Method for monitoring and collecting physiological data using a flexible patch device

Abstract

The present invention discloses a method for monitoring and collecting physiological data using a flexible patch device. The method comprises a step of providing a flexible patch device comprising: a flexible patch comprising a first layer configured to be attachable to skin of a user, a plurality of electrode plates embedded on the first layer to provide conformal contact with the skin of the user, and an electronic package disposed within the patch is in electrical contact with the electrode plates. The method further comprises the step of applying the flexible patch device to the user to establish a direct contact with a skin surface of the user, and collecting physiological data of the user.

Description

METHOD FOR MONITORING AND COLLECTING PHYSIOLOGICALDATA USING A FLEXIBLE PATCH DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Application Serial No. 63 / 653,671, entitled “METHOD FOR MONITORING AND COLLECTING PHYSIOLOGICAL DATA USING A FLEXIBLE PATCH DEVICE” filed May 30, 2024, the contents of which are incorporated herein by reference in their entirety.TECHNICAL FIELD

[0002] The present disclosure relates generally to a physiological monitoring system and method, and more particularly, a method for monitoring and collecting physiological data using a flexible patch device.BACKGROUND

[0003] Traditional methods for remotely monitoring physiological parameters of individuals often involve the use of cumbersome sensors and wires, which may limit the effectiveness of measuring active individuals. These conventional approaches may rely on wired connections between sensors and monitoring equipment, which may restrict movement and impede the user’s mobility.

[0004] Moreover, even with the advent of wireless communication solutions, some wireless monitoring systems still incorporate external wires, which could become easily tangled and cumbersome. Additionally, bulky electronic packages associated with these systems may contribute to discomfort and difficulty for the user, particularlyduring prolonged wear or physical activity.

[0005] Further, recent advancements in wearable technology have led to the development of wearable devices configured to measure and monitor signals indicative of electrical activities of the user’s heart, such as ECG signals. However, existing devices still face challenges related to signal fidelity, durability, and adherence to the skin, particularly in applications requiring robust and reliable signal acquisition over extended periods.

[0006] Therefore, there is a need for a flexible patch device that enables direct-to- skin contact, optimizing signal capture from underlying muscle fibers and ensuring reliable signal transmission. Further, the device needs to seamlessly integrate with advanced physiological monitoring systems capable of capturing multiple physiological signals, such as electromyography (EMG), electroencephalography (EEG), and electrocardiography (ECG). Further, there a need for a method for monitoring and collecting physiological data using the flexible patch device.SUMMARY OF THE INVENTION

[0007] The present invention discloses a method for monitoring and collecting physiological data using a flexible monitoring device that adheres to the skin of a subject. The method comprises a step of providing a flexible monitoring device comprising: a flexible patch comprising a first layer configured to be attachable to the skin of a user, a plurality of electrode plates embedded on the first layer to provide conformal contact with the skin of the user, and an electronic package disposed within the patch configured in electrical contact with the electrode plates. The method further comprises the step of applying the flexible patch device to the user to establish a direct contact with the skin surface of the user and collecting physiological data of the user.

[0008] In one embodiment, the present invention provides for systems and methods for medical monitoring of physiological signals and parameters and, more particularly, to wearable devices with integrated sensors for at least one physiological input of electromyogram (EMG), electroencephalogram (EEG), body temperature, heart rate, pedometer, blood pressure, pulse oximetry, respiratory rate, posture / body orientation, and sleep monitoring. In another embodiment, the flexible patch device is a physiological signal monitoring system comprising physiological input of at least one of electroencephalogram (EEG) signal, electromyography (EMG) signal, electrooculography (EOG) signal, and electrocardiogram (ECG) signals, and related systems and methods.

[0009] An embodiment of the invention, as shown and described by the various figures and accompanying text, provides a device, system, and / or method capable of advantageously harvesting and monitoring a plurality of physiological signals. This device may be used in a formal medical setting (medically prescribed form), or as an over-the-counter (OTC) device available for commercial sale to the public for those interested in general health and fitness.

