Wearable flex probe device for determining BIO-physical signals of a user

Abstract

The present invention discloses a wearable flex probe device for determining bio¬ physical signals of a user. The wearable flex probe device (100) for determining the one or more bio-physical signals of the user comprises a plurality of flexible layers (102, 104, 106, 108, 110, 112), one or more sensors (114), and a pair of electrical terminals (116). The plurality of flexible layers (102, 104, 106, 108, 110, 112) comprises at least one of: a hypoallergenic layer (102), a metal shield layer (104), a thermal conductivity layer (106), a substrate layer (108), a thermal insulation layer (110), and a reflective layer (112). The integration of the one or more sensors (114), the pair of electrical terminals (116), and the plurality of flexible layers (102, 104, 106, 108, 110, 112) provide real-time monitoring and insightful analysis of one or more physiological parameters of the user.

Description

[0001] WEARABLE FLEX PROBE DEVICE FOR DETERMINING BIOPHYSICAL SIGNALS OF A USER

[0002] EARLIEST PRIORITY DATE:

[0003] This Application claims priority from a Provisional patent application filed in India having Patent Application No. 202411012712, filed on February 22, 2024, and titled “WEARABLE FLEX PROBE DEVICE FOR DETERMINING BIO¬

[0004] PHYSICAL SIGNALS OF A USER”

[0005] FIELD OF INVENTION

[0006] Embodiments of the present invention relate to biomedical devices, and more particularly relate to a wearable flex probe device for determining one or more biophysical signals from a user for health monitoring purposes, with a specific emphasis on breast cancer detection.

[0007] BACKGROUND

[0008] The field of biomedical devices has witnessed remarkable advancements in recent years, driven by the increasing emphasis on preventive healthcare and early disease detection. Wearable health monitoring devices have emerged as pivotal tools in this landscape, offering non-intrusive and continuous monitoring of one or more biophysical signals. These one or more bio-physical signals, which encompass one or more physiological parameters such as heart rate, temperature, and respiratory rate, play a crucial role in assessing the health status of a user.

[0009] Wearable devices have gained popularity due to their potential to empower individuals with real-time insights into their well-being. They provide a bridge between traditional medical diagnostics and everyday life, offering continuous monitoring without disrupting daily activities. These wearable devices are particularly promising in the context of early disease detection, where timely identification of health anomalies can significantly improve treatment outcomes. In the realm of women's health, there exists a notable need for innovative solutions focused on breast cancer detection. Traditional screening methods often involve complex and uncomfortable procedures, limiting their accessibility and adoption. The wearable device designed specifically for obtaining the one or more biophysical signals with an emphasis on the breast cancer detection holds the promise of revolutionizing early screening processes, making them more accessible, user- friendly, and effective. However, the wearable device may not be comfortable for long-term use, leading to user discomfort and decreased adherence to monitoring routines. Moreover, existing wearable devices may have a standard design that does not adequately adapt to the diverse anatomies of individuals.

[0010] In the existing technology, a wearable device and pattern paper are disclosed. The wearable device includes one or more sensors positioned on both a front side and a backside of the wearable device. A single controller is responsible for controlling the one or more sensors. The boundary between the front side and the backside features first seamed portions and second seamless portions. Wires are present on both the front and back sides, running across the second seamless portions to electrically couple the one or more sensors to the controller. However, the wearable device have limited adaptability to different body anatomies. The fixed placement of the one or more sensors on both the front and back sides might not be optimal for conforming to diverse body shapes. The arrangement of wires across the seamless portions leads to a complex wiring structure. This complexity may hinder the flexibility and comfort of the wearable device, especially during body movements. The presence of wires running across seamless portions causes discomfort or irritation for the wearer, particularly during extended use. The fixed placement of the one or more sensors and the wiring configuration impact wearability, limiting the ability of the wearable device to seamlessly integrate with daily activities. Similarly, a method to generate an ultra-stretchable electrical and heat-conductive arrangement is disclosed. The method includes a wearable accessory capable of communicating data to actuators from the one or more sensors. The wearable accessory includes a conductor wire disposed in a moldable medium according to a predetermined pattern, the moldable medium being an electrically insulating material, the conductor wire terminating at an input and an output. The wearable accessory generates a stretchable conductor by using zigzag patterns via printing and a dissolvable filament into a moldable medium. The process of generating the ultra-stretchable conductor appears to involve multiple steps, including the use of printing and a dissolvable filament. This complexity may impact the scalability and practicality of the method. However, the wearable accessory does not provide information on the adaptability of the generated stretchable conductor to different types of wearable accessories or its compatibility with diverse materials and form factors.

