Wearable device and method for detecting BIO-signals within wearable device

Abstract

Disclosed is a wearable device (100). The device (100) includes at least one sensing unit (104) which is configured to detect bio-signals from skin contacting area of a user. The at least one sensing unit (104) includes at least one photosensitive element, at least one light source, and at least one electrode. The at least one photosensitive element (106) is configured to detect an optical signal and generate one or more electrical signals. The at least one light source (110) operatively coupled to the at least one photosensitive element (106), is configured to generate the light-based signals. The at least one electrode (108) is configured to detect the one or more electrical signals. The at least one photosensitive element (106), the at least one light source (110), and the at least one electrode (108) are arranged in an array.

Description

[0001] WEARABLE DEVICE AND METHOD FOR DETECTING BIO-SIGNALS WITHIN WEARABLE DEVICE FIELD OF THE INVENTION

[0001] The present invention relates generally to the field of biomedical devices, and more particularly relates to a wearable device and method for detecting bio-signals within wearable device. BACKGROUND

[0002] Biomedical devices rely on skin contact to obtain accurate data for healthcare applications. The precision of data obtained by a biomedical device depends on quality of interface between a subject’s skin and electrodes. Therefore, ensuring optimal contact with the skin is essential for obtaining precise biomedical measurements.

[0003] Measurement of impedance plays a critical role in biomedical contexts by enhancing signal fidelity through effective electrode-skin contact. The measurement of impedance establishes a reference point for the interface between electrodes and the skin, aiding in the detection of changes during bio signal acquisition. The measurement of impedance is particularly vital for identifying ineffective electrodes, which is crucial for the accuracy of applications like electroencephalogram EEG recording. However, the impedance measurement, which relies solely on electrical properties, has limitations when conducted simultaneously with bio signal recording, potentially compromising the integrity of the sensitive bio signals being captured.

[0004] Moreover, the impedance measurement techniques introduce latency, presenting challenges for real-time assessments and potentially causing delays, especially in dynamic scenarios where quick decisions are essential. The real-time assessments facilitate prompt identification of suboptimal electrodes, enabling immediate actions such as excluding data from affected electrodes to enhance overall quality of datasets. Further, environmental factors such as sweat, temperature, humidity, and external electromagnetic interference may disrupt the impedance measurements. Additionally, inconsistent or inadequate contact between measurement probes and samples may introduce artifacts, potentially distorting measurement outcomes.

[0005] Therefore, there lies a need for an improved solution that can address the above-mentioned issues and the limitations of the existing systems and methods. SUMMARY

[0006] This summary is provided to introduce a selection of concepts, in a simplified format, that are further described in the detailed description of the invention. This summary is neither intended to identify key or essential inventive concepts of the invention nor is it intended to determine the scope of the invention.

[0007] In accordance with an embodiment of the present disclosure, a wearable device is disclosed. The device includes at least one sensing unit, which is configured to detect bio-signals from skin contacting area of a user. The skin contacting area comprises at least one of: skin surface, an inner ear surface and outer ear surface. The at least one sensing unit includes at least one photosensitive element, at least one light source, and at least one electrode. The at least one photosensitive element is configured to detect an optical signal and generate one or more electrical signals. The at least one light source operatively coupled to the at least one photosensitive element is configured to generate light-based signals. The at least one electrode is configured to detect the one or more electrical signals. The at least one photosensitive element, the at least one light source, and the at least one electrode are arranged in an array. The at least one light source is disposed within an outermost region of the array. The at least one electrode is positioned in a middle region surrounded by the outermost region. The at least one photosensitive element is positioned in an innermost region with the outermost region, and the middle region.

[0008] According to another embodiment of the present disclosure, a method for detecting bio- signals in a wearable device is disclosed. The device includes at least one sensing unit which is configured to detect bio-signals from skin contacting area of a user. The skin contacting area comprises at least one of: skin surface, an inner ear surface and an outer ear surface. The at least one sensing unit includes at least one photosensitive element, at least one light source, and at least one electrode. The at least one photosensitive element is configured to detect an optical signal and generate one or more electrical signals. The at least one light source operatively coupled to the at least one photosensitive element is configured to generate light-based signals. The at least one electrode is configured to detect the one or more electrical signals. The method includes receiving the light-based signals reflected from the skin contacting area of the user. Further, the method includes gauging pressure received on the at least one electrode in contact with the inner ear surface of the user. Furthermore, the method includes determining one or more optical parameters from the light-based signals and pressure data. Moreover, the method includes determining whether the one or more optical parameters and the pressure data meet a predefined threshold condition based on: correlation of the one or more optical parameters with predefined optical metrics, and correlation of the pressure data with predefined pressure range. Further, the method includes transmitting a signal to record the one or more optical parameters and pressure data based on the determination that the one or more optical parameters and the pressure data meet the predefined threshold condition, thereby recording the bio-signals.

[0009] To further clarify the advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof, which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail in the accompanying drawings. BRIEF DESCRIPTION

[0010] These and other features, aspects, and advantages of the present invention will become better understood when the following detailed description is read with reference to the accompanying drawings in which like characters represent like parts throughout the drawings, wherein: Figure 1 illustrates an exemplary wearable device, in accordance with an embodiment of the present disclosure; Figure 2 illustrates a cross-section view of the wearable device with a sensing unit, in accordance with an embodiment of the present disclosure; Figure 3 illustrates a top view of a sensing unit within the wearable device, in accordance with an embodiment of the present disclosure; Figure 4 illustrates a block diagram of the processing unit for the wearable device, in accordance with an embodiment of the present disclosure; Figure 5 illustrates an example implementation of at least one sensing unit within the wearable device, in accordance with an embodiment of the present disclosure; and Figure 6 illustrates a process flow of a method for detecting bio-signals in the wearable device, in accordance with an embodiment of the present disclosure.

[0011] Further, skilled artisans will appreciate that elements in the drawings are illustrated for simplicity and may not have necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help improve understanding of aspects of the present invention. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present invention so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. DETAILED DESCRIPTION

[0012] For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the various embodiments, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein, being contemplated as would normally occur to one skilled in the art to which the invention relates.

