a first emitter group Light Emitting Diode (LED) mounted on the substrate; a second emitter group LED mounted on the substrate and spaced apart from the first emitter group LED; and a plurality of detectors mounted on the substrate and arranged in an annular configuration surrounding the first emitter group and the second emitter group, the detectors may be substantially rectangular with a length of the first side and a width of the second side, wherein the detectors are oriented on the substrate such that the first side of each detector with the length is substantially orthogonal to a radius of the annular configuration.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a first emitter group Light Emitting Diode (LED) mounted on the substrate; a second emitter group of LEDs mounted on the substrate and spaced apart from the first emitter group of LEDs, wherein the LEDs of the first emitter group are arranged on the substrate to mirror the arrangement of the LEDs of the second emitter group on the substrate across the centerline of the sensor; and a plurality of detectors mounted on the substrate and arranged in a spatial configuration surrounding the first emitter group and the second emitter group.

In some configurations, the four wavelengths emitted by the first emitter group LEDs are the same wavelengths as the four wavelengths emitted by the second emitter group LEDs.

In some configurations, the first emitter group LED includes a first LED configured to emit light at a first wavelength; a second LED configured to emit light of a second wavelength; a third LED configured to emit light at a third wavelength; and a fourth LED configured to emit light of a fourth wavelength, and the second emitter group LED comprises: a fifth LED configured to emit light of a first wavelength; a sixth LED configured to emit light of a second wavelength; a seventh LED configured to emit light of a third wavelength; an eighth LED configured to emit light of a fourth wavelength.

In some configurations, the first LED is located on the PCB at a position that mirrors the position of the fifth LED on the PCB across the centerline of the sensor; and the second LED is located on the PCB at a position that mirrors the position of the sixth LED on the PCB across the centerline of the sensor; the third LED is located on the PCB at a position that mirrors the position of the seventh LED on the PCB across the centerline of the sensor; and the fourth LED is located on the PCB at a position that mirrors the position of the eighth LED on the PCB across the centerline of the sensor.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a first emitter group Light Emitting Diode (LED) mounted on the substrate; a second emitter group LED mounted on the substrate and spaced apart from the first emitter group LED, wherein the second emitter group is isolated from the first emitter group; and a plurality of detectors mounted on the substrate, wherein the plurality of detectors are arranged in a spatial configuration surrounding the first emitter group and the second emitter group and isolated from each other, wherein the plurality of detectors includes a first detector group and a second detector group, and the first emitter group may be proximate to the first detector group and remote from the second detector group, and the second emitter group may be proximate to the second detector group and remote from the first detector group.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a first emitter group light emitting diode and a second emitter group light emitting diode mounted on the substrate; a first emitter chamber housing a first emitter group Light Emitting Diode (LED); a second emitter chamber housing a second emitter group LED, wherein the first emitter group is isolated from the second emitter group; a plurality of detector chambers accommodating detectors mounted on the substrate and arranged in a spatial configuration surrounding the first and second emitter chambers; a light blocking layer construction mounted on the substrate and comprising one or more light blocking layers configured to prevent light from transmitting therethrough, wherein the light blocking layer of the light blocking layer construction isolates the emitter chamber and the detector chamber; and a convex surface configured to be positioned between the tissue of the wearer and the emitter and detector chambers, the convex surface comprising at least a portion of the light blocking layer construction.

In some configurations, the height of the convex surface from the center of the substrate is between about 2.80mm and about 2.90 mm.

In some configurations, the height of the convex surface from the center of the substrate is between about 2.55mm and about 2.65 mm.

In some configurations, a centerline of the sensor bisects a first detector of the detectors, and wherein the first detector is configured to generate one or more signals for calibrating or normalizing physiological parameter measurements of the sensor in response to detecting light emitted from the first emitter group and the second emitter group.

The present disclosure provides an optical physiological sensor integrated into a wearable device. The optical physiological sensor may include: a circuit layer; a light blocking layer construction positioned adjacent to the circuit layer, the light blocking layer construction including a plurality of openings defining at least a first emitter chamber, a second emitter chamber, and a plurality of detector chambers. The first emitter chamber and the second emitter chamber may be spaced apart from each other and inwardly spaced apart from and surrounded by the plurality of detector chambers; and the first emitter chamber, the second emitter chamber, and the plurality of detector chambers may be isolated from one another by portions of the light blocking layer construction. In some configurations, the sensor comprises: a first plurality of emitters mounted on the circuit layer and positioned within a first emitter chamber of the light blocking layer construction; a second plurality of emitters mounted on the circuit layer and positioned within a second emitter chamber of the light blocking layer construction; and a plurality of detectors, each detector of the plurality of detectors mounted on the circuit layer and positioned within a different one of the plurality of detector cells of the light blocking layer construction. In some configurations, each detector chamber of the plurality of detector chambers includes only one detector.

In some configurations, the sensor further comprises a first Electrocardiogram (ECG) electrode and a second ECG electrode, and wherein the first ECG electrode and the second ECG electrode partially surround the first plurality of emitters, the second plurality of emitters, and the plurality of detectors.

In some configurations, each of the first ECG electrode and the second ECG electrode comprises a semi-annular shape having a first end and a second end; and the first ends of the first and second ECG electrodes are separated from each other by a first gap and the second ends of the first and second ECG electrodes are separated from each other by a second gap.

In some configurations, the light blocking layer construction further comprises: a first recess sized and shaped to receive a first ECG electrode; and a second recess sized and shaped to receive a second ECG electrode; each of the first and second recesses includes a semi-annular shape having a first end and a second end; the first ends of the first and second recesses are separated from each other by the first gap, and the second ends of the first and second recesses are separated from each other by the second gap; and the first recess and the second recess partially surround the first emitter chamber, the second emitter chamber, and the plurality of detector chambers.

In some configurations, the plurality of detector chambers are spaced inwardly from the first recess and the second recess.

In some configurations, the sensor does not include any transmitters positioned outward from the first ECG electrode and the second ECG electrode.

In some configurations, the sensor does not include any detectors positioned outward from the first ECG electrode and the second ECG electrode.

In some configurations, the first gap and the second gap are substantially equal.

In some configurations, the first and second ends of the first and second ECG electrodes comprise a circular shape.

In some configurations, each of the first gap and the second gap is between about 1.5mm and about 1.75 mm.

In some configurations, each of the first gap and the second gap is between about 0.5mm and about 0.75 mm.

In some configurations, the sensor does not include any emitters positioned within any one of the plurality of detector cells.

In some configurations, the sensor does not include any detector positioned within any one of the first emitter chamber and the second emitter chamber.

In some configurations, a plurality of detector cells are arranged in a circular configuration around the first and second emitter cells.

In some configurations, the sensor does not include any transmitters other than the first plurality of transmitters and the second plurality of transmitters.

In some configurations, the sensor does not include any detector other than a plurality of detectors.

In some configurations, the circuit layer includes a printed circuit board.

In some configurations, each of the first and second plurality of emitters comprises a Light Emitting Diode (LED).

In some configurations, each detector of the plurality of detectors includes a photodiode.

In some configurations, each of the first plurality of emitters and the second plurality of emitters is configured to emit light into tissue of a user; each detector of the plurality of detectors is configured to: (i) Detecting at least a portion of light emitted by at least one of the first plurality of emitters and the second plurality of emitters after being attenuated by the tissue; and (ii) outputting at least one signal responsive to the detected light; and the sensor further comprises one or more processors configured to receive and process the output at least one signal and determine at least one physiological parameter of the user.

The present disclosure provides a system for monitoring a physiological parameter. The system may include: a wearable device comprising one or more physiological sensors configured to monitor one or more physiological parameters of a user; and a computing device external to and in wireless communication with the wearable device, the computing device configured to: receiving user input via an interactive user interface; in response to receiving the user input, wirelessly transmitting a first signal to the wearable device to instruct the wearable device to perform a physiological monitoring operation; receive physiological parameter data measured by a physiological monitoring operation from a wearable device; and causing presentation of physiological parameter data in the interactive user interface.

In some configurations, the monitoring operation includes continuously measuring the physiological parameter.

In some configurations, the monitoring operation includes measuring a physiological parameter over a predetermined length of time; and stopping measuring the physiological parameter when the predetermined length of time expires.

In some configurations, the wearable device is configured to: in response to receiving the first signal from the computing device, determining a charge level of a battery of the wearable device; determining whether the charge level is sufficient to perform a monitoring operation; and performing a monitoring operation in response to determining that the charge level is sufficient.

In some configurations, the wearable device is configured to: in response to receiving the first signal from the computing device, determining a charge level of a battery of the wearable device; determining whether the charge level is sufficient to perform a monitoring operation; responsive to determining that the charge level is insufficient, determining a modified monitoring operation based at least in part on the charge level; and performing the modified monitoring operation.

In some configurations, the wearable device is configured to: determining that one or more physiological parameters exceed respective predetermined thresholds; and in response to determining that the one or more physiological parameters exceeds the respective predetermined thresholds, sending a second signal to the computing device to cause the computing device to generate an alert.

In some configurations, the computing device is further configured to: one or more of graphs, charts, or trends of historical and substantially real-time physiological parameter data are caused to be presented in an interactive user interface.

It is noted that a "plethysmograph" (commonly referred to as a "photoplethysmograph") as used herein encompasses its broad, common meaning known to those skilled in the art, including at least data representative of the change in absorption of light at a specific wavelength according to the change in body tissue caused by pulsatile blood. Furthermore, "oximetry" as used herein encompasses its broad common meaning known to those skilled in the art, including at least those non-invasive procedures for measuring parameters of circulating blood by spectroscopy.

For purposes of summarizing, certain aspects, advantages, and novel features are described herein. Of course, it is to be understood that not necessarily all such aspects, advantages or features may be required to be present in any particular aspect.

Drawings

The drawings and the related description are provided to illustrate aspects of the disclosure and not to limit the scope of the claims. In this disclosure, "bottom" refers to a side that faces toward a wearer's wrist when the example wearable device disclosed herein is worn on the wearer's wrist, and "top" refers to a side that faces away from the wearer's wrist.

Fig. 1A shows a first view of an example wearable device that includes a physiological parameter measurement sensor or module worn on the wrist using a strap.

FIG. 1B illustrates a second view of the example wearable device of FIG. 1A worn on a wrist.

Fig. 1C illustrates an example fingertip sensor that may be coupled to a wearable device of the present disclosure.

Fig. 1D illustrates a top perspective view and a partial view of the strap of the example wearable device of fig. 1A-1C.

Fig. 1E shows a bottom perspective view of the example wearable device of fig. 1D.

Fig. 1F shows a side view of an example wearable device without straps when the device is engaged with the skin of a wearer.

Fig. 1G shows a top perspective view of the example wearable device of fig. 1F.

Fig. 1H illustrates a bottom perspective view of an example wearable device.

Fig. 1I illustrates a perspective view of an example strap configured to secure a wearable device disclosed herein to a wearer's wrist.

Fig. 1J-1K illustrate perspective views of an example wearable device and a physiological sensor or module removably secured to the wearable apparatus.

Fig. 2 is a diagram schematically illustrating a network of non-limiting examples of devices that may communicate with the wearable devices disclosed herein.

Fig. 3 illustrates an example display of physiological parameter measurements on a wearable device as disclosed herein.

Fig. 4 illustrates an example physiological parameter measurement module of a wearable device.

Fig. 5A illustrates a side view of an example wearable device incorporating an example physiological parameter measurement module.

Fig. 5B illustrates a cross-sectional view of the example wearable device of fig. 5A.

Fig. 5C shows a perspective view of the wearable device of fig. 5A.

Fig. 5D shows a bottom view of the wearable device of fig. 5A.

Fig. 6 schematically illustrates arteries and capillaries of a human hand and a proximal portion of a human forearm.

Fig. 7A shows a schematic system diagram of a wearable device including a physiological parameter measurement module.

Fig. 7B illustrates a partially exploded view of an example wearable device.

FIG. 7C illustrates an example light transmissive cover of the physiological parameter measurement module of FIG. 7B.

FIG. 7D shows an exploded view of the ECG electrode, light transparent cover and opaque frame of the physiological parameter measurement module of FIG. 7B.

FIG. 7E shows a bottom perspective view of a physiological parameter measurement module incorporating the ECG electrode, light transparent cover and opaque frame of FIG. 7C or 7D.

FIG. 7F illustrates a top perspective view of the example physiological parameter measurement module of FIG. 7E.

Fig. 7G and 7H schematically illustrate top and bottom views of an example device processor board of a wearable device disclosed herein.

Fig. 8A and 8B schematically illustrate top and bottom views of an example sensor or module processor board of an example physiological parameter measurement module.

Figures 8C-8E illustrate various views of a PCB substrate bonding a detector to a physiological parameter measurement module.

Fig. 8F shows a perspective view of a PCB substrate with a physiological parameter measurement module having a different wire bonding arrangement than that shown in fig. 8C-8E.

Fig. 9A and 9B illustrate light diffusing material filling channels and vent channels in an opaque frame of an example physiological parameter measurement module.

FIG. 10 illustrates a longitudinal cross-sectional view of an example physiological parameter measurement module and an example optical path between an emitter and a detector of the module.

FIG. 11A shows a schematic system diagram of an example wearable device including a physiological parameter measurement module.

FIG. 11B shows a schematic diagram of the example device processor shown in FIG. 11A.

FIG. 11C shows a schematic system diagram of the example sensor or module processor shown in FIG. 11A.

FIG. 11D shows a block diagram of an example front-end circuit of the sensor or module processor of FIG. 11C.

FIG. 12A illustrates a bottom view of an example physiological parameter measurement module having a first ECG electrode and a second ECG electrode.

Fig. 12B shows a top perspective view of an example wearable device including a third ECG electrode.

Fig. 12C shows a partial top perspective view of the example wearable device of fig. 12B, with the third ECG electrode shown transparent to show the contact spring underneath the third ECG electrode.

Fig. 13A shows an example block diagram of an LED drive circuit of the physiological parameter measurement module disclosed herein.

Fig. 13B illustrates an example block diagram of a transmitter circuit of the physiological parameter measurement module disclosed herein.

Fig. 13C illustrates an example block diagram of a detector circuit of the physiological parameter measurement module disclosed herein.

Fig. 13D illustrates an example block diagram of a temperature sensor circuit of the physiological parameter measurement module disclosed herein.

Fig. 14A and 14B are example block diagrams illustrating signal processing of a conventional plethysmograph sensor.

Fig. 15A and 15B illustrate example schematic input and output flowcharts of the physiological parameter measurement modules disclosed herein.

FIG. 15C shows an example schematic input and output flow diagram of a gyroscope and accelerometer of the physiological parameter measurement module disclosed herein.

Fig. 15D illustrates an example schematic block diagram for determining pulse rate using the physiological parameter measurement module disclosed herein.

Fig. 15E illustrates example decision logic for determining pulse rate using the physiological parameter measurement modules disclosed herein.

FIG. 15F illustrates an example schematic input and output flow diagram for determining oxygen saturation using the physiological parameter measurement module disclosed herein.

FIG. 15G illustrates example decision logic for determining oxygen saturation using the physiological parameter measurement module disclosed herein.

Fig. 16A schematically illustrates an example plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device.

Fig. 16B shows a bottom view of an example physiological parameter measurement module that incorporates the plethysmograph sensor arrangement of fig. 16A.

FIG. 16C illustrates a side view of the example physiological parameter measurement module of FIG. 16B.

FIG. 16D illustrates a bottom perspective view of the example physiological parameter measurement module of FIG. 16B.

FIG. 16E shows a bottom view of a variation of the example physiological parameter measurement module of FIG. 16B including ECG electrodes.

FIG. 16F illustrates a side view of the example physiological parameter measurement module of FIG. 16E.

FIG. 16G illustrates a bottom perspective view of the example physiological parameter measurement module of FIG. 16E with the opaque frame and light transmissive cover hidden to show ECG electrodes assembled with the sensor or module processor board.

FIG. 17A shows a bottom perspective view of an example physiological parameter measurement module that incorporates the plethysmograph sensor arrangement of FIG. 16A.

FIG. 17B illustrates a bottom view of the example physiological parameter measurement module of FIG. 17A.

FIG. 17C illustrates a side view of the example physiological parameter measurement module of FIG. 17A.

Fig. 18A schematically illustrates an example plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device.

Fig. 18B schematically illustrates an example plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device.

Fig. 19A schematically illustrates an example plethysmograph sensor arrangement on a sensor or module processor board of a physiological parameter measurement module of a wearable device.

Fig. 19B shows a bottom view of an example physiological parameter measurement module that incorporates the plethysmograph sensor arrangement of fig. 19A.

FIG. 19C illustrates a side view of the physiological parameter measurement module of FIG. 19B.

FIG. 20A shows a bottom view of an example physiological parameter measurement module of a wearable device as worn on a schematic representation of a wearer's wrist.

FIG. 20B illustrates a side view of the physiological parameter measurement module of FIG. 20A.

FIGS. 20C and 20D illustrate exploded views of the physiological parameter measurement module of FIG. 20A.

FIG. 20E illustrates a first side view of an example wearable device incorporating the physiological parameter measurement module of FIGS. 20A-20D.

Fig. 20F shows a bottom view of the wearable device of fig. 20E.

Fig. 20G shows a second side view of the wearable device of fig. 20E.

Fig. 20H shows a third side view of the wearable device of fig. 20E.

Fig. 20I shows a bottom perspective view of the wearable device of fig. 20E.

Fig. 20J shows a top perspective view of the wearable device of fig. 20E.

FIGS. 21A and 21B illustrate perspective views of an example physiological parameter measurement module having an alternative light transmissive cover curvature from the module in FIG. 20A.

FIG. 21C illustrates a longitudinal cross-sectional view of the physiological parameter measurement module of FIGS. 21A and 21B.

FIGS. 22A and 22B illustrate perspective views of an example physiological parameter measurement module having another alternative light transmissive cover curvature from the module in FIG. 20A.

FIG. 22C illustrates a longitudinal cross-sectional view of the physiological parameter measurement module of FIGS. 22A and 22B.

FIG. 23A illustrates a bottom perspective view of an example wearable device incorporating the physiological parameter measurement module of FIGS. 20A-20D.

Fig. 23B shows a side view of the wearable device of fig. 23A.

Fig. 23C shows a top perspective view of the wearable device of fig. 23A.

Fig. 23D shows a top view of the wearable device of fig. 23A.

Fig. 23E shows a bottom view of the wearable device of fig. 23A.

Fig. 24A illustrates a bottom view of another example physiological parameter measurement module of a wearable device.

FIG. 24B illustrates a side view of the physiological parameter measurement module of FIG. 24A.

Fig. 25A illustrates a bottom view of another example physiological parameter measurement module of a wearable device.

FIG. 25B illustrates a side view of the physiological parameter measurement module of FIG. 25A.

FIG. 25C illustrates a first side view of another example wearable device incorporating the physiological parameter measurement module of FIGS. 25A-25B.

Fig. 25D shows a bottom view of the wearable device of fig. 25C.

Fig. 25E shows a second side view of the wearable device of fig. 25C.

Fig. 25F shows a top perspective view of the wearable device of fig. 25C.

Fig. 25G shows a third side view of the wearable device of fig. 25C.

Fig. 25H shows a bottom perspective view of the wearable device of fig. 25C.

Fig. 26A schematically illustrates a microneedle inserted into the skin of a wearer.

Fig. 26B schematically illustrates a microneedle patch coupled to a body of a wearable device disclosed herein.

Fig. 26C schematically illustrates a microneedle patch coupled to a strap of a wearable device disclosed herein.

Fig. 26D schematically illustrates a simplified system diagram of a microneedle patch and wearable device.

FIG. 27A illustrates a front view of an example aspect of a physiological parameter measurement sensor or module.

FIG. 27B illustrates an exploded view of an example aspect of a physiological parameter measurement sensor or module.

FIGS. 27C and 27D illustrate light diffusing material filling channels and vent channels in an opaque frame of an example physiological parameter measurement sensor or module.

FIG. 27E illustrates an example physiological parameter measurement sensor or module and an example optical path between an emitter and detector of the module.

Fig. 27F shows a perspective view of a PCB substrate of a physiological parameter measuring sensor or module with an example plethysmograph sensor arrangement.

FIG. 27G illustrates a longitudinal cross-sectional view of an example physiological parameter measurement sensor or module.

FIG. 27H illustrates a longitudinal cross-section orthogonal to the view of FIG. 27G of an example physiological parameter measurement sensor or module.

Fig. 27I shows a perspective view of a PCB substrate of a physiological parameter measuring sensor or module with an example plethysmograph sensor arrangement.

FIG. 27J illustrates a perspective cross-sectional view of an example physiological parameter measurement sensor or module.

FIGS. 27K-27L illustrate example optical paths between an example physiological parameter measurement sensor or module and an emitter and detector of the module.

27M-27P illustrate example physiological parameter measurement sensors or modules and example light blocking layers or light barriers between an emitter chamber and a detector chamber of the modules.

FIG. 27Q illustrates an example physiological parameter measurement sensor or module and an example light diffusing material and a light transmissive lens or cover.

Fig. 28 shows a block diagram illustrating example aspects of a wearable device in communication with an external device via a network.

FIG. 29 illustrates an example dashboard user interface for a health application.

FIGS. 30A-30D illustrate an example spot check monitoring user interface for a health application.

FIGS. 30E-30H illustrate example continuous monitoring user interfaces for a health application.

31A-31D illustrate an example measurement setup user interface for a health application.

FIG. 32 illustrates an example active user interface of a health application.

33A-33C illustrate an example exercise user interface for a health application.

34A-34C illustrate an example sleep user interface of a health application.

Fig. 35A-35B illustrate example historical user interfaces for a health application.

Fig. 36A illustrates example aspects of a wearable device having a display screen.

36B-36E illustrate example display screens of a wearable device.

Fig. 37A illustrates example aspects of a wearable device having a display screen.

Fig. 37B-37E illustrate example display screens of a wearable device.

38A-38B illustrate example display screens of a wearable device.

Fig. 39 is a flowchart illustrating an example process for performing a monitoring operation of a wearable device.

FIG. 40 illustrates a block diagram of an example computing device that can implement one or more aspects of the present disclosure, in accordance with various aspects of the present disclosure.

Detailed Description

Although certain aspects and examples are described below, it will be understood by those skilled in the art that the present disclosure extends beyond the specifically disclosed aspects and/or uses based on the disclosure herein and obvious modifications and equivalents thereof. Therefore, the scope of the disclosure herein should not be limited by any particular aspect described below.

Wearable device overview including physiological parameter measurement sensors or modules

Daily use of a wearable healthcare monitoring device (which may include oximetry-based or plethysmograph-based and/or ECG physiological parameters) may be beneficial to the wearer. The device (such as the device 10 shown in fig. 1A-1H) may be a wrist watch incorporating the physiological parameter measuring sensor 100 or a wrist-worn physiological parameter measuring sensor with a built-in watch or time indicating function. The device 10 may include an adjustable strap 30. Thus, the wearer does not need to wear additional sensors while performing daily activities, and the appearance of the device is less noticeable to the public, so that the wearer may feel less uncomfortable wearing pulse oximeter sensors on his/her body. The wearer may also connect additional sensors (e.g., the fingertip plethysmograph sensor shown in fig. 1C) and/or other physiological monitoring devices to the wearable device to expand the functionality of the wearable device.

The wearer may 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 may display one or more measured physiological parameters on its display 12. This information may help provide feedback to the wearer and/or third party user (e.g., a healthcare professional or a family member of the wearer) while the wearer is exercising, or otherwise alert the wearer of possible health-related conditions, including but not limited to changes in the physiological parameters of the wearer in response to the medication taken by the wearer.

As shown in fig. 1A-1H, the wearable device 10 may be a watch that may include a physiological parameter measurement sensor or module 100 configured to measure an indication of a physiological parameter of the wearer, which may include, for example, pulse rate, respiration rate, oxygen saturation (SpO ₂), pulse Variation Index (PVI), perfusion Index (PI), pulse respiration (RRp), hydration, glucose, blood pressure, and/or other parameters. The physiological parameter measuring sensor or module 100 may be an optical sensor. Additionally, the sensor or module 100 may optionally calculate the health index based on more than one individual physiological parameter measured by the module and/or received by the sensor or module 100 based on an externally connected sensor and/or patient monitoring device. The sensor or module 100 may perform intermittent and/or continuous monitoring of the measured parameter. The sensor or module 100 may additionally and/or alternatively perform spot checks of the measured parameters, for example, upon request by the wearer.

As shown in fig. 1E and 1H, the bottom side of the device (or watch) housing 101 may include an opening sized to hold the physiological parameter measurement module 100 while still allowing exposure of the tissue facing surface of the sensor or module 100. The retention of the sensor or module 100 in the device housing 101 may be aided by any suitable retention mechanism. As shown in fig. 1F and 1H, the physiological parameter measurement module 100 can include a skin interface light transmissive cover 102 that encloses a plurality of light emitters 104 (such as LEDs) and one or more photodetectors (also referred to as "detectors") 106. Additionally, the sensor or module 100 may optionally include an Electrocardiogram (ECG) sensor, which may include a plurality of ECG electrodes 124, 125. As shown in fig. 1G and 1H, some of the ECG electrodes 125 may be located remotely from the sensor or module 100 and some of the ECG electrodes 124 may be located on the sensor or module 100. The cover 102 may include multiple lenses or covers or a single configuration of lenses or covers. The physiological parameter measurement module 100 is designed to reduce noise in the signal detected by the detector 106, for example, by reducing the mixing of emitted and reflected light using a substantially opaque light blocking layer. As shown in fig. 1F, the light blocking layer 120 may include a first light blocking layer that may be placed between the emitter and detector of the sensor or module 100. The first light blocking layer may extend (e.g., extend entirely) along an interior portion of the cover 102. The first light blocking layer may also suppress light emitted by the emitter at an angle. The sensor or module 100 may include additional light blocking layers including, for example, side perimeter walls and additional light blocking layers to separate the detector from the emitter and/or separate different groups of detectors from each other.

Fig. 1F shows the device 10 worn on the wrist 2 of a wearer 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 gaps between the surface of the physiological parameter measurement module 100 and the skin of the wearer at the measurement site where the device 10 is worn. At the wrist, if the device 10 is worn too loosely (which may be the case when the device 10 is able to slide over the skin when the device 10 is moving), the gap between the tissue facing surface of the physiological parameter measurement module 100 and the skin of the wearer may result in inaccurate measurements. This is because the gap may result in both the light conduit and the emitted light not penetrating deep enough into the wearer's tissue, e.g., not deep into the top skin layer (e.g., epidermis) of the wearer's tissue, which is generally free of any blood vessels. Thus, light cannot reach or interact with tissue, such as arterial blood in the dermis below the top skin layer. The gap may also result in loss of attenuated and reflected light passing through the gap such that less attenuated and reflected light may reach the detector 106.

The tightness of the device 10 on the wearer's body (e.g., wrist) may be adjusted by adjusting any suitable strap 30 for securing the device to the wearer's body. The strap may be connected to the device 10 using any suitable strap connector 22. For example, strap connector 22 may be compatible with third party watchbands, wearable blood pressure monitors, and the like. As shown in fig. 1I, the example strap 30 may be stretchable and evenly distribute the pressure of the device 10 around the wrist to provide better contact between the sensor or module 100 and the wrist 2, while not compromising the comfort of the wearer and/or reducing blood flow through the wrist 2 in a manner that reduces the accuracy of the measurements of the sensor or module 100. As shown in fig. 1L, the rubber mount 302 may be molded by a plurality of metal rings 304 disposed along the length of the strap 30 to form the strap 30. The metal ring 304 may include a thin wall of metal (e.g., less than about 1 mm) that forms a closed loop with a through hole in a direction generally transverse to the length of the band 30 (i.e., along the width of the band 30) and perpendicular to the thickness of the band 30. During the over-molding process, the rubber material may fill or substantially fill the space in the through-hole. The metal loops 304 may be arranged in two rows along the length of the strap 30. Alternatively, the metal ring may comprise a partial ring with an opening, or the strap may comprise more than one partial metal ring that snap around the rubber base to each other. Additional details of the band 30 are described in U.S. provisional application No.63/068256, filed 8/20/2020, entitled "WEARABLE PHYSIOLOGICAL MONITORING DEVICE WITH ADJUSTABLE STRAPS," the entire contents of which are incorporated herein by reference.

In addition, by the design of the light-transmitting cover 102, the gap between the surface of the physiological parameter measurement module 100 and the skin of the wearer at the measurement site can be reduced. As shown in fig. 1F, the cover 102 of the physiological parameter measurement module 100 can include a convex curvature or convex protrusion on its skin interface cover 102. As will be described in more detail below, the curvature of the cover 102 (which may include multiple lenses or covers or a single lens or cover) of the sensor or module 100 may be discontinuous or continuous.

As shown in fig. 1F, when the device 10 is worn by a wearer, the male cap 102 may be pressed against the skin and the tissue 2 of the wearer may conform around the male curvature. Contact between the male cap 102 and the wearer's tissue 2 may leave no air gap between the tissue 2 and the male cap 102. And since the emitters and/or detectors may be surrounded by light diffusing material (as will be described below), the physiological parameter measurement module 100 may leave no air gap between the tissue 2 and any of the emitters and/or detectors. Alternatively, some portions of the cover 102 may protrude more into the skin than the rest of the cover. The pressure exerted on the skin by the curvature of the cap 102 and/or the absence of an air gap may increase the light irradiation and/or detection area, improve optical coupling of emitted light to blood vessels and/or reflected light to a detector, reduce light piping, and/or reduce blood stagnation. The cover curvature may be configured to balance the pressure required to improve contact between the cover 102 and the skin, and comfort to the wearer.