[0011] There are various technical problems with the biomedical devices in the prior art. In the existing technology, the breast cancer detection is an expensive and uneasy process for the users. Ensuring the reliability and accuracy of the one or more biophysical signals captured by the one or more sensors is a critical challenge. Balancing the need for flexibility with durability is a technical challenge. The wearable devices are not flexible enough to conform to body movements and contours. Maintaining stable and reliable connections between the wearable device and a computing unit is challenging. Integrating the one or more sensors seamlessly within the wearable device is complex. Ensuring biocompatibility and hypoallergenic properties is also challenging, considering individual variations in skin sensitivity.

[0012] Therefore, there is a need for a device to address the aforementioned issues by providing a non-invasive, real-time monitoring of the one or more bio-physical signals, thereby extracting valuable insights into the one or more physiological parameters.

[0013] SUMMARY

[0014] This summary is provided to introduce a selection of concepts, in a simple manner, which is further described in the detailed description of the disclosure. This summary is neither intended to identify key or essential inventive concepts of the subject matter nor to determine the scope of the disclosure.

[0015] In order to overcome the above deficiencies of the prior art, the present disclosure is to solve the technical problem by providing a wearable flex probe device for determining one or more bio-physical signals of a user for health monitoring purposes, with a specific emphasis on breast cancer detection.

[0016] In accordance with an embodiment of the present disclosure, the wearable flex probe device for determining the one or more bio-physical signals of the user is provided. The wearable flex probe device comprises a plurality of flexible layers configured to adhere to a defined position of a skin of the user.

[0017] In an embodiment, the wearable flex probe device comprises one or more sensors detachably positioned on one of the flexible layers within the plurality of flexible layers. The one or more sensors are configured to generate the one or more biophysical signals by measuring the one or more physiological parameters of the skin of the user. The one or more sensors comprises electrocardiogram (ECG or EKG) sensors, electromyogram (EMG) sensors, electroencephalogram (EEG) sensors, photoplethysmography (PPG) sensors, accelerometers, thermistors, piezoelectric sensors, strain gauges, and bioimpedance electrodes. The one or more physiological parameters comprises a heart rate (HR), electrocardiogram (ECG or EKG), blood pressure (BP), respiratory rate (RR), body temperature, electromyogram (EMG), electroencephalogram (EEG), galvanic skin response (GSR), blood volume changes, motion, and activity levels. The one or more bio-physical signals comprise electrical signals, mechanical signals, thermal signals, and motion signals.

[0018] In an embodiment, the wearable flex probe device comprises a pair of electrical terminals operatively connected to the one or more sensors. The pair of electrical terminals are configured to provide the generated one or more bio-physical signals to a computing unit for determining the one or more bio-physical signals from the user.

[0019] In an embodiment, the plurality of flexible layers comprises at least one of: a hypoallergenic layer, a metal shield layer, a thermal conductivity layer, a substrate layer, a thermal insulation layer, and a reflective layer.

[0020] In an embodiment, the hypoallergenic layer is configured to provide a biocompatible interface by adhering to the skin of the user. The hypoallergenic layer is a double-sided adhesive layer with a thickness ranging between 10 microns and 50 microns. The hypoallergenic layer is selected for a group of layers that comprises a polyethylene layer with silicone adhesive, medical-grade polyurethane layer with acrylic adhesive, hydrocolloid layer, and silicone gel adhesive layer. The hypoallergenic layer is configured with one or more properties that comprises at least of a: hypoallergenic, latex-free, breathable, sterile, transparent, and waterproof.

[0021] In an embodiment, the metal shield layer is operatively positioned on the hypoallergenic layer. The metal shield layer is configured to provide shielding against an electromagnetic interference (EMI) and an electromagnetic compatibility (EMC) at a time of determining the one or more bio-physical signals. The metal shield layer is a single- sided adhesive layer with a thickness ranging between 20 microns and 30 microns. The metal shield layer is selected from a group of materials that comprises an aluminium, copper, nickel-coated polyester layer, tin-plated copper, silver-coated fabric, and graphite-infused conductive tape.