[0010] In one embodiment, the patch device comprises a second layer opposite to the first layer and an internal portion formed between the first layer and the second layer. Further, the electronic package comprises a first printed circuit board comprising the microcontroller and a second printed circuit board comprising a digital assembly disposed at the internal portion. The first printed circuit board and the second printed circuit board are connected via a digital connector. In one embodiment, the connector is a ribbon connector. In one embodiment, the connector configured to have flexibility such that it does not induce upward tension on the first and second printed circuit board that would cause disengagement from the skin. In one embodiment, the connector and the first and second printed circuit board are sections of a single, hybrid printed circuit board. In one embodiment, the hybrid printed circuit board is a rigid-flex printed circuit board. In one embodiment, the connector within the rigid-flex printed circuit board provides flexibility between the first and second printed circuit board sections of the rigid-flex printed circuit board.

[0011] In one embodiment, the first printed circuit board is a flexible printed circuit board. The first printed circuit board is configured to conform to a curvature of a body part of the user (a wearer of the device). In one embodiment, the first and second printed circuit boards are coated with a biocompatible conformal coating.

[0012] The first printed circuit board comprises a plurality of electronic components. The electronic components are arranged at a side of the first print circuit board adjacent to the second layer to ensure unobstructed contact of the electrode plates disposed at the first layer with the user. The digital assembly comprises at least one battery. In one embodiment, the battery is a lithium-ion battery. The digital assembly further comprises a user interface module. The user interface module includes one or more LED indicators and a push button. The digital assembly further comprises a programming port.

[0013] The above summary contains simplifications, generalizations and omissions of detail and is not intended as a comprehensive description of the claimed subject matter but, rather, is intended to provide a brief overview of some of the functionality associated therewith. Other systems, methods, functionality, features and advantages of the claimed subject matter will be or will become apparent to one with skill in the art upon examination of the following figures and detailed written description.

[0014] Various objects and advantages of the present invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings submitted herewith constitute a part of this specification, including exemplary embodiments of the present invention, and illustrate various objects and features thereof.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] FIG. 1 exemplarily illustrates a patch device applied to a neck of a user, according to an embodiment of the present invention.

[0016] FIG. 2 exemplarily illustrates a patch device applied to a forearm of a user, according to an embodiment of the present invention.

[0017] FIG. 3 exemplarily illustrates a perspective view of a patch device with a cover, according to an embodiment of the present invention.

[0018] FIG. 4 exemplarily illustrates the skin side of the patch device without a cover and exposing conductive targets, according to an embodiment of the present invention.

[0019] FIG. 5 exemplarily illustrates a perspective of printed circuit boards of the patch device embedded into a first layer of a flexible patch, according to an embodiment of the present invention.

[0020] FIG. 6 exemplarily illustrates a top view of the printed circuit boards of the patch device embedded into a first layer of a flexible patch, according to an embodiment of the present invention.

[0021] FIG. 7 exemplarily illustrates a rear view of the printed circuit boards of the patch device , according to an embodiment of the present invention.DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS

[0022] Example embodiments of the disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which example embodiments are shown. The concepts discussed herein may, however, be embodied in many different forms and should not be construed as limited to the example embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope to those of ordinary skill in the art. Like numbers refer to like elements but not necessarily the same or identical elements throughout.

[0023] Referring to FIG. 1 and FIG. 2, the flexible patch device 100 for monitoring physiological data of a user. In some embodiments, the user may be a patient or other subject to be monitored. The device 100 is configured to be bendable and conform comfortably to various body shapes and movements of the user. The device 100 is configured to collect to physiological data. Further, the device 100 could be used in various applications including, but not limited to, electroencephalogram (EEG), electromyography (EMG), electrooculography (EOG), electrocardiogram (ECG), body temperature, heart rate, pedometer, blood pressure, pulse oximetry, respiratory rate, posture / body orientation, and sleep monitoring. In another embodiment, the flexible patch device 100 monitors at least one of electroencephalogram (EEG) signal, electromyography (EMG) signal, electrooculography (EOG) signal, and electrocardiogram (ECG) signal.