Fig. 1J-1K illustrate perspective views of an example wearable device 10 detachably secured to a wearable apparatus 135. The wearable device 135 includes one or more straps 30 and a frame 177. The wearable device 10 may include a physiological sensor or module 100 and an electrode 58. The electrode may be a positive electrode. In some aspects, the wearable device 10 may include a screen or display. In some aspects, wearable device 10 may not include a screen or display.

The device 10 may be removably secured to the frame 177. The frame 177 may retain the device 10 within the frame 177 via a press fit, friction fit, snap fit, or the like. The strap 30 may secure the device 135 to a body part of the wearer. The wearable device 135 may be configured to maintain the wearable device 10 (e.g., sensor or module 100) in contact with the skin of the wearer when the device 10 is secured within the frame 177 and the wearable device 135 is secured to the body. The wearable device 135 (e.g., the band 30) may be sized and/or shaped to be secured to the wearer's wrist. In some aspects, the wearable device 135 (e.g., the band 30) may be sized and/or shaped to be secured to other portions of the wearer's body, including, as non-limiting examples, ankles, legs, arms, fingers, chest, torso, stomach, back, neck, head, forehead.

The wearable device 10 may be used in a stand alone manner and/or in combination with other devices and/or sensors. As shown in fig. 2, the device 10 may be connected (e.g., wirelessly) with a plurality of devices, including but not limited to a patient monitor 202 (e.g., a bedside monitor, such as Masimo (Optionally noninvasive blood pressure or NomoLine capnography),Bedside monitor, patient monitoring and connection center (such as Masimo/>)Platform), any handheld patient monitoring device, and any other wearable patient monitoring device), a mobile communication device 204 (e.g., a smart phone), a computer 206 (which may be a laptop or desktop computer), a tablet computer 208, a nurses' station system 201, glasses (such as smart glasses configured to display images on the surface of the glasses), and so forth. The wireless connection may be based on bluetooth technology, near Field Communication (NFC) technology, etc. In addition, wearable device 10 may be connected to computing network 212 (e.g., via any of the connected devices disclosed herein, or directly). Network 212 may include Local Area Networks (LANs), personal Area Networks (PANs), metropolitan Area Networks (MANs), wide Area Networks (WANs), etc., and may allow geographically dispersed devices, systems, databases, servers, etc., to connect to each other (e.g., wirelessly) and communicate (e.g., transfer data). The wearable device 10 may establish a connection to one or more electronic medical records systems 214, remote servers with databases 216, etc., via the network 212.

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

The device 10 may act as a hub for external sensors, such as the sensors described in U.S. patent publication No. 2020/0138882, published 5/7/2020, the entire contents of which are incorporated herein by reference. The sensor described in U.S. patent publication No. 2020/0138882 can collect patient physiological data and provide power to the reusable paired device. The reusable pairing device may establish wireless communication with the patient monitoring device. The wearable device 10 may replace the patient monitoring device of U.S. patent publication No. 2020/0138882. As another example, the device 10 may replace the patient monitoring device described in U.S. patent publication No.2020/0329993, published at 22, 10, 2020, which is incorporated herein by reference in its entirety. By replacing the patient monitoring device of U.S. patent publication No.2020/0329993, the wearable device 10 performs all calculations based on the sensor data, such that the connected external sensor (e.g., the ECG sensor disclosed in U.S. patent publication No. 2020/0329993) does not require heavy computational power.

The device 10 may include an open architecture to allow connection of third party wireless sensors and/or to allow third parties to access multiple sensors on the wearable device 10 or connected to the wearable device 10. The plurality of sensors may include, for example, temperature sensors, altimeters, gyroscopes, accelerometers, transmitters, LEDs, and the like. The third party application may be installed on the wearable device 10 and may use data from one or more sensors on the wearable device 10 and/or be in electrical communication with the wearable device.

Alternatively, the wearable device 10 may communicate with any other suitable non-invasive sensor (such as an acoustic sensor, a blood pressure sensor, a temperature sensor, a motion sensor, an ECG sensor, etc.). Examples of some of these devices include Masimo's Radius PPG ^TM sensor, radius T ^TM sensor, and Centroid ^TM sensor, or other sensors. One or more of these sensors (e.g., centroid ^TM sensors) may be used for stroke detection. The wearable device 10 may output an alert that the wearer detected a stroke and/or automatically initiate communication with the first responder and/or a guardian or close proximity of the wearer upon detection of a stroke.

The wearable device 10 may optionally communicate with chemical sensors that may detect chemicals on the wearer's skin and/or sweat and/or odors of certain chemicals in the air, for example. The chemical sensor may comprise an electrochemical sensor or any other suitable type of chemical sensor. Chemical sensors configured to analyze sweat components may output measurements that assist the wearable device 10 in detecting pressure and/or hydration status of the wearer. The wearable device 10 may optionally communicate with a skin impedance sensor that may be used to monitor the hydration state of the wearer.

Another example sensor that may be integrated into or connected to the device 10 and/or the sensor or module 100 may include a toxin and/or radiation detector configured to detect toxins in air (e.g., pollution or contaminant particles in air, carbon monoxide, smoke, etc.). Toxin detection may assist a caregiver and/or firefighter wearing device 10. Alternatively, the device 10 may be wirelessly connected to an external toxin and/or radiation detector. Toxin and/or radiation detectors may be used with a smart mask. For example, an external toxin and/or radiation detector may be located on the mask, which may allow the mask to output a warning to the mask wearer when the mask filter or cartridge needs to be replaced.

Alternatively, the wearable device 10 may communicate with a glucose monitor, which may be invasive or minimally invasive, such as a finger-stick glucose monitor, or a continuous non-invasive glucose monitor. The wearable device 10 may receive and display the blood glucose level of the wearer from the blood glucose monitor. The wearable device 10 may also optionally communicate with an insulin pump. The wearable device 10 may send a control signal to dispense insulin from the insulin pump to the wearer based on the monitored glucose level of the wearer.

As shown in fig. 3, the device 10 may include a display screen 12 positioned on a top side of the device housing 101. In addition to the time and date indicators, one display layout (e.g., a default display layout) of the display screen 12 may display the SpO ₂ measurements, pulse Rate (PR) measurements, respiration Rate (RR) measurements, and/or hydration status (H2O) of the wearer. The format of the displayed measurement is not limited. For example, some measurements (such as SpO ₂ measurements and PR measurements) may be displayed as numerical values. As another example, some measurements (such as RR measurements and hydration state) may be displayed as sliding scales. In the example shown, the hydration state may be shown as having three levels from low (L) to high (H). In the illustrated example, the respiration rate may be shown as ranging from 5bpm to 25 bpm. The wearer may optionally view a separate display layout for each measurement or group of measurements by clicking on the display 12 (which may be a touch screen) and/or pressing a button on the device 10. Each of the measurements may be displayed continuously at specific intervals and/or immediately upon receipt of a display instruction (e.g., by the wearer clicking on the display screen 12 and/or pressing a button on the device 10). Each of the measurements may be configured to be displayed at a different or the same frequency. Time and certain physiological parameters (e.g., spO ₂ and pulse rate) may be available immediately and/or intermittently, and/or measured continuously (e.g., at least every 5 to 10 measurements per minute or more), and the values displayed are updated continuously. Optionally, the display may further show trend lines for some parameters, such as SpO ₂ and pulse rate. In one example, the display of the wearable device may be configured to display only time, spO ₂, and pulse rate.

As shown in fig. 4, the physiological parameter measurement module 100 may be preassembled prior to being integrated into the device 10. The physiological parameter measurement module 100 can be characterized prior to assembly with the rest of the device 10. The pre-assembled physiological parameter measurement module 100 can 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 in the device 10. For example, the sensor or module 100 may include a quick connect (and/or quick release) feature for attaching the sensor or module 100 to the rest of the device 10, such as may be attached to the device 10 by a magnet. 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, including, for example, the device processor and the display 12. Alternatively, the electrical connection may include a connector 32 on the sensor or module 10. The connector 32 is configured to electrically connect to a flexible circuit. The wearable device 10 and sensor or module 100 are portable and can be moved from place to place. As described above, the functionality of the wearable device 10 may be integrated and/or interchangeable with various other patient monitoring devices, displays, and the like.

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

As shown in fig. 5A-5D, an example wearable device 500 may include a watch case 501. Features of device 500 may be incorporated into features of device 10, and features of device 10 may be incorporated into features of device 500. The watch case 501 may have a length of, for example, between about 40mm and 50mm or between about 42mm and 46 mm. The watch case may have a width, for example, between about 32mm to about 40mm or between about 35mm to about 38 mm. When fully assembled, the watch 500 may have a thickness or height, for example, between 10mm and about 15mm or between 12mm and about 14 mm.

As described above, the physiological parameter measurement module may include a plurality of emitters and a plurality of detectors. The emitter may transmit multiple wavelengths of optical radiation to a tissue site (near the wrist of the wearer) and the detector may be responsive to the intensity of the optical radiation (which may reflect from the tissue site) after absorption by pulsatile arterial blood flowing within the tissue site. In addition to the attenuation of light by blood in the artery, light interactions also occur at the capillary level. Arteries are located below the skin surface deeper than capillaries, thus requiring LED emitters with greater light intensity, and thus greater power consumption, in order for the emitted light to reach the artery. Furthermore, measuring the light intensity signal of the attenuated light of the blood in the artery requires more selective placement of emitters and detectors directly over the artery to capture the pulsations of the blood. The physiological parameter measurement module disclosed herein is designed to take advantage of the attenuation of blood in capillaries and is independent of blood flow in arteries. Patient parameter measurements made by the modules disclosed herein may be accurate enough for clinical use. The modules disclosed herein may provide plethysmograph-based patient parameter measurements with an accuracy within about 4% error or about 2% error. As shown in fig. 6, wrist 62 has fewer capillaries per unit volume than fingertip 64. Thus, the module is designed to have a certain width to provide a larger coverage area of the wearer's wrist, which may enhance the signal from the sensor located on the module (which will be described in more detail below).

When oxygen saturation is measured based on the attenuation of blood in capillaries, it is desirable to avoid veins. Since venous blood contains less oxygen, the attenuated light intensity signal of venous blood may cause oxygen saturation measurement readings to be erroneous. Alternatively, the sensor or module processor of the physiological parameter measurement module disclosed herein may reduce the impact of the pulsatile vein on the signal by comparing signals from multiple detectors to determine which detectors receive better and/or clearer signals and disabling detectors that are more likely to cover and/or lie around the pulsatile vein. The sensor or module processor may dynamically adjust the detector to be deactivated. Disabling the detector may include disabling operation of the detector and/or ignoring signals from the detector.

Alternatively, the sensors of the physiological parameter measurement module or the module processor may map physiological parameter measurements calculated from signals received at detectors and/or clusters of detectors located in different areas of the module. A change in the measurement of the mapping (e.g., if outside a particular range) may indicate that the pressure profile of the wearable device on the wearer's body is unbalanced, and thus that the pressure of the device on the wearer is too high or too low and/or that the wearable device is tilted on the wrist. The wearable device may output instructions to the wearer to re-adjust the tightness of the strap and/or to re-center the wearable device on the wrist. The change in the mapped measurement (e.g., if outside a particular range) may additionally or alternatively provide an indication that a particular detector or cluster of detectors is placed over a large pulsatile vein as described above. Readings from that particular detector or cluster of detectors may be ignored, or the detector suspected of covering the pulsatile vein may be deactivated. When two or more physiological parameter measurements (such as oxygen saturation measurements) are inconsistent between two or more detectors (e.g., have a change beyond a certain range), the sensor or module processor may use the higher or highest measurement, or alternatively use a combination of measurements from two or more detectors (e.g., use one of the two measurements at a different time or otherwise).

Alternatively or additionally, the mapped measurements may be compared to data determined experimentally at the same detector location or detector cluster location. The experimentally determined data may be obtained using, for example, a conventional reflection type pulse oximeter glued over the corresponding detector locations, or any other suitable known method for making the same measurements, including the same wrist-based sensor arrangement described herein. A comparison between the mapped measurement and the experimentally determined data may provide an indication of: whether the device has reached a desired pressure on the wearer's body, whether certain detectors and/or detector clusters are placed over or near the pulsatile vein (which may interfere with physiological parameter measurements), or in other ways. For example, if the difference between the mapped measurement and experimental data at a location falls outside of a predetermined range, the sensor or module processor may determine that the pressure at the location is too high or too low and/or that the pressure distribution over the body is not balanced enough to make an accurate measurement and/or to place a detector or cluster of detectors over the pulsatile vein of the wearer. The experimental data may be stored in a memory device of the sensor or the module processor.

The comparison between the mapped measurements and/or between the mapped measurements and the experimental data may be performed when the device is first worn by the wearer and/or at specific time intervals during the duration of the device being worn on the wearer. Additionally, running a comparison-based diagnosis may allow the sensor or module processor to dynamically determine which detector or detectors provide the most accurate and/or reliable measurements at the beginning of the measurements and/or during use of the device.

Various example components of a wearable device

The components of the wearable device will now be described. As shown in fig. 7A and 7B, the device 10 may include its own device processor 14, which may be a digital/analog chip or other processor, such as a digital watch processor or a smart watch processor. As shown in fig. 7B, 7G, and 7H, the device processor 14 may be located on a PCB. Fig. 7G and 7H show an example layout of a PCB of the device processor 14. As shown in fig. 7A and 7B, the device 10 may include a power source 16, which may be a battery, for powering the device processor 14, the display 12, and/or the physiological parameter measurement module 100. In the case of continuous measurement and/or display of certain physiological parameters, such as SpO ₂ and pulse rate, the battery 16 may last at least 10 hours or at least 12 hours or at least 14 hours or at least about 16 hours after each charge.

The device 10 may be configured to display time after the battery 16 is depleted, even though other features (e.g., measuring physiological parameters using a module) may not be available when the battery 16 is depleted. Additionally, when the device 10 is in clinical use, the display 12 may also continue to display critical patient information (e.g., patient name, date of admission, etc.) after the battery 16 is depleted. The device 10 may include non-volatile memory to store critical patient information. The device 10 may include a dual battery configuration having a main battery and a back-up battery. When the main battery is depleted, the power management of the device 10 may automatically switch to the device 10 being powered by the backup battery. The device may additionally or alternatively be configured to be solar powered, for example by including a solar panel on the dial of the wearable device 10 or elsewhere. The display 12 of the device 10 may use electronic ink or ULP (ultra low power consumption screen) technology that consumes a small amount of current to display information. The display 12 may automatically adjust brightness, be brighter when outdoors, and darker when indoors to further extend battery life.

As shown in fig. 7A and 7B, the sensor or module 100 of the wearable device 10 may include a sensor or module processor 108 (which may include memory and/or other electronics, such as shown in fig. 11C). The sensor or module processor 108 can process signals from one or more sensors in the sensor or module 100 (or alternatively other sensors in communication with the device 10) to determine a plurality of physiological parameters. All processing of raw sensor data of the sensor in communication (via wired and/or wireless connection) with the sensor or module processor 108 is performed by the sensor or module processor 108. The sensor or module processor 108 may be configured to drive the emitter 104 to emit light of different wavelengths and/or to process the attenuated light signal from the detector 106 after absorption by the body tissue of the wearer. The sensor or module processor 108 can determine and output to display the physiological parameter on the device display 12 based on the detected signal. Alternatively, the sensor or module 100 may send a signal (e.g., a pre-processed signal) from the detector 106 to the device processor 14, which device processor 14 may determine and output to display the physiological parameter based on the detected signal. The absorption of light may be achieved via the transreflection of the body tissue of the wearer, for example by pulsating arterial blood flowing through capillaries (and optionally also arteries) within the tissue site (e.g. wrist) of the wearing device 10. The sensor or module processor 108 may be located on a PCB 116, such as shown in fig. 7B.

The sensor or module 100 may include more than one group or cluster of light emitters (such as LEDs) 104 and more than one group of photodetectors (also referred to as "detectors") 106. Each set 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 thermistor 110 can be placed near one or more sets of emitters 104. There may be at least one thermistor 110 near each set of transmitters 104. The thermistor 110 can provide wavelength correction of the light emitted by the emitter. Alternatively, the thermistor 110 may additionally measure the temperature of the wearer of the device 10. Alternatively, there may be one or more thermistors 110 located at other locations of the sensor or module 100. The emitter 104, thermistor 110, and/or detector 106 may be positioned on the PCB 116.

As shown in fig. 7A, 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 the accelerometer 114. The motion information may provide a noise reference for analysis of the volume 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.

Fig. 8A shows an example layout of the top side of PCB 116. Fig. 8B shows an example layout of the bottom side of PCB 116. The first or bottom side of the PCB 116 may include the emitter 104, the detector 106, the temperature sensor 110, and any other sensors, such as gyroscopes, accelerometers, and the like. Fig. 8C-8E illustrate the detector 106 electrically connected to the PCB 116 via wire bonds 107. The module may include leads 105 extending over the detector 106 for shielding purposes. The number of leads 105 extending over the detector 106 may vary. The manner in which the leads 105 extend over the detector 106 may vary. The leads 105 may not extend all the way over the detector 106 across the width or length of the detector. For example, as shown in fig. 8F, the detectors in the detector sets 106a, 106b, 106a/b may each be electrically connected to a first side of the PCB 816 via wire bonds 107. Leads 105 may extend along each side of the detector for noise shielding. In the example shown, leads 105 may extend along each long side of the detector. The leads 105 may extend parallel to the length of the detector. The leads 105 may not extend over the body of the detectors 106a, 106b, 106 a/b. In some aspects, a single lead 105 may extend along all four sides of the emitter for shielding. In some aspects, four leads 15 may each extend along one of the four sides of the emitter for shielding. In some aspects, a metal cover, such as a can-shaped metal cover, may cover each of the detector and/or emitter for shielding. The emitters in emitter groups 104a, 104b may each be electrically connected to a first side of PCB 816 via wire bonds 107. The thermistor 110 at each of the emitter groups 104a, 104b may be electrically connected to the first side 816 of the PCB via wire bonds 107. The detector, emitter, and/or thermistor may alternatively be electrically connected to the PCB 116 via other suitable types of electrical connectors.

A second or top side of the PCB 116 may include a sensor or module processor 108 and other circuit hardware. The second side of the PCB 116 may be electrically noisy and isolated from the sensors on the first side of the PCB 116 by the board. The electronics on the same side of the PCB 116 may be substantially completely overmolded to reduce or avoid shifting or damage to the components during use. On a second side of the PCB 116 facing away from the light transmissive cover 102, the PCB 116 may be covered with a molten plastic or other suitable electronic protective material 130, such as shown in fig. 7B and 7F. As shown in fig. 7F, the electronic components on the second side of the PCB 116 may generally be sealed by a protective material 130, except that the connector 132 may extend from the second side of the PCB 116 and be exposed. The connector 132 may electrically connect the sensor or module 100 to the circuitry of the wearable device 10.

Alternatively, as shown in fig. 7A, 7B, and 7D, the device 10 may include an Electrocardiogram (ECG) sensor that includes a plurality of electrodes 124, 125 configured to contact the skin of the wearer. One or more ECG electrodes 124 can be located on the sensor or module 100 (such as shown in fig. 7B and 7E). One or more ECG electrodes 125 may be located elsewhere on the device (e.g., ECG electrodes 125 may form part of the housing of wearable device 10, as shown in fig. 7B). The ECG sensor may be in electrical communication with the sensor or module processor 108 via an ECG connector.

As shown in fig. 7B-7E, the physiological parameter measurement module 100 can include a skin interface light transmissive cover 102 that encloses a first side of a PCB 116 that positions a plurality of light emitters 104 and detectors 106. The sensor or module 100 may include a light blocking layer configuration 120, the light blocking layer configuration 120 being configured to separate the emitter 104 and the detector 106 into different chambers such that light cannot travel or substantially cannot travel between the chambers. The light transmissive cover 102 may extend over the respective emitter and detector chambers formed by the light blocking layer construction 120 and the PCB 116. The light transmissive cover 102 may include a single lens or cover such as shown in fig. 7D, a single lens or cover such as shown in fig. 17A-17C, or a combination of a single emitter chamber covering a lens or cover and a single lens or cover covering multiple detector chambers such as shown in fig. 7C. In the example lens or cover 102b shown in fig. 7C, individual lenses or covers configured to cover the detector chambers as shown in fig. 7D may be interconnected with bridging portions 103 between the detector chambers, forming a single piece lens or cover. The lens or cover 102b may be combined with the lens or cover 102a covering the emitter chamber to cover all openings in the light blocking layer construction 120 for forming sealed emitter and detector chambers. The light blocking layer construction 120 may be over molded to the lens or cover 102b and the lens or cover 102a. The lens or cover 102b may not be configured to cover the emitter chamber, which may be covered by a separate lens, in order to avoid any light travelling between the emitter chamber and the detector chamber.

As shown in fig. 7B, the physiological parameter measurement module 100 can include an opaque frame 126. The opaque frame 126 may house the light blocking layer construction 120. Alternatively, the opaque frame 126 and the light blocking layer construction 120 may be formed as a unitary piece, such as shown in fig. 7D. The opaque frame 126 may include a recess shaped and sized to receive the ECG electrode 124 or other component of suitable shape and size. The front side of the electrode 124 may have one or more posts 137, which posts 137 extend through openings in the opaque frame 126 into corresponding openings on the PCB 116. The posts 137 of the electrode 124 may establish electrical connection with corresponding openings of the PCB 116. A plurality of screws (or other types of fasteners) may extend from the front side of the PCB 116 into corresponding openings of the PCB 116 to threadably mate with the posts 137 or otherwise secure the electrodes 124 to the sensor or module 100. When the wearer wears the wearable device incorporating the sensor or module 100 on the wearer's wrist, the electrodes 124 may contact the wearer's skin.

Fig. 27A, 27B and 27E illustrate additional example aspects of an alternative Electrocardiogram (ECG) sensor. An Electrocardiogram (ECG) sensor may include a plurality of electrodes 2724 configured to contact the skin of the wearer. A plurality of ECG electrodes 2724 can be located on a sensor or module 2700 (such as shown in fig. 27A, 27B, and 7E). As disclosed herein, a wearable device incorporating the module may include another ECG electrode 125 located on a housing of the wearable device configured to contact the skin of the wearer.

Fig. 27B is an exploded perspective view of an example aspect of a sensor or module 2700. As shown in fig. 27B, the opaque frame 2726 can include a recess (which can also be referred to as a "recess") that is shaped and sized to accommodate the ECG electrode 2724 or other component of suitable shape and size. For example, in some embodiments, the frame 2726 includes a recess 2824. The recess 2824 may be sized and/or shaped to receive the ECG electrode 2724. In some embodiments, the recess 2824 has a depth (e.g., measured from the plane of the frame 2726) that is substantially equal to the thickness of the ECG electrode 2724. In some embodiments, the recess 2824 has a size and/or shape that matches the size and/or shape of the ECG electrode 2724. For example, in some embodiments where the ECG electrode has a semi-annular shape (such as the shape shown in at least fig. 27A-27B), the recess 2824 may have a semi-annular shape.

The front side of the electrode 2724 may have one or more posts 2737, which posts 2737 extend through openings in the opaque frame 2726 into corresponding openings on the substrate 2716. The posts 2737 of the electrode 2724 may establish electrical connection with corresponding openings on the substrate 2716. A plurality of screws (or other types of fasteners) may extend from the front side of substrate 2716 into corresponding openings of substrate 2716 to threadably engage or otherwise fasten electrodes 2724 to sensor or module 2700 by way of posts 2737. When the wearer wears the wearable device incorporating the sensor or module 2700 onto the wearer's wrist, the electrodes 2724 may contact the wearer's skin.

With continued reference to fig. 27B, substrate 2716 may include a Printed Circuit Board (PCB). Substrate 2716 may include conductive liquid adhesive 2739. Conductive liquid adhesive 2739 may be disposed on copper of substrate 2716. The conductive liquid adhesive 2739 can facilitate a conductive electrical connection between the electrode 2724 and the substrate 2716.

With continued reference to fig. 27B, one or more spring contacts (such as spring contact 2755' shown in fig. 27I) may be located between electrode 2724 and substrate 2716. The shape, size, and/or number of spring contacts may vary. Spring contacts may establish electrical connection between electrode 2724 and substrate 2716. The spring contacts may be biased toward the electrode 2724 to ensure a secure electrical connection between the spring contacts and the electrode 2724 and the substrate 2716.

The physiological parameter measurement module 100 may include a diffusing material or sealant, which may include, for example, microspheres or glass microspheres. As described above, the encapsulant may eliminate an air gap between the surface of the light transmissive cover 102 and the emitter 104 and/or detector 106. The encapsulant may include a more uniform spreading of the emitted light around the emitter 104, which appears to be emitted from the entire emitter chamber, rather than from a point source (that is, a single LED emitter), if no encapsulant is present. The encapsulant may allow the emitted light to travel through a larger volume of tissue at the tissue site. The diffusing material may act as a beam shaper that may homogenize an input beam from the emitter, shape an output intensity distribution of received light, and define the manner (e.g., shape or pattern) in which the emitted light is distributed to the tissue measurement site. Such diffuser material may, for example, deliver substantially uniform illumination over a designated target area in an energy efficient manner. According to Beer-Lambert law, the amount of light absorbed by a substance is proportional to the concentration of the light absorbing substance in an illuminated solution (e.g., arterial blood). Thus, by illuminating a larger volume of tissue and/or by increasing the amount of light detected, a larger sample size of light attenuated by the tissue of the wearer may 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 than a smaller sample size.

The diffusing material may be any suitable material, such as glass, frosted glass, glass beads, opal glass, gray glass, polytetrafluoroethylene, or a microlens-based band-limited engineered diffuser that can inject highly efficient and uniform illumination UV-cured flow glass microspheres into one or more openings on the sensor or module 100 (e.g., after the sensor or module 100 is assembled). Examples of engineered diffusers may include molded plastic with specific shapes, patterns, and/or textures designed to diffuse emitter light entirely across a tissue surface. The diffusing material may be made of ground glass that spreads the emitted light in a gaussian intensity profile. The diffusing material may comprise glass beads. The diffusing material may be configured to diffuse the emitted light in a lambertian pattern. A lambertian pattern is one in which the radiation intensity is substantially constant throughout the dispersive region. One such diffusing material may be made of opal glass. Opal glass is similar to frosted glass, but has one surface coated with a opal coating to uniformly diffuse light. 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 predefined geometry (e.g., rectangular, square, circular, or other shape) as well as employing 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. patent No.10,448,871, which is incorporated herein by reference in its entirety and should be considered part of this disclosure.

Additionally or alternatively, the physiological parameter measurement module 100 may include an encapsulant or light diffusing material in the detector chamber to more evenly spread the reflected light so as to increase the amount of reflected light reaching the detector. The module may include a light diffusing material positioned around the detector to scatter and/or deflect the reflected light so that the detector may detect more of the reflected light. For example, the reflected light may remain bouncing out of the diffuse material until the reflected light reaches the detector. Thus, the light detection surface area in the module may be larger than the surface area of the detector. Having a light diffusing material may reduce the power required to drive the LEDs of the emitter and/or the number of detectors at specific locations of the module, which may reduce the power consumption of the module.

As shown in fig. 9A, the opaque frame 126 of the sensor or module 100 may include a plurality of light diffusing material (or encapsulant) filled holes 144. A light diffusing material or encapsulant (e.g., a glass microsphere stream) may be injected into the plurality of chambers via the fill holes 144 and directed to the respective emitter or detector chambers along a plurality of fill channels 146 (see fig. 9B) interconnected with the fill holes 144 as indicated by arrows in fig. 9A. The fill channel 146 may be located 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 may further include a plurality of vent channels 145. When the diffusion material solution or the sealant is injected into the respective chambers via the filling holes 144, air may escape into the exhaust channel 145, so that the injected solution more easily flows into the respective chambers. As shown in fig. 9B, the module 100 may have no vent or fill channels between the emitter and detector chambers to avoid light pipes along such channels. The sealant may be UV-cured after being injected into the corresponding chamber.

The opaque frame 126 may be configured such that the fill holes 144 and channels 146 allow the light diffusing material to fill only the emitter chamber, or only the detector chamber, or both the emitter chamber and the detector chamber. Alternatively, the detector chamber may comprise a light transmissive lens or cover on the surface of the PCB not occupied by the detector, in addition to or instead of the light diffusing material. The light transmissive lens or cover may be polycarbonate. A light transmissive lens or cover inside the detector chamber may help focus the reflected light onto the detector inside the detector chamber.