[0022] In an embodiment, the thermal conductivity layer is operatively positioned on the metal shield layer, The thermal conductivity layer is configured to maintain optimal operating temperatures by avoiding an electrical shorting from the metal shield layer. The thermal conductivity layer is configured with a thickness ranging between 150 microns and 200 microns.

[0023] In an embodiment, the substrate layer is operatively positioned on the thermal conductivity layer. The substrate layer is configured to provide a foundation for the one or more sensors placements. The substrate layer is configured with a pair of attachment pads for connecting the pair of electrical terminals by a flexible printed circuit board (PCB) technology. The substrate layer is a flexible polyethylene terephthalate (PET) layer. The substrate layer is configured with a thickness ranging between 120 microns and 200 microns. The substrate layer is configured with one or more apertures for detachably positioning the one or more sensors for obtaining the one or more bio-physical signals. The substrate layer and the one or more sensors are connected by a bonding process comprises at least one of: a soldering process, a chip bonding process, and the flexible printed circuit board (PCB) technology.

[0024] In an embodiment, the thermal insulation layer is operatively positioned on the substrate layer. The thermal insulation layer is configured to abate a heat dissipation to surroundings. The thermal insulation layer is made up of a flannel cloth with a thickness ranging between 120 microns and 200 microns. In an embodiment, the reflective layer is operatively positioned on the thermal insulation layer. The reflective layer is configured to avoid a radiant heat absorption from the surroundings.

[0025] In an embodiment, the plurality of flexible layers is placed on a stretchable fabric cloth. The stretchable fabric cloth is configured to adapt to diverse contours of the skin of the user for an optimised fit.

[0026] To further clarify the advantages and features of the present invention, a more particular description of the invention will follow by reference to specific embodiments thereof, which are illustrated in the appended figures. It is to be appreciated that these figures depict only typical embodiments of the invention and are therefore not to be considered limiting in scope. The invention will be described and explained with additional specificity and detail with the appended figures.

[0027] BRIEF DESCRIPTION OF THE DRAWINGS

[0028] The disclosure will be described and explained with additional specificity and detail with the accompanying figures in which:

[0029] FIG. 1A illustrates an exemplary schematic view of a wearable flex probe device for determining one or more bio-physical signals of a user, in accordance with an embodiment of the present disclosure;

[0030] FIG. IB illustrates an exemplary side view of the wearable flex probe device for determining the one or more bio-physical signals of the user, in accordance with an embodiment of the present disclosure; and FIG. 1C illustrates an exemplary isometric view of the wearable flex probe device for determining the one or more bio-physical signals of the user, in accordance with an embodiment of the present disclosure.

[0031] Further, those skilled in the art will appreciate that elements in the figures are illustrated for simplicity and may not have necessarily been drawn to scale. Furthermore, in terms of the method steps, chemical compounds, equipments and parameters used herein may have been represented in the figures by conventional symbols, and the figures may show only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the figures with details that will be readily apparent to those skilled in the art having the benefit of the description herein.

[0032] DETAILED DESCRIPTION OF THE PRESENT INVENTION

[0033] For the purpose of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiment illustrated in the figures and specific language will be used to describe them. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended. Such alterations and further modifications in the illustrated system, and such further applications of the principles of the disclosure as would normally occur to those skilled in the art are to be construed as being within the scope of the present disclosure.

[0034] The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such a process or method. Similarly, one or more components, compounds, and ingredients preceded by "comprises... a" does not, without more constraints, preclude the existence of other components or compounds or ingredients or additional components. Appearances of the phrase "in an embodiment", "in another embodiment" and similar language throughout this specification may, but not necessarily do, all refer to the same embodiment.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. The system, methods, and examples provided herein are only illustrative and not intended to be limiting.

[0036] In the following specification and the claims, reference will be made to a number of terms, which shall be defined to have the following meanings. The singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise.

[0037] Embodiments of the present disclosure relate to a wearable flex probe device for determining one or more bio-physical signals of a user for health monitoring purposes, with a specific emphasis on breast cancer detection.

[0038] FIG. 1A refers to an exemplary schematic view of the wearable flex probe device 100 for determining the one or more bio-physical signals of the user, in accordance with an embodiment of the present disclosure;

[0039] FIG. IB refers to an exemplary side view of the wearable flex probe device 100 for determining the one or more bio-physical signals of the user, in accordance with an embodiment of the present disclosure; and FIG. 1C refers to an exemplary isometric view of the wearable flex probe device 100 for determining the one or more bio-physical signals of the user, in accordance with an embodiment of the present disclosure.