[0024] The potential users of the apparatus (and related methodologies) of the present invention include individual consumers and / or patients, with a view to improving nonmedical indications and medical indications. The non-medical indications include, but are not limited to, sports performance and endurance, including addressing fatigue, alertness and motor skill development. The non-medical indications may further include, but again are not limited to, improving cognitive performance, such as learning,reading, attention or multitasking, weight loss and jet lag, as well as mindfulness.

[0025] Referring to FIG. 1 to FIG. 4, the device 100 comprises a flexible patch 102 comprising a first layer 104 configured to be attachable to the skin of a user, and a plurality of electrode plates 120 embedded on the first layer 104 to provide conformal contact with the skin of the user. In one embodiment, the patch 102 comprises at least three electrode plates 120. The patch 102 further comprises a second layer 124 disposed opposite to the first layer 104.

[0026] The terms “flexible” and “bendable” are used synonymously in the present description and refer to the ability of a material, structure, device or device component to be deformed into a curved or bent shape without undergoing a transformation that introduces significant strain, such as strain characterizing the failure point of a material, structure, device or device component. In an exemplary embodiment, a flexible material, structure, device or device component may be deformed into a curved shape without introducing strain larger than or equal to 5%, for some applications larger than or equal to 1%, and for yet other applications larger than or equal to 0.5% in strain-sensitive regions. As used herein, some, but not necessarily all, flexible structures are also stretchable. A variety of properties provide flexible structures (e.g., device components) of the invention, including materials properties such as a low modulus, bending stiffness and flexural rigidity; physical dimensions such as small average thickness and device geometries such as thin film and mesh geometries.

[0027] As used herein, the term “conformable” refers to a device, material or substrate which has a bending stiffness that is sufficiently low to allow the device, material or substrate to adopt any desired contour profile, for example a contourprofile allowing for conformal contact with a curvilinear surface, including a surface whose shape may change over time, such as with physical exertion or normal everyday movement, such as skin.

[0028] As used herein, the term “conformal contact” refers to contact established between a device and a receiving surface. In one aspect, conformal contact involves a macroscopic adaptation of one or more surfaces (e.g., contact surfaces) of a device to the overall shape of a surface. In another aspect, conformal contact involves a microscopic adaptation of one or more surfaces (e.g., contact surfaces) of a device to a surface resulting in an intimate contact substantially free of voids. In an embodiment, conformal contact involves adaptation of a contact surface(s) of the device to a receiving surface(s) such that intimate contact is achieved, for example, wherein less than 20% of the surface area of a contact surface of the device does not physically contact the receiving surface, or optionally less than 10% of a contact surface of the device does not physically contact the receiving surface, or optionally less than 5% of a contact surface of the device does not physically contact the receiving surface. Devices of certain aspects are capable of establishing conformal contact with skin tissue. Devices of certain aspects are capable of establishing conformal contact with skin surfaces characterized by a range of surface morphologies including planar, curved, contoured, macro-featured and micro-featured surfaces and any combination of these.

[0029] In one or more embodiments, the first layer 104 comprises an adhesive layer (not shown) to attach to the skin of the user. Examples of suitable materials for the adhesive layer include any suitable biocompatible adhesive that is designed to be removably affixed to a person's skin. Examples of suitable materials for the first layer 104 include polymers including, but not limited to silicone, silicone rubber, naturalrubber, poly cis-isoprene, polyisobutylene, chloroprene, cis-polybutadiene, styrenebutadiene, styrene-acrylonitrile-butadiene, polyurethane, EPDM, EVA polymers, and perfluoropolymers. Such polymers can be modified to produce conductive versions of the polymers by infusing them with conductive particles, such as, for example, metal particles or carbon particles. Carbon particles may include, for example, carbon flakes, carbon granules, carbon fibers, carbon black powder, graphite powder, carbon nanotubes, carbon nanowires, and the like. In one embodiment, the first layer 104 comprises a type of surgical tape such as 3M™ Micropore™ Surgical Tape, 1530 Series.