[0013] The term “some” as used herein is defined as “none, or one, or more than one, or all.” Accordingly, the terms “none,” “one,” “more than one,” “more than one, but not all,” or “all” would all fall under the definition of “some.” The term “some embodiments” may refer to no embodiments or to one embodiment or to several embodiments or to all embodiments. Accordingly, the term “some embodiments” is defined as meaning “no embodiment, or one embodiment, or more than one embodiment, or all embodiments.”

[0014] The terminology and structure employed herein are for describing, teaching, and illuminating some embodiments and their specific features and elements, and do not limit, restrict, or reduce the spirit and scope of the claims or their equivalents.

[0015] More specifically, any terms used herein such as but not limited to “includes,” “comprises,” “has,” “consists,” and grammatical variants thereof do NOT specify an exact limitation or restriction and certainly do NOT exclude the possible addition of one or more features or elements, unless otherwise stated, and furthermore must NOT be taken to exclude the possible removal of one or more of the listed features and elements, unless otherwise stated with the limiting language “MUST comprise” or “NEEDS TO include.”

[0016] Unless otherwise defined, all terms, and especially any technical and / or scientific terms, used herein may be taken to have the same meaning as commonly understood by one having ordinary skill in the art.

[0017] Reference is made herein to some “embodiments.” It should be understood that an embodiment is an example of a possible implementation of any features and / or elements presented in the attached claims. Some embodiments have been described for the purpose of illuminating one or more of the potential ways in which the specific features and / or elements of the attached claim fulfill the requirements of uniqueness, utility, and non-obviousness.

[0018] Use of the phrases and / or terms such as but not limited to “a first embodiment,” “a further embodiment,” “an alternate embodiment,” “one embodiment,” “an embodiment,” “multiple embodiments,” “some embodiments,” “other embodiments,” “a further embodiment”, “furthermore embodiment”, “additional embodiment” or variants thereof do NOT necessarily refer to the same embodiments. Unless otherwise specified, one or more particular features and / or elements described in connection with one or more embodiments may be found in one embodiment or may be found in more than one embodiment, or may be found in all embodiments, or may be found in no embodiments.

[0019] Although one or more features and / or elements may be described herein in the context of only a single embodiment, or the context of more than one embodiment, or further alternatively in the context of all embodiments, the features and / or elements may instead be provided separately or in any appropriate combination or not at all. Conversely, any feature and / or element described in the context of separate embodiments may alternatively be realized as existing together in the context of a single embodiment.

[0020] Any particular and all details set forth herein are used in the context of some embodiments and therefore should NOT be necessarily taken as limiting factors to the attached claims. The attached claims and their legal equivalents can be realized in the context of embodiments other than the ones used as illustrative examples in the description below.

[0021] Further, skilled artisans will appreciate those elements in the drawings that are illustrated for simplicity and may not have necessarily been drawn to scale. For example, the flow charts illustrate the method in terms of the most prominent steps involved to help improve understanding of aspects of the present disclosure. Furthermore, in terms of the construction of the device, one or more components of the device may have been represented in the drawings by conventional symbols, and the drawings may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the drawings with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.

[0022] The present disclosure provides a wearable device and a method for detecting bio-signals within the wearable device.

[0023] An object of the present disclosure is to provide a system and method that overcomes the limitations found in prior art methods and devices related to biomedical devices.

[0024] Another object of the present disclosure is to provide the wearable device that includes at least one sensing unit, which is configured to detect bio-signals from skin contacting area of a user.

[0025] Another object of the present disclosure is to ensure calibrated contact between electrodes and skin.

[0026] Yet another object of the present disclosure is to facilitate identification and exclusion of suboptimal electrodes.

[0027] Embodiments of the present invention will be described below in detail with reference to the accompanying drawings.

[0028] Figure 1 illustrates an exemplary wearable device 100, in accordance with an embodiment of the present disclosure.

[0029] In an exemplary embodiment, the wearable device 100 may be a wearable device such as smart earbuds, smartwatches, and other wearable monitoring devices. In another exemplary embodiment, the wearable device 100 may be a biomedical device used for vivo diagnosis. According to the World Health Organization (WHO), biomedical devices are medical devices intended for human use that incorporate living or non-living parts or components. The biomedical device may be any instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material, or other similar or related article, intended by the manufacturer to be used, alone or in combination, for a medical purpose. Further, an optimal electrode-tissue contact is crucial in biomedical devices that require precise bio signal acquisition, ensuring accurate diagnostics, effective therapies, and patient comfort. The optimal electrode-tissue contact minimizes signal artifacts, reduces noise, and contributes to long-term stability, essential for reliable and informed medical decision-making.

[0030] In an embodiment, the wearable device may include a housing configured to be positioned within an outer ear surface, i.e., external auditory canal of a user, an ear tip 102 formed of a flexible, biocompatible material adapted to seal the ear canal for acoustic isolation, and a processing unit 112.

[0031] In an embodiment, the wearable device 100 includes at least one sensing unit 104 configured to detect bio-signals from skin contacting area of a user. The skin contacting area of a user may be at least one of: skin surface, an inner ear surface and the outer ear surface of the user. In an embodiment, the at least one sensing unit 104 may be disposed within or adjacent to the ear tip 102, such that the at least one sensing unit 104 may maintain direct or proximate contact with ear surface of the ear canal during use. The placement of the at least one sensing unit 104 within the ear tip 102 may enable stable sensor-to-skin contact, minimize ambient interference, and facilitate continuous monitoring without compromising acoustic performance or user comfort.

[0032] In an embodiment, the at least one sensing unit 104 may include at least one of a photosensitive element 106, at least one light source 110, and at least one electrode 108. In a non- limiting example, the at least one sensing unit 104 may be configured to detect fitting and alignment of the at least one electrode 108 and simultaneously perform optical and electrical sensing from the skin contacting area, for example, at least the inner ear surface and the outer ear surface of the user. In a non-limiting example, the at least one sensing unit 104 may be embedded within the housing of the wearable device 100 and positioned to maintain contact with tissue surface of the user during use. In a non-limiting example, the at least one sensing unit 104 may be embedded in, but not limited to, concha and tragus region of the ear during the wearable device usage.

