Skin patch system for detecting biosignals

The laminated skin patch system integrates flexible and rigid components to overcome mechanical and electrical challenges, ensuring durable and accurate biosignal detection with enhanced user comfort and aesthetic design.

JP3256315UActive Publication Date: 2026-06-22ファワズ エイチアラナジ

Patent Information

Authority / Receiving Office
JP · JP
Patent Type
Utility models
Current Assignee / Owner
ファワズ エイチアラナジ
Filing Date
2026-04-24
Publication Date
2026-06-22

AI Technical Summary

Technical Problem

Conventional wearable biosignal monitoring devices face challenges with mechanical, electrical, and ergonomic limitations, including low skin adhesion, signal artifacts due to movement, bulkiness, user discomfort, and unreliable signal acquisition, especially when integrating rigid and flexible components.

Method used

A laminated skin patch system with a flexible substrate, conductive trace elements, a central rigid island member, electrode contact pads, and an optical sensing assembly, configured to maintain structural integrity and electrical connectivity while conforming to skin contours, ensuring durable and accurate signal detection.

Benefits of technology

The system provides a mechanically integrated, ultra-thin, and flexible biosignal detection patch that maintains stable electrical and optical signal acquisition, reduces motion artifacts, and enhances user comfort with improved durability and aesthetic design.

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Abstract

We provide a skin patch system for detecting biosignals. [Solution] The biosignal detection skin patch system (100) according to the present invention has a laminated structure comprising an outer encapsulation layer (102), a flexible substrate layer (104), a plurality of conductive trace elements (106), a central rigid island member (108), a plurality of electrode contact pads (110), at least one optical sensing assembly (112), and an adhesive layer (114) for skin contact. These components are arranged in a laminated configuration and physically bonded to form an integrated structure, which can adhere closely to the contours of human skin while maintaining structural integrity and reliable electrical connectivity. The conductive trace elements interconnect the electrode contact pads (110) and the central rigid island member (108), enabling the transmission of biosignals acquired from the skin. The central rigid island member (108) is mechanically isolated from the surrounding flexible region to reduce stress concentration and increase durability.
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Description

Technical Field

[0001] The present invention relates to a skin patch system for detecting biological signals using artificial intelligence configured as a mechanically integrated ultra-thin skin-adhering structure. More specifically, it relates to a laminated skin patch for sensing biological signals incorporating structurally arranged conductive paths, a sensing interface, and a mechanically stabilized central unit for continuous physiological monitoring.

Background Art

[0002] Continuous monitoring of physiological parameters using wearable devices has become extremely important in preventive medicine, diagnosis, and remote patient management. Conventional wearable systems such as wristbands and chest straps have problems such as low skin adhesion, signal artifacts due to movement, bulkiness, and user discomfort associated with long-term use. Existing patch-type systems tend to lack structural strength when integrating rigid electronic components and flexible substrates, resulting in problems such as mechanical stress concentration, peeling, or unreliable signal acquisition. There is a need for a mechanically robust and highly flexible biological signal sensing patch that can maintain stable electrical connectivity and sensor performance while conforming to complex skin contours.

[0003] Wearable biosignal monitoring technology has evolved significantly over the past decade, driven by the growing demand for continuous health tracking, early disease detection, and remote patient monitoring. Traditional systems initially relied on rigid or semi-rigid devices such as bedside monitors, Holter monitors, and chest-belt electrocardiogram systems. While clinically reliable, these systems inherently limited user mobility and long-term wearability. These systems typically employ individual electrodes connected to external recording devices via wired interfaces, resulting in cumbersome setups and restricted patient movement, making them unsuitable for continuous, routine monitoring. Furthermore, reliance on rigid housings and external connectivity not only causes discomfort but also limits the applicability of these devices in outpatient and home settings.

[0004] To address these constraints, the industry has shifted to compact wearable devices such as smartwatches, wristbands, and adhesive patches. While wrist-worn devices are widely adopted due to their convenience and compatibility with consumer electronics, they have inherent limitations in their ability to acquire high-precision biosignals. For example, the optical sensors used in wrist-worn plethysmography systems are highly sensitive to movement artifacts and changes in skin contact pressure, resulting in variability in signal quality. Furthermore, wrist-worn devices are generally unsuitable for acquiring signals such as electrocardiograms and electromyograms with clinical-level accuracy due to their suboptimal electrode placement and insufficient stability at the skin-electrode interface.