Fig. 27C and 27D illustrate another example opaque frame 2726 and light blocking layer construction 2720 of a sensor or module 2700. The opaque frame 2726 and/or the light blocking layer construction 2720 may include a variety of light diffusing materials (or encapsulants) filling the holes 2744. A light diffusing material or encapsulant (e.g., a glass microsphere stream) may be injected into the plurality of chambers via fill holes 2744 and directed to the respective emitter or detector chambers along a plurality of fill channels 2746 (see fig. 27D) interconnected with fill holes 2744 as indicated by red arrows in fig. 27C and 27D. The filling channel 2746 may be located at a side of the opaque frame 2726 facing away from the wearer's tissue. The fill channel 2746 can travel through portions of the opaque frame 2726 and/or portions of the light blocking layer construction 2720. As shown in fig. 27D, the side of the opaque frame 2726 facing away from the wearer's tissue may further include a plurality of vent channels 2745. When the diffusion material solution or the sealant is injected into the respective chambers via the filling holes 2744, air may escape into the exhaust channel 2745, so that the injected solution more easily flows into the respective chambers. As shown in fig. 27D, each of fill channel 2746 and/or vent channel 2745 may connect more than one emitter chamber or more than one detector chamber. However, module 2700 may not have an exhaust channel or fill channel extending between the emitter and detector chambers to avoid light pipes along such channels. The sealant may be UV-cured after being injected into the corresponding chamber.

The opaque frame 2726 may be configured such that the fill holes 2744 and channels 2746 allow the light diffusing material to fill only the emitter chamber, or only the detector chamber, or both the emitter chamber and the detector chamber.

In fig. 10, a cross-sectional view of a sensor or module 100 shows some of the emitter and detector chambers. The chambers shown in fig. 10 include a first emitter chamber 136a enclosing a first emitter group 104a, a second emitter chamber 136b enclosing a second emitter group 104b, a first detector chamber 140 enclosing one detector of the first group of detectors 106a surrounding the first emitter group 104a, a second detector chamber 142 enclosing one detector of the second group of detectors 106b surrounding the second emitter group 104b, and a third detector chamber 138 enclosing one of the detectors 106a/b surrounding a shared group of the first emitter group 104a and the second emitter group 104b located on opposite sides of the third detector chamber 138.

As shown in fig. 10, light from the first emitter group 104a may travel a shorter path, as indicated by the shorter arrow, to the first group of detectors 106a or the shared group of detectors 106a/b; and light from the first emitter group 104a may travel a longer path, as indicated by the longer arrow, to the second group of detectors 106b. The opposite is true for light from the second emitter group 104b, which may travel a shorter path to the second group of detectors 106b or the shared group of detectors 106a/b, and a longer path to the first group of detectors 106a. As described herein, different sets of emitters 104a, 104b and/or detectors 106a, 106b, 106a/b may operate independently and/or simultaneously. Based on the light emitted from the first emitter group 104a and/or the second emitter group 104b, the signals output by the different groups of detectors 106a, 106b, 106a/b may provide different information due to different optical paths that may travel through different regions of tissue. A longer path penetrates deeper into tissue and through a larger volume of tissue to reach the "far" set of detectors than a shorter path, which is less deep into tissue and travels through a smaller volume of tissue to reach the "near" set of detectors. The different information may be separated and/or combined to calculate a plurality of physiological parameters of the wearer of the sensor or module 100, for example, an indication of the hydration state of the wearer, as will be described in more detail below.

Fig. 27E is a front perspective view of an example aspect of a sensor or module 2700 including another example arrangement of an emitter chamber and a detector chamber. The emitter chamber and the detector chamber may comprise one or more light barriers. The chambers shown in fig. 27E include a first emitter chamber 2736a enclosing a first emitter group, a second emitter chamber 2736b enclosing a second emitter group, a first set of detector chambers 2740, a second set of detector chambers 2742, and a third set of detector chambers 2738. Each detector chamber may enclose one detector. The first emitter chamber 2736a and the second emitter chamber 2736b may be adjacent to each other. The first, second, and third sets of detector cells 2740, 2742, 2738 may extend around the first and second emitter cells 2736a, 2736 b.

As shown in fig. 27E, light from the first and second emitter groups in the first and second emitter chambers, respectively, may emit light traveling paths of different lengths, e.g., to different detectors. Light from the first emitter group may travel a shorter path, as indicated by the shorter arrow, to the first group detector cells 2740; and light from the first emitter group may travel a middle path, as indicated by the middle arrow, to the second set of detector cells 2742; and light from the first emitter group may travel a longer path, as indicated by the longer arrow, to the third group of detector cells 2738. The opposite is true for light from the second emitter group, which may travel a shorter path to the third group of detector cells 2738, and an intermediate path to the second group of detector cells 2742, and a longer path to the first group of detector cells 2740.

As described herein, different transmitters may operate independently and/or simultaneously. For example, the emitters may be selectively activated (e.g., modulated) such that only one emitter (or a subset of emitters) is emitting light at a given time. For example, in aspects where the first emitter group includes four emitters, each of the four emitters of the first emitter group may be activated for a quarter period (e.g., a different quarter period than the other emitters) and turned off for the remaining three-quarters period. For example, a first emitter in a first emitter group may be activated to emit light only during a first quarter period, a second emitter in the first emitter group may be activated to emit light only during a second quarter period, a third emitter in the first emitter group may be activated to emit light only during a third quarter period, and a fourth emitter in the first emitter group may be activated to emit light only during a fourth quarter period. The emitters of the second emitter group may operate in a similar manner as described.

As another example, in aspects in which the first emitter group includes four emitters, each of the four emitters of the first emitter group may be activated for one eighth of a period (e.g., one eighth of a period different from the other emitters) and turned off for the remaining seven eighth of a period. An eighth of the periods in which no transmitter is activated may occur between each of the periods in which the transmitter is activated. For example, a first emitter in a first emitter group may be activated to emit light only during a first quarter period, a second emitter in the first emitter group may be activated to emit light only during a third quarter period, a third emitter in the first emitter group may be activated to emit light only during a fifth quarter period, and a fourth emitter in the first emitter group may be activated to emit light only during a seventh quarter period. The emitters of the second emitter group may operate in a similar manner as described.

The above examples are not meant to be limiting. An alternate activation sequence of the transmitter may be used to provide the time division multiplexed signal. In some aspects, the emitters may be selectively activated (e.g., modulated) such that two or more emitters emit light at a given time (e.g., during the same period or during an overlapping period), for example, in a manner similar to the examples given above.

The transmitters may be modulated within a transmitter group (e.g., a first transmitter group and a second transmitter group), or all of the transmitters of the wearable device 10 may be modulated according to a single activation sequence. For example, the transmitters of the first group may be modulated according to one activation sequence, and the transmitters of the second group may be modulated according to a second activation sequence. Alternatively, the transmitters of the first and second transmitter groups may all be modulated according to a single activation sequence.

In some aspects, the detector may operate independently of and/or concurrently with each of the other detectors. For example, each of the detectors may provide a separate signal to the module processor 108.

The signals output by the different detectors of the different detector chambers 2740, 2742, 2738 based on light emitted from the first emitter set and/or the second emitter set may provide different information due to different optical paths that may travel through different regions of tissue. The longer path penetrates deeper into the tissue and through a larger volume of tissue to the detectors of the "far" set of detector cells than the intermediate and shorter paths. The shorter path is less deep into the tissue and travels through a smaller volume of tissue to reach the "near" set of detectors than the intermediate and longer paths. The different information may be separated and/or combined to calculate multiple physiological parameters of the wearer of the sensor or module 2700.

For convenience, the terms "proximal" and "distal" are used herein to describe the structure relative to the first emitter group or the second emitter group. For example, the detector may be located proximal or distal to the first emitter group and may be located proximal or distal to the second emitter group. The term "distal" refers to one or more detectors that are farther from the emitter group than at least some of the other detectors. The term "proximal" refers to one or more detectors that are closer to the emitter group than at least some other detectors. The term "intermediate detector" refers to a detector that is closer to the emitter group than the distal detector and further from the emitter group than the proximal detector. The term "proximal detector" may be used interchangeably with "proximal detector" and the term "distal detector" may be used interchangeably with "distal detector".

A single detector may be both close to one detector and remote from the other detector. For example, the detector may be a proximal detector relative to the first emitter group and may be a distal detector relative to the second emitter group.

Fig. 11A schematically illustrates an example 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 include emitters, detectors, thermistors, and other sensors disclosed herein. The electrical connection between the device processor 14 and the sensor or module processor 108 may optionally be established via the flexible connector 32. The sensor or module processor 108 may optionally be coupled to the ECG electrodes 124, 125 via an ECG flexible connector 123.

The device processor 14 may be connected to the display 12, and the display 12 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 the wirelessly transmitted signal to an external device as described for example with reference to fig. 2. The device processor 14 may include a connection 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. 1D, example 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 buttons, a microphone, and/or a touch screen. User input may instruct the device 10 to turn certain measurements on and/or off, and/or to control an externally connected device, such as an insulin pump, a therapy delivery device, or other device. The device processor 14 may be connected to a user feedback output 15 to provide feedback to the wearer, for example in the form of vibrations, audio signals, and/or other forms. The device processor 14 may optionally be connected to an accelerometer and/or gyroscope 42 located on the device 10 that is different from the accelerometer 114 and gyroscope 112 on the 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, e.g., for sensing that the wearer has been awakened, rotating the display 12, etc.

Fig. 11B shows example components of the device processor 14PCB 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 run the peripheral functions of the device 10, receive user (that is, wearer) input and communicate to the sensor or module processor 108. Bluetooth coprocessor 1400 may be dedicated to managing bluetooth communications in order to allow system processor 1402 to be dedicated to high-memory-utilization tasks, such as managing display 12. The bluetooth coprocessor 1400 may be activated when there is incoming and/or outgoing bluetooth communication. Alternatively, bluetooth coprocessor 1400 may be replaced by a different wireless coprocessor configured to manage wireless communications using a different wireless communication protocol.

Fig. 11C shows example components of the module processor PCB board 116. As shown in fig. 11C, the sensor or module processor 108 may include a computing processor 1080 and a system processor 1082. Computing processor 1080 may manage host communications with device processor 14 via host connector 1084. The calculation processor 1080 may perform algorithmic calculations 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 from other sensors in communication with the sensor or module processor 108. The computing processor 1080 may have a relatively large memory suitable for running the algorithmic computations. The system processor 1082 may be in communication with a Power Management Integrated Circuit (PMIC) 1090. The system processor 1082 may run the physical system of the sensor or module 100 (e.g., including turning on and off the transmitter LEDs, changing gain, setting current, reading the accelerometer 114 and/or gyroscope 112, etc.) and decimating the data to a lower sampling rate. The system processor 1082 may be dedicated to data processing, measurement and diagnosis, and the basic functions of the sensor or module processor 108. The system processor 1082 may allow the computing processor 1082 to sleep (inactive) most of the time and wake up only when there is enough measurement data to perform the computation.

Fig. 11D shows an example front-end analog signal conditioning circuit 1088 of the module PCB 116 shown in fig. 11C. The entire front-end circuit 1088 may be located on a single Application Specific Integrated Circuit (ASIC).

Front-end circuit 1088 may include a transimpedance amplifier 1092 configured to receive an analog signal from an optical sensor comprising emitter 104, detector 106, and temperature sensor 110, which may be pre-processed (e.g., via low-pass filter 1094 and high-pass filter 1096) before being sent to analog-to-digital converter 1098. Analog-to-digital converter 1098 may output digital signals to system processor 1082 and calculation processor 1080 based on analog signals from light sensors (including emitter 104, detector 106, and temperature sensor 110). Front-end circuit 1088 may include a detector cathode switch matrix 1083 configured to activate the cathode of the detector selected to be activated. The matrix 1082 may be further configured to deactivate (e.g., by shorting) anodes of detectors that are selected to be deactivated in configurations where the detectors share a common cathode and have different cathodes.

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

ECG electrode 124 may include a negative electrode, a positive electrode, and a reference electrode. As shown in fig. 12A, two electrodes 124 located on the sensor or module 100 may act as a reference electrode and a negative (or positive) electrode, respectively. As shown in fig. 12B and 12C, the portion of the device housing 101 surrounding the display screen 12 may serve as another ECG electrode 125. The electrically insulating material 127 may separate the ECG electrode 125 from the rest of the housing 101 such that electrical current between the ECG electrode 125 and the ECG electrode 124 will travel through the body of the wearer. When a wearer wants to make measurements using an ECG sensor comprising ECG electrodes 124, 125, the wearer can press or touch electrode 125 using the wearer's finger or another part of the wearer's body so that the wearer's skin is in contact with electrode 125.

In the illustrated example, ECG electrode 125 can be a positive electrode (or a negative electrode if one of electrodes 124 is used as a positive electrode). As shown in fig. 12C, the electrode 125 is shown transparent to show one or more spring contacts 131 located below the electrode 125. The shape, size, and/or number of spring contacts 131 may be different from the example shown in fig. 12C. Spring contacts 131 may establish an electrical connection between electrodes 125 and sensor or module processor 108 of sensor or module 100. For example, spring contact 131 may establish an electrical connection between electrode 125 and connector 132. Spring contact 131 may be biased toward electrode 125 to ensure a secure electrical connection between spring contact 131 and electrode 125. Readings from the electrodes 124, 125 may allow the sensor or module processor 108 to obtain an ECG signal of the wearer and optionally make physiological measurements based on the obtained ECG (e.g., heart rate, respiratory rate, and/or other parameters). The sensor or module processor 108 may communicate the ECG signals and/or ECG related measurements to the wearable device processor 14. The wearer's ECG waveform and/or measurements made by the ECG may be displayed on the display screen 12. Fig. 13A shows 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 a front-end circuit 1088. As described above, the system processor 1802 may output control signals to turn the emitter LEDs on and off. As shown in fig. 13A, the LED driver circuit 1086 may include an emitter switch matrix 1085, the emitter switch matrix 1085 configured to drive any emitter (or group of emitters) selected to be turned on or to turn off any emitter (or group of emitters) selected to be turned off.

Fig. 13B shows an example emitter circuit including eight different emitter LEDs 104. The number of LEDs may vary and may be less than or greater than eight. The transmitter of the physiological parameter measurement module may be configured to transmit a plurality (e.g., three, four, or more) of wavelengths. Each of the emitters may be configured to emit light of a different wavelength than the other emitters. Alternatively, one or more emitters may emit light of more than one wavelength. In the example shown, the emitter circuit may include four drivers to drive eight emitter LEDs. Alternatively, each emitter group of the module may comprise more than four LEDs. Each LED driver may drive an LED to emit light of a different wavelength. For example, for measurement purposes, a device or module may grant access to some LEDs to a third party device. The LED driver may selectively drive some, but not all, of the LEDs.

The transmitter may be configured to emit light of a first wavelength providing an intensity signal that may serve as a reference signal. The first wavelength is more easily absorbed by the human body than the other wavelengths of light emitted by the emitter. The reference signal may be stronger and less likely to be affected by noise than signals from other wavelengths transmitted by the transmitter. The physiological parameter measurement sensor or module processor may use the reference signal to extract information from other signals, such as information related to and/or indicative of pulse rate, harmonics, or other. The physiological parameter measuring sensor or module processor may collectively analyze the extracted information to calculate the physiological parameter of the wearer. The inclusion of the reference signal may reduce power consumption and extend battery life of the device. The first wavelength may be about 525nm to about 650nm, or about 580nm to about 585nm, or about 645nm to about 650nm, or about 525nm, or about 580nm, or about 645nm. The light providing the reference signal may have an orange or yellow color. Alternatively, the light providing the reference signal may have a green color.

The emitter may be configured to emit light having a second wavelength of red. The second wavelength may be about 620nm to about 660nm. The light of the second wavelength may be more sensitive to changes in oxygen saturation (SpO ₂) than the light of the other wavelengths emitted by the emitter. The second wavelength is preferably closer to 620nm (e.g., about 625 nm), which results in greater absorption by the wearer's body tissue, and thus a stronger signal and/or a steeper curve in the signal, than a wavelength closer to 660nm. The physiological parameter measurement sensor or module processor 108 can extract information, such as a volumetric waveform, from the signal at the second wavelength.

The emitter may be configured to emit light having a third wavelength of about 900nm to about 910nm, or about 905nm, or about 907 nm. The third wavelength may be in the infrared range. The sensor or module processor may use the third wavelength as a normalized wavelength when calculating the ratio of the intensity signals of other wavelengths, such as the ratio of the intensity signals of the second wavelength (red) to the third wavelength (infrared).

Additionally or alternatively, the emitter may be configured to emit light having a fourth wavelength that is more sensitive to changes in water than the remaining emission wavelengths. The fourth wavelength may be in the infrared range and about 970nm. The physiological parameter measurement sensor or module processor may determine a physiological parameter such as the hydration state of the wearer based at least in part on a comparison of the fourth wavelength and the intensity signals of different wavelengths detected by certain detectors. The detectors used for hydration monitoring may be located a predetermined distance from the emitter (that is, as the "far" detectors disclosed herein) such that light travels through a depth of tissue before being detected by those detectors.

The transmitters in the physiological parameter measurement sensor or module may be placed in two transmitter groups. Each emitter group may include four emitter LEDs configured to emit at the first, second, third, and fourth wavelengths described above. The emitters in the same emitter group may be located 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.

In some aspects, the driver may drive the emitter at different intensities. The intensity at which the driver drives the emitter may affect the amount of light output (e.g., lumens), the intensity of the light signal output, and/or the distance traveled by the light output. The driver may drive the emitters at different intensities according to modeling, logic, and/or algorithms. Logic and/or algorithms may be based at least in part on various inputs. The input may include historical data, an amount of attenuated light (e.g., as light penetrates and travels through the wearer's tissue), or an amount of blood interacting with the light, or a blood type (e.g., vein, artery) or vessel type (e.g., capillary, arteriole) interacting with the light, and/or heat generated by the emitter. For example, the drivers may increase the intensity at which they drive the emitters based on a determination that too much light is attenuated in the tissue or that the light does not interact with enough blood. As another example, the drivers may decrease the intensity at which they drive the emitters based on a determination that the emitters have exceeded a threshold temperature. The threshold temperature may be a temperature that may be uncomfortable for human skin.

In some aspects, each of the drivers may be capable of driving a corresponding emitter at various intensities independent of the other drivers. In some aspects, each of the drivers may drive a corresponding emitter at various intensities in concert with each of the other drivers.

In addition, various LEDs may be used in various aspects. For example, some LEDs may be used that are capable of outputting more light at the same amount of power as other LEDs. These LEDs may be more expensive. In some aspects, cheaper LEDs may be used. In some aspects, combinations of various types of LEDs may be used.

Fig. 13C shows an example detector circuit including fourteen detectors 106. The total number of detectors on a module may vary. Fourteen detectors may form seven detector groups, each group comprising two detectors. The number of detectors in each set may be different. The detectors of the same detector set may be located in the same detector chamber as disclosed herein. Each detector group may output a signal, which may be a combined signal of two detectors in the same group. As shown in fig. 13C, the detectors may share a common anode, but have seven different cathodes corresponding to the seven detector groups.

Fig. 13D shows an example thermistor circuit. In the illustrated example, the physiological parameter measurement module may include two thermistors 110. The two thermistors may be located in two emitter chambers proximate to the two emitter groups, respectively.

Example Signal processing of physiological parameter measurement Module

Fig. 14A and 14B depict 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) and a microcontroller that provides system management. As shown in fig. 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 engineSST ^TM and MST ^TM are used to separate arterial signals from noise sources, including venous signals, to accurately measure SpO ₂ and pulse rate, even during exercise. Fig. 14B depicts a general functional block diagram of operations performed on 20Khz sample data from an analog-to-digital converter (ADC) into a digital signal processing system. As shown in fig. 14B, the DSP first performs demodulation, as represented in demodulation block 400. The processor performs decimation on the resulting data from demodulation, as represented in decimation module 402. The processor calculates certain statistics, as represented in statistics module 404, and performs a saturation transformation on the data resulting from the decimation operation, as represented in saturation transformation module 406. The processor forwards the statistically processed data and the saturation transformed processed data to a saturation operation (as represented by the saturation calculation module 408) to output an oxygen saturation measurement and a pulse rate operation (as represented by the pulse rate calculation module 410) to output a pulse rate value.

15A-15G illustrate example signal processing of the physiological parameter measurement sensors or modules disclosed herein. As shown in fig. 15A, the sensor or module processor may receive the intensity signal from the detector, as well as the signals from the gyroscope and accelerometer, in response to the detection of reflected light of the first wavelength (reference signal or green or yellow signal), the second wavelength (red signal), the third wavelength (infrared signal), and the fourth wavelength (infrared signal having a wavelength of 970 nm) as described above. The sensor or module processor may output a plurality of physiological parameters based on input signals from the sensor. The plurality of physiological parameters may include, for example, spO ₂ (Sat), pulse Rate (PR), perfusion Index (PI), volume variation index (PVI), volume respiration rate (RRp), and hydration index.

As shown in more detail in fig. 15B, the sensor or module processor may process the intensity signals in response to the detected light of the first, second, and third wavelengths in non-normalized and normalized form (in normalized modules "Norm"1500, "Norm 1"1502, and "Norm 2" 1504). As described above, the signal of the third wavelength may be used as a normalized signal. The sensor or module processor may extract various information from the intensity signal in response to the detected light at the first, second, and third wavelengths and signals from the accelerometer and gyroscope in the pulse rate determination module 1506, such as PR (which may be output as a PR measurement), time Domain (TD) saturation information, frequency Domain (FD) saturation information, PI information, and PVI information.

Fig. 15C illustrates example processing of raw signals from an accelerometer and a gyroscope to output gyroscope and accelerometer signals. The sensor or module processor may combine each of the raw gyroscope and accelerometer signals (which may be raw signals from any axis of the gyroscope and/or accelerometer) with the gyroscope/accelerometer time and volume time signals in interpolation module 1518 or interpolation 1 module 1520, respectively. The sensor or module processor may further process the output from interpolation module 1518 or interpolation 1 module 1520 in low pass filter and decimator module 1522 or low pass filter and decimator 1 module 1524, respectively, to output a gyroscope 1 signal and an accelerometer 1 signal. The output gyroscope 1 and accelerometer 1 signals may be sent to the ASIC described above.

As shown in fig. 15D, the sensor or module processor may extract motion information from the gyroscope and accelerometer inputs and the normalized signals of the first, second, and third wavelengths in the Interference Mitigation (IM) and motion analysis module 1526. As also shown in fig. 15D, a sensor or module processor may 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 may 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 decision logic 1532 based on TDPR information, FDPR information, interference Mitigation (IM) PR information (output by interference mitigation and motion analysis module 1526), and motion information.

Fig. 15E illustrates example pulse rate determination decision logic. In this example, the decision logic level 2 module 1534 may receive as input raw pulse rate calculations from various pulse rate determination engines (e.g., time domain pulse rate determination module 1528, frequency domain pulse rate determination module 1530, and interference mitigation and motion analysis module 1526, as shown in fig. 15D), volume features including time and frequency domains from N channels (e.g., n=4 or more) volume signals, and motion features obtained from the motion analysis module 1536. The motion analysis module 1536 may evaluate the amount of motion based on motion information from a 6DOF (degree of freedom) Inertial Measurement Unit (IMU), define the type of motion, calculate the rate of motion (e.g., per minute) (if motion is determined to be periodic), and so forth. The IMU may include accelerometers and gyroscopes on a physiological parameter measurement module.

With continued reference to fig. 15B, the sensor or module processor may determine an oxygen saturation measurement in an oxygen saturation determination module 1508 based on the normalized signal of the third wavelength, the normalized signal of the second wavelength, the TD saturation information, the FD saturation information, the PR, and the motion information. Fig. 15F illustrates an oxygen saturation determination module, such as a seed saturation module 1538, SST saturation module 1540, DST saturation module 1542, interference Mitigation (IM) saturation module 1544, and signal/noise reference saturation module 1546, including a plurality of parallel signal processing engines configured to feed respective raw oxygen saturation (SpO ₂) values to decision logic 1548. Decision logic 1548 may further receive motion information as input and output a final oxygen saturation measurement based on the motion information and the raw oxygen saturation value determined by the parallel engine.

FIG. 15E illustrates example oxygen saturation determination decision logic. In this example, the saturation decision logic level 2 module 1550 may receive as inputs the raw oxygen saturation calculations, the volume characteristics, the pulse rate, and the motion characteristics obtained from the motion analysis module 1552 from the parallel engines described above. The volumetric characteristics received by module 1550 may include the characteristics in the pulse rate decision logic shown in fig. 15E. Additionally, the volumetric characteristic received by the module 1550 may include a saturation-related characteristic, such as a DC ratio of the second wavelength and the third wavelength. The motion analysis module 1552 may receive the same features as the pulse rate decision logic shown in fig. 15E.

With continued reference to fig. 15B, the sensor or module processor may determine a PI measurement based on the normalized signal at the third wavelength and PI information in the perfusion index determination module 1510. The sensor or module processor may determine PVI measurements based on the PVI information in the volume variation index determination module 1512. The sensor or module processor may determine an RRp measurement in the respiration rate determination module 1514 based on the intensity signals of the first wavelength and the second wavelength. The sensor or module processor may determine a hydration index in a hydration determination module 1516 based on an intensity signal (e.g., from a "far detector" as disclosed herein) of a fourth wavelength that is more sensitive to changes in water in the measurement site and another wavelength that is less sensitive to changes in water (e.g., the third wavelength or about 905 nm). The sensor or module processor may focus on the DC component of the signal for hydration state monitoring.

Various example physiological parameter measurement modules and wearable devices incorporating the modules are described below. Each of the example modules and devices may incorporate any of the features of the physiological parameter measurement module 100 and device 10 described above, and for brevity, all of these features will not be repeated. Features of example modules and apparatus disclosed herein may be combined with one another.

Examples of physiological parameter measurement modules for dual emitter sets

Fig. 16A schematically illustrates an example arrangement of an optical sensor including an emitter, detector and thermistor on a sensor or module processor PCB 116. As shown in fig. 16A, PCB 116 may include a first set of emitters 104a and a second set of emitters 104b. Each set of transmitters may include four transmitters. The emitters in each set 104a, 104b may emit at least first, second, third, and fourth wavelengths as described above. The first set of emitters 104a and the second set of emitters 104b may be located at a distance from each other on a first side of the PCB 116. The PCB 116 may include a temperature sensor (such as a thermistor) 110 located on a first side of the PCB 116 as described above. One temperature sensor 110 may be near the first set of emitters 104 a. Another temperature sensor 110 may be near the second set of emitters 104b.

The shape of the PCB 116 may be elliptical, but the shape of the PCB is not limited. The two sets of emitters 104a, 104b may be located on different portions of a first side of the PCB 116 divided along the minor diameter of the ellipse. Each of the two sets of emitters 104a, 104b may be surrounded by a first light blocking layer and form an emitter chamber.

The first set of emitters 104a and the second set of emitters 104b may be surrounded by two rings of detectors 106a, 106b that are separated from the first set of emitters 104a and the second set of emitters 104b, respectively. The two rings of detectors 106a, 106b may share multiple (e.g., two or more) detectors 106a/b that are common to the two rings. The detector 106a/b common to both rings may be positioned along the minor axis of the ellipse. In the illustrated example, the PCB 116 may include fourteen detectors coupled to the PCB 116, but the total number of detectors may vary.

The detector 106b may be a far detector of the first set of emitters 104a and the detectors 106a, 106a/b may be near detectors of the first set of emitters 104 a. The detector 106a may be a far detector of the second set of emitters 104b and the detectors 106b, 106a/b may be near detectors of the second set of emitters 104 b. Thus, each detector 106a, 106b, 106a/b may receive two signals at each wavelength emitted by the first set of emitters 104a and the second set of emitters 104b, respectively. As described above, the signals output by the far and near detectors may provide different information due to the different optical paths that may travel through different regions of tissue. In addition, the far detectors of each set of emitters 104a, 104b may detect light emitted by the respective set of emitters 104a, 104b, e.g., light of a fourth wavelength and another wavelength, and attenuated by tissue to provide an indication of hydration state of the wearer as described herein.

The detectors 106a, 106b, 106a/b may be separated or divided into seven detector areas. Each detector area may comprise two detectors or any other number of detectors. Each detector region may form a detector chamber surrounded by a light blocking layer. As described above, the sensor or module processor may process signals from a particular emitter and received at a detector within the same detector area as one signal source. Thus, for each wavelength, the sensor or module processor may receive data from a total of fourteen signal sources, with the two detectors from each detector region acting as far and near detectors, respectively, of different sets of emitters.

Fig. 16B-16D illustrate an example physiological parameter measurement module 400 of a wearable device. Module 400 may incorporate any of the features of the module examples described herein.

As shown in fig. 16B, the physiological parameter measurement module 400 may include a first set of transmitters 404a and a second set of transmitters 404B that incorporate the arrangement shown in fig. 16A. Each group of emitters may comprise four emitters (or alternatively a different number of emitters, such as six or eight emitters). The emitters in each group 404a, 404b may emit at least first, second, third, and fourth wavelengths as described above. Each of the two sets of emitters 404a, 404b may be surrounded by a first light blocking layer 420 and form an emitter chamber.

The first set of emitters 404a and the second set of emitters 404b in the module 400 may be surrounded by two rings of detectors 406a, 406b that are separated from the first set of emitters 404a and the second set of emitters 404b by a first light blocking layer 420. The two rings of detectors 406a, 406b may share multiple (e.g., two or more) detectors 406a/b that are common to the two rings. The detectors 406A, 406b, 406A/b may have the same arrangement as the detectors shown in fig. 16A. In the example shown, module 400 may include fourteen detectors, but module 400 may include a different total number of detectors.

