An electro-optical physiologic sensor comprises a printed circuit board (PCB) and a light emitter and a photodetector respectively mounted to the PCB. A first sensor element is disposed on the PCB and comprises a first electrode configured to contact tissue of a subject and a first light channel co-located with the first electrode, the first light channel optically coupled to the light emitter and configured to direct light into the subject's tissue. A second sensor element is disposed on the PCB and comprises a second electrode configured to contact the subject's tissue and a second light channel co-located with the second electrode, the second light channel optically coupled to the photodetector and configured to receive light from the tissue of the subject resulting from the light generated by the light emitter.

TECHNICAL FIELD

This application relates generally to electro-optical physiologic sensors and sensing devices including cutaneous, subcutaneous, transcutaneous, and implantable medical and/or diagnostic devices, physiologic monitoring devices, biometric devices, personal activity monitoring device, personal amplification devices, hearing aids, bone conduction, and medical and consumer hearables.

SUMMARY

An electro-optical physiologic sensor comprises a printed circuit board (PCB) and a light emitter and a photodetector respectively mounted to the PCB. A first sensor element is disposed on the PCB and comprises a first electrode configured to contact tissue of a subject and a first light channel co-located with the first electrode, the first light channel optically coupled to the light emitter and configured to direct light into the subject's tissue. A second sensor element is disposed on the PCB and comprises a second electrode configured to contact the subject's tissue and a second light channel co-located with the second electrode, the second light channel optically coupled to the photodetector and configured to receive light from the tissue of the subject resulting from the light generated by the light emitter.

An electro-optical physiologic sensor comprises a printed circuit board (PCB), a light emitting unit connected to the PCB, and a light receiving unit connected to the PCB. The light emitting unit comprises a light emitter mounted to the PCB and a first optical window through which light produced by the light emitter can pass into tissue of a subject. The light receiving unit comprises a photodetector mounted to the PCB and a second optical window through which light received from the subject's tissue resulting from the light produced by the light emitter can pass. An optical barrier is disposed between the light emitting unit and the light receiving unit, and at least a tissue contacting surface of the first and second optical windows comprises optically transparent and electrically conductive material. An electrical insulator is disposed between the first and second optical windows.

DETAILED DESCRIPTION

Embodiments of the disclosure are directed to electro-optical physiologic sensors and sensing devices that facilitate electrode-based and optical-based sensing of one or more physiologic parameters or physiologic conditions of a subject. Embodiments of the disclosure are directed to electro-optical physiologic sensors and sensing devices that can include one or more of a pressure sensor, one or more temperature sensors, and one or more biochemical sensors. Embodiments of the disclosure are directed to physiologic sensors and sensing devices which include co-located electrode-based and optical-based sensing elements. Embodiments of the disclosure are directed to physiologic sensors and sensing devices which include co-located electrode-based and optical-based sensing elements and, additionally, one or more of a co-located pressure sensor, one or more co-located temperature sensors, and one or more co-located biochemical sensors.

Embodiments of physiologic sensors and sensing devices can include any two or more of the physiologic sensors disclosed herein arranged to be co-located relative to one another. In some embodiments, physiologic sensors and sensing devices can include any two or more of the physiologic sensors arranged to be co-located relative to one another and, in addition, include one or more other physiologic sensors disclosed herein spaced apart from the co-located physiologic sensors.

Embodiments of physiologic sensors and sensing devices disclosed herein can be implemented for deployment in cutaneous, subcutaneous, transcutaneous, and implantable medical and diagnostic devices, biometric devices, personal activity monitoring device, personal amplification devices, hearing aids, bone conduction hearing devices, and medical and consumer hearables.

Conventional optical physiologic sensors (e.g., PPG sensors) and electrode-based sensors (e.g., capacitive sensors, impedance sensors) can suffer from motion induced noise when worn during activities. It is desirable in many cases to measure accurate biometrics from the optical and electrode-based sensors during activity. In many cases, it is desirable to measure optical and electrical biomarkers simultaneously from the exact same position on the body. Embodiments of the disclosure are directed to a new measurement modality that can unlock new and/or more accurate biomarker readings, such as blood pressure, heart rate, oxygen saturation (SpO2), blood glucose, respiration rate, and/or hydration, for example.

By having disparate physiologic sensors co-located and positionable at the same region of body tissue, the electro-optical sensor provides superior motion noise correlation as is possible. As such, the optical sensor signal noise can be canceled using the electrode-based sensor signal noise, and the electrode-based sensor signal noise can be canceled using the optical sensor signal noise. This arrangement provides a robust, virtually noise free signal for optical and electrical measurements of the tissue free of motion artifacts. This arrangement provides better noise artifact elimination or reduction than use of an IMU, because the IMU measures both motions of the entire system but not relative motion of the sensor against the tissue (e.g., skin). It is noted that an IMU would be beneficial for canceling noise that is not caused by relative motion of the sensor against the tissue (e.g., skin) but instead system motion.

In some embodiments, physiologic sensing devices of the present disclosure can include a tissue (e.g., skin) contact sensor and one or more physiologic sensors. Some physiologic sensing devices of the present disclosure (e.g., ear-worn electronic devices) can be relatively small, such that their power source capacity (e.g., battery capacity) is necessarily limited. Conserving battery capacity is an important objective when designing relatively small physiologic sensing devices, such as a hearing aid equipped with a physiologic sensing facility. Physiologic sensing devices disclosed herein include one or more physiologic sensors that consume varying amounts of power when in use. Physiologic sensing devices disclosed herein can also include a tissue (e.g., skin) contact sensor configured to sense contact between the device and tissue of a subject user.

The tissue (e.g., skin) contact sensor, alone or in cooperation with one or more other physiologic sensors, can be configured to prevent or limit false tissue-device detections (e.g., a false positive or a false negative). In response to detecting contact between the device and the subject's tissue (e.g., skin), the one or more physiologic sensors can be energized for sensing one or more physiologic parameters or physiologic conditions of the subject user. The one or more physiologic sensors can remain energized until a termination event is detected (e.g., expiration of a timer, collection of sufficient physiologic data) and/or the tissue contact sensor senses an absence of tissue-device contact. Physiologic sensing devices disclosed herein advantageously reduce or eliminate wasteful power consumption by physiologic and/or other sensors of the devices. Physiologic sensing devices disclosed herein provide for enhanced physiologic sensing due to robust sensing of tissue-device contact which can indicate that one or more physiologic sensors of the device are properly or optimally positioned relative to the subject user's tissue (e.g., skin) for operation.