[0005] In addition to these technical challenges, conventional designs often overlook aesthetic and ergonomic considerations. Many devices are bulky or visually conspicuous, hindering their long-term use in daily life. Transparent or translucent designs have been proposed to achieve visual harmony with the skin, but achieving such aesthetics while maintaining structural and functional integrity remains a complex engineering challenge.

[0006] Existing solutions for wearable biosignal monitoring face challenges due to a combination of mechanical, electrical, and ergonomic constraints. The difficulty in effectively integrating rigid and flexible components, maintaining reliable skin contact, accommodating dynamic deformation, and ensuring long-term durability highlights the need for improved structural design. Addressing these challenges requires a comprehensive approach that considers material selection, mechanical structure, wiring design, sensor integration, and user comfort. [Overview of the project] [Problems that the invention aims to solve]

[0007] This invention provides a skin patch system for detecting biosignals, configured as a layered mechanical assembly in which flexible and rigid components are structurally integrated through a laminated structure. The device consists of an outer encapsulation layer, a flexible substrate layer, a conductive trace element, a centrally located rigid island member, dispersed electrode contact pads, an optical sensing assembly, and a skin contact adhesive layer, all of which are physically coupled to form a single integrated structure. This configuration ensures mechanical decoupling between rigid and flexible regions while maintaining a continuous conductive path, resulting in improved durability, responsiveness, and detection accuracy.

[0008] The primary objective of this invention is to provide a biosignal detection skin patch configured as a mechanically integrated device that maintains structural integrity and reliable signal transmission while achieving high adhesion to human skin even during continuous use. This invention aims to overcome the limitations associated with rigid or semi-flexible wearable systems by introducing a layered structure that mechanically coordinates flexible and relatively rigid components, enabling them to function as an integrated structure without causing stress concentration or material failure.

[0009] Another objective of this invention is to provide a skin-contact sensing device that is ultra-thin and low-profile, enhancing user comfort and allowing for discreet, long-term wear. This invention aims to achieve a shape that closely conforms to the natural curves of the human body, thereby minimizing displacement during movement and improving the stability of sensor contact with the skin surface. This makes it possible to stably acquire physiological signals under various operating conditions.

[0010] A further objective of this invention is to provide a mechanically stable configuration that integrates a central rigid island member with a surrounding flexible region through a structurally optimized connection. This invention aims to prevent delamination, breakage, or electrical disconnection during repeated bending and stretching by incorporating flexible conductive paths and localized deformation regions, thereby dispersing mechanical strain away from highly sensitive electronic components.

[0011] Another objective of this invention is to provide a conductive trace configuration that can accommodate multidirectional deformation without impairing electrical conductivity. By employing geometrically adaptable conductive paths, this invention ensures that electrical connections are maintained even under dynamic mechanical load conditions associated with normal body movements.

[0012] A further objective of this invention is to provide an improved electrode contact interface that achieves stable and low-impedance contact with the skin without relying on excessive conductive gels or rigid structures. This invention aims to maintain constant electrode position and contact quality over long periods, thereby increasing signal fidelity and reducing noise caused by motion artifacts and fluctuations.

[0013] A further objective of this invention is to provide an integrated optical sensing device that maintains proper alignment and proximity between optical components and the skin surface. This invention aims to ensure accurate acquisition of optical signals by minimizing air gaps, misalignment, and deformation-induced distortion through structural embedding and alignment functions within the laminated structure.

[0014] Another objective of this invention is to provide an adhesive interface that enables secure fixation to the skin while appropriately securing the functional area of ​​the device. This invention aims to improve both functionality and usability while maintaining sufficient breathability and fit by incorporating patterned or region-specific adhesive configurations that do not interfere with the sensing element.

[0015] A further objective of this invention is to provide a sealed and protective encapsulation structure that selectively exposes the sensing interface while protecting internal components from environmental factors such as moisture, sweat, and mechanical wear. This invention aims to achieve durability and a long service life without increasing thickness or compromising flexibility.