[0033] In an embodiment, the at least one photosensitive element 106 may be configured to detect an optical signal and generate one or more electrical signals.

[0034] In an embodiment, the at least one photosensitive element 106 may refer to one or more components configured to detect incident light or other forms of electromagnetic radiation and generate the one or more electrical signals. The at least one photosensitive element 106 may include, but is not limited to, photodiodes, phototransistors, Complementary Metal-Oxide- Semiconductor (CMOS) image sensors, or other light-detecting devices. The at least one photosensitive element 106 may be adapted to sense ambient light, infrared radiation, ultraviolet light, or specific wavelengths for purposes such as biometric sensing, proximity detection, environmental monitoring, or optical communication.

[0035] In an embodiment, the at least one light source 110 is operatively coupled to the at least one photosensitive element 106, configured to generate light-based signals.

[0036] In an embodiment, the at least one light source 110 may include one or more optoelectronic components configured to emit electromagnetic radiation suitable for interaction with biological tissue for biometric sensing. The at least one light source 110 may include, but is not limited to, light-emitting diodes (LEDs), laser diodes, or organic LEDs (OLEDs), and may be configured to emit light in specific wavelengths, such as red, green, or infrared, optimized for penetration into skin and detection of physiological parameters.

[0037] In an embodiment, the at least one light source 110 may be operable to generate pulsed or continuous light-based signals that interact with blood vessels, skin layers, or other biological structures, enabling measurement of biometric data such as heart rate, blood oxygen saturation, or tissue perfusion, and the like.

[0038] In an embodiment, the at least one electrode 108 may be configured to detect the one or more electrical signals. In an embodiment, the at least one electrode 108 may be one or more electrically conductive components configured to detect bioelectrical signals generated by physiological activity within the user’s body. The at least one electrode 108 may be formed from conductive materials such as silver, gold, platinum, conductive polymers, or carbon-based composites, and may be positioned to maintain electrical contact with the skin contacting area. In an embodiment, the at least one electrode 108 may be integrated into or positioned adjacent to the ear tip 102, to enable acquisition of the one or more electrical signals.

[0039] In an embodiment, the at least one photosensitive element 106, the at least one light source 110, and the at least one electrode 108 are arranged in an array.

[0040] In an embodiment, the at least one light source 110 may be a singular light source positioned within the housing to illuminate the ear, enabling light to fall on the at least one electrode 108 at diverse angles. The at least one photosensitive element 106 may be closely integrated with the at least one electrode 108, either alongside different orientations or embedded within, creating a unified entity. The array may facilitate comprehensive coverage, enabling a thorough assessment of contact quality from multiple angles.

[0041] In another embodiment, the at least one light source 110 may be tiny light sources that are distributed along the ear tip 102 at uniform intervals to optimize contact area and geometric precision.

[0042] In an embodiment, the at least one light source 110 may be configured to emit light towards the inner ear surface and the outer ear surface, enabling illumination of the ear and interaction with the at least one photosensitive element 106 to generate the light-based signals. In a non-limiting example, the emitted light is in at least one of red light, green light, and infrared spectrum.

[0043] In an embodiment, the at least one light source 110 may be disposed within an outermost region of the array.

[0044] In an embodiment, the at least one electrode 108 may be positioned in a middle region surrounded by the outermost region.

[0045] In an embodiment, the at least one photosensitive element 106 may be positioned in an innermost region concentric with the outermost region and the middle region.

[0046] In an alternate embodiment, the at least one light source 110 may be disposed within the innermost region of the array and the at least one photosensitive element 106 may be positioned in the outermost region.

[0047] In an embodiment, the wearable device 100 may include at least one pressure sensor configured to detect contact pressure between the at least one electrode and at least one of the inner ear surface and the outer ear surface. In an embodiment, the at least one actuator unit may be configured to generate a notification for at least one of an auditory alert and a visual alert. In a non-limiting example, the auditory alert, for instance, a beep or alarm tone, may immediately capture attention of the user. In a non-limiting example, the visual alert, for instance, a flashing icon, color change, or pop-up message, may provide clear, contextual information that may be quickly interpreted.

[0048] In an embodiment, the at least one pressure sensor may be a miniature sensor integrated into the ear tip 102 of the wearable device 100 that may detect changes in pressure within the ear canal. In a non-limiting example, the changes may result from physiological activities, for instance, heartbeat, respiration, or movement, environmental factors, for instance, altitude or ambient pressure, or device-related actions, for instance, insertion or removal. In an embodiment, the at least one pressure sensor may convert the changes in pressure into the one or more electrical signals, which may be used for health monitoring, adaptive noise control, or user interaction.

[0049] In an embodiment, the wearable device 100 may include at least one actuator unit configured to apply a controlled force to maintain calibrated contact between the at least one electrode 108 and the skin contacting area, for instance, the inner ear surface.

[0050] In an embodiment, the at least one actuator unit may be a mechanical component integrated within the wearable device 100 that is designed to apply a controlled and calibrated force. In a non-limiting example, the controlled and calibrated force may be applied using a motor-based mechanism, voice coil actuator, Micro-Electro-Mechanical Systems (MEMS) actuators or linear electromagnetic transduce. The purpose of at least one actuator unit is to maintain stable contact between the at least one electrode 108 and the ear surface. The at least one actuator unit may compensate for variations in ear anatomy, movement, or device positioning, ensuring reliable sensor performance or signal acquisition.

[0051] In an embodiment, the wearable device 100 may include an ultrasonic sensor positioned along a central axis of a housing of the wearable device and configured to rotate, the ultrasonic sensor is configured to measure time taken for ultrasound waves to reflect from tissue surface of the user to determine position and contact of the at least one electrode 108.

[0052] In an embodiment, the ultrasonic sensor may emit high-frequency sound waves and detect reflections to measure distance, movement, or changes in the ear canal environment.