Embodiments of the disclosure are defined in the claims. However, below there is provided a non-exhaustive listing of non-limiting examples. Any one or more of the features of these examples may be combined with any one or more features of another example, embodiment, or aspect described herein.

Example Ex1. An electro-optical physiologic sensor comprises a printed circuit board (PCB) and a light emitter and a photodetector respectively mounted to the PCB. A first sensor element is disposed on the PCB and comprises a first electrode configured to contact tissue of a subject and a first light channel co-located with the first electrode, the first light channel optically coupled to the light emitter and configured to direct light into the subject's tissue. A second sensor element is disposed on the PCB and comprises a second electrode configured to contact the subject's tissue and a second light channel co-located with the second electrode, the second light channel optically coupled to the photodetector and configured to receive light from the tissue of the subject resulting from the light generated by the light emitter.

Example Ex2. The sensor according to Ex1, wherein the first electrode encompasses the first light channel and the second electrode encompasses the second light channel.

Example Ex3. The sensor according to Ex1, wherein the first electrode is situated adjacent the first light channel and does not encompass the first light channel, and the second electrode is situated adjacent the second light channel and does not encompass the second light channel.

Example Ex4 The sensor according to one or more of Ex1 to Ex3, wherein the light emitter comprises a single fixed-wavelength light source or a wavelength-tunable light source.

Example Ex5. The sensor according to one or more of Ex1 to Ex3, wherein the light emitter comprises a plurality of fixed-wavelength light sources or a plurality of wavelength-tunable light sources.

Example Ex6. The sensor according to one or more of Ex1 to Ex5, wherein the light emitter comprises one or more LEDs.

Example Ex7. The sensor according to one or more of Ex1 to Ex6, wherein the light emitter comprises one or more laser diodes.

Example Ex8. The sensor according to one or more of Ex1 to Ex7, wherein the first light channel comprises a light pipe having an outwardly tapered coupling portion that extends beyond a terminal end of the first electrode and is configured to optically couple to a plurality of the light emitters.

Example Ex9. The sensor according to one or more of Ex1 to Ex8, comprising a pressure sensor disposed between the first and second sensor elements, the pressure sensor configured to one or both of sense pressure developed between the electro-optical physiologic sensor and the subject's tissue, and sense pressure changes in tissue in contact with the electro-optical physiologic sensor.

Example Ex10. The sensor according to one or more of Ex1 to Ex9, wherein the first and second electrodes are configured to electrically couple electrical signals between the subject's tissue and bioelectric sensing circuitry disposed on, or coupled to, the PCB.

Example Ex11. The sensor according to Ex10, wherein the bioelectric sensing circuitry is configured to sense changes in one or more of impedance, conductance, resistance, and capacitance of the subject's tissue.

Example Ex12. The sensor according to Ex10, wherein the bioelectric sensing circuitry is configured to sense electrodermal activity of the subject's tissue.

Example Ex13. The sensor according to one or more of Ex1 to Ex12, wherein the light emitter and the photodetector are electrically coupled to optical sensing circuitry disposed on, or coupled to, the PCB.

Example Ex14. The sensor according to Ex13, wherein the optical sensing circuitry is configured to produce a photoplethysmographic signal.

Example Ex15. The sensor according to Ex13, wherein the optical sensing circuitry is configured to produce a pulse oximetry signal.

Example Ex16. An electro-optical physiologic sensor comprises a printed circuit board (PCB), a light emitting unit connected to the PCB, and a light receiving unit connected to the PCB. The light emitting unit comprises a light emitter mounted to the PCB and a first optical window through which light produced by the light emitter can pass into tissue of a subject. The light receiving unit comprises a photodetector mounted to the PCB and a second optical window through which light received from the subject's tissue resulting from the light produced by the light emitter can pass. An optical barrier is disposed between the light emitting unit and the light receiving unit, and at least a tissue contacting surface of the first and second optical windows comprises optically transparent and electrically conductive material. An electrical insulator is disposed between the first and second optical windows.

Example Ex17. The sensor according to Ex16, wherein the first and second optical windows are configured to serve as first and second tissue contact electrodes of the sensor.

Example Ex18. The sensor according to Ex16 or Ex17, wherein the first and second optical windows comprise a transparent conductive oxide (TCO).

Example Ex19. The sensor according to one or more of Ex16 to Ex18, wherein at least a tissue contacting surface of the first and second optical windows comprise ITO (Indium Tin Oxide), AZO (Aluminum-doped Zinc Oxide), IZO (Indium Zinc Oxide) or graphene.

Example Ex20. The sensor according to one or more of Ex16 to Ex19, wherein the light emitting unit and the light receiving unit are disposed in a unitary housing.

Example Ex21. The sensor according to Ex20, wherein the housing comprises one or both of a biocompatible metal and a biocompatible plastic.

Example Ex22. The sensor according to one or more of Ex16 to Ex21, comprising a housing disposed around at least a portion of the light emitting unit and the light receiving unit, and optically transparent fill material disposed within voids of the housing and contacting the first and second optical windows.

Example Ex23. The sensor according to one or more of Ex16 to Ex22, wherein the light emitting unit comprises a third optical window comprising optically transparent and electrically conductive material, the light receiving unit comprises a fourth optical window comprising optically transparent and electrically conductive material, and the first, second, third, and fourth windows are configured to electrically couple electrical signals between the subject's tissue and bioelectric sensing circuitry disposed on, or coupled to, the PCB to perform a 4-electrode electrical measurement.

Example Ex24. The sensor according to Ex23, wherein a second light emitter is mounted to the PCB and configured to produce light that can pass into the subject's tissue via the third optical window, and the photodetector is configured to receive light produced by the light emitter and the second light emitter via the second optical window.