[0016] A further objective of this invention is to improve the mechanical compliance of the device by incorporating structural features such as micro-perforations, thin-walled sections, and segmented patterns that allow for localized deformation. These features enable the device to adapt to complex skin irregularities and dynamic movements without causing structural damage or reduced adhesion.

[0017] Another objective of this invention is to provide a biosignal sensing patch that combines functional efficiency with aesthetic harmony, including a transparent or translucent structure in which the device visually integrates with the skin. This improves user acceptance and allows for discreet use in daily life.

[0018] A further objective of this invention is to provide a device architecture that enables scalable manufacturing while maintaining the precise alignment of structural and functional components. This invention aims to facilitate practical application and commercialization by enabling the reproducible manufacturing of stacked assemblies with consistent performance characteristics.

[0019] In general, this invention aims to overcome the limitations of existing technologies and provide a comprehensive mechanical solution for wearable biosignal monitoring by integrating flexibility, durability, detection accuracy, and wearing comfort into a single, unified device structure. [Means for solving the problem]

[0020] To solve the above problems, the present invention provides a biosignal detection skin patch system configured as an adaptable mechanical assembly for attachment to the skin of the human body, comprising: an outer sealing layer formed as a continuous flexible sheet having a predetermined thickness, top surface and bottom surface, the outer sealing layer defining a peripheral boundary with rounded corners; a substrate layer positioned directly beneath the outer sealing layer and fixed thereto by lamination, the substrate layer comprising a flexible sheet extending over the entire area of ​​the outer sealing layer; a plurality of conductive trace elements positioned on the substrate layer, the conductive trace elements comprising elongated conductive strips physically bonded to the substrate layer and extending between spaced positions; a central rigid island member mounted on the substrate layer, the central rigid island member comprising a relatively thick, less flexible body fixed to the substrate layer and surrounded by a flexible area of ​​the substrate layer; a plurality of electrode contact pads positioned at intervals on the substrate layer, the electrode contact pads being mechanically connected to at least one of the conductive trace elements and aligned with corresponding openings formed in the outer sealing layer A conductive surface portion is provided; at least one optical sensing assembly comprising a transparent window portion formed in the outer sealing layer and an optical element portion fixed on the substrate layer and aligned with the transparent window portion; an adhesive layer disposed on the lower surface of the substrate layer, the adhesive layer extending continuously over the entire substrate layer and forming a skin contact surface; wherein the outer sealing layer, the substrate layer, the conductive trace element, the central rigid island member, the electrode contact pads, the optical sensing assembly, and the adhesive layer are arranged in a laminated configuration and physically bonded to form an integral laminated structure, wherein the conductive trace element extends continuously along the substrate layer between the central rigid island member and a plurality of the electrode contact pads, wherein the adhesive layer includes a pressure-sensitive adhesive sheet bonded to the entire substrate layer and includes a removable protective liner that peelably covers the adhesive layer before use, and the adhesive layer includes a plurality of patterned recesses or non-adhesive areas aligned with the electrode contact pads and the optical sensing assembly to avoid shielding of the corresponding functional areas. [Effects of the Invention]

[0021] This invention provides a biosignal detection skin patch that is ultra-thin, flexible, and mechanically integrated, for continuous physiological monitoring. [Brief explanation of the drawing]

[0022] These features, aspects, and advantages of the present invention, as well as other features, aspects, and advantages, will be better understood by reading the following detailed description with reference to the accompanying drawings. Throughout the drawings, the same symbols indicate the same components.