As shown in fig. 16B and 16D, the detectors 406a, 406B, 406a/B may be separated or partitioned into seven detector cells by a portion of the first light blocking layer 420 and the second light blocking layer 422. Each detector area may include two detectors, or any other number of detectors. Along the periphery of the module 400, the detectors 406a, 406b, 406a/b may be enclosed within the module sidewall 424. The sensor or module processor of module 400 may process signals from a particular emitter as well as signals received at a detector within the same detector area as the one signal source. The arrangement of the emitters 104a, 104b and detectors 106a, 106b, 106a/b and the light diffusing material enclosing the emitters 104a, 104b and/or detectors 106a, 106b, 106a/b may improve the sensing coverage on the wearer's wrist, which has fewer capillaries per unit volume than fingertips as described above. The total light detection area of 106a, 106B, 106a/B in fig. 16B (that is, the total surface area of all detector cells) may occupy about 50% or more of the tissue-facing surface of the physiological parameter measurement module. The total light detection area in fig. 16B may be, for example, greater than about 100mm ², or greater than about 125mm ², or about 150mm ², or about 165mm ². The total light emitting area (that is, the total surface area of the two emitter chambers) in fig. 16B may be, for example, greater than about 25mm ², or about 30mm ², or about 35mm ². Any other example physiological parameter measurement module disclosed herein can have a total light detection area and/or light emitting area that is the same or substantially similar to module 400 shown in fig. 16B.

On a first side of PCB 416, module 400 may be enclosed by a curved light transmissive cover 402 having a convex protrusion. As shown in fig. 16C, the cover 402 may have a continuous curvature. The first light blocking layer 420 and the second light blocking layer 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 blocking layers 420 and 422 and the sidewalls 424 may generally follow the curvature of the cover 402. The sidewall 424 may be shorter than the second light blocking layer 422. The height of the second light blocking layer 422 may increase from the perimeter of the module 400 toward the center of the module 400 until the second light blocking layer 422 merges with the first light blocking layer 420, which first light blocking layer 420 is the highest of the light blocking layers. The light blocking layers 420, 422 may 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 the device incorporating the module 400, the tissue-facing surfaces of the first and second light blocking layers 420, 422 and the sidewall 424 may be configured to contact the skin of the wearer. Cover 402 may include a separate lens or cover such as shown in fig. 7D, or a combination of a separate emitter chamber and a lens or cover covering multiple detector chambers such as shown in fig. 7C. The lens or cover may be polycarbonate. The tissue-facing surface of the module 400 may include a continuous convex curvature.

The first and second light blocking layers 420 and 422 and the sidewalls 424 may optionally form a single light blocking layer configuration. The individual light blocking layer constructions may be formed by any suitable fabrication technique and any suitable material, such as plastic, colored or opaque sapphire glass, or other materials. The single light blocking layer configuration may include a recess at one end that is shaped and sized to receive PCB 416, including electronics on PCB 416. The first side of the PCB 416 may include emitters 404a, 404b, detectors 406a, 406b, 406a/b, temperature sensor 410, and any other sensor, such as gyroscopes, accelerometers, etc. The second side of the PCB 416 may include a sensor or module processor and other circuit hardware.

As described above, module 400 may include multiple chambers such that light cannot travel between the chambers due to various light blocking layers extending from PCB 416 to the tissue-facing surface of cover 402 as described herein. The light diffusing material described above may be added over and around the emitters 404a, 404b (e.g., via fill holes as described herein) and/or optionally over and around the detectors 406a, 406b, 406a/b to improve the distribution of emitted and/or detected light after tissue attenuation. The light diffusing material may include a flow of glass microsphere solution that may be injected into the chamber after the module 400 is assembled. After the solutions are injected into the respective chambers, the solutions may be UV cured. When the diffusion material solution is injected into the respective chamber via the injection opening, air may escape via the exhaust openings disclosed herein, making it easier for the glass microsphere solution to flow into the respective chamber. Cover 402 may also include glass microspheres. The light diffusing material in the cover 402 and inside the emitter chamber and/or the first light blocking layer 420 may cause the emitted light to leave the emitter chamber enclosing the emitters 404a, 404b in a direction generally parallel to the height of the first light blocking layer 420. The light diffusing material in the cover 402 and the detector chamber may increase the amount of reflected light that is directed to and detected by the detectors 406a, 406b, 406 a/b.

Fig. 16E-16G illustrate an example physiological parameter measurement module 401 of a wearable device. The module 401 may include the same optical sensor arrangement as shown in fig. 16A-16D and have any of the features of the module 400 in fig. 16B-16D, with differences noted in the description of fig. 16E-16G. The module 401 may have any of the features of the other physiological parameter measurement module examples described herein.

The module 401 may include a generally circular outer shape. The generally circular outer shape may be defined by an opaque frame 426 extending from a first side of the PCB 416 to above the PCB 416. The opaque frame 426 may have a height such that a top side of the opaque frame 426 may be generally flush (or slightly backed or protruding) with a second side of the PCB 416. As shown in fig. 16G, the shape of PCB 416 may be generally circular. The opaque frame 426 may be generally concentric with the PCB 416. The opaque frame 426 and the PCB 416 are opaque. The opaque frame 426 in fig. 16E and 16F may include the first light blocking layer 420 and the second light blocking layer 422 as a unitary piece.

The module 401 may include one or more (e.g., two or other) ECG electrodes 424. In the example shown in fig. 16E-16G, one of the ECG electrodes 424 may be a reference electrode, while the other of the ECG electrodes 424 may be a negative or positive electrode. The opaque frame 426 may have a recess similar in shape and size to the recess on the opaque frame 126 shown in fig. 7D to receive the electrode 424. 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 light transmissive cover 402. As shown in fig. 16G, the top side of the electrode 424 may have one or more posts 437 extending through openings in the opaque frame 426 into corresponding openings on the PCB 416. The posts 437 of the electrode 424 may establish electrical connection with corresponding openings of the PCB 416. A plurality of screws (or other types of fasteners) may extend from the front side of PCB 416 into corresponding openings of PCB 416 to secure electrodes 424 to module 401 by threaded engagement with the posts. When the wearer wears the wearable device incorporating module 401 on the wearer's wrist, electrodes 424 may contact the wearer's skin. Electrode 424 may have the same polarity as electrode 124 disclosed herein. As disclosed herein, the wearable device incorporating module 401 may include another ECG electrode 125 located on a housing of the wearable device configured to contact the skin of the wearer.

On a second side of PCB 416 facing away from cover 402, PCB 416 may be covered with a molten plastic or other suitable electronic protective material 430 (similar to protective material 130 disclosed herein), except that flexible connector 432 may remain exposed. The flexible connector 432 may be configured to electrically connect the module 401 to a wearable device incorporating the module 401.

Fig. 17A-17C illustrate an example physiological parameter measurement module 403 of a wearable device. The module 403 may include the same optical sensor arrangement as shown in fig. 16A-16G and have any of the features of the module 400 in fig. 16B-16D and any of the features of the module 401 in fig. 16E-16G, with the differences noted in the description of fig. 17A-17C. The module 401 may have any of the features of the other physiological parameter measurement module examples described herein.

As shown in fig. 17A-17C, the opaque frame 426 may include an opening that mates with the light transmissive cover 402. Cover 402 extends over an emitter or detector chamber formed by light blocking layers 420, 422, 423 and PCB 415 may include a single lens or cover. The shape of cover 402 may be elliptical. Cover 402 may have a continuous convex curvature. As shown in fig. 17C, the light blocking layers 420, 422, 423 may not extend to the tissue-facing surface of the cover 402 and may extend below the cover 402 such that when the wearable device incorporating the module 402 is worn by a wearer, the wearer's tissue is in contact with the cover 402 and the electrode 424, but not with any of the light blocking layers 420, 422, 423.

Fig. 18A-19C illustrate other non-limiting examples of physiological parameter measurement modules having two emitter groups in two separate emitter chambers formed by light blocking layers. In these configurations, the perimeter of the module may have different shapes. For example, fig. 19A schematically illustrates a module 300 having an outer shape of two circles partially overlapping each other. The circles in the module 300 may have a radius of, for example, between about 6mm and about 12mm or between about 8mm and about 10 mm. The module 300 may have any of the features of the other modules disclosed herein. The module 300 may comprise an arrangement of emitters 300a, 300b and detectors 306a, 306b, 306a/b substantially identical to the modules 400, 401, 403 described above, except that each emitter group 304a, 304b comprises three emitters. The module 300 may include a thermistor proximate each emitter group 304a, 304 b. The module 300 may have a length of, for example, between about 22mm and about 28mm or between about 24mm and about 26 mm.

Fig. 18B illustrates a physiological parameter measurement module 301 that includes a variation of the arrangement of emitters and detectors of module 300 in fig. 18A, and may include any feature of module 300 other than the differences described herein. The module 301 differs from the module 300 in that the detector located between the two sets of emitters 304a, 304b is not shared. The first set 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 set of emitters 304b may be surrounded by a second ring of detectors 306b on a second side of the minor axis A2.

Fig. 19A shows a physiological parameter measurement module 201 that includes a variation of the arrangement of emitters and detectors of module 300 in fig. 18A. The physiological parameter measurement module 201 can have any of the features of module 300, with differences noted in the description of fig. 19A. The module 201 may have any of the features of the other modules disclosed herein. In block 201, the two overlapping circles of detectors 206a, 206b are closer to each other than in block 300. The detectors 206a/b may be farther from each other than in the module 300 and may not be located between the two emitter groups 204a, 204b or separate the two emitter groups 204a, 204b. The module 201 may comprise two sets of emitters separated from each other by a light blocking layer. Each of the detectors in module 201 may form its own detector chamber with one or more light blocking layers. The circle may have a radius of, for example, between about 6mm and about 12mm or between about 8mm and about 10 mm. The module 300 may have a length of, for example, between about 18mm and about 24mm or between about 20mm and about 22 mm.

Fig. 19B and 19C show a modification of the module 201 in fig. 19A, the differences of which are pointed out in the descriptions of fig. 19B and 19C. The module 200 in fig. 19B and 19C may have any of the features of the module examples described herein. In fig. 19B and 19C, the physiological parameter measurement module 200 can include two sets of emitters 204a, 204B surrounded by a ring of detectors 206. The module 200 may have a width of, for example, between about 16mm and about 22mm or between about 18mm and about 20 mm. The module 200 may have a length of, for example, between about 20mm and about 28mm or between about 22mm and about 25 mm.

Each set of transmitters 204a, 204b may include three transmitters. Each set 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 transmitter may be located at or near a central portion of the PCB 216 of the module 200. The module 200 may include temperature sensors located on the PCB 216 proximate to each set of emitters 204a, 204 b.

The emitter may be covered by an inner lens or cover 202 a. In the example shown, 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 sets of emitters 204a, 204b may be located on two portions of the central portion of the PCB divided along the minor diameter of the ellipse. The two sets of emitters 204a, 204b may be separated by an opaque separation barrier 228, which may reduce the mixing of light emitted by the two sets of emitters 204a, 204 b. As shown in fig. 19C, when assembled in module 200, separation barrier 228 may have the same or substantially the same height as the highest point of inner lens or cover 202 a. The inner lens or cover 202a may include two components separated by a separation barrier 228.

The module 200 may include a plurality of detectors 206 (e.g., about six, eight, ten, or more) that may be arranged on a PCB such that the detectors 206 are spaced around the emitters 204a, 204 b. The emitter groups 204a, 204b and the detector 206 may be separated by a first light blocking layer 220. The first light blocking layer 220 may extend along the inner lens or cover 202a and surround the inner lens or cover 202a. The separation barrier 228 and the first light blocking layer 220 may form two emitter chambers 234a, 234b, each enclosing one of the two emitter groups 204a, 204 b. The first light blocking layer 220 and the separation blocking layer 228 may also suppress light emitted by the emitters 204a, 204b at an angle such that light emitted by each set of emitters 204a, 204b may exit the inner lens or cover 202a in a direction generally parallel to the height of the first light blocking layer 220. The detector 206 may be enclosed within a module sidewall 224. The module side walls 224 may define a perimeter of the module 200. As shown in fig. 19B, the perimeter of the module 200 may have a generally oval shape. The detectors 206 may be further separated from one another by a plurality of separation barriers 226 to form detector cells 236, each containing one detector 206.

As shown in fig. 19C, the first light blocking layer 220 may protrude slightly from, that is, protrude from, the edge of the inner lens or cover 202a and other lenses or covers to be described below. The detector 206 may be covered by an outer lens or cover 202 b. The outer lens or cover 202b may be generally concentric with the inner lens or cover 202 a. In the example shown, the outer lens or cover 202B may be an elliptical disk, as shown in fig. 19B. In other examples, such as those disclosed herein, the outer lens or cover may have other shapes. As shown in fig. 19C, the outer lens or cover 202b may have a smaller curvature than the inner lens or cover 202a, such that the inner lens or cover 202a protrudes more than if the inner lens or cover had the same curvature as the outer lens or cover 202 b.

As shown in fig. 19C, the sidewall 224 may be shorter than the first light blocking layer 220. The height of the sidewall 224 may be configured such that the tissue-facing end of the sidewall 224 is generally continuous with the curvature of the outer lens or cap 202 b. The separation blocking layer 226 may have a lower height than the first light blocking layer 220. The height of the separation barrier 226 may 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 sidewall 224. The tissue-facing ends of the first light blocking layer 220 and the side walls 224 and the tissue-facing surfaces of the inner lens or cover 202a and the outer lens or cover 202b may form the tissue-facing surfaces of the module 200. The slightly protruding first light blocking layer 220 and/or the inner lens or cover 202a may be pressed into the skin of the wearer with a higher pressure than the rest of the lens or cover or light blocking layer.

The light diffusing material described above may 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 may include injection openings 244 such that light diffusing material, which may include a stream of glass microsphere solution, may be injected into the respective chambers 234a, 234B, 236 after the module 200 is assembled. After injection, the solution may be UV cured. The lenses or caps 202a, 202b may include one or more vent openings that are smaller than the injection openings 244. When the diffusion material solution is injected into the respective chamber 234a, 234b, 236 via the injection opening 244, air may optionally escape via a separate exhaust opening. The inner lens or cover 202a and the outer lens or cover 202b may also include glass microspheres to act as a light diffuser.

Fig. 27A-27J illustrate other non-limiting examples of a physiological parameter measurement module 2700 of a wearable device. Module 2700 may incorporate any of the features of the module examples described herein. Fig. 27F shows an example arrangement of optical sensors (including emitters, detectors, and thermistors) on a sensor or module processor substrate 2716. Substrate 2716 may include a Printed Circuit Board (PCB). As shown in fig. 27F, substrate 2716 may include a first set of emitters 2704a and a second set of emitters 2704b. Each of the first set of emitters 2704a and the second set of emitters 2704b can include four emitters (or alternatively a different number of emitters, such as three, six, or eight emitters or any other number of emitters as needed or desired). Each of the emitters in the first set of emitters 2704a and the second set of emitters 2704b may include an LED.

The emitters of the first set of emitters 2704a and the second set of emitters 2704B may include operational and/or structural features discussed above, for example, with reference to fig. 13A-13B. For example, the first set of emitters 2704a and the second set of emitters 2704b may be configured to emit multiple (e.g., three, four, or more) wavelengths. In some aspects, each of the emitters (e.g., within a group) may be configured to emit light of a different wavelength than the other emitters (e.g., in the group). Alternatively, one or more emitters may emit light of more than one wavelength. The emitters of the first set of emitters 2704a and the second set of emitters 2704B may emit at least first, second, third, and fourth wavelengths as described above with reference to fig. 13B.

Each emitter of the first set of emitters 2704a may be positioned immediately adjacent to each other emitter of the other emitters of the first set of emitters 2704 a. For example, each of the emitters in the first set of emitters 2704a may be located between 0.2mm and 2mm on the PCB from each of the other emitters in the first set of emitters 2704 a. For example, each of the emitters in the first set of emitters 2704a may be located about 0.5mm on the PCB from each of the other emitters in the first set of emitters 2704 a. In some aspects, each of the emitters in the first set of emitters 2704a is positioned such that the distance between each of the emitters in the first set of emitters 2704a does not exceed a distance, such as 0.5mm, 1mm, 1.5mm, and/or 2mm, or any other distance as needed or desired. Each of the transmitters in the second set of transmitters 2704b may be positioned immediately adjacent to each of the other transmitters in the second set of transmitters 2704b, for example as described above with reference to the first set of transmitters 2704 a.

Each of the two sets of emitters 2704a, 2704b may be surrounded by a first light blocking layer and form an emitter chamber for the set of emitters 2704a and 2704b, respectively. The first set of emitters 2704a and the second set of emitters 2704b can be located at a distance from each other on a first side of the substrate 2716. Substrate 2716 may include one or more temperature sensors (e.g., thermistors) 2710 located on a first side of substrate 2716 as described above. One temperature sensor 2710 may be located near a first set of emitters 2704a within a respective emitter chamber. Another temperature sensor 2710 may be located near a second set of emitters 2704b within the respective emitter chamber.

The shape of the substrate 2716 may be circular, but the shape of the PCB is not limited. The two sets of emitters 2704a, 2704b may be located on different portions of a first side of the substrate 2716 divided along the centerline of a circle. Each of the two sets of emitters 2704a, 2704b may be surrounded by a first light blocking layer and form an emitter chamber.

The first set of emitters 2704a and the second set of emitters 2704b may be surrounded by a detector 2706. As described in more detail with reference to fig. 27A, detectors 2706 may be positioned in a substantially circular or annular arrangement on substrate 2716. The detector 2706 may surround and/or enclose the first set 2704a and the second set 2704b. Each of the detectors may be a similar or identical distance from the geometric center of substrate 2716 and/or sensor or module 2700. In some aspects, detector 2706 may be rectangular including longer sides and shorter sides. The detectors 2706 may be positioned on the substrate 2716 such that the long side of each detector is orthogonal to the radius of the substrate 2716. In the example shown, substrate 2716 includes six detectors coupled to substrate 2716, but the total number of detectors may vary.

The detector 2706b may be a far detector of the first set of emitters 2704 a. The detector 2706a may be a near detector of the first set of emitters 2704 a. The detector 2706a may be a far detector of the second set of emitters 2704 b. The detector 2706b may be a near detector of the second set of emitters 2704 b. The detector 2706c may be an intermediate detector of the first set of emitters 2704a and the second set of emitters 2704 b. Thus, each detector 2706a, 2706b, 2706c may receive two signals for each wavelength emitted by the first set of emitters 2704a and the second set of emitters 2704b, respectively. As described above, the signals output by the far detector, the near detector, and the intermediate detector may provide different information due to the different optical paths that may travel through different regions of tissue.

In some aspects, the sensor or module processor may evaluate the various signals output by the detector, for example, by comparing the signal quality of the detector. The sensor or module processor may select less than all of the detector signals to process each of the far detector, the near detector, and the intermediate detector. For example, the sensor or module processor may rely on signals from one or two of four possible far detectors, one or two of four possible near detectors, and one or two of four possible intermediate detectors.

In addition, the far detectors of each set of emitters 2704a, 2704b may detect light emitted by the respective set of emitters 2704a, 2704b, e.g., light of a fourth wavelength and another wavelength, and attenuated by tissue to provide an indication of hydration status of the wearer as described herein.

The detectors 2706a, 2706b, 2706c may be separated or divided into six detector areas. Each detector area may comprise one detector or any other number of detectors. Each detector region may form a detector chamber surrounded by a light blocking layer (as shown in fig. 26E). As described above, the sensor or module processor may process signals from a particular emitter and received at a detector within the same detector area as one signal source.

Module 2700 may include a separate lens or cover or a combination of a separate emitter chamber covering a lens or cover and a lens or cover covering multiple detector chambers. The lens or cover may be polycarbonate. The tissue-facing surface of the module 2700 can include a continuous convex curvature.

Fig. 27I shows another example arrangement of optical sensors (including emitters, detectors, and thermistors) on a sensor or module processor substrate 2716'. Substrate 2716' of fig. 27I may include structural and/or operational features similar to those discussed above with reference to fig. 27F. As shown in fig. 27I, each of the first set of emitters 2704a 'and the second set of emitters 2704b' may include five emitters (or alternatively a different number of emitters as needed or desired). Each of the emitters in the first set of emitters 2704a 'and the second set of emitters 2704b' may include LEDs and may be configured to emit light at various wavelengths, such as any of the wavelengths discussed herein, for example, a first wavelength of about 525nm to about 650nm (such as about 525nm or about 580nm or about 645 nm), a second wavelength of about 620nm to about 660nm (such as about 625 nm), a third wavelength of about 650nm to about 670nm (such as about 660 nm), a fourth wavelength of about 900nm to about 910nm, and a fifth wavelength of about 970 nm.

As shown in fig. 27I, substrate 2716' may include spring contacts 2755' for facilitating physical and/or electrical connection between substrate 2716' and an electrode (e.g., electrode 2724 shown in fig. 27B).

As shown in fig. 27G-27H, on a second side of substrate 2716 facing away from the cover, substrate 2716 may be covered with molten plastic or other suitable electronic protective material 2730 (similar to protective material 130 disclosed herein), except that flexible connector 2732 may remain exposed. The flexible connector 2732 may be configured to electrically connect the module 2700 to a wearable device that incorporates the module 2700.

Fig. 27J illustrates a perspective cross-sectional view of an example physiological parameter measurement sensor or module 2700. As shown, sensor or module 2700 can include a first circuit board (e.g., substrate 2716) and a second circuit board (e.g., instrument PCB 2768). The sensor or module 2700 may include an induction coil 2765. Induction coil 2765 may be electrically and/or physically connected to substrate 2716, for example, via solder and/or flexible connector connection 2762. The induction coil may provide a voltage to substrate 2716, for example, via solder and/or flexible connector connection 2762. Substrate 2716 may include a charging circuit that may be configured to receive and/or control the voltage received from inductive coil 2765. Substrate 2716 may be configured to transmit voltages received from induction coil 2765 to instrument PCB 2768, for example, via flexible connector 2761. Instrument PCB 2768 may be configured to transmit the voltage received from substrate 2716 to a battery or sensor or other component of module 2700 as needed or desired.

Examples of physiological parameter measurement modules with internal and external detector sets and examples of wearable devices incorporating the same

Fig. 20A-20D illustrate an example physiological parameter measurement module 600 of a wearable device. The module 600 may have any of the features of the module examples described herein, with differences noted in the descriptions of fig. 20A-20D. The physiological parameter measurement module 600 can include a single emitter group having a plurality of emitters 604, such as four emitters, six emitters, or eight emitters as shown in fig. 20A. The transmitter 604 of the module 600 may transmit at least the first, second, third, and fourth wavelengths as described above. The transmitter 604 may be located at or near a central portion of the PCB 616 of the module 600. The module 600 may include a temperature sensor 610 located on a PCB 616 near the transmitter 604.

The module 600 may include a plurality of detectors 606 that may be arranged on a PCB 616 as an inner set of detectors 606 and an outer set of detectors 606. An inner group 606c of detectors 606, which may include, for example, approximately ten (or a different number) detectors 606, may surround the emitter 604 and be spaced apart from one another.

The outer set of detectors 606 may be positioned farther from the emitter 604 than the inner set of detectors 606. The outer set of detectors 606 may be divided into a first outer set 606a and a second outer set 606b of detectors 606. As shown in fig. 20A, the module 600 may have a first axis A1 and a second axis A2. The outer groups 606a, 606b of detectors 606 may be positioned generally farther from the emitter 204 along the first axis A1 than the inner groups of detectors 606. The two outer sets 606a, 606b of detectors 606 are located along a first axis A1 on opposite sides of the inner set of detectors. The first outer set 606a and the second outer set 606b of detectors 606 may be generally symmetrical about a first axis A1 and a second axis A2. Each of the first outer set 606a or the second outer set 606b of detectors 606 may include approximately five (or a different number) of detectors 606 that are generally spaced apart from each other along the second axis A2. The outer sets 606a, 606b of detectors 606 may be arranged generally concentric with the inner set 606c of detectors 606.

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

As shown in fig. 20A, the emitter 604 may be covered by an inner lens or cover 602 a. In the example shown, 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 other shapes. The inner set 606c of detectors 606 may be covered by a first outer lens or cover 602 b. The first outer lens or cover 602b may be generally concentric with the inner lens or cover 602 a. In the illustrated example, the first outer lens or cover 602b may be disk-shaped. The first outer set 606a and the second outer set 606b of detectors 606 may be covered by a second outer lens or cover 606c and a third outer lens or cover 606d, respectively. The second outer lens or cover 606c and the third outer lens or cover 606d may be symmetrical about the second axis A2. As shown in fig. 20B, the first outer lens or cover 602B, the second outer lens or cover 602c, and the third outer lens or cover 602d may have substantially the same curvature. The inner lens or cover 602a may 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, 602 d.

The inner set 606c of detectors 606 and the emitter 604 may be separated by a first light blocking layer 620. The first light blocking layer 620 may extend along the inner lens or cover 602a and surround the inner lens or cover 602a, thereby forming an emitter chamber. The first outer set 606a and the second outer set 606b of detectors 606 may be separated from the inner set 606c of detectors 606 by a second light blocking layer 622. The second light blocking layer 622 may be shorter than the first light blocking layer 620. The first outer set 606a and the second outer set 606b of detectors 606 may be enclosed within a module sidewall 624 that encloses the perimeter of the module 600. The perimeter of the module 600 may be oval or any other shape. The sidewall 624 may be shorter than the second light blocking layer 622. The heights of the first and second light blocking layers 620, 622 and the sidewalls 624 may generally follow or be substantially continuous with the curvature of the first outer lens or cover 602b, the second outer lens or cover 602c, and the third outer lens or cover 602 d. The first light blocking layer 620 and the second light blocking layer 622 of the sidewall 624 may have a height so as to be configured to contact the skin of the wearer. Thus, the tissue facing surface of the module 600 may be defined by the tissue facing sides of the first and second light blocking layers 620, 622 and the side walls 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, 602 d.

In the illustrated example, the inner set 606C of detectors 606 may be separated by a third light blocking layer 626 and a fourth light blocking layer 628 (see fig. 20C and 20D). The third light blocking layer 626 and the fourth light blocking layer 628 may have a lower height than the first light blocking layer 620 or the second light blocking layer 622. The height of the third and fourth light blocking layers 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 outer lens or cover 602c and the third outer lens or cover 602 d. The first outer lens or cap 602b may sit atop the third light blocking layer 626 and the fourth light blocking layer 628.

The first light blocking layer 620 may protrude slightly from, that is, protrude from, the edges of the inner lens or cover 602a and the outer lenses or covers 602b, 602c, 602 d. The slightly protruding first light blocking layer 620 and/or inner lens or cover 602a may be pressed into the skin of the wearer with a higher pressure than the rest of the lens or cover or light blocking layer. The first light blocking layer 620 may also reduce mixing of the emitted light and the reflected light and/or suppress light emitted by the emitter 604 at an angle such that the emitted light exits the inner lens or cover 602a generally in a direction parallel to the height of the first light blocking layer 620.

As shown in fig. 20C and 20D, the first, second, third, and fourth light blocking layers 620, 622, 626, 628, and the sidewalls 624 may optionally form a single light blocking layer construction 630. The individual light blocking layer constructions 630 may be formed by any suitable fabrication technique. The single light blocking layer construction 630 may include a recess 632 (see fig. 20C) at one end, the recess 632 being configured to receive the PCB 616 (as well as the emitter 604, the detector 606, the temperature sensor 610, and any other sensors, such as gyroscopes, accelerometers, etc., as well as sensors or module processors located on the PCB 616). The single light blocking layer construction 630 may receive a lens at the other end opposite the end comprising the recess 632, comprising an inner lens or cover 602a, a first outer lens or cover 602b, a second outer lens or cover 602c, and a third outer lens or cover 602d.

The module housing may include a plurality of chambers such that light cannot travel between the chambers due to the various light blocking layers described herein. As described above, the first chamber may be enclosed by the inner lens or cover 602a, the first light blocking layer 620, and a portion of the PCB 616. The first chamber 634 encloses the emitter 604. The second and third chambers may be enclosed by a first outer lens or cover 602b, a first light blocking layer 620, a second light blocking layer 622, a third light blocking layer 626, a fourth light blocking layer 628, and a portion of the PCB 616. The second and third chambers may enclose an inner set 606c of detectors 606, wherein half of the inner set 606c of detectors is enclosed by each of the second and third chambers. The fourth chamber may be enclosed by a second outer lens or cover 602c, a second light blocking layer 622, sidewalls 624, and a portion of the PCB 616. The fifth chamber may be enclosed by a third outer lens or cover 602d, a second light blocking layer 622, sidewalls 624, and a portion of the PCB 616. The fourth and fifth chambers may enclose the first and second outer sets 606a and 606b, respectively, of the detector 606.

Light from the emitter 604 may travel a shorter path to the inner set 606c of detectors 606 and a longer path to the first and second outer sets 606a, 606b of detectors 606. The inner set 606c of detectors 606 and the first outer set 606a and the second outer set 606b of detectors 606 may operate independently and/or simultaneously. The signals output by the inner and outer sets 606a, 606b of detectors 606 may provide different information due to different optical paths that may travel through different regions of tissue. The longer path penetrates deeper into the tissue and through a larger volume of tissue to one of the outer sets 606a, 606b of the detector 606 than the shorter path, which is less deep into the tissue and travels through a smaller volume of tissue to one of the inner sets 606c of the detector 606. The different information may be separated and/or combined to calculate a plurality of physiological parameters of the wearer of the module 600, for example, an indication of the hydration state of the wearer, as will be described in more detail below.