Example Ex25. The sensor according to one or more of Ex16 to Ex24, wherein the light emitter comprises a single fixed-wavelength light source or a wavelength-tunable light source.

Example Ex26. The sensor according to one or more of Ex16 to Ex24, wherein the light emitter comprises a plurality of fixed-wavelength light sources or a plurality of wavelength-tunable light sources.

Example Ex27. The sensor according to one or more of Ex16 to Ex26, wherein the light emitter comprises one or more LEDs.

Example Ex28. The sensor according to one or more of Ex16 to Ex27, wherein the light emitter comprises one or more laser diodes.

Example Ex29. The sensor according to one or more of Ex16 to Ex28, comprising a pressure sensor configured to one or both of sense pressure developed between the electro-optical physiologic sensor and the subject's tissue, and sense pressure changes in tissue in contact with the electro-optical physiologic sensor.

Example Ex30. The sensor according to one or more of Ex16 to Ex29, wherein the first and second optical windows are configured to electrically couple electrical signals between the subject's tissue and bioelectric sensing circuitry disposed on, or coupled to, the PCB.

Example Ex31. The sensor according to Ex30, wherein the bioelectric sensing circuitry is configured to sense changes in one or more of impedance, conductance, resistance, and capacitance of the subject's tissue.

Example Ex32. The sensor according to Ex30, wherein the bioelectric sensing circuitry is configured to sense electrodermal activity of the subject's tissue.

Example Ex33. The sensor according to one or more of Ex16 to Ex32, wherein the light emitter and the photodetector are electrically coupled to optical sensing circuitry disposed on, or coupled to, the PCB.

Example Ex34. The sensor according to Ex33, wherein the optical sensing circuitry is configured to produce a photoplethysmographic signal.

Example Ex35. The sensor according to Ex33, wherein the optical sensing circuitry is configured to produce a pulse oximetry signal.

FIGS. 1A-1Cillustrate an electro-optical physiologic sensor in accordance with various embodiments. The electro-optical physiologic sensor101a,101b,101cshown inFIGS. 1A-1Cincludes a printed circuit board (PCB)104configured to support a number of components of the sensor101a,101b,101c. InFIGS. 1A-1C, a light emitter114and a light detector116are respectively mounted to a first surface104aof the PCB104. A first sensor element102ais disposed on the first surface104aof the PCB104and comprises a first electrode106aconfigured to contact tissue of a subject. The first sensor element102aalso includes a first light channel108aconfigured to direct light into the subject's tissue.

A second sensor element102bis disposed on the first surface104aof the PCB104and comprises a second electrode106bconfigured to contact the subject's tissue. As illustrated, the first sensor element102ais spaced apart from the second sensor element102b. This spacing can vary depending on the design and intended use of the electro-optical physiologic sensor101a,101b,101c. The second sensor element102balso includes a second light channel108bconfigured to receive light from the subject's tissue resulting from the light generated by the light emitter114. The electro-optical physiologic sensor101a,101b,101ccan be deployed as a stand-alone sensor arrangement or can be integral or coupled to a physiologic sensor arrangement100a,100b,100cwhich can include other sensing, signal processing, and/or power resources (e.g., bioelectric sensing circuitry120and optical physiologic sensing circuitry130).

As will be described in greater detail hereinbelow, and according to some embodiments, the first electrode106acan be situated adjacent (e.g., immediately adjacent to, in contact with) the first light channel108a, such that the first electrode106adoes not encompass the first light channel108a. The second electrode106bcan be situated adjacent (e.g., immediately adjacent to, in contact with) the second light channel108b, such that the second electrode106bdoes not encompass the second light channel108b. According to other embodiments, the first electrode106acan encompass (e.g., circumferentially) the first light channel108a, and the second electrode106bcan encompass (e.g., circumferentially) the second light channel108b. According to these and other embodiments disclosed herein, the electrodes106a,106bare co-located relative to their corresponding light channel108a,108b, which provides for a compact electro-optical physiologic sensor implementation.

As will be described hereinbelow, co-location of the electrodes106a,106bwith their corresponding light channel108a,108bprovides a number of advantages including, but not limited to, an optical output signal which can be free or substantially free of motion artifacts resulting from relative movement between the electro-optical physiologic sensor101a,101b,101cand tissue of the subject user. Because the electro-optical physiologic sensor101a,101b,101cincorporates co-located electrodes106a,106band light channels108a,108b, the signal produced by the electro-optical physiologic sensor101a,101b,101cdoes not require additional signal processing to remove motion artifacts, which would otherwise require signals produced by a motion sensor, such as an inertial measurement unit (IMU). As such, devices that incorporate the electro-optical physiologic sensor101a,101b,101ccan exclude a motion sensor (e.g., an IMU) typically required to remove motion artifacts from signals produced by conventional optical sensors, thereby facilitating a reduction in the size of such devices.

According to some embodiments, the light emitter114can include a single fixed-wavelength light source or a wavelength-tunable light source. In other embodiments, the light emitter114can include a plurality of fixed-wavelength light sources or a plurality of wavelength-tunable light sources. In some implementations, the light emitter114can include one or more light emitting diodes (LEDs). In other implementations, the light emitter114can include one or more laser diodes, such as vertical-cavity surface-emitting laser (VCSEL) diodes or edge-emitting laser diodes. In further implementations, the light emitter114can include one or more LEDs and one or more laser diodes. Suitable laser sources include any type of injection laser diode (ILD) or optically pumped semiconductor laser (OPSL). A wavelength-tunable light source can be implemented using an external cavity laser diode, for example. The light emitter circuitry110includes circuitry for driving the light emitter114, such as an LED/laser diode driver, LED/laser diode current control DAC, timing controller, and oscillator.