[0040] According to an embodiment of the present disclosure, the wearable flex probe device 100 for determining the one or more bio-physical signals of the user comprises a plurality of flexible layers (102, 104, 106, 108, 110, 112), one or more sensors 114, and a pair of electrical terminals 116.

[0041] In an exemplary embodiment, the plurality of flexible layers (102, 104, 106, 108, 110, 112) comprises at least one of: a hypoallergenic layer 102, a metal shield layer 104, a thermal conductivity layer 106, a substrate layer 108, a thermal insulation layer 110, a reflective layer 112, and the like. The plurality of flexible layers (102, 104, 106, 108, 110, 112) is configured to cling to a defined position of a skin of the user. The plurality of flexible layers (102, 104, 106, 108, 110, 112) collectively contributes to a versatile and responsive interface that enhances the user experience while maintaining a secure and unobtrusive connection to the skin of the user. The diameter of each flexible layer (102, 104, 106, 108, 110, 112) of the plurality of flexible layers (102, 104, 106, 108, 110, 112) is, but not limited to, 7 millimetres. In another exemplary embodiment, the diameter of each flexible layer (102, 104, 106, 108, 110, 112) of the plurality of flexible layers (102, 104, 106, 108, 110, 112) is altered based on the application and the specific requirements of the user. The adaptability of the diameter may be designed to the intended use and the unique anatomical features of the user. In this way, the wearable flex probe device is tailored for diverse applications, ensuring a comfortable and effective fit for a variety of users and health monitoring scenarios.

[0042] In an exemplary embodiment, the hypoallergenic layer 102 is configured to provide a biocompatible interface, thereby ensuring the skin adherence while minimizing the risk of allergic reactions for the user. The hypoallergenic layer 102 functions as a double- sided adhesive layer. An optimal thickness of the hypoallergenic layer 102 ranges between, but not limited to, 10 microns and 50 microns, thereby striking a balance between flexibility and stability. The hypoallergenic layer 102 is selected for a group of layers that may include, but not limited, at least one of a: polyethylene layer with silicone adhesive, medical-grade polyurethane layer with acrylic adhesive, hydrocolloid layer, silicone gel adhesive layer, and the like. The hypoallergenic layer 102 is configured with one or more properties that may include, but not limited to, at least one of a: hypoallergenic, latex-free, breathable, sterile, transparent, waterproof, and the like. The hypoallergenic layer 102 also provides a shield against external contaminants.

[0043] In an exemplary embodiment, the metal shield layer 104 is strategically positioned on the hypoallergenic layer 102, forming an integral part of the configuration. The metal shield layer 104 is designed to counteract electromagnetic interference (EMI) and ensure electromagnetic compatibility (EMC) during the determination of the one or more bio-physical signals. The metal shield layer 104 acts as a protective barrier against external electromagnetic influences. The metal shield layer 104 functions as a single-sided adhesive layer with the optimal thickness ranging between 20 microns and 30 microns. This carefully calibrated optimal thickness allows the metal shield layer 104 to effectively shield against the EMI and the EMC without compromising the overall flexibility and adherence of the wearable flex probe device 100 to the skin of the user. The metal shield layer 104 is selected from a group of materials that may include, but not limited to, at least one of a: aluminium, copper, nickel-coated polyester layer, tin-plated copper, silver-coated fabric, graphite-infused conductive tape, and the like. The metal shield layer 104 also serves the additional function of providing metal conductivity, thereby enhancing the efficiency of electrical signal transmission and reception within the wearable flex probe device 100. In an exemplary embodiment, the thermal conductivity layer 106 is strategically placed on top of the metal shield layer 104. Tailored for optimal performance, the thermal conductivity layer 106 is configured to prevent electrical shorting originating from the metal shield layer 104 and to ensure the maintenance of optimal operating temperatures. The thermal conductivity layer 106 possesses the thickness ranging between 150 microns and 200 microns, effectively dissipating heat generated during the operation of the wearable flex probe device 100. By mitigating the risk of electrical shorting and promoting efficient heat dissipation, the thermal conductivity layer 106 contributes to the overall stability and reliability of the wearable flex probe device 100.