[0023] Figure 1 shows a block diagram of a biosignal detection skin patch system configured as an adaptable mechanical assembly for attachment to human skin, according to an embodiment of the present invention. Figure 2 shows a schematic diagram of a skin patch system for detecting biosignals according to an embodiment of the present invention. Furthermore, those skilled in the art will understand that elements in the drawings are shown for simplification and are not necessarily drawn to actual size. For example, flowcharts illustrate the method with respect to the most prominent steps involved to aid in understanding aspects of the disclosure. Also, with respect to the configuration of the apparatus, one or more components of the apparatus may be represented in the drawings by conventional symbols, and the drawings may show only certain details relevant to understanding embodiments of the disclosure so as not to obscure the drawings with details that are easily understood by those skilled in the art who enjoy the description herein. [Modes for carrying out the invention]

[0024] For the purpose of facilitating the understanding of the principles of the invention, the embodiments shown in the drawings will be referenced and specific terminology will be used in describing them. However, this is not intended to limit the scope of the invention, and it should be understood that any modifications or further improvements to the illustrated system, and further applications of the principles of the invention shown therein, are within the realm of what a person skilled in the art would ordinarily conceive.

[0025] Those skilled in the art will understand that the foregoing general description and the following detailed description are for purposes of illustrating and explaining the present invention and are not intended to be limiting.

[0026] Expressions such as "in one aspect", "in another aspect" or similar expressions throughout this specification mean that a particular function, structure, or feature described in connection with an embodiment is included in at least one embodiment. Thus, the appearances of "in one embodiment", "in another embodiment" and similar expressions throughout this specification do not necessarily refer to the same embodiment.

[0027] "Comprising", "being a thing that comprises" or other similar expressions are intended to be non-exclusive inclusion, and a process or method including a list of steps does not include only those steps but may include other steps not explicitly described or inherent in the process or method. Similarly, one or more devices, subsystems, elements, structures, or components preceded by "... comprising" do not exclude the existence of other devices, other subsystems, other elements, other structures, other components, additional devices, additional subsystems, additional elements, additional structures, additional components, provided there are no further restrictions.

[0028] Unless otherwise defined, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The systems, methods, and examples described in this specification are illustrative only and not intended to be limiting.

[0029] The embodiments of this specification will be described in detail below with reference to the accompanying drawings. Referring to Figure 1, a block diagram of a biosignal detection skin patch system configured as an adaptable mechanical assembly for attachment to human skin is shown. The system 100 includes an outer covering layer (102) formed as a continuous flexible sheet having a predetermined thickness, top surface, and bottom surface, and a substrate layer (104) positioned directly beneath the outer covering layer and fixed thereto by lamination, the substrate layer consisting of a flexible sheet extending over the entire area of ​​the outer covering layer. A plurality of conductive trace elements (106) are arranged on the substrate layer. Each conductive trace element includes an elongated conductive strip physically coupled to the substrate layer and extending between spaced positions; a central rigid island member (108) is mounted on the substrate layer. The central rigid island member comprises a relatively thick, less flexible body fixed to the substrate layer and surrounded by a flexible region of the substrate layer; a plurality of electrode contact pads (110) spaced apart on the substrate layer, each electrode contact pad mechanically connected to at least one conductive trace element and including a conductive surface portion aligned with a corresponding opening formed in the outer sealing layer; at least one optical sensing assembly (112) comprising a transparent window portion formed in the outer sealing layer and an optical element portion fixed on the substrate layer and aligned with the transparent window portion; and an adhesive layer (114) positioned on the underside of the substrate layer, which extends continuously across the entire substrate layer and forms a skin contact surface; here, the outer sealing layer, the substrate layer, the conductive trace element, the central rigid island member, the plurality of electrode contact pads, the optical sensing assembly, and the adhesive layer are arranged in a stacked configuration and physically bonded to form an integrated stacked structure; here, the conductive trace element extends continuously along the substrate layer between the central rigid island member and the plurality of electrode contact pads.

[0030] In one embodiment, the conductive trace element (106) consists of a serpentine conductive strip in which curved and straight sections are alternately formed, and this serpentine conductive strip is arranged to extend between the central rigid island member and the electrode contact pad while absorbing the relative displacement between the central rigid island member and the surrounding flexible portion of the substrate layer.

[0031] In one embodiment, the substrate layer (104) includes a plurality of localized thinned areas formed by mechanical thinning or material removal around the central rigid island member, and these thinned areas define a flexible hinge area surrounding the central rigid island member.