The light detector116can include one or more photodetectors or photon detectors. Suitable photodetectors include photodiodes, metal-semiconductor-metal (MSM) photodetectors, phototransistors, photoconductive detectors, phototubes, and photomultipliers. The light detector circuitry112includes circuitry for processing input photodiode signals, such as a differential current-to-voltage transimpedance amplifier, a current digital-to-analog converter (DAC), and an amplifier. The light detector circuitry112can be coupled to a processor to calculate physiologic measurements using the output of the light detector circuitry112. In some embodiments, the electro-optical physiologic sensor101a,101b,101ccan be configured as, or includes optical elements (e.g., light channels) of, a photoplethysmogram (PPG) sensor. In such embodiments, the electro-optical physiologic sensor101a,101b,101cis configured as an integrated bioelectric-PPG sensor.

The electro-optical physiologic sensor101a,101b,101cshown inFIGS. 1A-1Ccan be incorporated in a wide variety of physiologic sensor arrangements which include bioelectric sensing circuitry120and optical physiologic sensing circuitry130. In some embodiments, and with reference toFIG. 1A, the physiologic sensor arrangement100aincludes bioelectric sensing circuitry120electrically coupled (via the PCB104) to the first and second electrodes106a,106bof the electro-optical physiologic sensor101a. The optical physiologic sensing circuitry130is electrically coupled to the light emitter circuitry110and the light detector circuitry112of the electro-optical physiologic sensor101a. In the embodiment shown inFIG. 1A, bioelectric sensing circuitry120and optical physiologic sensing circuitry130are operatively coupled to, but physically spaced apart from, the electro-optical physiologic sensor101a(e.g., not situated in PCB104). The bioelectric sensing circuitry120is configured to produce a bioelectric sensor output signal124, and the optical physiologic sensing circuitry130is configured to produce an optical sensor output signal134. These output signals124,134can be communicated to other components (e.g., a processor, DSP) of the physiologic sensor arrangement100aor an external electronic device or system.

In the embodiment shown inFIG. 1B, the physiologic sensor arrangement100bis configured as an integrated physiologic sensor which includes bioelectric sensing circuitry120and optical physiologic sensing circuitry130mounted to the PCB104of the electro-optical physiologic sensor101b. The bioelectric sensing circuitry120is electrically coupled (via traces122of the PCB104) to the first and second electrodes106a,106bof the electro-optical physiologic sensor101a. The optical physiologic sensing circuitry130is electrically coupled (via traces132of the PCB104) to light emitter circuitry110and light detector circuitry112of the electro-optical physiologic sensor101b. Although bioelectric sensing circuitry120and optical physiologic sensing circuitry130are shown mounted to a second surface104bof the PCB104opposing the first surface104a, one or both of the bioelectric sensing circuitry120and optical physiologic sensing circuitry130can be mounted to the first surface104aof the PCB104. The bioelectric sensing circuitry120is configured to produce a bioelectric sensor output signal124, and the optical physiologic sensing circuitry130is configured to produce an optical sensor output signal134. These output signals124,134can be communicated to other components (e.g., a processor, DSP) of the physiologic sensor arrangement100bor an external electronic device or system.

In the embodiment shown inFIG. 1C, the electro-optical physiologic sensor101cis similar to that shown inFIGS. 1A and 1B, but can further include a pressure sensor105. The pressure sensor105is mounted to the first surface104aof the PCB104directly or via a support member107. The pressure sensor105is shown disposed on the PCB104between the first and second sensor elements102a,102b, but can be located elsewhere on the PCB104. The pressure sensor105can be configured to sense pressure developed between the electro-optical physiologic sensor101cand tissue of the subject. Alternatively or additionally, the pressure sensor105can be configured to sense pressure changes in tissue in contact with the electro-optical physiologic sensor101c. The pressure sensor105can be implemented to include a strain gauge sensor, a MEMS pressure sensor, a thin film pressure sensor, or other pressure sensor technology. Pressure sensing circuitry140is provided and configured to produce a pressure sensor output signal144using signals produced by the pressure sensor105. The pressure sensor output signal144can be communicated to other components (e.g., a processor, DSP) of the physiologic sensor arrangement100cor an external electronic device or system.

The electro-optical physiologic sensor101ccan also include a biochemical sensor109, such as a blood glucose sensor. The biochemical sensor109is mounted to the first surface104aof the PCB104directly or via a support member111. The biochemical sensor109is disposed on the PCB104between the first and second sensor elements102a,102b, but can be located elsewhere on the PCB104. The biochemical sensor109can be implemented as a device capable of converting a chemical or biological quantity into an electrical signal. The biochemical sensor109can be configured to interact with one of a variety of body fluids, such as sweat, saliva, tears, and interstitial fluids. In various implementations, the biochemical sensor109includes an analyte molecule, a chemically sensitive layer, and a transducer. In some implementations, the biochemical sensor109can include a bed of microneedles or microelectrodes.

The biochemical sensor109can be configured to sense an ingredient and concentration of one of more body fluids. For example, biochemical sensor109can be configured to detect one or more of PH value, Ca+ concentration, and glucose concentration. Biochemical sensing circuitry150is provided and configured to produce a biochemical sensor output signal154using signals produced by the biochemical sensor109. The biochemical sensor output signal154can be communicated to other components (e.g., a processor, DSP) of the physiologic sensor arrangement100cor an external electronic device or system.

In some embodiments of the electro-optical physiologic sensor101c, the bioelectric sensing circuitry120and optical physiologic sensing circuitry130are operatively coupled to, but physically spaced apart from, the electro-optical physiologic sensor101c(e.g., seeFIG. 1A). In other embodiments of the electro-optical physiologic sensor101c, the bioelectric sensing circuitry120and optical physiologic sensing circuitry130are mounted to the PCB104of the electro-optical physiologic sensor101b(e.g., seeFIG. 1B). In various embodiments, the pressure sensing circuitry140and the biochemical sensing circuitry150can be operatively coupled to, but physically spaced apart from, the electro-optical physiologic sensor101c. In other embodiments, the pressure sensing circuitry140and the biochemical sensing circuitry150can be mounted to the PCB104of the electro-optical physiologic sensor101c.