The light diffusing material described above may be included in one or more chambers of the 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 the lenses or covers 602a, 602b, 602c, 602d may include injection openings 644 such that light diffusing material, which may include a stream of glass microsphere solution, may be injected into the respective chambers after the module 600 is assembled. After the solutions are injected into the respective chambers, the solutions may be UV cured. The lenses or caps 602a, 602b, 602c, 602d may include one or more vent openings 645 that are smaller than the injection openings 644. Each of the lenses or covers may include at least one vent opening 645. Air may escape through the exhaust openings 645 when the diffusion material solution is injected into the respective chamber through the injection openings 644, making it easier for the glass microsphere solution to flow into the respective chamber. The inner lens or cover 602a and/or the outer lenses or covers 602b, 602c, 602d may also include glass microspheres. The light diffusing material in the inner lens or cover 602a and the UV curable material in the first chamber 634 and/or the first light blocking layer 620 may cause the emitted light to leave the first chamber 634 in a direction generally parallel to the height of the first light blocking layer 620. The light diffusing material in the outer lenses or covers 602b, 602c, 602d and the UV curable material in the other chambers 636, 638, 640, 642 may increase the amount of reflected light directed to the detector 606.

The module 600 shown in fig. 20A-20D may be incorporated into a wearable device disclosed herein, such as the watch 900 shown in fig. 20E-20J. Watch processor 914 and power supply may be enclosed within watch case 901. Watch case 901 may include a connection port opening 950 configured to allow access to a connection port 952 in electrical communication with watch processor 914 and/or a power source. The connection port opening 950 may be located at an end of the watch case 901 transverse to the first axis A1 of the module 600. Connection port 952 may allow for power charging and/or data transfer to and from the watch processor. Optionally, as shown in fig. 20F and 20I, watch 900 may include a cable connector 945 extending outwardly from watch case 901. The cable connector 945 may be positioned adjacent or proximate to the connection port opening 950.

The watch 900 may include a display 912 positioned at a first side of the watch case 901. The watch case 901 has a second side opposite the first side. The second side of the watch case 901 may 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 case 901 may be removably attached to the first side of the watch case 901 without the use of external fasteners or alternatively via one or more fasteners. An electrical connection may be established between the physiological parameter measurement module PCB and the watch circuit, for example, using the flexible connectors disclosed herein.

The watch case 901 may include strap coupling extensions 948 on opposite sides of the watch 900 along the length of the case 901 (that is, along the first axis A1 of the module 600). Extension 948 may include a bar 946 for coupling to any suitable wristband.

Fig. 21A-21C and 22A-22C illustrate alternative lens or cover curvatures of the physiological parameter measurement module 600 of fig. 20A-20D, and any feature of the module 600 of fig. 20A-20D may be incorporated, except for the differences described below. As shown in fig. 21A-21C, the first outer lens or cover 602b of the module 601 may be more convex (i.e., protrude more) than the inner lens or cover 602a, the second and third outer lenses or covers 602C, 602 d. The curvature of the tissue-facing side of the second light blocking layer 622 and the sidewall 624 may be substantially continuous with the curvature of the second outer lens or cover 602c and the third outer lens or cover 602 d. The second light blocking layer 622 may be shorter than the first light blocking layer 620. The first light blocking layer 620 may be higher than the outer edge of the inner lens or cover 602a, which may facilitate separation of light emitted by the emitter 604 and light detected by the detector 606 before the light is attenuated by the body tissue of the wearer. In fig. 22A-22C, the module 603 may differ from the module 601 in fig. 21A-21C in that the inner lens or cover 602A may have the same height as the first light blocking layer 620 and the first outer lens or cover 602 b. The inner lens or cover 602a may have a generally planar surface or may have a slight curvature that is substantially continuous with the curvature of the first outer lens or cover 602 b. The modules 601, 603 in fig. 21A-22C may facilitate pressing the first outer lens or cover 602b or the first outer lens or cover 602b and the inner lens or cover 602a more into the skin of the wearer than the rest of the tissue facing surface of the module 600.

Fig. 23A-23E illustrate a watch 700 that may incorporate the physiological parameter measurement module 600. Watch 700 may have any of the features of watch 900, with differences noted in the descriptions of fig. 23A-23E. As shown in fig. 23A-23E, the watch case 701 of the watch 700 may include a flip cover 750 on one side of the case 701 along a length of the watch case 701 along a first axis A1 of the physiological parameter measurement module (see fig. 23E). Flip cover 750 may be opened to allow access to a connection port (such as a connection port in wristwatch 900) in electrical communication with wristwatch processor 714 and/or power supply 716. The connection port may allow for charging of the power supply 716 and/or data transfer to and from the watch processor 714. When the connection port 752 is not in use, the flip cover 750 may be closed.

The watch 700 may include a display screen positioned at a first side of the watch case 701. The watch case 701 has a second side opposite the first side. The second side of the watch case 701 may 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 case 701 may be removably attached to the first side of the watch case 701 via one or more screws 718 or other fasteners. When fully assembled, the watch 700 may have a thickness or height, for example, between 10mm to about 15mm or between 12mm to about 14 mm.

The watch case 701 may include a suitable strap connector configured to couple to a wristband. The strap connector in the watch case 701 may be different from the strap connector shown in the watch 900. In an example, the plurality of strap openings may be located at opposite ends of the watch, and the watch case may additionally and/or alternatively include a strap slot at the same opposite end of the watch as the strap openings. In this example, the strap slot may be configured to slidably receive an end of the strap, the end of the strap including a shape corresponding to a shape of the strap slot. The strap opening may be configured to receive a spring-biased button near the end of the wristband to releasably retain the strap after the end of the wristband is received into the strap slot. Alternatively, the watch may not include the strap opening. The straps coupled to the watch examples disclosed herein may be configured to allow adjustment of tightness around the wearer's wrist, for example, using buckle connectors, velcro connectors, and the like.

Hydration monitoring by a wearable device incorporating an example physiological parameter measurement module with "near" and "far" detectors or groups of detectors

Examples of physiological parameter measurement modules disclosed herein may monitor the hydration state of a wearer. This is because water in the body tissue may allow a greater portion of the third (or first or second) wavelength of light disclosed herein to pass through (i.e., act as a light pipe), but may substantially absorb the fourth wavelength of light disclosed herein. The physiological parameter measurement processor may compare the intensity signal at a fourth wavelength from the same detector to another wavelength less sensitive to changes in water. When the hydration state of the wearer is within the normal range such that the wearer is not considered to be dehydrated in a medical sense, the signals of the fourth wavelength and the other wavelength may show opposite trends, that is, one increasing and the other decreasing. The opposite trend may become less pronounced when the wearer dehydrates in a medical sense, e.g. falls below a threshold.

Hydration monitoring may 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 from one of the transmitters 104 (or group of transmitters) than other detectors 106 (near detectors), such as shown in fig. 10. In configurations where there are two emitter groups, each detector 106 or detector area (which may include more than one detector 106 placed enclosed in the same detector chamber) may act as a near (or shallow) detector or detector area of the emitter group closer to that detector 106 or detector area, and as a far (or deeper) detector or detector area of the emitter group farther from that detector 106 or detector area.

The physiological parameter measurement modules 400, 401, 403 illustrate example configurations for hydration monitoring of a wearer. The detector 406a may be a far detector of the second set of emitters 404b and the detectors 406b, 406a/b may be near detectors of the second set of emitters 404 b. The detector 406b may be a far detector of the first set of emitters 404a and the detectors 406a, 406a/b may be near detectors of the first set of emitters 404 a. The physiological parameter measurement modules 300, 301 show a similar detector arrangement in configuration (except that in the module 301 there is no shared detector between the two sets of emitters 304a, 304 b), wherein the module 300, 301 comprises a fourth emitter in at least one of the sets of emitters configured to emit light of four wavelengths.

The physiological parameter measurement modules 200, 201 illustrate that in configurations in which the modules 200, 201 include a fourth emitter configured to emit light at a fourth wavelength, additional example detector configurations may be included for a "near" detector of one emitter group and a "far" detector of another emitter group. For example, the detector 206 on the distal side of each set of emitters 204a, 204b may act as a "far" detector for detecting light (e.g., light of a fourth wavelength and another wavelength) emitted by the respective set of emitters 204a, 204b and attenuated by tissue to provide an indication of the hydration state of the wearer.

The physiological parameter measurement module 600 shows an example configuration for hydration monitoring of a wearer in which an inner set 606c of detectors 606 acts as a "near" detector and outer sets 606a, 606b of detectors act as "far" detectors.

In the above configuration, each detector or detector region may provide two measurements calculated from the signal received from the closer emitter group and the signal from the farther emitter group, respectively. The signal detected at the far detector may provide an indication of the hydration state of the wearer as light travels through deeper portions of the wearer's tissue to the far detector rather than to the near detector. When the physiological parameter measurement sensor or module processor determines the hydration state of the wearer, the signal detected at the near detector may optionally be used as a reference or for comparison with the signal detected at the far detector. The sensor or module processor of the physiological parameter measurement module disclosed herein can compare the fourth wavelength to the intensity signal of another wavelength (e.g., a third wavelength or about 905 nm) that is less sensitive to changes in water from one of the "far" detectors. The module processor may focus on the DC component of the signal detected by the "far" detector, or the DC body absorption measurements, to monitor the hydration state. At DC level, water may act as a light barrier for the fourth wavelength (i.e., lower light transmission) and may act as a lens or cover for other wavelengths (i.e., higher light transmission).

Additionally and/or alternatively, any of the modules disclosed herein may monitor the hydration state of the wearer by monitoring the PVI value of the wearer. The module may determine a baseline PVI value for the wearer and may output a notification of dehydration or hydration of the wearer based on fluctuations in the PVI value relative to the baseline.

The module may further output an indication of the final hydration state of the wearer in conjunction with the hydration state monitoring of the optical detector and other sensors, such as sweat sensors or skin impedance sensors. The module may calculate an average, weighted average, or other of raw hydration index values calculated based on signals from different sensors, and/or rely on different hydration monitoring sensors to achieve redundancy.

Because the hydration state of the person is not expected to change rapidly, the physiological parameter measurement module may optionally take measurements of the hydration state less frequently than taking measurements related to the pulse rate or SpO ₂ or other parameters of the wearer. For example, the physiological parameter measurement sensor or module processor may make measurements of hydration status every 5 minutes or more and/or upon request by the wearer (e.g., only upon) such as when the wearer presses a button on the device (physical button and/or touch button on the display) or otherwise indicates the device using voice commands, gestures, etc.

Examples of generally circular physiological parameter measurement modules and examples of wearable devices incorporating the same

The physiological parameter measurement module may alternatively include an inner portion of the emitter and an outer ring of the detector, as shown in fig. 24A-24B and fig. 25A-25B. The sensor or module 1000 in fig. 24A-24B and the module 1100 in fig. 25A-25B may have any of the features of the examples of modules described herein, with the differences noted in the descriptions of fig. 24A-24B and fig. 25A-25B. Such physiological parameter measurement modules may have a generally circular outer shape. The sensor or module 1000 of fig. 24A-24B may be smaller than the module 1100 of fig. 25A-25B. For example, the sensor or module 1000 may have an outer diameter of about 12mm to about 16mm or about 14mm to about 15 mm. For example, the module 1100 may have an outer diameter of about 16mm to about 22mm or about 18mm to about 20 mm.

The physiological parameter measurement modules 1000, 1100 can each include a single emitter group having multiple emitters 1004, 1104 (such as three emitters). The transmitters 1004, 1104 of the sensors or modules 1000, 1100 may transmit at least first, second, and third wavelengths as described above. The transmitters 1004, 1104 may be located at or near a central portion of the PCB of the sensor or module 1000, 1100. The sensors or modules 1000, 1100 may include temperature sensors located on the PCB near the emitters 1004, 1104.

The sensor or module 1000, 1100 may include a plurality of detectors 1006, 1106 (e.g., about six, eight, or more) which may be arranged on a PCB such that the detectors 1006, 1106 are spaced around the emitters 1004, 1006. The emitter 1004, 1104 and the detector 1006, 1106 may be separated by a first light blocking layer 1020, 1120. The first light blocking layer 1020, 1120 may surround the emitters 1004, 1104. The first light blocking layer 1020, 1120 may also suppress light emitted by the emitter 1004, 1104 at an 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 blocking layer 1020, 1120.

The emitters 1004, 1104 may be covered by inner lenses or covers 1002a, 1102 a. In the example shown, the inner lenses or covers 1002a, 1102a may be generally circular. The detectors 1006, 1106 may be covered by an outer lens or cover 1002b, 1102 b. The outer lenses or covers 1002b, 1102b may be generally concentric with the inner lenses or covers 1002a, 1102 a. In the example shown, the outer lenses or covers 1002b, 1102b may be discs when viewed from directly above the sensors or modules 1000, 1100. In other examples such as those disclosed herein, the outer lens or cover may have other shapes, such as elliptical or other shapes. The outer lenses or covers 1002b, 1102b may have a smaller curvature than the inner lenses or covers 1002a, 1102a such that the inner lenses or covers 1002a, 1102a protrude more than if the inner lenses or covers had the same curvature as the outer lenses or covers 1002b, 1102 b. As shown in fig. 24B and 25B, the first light blocking layer 1020, 1120 may protrude slightly from, i.e., protrude from, the outer edge of the inner lens or cover 1002a, 1102 a. The slightly protruding first light blocking layer 1020, 1120 and/or inner lens or cover 1002a, 1102a may be pressed into the skin of the wearer at a higher pressure than the rest of the light blocking layer or lens or cover of the sensor or module 1000, 1100.

The detectors 1006, 1106 may be enclosed within module sidewalls 1024, 1124, which module sidewalls 1024, 1124 define the perimeter of the sensor or module 1000, 1100. The perimeter may be generally circular or any other shape. The sidewalls 1024, 1124 may be shorter than the first light blocking layers 1020, 1120. The height of the side walls 1024, 1124 may be such that the tissue facing ends of the side walls 1024, 1124 are generally continuous with the curvature of the outer lenses or covers 1002b, 1102 b. In the example shown, the detectors 1006, 1106 may be separated from one another by a plurality of generally opaque separation barriers 1026, 1126. The separation barriers 1026, 1126 may have a lower height than the first light blocking layers 1020, 1120. The height of the separation barriers 1026, 1126 can be configured to accommodate the outer lenses or covers 1002b, 1102b such that when assembled, the outer lenses or covers 1002b, 1102b form a substantially smooth surface with the module sidewalls 1024, 1124. The outer lenses or covers 1002b, 1102b may sit on top of the separation barriers 1026, 1126. The tissue-facing ends of the first light blocking layer 1020, 1120 and the side walls 1024, 1124 and the tissue-facing surfaces of the inner lenses or covers 1002a, 1102a and the outer lenses or covers 1002b, 1102b may be configured to contact the skin of the wearer and form the tissue-facing surfaces of the sensors or modules 1000, 1100.

The first light blocking layers 1020, 1120, sidewalls 1024, 1124, and the separation blocking layers 1026, 1126 may optionally form a single light blocking layer configuration. A single light blocking layer configuration may receive the PCB of the sensor or module 1000, 1100 and the emitters 1004, 1104, detectors 1006, 1106, temperature sensors and any other sensors, such as gyroscopes, accelerometers, etc., and sensor or module processors located on the PCB. The single light blocking layer configuration may receive a lens on the other end opposite the end receiving the PCB, including an inner lens or cover 1002a, 1102a and an outer lens or cover 1002b, 1102b. As shown in fig. 25A and 25B, the light blocking layer configuration of the module 1100 or PCB may additionally include a plurality (e.g., four or other) of extension pins 1152. The plurality of extension pins 1152 may be generally equally spaced about the sidewall 1124.

The sensor or module 1000, 1100 may include multiple chambers such that light cannot travel between the chambers due to the various light blocking layers described herein. The first chambers 1034, 1134 may be enclosed by the inner lenses or covers 1002a, 1102a, the first light blocking layers 1020, 1120, and a portion of the PCB. The first chambers 1034, 1134 may enclose the emitters 1004, 1104. The plurality of second chambers 1036, 1136 may be enclosed by the outer lenses or covers 1002b, 1102b, the first light blocking layers 1020, 1120, the separation blocking layers 1026, 1126, the side walls 1024, 1124, and a portion of the PCB. Each of the second chambers 1036, 1136 may enclose one detector 1006, 1106.

The light diffusing material described above may be contained 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. The inner lenses or covers 1002a, 1102a and the outer lenses or covers 1002b, 1102b may also include glass microspheres as described above.

The wristwatch 1200 in fig. 25C-25H is shown incorporated into the module 1100 shown in fig. 25A-25B. However, any of the example watches disclosed herein may incorporate the physiological parameter measurement modules 1000, 1100 shown in fig. 24A-24B or fig. 25A-25B. Watch 1200 may have any of the features of the wearable devices disclosed herein, such as watches 700, 900, all of which are not repeated for the sake of brevity. Watch processor 1214 and power supply may be enclosed within watch case 1201. Watch case 1201 may include a connection port opening 1250 configured to allow access to a connection port 1252 in electrical communication with watch processor 1214 and/or a power source. Opening 1250 may be located on a side of wristwatch 1200 that is closer to the strap coupling mechanism, perpendicular to the first axis A1 of module 1100. The connection port 1252 may allow for charging of a power source and/or transmission of data to and from the watch processor 1214. Alternatively, as shown in fig. 25D, 25F, and 25H, watch 1200 may include a cable connector 845 extending outwardly from watch case 1201. The cable connector 1245 may be positioned adjacent or proximate to the connection port opening 1250.

Watch 1200 may include a display screen 1212 positioned at a first side of watch case 1201. Watch case 1201 has a second side opposite the first side. The second side of the watch case 1201 may 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. Extension pins 1152 of module 1100 may be received in corresponding structures, such as recesses, on the second side of watch case 1201, which may prevent module 1100 from rotating when installed in watch 1200. The second side of the watch case 1201 may be removably attached to the first side of the watch case 1201 without the use of external fasteners or via one or more fasteners as described above. An electrical connection may be established between the physiological parameter measurement module circuit and the watch circuit. Alternatively, the electrical connection may comprise a flexible circuit.

Watch case 1201 may include strap coupling extensions 1248 on opposite sides of watch 1200 along first axis A1 of module 1100. Extension 1248 may include a rod 1246 for coupling to any suitable wristband.

Example second sensor connection on physiological parameter measurement module for preventing opioid overdose

Examples of physiological parameter measurement modules disclosed herein may include an optional connector 118 (see fig. 7A) for receiving a second sensor, which may be a plethysmograph sensor or other suitable sensor. The connector 118 may be oriented such that the second sensor may extend from the housing of the device 10 with reduced or no impact of tissue at the device/tissue interface, resulting in little or no effect of the connection of the second sensor to the connector 118 on blood flow through the device measurement site. The second plethysmograph sensor may comprise any suitable plethysmograph sensor, for example, a fingertip sensor configured to monitor opioid overdose, as described in U.S. publication No.20190374173, which is incorporated herein by reference in its entirety and should be considered as part of the present disclosure. Fig. 1C shows a non-limiting example of a second sensor 119 as a fingertip sensor. The second sensor 119 may extend from a wearable device as shown in fig. 1C or any wearable device example disclosed herein.

As an alternative to connection with a wearable device as shown in fig. 1C, the connector of the watch disclosed herein may extend from an opening on the tissue facing side of the device housing (e.g., on the raised platforms 703, 903 (fig. 20I and 23A)). The connector may be coupled to the PCB616 via a cable, which may optionally have a length configured to extend around the raised platforms 703, 903 (e.g., in a groove of the raised platforms 703, 903 or elsewhere). Extending the cable around the raised platforms 703, 903 may allow for adjusting the sag of the cable when the connector is connected to the second sensor. Extending the connectors from the openings in the raised platforms 703, 903 may also prevent the connectors and/or cables from striking tissue at the watch/tissue interface, as described above. The connectors may alternatively be located at other suitable locations on the watches 700, 900.

The second plethysmograph sensor may have higher measurement accuracy than the physiological parameter measurement module disclosed herein. The wearer may disconnect the second sensor and/or deactivate the second sensor while the wearer is awake and/or walking around. The wearer may for example connect and activate the second sensor when about to go to sleep or rest. When the second sensor is activated, the sensor or module processor may ignore the signal from the detector of the module, such that the sensor or module processor may output a physiological parameter based on the reading from the second sensor. Alternatively, the sensor or module processor may output the physiological parameter based on a combination of readings from the second sensor and the detector of the module. The wearer may flexibly choose to use the physiological parameter measurement module and/or the second sensor depending on the needs of the wearer.

The second plethysmograph sensor may assist in detecting opioid overdose of the wearer with opioid (e.g., for medical reasons), particularly by detecting hypoxia saturation in the wearer's blood. Respiratory depression is the most dangerous side effect of opioid overdose. Hypoxia of the brain can lead not only to permanent nerve damage, but also to extensive failure of other organ systems, including the heart and kidneys. If an opioid overdose person sleeps alone, the person easily dies as respiratory depression worsens. The second plethysmograph sensor may be configured to detect inhibited respiration by detecting reduced oxygen saturation in the blood of the wearer. The wearable device may be configured to automatically notify the first responder and/or the family or guardian of the wearer in response to detecting an opioid overdose of the wearer.

Optionally, the device processor of the wearable device may communicate (e.g., via bluetooth or NFC communication, or via a network) with a processor of a drug delivery apparatus that is wearable by the wearer and configured to deliver one or more doses of a therapeutic drug, such as an opioid. The drug delivery device may comprise: a delivery device comprising a dose of therapeutic drug stored in a reservoir; a drug delivery channel; dispensing means for dispensing 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 may receive parameters measured by the second plethysmograph sensor of the wearable apparatus disclosed herein. The processor of the drug delivery device may store the memory storing instructions and be configured to execute the instructions to at least compare the parameter received from the wearable device to a threshold indicative of opioid overdose. The processor of the drug delivery device may determine whether an excessive event is occurring or likely to occur based on the comparison, and 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.

Alternatively, the sensor or module processor of the physiological parameter measurement module may perform a comparison of the parameter measured by the second plethysmograph sensor with a predetermined opioid overdose threshold. Alternatively, microneedle patches may be used to provide drugs that counteract opioid overdose. When the wearable device outputs an alert that the physiological parameter of the wearer (e.g., spO ₂) has exceeded a threshold (which may indicate opioid overdose), the wearer may apply the microneedle patch containing the drug to the skin.

Alternatively, or additionally, the second sensor may be any other suitable non-invasive sensor disclosed herein. Alternatively or additionally, examples of physiological parameter measurement modules disclosed herein may be connected to the second sensor via a wireless connection (e.g., using bluetooth technology). The module may receive measured parameters from the connected second sensor and/or process sensor data received from the second sensor to calculate additional physiological parameters.

Example microneedle patch

In addition to and/or instead of delivering drugs as described herein to prevent opioid overdose, microneedle patches may be used in combination with a wearable device for other purposes. In recent years, microneedles have been used as painless substitutes for hypodermic needles to deliver drugs into the body. The microneedles on the patch may be placed on the arms or legs or other parts of the body, and then small holes may be formed in the outermost layer of the skin, thereby allowing the drug applied to each needle to be diffused into the body. The microneedles may be made of silicon, metal, synthetic polymers, or natural biodegradable materials such as silk and chitin.

Because of its small size, the microneedle is minimally invasive and causes less pain than a larger needle (e.g., a hypodermic needle). In addition, microneedle patches are easier for the wearer to use than cryoneedles. In contrast, larger needles may require the correct injection depth and injection angle to ensure that the drug is injected into the correct location.

Fig. 26A schematically illustrates a microneedle 3100 of a microneedle patch having penetrated the tissue surface 2 of a wearer. The microneedle 3100 may have different injection depths depending on its height. For example, the microneedle 3100 may only pierce the epidermis (including the stratum corneum, which is the outer layer of the epidermis) 42. In other examples, the microneedles 102 may pierce the epidermis 42 and dermis 44, with the tips of the microneedles 3102 terminating on the dermis 44. In other examples, such as shown in fig. 26A, the microneedle 3100 can pierce the epidermis 42 and dermis 44 with the tip 3102 terminating in subcutaneous tissue 46.

Depending on the application, microneedles 3100 having different heights may be used to deliver drugs and/or irrigation fluids 3104 into different portions of the wearer's tissue. The microneedle 3100 can be used to deliver a wide range of drugs, biotherapeutic drugs, and vaccines. The microneedle 3100 can be hollow, with an internal reservoir to store and deliver a drug or irrigation fluid 3104. Alternatively, the microneedle 3100 may be solid and coated with the drug 3104 and optionally other surfactants/thickeners. Alternatively, the microneedle 3100 may be dissolvable and encapsulate the drug in a non-toxic polymer that can dissolve once it is into the skin.

Alternatively or additionally, the microneedle 3100 can be used to extract a tissue fluid sample 3104 (e.g., interstitial fluid of a wearer) for detecting and/or analyzing analytes in the sample 3104. Alternatively, the microneedle 3100 can flush the tissue of the wearer with fluid before the fluid (e.g., which can equilibrate with the chemical composition of the body fluid sample of the wearer) is withdrawn from the microneedle 3100. The microneedle 3100 may be hollow and may extract a fluid sample via surface tension. Analyte detection and/or analysis may provide information such as hydration status, glucose concentration, hemoglobin concentration, and/or quadrature information about the fluid. 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, pH, and the like.

The microneedle patch may be located under one of the straps or the body of the wearable device, or applied remotely from the wearable device (anywhere else on the wearer's body) without contacting the device. Multiple microneedle patches may be applied to different locations on the body of a wearer. As shown in fig. 26B and 26C, a microneedle 3100 may be connected to the patch body 3106, forming a microneedle patch 3108. The patch body 3106 may be circular, oval, rectangular, square, triangular, teardrop-shaped, or any other shape. The size of the patch body 3106 is not limited. The surface of the patch body 3106 not connected to the micro-needle 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.

As shown in fig. 26B, a microneedle patch 3108 may be placed on the body of the device 10. Patch 3108 may be applied under the skin-facing surface of physiological parameter measurement sensor or module 100. The microneedles 3100 of the microneedle patch 3108 may face the skin of the wearer of the device 10 when the device 10 is worn. Thus, when the device 10 (with a band wrapped around the wrist of a wearer) is worn, for example, on the wrist of a wearer, the microneedle 3100 can pierce the skin on the wrist.

Additionally or alternatively, the microneedle patch 3108 may be integrally or releasably secured to the inside of the adjustable strap 30 of the wearable device 10, such as shown in fig. 26C. When the device 10 is worn, the micro-needles 3100 may be directed toward the skin around the wearer's wrist. When the band 30 is wrapped around the wearer's wrist, the microneedle patch 3108 may be in contact with the skin around the wearer's wrist, and the microneedles 3100 may penetrate the wearer's skin.

As shown in fig. 26D, the microneedle patch 3108 may communicate with the wearable device 10, using the wearable device 10 as a platform or hub to detect and/or analyze analytes in the fluid sample collected in the microneedle patch 3108. Patch 3108 may optionally include a sensor 3110, such as an electrochemical sensor (with electrodes built into the microneedles), a colorimetric sensor, or other sensor. Alternatively, patch 3108 may be brought to an external sensor for analyte detection and analysis. Patch 3108 may include antenna 3112, which may be an NFC antenna or other antenna. The sensor 3100 may output a signal via an antenna 3112. The wearable device may receive signals from the sensor 3100 via the antenna 19. The device processor 14 (or alternatively, a sensor or module processor of a physiological parameter measurement sensor or module on the device 10) may process signals from the sensor 3100 to determine the presence and/or concentration of certain analytes in the fluid sample.

Example device tightness monitoring systems and methods

The desired tightness and/or pressure of the device on the body may be indicated by the skin engaging the wearable device as the device moves. If there is insufficient tightness and/or pressure of the device against the wearer's body, ambient light entering the device-skin interface may cause noise in the signal detected by the detector and thus inaccurate measurements by the device. If the device is worn too tightly (and/or the pressure applied by the device to the body is too high), blood pulsation and circulation at the wrist may be limited, which may result in a decrease in the oxygen saturation reading of the wearer of the device. Alternatively, when the device has determined that the wearer's oxygen saturation reading is decreasing at a certain rate and/or a certain percentage of the predetermined amount of time at a certain rate, the device may output a warning that the device is wearing too tightly (which may include a message displayed on the device prompting the wearer to loosen the strap).

The device 10 may include an optional strain gauge 20 (see fig. 7A) to measure the pressure of the device 10 on the wearer. The strain gauge 20 may be located in 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 otherwise). For example, the strain gage 20 may be flanged between the physiological parameter measurement module 100 and the device processor 14. When the device 10 is worn on a wearer (e.g., on a wrist), the pressure exerted by the module (particularly by the convex protrusion of the cover 102 against tissue) may be sent to and measured by the strain gauge 20. The strain gage 20 may also be incorporated into other wearable device examples disclosed herein.