[0053] In an embodiment, the wearable device 100 may include the signal processing unit 112 operatively coupled with the at least one sensing unit 104 and may be configured to extract physiological parameters from the one or more electrical signals. In a non-limiting example, the physiological parameters may comprise electroencephalogram (EEG) data, electrocardiogram (ECG) data, heart rate, heart rate variability, temporal pulse waveform features, pressure- modulated vascular response, blood oxygen saturation, blood pressure trends, peripheral oxygen saturation, and biomarkers such as blood glucose trends and glycated haemoglobin.

[0054] Furthermore, the estimated biomarkers or physiological parameters derived from the at least one sensing unit 104 may be integrated with biopotential measurements, such as electroencephalography and electrocardiography, to produce multimodal indicators of cognitive, physiological, or overall health states.

[0055] In an embodiment, the wearable device 100 may include a communication unit operatively coupled with the signal processing unit 112. In a non-limiting example, the communication unit may enable transmission and reception of data over a medium, such as radio waves, infrared, Bluetooth, or physical cables. The communication unit may be integrated into systems, such as the wearable device, to facilitate remote connectivity, data exchange, and control between devices. The communication unit may be configured to transmit the physiological parameters to at least one of an output device, external device and local device.

[0056] In an embodiment, the external device may refer to any computing or communication- enabled device located outside the wearable device 100 that is capable of receiving, processing, or displaying physiological data transmitted wirelessly or through wires. The external device may include, but is not limited to, smartphones, tablets, smartwatches, laptops, medical monitoring systems, or cloud-connected servers. In an embodiment, the local device may refer to any computing or communication-enabled device located the wearable device 100 that is capable of receiving, processing, or displaying physiological data locally on the wearable device.

[0057] Figure 2 illustrates a cross-section view of the wearable device 100 with the at least one sensing unit 104, in accordance with an embodiment of the present disclosure.

[0058] As shown in Figure 2, the wearable device 100 may include the at least one photosensitive element 106, the at least one light source 110, the at least one electrode 108, the at least one actuator unit 202, the at least one pressure sensor 204, the communication unit 206, and a base plate 208, operatively coupled with each other.

[0059] In an embodiment, upon placement of the wearable device 100 within the ear canal, the at least one light source 110 may emit light across the entire ear surface, and the reflected or transmitted light may be received by the at least one photosensitive element 106 and the at least one electrode 108, which may be configured to assess contact quality and anatomical alignment.

[0060] The at least one sensing unit 104 may include the at least one light source 110 and the at least one photosensitive element 106, and may be adapted to derive physiological metrics,including but not limited to peripheral capillary oxygen saturation (SpO ) and other biomarkersobtained through spectral analysis. The at least one sensing unit 104 may be configured to emit light, such as infrared wavelengths, into the ear canal to detect spatial orientation and location of vascular structures, including blood vessels and capillaries.

[0061] In an embodiment, the at least one sensing unit 104 may include the at least one light source 110 and the at least one photosensitive element 106 may be operatively coupled with the at least one actuator unit 202. When positioned adjacent to a dominant vessel, the at least one actuator unit 202 may apply controlled pressure modulation to alter local hemodynamics. Further, analysis of blood flow variations under graded constriction may enable estimation of systolic and diastolic blood pressure, arterial stiffness, and other vascular aging markers. In addition, the at least one pressure sensor 204 may be configured for multi-axis pressure sensing and may be employed to generate a three-dimensional (3D) pressure map of the electrode–tissue interface. The 3D pressure map may facilitate dynamic adjustment of actuator force and positioning, thereby enabling sustained and precise cardiovascular monitoring. The 3D map may be utilized to guide selective placement of the at least one electrode 108. The electrodes positioned distal to major vessels may reduce cardiac signal contamination in EEG recordings, whereas the electrodes positioned proximal to vascular structures may enhance ECG signal fidelity. Further, spectral analysis of transmitted and reflected light may be employed in conjunction with intensity-based detection to differentiate tissue types, thereby optimizing electrode placement over soft tissue versus osseous regions and improving signal interpretation.

[0062] In an embodiment, the signal processing unit 112 may further be configured to analyzemultimodal optical and biopotential signals in accordance with principles analogous to N iChikilsa (traditional pulse diagnosis). In this context, temporal pulse waveform features, variability patterns, and pressure-modulated vascular responses are extracted and correlated with biopotential activity to provide holistic indicators of systemic health, autonomic balance, stress resilience, or early pathological deviations.

[0063] In an embodiment, the at least one actuator unit 202 may ensure that no gap exists between the wearable device 100 and the ear surface, thereby preventing light leakage and maintaining calibrated contact pressure. The at least one pressure sensor 204 may detect contact pressure between the at least one electrode 108 and both the inner ear surface and outer ear surface, enabling multi-axis force measurement with high spatial resolution. The at least one pressure sensor 204 may be embedded within the structure of the at least one electrode 108 or positioned adjacent to the at least one electrode 108. The at least one pressure sensor 204 may be configured to optimally detect forces exerted by the at least one electrode 108 on the inner ear surface, ensuring measurement integrity. The at least one pressure sensor 204 may be enclosed using environmental sealing mechanisms designed to protect against moisture, dust, and mechanical stress, thereby safeguarding sensor longevity and operational performance without compromising responsiveness or sensitivity. The environmental sealing mechanism may be configured to maintain full functionality of the at least one pressure sensor 204 and the at least one electrode 108 during the wearable device 100 usage. The at least one pressure sensor 204 may be arranged in full-coverage arrays or localized units near the at least one electrode 108, allowing real-time monitoring of pressure levels and dynamic assessment of electrode-skin contact effectiveness.

[0064] In an embodiment, the at least one actuator unit 202 may function as a haptic interface, delivering tactile feedback signals such as nudges or pulses. The haptic interface may serve as a silent alternative to auditory or visual alerts, particularly in scenarios where audible notifications are undesirable, such as during music playback in exercise contexts. Further, actuator control may be synchronized with bio-signal acquisition subsystems to ensure that haptic feedback does not interfere with physiological signal integrity.

[0065] In an additional embodiment, the at least one actuator unit 202 may be configured to enhance acoustic sealing of the ear canal, thereby improving both active and passive noise cancellation. The at least one actuator unit 202 may be dynamically controlled to modulate isolation in synchrony with audio playback dynamics, enhancing perceived audio range and immersion without altering the audio signal path.