[0044] In an exemplary embodiment, the substrate layer 108 is strategically positioned above the thermal conductivity layer 106. The primary purpose of the substrate layer 108 is to establish a stable foundation for the placement of the one or more sensors 114, crucial for the acquisition of the one or more bio-physical signals. The substrate layer 108 is configured with a pair of attachment pads employing a flexible printed circuit board (PCB) technology for facilitating the connection of the pair of electrical terminals 116. Moreover, the substrate layer 108 incorporates one or more apertures, strategically positioned to allow the detachable placement of the one or more sensors 114. This feature enhances versatility by accommodating the various one or more sensor 114 configurations, thereby optimizing the wearable flex probe device 100 for the precise capture of the one or more bio-physical signals while maintaining a flexible and resilient structure. The substrate layer 108 and the one or more sensors 114 are connected by a bonding process comprises at least one of: a soldering process, a chip bonding process, and the flexible printed circuit board (PCB) technology.

[0045] In essence, the substrate layer 108 plays a pivotal role in establishing the groundwork for the one or more sensors 114 integration and connectivity, offering a versatile platform for obtaining the accurate one or more bio-physical signals. The substrate layer 108 is configured with the thickness ranging between 120 microns and 200 microns. In an exemplary embodiment, the substrate layer 108 is constructed from at least one of: flexible polyethylene terephthalate (PET), polyimide (PI), rigid-flex substrate, fiberglass -reinforced epoxy (FR-4), polyester, ceramic substrate, and the like.

[0046] In an exemplary embodiment, the thermal insulation layer 110 is operatively positioned on the substrate layer 108. The thermal insulation layer 110 plays a crucial role in minimizing heat dissipation to the surroundings. The thermal insulation layer 110 is configured to act as a thermal barrier with the thickness ranging between 120 microns and 200 microns. In an exemplary embodiment, the thermal insulation layer 110 is constructed from at least one of: fiberglass insulation, foam insulation, reflective foil insulation, flannel cloth, and the like.

[0047] In an exemplary embodiment, the reflective layer 112 is operatively positioned on the thermal insulation layer 110. The reflective layer 112 is designed to prevent the absorption of a radiant heat from the surroundings. The reflective layer 112 acts as a barrier, redirecting and reflecting the radiant heat away from the wearable flex probe device 100. Henceforth, the reflective layer 112 assists in maintaining a cooler temperature within the wearable flex probe device 100, thereby contributing to efficient heat management and preventing the unwanted absorption of the external radiant heat.

[0048] In an exemplary embodiment, the plurality of flexible layers (102, 104, 106, 108, 110, 112) is strategically positioned on a stretchable fabric cloth 118. The stretchable fabric cloth 118 is meticulously configured to conform to diverse contours of the skin of the user, thereby ensuring an optimised and snug fit. The inherent elasticity of the stretchable fabric cloth 118 allows the stretchable fabric cloth 118 to adapt seamlessly to the varying curves and movements of the skin, thereby providing flexibility and enhancing the user's comfort. This design of the wearable flex probe device 100 maintains a close and adaptable connection with the skin of the user.

[0049] In an exemplary embodiment, the one or more sensors 114 are strategically and detachably positioned on the flexible layer (102, 104, 106, 108, 110, 112) within the plurality of flexible layers (102, 104, 106, 108, 110, 112). In an embodiment, the flexible layer (102, 104, 106, 108, 110, 112) within the plurality of flexible layers (102, 104, 106, 108, 110, 112) is the substrate layer 108. The one or more sensors 114 are strategically and detachably positioned by at least one of: a soldering method and a bonding method. The one or more sensors 114 are designed to measure one or more physiological parameters of the user's skin, thereby enabling the generation of the one or more bio-physical signals. By capturing essential data related to skin characteristics and physiological responses, the one or more sensors 114 play a crucial role in the functionality of the wearable flex probe device 100. The wearable flex probe device 100 facilitates real-time monitoring and analysis of the health of the user and performance metrics in a non-intrusive and adaptable manner.

[0050] In an exemplary embodiment, the one or more sensors 114 that may include, but not limited to, at least one of: electrocardiogram (ECG or EKG) sensors, electromyogram (EMG) sensors, electroencephalogram (EEG) sensors, photoplethysmography (PPG) sensors, accelerometers, thermistors, piezoelectric sensors, strain gauges, bioimpedance electrodes, and the like. The one or more physiological parameters that may include, but not limited to, at least one of a: a heart rate (HR), electrocardiogram (ECG or EKG), blood pressure (BP), respiratory rate (RR), body temperature, electromyogram (EMG), electroencephalogram (EEG), galvanic skin response (GSR), blood volume changes, motion, activity levels, and the like. The one or more bio-physical signals may include, but not limited to, at least one of a: electrical signals, mechanical signals, thermal signals, motion signals, and the like.