As previously discussed, the bioelectric sensing circuitry120is configured to produce a bioelectric sensor output signal124, the optical physiologic sensing circuitry130is configured to produce an optical sensor output signal134, the pressure sensing circuitry140is configured to produce a pressure sensor output signal144, and the biochemical sensing circuitry150is configured to produce a biochemical sensor output signal154. These output signals124,134,144,154can be communicated to other components (e.g., a processor, DSP) of the physiologic sensor arrangement100cor an external electronic device or system.

The bioelectric sensing circuitry120shown inFIGS. 1A-1Ccan be configured to implement one or a number of different electrode-based measurements of the subject's tissue. The electrodes106a,106bof the first and second sensor elements102a,102bare configured to make electrical contact with tissue of the subject and couple electrical signals between the subject's tissue and the bioelectric sensing circuitry120. The bioelectric sensing circuitry120can be configured to one or more of sense, measure, and monitor changes in one or more of impedance, conductance, resistance, and capacitance of the subject's tissue. The bioelectric sensing circuitry120can be configured to one or more of sense, measure, and monitor changes in electrodermal activity of the subject's tissue. The bioelectric sensing circuitry120can be configured to measure and monitor electrical activity of various organs of the body, such as a subject's heart (via an electrocardiogram or ECG), musculature (via an electromyogram or EMG), muscle or nerve action potential, brain (via an electroencephalogram or EEG), vision system (via an electrooptigram or EOG, electroretinogram or ERG), stomach (via an electrogastrogram or EGC), and skin (via a galvanic skin reflex or GSR).

The optical physiologic sensing circuitry130can be configured to include components of a PPG sensor which utilizes the first light channel108aof the first sensing element102ato couple light into tissue of the subject and the second light channel108bto receive light from the subject's tissue resulting from the light produced by the light emitter114. The optical physiologic sensing circuitry130can be configured to produce a photoplethysmographic signal in response to light received by the light detector116via the second light channel108b. In some embodiments in which at least two light emitters114of different wavelengths are included in the first sensing element102a, the optical physiologic sensing circuitry130can be configured to produce a pulse oximetry signal in response to light received by the light detector116via the second light channel108b.

The PPG waveform produced by the optical physiologic sensing circuitry130comprises a pulsatile (‘AC’) physiological waveform attributed to cardiac synchronous changes in the blood volume with each heartbeat, and is superimposed on a slowly varying (‘DC’) baseline with various lower frequency components attributed to respiration, sympathetic nervous system activity and thermoregulation. The optical sensor output signal134produced by the optical physiologic sensing circuitry130can be used to perform a number of different physiologic measurements, such as measuring blood oxygen saturation, blood pressure, cardiac output, assessing autonomic function, and detecting peripheral vascular disease. By way of example, the optical sensor output signal134produced by the optical physiologic sensing circuitry130can be used for measuring and monitoring one or more of heart rate, respiration, vascular condition/disease, arterial condition/disease, compliance and ageing, venous condition/disease, compliance and ageing, endothelial function, microvascular blood flow, vasospastic conditions, autonomic function monitoring, vasomotor function and thermoregulation, heart rate variability, orthostasis, and other cardiovascular variability conditions.

The electro-optical physiologic sensor101a,101b,101ccan be enclosed alone or together with other components in a housing103(see, e.g.,FIGS. 1A and 1B). For example, the housing103can be configured to accommodate at least the electro-optical physiologic sensor101a,101b,101c. In some embodiments, the housing103can be configured to accommodate at least the electro-optical physiologic sensor101a,101b,101cand one or more of a power source (battery, supercapacitor, inductive or capacitive wireless power receiver), power management circuitry, processor, DSP, DACs, ADCs, amplifiers, filters, wired (e.g., USB) input/output interface and/or wireless (e.g., Bluetooth®, Zigbee®) input/output interface. The housing103can be configured for deployment at a specified cutaneous, subcutaneous, transcutaneous, or implantable location of a human or animal subject. The housing103can be constructed from materials commonly used in the medical industry. A representative list of biocompatible materials from which the housing103can be constructed include silicon dioxide, silicon nitride, Parylene-C, Nafion, biocompatible EPO-TEK® epoxy resin, and platinum.

The electro-optical physiologic sensor101a,101b,101ccan be permanently attached to specified tissue of the body, such as by use of sutures and/or structures that encourage fibrous encapsulation (e.g., mesh structures). The electro-optical physiologic sensor101a,101b,101ccan be temporarily attached to specified tissue of the body, such as by use of a biocompatible adhesive or sutures. Representative anatomical locations of the body at which the electro-optical physiologic sensor101a,101b,101ccan be deployed include the epidermis (skin), arterial and/or venous system, and an organ (e.g., heart, kidneys, brain) of a subject. In some embodiments, the electro-optical physiologic sensor101a,101b,101cis configured for temporary contact with a subject's skin (e.g., a hand-held sensor apparatus), in which case no attachment mechanism or structures need be included.

FIGS. 2A-3illustrate variations of an electro-optical sensor in accordance with any of the embodiments disclosed herein. The electro-optical sensors shown inFIGS. 2A-3define a compact, integrated sensor that provides for co-location of an optical sensor and an electrode-based sensor at the same location of a subject's tissue (e.g., skin of a person's ear, forehead, a digit, scalp, torso, internal organ or vascular tissue). The electro-optical sensors shown inFIGS. 2A-3can be incorporated in a wide variety of electronic devices, including any of those disclosed herein. For example, the electro-optical sensors shown inFIGS. 2A-3can be incorporated in cutaneous, subcutaneous, transcutaneous, and implantable medical and diagnostic devices, physiologic monitoring devices, biometric devices, personal activity monitoring device, personal amplification devices, hearing aids, bone conduction, and medical and consumer hearables.

FIGS. 2A-2Cillustrate an electro-optical sensor201a,201b,201cin accordance with any of the embodiments disclosed herein. FIGS.2A1-2C1show top views of the electro-optical sensor201a,201b,201cshown inFIGS. 2A-2C. The electro-optical sensor201a,201b,201cshown inFIGS. 2A-2Ccan be configured as an integrated and compact tissue-contact and physiologic signal sensing module in some implementations. The electro-optical sensor201a,201b,201cincludes first and second sensor elements202a,202bdisposed on a PCB204. Each of the first and second sensor elements202a,202bincludes an electrically conductive electrode206a,206band a co-located light channel208a,208b. The light channel208a,208bis an optical channel (e.g., light pipe) of an optical physiologic sensor, such as a PPG sensor.