[0066] Further, a uniform and standardized baseline pressure may be applied across the at least one electrode 108 during initialization. The wearable device 100 may be configured to accommodate intra-subject and inter-subject anatomical variability, particularly within the ear canal, through a distributed array of strategically positioned the at least one pressure sensor 204, which may be adapted to evaluate contact uniformity across the electrode interface. Once the wearable device 100 is secured within the ear canal, the at least one actuator unit 202 may apply a standardized initial pressure across contact surface of the at least one electrode 108, ensuring consistent baseline measurements from each pressure sensor and allowing uniform calibration.

[0067] In an embodiment, the at least one actuator unit 202 may be configured to apply a predetermined preset pressure level across the at least one electrode 108 to optimize initial contact conditions. Additionally, the at least one actuator unit 202 may serve to improve acoustic sealing within the ear canal. The at least one actuator unit 202, multiple adaptive actuator units may be employed that may dynamically adjust in real-time based on pressure feedback received from the at least one pressure sensor 204. The at least one actuator unit 202 may dynamically modulate earbuds fit in response to detected audio signals or ambient noise, thereby enhancing both passive and active noise cancellation, particularly during low-frequency or transient audio events. Further, in the at least one actuator unit 202, excessive pressure may trigger actuator contraction, while insufficient pressure may induce expansion, thereby achieving continuous and automatic pressure regulation. Based on the observed intensity values, the at least one pressure sensor 204 may make dynamic micro-adjustments to maintain comfort and safety, limiting the maximum pressure exerted on tissue. When pressure exceeds predefined thresholds, electrode arms may contract; when under-pressure is detected, expansion may occur.

[0068] In an alternate embodiment, the wearable device 100 may be augmented with an electrically driven actuator, such as a motor-based mechanism, voice coil actuator or MEMS actuators, to enhance precision and control of contact pressure regulation. The wearable device 100 may be configured to evaluate both light-based and pressure-based metrics for optimizing bio- signal quality. In operation, the wearable device 100 may iteratively analyze configurations of the at least one electrode 108 and may select an optimal arrangement of the at least one electrode 108 based on real-time feedback, thereby facilitating superior electrode placement and signal acquisition fidelity. The at least one sensing unit 104 , comprising the at least one photosensitive element 106, the at least one light source 110, and the at least one electrode 108, may be configured to measure reflected or transmitted light intensity to assess contact quality between the electrode and the ear surface. The at least one sensing unit 104 may support dynamic adjustment and calibration of the at least one electrode 108, contributing to improved signal reliability, user comfort, and overall system performance.

[0069] In an embodiment, a machine learning model may be employed for adaptive adjustment of the wearable device 100 based on both pressure and light data acquired from the at least one pressure sensor 204 and the at least one photosensitive element 106, respectively. The machine learning model may include, but is not limited to, algorithms such as Support Vector Machines (SVM), transformer models and Convolutional Neural Networks (CNN), which may be configured to identify patterns between pressure distributions and optimal configurations of the at least one electrode 108. The wearable device 100 provides an adaptive framework that may enhance signal acquisition precision and facilitate personalized adjustment across diverse anatomical geometries. If pressure and optical sensor readings fall outside predefined thresholds, gating mechanisms may be activated to deactivate the corresponding electrode channels, thereby discarding unreliable bio- signal data. In an alternate embodiment, inverse logic may be employed to selectively retain channels based on threshold logic. Further, hardware-based filtering may be implemented at the at least one sensing unit 104 to enable real-time rejection of poor-quality signals at source, minimizing processing latency and reducing reliance on external computation. Moreover, the electrode contact quality may alternatively be assessed using time-based signature signals, including pulse-width modulation (PWM), amplitude modulation (AM), Direct Current (DC) or Alternate Current (AC) signals, or binary digital signals. These signals may be transmitted cyclically or in parallel, and their integrity may be verified using parity checks to ensure robust transmission and reception. Data signal transmission may be selectively enabled for the at least one electrode 108 that meets predefined signal accuracy thresholds, ensuring reliable bio-signal acquisition. Additionally, a data normalization and stabilization features may be provided to compensate for motion artifacts, variability in electrode-skin contact, and inconsistent placement, thereby improving the consistency and accuracy of bio-signal measurements under dynamic conditions.

[0070] In an embodiment, the communication unit 206 may transmit all relevant sensor data and bio-signals to external systems for further processing, and the base plate 208 may provide structural support and mechanical stability for all integrated components.

[0071] In an embodiment, the wearable device 100 may be configured to collect pressure data from the at least one pressure sensor 204, which may be compiled into a three-dimensional (3D) pressure map. The 3D pressure map may enable dynamic selection of an optimal subset of the at least one electrode 108 for enhanced bio-signal acquisition. In an embodiment, one or more advanced computational techniques may be applied to analyze the 3D pressure map in correlation with individual anatomical characteristics. The data obtained from the 3D pressure map may be used to enhance precision in pressure regulation, thereby facilitating personalized electrode configuration and improved contact quality across variable ear canal morphologies.

[0072] In an embodiment, the wearable device 100 may be configured for non-invasive arterial blood pressure estimation through combined use of optical sensing, pressure sensing, and actuator control. An anatomical region exhibiting pulsatile signals may be identified optically using the at least one photosensitive element 106 and the at least one light source 110, while the at least one actuator unit 202 may apply incremental pressure and the at least one pressure sensor 204 may record the applied force. Simultaneously, optical pulsation signals may be tracked, and systolic and diastolic pressure values may be derived without the need for a traditional cuff.

[0073] In an embodiment, an edge computing may be employed to process the data from the at least one pressure sensor 204 and the at least one photosensitive element 106, as well as bio-signal data acquired via the at least one electrode 108. By offloading computation to the wearable device 100, latency may be minimized, data privacy may be preserved, and energy efficiency may be enhanced. Additionally, a memristor-based non-volatile memory may be incorporated for in- memory computing, reducing data transmission delays and improving energy efficiency. Further, an analog signal processing enabled by memristors may be particularly suited for handling analog bio-signals such as EEG and ECG, thereby enhancing real-time responsiveness.