[0051] In an exemplary embodiment, the pair of electrical terminals 116 establishes operational connections with the one or more sensors 114 integrated into the plurality of flexible layers (102, 104, 106, 108, 110, 112). The pair of electrical terminals 116 is configured to transmit the generated one or more bio-physical signals from the one or more sensors 114 to a computing unit (not shown in figures). Subsequently, the computing unit processes and analyses the received one or more bio-physical signals, enabling the determination of bio-physical information of the user. This integration of the one or more sensors 114, the pair of electrical terminals 116, the computing unit, and the plurality of flexible layers (102, 104, 106, 108, 110, 112) underscore the comprehensive functionality of the wearable flex probe device 100, thereby allowing for real-time monitoring and insightful analysis of the user's one or more physiological parameters.

[0052] In an exemplary embodiment, the computing unit is an electronic data acquisition device that may include, but not limited to, at least one of: a mobile device, a smartphone, a personal digital assistant (PDA), a tablet computer, a phablet computer, a wearable computing device, a laptop, a desktop, and the like. The pair of electrical terminals 116 within the wearable flex probe device 100 may establish connections through at least one of a: wired connection and wireless connection, thereby offering flexibility in data transmission options based on user preferences and application requirements.

[0053] In an exemplary embodiment, extensive testing is undertaken to ensure the functionality of the wearable flex probe device 100 and demonstrate a reliable performance. The validation of the wearable flex probe device 100 is carried out employing the black stack thermometer readout, a reference thermometer equipped with accredited calibration. The black stack thermometer readout is an automated calibration system reading both the reference probe and the one or more sensors 114 under examination. The black stack thermometer readout is also referred to as a high-precision data acquisition system.

[0054] Numerous advantages of the present disclosure may be apparent from the discussion above. In accordance with the present disclosure, the wearable flex probe device for determining the one or more bio-physical signals of the user is provided. The wearable flex probe device is a breast-conforming structure that seamlessly shapes itself around the breast without exerting pressure and requiring force-fit, thereby ensuring optimal comfort to the user. The one or more sensors are versatile, allowing effortless interchangeability with various wearables. The layered architecture enhances speed and reliability in acquiring the one or more biophysical signals from the skin of the user, thereby promoting maximum contact with more than 32 sensors. The innovative employment of the pair of electrical terminals for connectivity is devoid of the requirement of complex routing strategies adapted in the PCB technology. Henceforth, the wearable flex probe device provides flexibility and accommodates a greater number of the pair of electrical terminals due to the thermal insulation layer.

[0055] The wearable flex probe device enables easy non-invasive acquisition of the one or more bio-physical signals, thereby providing compatibility with the various computing units for analogue signal reading. The wearable flex probe device is radiation-free and devoid of radiative components. The wearable flex probe device maintains the bio-physical signal integrity even during stretching. The battery-free passive wearable flex probe device with the stretchable fabric cloth and the one or more sensors provides a comfortable and efficient solution for cancer screening. The wearable flex probe device provides early disease diagnosis for a breast cancer. While specific language has been used to describe the invention, any limitations arising on account of the same are not intended. As would be apparent to a person skilled in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.

[0056] The figures and the foregoing 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, order of processes described herein may be changed and are not limited to the manner described herein. Moreover, the actions of any flow diagram need not be implemented in the order shown; nor do all of the acts need to be necessarily performed. Also, those acts that are not dependent on other acts may be performed in parallel with the other acts. The scope of embodiments is by no means limited by these specific examples.

Claims

1 / We claim:

1. A wearable flex probe device (100) for determining one or more bio-physical signals of a user, comprising: a plurality of flexible layers (102, 104, 106, 108, 110, 112) configured to adhere to a defined position of a skin of the user; one or more sensors (114) detachably positioned on one of the flexible layers within the plurality of flexible layers (102, 104, 106, 108, 110, 112), configured to generate the one or more bio-physical signals by measuring one or more physiological parameters of the skin of the user; and a pair of electrical terminals (116) operatively connected to the one or more sensors (114), configured to provide the generated one or more bio-physical signals to a computing unit for determining the one or more bio-physical signals from the user.