[0032] In one embodiment, the electrode contact pad (110) consists of an enlarged conductive plate portion having a planar contact surface, each electrode contact pad is surrounded by an insulating boundary region formed in the substrate layer to electrically insulate adjacent electrode contact pads, and the electrode contact pads are arranged in a dispersed pattern along the longitudinal and transverse directions of the substrate layer, and each electrode contact pad is connected to a central rigid island member via a dedicated conductive trace element.

[0033] In one embodiment, the optical sensing assembly (112) further includes a concave cavity formed in the substrate layer, and the optical element is housed within the concave cavity such that its upper surface is flush with the inner surface of the outer encapsulation layer.

[0034] In one embodiment, the adhesive layer (114) includes a pressure-sensitive adhesive sheet bonded to the entire substrate layer and includes a removable protective liner that peelably covers the adhesive layer before use, wherein the adhesive layer includes a plurality of patterned recesses or non-adhesive areas aligned with electrode contact pads and optical sensing assemblies to avoid obstruction of corresponding functional areas.

[0035] In one embodiment, the substrate layer (104) is provided with a plurality of micro-perforations distributed throughout the entire bendable region, and these micro-perforations form openings that penetrate the entire thickness of the substrate layer to enhance the flexibility of the system. The substrate layer is also provided with a plurality of radial slits extending from the central rigid island member toward the outer boundary, and these slits define independently deformable segments within the substrate layer.

[0036] In one embodiment, an outer sealing layer (102) and a substrate layer (104) are joined by thermal lamination along a continuous interface to form a sealed housing surrounding a conductive trace element and a central rigid island member, wherein the outer sealing layer includes a transparent polymer sheet that allows the conductive trace element and the central rigid island member to be visible through the outer sealing layer, and the outer sealing layer includes a plurality of through holes aligned with the electrode contact pads, each through hole defining an exposed conductive interface region, while the rest of the conductive trace element is completely covered by the outer sealing layer.

[0037] In one embodiment, the conductive trace element (106) is formed as a metal foil strip embedded in a substrate layer and covered with an outer sealing layer, and these metal foil strips are fixed in place by interlayer sealing.

[0038] In one embodiment, the central rigid island member (108) has a multilayer laminated structure including a base plate fixed to the substrate layer and a cover plate fixed on the base plate, and the conductive trace element is mechanically connected between the base plate and the substrate layer, where the central rigid island member is fixed to the substrate layer by an adhesive layer and is further mechanically held by at least one peripheral fixing flange extending outward from the central rigid island member and embedded in the substrate layer.

[0039] Figure 2 shows a schematic diagram of a biosignal detection skin patch system according to an embodiment of the present invention. The illustrated biosignal detection skin patch has a flexible, transparent outer layer that enables optical detection while encapsulating and protecting internal components. Beneath this layer is a substrate with integrated sensors, supporting multiple functional elements such as electrocardiogram electrodes positioned for acquiring electrical signals, an optical sensor for optical pulse wave measurement, and temperature sensors placed throughout the patch for body temperature monitoring. A microprocessor for processing acquired physiological signals is mounted in the center and connected to each sensing element via conductive paths. A micro power supply unit is also incorporated to supply power to all components.

[0040] The present invention further includes a predictive processing mechanism integrated within a mechanically constructed biosignal detection skin patch, where the structural arrangement of sensing elements and conductive paths enables continuous acquisition of physiological signals, and the acquired signals are subsequently subjected to technical processing for interpretation and prediction. As described above, the device is configured as a laminated mechanical assembly consisting of an encapsulation layer, a flexible substrate, conductive trace elements, a central rigid island member, electrode pads, and an optical sensing assembly, enabling stable, low-noise signal acquisition, which forms the basis for reliable computational analysis.

[0041] During operation, the electrode contact pads establish direct electrical contact with the skin surface to capture bioelectrical signals such as electrocardiograms, muscle activity, or physiological parameters. Simultaneously, the optical sensing assembly acquires luminosity signals corresponding to these characteristics. These raw analog signals are transmitted via conductive trace elements that extend continuously between the sensing area and the central rigid island member. The meandering or geometrically adaptable configuration of the conductive traces ensures that signal transmission is not interrupted even if the patch is mechanically deformed.