In the configurations shown inFIGS. 2A and 2C, the electrically conductive electrode206aencompasses (e.g., fully encircles) the light channel208a. As shown, the electrically conductive electrode206adefines a hollow cylindrical electrode within which the cylindrical light channel208ais situated. In the configuration shown inFIG. 2B, the electrically conductive electrode206band the light channel208bhave a geometric cross-section, such as a square or rectangle. In this configuration, the electrically conductive electrode206bis situated adjacent to, but does not fully encompass, the light channel208b.

The PCB204is configured to support a light emitter214and a photodetector216. The light emitter214can include one or more LEDs or one or more laser diodes of a type previously described. The photodetector216can include one or more photodiodes or other light sensor previously described. Circuitry210for controlling and driving the light emitter214is mounted to the PCB204. Circuitry22for controlling and driving the photodetector216is mounted to the PCB204. As shown, the circuitry210,212is mounted to the surface of the PCB204opposing the surface to which the light emitter214and photodetector216are mounted. It is understood that the circuitry210,212can alternatively be mounted on the same surface of the PCB204that supports the light emitter214and photodetector216.

The light channel208a,208bof the first sensor element202ais optically coupled to the light emitter214and configured to direct light produced by the light emitter214into tissue (e.g., skin) of a subject (e.g., a subject of an ear-worn electronic device which incorporates the electro-optical sensor201a,201b,201c). The light channel208a,208bof the second sensor element202bis optically coupled to the photodetector216and configured to receive return light from the tissue of the subject resulting from the incident light generated by the light emitter214.

According to some implementations, the light channel208a,208bcan be an optical channel of a PPG sensor configured as a single-wavelength or multi-wavelength photoplethysmography sensor. In the case of a single-wavelength PPG sensor, the light emitter214can be configured to emit red light (a wavelength of 660 nm) or infrared (IR, a wavelength of 920 nm). In the case of a multi-wavelength PPG sensor, the light emitter214can include two or more light emitting elements, each of which has a different wavelength. For example, a multi-wavelength PPG sensor can include up to four LEDs having different wavelengths, such as IR (e.g., 850 and/or 920 nm), red (e.g., 660 nm), green (e.g., 530 nm), and blue (e.g., 460 nm). It is noted that the PPG sensor can be configured as a pulse oximeter, in which case the light emitter214includes at least two LEDs having different wavelengths.

During use of the electro-optical sensor201a,201b,201c, and as is shown inFIGS. 2A and 2B, an electrical path224through the subject's tissue220(shown as skin for purposes of illustration) is created by current flowing between the electrically conductive electrodes206a,206bof the first and second sensor elements202a,202b. Concurrently, an optical path222is created through the same tissue220between the light channels208a,208band corresponding light emitter214and photodetector216. As can be appreciated, the co-located electrically conductive electrodes206a,206band light channels208a,208bprovide for co-located electrical and optical paths224,222created within the same volume of tissue220.

The embodiment of the electro-optical sensor201cshown inFIG. 2Cis essentially the same as that shown inFIG. 2A, but further includes a pressure sensor205co-located with the first and second sensor elements202a,202b. The pressure sensor205is physical and electrically (or optically) coupled to the PCB204and situated between the first and second sensor elements202a,202b. The pressure sensor205can be mounted to the PCB204directly or via a support member207. In some implementations, the pressure sensor205is configured to sense pressure in response to forceable contact between the electro-optical sensor201cand tissue (e.g., skin) of the subject. In addition or alternatively, the pressure sensor205can be configured to sense pressure changes in tissue in contact with the electro-optical physiologic sensor201c. The pressure sensor205can be implemented to include a strain gauge sensor, a MEMS pressure sensor, a thin film pressure sensor, or other pressure sensor technology. Provision of the pressure sensor205provides additional robustness to the electro-optical sensor201cwhen implemented as an electro-optical contact sensor. In such of implementations, contact between the electro-optical sensor201cand a subject's tissue220(e.g., skin) can be robustly detected using signals acquired from the electrically conductive electrodes206a,206band the pressure sensor205.

In some implementations, and in the context of a cutaneous or transcutaneous electro-optical sensor201c, the pressure sensor205can be used to record how much pressure the pressure sensor205is applying to the skin220. Other methods of measuring pressure applied to the skin220can be used, including capacitance and microphones, which may need to be calibrated for a specific subject. The pressure sensor205can additionally be used to inform the subject when electrodes/sensors of the electro-optical sensor201care optimally coupled to the skin when the correct pressure is applied.

FIG. 3shows a first sensor element302aof an electro-optical sensor in accordance with any of the embodiments disclosed herein. The first sensor element302aincludes a light channel in the form of a light pipe308fully or partially encompassed by an electrically conductive electrode306(see, e.g.,FIGS. 2A and 2B). The light pipe308includes an outwardly tapered coupling portion309that extends beyond the electrically conductive electrode306. The outwardly tapered coupling portion309serves to accommodate a multiplicity of light emitters314(e.g., two, three, or four light emitters), which provides for increased light output. As shown, the PCB302supports three light emitters314optically coupled to the light pipe308via the outwardly tapered coupling portion309and driven by circuitry312mounted to the PCB302.

FIG. 4shows an electro-optical sensor in the form of an electro-optical sensor module401in accordance with any of the embodiments disclosed herein. The electro-optical sensor module401includes an optical physiologic sensor comprising a light emitter414and a photodetector416mounted to a PCB404. The electro-optical sensor module401includes a contact surface405configured to contact tissue (e.g., skin) of the subject. The contact surface405includes a first optical window406afor the light emitter414and a second optical window406bfor the photodetector416. An optical barrier412is disposed between a light emitting unit408aand a light collection unit408bof the electro-optical sensor module401.