The readings from the strain gauge 20 may be transmitted to the device processor 14, and the device processor 14 may process the readings and output an indication of the pressure applied by the device 10 to the wearer for display on the display 12. The indication may be in a variety of suitable forms, for example, using different colors to indicate whether the pressure is too low, proper, or too high for accurate or reliable measurements to be obtained using the physiological parameter measurement module 100. In one example, the device 10 may display green light when pressure on the wearer is appropriate for use of the physiological parameter measurement module 100; and when the pressure is too high or too low compared to the desired pressure or pressure range, red light or other colored light is displayed. The physiological parameter measurement module 100 may not be activated unless the reading from the strain gauge 20 indicates that the desired pressure or pressure range has been achieved. Optionally, in response to not detecting any readings from the strain gauge 20, indicating that the device 10 is not being worn on the wearer, the device processor may also deactivate the physiological parameter measurement module 100 and/or any other sensors on the device 10 or attached to the device 10. Automatically switching on and/or off sensors on device 10 or attached to device 10 may reduce power consumption and increase battery life of device 10.

Optionally, the wearable device 10 may include a motor to adjust the tightness of the strap based on the monitored tightness of the strap and/or the pressure exerted by the sensor or module 100 on the wearer's skin.

Example additional functionality of wearable device

Examples of wearable devices disclosed herein may provide protection for the wearer by alerting a first responder (e.g., a hospital emergency room, firefighter, 911, security personnel at the facility where the wearer is located, or other personnel) and/or the family or guardian of the wearer when the wearer is at risk, such as when the wearer is drowned. The wearable device may include a swimming pattern that the wearer may activate while swimming. The physiological parameter measurement module of the wearable device may monitor one or more parameters to determine that the wearer is likely drowned (such as a child drowning), for example, by determining that the respiratory rate of the wearer becomes irregular (such as showing fluctuations greater than a predetermined amount per minute), or that the SpO ₂ value of the wearer drops by a predetermined amount, or other conditions. Alternatively, the module processor may determine that the wearer is likely drowned 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 likely drowned, the module may send a notification to a processor of the wearable device, which may send an alert to the first responder and/or the wearer's family or guardian. Additionally or alternatively, the wearable device may include a distress button that the wearer may press in an emergency, such as a sustained fall when the wearer is drowned, alone (which may alternatively or additionally be determined using gyroscope and/or accelerometer readings, which may be further combined with other sensor monitored parameters) or other conditions.

Physiological parameters (e.g., without limitation SpO ₂, PR, PI, PVI, RR, hydration, ECG related parameters, etc.) measured by the modules disclosed herein may be sufficiently reliable for healthcare or medical purposes (e.g., in a hospital). The module may be configured to take measurements at the same time of day. The wearable device (or physiological parameter measurement module of the device) may further comprise a Near Field Communication (NFC) or bluetooth chip or a hospital patient ID tag on a wristband or strap. Basic information of the patient, such as patient name, date of admission, reason for admission, blood type, drug allergies, etc. may be stored on the memory device of the watch or on the physiological parameter measuring module. Patient ID tags cannot be easily removed and/or may include special tools, such as anti-theft devices, for example, requiring the patient to cut through the wristband. Alternatively, when a patient is admitted, the wearable device may display patient information (e.g., name, date of admission, etc.) on the screen. The patient ID tag may be disposable after discharge of the patient, or may be reusable after sterilization. When a patient ID tag (e.g., wristband) is replaced, the physiological parameter measurement module may be removed and replaced. If the wearable device is worn by a caregiver, the caregiver can use the wearable device to communicate with other caregivers (e.g., share critical, substantially real-time information about the patient, update changes in patient status, etc.), instead of communicating with a dedicated communication tool (e.g.Etc.).

Additional example aspects and embodiments of a sensor or module

Fig. 27A is a front view of an example aspect of a sensor or module 2700. The sensor or module 2700 includes an opaque frame 2726, one or more electrodes 2724, one or more detector chambers 2788, one or more emitter chambers 2778, and a light blocking layer configuration 2720.

The opaque frame 2726 may include one or more materials configured to prevent or block transmission of light. In some aspects, the opaque frame 2726 may form a single integrated unit. In some aspects, the opaque frame 2726 may be formed from a continuous material. The light blocking layer construction 2720 may include one or more materials configured to prevent or block transmission of light. In some aspects, the light blocking layer construction 2720 may form a single integrated unit. In some aspects, the light blocking layer construction 2720 may be formed from a continuous material. In some aspects, the light blocking layer construction 2720 and the opaque frame 2726 may form a single integrated unit. In some aspects, the light blocking layer construction 2720 and the opaque frame 2726 may be detachably connected.

The light blocking layer configuration 2720 may include one or more light blocking layers, such as light blocking layers 2720a, 2720b, 2720c, 2720d, which are provided as non-limiting examples. In some aspects, the light blocking layer may also be referred to herein as a light barrier. The light blocking layer may form one or more portions of the light blocking layer construction 2720. The light blocking layer construction 2720 (or a light blocking layer portion thereof) may prevent light from passing therethrough. The light blocking layer construction 2720 may include spaces between various light blocking layers, which may define one or more chambers (e.g., detector chamber 2788, emitter chamber 2778). In some aspects, one or more chambers (e.g., detector chamber 2788, emitter chamber 2778) may be enclosed by light blocking layer configuration 2720 or a light blocking layer portion thereof, a surface of a substrate (e.g., PCB), and a lens or cover. In some aspects, light may enter the chamber only through the lens or cover.

Examples of light blocking layers are provided with reference to example light blocking layers 2720 a. The light blocking layer 2720a forms part of the light blocking layer construction 2720. The light blocking layer 2720a may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720a may prevent light from passing through the light blocking layer configuration 2720 between the emitter chamber 2778 and the detector chamber 2788. The light blocking layer 2720a or a portion thereof may include a width 2771. In some aspects, width 2771 may be less than about 1.85mm. In some aspects, the width 2771 may be less than about 1.9mm. In some aspects, width 2771 may be less than about 1.95mm. In some aspects, width 2771 may be about 1.88mm. In some aspects, width 2771 may be less (e.g., less) than length 2779. In some aspects, width 2771 may be less than about 55% of length 2779. In some aspects, width 2771 may be less than about 60% of length 2779. In some aspects, width 2771 may be less than about 65% of length 2779. In some aspects, width 2771 may be about 58.9% of length 2779.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 b. The light blocking layer 2720b forms part of the light blocking layer construction 2720. The light blocking layer 2720b may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720b may prevent light from passing through the light blocking layer configuration 2720 between the emitter chamber 2778 and the detector chamber 2788. The light blocking layer 2720b or a portion thereof may include a width 2772. In some aspects, the width 2772 may be less than about 1.35mm. In some aspects, the width 2772 may be less than about 1.40mm. In some aspects, the width 2772 may be less than about 1.45mm. In some aspects, the width 2772 may be about 1.37mm. In some aspects, width 2772 may be substantially similar to width 2771. In some aspects, width 2772 may be less (e.g., less) than width 2771. In some aspects, width 2772 may be less than about 70% of width 2771. In some aspects, width 2772 may be less than about 75% of width 2771. In some aspects, width 2772 may be less than about 80% of width 2771. In some aspects, width 2772 may be about 72.9% of width 2771.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 c. The light blocking layer 2720c forms part of the light blocking layer construction 2720. The light blocking layer 2720c may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720c may prevent light from passing through the light blocking layer configuration 2720 between adjacent detector cells 2788.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 d. The light blocking layer 2720d forms part of the light blocking layer construction 2720. The light blocking layer 2720d may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720d may prevent light from passing through the light blocking layer configuration 2720 between adjacent emitter chambers 2778. In some aspects, the light blocking layer 2720d may have a width 2775 that separates adjacent emitter chambers of less than about 1.30 mm. In some aspects, the width 2775 may be less than about 1.25mm. In some aspects, the width 2775 may be less than about 1.20mm. In some aspects, the width 2775 may be about 1.20mm. In some aspects, width 2775 may be substantially similar to width 2772. In some aspects, width 2775 may be less (e.g., less) than width 2772. In some aspects, width 2775 may be less than about 95% of width 2772. In some aspects, width 2775 may be less than about 90% of width 2772. In some aspects, width 2775 may be less than about 85% of width 2772. In some aspects, width 2775 may be about 87.6% of width 2772.

An emitter chamber 2778 is positioned within a central region of the sensor or module 2700. The emitter chambers 2778 may be positioned adjacent to each other across a centerline of the sensor or module 2700, for example, as described in more detail with reference to fig. 27K. The emitter chamber 2778 may be positioned adjacent to the center point C ₁. Each of the emitter chambers 2778 may have a similar size and/or shape. The emitter chamber 2778 may be at least partially separated by a light blocking layer 2720d of the light blocking layer configuration 2720. In some aspects, as shown in this example, the light blocking layer 2720d may form the entire distance between the emitter chambers 2778. For example, the emitter chambers 2778 may be separated only by the light blocking layer 2720d such that other components (e.g., detectors, detector chambers, etc.) are not positioned between the emitter chambers 2778.

A portion of the emitter chamber 2778 may extend a length 2779 away from the center point C ₁. In some aspects, the length 2779 may be less than about 3.15mm. In some aspects, the length 2779 may be less than about 3.20mm. In some aspects, the length 2779 may be less than about 3.25mm. In some aspects, the length 2779 may be about 3.19mm. In some aspects, the length 2779 may be greater (e.g., more) than a width of the light blocking layer separating the emitter chamber from the detector chamber, such as width 2771. In some aspects, the length 2779 may be greater than about 165% of the width 2771. In some aspects, the length 2779 may be greater than about 170% of the width 2771. In some aspects, the length 2779 may be greater than about 175% of the width 2771. In some aspects, the length 2779 may be about 169.7% of the width 2771.

As shown in this example aspect, the detector chambers 2788 are arranged in a substantially circular pattern. Each of the detector chambers 2788 houses a detector 2706 positioned in a substantially circular or annular pattern on a substrate (e.g., PCB). The detector 2706 may be positioned in a central region of each of the respective detector chambers 2778. The detector chamber 2788 is arranged along a ring defined by the ring L ₁. In some aspects, such as shown in this example aspect, the detectors 2706 of the respective detector chambers 2788 may also be arranged along the same ring along which the detector chambers 2788 are arranged (such as in aspects in which the detectors are positioned in a central region of the respective detector chambers 2788). The loop L ₁ may intersect a central region of the detector chamber 2788. In this example aspect, the ring L ₁ encloses the entirety of the emitter chamber 2778 such that the emitter chamber 2778 is positioned within an interior region (e.g., a central region) of the ring L ₁ defined by the detector chamber 2788. In some aspects, each of the detector chambers 2788 (and corresponding detectors 2706 within the respective detector chambers 2788) may be positioned at a substantially similar or identical distance from the center point C ₁ (e.g., the center of the sensor or module 2700). In some aspects, detector 2706 may be rectangular including longer sides and shorter sides. The detectors 2706 can be positioned on the substrate of the sensor or module 2700 such that the long side of each detector is orthogonal to a radius (e.g., radius r ₁, radius r ₂, radius r ₃) extending away from the center point C ₁. Advantageously, the detectors 2706 on the sensor or module 2700 are oriented in a circular arrangement, wherein the long sides of the detectors 2706 are orthogonal to the center point C ₁, the accuracy of the physiological measurement can be improved by ensuring that light from the emitters travels along a known path length from the emitters to the detectors 2706, and the processing requirements of the sensor or module 2700 can also be reduced by reducing the amount of variables (e.g., the number of path lengths) required for processing in order to determine the physiological data.

The electrode 2724 may include a reference electrode and a negative electrode (and/or positive electrode). In some aspects, a wearable device, such as a watch incorporating a sensor or module 2700, may include another ECG electrode (e.g., positive electrode) located on a housing of the wearable device configured to contact the skin of the wearer. In some configurations, the surface of the electrode 2724 may be flush with the surface of the opaque frame 2726.

The electrode 2724 is positioned within a portion of the opaque frame 2726 or along a portion of the opaque frame 2726, such as shown in fig. 27B, for example. In some aspects, the electrode 2724 may be substantially semi-circular. In some aspects, each of the electrodes 2724 may be substantially semi-annular. In the example aspect shown, each of the electrodes 2724 forms a substantially half-ring. Advantageously, the ring electrode may improve contact with the wearer's skin (e.g., by contacting different areas of the skin) while reducing the amount of surface area of the electrode. In some aspects, each of the electrodes 2724 may have a similar size and/or shape. In some aspects, the electrode 2724 can have various sizes and/or shapes. In this example aspect, the electrode 2724 is positioned within the sensor or module 2700 (e.g., within the opaque frame 2726) along a loop defined by L ₂. In various aspects described herein, the loop L ₂ can include various radii, which can advantageously provide improved contact between the electrode 2724 and the skin of a wearer of the device.

The opaque frame 2726 includes one or more gaps (e.g., g ₁、g₂) between the electrodes 2724. The gap g ₁、g₂ (or other portion of the opaque frame 2726) may electrically insulate each of the electrodes 2724 from each other. Each of the electrodes 2724 includes a substantially straight edge along a portion of the respective gap g ₁、g₂. In some aspects, the gaps g ₁、g₂ can have similar or identical sizes. In some aspects, the gaps g ₁、g₂ may have different sizes from one another. In some aspects, gap g ₁、g₂ may be less than about 1.6mm. In some aspects, gap g ₁、g₂ may be less than about 1.65mm. In some aspects, gap g ₁、g₂ may be less than about 1.7mm. In some aspects, gap g ₁、g₂ may be about 1.62mm. As described above, in some embodiments, the frame 2726 includes a recess 2824 sized and/or shaped to receive the ECG electrode 2724. In some embodiments, each of such recesses 2824 includes a first end and a second end, the first ends of the recesses 2824 being separated from each other by a gap g ₁, and the second ends of the recesses 2824 being separated from each other by a gap g ₂.

The ring L ₁ may be concentric with the outer circumference of the sensor or module 2700. The ring L ₂ may be concentric with the outer circumference of the sensor or module 2700. The ring L ₂ may be concentric with a ring (such as ring L ₁) defined by the position of the detector chamber 2788. The center point C ₁ may define the geometric center of the ring L ₁. The center point C ₁ may define the geometric center of the ring L ₂. The center point C ₁ may define the geometric center of the outer perimeter of the sensor or module 2700. In some aspects, such as shown in fig. 27A, each of L ₁、L₂ and the outer perimeter of sensor or module 2700 are concentric with each other and share the same geometric center shown as C ₁.

The loop L ₁ may include a radius r ₁. In some aspects, the radius r ₁ may be less than about 6.25mm. In some aspects, the radius r ₁ may be less than about 6.50mm. In some aspects, the radius r ₁ may be less than about 6.75mm. In some aspects, the radius r ₁ may be about 6.34mm. In some aspects, radius r ₁ may be less (e.g., less) than radius r ₂. In some aspects, the radius r ₁ may be less than about 55% of r ₂. In some aspects, the radius r ₁ may be less than about 60% of r ₂. In some aspects, the radius r ₁ may be less than about 65% of r ₂. In some aspects, the radius r ₁ may be about 59% of r ₂. In some aspects, radius r ₁ may be less (e.g., less) than radius r ₃. In some aspects, the radius r ₁ may be less than about 40% of r ₃. In some aspects, the radius r ₁ may be less than about 45% of r ₃. In some aspects, the radius r ₁ may be less than about 50% of r ₃. In some aspects, the radius r ₁ may be about 41.7% of r ₃.

The loop L ₂ may include a radius r ₂. In some aspects, the radius r ₂ may be less than about 10.5mm. In some aspects, the radius r ₂ may be less than about 10.75mm. In some aspects, the radius r ₂ may be less than about 11.0mm. In some aspects, the radius r ₂ may be about 10.73mm. In some aspects, radius r ₂ may be less (e.g., less) than radius r ₃. In some aspects, the radius r ₂ may be less than about 65% of r ₃. In some aspects, the radius r ₂ may be less than about 70% of r ₃. In some aspects, the radius r ₂ may be less than about 75% of r ₃. In some aspects, the radius r ₂ may be about 70.6% of r ₃.

In some aspects, the sensor or module 2700 (e.g., the outer perimeter of the sensor or module 2700) can include a radius r ₃. In some aspects, the radius r ₃ may be less than about 14.5mm. In some aspects, the radius r ₃ may be less than about 15.0mm. In some aspects, the radius r ₃ may be less than about 15.50mm. In some aspects, the radius r ₃ may be less than about 16.0mm. In some aspects, the radius r ₃ may be about 15.19mm.

27K-27L illustrate example optical paths between an example physiological parameter measurement sensor or module 2700 'and an emitter and detector of module 2700'.

Fig. 27K shows an example arrangement of an emitter chamber and a detector chamber of a sensor or module 2700'. As shown, the sensor or module 2700 'can include a first emitter chamber 2736a' enclosing a first emitter group including one or more emitters, a second emitter chamber 2736b 'enclosing a second emitter group including one or more emitters, one or more first detector chambers 2740', one or more second detector chambers 2742', and one or more third detector chambers 2738'. In some aspects, each detector chamber may enclose one detector.

The first emitter group of the first emitter chamber 2736a 'may include the same number and type of emitters as the second emitter group of the second emitter chamber 2736 b'. In other words, each emitter of the first emitter group may correspond to an emitter of the same type (e.g., same wavelength) of the second emitter group. The emitters of the first emitter group may be arranged to mirror the configuration of the emitters of the second emitter group across the centerline 2750 of the sensor or module 2700', as shown in fig. 27K. For example, each emitter in the first set of emitters may be located at the same distance from the centerline 2750 of the sensor or module 2700' as the corresponding emitter in the second set of emitters. For example, the first emitter group and the second emitter group may each include emitters that emit light at a first wavelength and are positioned at positions that mirror each other across a centerline 2750 of the sensor or module 2700'. In addition, the first emitter group and the second emitter group may each include emitters that emit light at a second wavelength and are positioned at positions that mirror each other across a centerline 2750 of the sensor or module 2700'. Each emitter in the first emitter group may correspond to an emitter of the second emitter group located at the mirror image position, and vice versa.

One or more second detector chambers 2742 'may be bisected by a centerline 2750 of sensor or module 2700'. Each of the detectors of the respective one or more second detector chambers 2742 'may be bisected by a centerline 2750 of the sensor or module 2700'. In other words, one or more second detector chambers 2742 'and corresponding detectors and sensors or modules 2700' may each share the same (e.g., parallel) centerline 2750. The sensor or module 2700' can be oriented (e.g., rotated) in any direction relative to the tissue of the wearer. In example embodiments where the sensor or module 2700 'is worn on the wrist of the user, the sensor or module 2700' may be rotated in any direction relative to the wrist or forearm of the wearer. In one example configuration, the sensor or module 2700 'can be oriented relative to the forearm (or other body part) of the wearer such that the centerline 2750' of the sensor or module is perpendicular to a line extending along the length of the forearm (e.g., from elbow to wrist) of the wearer. Advantageously, such a configuration may improve physiological measurements by facilitating penetration of light emitted from the emitter chamber and detected at the detector chamber (e.g., light traveling from the emitter chamber 2736a 'to the detector chamber 2738') to the soft tissue (e.g., blood vessels) of the wearer, rather than other tissue (such as bone). In another example configuration, the sensor or module 2700 'can be oriented relative to the forearm (or other body portion) of the wearer such that the centerline 2750' of the sensor or module is parallel to a line extending along the length of the forearm (e.g., from elbow to wrist) of the wearer. Advantageously, such a configuration may improve physiological measurements by facilitating penetration of light emitted from the emitter chamber and detected at the detector chamber (e.g., light traveling from the emitter chamber 2736a 'to the detector chamber 2742') to the soft tissue (e.g., blood vessels) of the wearer, rather than other tissue (e.g., bone).

As shown in fig. 27K, the emitters of the first and second emitter groups that correspond to each other (e.g., emit the same wavelength and mirror each other) may each emit light that travels along a respective path to the detectors of the one or more second detector chambers 2742'. The respective optical paths from the corresponding emitters may be of equal length. This may be because the corresponding emitters are each positioned an equal distance from the detector of chamber 2742'. The corresponding emitters may each be equidistant from the detectors of chamber 2742' in that they are positioned at mirror images of each other across a centerline 2750 of the sensor or module 2700', which centerline 2750 bisects the one or more second detector chambers 2472' and the corresponding detectors.

The one or more second detector chambers 2742' and their corresponding detectors may be used, at least in part, for calibration, for example, to characterize the emitters by providing known information, such as a known ratio. For example, the information corresponding to the wavelength detected at the detector of chamber 2742 'from the emitters of the first set of emitters may be similar or identical information to the information corresponding to the wavelength detected at the detector of chamber 2742' from the emitters of the second set of emitters, and the comparison (e.g., subtraction, division, etc.) of the information generated by the first and second sets of emitters may generate a known number, such as zero or one, because the corresponding emitters from the first and second sets of emitters may be an equal distance from the detector of chamber 2742 'and the light emitted therefrom may travel the same distance to the detector of chamber 2742'. As a normalization example, the ratio of wavelengths detected at the detectors of chambers 2738', 2740' may be a normalized (e.g., divided by) ratio of wavelengths detected at the detectors of chamber 2742 '. In the event that the information generated by the detection of light from the first and second sets of emitters is different or substantially different (e.g., as a result of a change in emission intensity or other such discrepancy), the information (e.g., calibration) may be adjusted or normalized to account for such discrepancy. This normalization or on-board calibration or characterization of the transmitter may improve the accuracy of the physiological measurement and provide continuous calibration or normalization during the measurement. In some aspects, the processor may be configured to continuously calibrate or normalize the physiological parameter measurements of the sensor. In some aspects, the processor may be configured to calibrate or normalize the physiological parameter measurement of the optical physiological sensor when the sensor measures the physiological parameter of the wearer.

Fig. 27L shows an example arrangement of an emitter chamber and a detector chamber of a sensor or module 2700'. As shown, the sensor or module 2700 'can include a first emitter chamber 2736a', a second emitter chamber 2736b ', one or more first detector chambers 2740', one or more second detector chambers 2742', and one or more third detector chambers 2738', e.g., as discussed elsewhere herein.

The first emitter chamber 2736a 'and the second emitter chamber 2736b' may be located at non-equidistant distances from each of the one or more detector chambers 2738', 2740'. Thus, the first emitter chamber 2736a 'and the second emitter chamber 2736b' may each be a "near" or "far" emitter chamber with respect to each of the detector chambers 2738', 2740'. In other words, each detector of detector chambers 2738', 2740' may detect light of any given wavelength from both the "near" emitter and the "far" emitter, where the near emitter and the far emitter are included in the first emitter group or the second emitter group, respectively.

As an example, as shown in fig. 27L, light of a given wavelength may travel along a path from an emitter in a first emitter group to a detector of detector chamber 2738', and light of the same wavelength may travel along a path from an emitter in a second emitter group to the same detector. Light from the first emitter group may travel a longer path than light from the second emitter group before reaching the detector of chamber 2738'. Thus, for any detector of detector chamber 2738 'or 2740', the detector may receive light of a given wavelength from a near (e.g., proximal) emitter and a far (e.g., distal) emitter. This may not be the case for the detector of chamber 2742 'because the first emitter set and the second emitter set may each be located at the same distance from any given detector of detector chamber 2742', as described herein.

For convenience, the terms "proximal" and "distal" may be used herein to describe structures associated with any detector chamber or its corresponding detector. For example, the emitter may be proximate to the detector chamber of the first detector chamber and remote from the detector of the second detector chamber. The term "distal" refers to one or more emitters that are farther from the detector chamber than at least some of the other emitters. The term "proximal" refers to one or more emitters that are closer to the detector chamber than at least some of the other emitters. The term "proximal emitter" may be used interchangeably with "proximal emitter" and the term "distal emitter" may be used interchangeably with "distal emitter".

A single emitter may be both close to one detector and remote from the other detector. For example, the emitter may be a proximal emitter relative to the detector of the first detector chamber and may be a distal emitter relative to the detector of the second detector chamber.

Depending on the length of the path it travels from the emitter (e.g., along a long path from the distal emitter or along a short path from the proximal emitter), the light of a given wavelength detected at the detector may provide different information. For example, light traveling along a long path from a distal emitter may penetrate deeper into the tissue of the device wearer and may provide information about pulsatile blood flow or composition. Using proximal and distal emitters for each wavelength may improve accuracy of the measurement, e.g., information about light traveling along a long path from the distal emitter may be normalized (e.g., divided) by information about light traveling along a short path from the proximal emitter.

27M-27P illustrate an example physiological parameter measurement sensor or module 2700 'and example light barriers or light barriers between the emitter and detector chambers of the module 2700'.

Fig. 27M is a front view of an example aspect of a sensor or module 2700'. The sensor or module 2700 'includes an opaque frame 2726', one or more electrodes 2724', one or more detector chambers 2788', one or more emitter chambers 2778', and a light blocking layer construction 2720'.

The opaque frame 2726' may include one or more materials configured to prevent or block transmission of light. In some aspects, the opaque frame 2726' may form a single integrated unit. In some aspects, the opaque frame 2726' may be formed from a continuous material. The light blocking layer construction 2720' may include one or more materials configured to prevent or block transmission of light. In some aspects, the light blocking layer construction 2720' may form a single integrated unit. In some aspects, the light blocking layer construction 2720' may be formed from a continuous material. In some aspects, the light blocking layer construction 2720 'and the opaque frame 2726' may form a single integrated unit. In some aspects, the light blocking layer construction 2720 'and the opaque frame 2726' may be detachably connected.

The light blocking layer configuration 2720' may include one or more light blocking layers, such as light blocking layers 2720a ', 2720b ', 2720c ', 2720d ', which are provided as non-limiting examples. In some aspects, the light blocking layer may also be referred to herein as a light barrier. The light blocking layer may form one or more portions of the light blocking layer construction 2720'. The light blocking layer construction 2720' (or a light blocking layer portion thereof) may prevent light from passing therethrough. The light blocking layer configuration 2720' may include spaces between various light blocking layers, which may define one or more chambers (e.g., detector chamber 2788', emitter chamber 2778 '). In some aspects, one or more of the chambers (e.g., detector chamber 2788', emitter chamber 2778 ') may be enclosed by a light blocking layer configuration 2720', or a light blocking layer portion thereof, a surface of a substrate (e.g., PCB), and a lens or cover. In some aspects, light may enter the chamber only through the lens or cover.

Examples of light blocking layers are provided with reference to example light blocking layers 2720 a'. The light blocking layer 2720a 'forms part of the light blocking layer construction 2720'. The light blocking layer 2720a' may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720a 'may prevent light from passing through the light blocking layer configuration 2720' between the emitter chamber 2778 'and the detector chamber 2788'. The light blocking layer 2720a 'or portions thereof may include a width 2771'. In some aspects, the width 2771' may be less than about 3.30mm. In some aspects, the width 2771' may be less than about 3.25mm. In some aspects, the width 2771' may be less than about 3.20mm. In some aspects, the width 2771' may be about 3.24mm. In some aspects, width 2771' may be greater (e.g., more) than length 2779. In some aspects, width 2771' may be less than about 165% of length 2779. In some aspects, width 2771' may be less than about 160% of length 2779. In some aspects, width 2771' may be less than about 155% of length 2779. In some aspects, width 2771' may be about 160% of length 2779. Advantageously, a greater width 2771' (e.g., a wider light blocking layer separating the emitter chamber 2778' and the detector chamber 2788 ') may result in light emitted from the emitter chamber 2778' traveling a greater distance before reaching the detector chamber 2788 '. Light traveling a greater distance may penetrate deeper into the wearer's tissue, which may improve the accuracy of physiological measurements.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 b'. The light blocking layer 2720b 'forms part of the light blocking layer construction 2720'. The light blocking layer 2720b' may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720b 'may prevent light from passing through the light blocking layer configuration 2720' between the emitter chamber 2778 'and the detector chamber 2788'. The light blocking layer 2720b 'or portions thereof may include a width 2772'. In some aspects, the width 2772' may be less than about 1.65mm. In some aspects, the width 2772' may be less than about 1.60mm. In some aspects, the width 2772' may be less than about 1.55mm. In some aspects, the width 2772' may be about 1.59mm. In some aspects, width 2772 'may be less (e.g., less) than width 2771'. In some aspects, width 2772 'may be less than about 60% of width 2771'. In some aspects, width 2772 'may be less than about 55% of width 2771'. In some aspects, width 2772 'may be less than about 50% of width 2771'. In some aspects, width 2772 'may be about 49% of width 2771'. Advantageously, the larger width 2772' may result in light emitted from the emitter chamber 2778' traveling a greater distance before reaching the detector chamber 2788 '. Light traveling a greater distance may penetrate deeper into the wearer's tissue, which may improve the accuracy of physiological measurements.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 c'. The light blocking layer 2720c 'forms part of the light blocking layer construction 2720'. The light blocking layer 2720c' may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720c ' may prevent light from passing through the light blocking layer configuration 2720' between adjacent detector cells 2788 '.