[0042] Within the central rigid island member, the acquired signal undergoes initial adjustment, during which amplification and noise reduction are performed. This processing technique begins with a preprocessing stage in which the input signal is digitized and normalized to compensate for variations due to electrode pressure, impedance, and ambient interference. Subsequently, filtering is performed using adaptive filtering techniques. This filtering is configured to remove operational artifacts and low-frequency noise components, and the adaptive filtering is dynamically adjusted based on detection patterns inferred from variations in signal amplitude and baseline drift.

[0043] After preprocessing, the system extracts features from the adjusted signal. For bioelectrical signals, characteristic waveform features such as peak spacing, amplitude variation, and temporal pattern are identified. For optical signals, parameters such as pulse waveform morphology, absorption variation, and periodicity are extracted. This method enhances robustness and reduces localized measurement errors by correlating these features across multiple sensors distributed along the substrate layer.

[0044] The extracted features are processed using a predictive analytics model configured to identify patterns indicating physiological states or abnormalities. This model works by comparing the extracted features in real time with stored reference patterns and a user-specific, dynamically updated baseline profile. The technology incorporates temporal analysis capabilities to evaluate changes over time, enabling the detection of not only rapid changes but also gradual deviations. This predictive mechanism allows the system to foresee conditions such as arrhythmias and abnormal physiological tendencies before they become serious.

[0045] To improve prediction accuracy, this method further incorporates a mechanism that weights signals obtained from different electrode contact pads and sensing areas based on signal quality metrics. These metrics include signal-to-noise ratio, stability, and consistency over time. Signals deemed unreliable due to inadequate or excessive motion interference are either given a lower weight or excluded from the prediction calculation. This ensures that the output is calculated based on the most reliable data.

[0046] Furthermore, this system performs intermodality validation by correlating the characteristics of electrical and optical signals. For example, it analyzes the temporal consistency between the peaks of electrical signals and their corresponding optical pulse signatures to verify physiological consistency. If inconsistencies are found between these modalities, they are flagged and used to adjust the confidence level of the prediction results. This multi-sensor fusion approach improves the robustness of the technology, especially in dynamic situations where individual sensing modalities may be affected by noise.

[0047] The processed output undergoes a further classification stage, where detected patterns are categorized into predefined physiological states or abnormal classes. Classification is performed using a trained model whose parameters are continuously updated based on accumulated data, enabling adaptive learning tailored to the individual user's characteristics. This technology maintains a historical data buffer within a central rigid island member, allowing for improved prediction accuracy through analysis over time.

[0048] This technology incorporates predictive analytics along with a feedback mechanism that works in conjunction with the device's mechanical configuration. It monitors signal quality fluctuations due to mechanical deformation and adjusts processing parameters accordingly. For example, if an increase in noise due to motion is detected, filtering may be enhanced or recalibration routines may be executed. This coordination between mechanical structure and technical processing ensures that the system maintains optimal performance under various conditions. The final output generated by this technology represents a quantitative assessment of the physiological state and its associated confidence level. This output is transmitted to external devices and interfaces through appropriate transmission means integrated into the central rigid island member. In this way, the system integrates mechanically stable signal acquisition with adaptive and predictive computational processing, resulting in a comprehensive biosignal monitoring system that provides accurate, real-time, and forward-looking physiological insights.

[0049] With the above configuration, this invention achieves a synergistic integration of mechanical design and technical knowledge. In other words, the structural characteristics of the patch directly support and enhance the effectiveness of signal processing and predictive analysis, thereby overcoming the limitations associated with conventional wearable monitoring systems.

[0050] The biosignal detection skin patch is formed as an ultra-thin, elongated, ergonomically shaped structure designed to adhere closely to the curved surfaces of human skin. The device features an outer covering layer formed as a continuous, flexible sheet with a predetermined thickness, defining the top and bottom surfaces. This covering layer extends along a rounded peripheral boundary to minimize discomfort during use and prevent lifting at the edges. The covering layer is made of a transparent or translucent polymer material, allowing visibility of the internal structural elements while ensuring a seamless and aesthetically pleasing appearance as described in the design specifications.