2. The wearable flex probe device (100) as claimed in claim 1, wherein the plurality of flexible layers (102, 104, 106, 108, 110, 112) comprises at least one of: a hypoallergenic layer (102) configured to provide a biocompatible interface by adhering to the skin of the user; a metal shield layer (104) operatively positioned on the hypoallergenic layer (102), configured to provide shielding against an electromagnetic interference (EMI) and an electromagnetic compatibility (EMC) at a time of determining the one or more bio-physical signals; a thermal conductivity layer (106) operatively positioned on the metal shield layer (104), configured to maintain optimal operating temperatures by avoiding an electrical shorting from the metal shield layer (104); a substrate layer (108) operatively positioned on the thermal conductivity layer (106), configured to provide a foundation for the one or more sensors (114) placements;a thermal insulation layer (110) operatively positioned on the substrate layer (108), configured to abate a heat dissipation to surroundings; and a reflective layer (112) operatively positioned on the thermal insulation layer (110), configured to avoid a radiant heat absorption from the surroundings.

3. The wearable flex probe device (100) as claimed in claim 2, wherein the hypoallergenic layer (102) is a double-sided adhesive layer with a thickness ranging between 10 microns and 50 microns, the hypoallergenic layer (102) is selected for a group of layers comprises a polyethylene layer with silicone adhesive, medical-grade polyurethane layer with acrylic adhesive, hydrocolloid layer, and silicone gel adhesive layer, the hypoallergenic layer (102) is configured with one or more properties comprises at least of a: hypoallergenic, latex-free, breathable, sterile, transparent, and waterproof.

4. The wearable flex probe device (100) as claimed in claim 2, wherein the metal shield layer (104) is a single-sided adhesive layer with a thickness ranging between 20 microns and 30 microns, the metal shield layer (104) is selected from a group of materials comprises an aluminium, copper, nickel-coated polyester layer, tin-plated copper, silver- coated fabric, and graphite-infused conductive tape.

5. The wearable flex probe device (100) as claimed in claim 2, wherein the thermal conductivity layer (106) configured with a thickness ranging between 150 microns and 200 microns.

6. The wearable flex probe device (100) as claimed in claim 2, wherein the substrate layer (108) configured with a pair of attachment pads for connecting the pair of electrical terminals (116) by a flexible printed circuit board (PCB) technology,the substrate layer (108) is a flexible polyethylene terephthalate (PET) layer configured with a thickness ranging between 120 microns and 200 microns, the substrate layer (108) and the one or more sensors (114) are connected by a bonding process comprises at least one of: a soldering process, a chip bonding process, and the flexible printed circuit board (PCB) technology.

7. The wearable flex probe device (100) as claimed in claim 2, wherein the substrate layer (108) is configured with one or more apertures for detachably positioning the one or more sensors (114) for obtaining the one or more biophysical signals.

8. The wearable flex probe device (100) as claimed in claim 2, wherein the thermal insulation layer (110) is made up of a flannel cloth with a thickness ranging between 120 microns and 200 microns.

9. The wearable flex probe device (100) as claimed in claim 1, wherein the plurality of flexible layers (102, 104, 106, 108, 110, 112) placed on a stretchable fabric cloth (118), the stretchable fabric cloth (118) is configured to adapt to diverse contours of the skin of the user for an optimised fit.

10. The wearable flex probe device (100) as claimed in claim 1, wherein the one or more sensors (114) comprises electrocardiogram (ECG or EKG) sensors, electromyogram (EMG) sensors, electroencephalogram (EEG) sensors, photoplethysmography (PPG) sensors, accelerometers, thermistors, piezoelectric sensors, strain gauges, and bioimpedance electrodes.

11. The wearable flex probe device (100) as claimed in claim 1, wherein the one or more physiological parameters comprises a heart rate (HR), electrocardiogram (ECG or EKG), blood pressure (BP), respiratory rate (RR), body temperature, electromyogram (EMG), electroencephalogram (EEG), galvanic skin response (GSR), blood volume changes, motion, and activity levels.

2. The wearable flex probe device (100) as claimed in claim 1, wherein the one or more bio-physical signals comprise electrical signals, mechanical signals, thermal signals, and motion signals.

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