The first and second optical windows406a,406bare implemented as optically transparent electrical conductors that serve as electrodes of the electro-optical sensor module401. Various transparent conductive oxides (TCOs) can be used to construct the first and second optical windows406a,406b, such as ITO (Indium Tin Oxide), AZO (Aluminum-doped Zinc Oxide), IZO (Indium Zinc Oxide), and graphene. An electrically insulating material407(e.g., an electrical insulator material, dielectric material) is disposed on the contact surface405between the first and second optical window406a,406bto electrically isolate the first and second optical window406a,406b. Suitable electrically insulating material407includes oxide ceramics and polymers, such as oxides of aluminum, titanium, and yttrium, and alloys thereof.

According to some embodiments, and as previously discussed, the light emitter414can include a single fixed-wavelength light source or a wavelength-tunable light source. In other embodiments, the light emitter414can include a plurality of fixed-wavelength light sources or a plurality of wavelength-tunable light sources. The first and second optical windows406a,406bcan be transparent to many wavelengths or designed for only one or more specific wavelengths of the light emitter414.

In some implementations, at least the light emitting unit408aand light collection unit408bcan be inserted into a tubular or polygonal housing (see, e.g.,FIGS. 1A and 1B) formed from a biocompatible material (e.g., stainless, Ag/AgCl, other material describe herein). As such, the first and second optical windows406a,406bthat define electrodes of the electro-optical sensor module401can have a cylindrical shape or any desired curved and/or polygonal shape. The housing can be filled with a transparent material (epoxy, acrylic, plastic, etc.) such that the transparent fill material contacts the light emitter414, photodetector416, first and second optical windows406a,406b, and voids of the light emitting and collection unit408a,408b.

The optical sensor components (e.g., light emitter414, photodetector416) of the electro-optical sensor module401are configured to couple light into specified tissue and detect the amount of light returning from the specified tissue, while the electrically conductive first and second optical windows406a,406bprovide for either capacitive or impedance sensing between these two electrodes. The electro-optical sensor module401advantageously provides for the electrical signal being measured to traverse the exact same path through the specified tissue as the optical signal.

In some embodiments, the electro-optical sensor module401(or other electro-optical sensor disclosed herein) can be configured to implement a 4-electrode electrical measurement, such as a 4-electrode impedance measurement. For example, the light emitting unit408acan include a third optical window comprising optically transparent and electrically conductive material of a type previously described. The light receiving unit408bcan include a fourth optical window comprising optically transparent and electrically conductive material of a type previously described. The first, second, third, and fourth optical windows of the electro-optical sensor module401can be configured to electrically couple electrical signals between the subject's tissue and bioelectric sensing circuitry disposed on, or coupled to, the PCB to perform a 4-electrode electrical measurement. In some embodiments, a second light emitter can be mounted to the PCB and configured to produce light that can pass into the subject's tissue via the third optical window. The photodetector of the light receiving unit408bcan be configured to receive light produced by the first light emitter and the second light emitter.

The electro-optical sensors and module disclosed herein (e.g.,FIGS. 1A-4) can include one or more other sensors, such as one or more pressure sensors, one or more temperature sensors, and/or one or more biochemical sensors to provide additional physiologic signals and enhanced reliability and robustness. In the embodiment shown inFIG. 4, an auxiliary sensor arrangement409is situated at the contact surface405of the electro-optical sensor module401. The auxiliary sensor arrangement409can include a single sensor, multiple sensors of the same type, or multiple sensors of different types. For example, the auxiliary sensor arrangement409can include one or more pressure sensors, one or more temperature sensors, one or more biochemical sensors, or any combination and number of the pressure sensors, temperature sensors, and biochemical sensors disclosed herein.

According to some implementations, the auxiliary sensor arrangement409can include one or more temperature sensors. Each temperature sensor can be situated adjacent or within the electrically insulating material407, which can serve to one or both of electrically and thermally isolate the temperature sensor from other electrical and heat-generating components. In other implementations, one of the electrodes406a,406bcan be grounded and used as a low thermal path to the temperature sensor(s). One or more temperature sensors can be implemented using various temperature sensing technologies. For example, the temperature sensor(s) can be a thermistor having a negative temperature coefficient (e.g., an NTC thermistor or NTC chip), a positive temperature coefficient (e.g., a PTC thermistor or PTC chip) or a digital thermistor. The temperature sensor(s) can be a surface mount device (SMD) thermistor, thermocouple, resistance temperature detector (RTDs) or other type of resistance temperature sensor.

Thermal paths between the temperature sensor(s) and heat generating components within the electro-optical sensor module401or a sensor arrangement incorporating the electro-optical sensor module401can be reduced or minimized using conventional techniques. This can be achieved, for example, by using thin copper traces on the PCB404(which may be a flexible PCB), removing solid copper ground and power planes, and placing thermal resistive materials between the temperature sensor(s) and heat generating or absorbing components (e.g., an LED, battery).

In some embodiments, the electro-optical sensor module401can be configured in a housing that facilitates contact with skin of a subject's forehead or ear. In such embodiments, a temperature sensor or sensors of the auxiliary sensor arrangement409can be used as a forehead or ear thermometer together with the optical sensor components configured as a PPG sensor. According to a representative use example, a subject can place the electro-optical sensor module401(or an apparatus incorporating the electro-optical sensor module401) in a sensor mode and place the electrode contacts406a,406bon the forehead or the ear canal and wait a few seconds (˜5-10 s) followed by the module401reporting the subject's temperature, heart rate, SpO2, and any other physiologic metrics computed from the PPG and temperature signals.

The reporting can be implemented wirelessly to a smartphone with a text to speech algorithm that then verbally reports the reading to the subject. Additionally, or alternatively, reporting can be implemented wirelessly to a smartphone configured to display the physiologic metrics graphically via the display of the smartphone.