Another example of a light blocking layer is provided with reference to example light blocking layer 2720 d'. The light blocking layer 2720d 'forms part of the light blocking layer construction 2720'. The light blocking layer 2720d' may prevent (e.g., block) light from passing between adjacent chambers. For example, the light blocking layer 2720d ' may prevent light from passing through the light blocking layer configuration 2720' between adjacent emitter chambers 2778 '. In some aspects, the light blocking layer 2720d 'may have a width 2775' that separates adjacent emitter chambers of less than about 1.40 mm. In some aspects, the width 2775' may be less than about 1.35mm. In some aspects, the width 2775' may be less than about 1.30mm. In some aspects, the width 2775' may be about 1.28mm. In some aspects, width 2775 'may be less (e.g., less) than width 2771'. In some aspects, width 2775 'may be less than about 50% of width 2771'. In some aspects, width 2775 'may be less than about 45% of width 2771'. In some aspects, width 2775 'may be less than about 40% of width 2771'. In some aspects, width 2775 'may be less than about 35% of width 2771'. In some aspects, width 2775 'may be about 39.5% of width 2771'.

The emitter chamber 2778 'is positioned within the central region of the sensor or module 2700'. For example, as described in more detail with reference to fig. 27K, the emitter chambers 2778 'may be positioned adjacent to each other across a centerline of the sensor or module 2700'. The emitter chamber 2778 'may be positioned adjacent to the center point C' ₁. Each of the emitter chambers 2778' may have a similar size and/or shape. The emitter chamber 2778' may be at least partially separated by a light blocking layer 2720d ' of the light blocking layer configuration 2720 '. In some aspects, as shown in this example, the light blocking layer 2720d 'may form the entire distance between the emitter chambers 2778'. For example, the emitter chambers 2778' may be separated only by the light blocking layer 2720d ' such that other components (e.g., detectors, detector chambers, etc.) are not positioned between the emitter chambers 2778 '.

A portion of the emitter chamber 2778 'may extend a length 2779 away from the center point C' ₁. In some aspects, the length 2779 may be less than about 2.15mm. In some aspects, the length 2779 may be less than about 2.10mm. In some aspects, the length 2779 may be less than about 2.05mm. In some aspects, the length 2779 may be less than about 2.0mm. In some aspects, the length 2779 may be about 2.02mm. In some aspects, the length 2779 may be less (e.g., less) than a width of a light blocking layer separating the emitter chamber from the detector chamber, such as width 2771'. In some aspects, the length 2779 may be less than about 70% of the width 2771'. In some aspects, the length 2779 may be less than about 65% of the width 2771'. In some aspects, the length 2779 may be less than about 60% of the width 2771'. In some aspects, the length 2779 may be about 62.3% of the width 2771'.

As shown in this example aspect, the detector cells 2788' are arranged in a substantially circular pattern. Each of the detector chambers 2788' houses a detector 2706 positioned in a substantially circular or annular pattern on a substrate (e.g., PCB). The detector 2706 may be positioned in a central region of each of the respective detector chambers 2778'. The detector chambers 2788 'are arranged along a ring defined by the ring L' ₁. In some aspects, such as shown in this example aspect, the detectors 2706 of the respective detector chambers 2788 'may also be arranged along the same ring as the detector chambers 2788' (such as in terms of the detectors being positioned in a central region in the respective chambers). The loop L '₁ may intersect a central region of the detector chamber 2788'. In this example aspect, the ring L ' ₁ encloses the entirety of the emitter chamber 2778' such that the emitter chamber 2778' is positioned within an interior region (e.g., a central region) of the ring L ' ₁ defined by the detector chamber 2788 '. In some aspects, each of the detector chambers 2788 '(and corresponding detectors 2706 within the respective detector chambers 2788') may be positioned at a substantially similar or identical distance from a center point C '₁ (e.g., the center of the sensor or module 2700'). In some aspects, detector 2706 may be rectangular including longer sides and shorter sides. The detectors 2706 may be positioned on the substrate of the sensor or module 2700' such that the long side of each detector is orthogonal to a radius (e.g., radius r ' ₁, radius r ' ₂, radius r ' ₃) extending away from the center point C ' ₁. Advantageously, the detectors 2706 on the sensor or module 2700' are oriented in a circular arrangement, wherein the long sides of the detectors 2706 are orthogonal to the center point C ' ₁, the accuracy of the physiological measurement can be improved by ensuring that light from the emitter travels along a known path length from the emitter to the detectors 2706, and the processing requirements of the sensor or module 2700' can also be reduced by reducing the amount of variables (e.g., the number of path lengths) required to process in order to determine the physiological data.

The electrode 2724' may include a reference electrode and a negative electrode (and/or positive electrode). In some aspects, a wearable device, such as a watch incorporating a sensor or module 2700', may include another ECG electrode (e.g., positive electrode) located on a housing of the wearable device configured to contact the skin of the wearer. In some configurations, the surface of the electrode 2724 'may be flush with the surface of the opaque frame 2726'.

The electrode 2724' is positioned within a portion of the opaque frame 2726' or along a portion of the opaque frame 2726', such as shown in fig. 27B, for example. In some aspects, the electrode 2724' may be substantially semicircular. In some aspects, the electrode 2724' may be substantially semi-annular. In the example aspect shown, each of the electrodes 2724' forms a substantially half-ring. Advantageously, the ring electrode may improve contact with the wearer's skin (e.g., by contacting different areas of the skin) while reducing the amount of surface area of the electrode. In some aspects, each electrode 2724' may have a similar size and/or shape. In some aspects, the electrode 2724' may have various sizes and/or shapes. In this example aspect, the electrode 2724 'is positioned within the sensor or module 2700' along a loop defined by L '₂ (e.g., within the opaque frame 2726'). In various aspects described herein, the loop L '₂ can include various radii, which can advantageously provide improved contact between the electrode 2724' and the skin of a wearer of the device. In some embodiments, the frame 2726 'includes a recess 2824', which recess 2824 'is sized and/or shaped to receive the ECG electrode 2724'. In some embodiments, the recess 2824' has a depth (e.g., measured from the plane of the frame 2726 ') that is substantially equal to the thickness of the ECG electrode 2724'. In some embodiments, the recess 2824 'has a size and/or shape that matches the size and/or shape of the ECG electrode 2724'. For example, in some embodiments where the ECG electrode has a semi-annular shape, the recess 2824' may have a semi-annular shape.

The opaque frame 2726' includes one or more gaps (e.g., g ' ₁、g'₂) between the electrodes 2724 '. The gap g ' ₁、g'₂ (or other portion of the opaque frame 2726 ') may electrically insulate each of the electrodes 2724' from each other. Each of the electrodes 2724 'includes a curved edge along a portion of the respective gap g' ₁、g'₂. In some aspects, the gaps g' ₁、g'₂ can have similar or identical sizes. In some aspects, the gaps g' ₁、g'₂ may have different sizes from one another. In some aspects, the gap g' ₁、g'₂ may be less than about 0.6mm. In some aspects, the gap g' ₁、g'₂ may be less than about 0.65mm. In some aspects, the gap g' ₁、g'₂ may be less than about 0.7mm. In some aspects, the gap g' ₁、g'₂ may be about 0.62mm. As described above, in some embodiments, the frame 2726' includes a recess 2824' sized and/or shaped to receive the ECG electrode 2724 '. In some embodiments, each of such recesses 2824' includes a first end and a second end, the first ends of the recesses 2824' being separated from each other by a gap g ' ₁, and the second ends of the recesses 2824' being separated from each other by a gap g ' ₂ (see fig. 27M). In some embodiments, such as at least the embodiment shown in fig. 27M, the ends of the recess 2824 'and/or the ends of the ECG electrode 2724' have a rounded shape.

The ring L '₁ may be concentric with the outer circumference of the sensor or module 2700'. The ring L '₂ may be concentric with the outer circumference of the sensor or module 2700'. The ring L ' ₂ may be concentric with a ring (such as ring L ' ₁) defined by the position of the detector chamber 2788 '. The center point C '₁ may define the geometric center of the ring L' ₁. The center point C '₁ may define the geometric center of the ring L' ₂. The center point C '₁ may define the geometric center of the outer perimeter of the sensor or module 2700'. In some aspects, such as shown in fig. 27M, each of L ' ₁、L'₂ and the outer perimeter of sensor or module 2700' are concentric with each other and share the same geometric center shown as C ' ₁.

The ring L '₁ may include a radius r' ₁. In some aspects, the radius r' ₁ may be less than about 6.5mm. In some aspects, the radius r' ₁ may be less than about 6.45mm. In some aspects, the radius r' ₁ may be less than about 6.40mm. In some aspects, the radius r' ₁ may be about 6.40mm. In some aspects, radius r '₁ may be less (e.g., less) than radius r' ₂. In some aspects, the radius r '₁ may be less than about 60% of r' ₂. In some aspects, the radius r '₁ may be less than about 55% of r' ₂. In some aspects, the radius r '₁ may be less than about 50% of r' ₂. In some aspects, the radius r '₁ may be about 50.9% of r' ₂. In some aspects, radius r '₁ may be less (e.g., less) than radius r' ₃. In some aspects, the radius r '₁ may be less than about 40% of r' ₃. In some aspects, the radius r '₁ may be less than about 45% of r' ₃. In some aspects, the radius r '₁ may be less than about 50% of r' ₃. In some aspects, the radius r '₁ may be about 42% of r' ₃.

The ring L '₂ may include a radius r' ₂. In some aspects, the radius r' ₂ may be less than about 13mm. In some aspects, the radius r' ₂ may be less than about 12.75mm. In some aspects, the radius r' ₂ may be less than about 12.5mm. In some aspects, the radius r' ₂ may be about 12.59mm. In some aspects, radius r '₂ may be less (e.g., less) than radius r' ₃. In some aspects, the radius r '₂ may be less than about 80% of r' ₃. In some aspects, the radius r '₂ may be less than about 85% of r' ₃. In some aspects, the radius r '₂ may be less than about 90% of r' ₃. In some aspects, the radius r '₂ may be about 82.7% of r' ₃.

In some aspects, the sensor or module 2700' (e.g., the outer perimeter of the sensor or module 2700 ') can include a radius r ' ₃. In some aspects, the radius r' ₃ may be less than about 15mm. In some aspects, the radius r' ₃ may be less than about 15.0mm. In some aspects, the radius r' ₃ may be less than about 15.25mm. In some aspects, the radius r' ₃ may be less than about 15.5mm. In some aspects, the radius r' ₃ may be about 15.22mm.

Fig. 27N is a side cross-sectional view of an example aspect of a sensor or module 2700'. Sensor or module 2700 'includes barrier layer construction 2720', outer surface 2791', and substrate 2716'. The outer surface 2791' may include a light blocking layer construction portion, a lens portion, an opaque frame portion, and/or an electrode portion. The outer surface 2791 'of the sensor or module 2700' may face and/or contact the skin of the wearer and may include a generally convex shape. The central region of the sensor or module 2700 'can have a height 2793'. For example, the height of the light blocking layer configuration 2720' at the central region of the sensor or module 2700' may correspond to the height 2793'. The height 2793' may be the maximum distance that the outer surface 2791' extends perpendicularly away from the substrate 2716' (e.g., toward the skin of the wearer). The outer region of sensor or module 2700' (e.g., along the perimeter of substrate 2716 ') can have a height 2795'. For example, the height of the light blocking layer configuration 2720 'and/or opaque frame 2726' at the outer region of the sensor or module 2700 'may correspond to the height 2795'. The height 2795' may be the minimum distance that the outer surface 2791' extends perpendicularly away from the substrate 2716' (e.g., toward the skin of the wearer).

In some aspects, the height 2793' may be less than about 2.95mm. In some aspects, the height 2793' may be less than about 2.90mm. In some aspects, the height 2793' may be less than about 2.85mm. In some aspects, the height 2793' may be less than about 2.80mm. In some aspects, the height 2793' may be about 2.85mm. In some aspects, the height 2793' may be less than about 2.70mm. In some aspects, the height 2793' may be less than about 2.65mm. In some aspects, the height 2793' may be less than about 2.60mm. In some aspects, the height 2793' may be less than about 2.55mm. In some aspects, the height 2793' may be about 2.58mm.

In some aspects, the height 2795' may be less than about 1.40mm. In some aspects, the height 2795' may be less than about 1.35mm. In some aspects, the height 2795' may be less than about 1.30mm. In some aspects, the height 2795' may be less than about 1.25mm. In some aspects, the height 2795' may be about 1.29mm. In some aspects, the height 2795' may be less than about 1.90mm. In some aspects, the height 2795' may be less than about 1.85mm. In some aspects, the height 2795' may be less than about 1.80mm. In some aspects, the height 2795' may be less than about 1.75mm. In some aspects, the height 2795' may be about 1.78mm.

In some aspects, the height 2793 'may be greater (e.g., more) than the height 2795'. In some aspects, the height 2793 'may be less than about 230% of the height 2795'. In some aspects, the height 2793 'may be less than about 225% of the height 2795'. In some aspects, the height 2793 'may be less than about 220% of the height 2795'. In some aspects, the height 2793 'may be less than about 215% of the height 2795'. In some aspects, the height 2793 'may be about 221% of the height 2795'. In some aspects, the height 2793 'may be less than about 155% of the height 2795'. In some aspects, the height 2793 'may be less than about 150% of the height 2795'. In some aspects, the height 2793 'may be less than about 145% of the height 2795'. In some aspects, the height 2793 'may be less than about 140% of the height 2795'. In some aspects, the height 2793 'may be about 145% of the height 2795'.

Advantageously, a greater height 2793' (and/or a greater ratio of height 2793' to 2795 ') (e.g., a higher light blocking layer at the central region of the sensor or module 2700) may result in light emitted from the emitter chamber traveling a greater distance before reaching the detector chamber. Light traveling a greater distance may penetrate deeper into the wearer's tissue, which may improve the accuracy of physiological measurements. A smaller height 2793 '(and/or a smaller ratio of height 2793' to height 2795 ') may reduce discomfort to the wearer wearing the wearable device 10 or may reduce obstruction to the wearer's blood flow by reducing the amount of pressure exerted by the wearable device on the wearer. The height 2793 'and/or the height 2795' may be selected to balance the above considerations, such as increasing the depth of light penetration into tissue and reducing discomfort or blood flow obstruction for the wearer.

Fig. 27O and 27P illustrate two example aspects of a sensor or module 2700' having different configurations of light blocking layer construction. Fig. 27O and 27P also show example optical paths from the emitter chamber to the detector chamber. The light blocking layer configuration 2720' (or portion thereof) shown in the example aspect of fig. 27O may be higher (e.g., extend away from the surface of substrate 2716) and/or wider than the light blocking layer configuration 2720 (or portion thereof) shown in the example aspect of fig. 27P. In the aspect of fig. 27O, the greater height and/or width of the light blocking layer configuration 2720' may result in light emitted from the emitter chamber 2778' traveling a greater distance before reaching the detector chamber and thus penetrating deeper into the wearer's tissue than in the aspect of fig. 27P. Thus, adjusting the height and/or width of the light blocking layer configuration may affect the path of light traveling from the emitter chamber to the detector chamber, which may affect the accuracy of the physiological measurement. According to various aspects, the height and/or width of the light blocking layer construction may be adjusted as needed or desired.

Fig. 27Q shows a cross-sectional side view of an example sensor or module 2700', showing a light transmissive lens or cover 2702' and light diffusing material. The light diffusing material may be contained in one or more of the emitter or detector chambers to improve the distribution of emitted and/or detected light. The diffusing material or encapsulant may include, for example, microspheres or glass microspheres. The encapsulant may eliminate air gaps between the surface of the light transmissive cover 2702' and the emitter and/or detector. The encapsulant may be included around the emitter to more evenly spread the emitted light, if not to make the emitted light appear to be emitted from the entire emitter chamber rather than from a point source (that is, a single LED emitter). The light transmissive lens or cover 2702' may comprise polycarbonate.

Example graphical user interface for external devices

As discussed herein and as shown in fig. 2, the wearable device 10 may communicate with an external device, e.g., wirelessly. Fig. 28 shows a block diagram illustrating example aspects of the wearable device 10 in communication with an external device 2802. The communication may be wireless, such as, but not limited to, bluetooth and/or Near Field Communication (NFC) wireless communication. As shown in fig. 2, the wearable device 10 may communicate with any number and/or type of external devices 2802, which external devices 2802 may include a patient monitor 202, a mobile communication device 204 (e.g., a smart phone), a computer 206 (which may be a laptop or desktop computer), a tablet computer 208, a nurse station system 201, glasses (such as smart glasses configured to display images on a surface of the glasses), and so forth. The external devices 2802 may include a health application 2804. "external device" and "computing device" may be used interchangeably herein.

The user may operate the external device 2802 as described herein. The wearer may wear the wearable device 10. In some implementations, the user of the external device 2802 and the wearer of the wearable device 10 are different people. In some implementations, the user of the external device 2802 and the wearer of the wearable device 10 are the same person. The terms "user" and "wearer" and "patient" may be used interchangeably herein and may all refer to the person wearing the wearable device 10 and/or the person using the health application 2804, and their use in any given example is not meant to limit the present disclosure.

The wearable device 10 may communicate information, such as physiological data of the wearer/user, to the external device 2802. The external device 2802 may display physiological parameters received from the wearable device 10, as described herein.

The external device 2802 may control the operation of the wearable device 10, for example, via a wireless connection as described herein. For example, the external device 2802 may cause the wearable device 10 to start or stop taking measurements of the physiological parameters of the wearer. In some aspects, the wearable device 10 may continuously measure and transmit the physiological parameter of the wearer to the external device 2802. In some aspects, the external device 2802 may continuously display physiological parameters of the wearer received from the wearable device 10. In some aspects, when user input is received at the external device 2802 that is transmitted to the wearable device 10, the wearable device 10 may measure and transmit the physiological parameter to the external device 2802 for a limited amount of time (such as 1 minute).

FIGS. 29, 30A-30H, 31A-31D, 32, 33A-33C, 34A-34C, and 35A-35B illustrate example graphical user interfaces for a health application 2804 in accordance with some aspects of the present disclosure. In various aspects, aspects of the user interface may be rearranged according to what is shown and described below, and/or may not include particular aspects. The health application 2804 may be executed on the external device 2802 to present the graphical user interfaces of FIGS. 29, 30A-30H, 31A-31D, 32, 33A-33C, 34A-34C, and 35A-35B. As described herein, the health application 2804 can receive respective client configuration packages that cause presentation of the graphical user interfaces of FIGS. 29, 30A-30H, 31A-31D, 32, 33A-33C, 34A-34C, and 35A-35B. The graphical user interfaces of fig. 29, 30A-30H, 31A-31D, 32, 33A-33C, 34A-34C, and 35A-35B may have similar user interface elements and/or capabilities.

Fig. 29 illustrates an example dashboard user interface 2900 of the health application 2804. The dashboard user interface 2900 may display the current physiological parameters 2902 of the wearer, such as pulse rate, spO ₂, RRp, PVi, pi, and the like. In addition to the presentation of the current wearer physiological parameters 2902, the dashboard user interface 2900 may present indicators associated with one or more of the physiological parameters 2902 that visually indicate the status of the parameters 2902 and the various status ranges for each parameter 2902. The indicator may be color coded or otherwise display the severity or status of the physiological parameter 2902. Dashboard user interface 2900 may additionally display a history of wearer statistics/information, such as workout history information, sleep information, activity levels, number of steps taken, and/or calories expended.

The dashboard user interface 2900 may additionally display one or more navigation selectors 2904 configured to be selected by a user. The one or more navigation selectors 2904 may include a home navigation selector, an active navigation selector, an exercise navigation selector, a vital sign navigation selector, a sleep navigation selector, a history navigation selector, a sharing navigation selector, and/or a setup navigation selector. Selection of the navigation selector 2904 may cause the health application 2804 to display any graphical user interface described herein associated with the selected navigation selector 2904. Navigation selector 2904 may be displayed in any graphical user interface described herein.

Fig. 30A-30D illustrate an example spot check monitoring user interface of the health application 2804. The wearable device 10 may be configured to perform spot checks. Spot check may be a discrete period of time for which the wearable device 10 performs physiological measurements of the wearer. For example, during spot check, the wearable device 10 may perform physiological measurements for one minute. The user/wearer may initiate spot checks at any desired time, for example, via the health application 2804 of the external device 2802.

Fig. 30A illustrates an example spot check monitoring user interface 3000 of a health application 2804. The user/wearer may initiate spot checks by selecting the begin spot check selectable component 3002. Upon selection of the begin spot check selectable component 3002 via the health application 2804, the external device 2802 may cause the wearable device 10 to begin measuring physiological parameters as described herein. In some aspects, upon selection of the begin spot check selectable component 3002 via the health application 2804, the external device 2802 may check the power level of the wearable device 10 (e.g., by checking the charge and/or voltage level of the power source 16) prior to causing the wearable device to begin spot checks to determine whether the wearable device 10 has sufficient power to perform the spot check. Upon determining that the wearable device 10 has sufficient power, the external application may cause the wearable device 10 to perform spot checks. Upon determining that the wearable device 10 does not have sufficient power, the external application may not cause the wearable device 10 to perform spot checks and/or may cause spot checks to be performed only for certain physiological parameters. In some aspects, upon receiving a command from the external device 2802 to perform a spot check, the wearable device 10 may check its power level (e.g., by checking the charge and/or voltage level of the power source 16) to determine if it has sufficient power to perform the spot check before beginning the physiological measurement of the spot check. Upon determining that it has sufficient power, the wearable device 10 may begin performing spot checks. When it is determined that it does not have sufficient power, the wearable device 10 may not perform spot check.

In some aspects, the wearable device 10 may perform spot checks for a predetermined amount of time, such as three minutes, two minutes, one minute, 30 seconds, 15 seconds, or any amount of time as needed or desired. In some aspects, the user may select a predetermined amount of time for spot check to be performed, for example, before or after selecting the selectable component 3002. In some aspects, the wearable device 10 may perform spot checks until it receives a command to stop performing spot checks. For example, the external device 2802 may cause the wearable device 10 to cease performing spot checks upon receiving a user command, e.g., via an optional component of the health application 2804 (e.g., similar to the optional component 3002).

Fig. 30B illustrates an example spot check monitoring user interface 3010 of the health application 2804. The spot check monitoring user interface 3010 may display substantially real-time measurements of physiological parameters measured by the wearable device 10 during the spot check, such as pulse rate, spO ₂, RRp, PVi, pi, and the like. As described herein, substantially real-time measurements, waveforms, parameters, etc. may refer to physiological measurements that are displayed (e.g., via a user interface of a health application) at the same or substantially the same time as obtained by the wearable device 10 (e.g., ignoring any minor delays, such as those that are imperceptible to humans, such as delays caused by electrical conduction or transmission). The spot check monitoring user interface 3010 may display a substantially real-time waveform 3012 of any of the physiological parameters, such as pulse waveforms and/or plethysmographic waveforms, obtained at the time of the spot check.

Fig. 30C illustrates an example spot check monitoring user interface 3020 of the health application 2804. The spot check monitoring user interface 3020 may display substantially real-time measurements of a physiological parameter of the wearer, such as those described with reference to fig. 30B. The spot check monitoring user interface 3020 may further include historical data. In particular, the spot check monitoring user interface 3020 may include a visualization that presents historical trends in the wearer's physiological parameters. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of parameter values.

Fig. 30D illustrates an example spot check monitoring user interface 3030 of the health application 2804. When the wearable device 10 has completed spot check, a spot check monitoring user interface 3030 may be displayed. In some aspects, as shown in fig. 30D, the user interface 3030 may display physiological parameters obtained during spot checks in a format similar to that shown in the user interface 3020 of fig. 30C. In some aspects, the user interface 3030 may display physiological parameters obtained during spot checks in a format similar to that shown in the user interface 3010 of fig. 30B.

In some aspects, the spot check monitoring user interface 3030 may display a predetermined length of time, such as one minute, after the spot check ends, and after the predetermined length of time, the health application 2802 may display another user interface, such as any of the user interfaces described herein, such as the dashboard user interface 2900 or spot check monitoring user interface 3000. In some aspects, upon selection of the selectable component 3032, the user may navigate to another user interface, such as any of the user interfaces described herein, such as the dashboard user interface 2900 or spot check monitoring user interface 3000. In some aspects, the health application 2804 may display the user interface 3030 until the user selects the selectable component 3032.

Figures 30E-30H illustrate an example continuous monitoring user interface of the health application 2804. The wearable device 10 may be configured to perform continuous measurements of physiological parameters of the wearer. For example, the wearable device may continuously measure a physiological parameter of the wearer indefinitely, e.g., as long as the device is powered on or until the user chooses to cease operation in a continuous mode of operation and/or until the user chooses operation in a discontinuous monitoring mode of operation, such as spot checks described herein.

In some aspects, the external device 2802 may check the power level of the wearable device 10 (e.g., by checking the charge and/or voltage level of the power source 16) before and/or during the continuous monitoring mode of the wearable device to determine whether the wearable device 10 has sufficient power to perform the continuous monitoring. Upon determining that the wearable device 10 has sufficient power, the external application may cause the wearable device 10 to initiate continuous monitoring and/or continue continuous monitoring. Upon determining that the wearable device 10 does not have sufficient power, the external application may not cause the wearable device 10 to initiate continuous monitoring and/or may cause the wearable device 10 to interrupt continuous monitoring, and/or may cause the wearable device 10 to initiate a different mode of operation than continuous monitoring, such as a modified continuous monitoring mode or spot check mode. In some aspects, upon receiving a command to perform continuous monitoring, for example, from the external device 2802, the wearable device 10 may check its power level (e.g., by checking the charge and/or voltage level of the power source 16) before starting and/or during continuous monitoring to determine whether it has sufficient power to perform continuous monitoring. Upon determining that it has sufficient power, the wearable device 10 may begin performing continuous monitoring and/or may continue performing continuous monitoring. Upon determining that it does not have sufficient power, the wearable device 10 may not initiate continuous monitoring and/or may interrupt continuous monitoring, and/or may cause the wearable device 10 to initiate a different mode of operation than continuous monitoring, such as a modified continuous monitoring mode or spot check mode.

Fig. 30E illustrates an example continuous monitoring user interface 3040 of the health application 2804. The user interface 3040 may be displayed when the wearable device 10 is operating in a continuous monitoring mode and while the physiological measurement is not available (or it is determined that the obtained physiological measurement is below an accuracy threshold), for example, when the wearable device 10 is not being worn (or not being properly worn) by the wearer.

Fig. 30F illustrates an example continuous monitoring user interface 3050 of the health application 2804. The continuous monitoring user interface 3050 may display substantially real-time measurements of physiological parameters measured by the wearable device 10 during continuous monitoring in a manner similar to that explained with reference to the display of physiological parameters during spot check in the example user interface 3010 of fig. 30B.

Fig. 30G illustrates an example continuous monitoring user interface 3060 of the health application 2804. The continuous monitoring user interface 3060 may display substantially real-time measurements of the physiological parameter of the wearer, such as those described with reference to fig. 30F or 30B. The continuous monitoring user interface 3060 may further include historical data. In particular, continuously monitoring the user interface 3060 may include presenting a visualization of historical trends in the physiological parameters of the wearer. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of parameter values.

Fig. 30H illustrates an example continuous monitoring user interface 3070 of the health application 2804. The continuous monitoring user interface 3070 can display information 3702 related to any physiological parameter discussed herein, such as those displayed in any graphical user interface discussed herein. The information 3072 may assist the user/wearer in understanding the physiological parameters. In the example of fig. 30H, the continuous monitoring user interface 3070 displays information 3072 related to the SpO ₂ physiological parameters. The continuous monitoring user interface 3070 may display information related to the physiological parameter in response to a displayed user selection of the corresponding physiological parameter. In some aspects, as shown in fig. 30H, a user may select physiological parameters from a display format similar to that shown in user interface 3050 of fig. 30F to display information 3072. In some aspects, the user may select physiological parameters from a display format similar to that shown in user interface 3060 of fig. 30G to display information 3072.

Fig. 31A-31D illustrate an example measurement setup user interface of the health application 2804. As discussed with reference to the example measurement setup interface, a user may adjust the settings of the health application 2804 and/or may adjust the operational mode of the wearable device 10 with respect to at least physiological measurements.

Fig. 31A illustrates an example measurement settings user interface 3100 of the health application 2804. The measurement setup user interface 3100 may allow a user to select an operational mode of the wearable device 10. For example, a user may select via user interface 3100 whether the wearable device is operating in a continuous monitoring mode or spot check mode. The user may also navigate to additional measurement settings user interfaces, such as user interface 3110, via selections in user interface 3100.

Fig. 31B illustrates an example measurement settings user interface 3110 of the health application 2804. The user interface 3110 may display various physiological parameters, as shown. The user may select any of the displayed physiological parameters to edit and/or adjust settings associated with the selected physiological parameters. User selection of a physiological parameter may navigate the user to an additional measurement setting user interface, such as user interface 3120 or 3130.

Fig. 31C illustrates an example measurement settings user interface 3120 of the health application 2804. The user interface 3120 may allow a user to set one or more threshold levels related to a physiological parameter, such as any physiological parameter measured by the wearable device 10 and/or displayed by a graphical user interface as discussed herein. In some aspects, the external device 2802 may generate a notification when a physiological parameter value reaches a threshold level as measured by the wearable device 10. For example, if the threshold level is violated, the external device 2802 may cause an emergency notification to be generated. The emergency notification may be displayed on a graphical user interface of the external device 2802 and/or transmitted to another device, such as the wearable device 10, another external device 2802, and/or a third party device. In some aspects, the generation of the physiological parameter notification may be activated or deactivated by the user.