[0051] Directly beneath the outer encapsulation layer is a substrate layer, formed as a flexible sheet that extends across almost the entire surface of the device. This substrate layer is fixed to the encapsulation layer by lamination, forming a composite structure. The substrate layer functions as a mechanical support base for conductive and sensing elements, and is designed to exhibit localized flexibility through variations in thickness, micro-perforations, and slit structures.

[0052] Multiple conductive trace elements are arranged on the substrate layer, and each trace element consists of an elongated conductive strip bonded to the substrate and extending between spatially separated regions. These conductive trace elements are arranged to interconnect a central rigid island member with dispersed electrode contact pads and sensing elements. In one embodiment, the conductive trace elements are formed in a meandering shape with alternating curved and straight sections, which allows for elastic deformation and strain absorption when the patch is bent or stretched.

[0053] A central rigid island member is mounted on the substrate layer, forming a relatively thick and less flexible structure compared to the surrounding area. This central rigid island member houses the main electronic components and is mechanically fixed to the substrate layer through adhesive bonding and, if necessary, structural fastening means such as peripheral flanges embedded within the substrate. The substrate surrounding the central rigid island member is configured to include thin-walled regions that form a flexible hinge zone, thereby allowing relative movement between the rigid island and the adjacent flexible region without generating excessive mechanical stress.

[0054] Furthermore, the device comprises multiple electrode contact pads distributed across the entire substrate layer. Each electrode contact pad is formed as a conductive surface region mechanically connected to at least one conductive trace element. The electrode contact pads are aligned with corresponding openings or through-holes formed in the outer sealing layer, so that the conductive surface is exposed and can come into direct contact with the skin. Each electrode pad is electrically insulated from adjacent pads by insulating boundary regions within the substrate layer to prevent signal interference.

[0055] In addition to electrical sensing, the device includes at least one optical sensing assembly. This optical sensing assembly includes a transparent window formed in the outer sealing layer and an optical element positioned on the substrate layer to align with the window. In certain embodiments, the substrate layer is provided with a concave cavity, and the optical element is fitted into this cavity such that its upper surface is flush with the inner surface of the sealing layer. This maintains a uniform shape and minimizes optical distortion.

[0056] An adhesive layer is positioned beneath the substrate layer to ensure secure attachment of the device to the skin. This adhesive layer is formed as a continuous pressure-sensitive adhesive sheet and may include a removable protective liner before application. Furthermore, this adhesive layer is designed to include patterned recesses or non-adhesive areas aligned with electrode contact pads and optical sensing areas to enhance skin compatibility without interfering with sensor operation.

[0057] The multilayer structure of this device consists of a sealing layer, a substrate layer, a conductive pattern, a rigid island member, electrode contact pads, an optical sensing assembly, and an adhesive layer. It is assembled through lamination processes such as thermal bonding or adhesive bonding to form a unified and sealed structure. The sealing layer encloses the conductive pattern elements and the central rigid island member while selectively exposing functional areas such as electrode interfaces and optical windows.

[0058] To enhance mechanical adaptability, the base layer can have fine perforations placed throughout the entire flexible area to reduce flexural stiffness and improve breathability. Furthermore, by forming radial slits extending outward from the central rigid island member toward the periphery, independently deformable segments can be defined, allowing the patch to adhere to irregular skin surfaces without causing delamination or structural damage.

[0059] This configuration enables a device that combines an ultra-thin structure, transparency, distributed sensing capabilities, and mechanically robust connections between rigid and flexible components. This structural arrangement allows for the distribution of mechanical stress to the flexible area while maintaining stable electrical connections, resulting in improved durability and signal fidelity over long-term use.

[0060] This invention provides a mechanically integrated biosignal sensing patch that achieves excellent responsiveness, reduced motion artifacts, improved durability, and reliable signal acquisition. The combination of a rigid central island and flexible wiring allows for the integration of complex electronic components without compromising flexibility. The layered structure ensures environmental protection and structural integrity, while transparent sealing and distributed sensor placement contribute to both functional efficiency and aesthetic design.

[0061] The biosignal detection skin patch of this invention represents a groundbreaking advance in wearable medical device engineering by integrating the principles of mechanical design with functional detection requirements. Through its meticulously designed multilayer structure, this invention achieves a balance between flexibility and structural stability, thereby enabling continuous, reliable, and comfortable physiological monitoring.