[0074] Further, in the wearable device 100, optical neural networks (ONNs) may be deployed for rapid bio-signal classification, including detection of anomalies such as seizures or arrhythmias. The ONNs may utilize optical elements for passive Fourier transform operations and may provide high-speed, energy-efficient signal processing. Further, in the wearable device 100, adaptive filtering and machine learning capabilities may enable real-time personalization of bio-signal analysis. In addition, data normalization and stabilization features may be provided to compensate for motion artifacts, variability in electrode-skin contact, and inconsistent placement, thereby enhancing bio-signal measurement accuracy in dynamic or suboptimal conditions.

[0075] In an embodiment, in the wearable device 100, an image-capturing unit may also be included to acquire visual data of the ear canal anatomy. The visual data may be processed using classification algorithms to identify structures such as bone, cartilage, and tissue. Based on the identification, the wearable device 100 may recommend optimal placement of the at least one electrode 108, supported by real-time feedback and visualization tools.

[0076] Additionally, the wearable device 100 may also include the ultrasonic sensor that may be positioned along a central axis of the housing of the wearable device 100. The ultrasonic sensor may be configured to rotate and measure time taken for ultrasound waves to reflect from the ear surface of the user, enabling determination of the position and contact quality of the at least one electrode 108.

[0077] In an embodiment, the wearable device 100 may be configured to perform photoplethysmography (PPG)-based monitoring for determination of heart rate and heart rate variability.

[0078] In an embodiment, the wearable device 100 may be implemented as smartwatches, smart glasses, smart rings, and other body-mounted devices where optimal sensor-to-skin pressure is essential. Further, the at least one electrode 108, the at least one light source 110, the at least one photosensitive element 106, and the at least one pressure sensor may be integrated into contact surfaces, for instance, underside of the smartwatches, nose bridge or temple pads of the smart glasses, or an inner circumference of the smart ring. In addition, controlled actuators and adaptive pressure sensing may dynamically sustain uniform contact across variable anatomies, reducing motion artifacts, improving signal fidelity, and enabling continuous physiological and cognitive monitoring. The principles of calibrated contact pressure and multimodal sensing are thus applicable across diverse wearable platforms for reliable bio-signal acquisition.

[0079] Figure 3 illustrates a top view of the at least one sensing unit 104 within the wearable device 100, in accordance with an embodiment of the present disclosure.

[0080] In an embodiment, the at least one photosensitive element 106, the at least one light source 110, and the at least one electrode 108 may be arranged in a structured array within the wearable device 100. The array may be configured in concentric regions to optimize sensing performance and signal acquisition fidelity. Specifically, the at least one light source 110 may be disposed within the outermost region of the array, forming a peripheral illumination ring.

[0081] In an embodiment, the at least one electrode 108 may be positioned in a middle region surrounding the outermost region, such that the electrodes are encircled by the light sources.

[0082] In an embodiment, the at least one photosensitive element 106 may be centrally located within the array and positioned in the innermost region concentric with both the outermost and middle regions. The array configuration of the at least one photosensitive element 106, the at least one light source 110, and the at least one electrode 108 may facilitate uniform illumination of the ear canal by the at least one light source 110, while enabling the at least one electrode 108 to maintain optimal contact with the ear surface and allowing the at least one photosensitive element 106 to receive reflected or transmitted light with minimal interference.

[0083] In an example implementation, the at least one light source 110 may emit infrared or visible light radially outward from the outermost region. The light may interact with the inner ear surface of the ear canal and reflect inward toward the at least one photosensitive element 106, which may detect variations in light intensity indicative of tissue type, contact quality, or anatomical features. Simultaneously, the at least one electrode 108 may acquire bio-signals such as EEG or ECG, with placement of the at least one electrode 108 in the middle region ensuring balanced pressure distribution and minimal signal distortion. The array arrangement may also support dynamic calibration routines to allow the wearable device 100 to adjust actuator force via the at least one actuator unit 202 based on feedback from the at least one pressure sensor 204, ensuring calibrated electrode-tissue contact and minimizing motion artifacts. The array configuration may further enhance spatial resolution of both optical and electrical measurements, contributing to improved diagnostic accuracy and adaptive signal processing.

[0084] Figure 4 illustrates a block diagram of the processing unit 112 for the wearable device 100, in accordance with an embodiment of the present disclosure.

[0085] In an embodiment, the processing unit 112 may include at least a processor 402, a memory 404, a plurality of units 406, and a data unit 408. The processor 402, the memory 404, the plurality of units 406, and the data unit 408 are communicably coupled with each other.

[0086] In an embodiment, the at least one processor 402 may be in communication with the memory 404. The at least one processor 402 may be a single processing unit or several units, all of which could include multiple computing units. The at least one processor 402 may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and / or any devices that manipulate signals based on operational instructions. Among other capabilities, the at least one processor 402 may be configured to fetch and execute computer-readable instructions and data stored in the memory 404.

[0087] In an embodiment, the memory 404 may include any non-transitory computer-readable medium known in the art including, for example, volatile memory, such as static random access memory (SRAM) and dynamic random access memory (DRAM), and / or non-volatile memory, such as read-only memory (ROM), erasable programmable ROM, flash memories, hard disks, optical disks, and magnetic tapes.

[0088] In an embodiment, the plurality of modules 406 may be configured to detect bio-signals in the wearable device 100.

[0089] In some embodiments, the plurality of modules 406 may include a set of instructions that can be executed to cause the processing unit 112 to perform any one or more of the methods disclosed. The processing unit 112 may operate as a standalone device or may be connected, e.g., using a network, to other computer systems or peripheral devices. Further, while a single processing unit 112 is illustrated, the term “processing unit” shall also be taken to include any collection of processing unit, implemented across the wearable device 100 that individually or jointly execute a set, or multiple sets, of instructions to perform one or more computer functions.