In some implementations, the electro-optical sensor module401or an apparatus incorporating the electro-optical sensor module401(e.g., hand-held physiologic monitor) can include or be coupled to a sound generator and audio processing circuitry, and may also or alternatively include a display (e.g., OLED, LCD). In such embodiments, the electro-optical sensor module401or an apparatus incorporating the electro-optical sensor module401can verbally and/or graphically report the physiologic metrics to the subject or caregiver. The electro-optical sensor module401or an apparatus incorporating the electro-optical sensor module401may also include a wireless transmitter or transceiver (e.g., Bluetooth®, Zigbee®, IEEE 802.11 radio, cellular radio) configured to wirelessly transmit the physiologic metrics to a remote destination via a communication device, system or network (e.g., tablet, laptop, internet, cloud server).

As discussed previously, and in accordance with a representative use example, an electro-optical sensor of the present disclosure can be implemented as an electro-optical contact sensor. For example, after skin or other tissue contact is detected using the electrodes of the electro-optical sensor, one or more of the temperature, capacitance, impedance, pressure, and/or PPG sensors can be activated to confirm the sensor contact is from a bodily tissue (e.g., by detecting a fast temperature rise, a large PPG signal, a large capacitance or impedance change). By using a combination of sensors, the tissue contact circuit of the electro-optical sensor is very robust to false actuations from sweat, wet hair, rain, and other conditions that may fool or confound a single sensor.

Continuing with another representative use example, one or more electro-optical sensor modules401can be incorporated in a medical or consumer device, such as a hearable (e.g., a hearing aid). At least one of the electro-optical sensor modules401can be implemented as an electro-optical contact sensor. The subject user can touch the electro-optical sensor module401with a finger or thumb (or one finger and a thumb in the case of two modules401) to take a biometric reading. If the subject user removes their finger from the module401before the reading is complete, this action can be interpreted as a button press (e.g., a user input command). If the subject user continues touching the module401, the readings will complete in ˜20-30 s for the most complex measurements such as blood pressure. The one or more modules401can then enter a low power state by turning off and waiting for either a timer to take another reading (e.g., every 10 min) or waiting for at least one of the modules401to be touched again, or not go into a low power state and continue reading indefinitely during contact with the tissue. In the continuous reading embodiment, the one or more modules401can go into a low power state when contact with tissue is no longer sensed, which can be useful in a smartphone/watch application or in a location on a hearing aid that is in continuous contact with the tissue.

According to another representative use example, if an electro-optical sensor module401is placed on the body where pressure is sometimes modified during normal daily activities, such as in the ear canal during jaw movements, then the PPG sensor recordings can be used in conjunction with a pressure sensor of the module401(see, e.g.,FIGS. 1C and 2C) to directly measure the local blood pressure. This works by measuring the pressure at the maximum pulsatile signal from the PPG sensor and the maximum pressure where the pulsatile signal from the PPG sensor is cut off. These two pressure measurements correlate to the local diastolic and systolic blood pressures, respectively.

In a further representative use example, the first and second optical windows406a,406bof module401(and electrodes shown in any other figures) can be configured to serve as charge contacts that can detachably engage corresponding charge contacts of a charger unit (e.g., a desk-top charger or a portable charging case). By electrically coupling the optical windows406a,406b(or electrodes shown in other figures) to electrical contacts of charge circuitry configured to charge a rechargeable power source (e.g., lithium-ion battery) of the apparatus supporting the module401, contacts of the charger unit can be configured to clean off the optical windows406a,406b(or electrodes shown in other figures) on every insertion by using scratching or wiping contacts. In such implementations, it is preferable to construct the optical windows406a,406busing a material with a hardness higher than that of the charger contacts to avoid being scratched or damaged.

It is understood that the representative use examples and other illustrative implementation details described above in the context of the electro-optical sensor module401shown inFIG. 4can similarly apply to any of the embodiments and implementations described above with reference toFIGS. 1A-3. It is also understood that the electro-optical sensor module401and other electro-optical sensors described above with reference toFIGS. 1A-3can be implemented in accordance with any of the circuits, devices, and systems disclosed in commonly-owned U.S. Patent Application Ser. No. 63/125,695 filed Dec. 15, 2020 under Attorney Docket No. ST0899PRV/0532.000899US60, which is incorporated herein by reference in its entirety.

Although reference is made herein to the accompanying set of drawings that form part of this disclosure, one of at least ordinary skill in the art will appreciate that various adaptations and modifications of the embodiments described herein are within, or do not depart from, the scope of this disclosure. For example, aspects of the embodiments described herein may be combined in a variety of ways with each other. Therefore, it is to be understood that, within the scope of the appended claims, the claimed invention may be practiced other than as explicitly described herein.

All references and publications cited herein are expressly incorporated herein by reference in their entirety into this disclosure, except to the extent they may directly contradict this disclosure. Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as being modified either by the term “exactly” or “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein or, for example, within typical ranges of experimental error.

The recitation of numerical ranges by endpoints includes all numbers subsumed within that range (e.g. 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range. Herein, the terms “up to” or “no greater than” a number (e.g., up to 50) includes the number (e.g., 50), and the term “no less than” a number (e.g., no less than 5) includes the number (e.g., 5).

The terms “coupled” or “connected” refer to elements being attached to each other either directly (in direct contact with each other) or indirectly (having one or more elements between and attaching the two elements). Either term may be modified by “operatively” and “operably,” which may be used interchangeably, to describe that the coupling or connection is configured to allow the components to interact to carry out at least some functionality (for example, a radio chip may be operably coupled to an antenna element to provide a radio frequency electric signal for wireless communication).

Terms related to orientation, such as “top,” “bottom,” “side,” and “end,” are used to describe relative positions of components and are not meant to limit the orientation of the embodiments contemplated. For example, an embodiment described as having a “top” and “bottom” also encompasses embodiments thereof rotated in various directions unless the content clearly dictates otherwise.

As used herein, “have,” “having,” “include,” “including,” “comprise,” “comprising” or the like are used in their open-ended sense, and generally mean “including, but not limited to.” It will be understood that “consisting essentially of” “consisting of,” and the like are subsumed in “comprising,” and the like. The term “and/or” means one or all of the listed elements or a combination of at least two of the listed elements.

The phrases “at least one of,” “comprises at least one of,” and “one or more of” followed by a list refers to any one of the items in the list and any combination of two or more items in the list.