[0062] The drawings and the preceding description illustrate examples of embodiments. Those skilled in the art will understand that it is entirely possible to integrate one or more of the described elements into a single functional element. Alternatively, certain elements can be divided into multiple functional elements. Elements of one embodiment can also be added to another embodiment. For example, the order of processes described herein is modifiable and is not limited to the methods described herein. Furthermore, the operations in any flowchart do not need to be implemented in the order shown, nor do all operations necessarily need to be performed. Operations that do not depend on other operations may be performed in parallel with other operations. The scope of embodiments is by no means limited by these specific examples. Numerous variations are possible, whether or not they are explicitly stated in the specification, including differences in structure, dimensions, and use of materials. The scope of embodiments is at least equivalent to, or broader than, the scope defined by the following claims.

[0063] The advantages, other merits, and solutions to problems of the specific embodiments described above have been explained. However, these advantages, merits, solutions to problems, and the components that bring them about or enhance their effects should not be construed as definitive, essential, or indispensable features or components in any or all of the claims.

Claims

1. This is a biosignal detection skin patch system configured as an adaptable mechanical assembly for attachment to human skin. An outer sealing layer is formed as a continuous, flexible sheet having a predetermined thickness, an upper surface, and a lower surface, and the outer sealing layer defines a peripheral boundary with rounded corners; A substrate layer positioned directly beneath the outer sealing layer and fixed thereto by lamination, the substrate layer comprising a flexible sheet extending over the entire area of ​​the outer sealing layer; A plurality of conductive trace elements are arranged on the substrate layer, and the conductive trace elements include elongated conductive strips that are physically bonded to the substrate layer and extend between spaced positions; A central rigid island member is mounted on the substrate layer, the central rigid island member comprising a relatively thick and inflexible body fixed to the substrate layer and surrounded by a flexible region of the substrate layer; A plurality of electrode contact pads are arranged at intervals on the substrate layer, each electrode contact pad being mechanically connected to at least one of the conductive trace elements and having a conductive surface portion aligned with a corresponding opening formed in the outer sealing layer; At least one optical sensing assembly comprising a transparent window portion formed in the outer sealing layer and an optical element portion fixed on the substrate layer in alignment with the transparent window portion; An adhesive layer disposed on the lower surface of the substrate layer, the adhesive layer extending continuously over the entire substrate layer and forming a skin contact surface; Here, the outer sealing layer, the substrate layer, the conductive trace element, the central rigid island member, the electrode contact pad, the optical sensing assembly, and the adhesive layer are arranged in a stacked configuration and physically bonded to form an integrated stacked structure. Here, the conductive trace element extends continuously along the substrate layer between the central rigid island member and the plurality of electrode contact pads. A biosignal detection skin patch system characterized in that the adhesive layer comprises a pressure-sensitive adhesive sheet fully bonded to the substrate layer, a removable protective liner that peelably covers the adhesive layer before use, and the adhesive layer comprises a plurality of patterned recesses or non-adhesive areas aligned with the electrode contact pads and the optical sensing assembly to avoid obstruction of the corresponding functional areas.

2. The conductive trace element includes a serpentine conductive strip in which curved segments and straight segments are alternately formed, the serpentine conductive strip is positioned to extend between the central rigid island member and the electrode contact pad, and is configured to absorb relative displacement between the central rigid island member and the flexible portion around the substrate layer. Here, the substrate layer includes a plurality of localized thin-walled regions formed by mechanical thinning or material removal around the central rigid island member, and these thin-walled regions define a flexible hinge zone surrounding the central rigid island member. Hereinafter, the electrode contact pads consist of enlarged conductive plate portions having a planar contact surface, the electrode contact pads are surrounded by insulating boundary regions formed in the substrate layer to electrically insulate adjacent electrode contact pads, the electrode contact pads are arranged in a dispersed pattern along the longitudinal and transverse directions of the substrate layer, and the electrode contact pads are connected to the central rigid island member via dedicated conductive trace elements, characterized in that the biosignal detection skin patch system according to claim 1.