[0090] In an embodiment, the plurality of modules 406 may be implemented using one or more artificial intelligence (AI) units that may include a plurality of neural network layers. Examples of neural networks include, but are not limited to, Convolutional Neural Network (CNN), Deep Neural Network (DNN), Recurrent Neural Network (RNN), and Restricted Boltzmann Machine (RBM). Further, ‘learning’ may be referred to in the disclosure as a method for training a predetermined target device (for example, a robot) using a plurality of learning data to cause, allow, or control the target device to make a determination or prediction. Examples of learning techniques include, but are not limited to, supervised learning, unsupervised learning, semi- supervised learning, or reinforcement learning. At least one of a plurality of CNN, DNN, RNN, RMB models and the like may be implemented to thereby achieve execution of the present subject matter’s mechanism through an AI model. A function associated with an AI unit may be performed through the non-volatile memory, the volatile memory, and the processor. The processor 402 may include one or a plurality of processors. At this time, one or a plurality of processors may be a general-purpose processor, such as a central processing unit (CPU), an application processor (AP), or the like, a graphics-only processing unit such as a graphics processing unit (GPU), a visual processing unit (VPU), and / or an AI-dedicated processor, such as a neural processing unit (NPU). One or a plurality of processors control the processing of the input data in accordance with a predefined operating rule or artificial intelligence (AI) model stored in the non-volatile memory and the volatile memory. The predefined operating rule or artificial intelligence model is provided through training or learning.

[0091] In an embodiment, the data unit 408, amongst other things, includes routines, programs, objects, components, data structures, and the like, which perform tasks or implement data types. The data unit 408 may also be implemented as signal processor(s), state machine(s), logic circuitries, and / or any other device or component that manipulates signals based on operational instructions. Further, the data unit 408 may be implemented in hardware, instructions executed by a processing unit, or by a combination thereof. The processing unit may comprise a processor, such as the at least one processor 402, a state machine, a logic array, or any other suitable device capable of processing instructions. The processing unit may be a general-purpose processor that executes instructions to cause the general-purpose processor to perform the required tasks, or the processing unit can be dedicated to performing the required functions. In another embodiment of the present disclosure, the data unit 408 may be machine-readable instructions (software) that, when executed by the processor 402, perform any of the described functionalities.

[0092] Figure 5 illustrates an example implementation 500 of the at least one sensing unit 104 within the wearable device 100, in accordance with an embodiment of the present disclosure.

[0093] As shown, the at least one sensing unit 104 comprising the at least one light source 110, the at least one electrode 108, and the at least one photosensitive element 106, may be strategically positioned to optimize signal acquisition, contact assessment, and spatial resolution. As depicted in Figure 5, the at least one sensing unit 104 may be placed on, for instance, the ear tip 102 such that the at least one sensing unit 104 may make direct contact with the inner ear surface. The strategic placement of the at least one sensing unit 104 may enable continuous and localized monitoring of physiological parameters, including bioelectrical signals, optical reflections, and pressure variations. By positioning the at least one sensing unit 104 at the ear tip 102, the wearable device 100 may ensure stable and intimate coupling with the ear canal, thereby enhancing signal fidelity and minimizing motion artifacts.

[0094] Figure 6 a process flow of a method for detecting bio-signals in the wearable device 100, in accordance with an embodiment of the present disclosure. The method 600 may be a computer- implemented method executed, for example, by the processing unit 112 of the wearable device 100. For the sake of brevity, constructional and operational features of the wearable device 100 that are already explained in the description of Figures 2-5 are not explained in detail in the description of Figure 6.

[0095] At step 602, the method 600 may include receiving the light-based signals reflected from the skin contacting area of the user.

[0096] At step 604, the method 600 may include gauging pressure data received on the at least one electrode 108 in contact with the skin contacting area the user.

[0097] At step 606, the method 600 may include determining one or more optical parameters from the light-based signals and the pressure data.

[0098] At step 608, the method 600 may include determining whether the one or more optical parameters and the pressure data meet a predefined threshold condition. The predefined threshold condition may be based on correlation of the one or more optical parameters with predefined optical metrics, and correlation of the pressure data with predefined pressure range. In a non- limiting example, the predefined optical metrics may comprise a criterion for detecting leakage light from the inner ear surface. In a non-limiting example, the predefined pressure range is based on a calibrated comfort threshold for in-ear electrode contact.

[0099] At step 610, the method 600 may include transmitting the one or more electrical signals to record the one or more optical parameters and the pressure data based on the determination that the one or more optical parameters and the pressure data meet the predefined threshold condition, thereby recording the bio-signals.

[0100] In an embodiment, the method 600 may include modifying at least one of pressure on the at least one actuator unit (202) and the one or more optical parameters, based on the determination that the predefined threshold condition for the pressure data and the one or more optical parameters are not met. In an embodiment, the method 600 may include disabling routing of the one or more electrical signals from the at least one electrode (108) via a gating circuitry.

[0101] In an embodiment, the method 600 may include generating the 3D pressure distribution map based on the pressure data. In a non-limiting example, the 3D pressure distribution map may correspond to the pressure received on the at least one electrode 108 in contact with the inner ear surface of the user.

[0102] In an embodiment, the method 600 may include modulating the pressure dynamically on the at least one actuator unit (202) based on at least one of an audio playback, one or more musical features, and ambient sound. In a non-limiting example, the modulation may indicate at least one of increasing sealing during low-amplitude passages, bass transients and relaxing sealing during high-amplitude passages.

[0103] In an embodiment, the method 600 may include identifying one or more vascular regions based on detecting localized pulsatile optical signatures. In response to identifying the one or more vascular region, the method 600 may include applying, by the at least one actuator unit (202), at least one of controlled pressure sequences and ramps at the one or more vascular region while monitoring optical pulsation changes, thereby determining systolic and diastolic blood pressure.

[0104] Thus, the present disclosure may provide a closed-loop, multi-modal feedback method configured to fuse optical, pressure, acoustic, and, in certain embodiments, time-signature or imaging data for the purpose of evaluating the at least one electrode 108 contact quality and physiological state.