The example measurement setup user interface 3120 displays a slidable component 3122 that is related to the SpO ₂ threshold. The user may slide the slidable component 3122 to adjust and/or select the threshold SpO ₂ limit. As shown, the user has set the SpO ₂ threshold limit to 88%. As discussed herein, in some aspects, the health application 2804 of the external device 2802 may generate a notification and/or alert when the wearable device 10 measures that the wearer's SpO ₂ level is 88% or less.

Fig. 31D illustrates an example measurement settings user interface 3130 of the health application 2804. The example measurement setup user interface 3130 displays a slidable component 3134 that is associated with the RRp threshold. The user may slide the slidable component 3134 to adjust and/or select the RRp threshold upper and lower limits. As shown, the user has set the RRp threshold lower limit to 6 and the RRp threshold upper limit to 30. As discussed herein, in some aspects, the health application 2804 of the external device 2802 may generate a notification and/or alert when the wearable device 10 measures an RRp level of the wearer that is less than 6 or greater than 30.

The example measurement setup user interface 3130 displays a switching component 3132 associated with RRp display. The user can select the switching component 3132 to enable or disable display of RRp physiological parameter measurements in any of the user interfaces discussed herein (e.g., user interfaces 29 or 30A-30H). A switching component or other component similar to switching component 3132 shown in user interface 3130 may be displayed in other user interfaces related to other physiological parameters. For example, a similar switching component can be displayed in the user interface 3120 to allow a user to enable or disable the display of SpO ₂ physiological parameter measurements in the user interface discussed herein.

Fig. 32 illustrates an example active user interface 3200 of a health application 2804. The activity user interface 3200 may display a history of activity levels of the wearer for any number of activity categories 3202, such as number of steps taken, distance traveled, and/or calories burned. The activity user interface 3200 may display the activity level of the wearer throughout a period of time, such as a 12 hour period, a 24 hour period, a week period, or any other period of time. For example, the activity user interface 3200 may include a visualization that presents historical trends of the wearer activity level 3202. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of activity level. The activity user interface 3200 may display targets of the wearer/user for any activity category 3202 and may display visualizations 3204 corresponding to the targets and/or the status of the wearer achieving the targets.

Fig. 33A illustrates an example exercise user interface 3300 of a health application 2804. The user may select selectable component 3302 of exercise user interface 3300 to cause the wearable device to begin monitoring the physiological parameters of the wearer and/or to cause health application 2804 to begin tracking/recording the physiological parameters of the wearer during an exercise. The selectable component 3302 may correspond to a type of workout such as running, swimming, high intensity intermittent training (h.i.i.t.), strength training, and the like. Exercise user interface 3300 may display information 3304 related to the previous exercise.

Fig. 33B illustrates an example exercise user interface 3310 of a health application 2804. The exercise user interface 3310 may be displayed by the health application 2804 during and/or after the wearer exercises. The exercise user interface 3310 may display physiological parameters of the wearer (such as received by the wearable device 10) as well as other information related to the exercise (such as the duration of the exercise). The exercise user interface 3310 may display the wearer's history and/or substantially real-time physiological parameters. The exercise user interface 3310 may display a visualization 3306 of any wearer physiological parameters. For example, the exercise user interface 3310 may include a visualization that presents historical trends in the physiological parameters of the wearer during exercise. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of parameter values.

Fig. 33C illustrates an example exercise user interface 3320 of the health application 2804. The exercise user interface 3320 may be displayed by the health application 2804 after the wearer exercises. The workout user interface 3320 may display information 3308 related to the wearer's workout.

Fig. 34A illustrates an example sleep user interface 3400 of the health application 2804. The sleep user interface 3400 may display a sleep quality index that may be calculated based at least in part on one or more physiological parameters of the wearer received from the wearable device 10. The sleep user interface 3400 may display a visualization 3402 of sleep quality index. For example, the sleep user interface 3400 may include a visualization that presents historical trends in sleep quality index during the sleep of the wearer. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of sleep quality index.

Fig. 34B illustrates an example sleep user interface 3410 of the health application 2804. The sleep user interface 3410 may display a history of events that occur during the sleep of the wearer. The event may be a primary event or a secondary event, as determined by, for example, the size of the event. For example, the event history may display all times during sleep of the wearer in which a physiological parameter such as SpO ₂ exceeds a threshold. The threshold may be set by the user/wearer as discussed with reference to fig. 31C-31D.

Fig. 34C illustrates an example sleep user interface 3420 of the health application 2804. The sleep user interface 3420 may display physiological parameters of the wearer, such as the wearer's current physiological parameters and/or average physiological parameters during sleep. The sleep user interface 3420 may display a visualization 3404 of the physiological parameters. For example, the sleep user interface 3420 may include a visualization that presents historical trends in physiological parameters during the sleep of the wearer. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of parameter values. The visualization may further include an indication of the threshold value and may display all times that the physiological parameter exceeds the threshold value. The threshold may correspond to the threshold discussed with reference to fig. 34B and may be set by the wearer as discussed with reference to fig. 31C-31D.

Fig. 35A illustrates an example history user interface 3500 for a health application 2804. The history user interface 3500 may display history data, such as history data of the wearer's physiological parameters received from the wearable device 10. History user interface 3500 may display history data over any time period, such as, for example, the history data of the day and/or the history data of the week. History user interface 3500 may display history data grouped according to any time frame, such as day-by-day history data and/or hour-by-hour history data. As shown in fig. 35A, history user interface 3500 may display historical data for the day and any number of previous days.

Fig. 35B illustrates an example history user interface 3510 of the health application 2804. The historical user interface 3510 may display historical data, such as historical physiological parameter values and/or activity levels of the wearer. The historical user interface 3510 may include a visualization that presents historical trends in the wearer's physiological parameters and/or activities, such as calories burned or number of steps taken. As shown, the visualization may include one or more graphs having an x-axis of time and a y-axis of values (such as physiological parameter values or activity levels). The history user interface 3510 may display a visualization such that the x-axis of time of one graph corresponds to the x-axis of time of any other graph. The history user interface 3510 may further display the history data values of the visualization map corresponding to the time of the visualization map upon user selection, such as by adjusting the slider along the x-axis of the graph shown in fig. 35B.

Appendix a, which is attached to this specification, is incorporated by reference herein in its entirety and forms a part of this specification. Appendix a shows an additional example graphical user interface for health application 2804. A1 illustrates an example user interface of the wearable device 10 for connecting the wearable device 10 with the external device 2802. A2 illustrates an example user interface for launching the health application 2804 on the external device 2802. A3-A5 illustrate example user interfaces for creating an account on the health application 2804. A6 illustrates an example user interface for the health application 2804 to successfully create an account. A7 illustrates an example user interface that successfully pairs the wearable device 10 with the external device 2802. A8 illustrates an example user interface for setting a target in the health application 2804. A9 illustrates an example user interface that was not successfully logged into the health application 2804.

A10 illustrates an example user interface for the home page of the health application 2804. A11-A13 illustrate an example user interface of a dashboard for the health application 2804. A14 illustrates an example user interface for monitoring physiological parameters of a wearer with a spot check of the wearable device 10. As shown in a14, a user may select a component via a user interface to begin taking physiological measurements with the wearable device 10. The wearable device 10 may measure the physiological parameter and display the measured value to the user interface for a predetermined amount of time (e.g., one minute) and/or until the user selects a component via the user interface to stop the physiological measurement. A15 illustrates an example user interface for displaying physiological parameters continuously measured with the wearable device 10. A16 illustrates an example user interface for adjusting physiological measurement settings. A17 illustrates an example user interface for displaying physiological parameter measurements.

A18-A19 illustrate an example user interface for displaying user activity. A20-A21 illustrate an example user interface for displaying workout information for a user. A22-A24 illustrate an example user interface for displaying sleep information of a user. A25-a26 illustrate an example user interface for setting sleep settings for a user. A27-A29 illustrate an example user interface for displaying a user's physiological parameter measurements and a history of activity.

A30-A36 illustrate an example user interface for setting settings of the wearable device 10.

A37 illustrates an example user interface of the dashboard of the health application 2804. A38 illustrates an example user interface of a history of physiological parameters of a user. A39 illustrates an example user interface for sharing information, such as physiological parameters, from the external device 2802 to another device. A40-A41 illustrate an example user interface for navigating between interfaces of the health application 2804 using an interactive navigation bar displayed at the bottom of the user interface. A42 illustrates an example user interface for the dashboard and account home page of the health application 2804. A43 shows an example user interface for navigating between interfaces of the health application 2804 using an interactive navigation bar displayed at the bottom of the user interface. A44 illustrates an example user interface of a dashboard for the health application 2804.

Example graphical user interface of wearable device

As discussed herein, for example, with reference to fig. 11A, the wearable device 10 may include a display 12, which display 12 may include a display screen and touch input from the wearer. For example, the display 12 may include a capacitive touch screen configured to receive touch input from a wearer to control the functionality of the wearable device 10. The wearable device 10 may also include a user interface on the device 10 to receive input from the wearer. As shown in fig. 1D, an example user interface may include a button 13.

Fig. 36A shows an example wearable device 10 including a display 12 and buttons 13. 36B-36E illustrate example screens of the display 12 of the wearable device 10. The display 12 may be configured to display a number of different screens. For example, in some aspects, the display 12 may display a screen with various physiological parameter information (such as values and trends), while in other aspects, the display 12 may display a screen without physiological parameter information. In some aspects, the display 12 may display a screen with non-physiological related information such as date, time, and other notifications.

The display 12 may display various screens in a cyclic manner. For example, the display 12 may display a screen with first physiological parameter information (such as values and trends), and then may display a screen with second physiological parameter information, and then may display a screen with third physiological parameter information, and so on. In some aspects, the order of the screens displayed by the display 12 is constant. The display 12 may automatically and/or manually cycle through various screens. For example, the display 12 may change the automatically displayed screen every 1 minute, every 30 seconds, every 10 seconds, every 5 seconds, every 3 seconds, every 2 seconds, every 1 second, or any other time frame needed or desired without user input. In some aspects, the wearer/user may select a time frame (e.g., frequency) that the display 12 will change the screen. In some aspects, the wearer/user may manually change the screen displayed by the display 12. For example, the wearer may touch the display 12 to provide touch input to the wearable device 10 and/or may press the button 13 to provide input to the wearable device 10. Upon receiving the input from the wearer, the display 12 may change the screen displayed. The display 12 may no longer change screen until another user input is received as described above.

In some aspects, the display 12 may automatically and manually cycle through various screens as a simultaneous mode of operation. For example, the display 12 may automatically cycle through the various screens (e.g., every 3 seconds) without user input unless or until the wearer/user provides input (via the display 12 and/or the buttons 13) after which the display 12 will change screen.

In some aspects, the display 12 may automatically or manually cycle through the various screens, but not both modes of operation. For example, the display 12 may automatically cycle through the various screens (e.g., every 3 seconds) regardless of received user input. As another example, the display 12 may only manually cycle through the various screens when user input is received, regardless of the time that has elapsed. In some aspects, the display 12 may switch between automatically and manually cycling through the display of various screens, for example, when adjusting user settings of the wearable device 10.

36A-36E illustrate example screens of the display 12 of the wearable device 10. Fig. 36A shows a screen without physiological parameter information (such as values and trends). Fig. 36B shows a screen with the wearer's SpO ₂ physiological parameter values. Fig. 36C shows a screen with RR physiological parameter values of the wearer. Fig. 36D shows a screen with the number of steps taken by the wearer. Fig. 36E shows a screen with PR physiological parameter values for the wearer. The display 12 may automatically and/or manually cycle through the various screens of fig. 36A-36E as described above.

Fig. 37A-37E illustrate example screens of the display 12 of the wearable device 10. The display 12 may automatically and/or manually cycle through the various screens of fig. 37A-37E as described above.

Fig. 38A shows an example screen of the display 12 of the wearable device 10. The display 12 displays a screen with time, RRp physiological parameter values and trends, and PR physiological parameter values and trends. In some aspects, the display 12 may automatically and/or manually cycle through physiological information (such as values and trends) of other parameters (such as SpO ₂, number of steps taken, etc.), for example, as described above with reference to fig. 37A-37E. In some aspects, the user/wearer may select physiological information displayed by default by display 12, for example, by adjusting a setting of wearable device 10.

Fig. 38B shows an example screen of the display 12 of the wearable device 10. The display 12 displays a screen having time, spO ₂ physiological parameter values and trends, and PR physiological parameter values and trends. In some aspects, if a parameter has exceeded a threshold, the display 12 may automatically display physiological information (such as values and trends) related to the parameter. For example, if the physiological parameter value exceeds a high threshold or a low threshold, the display 12 may automatically display the physiological parameter value and trend. This may replace the physiological information of another parameter that has been displayed. For example, as shown in fig. 38B, the wearer may have a SpO ₂ parameter value of 89. This value may be below a lower threshold of SpO ₂ (e.g., set by the user/wearer as described with reference to fig. 31C). Upon determining that SpO ₂ has fallen below the lower threshold, wearable device 10 may cause display 12 to display physiological information (such as values and trends) of SpO ₂. This may replace the displayed physiological information of another parameter that does not exceed the threshold. In this example, the display 12 replaces RRp (which has not exceeded any threshold) in the screen (shown in fig. 38A) with SpO ₂ in the screen (shown in fig. 38B). The physiological parameter that has exceeded the threshold, as displayed on the screen by the display 12, may differ in color or some other way from the physiological parameter that has not exceeded the threshold.

Fig. 39 is a flowchart illustrating an example process 3900 for performing a monitoring operation of one or more physiological parameters of a user/wearer. Process 3900 may be performed by a system including wearable device 10 and computing device 2802. The computing device 2802 may be, for example, any of the devices discussed with reference to fig. 2, such as the patient monitor 202, the mobile communication device 204, the computer 206, the tablet computer 208, the nurses' station system 210, or any other device that is needed or desired. As discussed herein, the wearable device 10 and the computing device 2802 may communicate with each other, for example, via bluetooth technology or Near Field Communication (NFC) technology.

At block 3902, wearable device 10 and computing device 2802 may establish communication with each other. For example, wearable device 10 may be paired with a computing device using bluetooth or NFC.

At block 3904, computing device 2802 may receive user input. For example, a user may provide user input via an interactive user interface of computing device 2802. Example user inputs may include user selections that initiate a monitoring operation, such as spot check or continuous monitoring. Additionally or alternatively, the wearable device 10 may receive user input, such as a user selection to initiate a monitoring operation (such as spot check or continuous monitoring).

At block 3906, the computing device 2802 may check to determine if it has received user input corresponding to an instruction to perform a monitoring operation. In response to receiving user input for monitoring operations, computing device 2802 may generate a signal to communicate with wearable device 10, such as by sending wireless communications to wearable device 10. The signal may instruct the wearable device 10 to perform one or more operations in accordance with the user input. For example, via a user interface of computing device 2802, a user may select spot check physiological monitoring operations. In response to user input, computing device 2802 may generate a signal to wirelessly communicate to wearable device 10 to instruct wearable device 10 to perform spot check monitoring operations.

If the user input is not associated with a monitoring operation, process 3900 may return to block 3904 to await additional input. In some aspects, computing device 2802 may perform some other operations associated with non-monitoring operational user inputs, as described herein.

The wearable device 10 may check to determine if it has received a signal indicating that it is performing a monitoring operation. If a signal to perform the monitoring operation has not been received, the wearable device 10 may continue to determine if it has received a signal at block 3906. If wearable device 10 has received a signal from computing device 2802, for example, indicating that it is performing a monitoring operation, process 3900 may continue to step 3908.

At block 3908, it may be determined whether the wearable device 10 has sufficient power to perform the requested monitoring operation. One or more techniques may be used to determine whether the battery has sufficient charge to initiate a particular monitoring operation. For example, the wearable device 10 may determine the current state of charge of its battery. In some aspects, the wearable device 10 may include an estimated power consumption rate for various operations and/or sensors. Additionally or alternatively, the wearable device 10 or another computing device 2802 may record the power consumption of a particular operation or sensor of the wearable device to determine an estimated power consumption rate. The determination of sufficient power for operation may be based on the particular operation. For example, spot check operations may use less power than continuous monitoring operations. Further, the estimation of power consumption may be based on a particular operation. The estimation of power consumption may include an estimated duration of operation. For example, the spot check operation may last for a predetermined period of time, such as 1 second, 5 seconds, or 15 seconds, and the estimated power consumption may be based on the duration and the particular sensor involved in the operation. Similarly, continuous monitoring operations may have an estimated duration for power consumption purposes, such as an estimated run time of thirty minutes, one hour, four hours, or eight hours. The wearable device 10 or another computing device 2802 may estimate the power consumption of an operation by multiplying the estimated power consumption rate by a predetermined or estimated duration of the particular operation. The estimated power consumption may then be compared to the current battery level. For example, if the estimated power operation is greater than the current battery level or the battery is estimated to be at less than five percent or ten percent capacity, the wearable device 10 or another computing device 2802 may determine that the requested monitoring operation does not have sufficient power. If the wearable device 10 has sufficient power to perform the requested monitoring operation, the process proceeds to block 3912 to perform the monitoring operation.

If wearable device 10 does not have sufficient power, process 3900 proceeds to block 3910 to provide a lower power alert.

At block 3910, a low power warning may be provided. For example, wearable device 10 may send a signal (such as a message) to computing device 2802 that wearable device 10 does not have sufficient power to perform a monitoring operation. This signal may cause computing device 2802 to display a lower power warning message to the user.

In some aspects, if the wearable device 10 does not have sufficient power to perform the requested monitoring operation, the wearable device may proceed to step 3912 to perform a different monitoring operation than the requested monitoring operation. For example, if the wearable device 10 does not have sufficient power to perform the requested operation, the wearable device 10 may determine modified monitoring operations that may be performed, such as modified continuous monitoring operations and/or modified spot check monitoring operations. The determination may be based at least in part on monitoring the power (e.g., remaining battery life) of the device. For example, the user may request a continuous monitoring operation, and upon determining that there is insufficient power to perform the continuous monitoring operation (e.g., at step 3908), the wearable device 10 may instead perform a spot check operation (which may require less power than continuous monitoring) for an amount of time commensurate with the power (e.g., remaining battery life) of the wearable device 10. As another example, the user may request that spot check monitoring operations be performed for an amount of time and upon determining that there is insufficient power to perform the spot check monitoring operations for the duration of the length of time (e.g., at step 3908), the wearable device 10 may instead perform a spot check operation for a short period of time (which may require less power than the spot check monitoring is requested) that may be commensurate with the power (e.g., remaining battery life) of the wearable device 10.

At block 3912, a monitoring operation may be performed. For example, the wearable device 10 may perform a monitoring operation. As described herein, example monitoring operations may include one or more of spot check monitoring operations, continuous monitoring operations, and/or any other monitoring operations as discussed herein. The wearable device 10 may perform monitoring operations on the wearer/user for one or more physiological parameters, such as, but not limited to SpO ₂, RR, PR, RRp, and the like.

Wearable device 10 may send physiological parameter measurement data to computing device 2802. In some aspects, the wearable device 10 may transmit measurement data during a monitoring operation (such as when the wearable device 10 measures a physiological parameter and/or during a continuous monitoring operation).

At block 3914, one or more user interfaces may be presented. For example, computing device 2802 may present physiological parameter measurement data received from wearable device 10 in a user interface. Similarly, the wearable device 10 may present physiological parameter measurement data in a user interface on the wearable device 10. In response to receiving physiological parameter measurement data from wearable device 10, computing device 2802 may display a user interface described herein, such as with reference to fig. 30B, 30C, 30F, and/or 30G. For example, computing device 2802 may display physiological parameter measurement data in substantially real-time as wearable device 10 performs a monitoring operation and measures one or more physiological parameters.

In some implementations, the wearable device 10 may generate user interface data to display physiological parameter measurement data to a wearer/user of the wearable device 10. For example, the wearable device 10 may display a user interface described herein, such as with reference to fig. 38A-38B, on the display screen 12 of the wearable device 10. For example, the wearable device 10 may display physiological parameter measurement data in substantially real-time as the wearable device 10 performs a monitoring operation and measures one or more physiological parameters.

Additional implementation details

Fig. 40 is a block diagram illustrating example components of a computing device 4000. Computing device 4000 may implement aspects of the present disclosure, and in particular, aspects of wearable device 10 and/or computing device 2802 of fig. 28. Computing device 4000 may communicate with other computing devices.

Computing device 4000 may include a hardware processor 4002, a data storage device 4004, a memory device 4006, a bus 4008, a display 4012, and one or more input/output devices 4014. The processor 4002 may also be implemented as a combination of computing devices, e.g., a combination of a digital signal processor and a microprocessor, a combination of multiple microprocessors, a combination of one or more microprocessors in conjunction with a digital signal processor, or any other such configuration. The processor 4002 may be configured to, among other things, process data, execute instructions to perform one or more functions, such as processing one or more physiological signals to obtain one or more measurements, as described herein. Data storage device 4004 may include magnetic disks, optical disks, or flash drives, among others, and is provided and coupled to bus 4008 for storing information and instructions. Memory 4006 may include one or more memory devices that store data, including, but not limited to, random Access Memory (RAM) and Read Only Memory (ROM). The computing device 4000 may be coupled to a display 4012, such as an LCD display or touch screen, for displaying information to a user via a bus 4008. The computing device 4000 may be coupled to one or more input/output devices 4014 via a bus 4008. The input device 4014 may include, but is not limited to, a keyboard, mouse, digital pen, microphone, touch screen, gesture recognition system, voice recognition system, imaging device (which may capture eye, hand, head, or body tracking data and/or position), gamepad, accelerometer, or gyroscope.

Terminology

The terms "about," "generally," and "substantially" as used herein mean a value, quantity, or characteristic that is near the value, quantity, or characteristic that still performs the desired function or achieves the desired result. For example, the terms "about," "generally," and "substantially" may refer to amounts within less than 10%, less than 5%, less than 1%, less than 0.1%, and less than 0.01% of the stated amount. As another example, in certain aspects, the terms "generally parallel" and "substantially parallel" refer to a value, quantity, or characteristic that deviates from perfect parallelism by less than or equal to 10 degrees, 5 degrees, 3 degrees, or 1 degree. As another example, in certain aspects, the terms "generally perpendicular" and "substantially perpendicular" refer to a value, amount, or characteristic that deviates from perfectly perpendicular by less than or equal to 10 degrees, 5 degrees, 3 degrees, or 1 degree.

Many other variations than those described herein will be apparent from the present disclosure. For example, some acts, events, or functions of any of the algorithms described herein can be performed in a different order, may be added, combined, or omitted entirely (e.g., not all of the described acts or events are necessary for algorithm practice). Further, acts or events may be performed concurrently, e.g., through multi-threaded processing, interrupt processing, or multiple processors or processor cores, or on other parallel architectures, rather than sequentially. In addition, different tasks or processes may be performed by different machines and/or computing systems that may be run together.

It should be understood that not all of these advantages may be necessarily achieved in accordance with any particular one of the examples disclosed herein. Thus, examples disclosed herein may be embodied or carried out 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.

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 combinations of both. To clearly illustrate this interchangeability of hardware and software, 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 upon the particular application and design constraints imposed on the overall system. The described functionality may be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present disclosure.

The various illustrative logical blocks and modules described in connection with the examples disclosed herein may be implemented or performed with a machine designed to perform the functions described herein, 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. A general purpose processor may be a microprocessor, but in the alternative, the processor may be a controller, a microcontroller, or a state machine, combinations thereof, or the like. The processor may include circuitry or digital logic configured to process computer-executable instructions. In another example, a processor may include an FPGA or other programmable device that performs logic operations without processing computer-executable instructions. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. The computing environment may 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 computing engine within a device, to name a few.

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. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of non-transitory computer-readable storage medium, or physical computer storage known in the art. An example 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 nonvolatile. The processor and the storage medium may reside in an ASIC.

The apparatus and methods described herein may be implemented by one or more computer programs executed by one or more processors. The computer program includes processor-executable instructions stored on a non-transitory tangible computer-readable medium. The computer program may further comprise stored data. Non-limiting examples of the non-transitory tangible computer readable medium are non-volatile memory, magnetic storage devices, and optical storage devices.

The term "substantially" when used in conjunction with the term "real-time" forms a phrase that will be readily understood by those of ordinary skill in the art. For example, it is readily understood that such language will include speeds at which no or little delay occurs.

Conditional language, such as "may," "might," "can," "for example," and the like, as used herein is generally intended to convey that certain examples include certain features, elements, and/or states, and others do not include unless specifically stated otherwise or otherwise understood in the context of use. Thus, such conditional language is not generally intended to imply that one or more examples require features, elements and/or states in any way or that one or more examples necessarily include a means for deciding, with or without author input or prompting, whether these features, elements and/or states are included or are to be performed in any particular example. The terms "comprising," "including," "having," and the like are synonymous and are used interchangeably in an open-ended fashion, and do not exclude additional elements, features, acts, operations, etc. Furthermore, the term "or" is used in its inclusive sense (rather than its exclusive sense) so that, for example, when used in connection with a list of elements, the term "or" means one, some, or all of the elements in the list. Furthermore, the term "each" as used herein may refer to any subset of the set of elements to which the term "each" applies, in addition to having its ordinary meaning.

Disjunctive language such as the phrase "at least one of X, Y or Z" is understood in a commonly used context to mean that the item, term, etc., may be X, Y or Z or any combination thereof (e.g., X, Y and/or Z), unless specifically stated otherwise. Thus, such disjunctive language is generally not intended and should not imply that certain examples require at least one of X, at least one of Y, or at least one of Z to each be present.

Articles such as "a" or "an" should generally be construed to include one or more of the described items unless specifically stated otherwise. Thus, phrases such as "a device configured as … …" are intended to include one or more of the listed devices. Such one or more enumerated devices may also be commonly configured to perform the enumeration. For example, a "processor configured to execute enumeration A, B and C" may include a first processor configured to execute enumeration a working in conjunction with a second processor configured to execute enumeration B and C.

While the above detailed description has shown, 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 device or algorithm illustrated may be made. Without departing from the spirit of the present disclosure. As will be recognized, the invention described herein may be embodied within a form that does not provide all of the features and benefits set forth herein, as some features may be used or practiced separately from others.

Furthermore, 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.

Claims

1. An optical physiological sensor integrated into a wearable device, the optical physiological sensor comprising:

A substrate having an optical center;

A first emitter group of Light Emitting Diodes (LEDs) positioned adjacent to and spaced apart from the optical center of the substrate by an offset;

A second emitter group of light emitting diodes positioned adjacent the optical center of the substrate at an offset from the optical center and spaced from the optical center opposite the first emitter group of light emitting diodes with respect to the optical center at an offset; and

A plurality of detectors arranged in a spatial configuration around the first emitter group and the second emitter group, wherein each detector of the plurality of detectors is positioned on a substrate at the same distance from the optical center of the substrate.

2. The sensor of claim 1, wherein the spatial configuration comprises a ring.

3. The sensor of claim 1, further comprising a light blocking layer construction mounted on the substrate and configured to isolate the first emitter group, the second emitter group, and the plurality of detectors, wherein the light blocking layer construction comprises a plurality of light blocking layers defining one or more chambers.

4. A sensor according to claim 3, wherein the light blocking layer configuration comprises a maximum height extending away from the substrate at the optical center of the substrate.

5. The sensor of claim 3, wherein the light blocking layer construction comprises a light blocking layer configured to isolate the first emitter group, wherein the light blocking layer comprises a width less than a distance from an emitter chamber defined by the light blocking layer construction and housing the first emitter group to a detector chamber defined by the light blocking layer construction and housing a detector bisected by a centerline of the sensor.

6. The sensor of claim 5, wherein a distance extending from the first emitter chamber to the detector chamber along a length parallel to the centerline of the sensor is less than half a width of the first emitter chamber along a length parallel to the centerline of the sensor.

7. The sensor of claim 5, wherein a distance extending from the first emitter chamber to the detector chamber along a length parallel to the centerline of the sensor is greater than half a width of the first emitter chamber along a length parallel to the centerline of the sensor.

8. The sensor of claim 1, wherein the first emitter group is configured to emit the same plurality of light wavelengths as the second emitter group.

9. The sensor of claim 1, wherein an arrangement of the light emitting diodes of the first emitter group on the substrate mirrors an arrangement of the light emitting diodes of the second emitter group on the substrate across a centerline of the sensor bisecting the sensor.

10. The sensor of claim 9, wherein the centerline of the sensor bisects at least one detector of the plurality of detectors.

11. The sensor of claim 10, wherein a distance from the first emitter group to the at least one of the plurality of detectors is substantially similar to a distance from the second emitter group to the at least one of the plurality of detectors.

12. The sensor of claim 1, further comprising an ECG sensor, wherein the ECG sensor comprises a reference electrode, a negative electrode, and a positive electrode, and wherein the reference electrode and negative electrode are located on the sensor, and wherein the positive electrode is located on a housing of the wearable device.

13. The sensor of claim 12, wherein the reference electrode is substantially semi-annular, and wherein the negative electrode is substantially semi-annular.

14. The sensor of claim 1, wherein the plurality of detectors comprises a first detector set and a second detector set.

15. The sensor of claim 14, wherein the first detector set comprises at least two detectors housed in respective detector chambers, and wherein the second detector set comprises at least two detectors housed in respective detector chambers.

16. The sensor of claim 14, wherein a distance between the first emitter set and the first detector set is greater than a distance between the second emitter set and the first detector set.