[0105] In an embodiment, the present disclosure may include the machine learning model deployed at the edge, i.e., proximal to the data acquisition hardware, to minimize latency and enhance real-time responsiveness. The machine learning model may be trained to compute a contact-quality metric based on one or more modalities of the at least one sensing unit 104, and to generate control signals to drive at least one actuator unit accordingly. In an embodiment, the machine learning model may be employed to discard corrupt or unreliable data at the point of acquisition, thereby reducing computational load and improving overall signal fidelity.

[0106] The present disclosure provides various advantages as mentioned below: a) The present disclosure facilities real-time monitoring and allow for the identification and exclusion of suboptimal electrodes, reducing noise and improving fidelity of EEG recordings. b) The present disclosure supports continuous monitoring without latency, ensuring uninterrupted data acquisition in dynamic scenarios. c) The present disclosure adjusts impedance readings accordingly for more accurate measurements. d) The present disclosure ensures calibrated contact between electrodes and skin, minimizing motion artifacts and improving signal stability.

[0107] As would be apparent to a person in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein. The drawings and the forgoing description give examples of embodiments. Those skilled in the art will appreciate that one or more of the described elements may well be combined into a single functional element. Alternatively, certain elements may be split into multiple functional elements. Elements from one embodiment may be added to another embodiment. For example, orders of processes described herein may be changed and are not necessarily limited to the manner described herein.

[0108] Moreover, the actions of any signal flow diagram need not be implemented in the order shown; nor do all of the acts necessarily need to be performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts.

Claims

We Claim:

1. A wearable device (100) comprising: at least one sensing unit (104) configured to detect bio-signals from skin contacting area of a user, wherein the skin contacting area comprises at least one of: skin surface, an inner ear surface and an outer ear surface, the at least one sensing unit (104) comprising: at least one photosensitive element (106) configured to detect an optical signal and generate one or more electrical signals; at least one light source (110) operatively coupled to the at least one photosensitive element, configured to generate a light-based signals; at least one electrode (108) configured to detect the one or more electrical signals; wherein the at least one photosensitive element (106), the at least one light source (110), and the at least one electrode (108) are arranged an array; wherein the at least one light source (110) is disposed within an outermost region of the array; wherein the at least one electrode (108) is positioned in a middle region surrounded by the outermost region; and wherein the at least one photosensitive element (106) is positioned in an innermost region concentric with the outermost region and the middle region.

2. The device as claimed in claim 1, wherein the one or more sensing unit (104) is configured to detect fitting and alignment of the at least one electrode (108) and simultaneously perform optical and electrical sensing from at least the skin contacting area.

3. The device as claimed in claim 1, comprising: at least one pressure sensor (204) configured to detect contact pressure between the at least one electrode (108) and the skin contacting area; and at least one actuator unit (202) configured to apply a controlled force to maintain calibrated contact between the at least one electrode (108) and at least one of the skin contacting area.

4. The device as claimed in claim 3, wherein the at least one actuator unit (202) is configured to generate a notification for at least one of an auditory alert and a visual alert.

5. The device as claimed in claim 1, comprising: a signal processing unit (112) operatively coupled with the at least one sensing unit (104), the signal processing unit (112) configured to extract physiological parameters from the one or more optical and electrical signals, wherein the physiological parameters comprise electroencephalogram (EEG) data, electrocardiogram (ECG) data, heart rate, heart rate variability, temporal pulse waveform features, pressure-modulated vascular response, blood oxygen saturation, blood pressure trends, blood glucose trends, glycated hemoglobin, peripheral oxygen saturation and biomarkers; and a communication unit (206) operatively coupled with the signal processing unit, the communication unit (206) configured to transmit the physiological parameters to at least one of an output device, external device and local device.

6. The device as claimed in claim 1, wherein the at least one sensing unit (104) is embedded within a housing of the wearable device and positioned to maintain contact with tissue surface of the user during use.

7. A method (600) for detecting bio-signals in a wearable device (100) comprising at least one sensing unit (104) configured to detect the bio-signals from skin contacting area of a user, wherein the skin contacting area comprises at least one of: skin surface, an inner ear surface and an outer ear surface, the at least one sensing unit (104) comprising: at least one photosensitive element (106) configured to detect an optical signal and generate one or more electrical signals; at least one light source (110) operatively coupled to the at least one photosensitive element, configured to generate a light-based signals; at least one electrode (108) configured to detect the one or more electrical signals;at least one pressure sensor (204) configured to detect contact pressure between the at least one electrode (108) and the skin contacting area; and at least one actuator unit (202) configured to apply a controlled force to maintain calibrated contact between the at least one electrode (108) and the skin contacting area; the method (600) comprising: receiving (602) the light-based signals reflected from the skin contacting area of the user; gauging (604) pressure data received on the at least one electrode in contact with the skin contacting area; determining (606) one or more optical parameters from the light-based signals and the pressure data; determining (608) whether the one or more optical parameters and the pressure data meet a predefined threshold condition based on: correlation of the one or more optical parameters with predefined optical metrics, and correlation of the pressure data with predefined pressure range; and transmitting (610) the one or more electrical signal to record the one or more optical parameters and the pressure data based on the determination that the one or more optical parameters and the pressure data meet the predefined threshold condition, thereby recording the bio-signals.

8. The method as claimed in claim 7, comprising: modifying at least one of: pressure on the at least one actuator unit (202) and the one or more optical parameters based on the determination that the predefined threshold condition for the pressure data and the one or more optical parameters are not met; and disabling routing of the one or more electrical signals from the at least one electrode (108) via a gating circuitry.

9. The method as claimed in claim 7, comprising:modulating the pressure dynamically on the at least one actuator unit (202) based on at least one of an audio playback, one or more musical features, and ambient sound, wherein the modulation indicates at least one of: increasing sealing during low-amplitude passages, bass transients and relaxing sealing during high-amplitude passages.

10. The method as claimed in claim 7, identifying one or more vascular regions based on detecting localized pulsatile optical signatures; and in response to identifying the one or more vascular region, applying, by the at least one actuator unit (202), at least one of: controlled pressure sequences and ramps at the one or more vascular region while monitoring optical pulsation changes, thereby determining systolic and diastolic blood pressure.

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