[0030] The patch 102 further comprises a cover 106 disposed over the adhesive layer. The cover 106 could be removed to expose portions of one or more conductive targets connected to the electrodes 120. The portion 108 refers to a portion of the one or more conductive targets that connect to electrode plate 120. The portion 110 refers to a portion of the one or more conductive targets that connect a skin surface of a user to electrode plate 120.

[0031] Examples of suitable materials for one or more conductive targets 110 include, but are not limited to, the OMNI-WAVE™ adhesive compositions manufactured and sold by FLEXcon® (Spencer, MA, USA), such as the developmental product FLX068983-FLEXcon® OMNI-WAVE™ TT 200 BLACK H-502 150 POLY H-9 44PP-8; and the adhesives from ADHESIVE RESEARCH, such as ARcare® 8006 electrically conductive adhesive composition manufactured and sold by Adhesives Research, Inc. (Glen Rock, PA, USA). Alternatively, Electrically Conductive Adhesive Transfer Tape 9712 or Electrically Conductive Adhesive Transfer Tape 9713(both manufactured by 3M, Saint Paul, MN, USA) may also be used. Note that the one or more conductive targets 110 depicted in the FIG. 4 example may be replaced with a layer of conductive gel (e g. a conductive hydrogel).

[0032] Referring to FIG. 1 to FIG. 7, the patch 102 further comprises an interiorportion defined between the first layer 104 (inner, skin-side layer) and the second layer 124 (outer facing layer). The patch 102 further comprises a first printed circuit board (PCB) 112 and a second printed circuit board 114. The first printed circuit board 112 and the second printed circuit board 114 are disposed within the interior portion of the patch 102. The first printed circuit board 112 and the second printed circuit board 114 also referred as second PCB (112, 114).Note that as used herein, the term “PCB” refers to a printed circuit board, and this term encompasses rigid PCBs (e.g., with copper traces on a rigid epoxy board), flex circuits (e.g., with copper traces on a flexible polyimide substrate), and printed circuits made by printing a conductive ink on a flexible substrate.

[0033] The first PCB 112 and the second PCB 114 are connected via a connector 116. In one embodiment, the connector 116 is a flexible connector configured to relieve torque applied to the first PCB 112 and the second PCB 114 whenever the flexible patch 102 is attached to a skin surface of a user. This relief of torque (or tension) prevents the flexible patch 102 (particularly the first PCB 112 and the second PCB 114 portions) from being peeled away from the skin surface of a user during active use such that contact is at least partially broken. In one or more embodiments, first PCB 112 is a flexible circuit board. The first PCB 112 has the flexibility to conform to the curvature of a body part for example, a shoulder and the biceps. The first PCB 112 comprises a plurality of electronic components. The electronic components are arranged at a side of the first PCB 112 that is in contact with the second layer 124. The first PCB 112 does not have any electronic components at a side adjacent to the first layer 104 or electrode plates 120. This configuration ensures that the plurality of electrode plates 120 could make unobstructed contact with the adhesive electrode targets of the patch 102. In one or more embodiments, PCB 112 includes two or more electrode plates 120. In another embodiment, PCB 112 includes at least 1, 2, 3, 4 or more electrode plates 120. The electrode material and electrode plates 120 are biocompatible. In one or more embodiments, nonconductive sections 113 of the PCB 112 are interspersed between the one or more electrode plates 120. The second PCB 114 comprises a battery 118, auser interface module and a programming port at portion 122.

[0034] In one embodiment, the first printed circuit board 112 and the second printed circuit board 114 are connected by a flexible connector 116 configured to have flexibility such that it does not induce upward tension on the first and second printed circuit board that would cause disengagement from the skin. In one or more embodiments, the connector 116 and the first and second printed circuit board (112, 114) are sections of a single, hybrid printed circuit board 130. In one embodiment, the hybrid printed circuit board 130 is a rigid-flex printed circuit board. In one embodiment, the connector portion within the rigid-flex printed circuit board 130 provides flexibility between the first and second printed circuit board sections of the rigid-flex printed circuit board.

[0035] In one embodiment, the circuit assembly 130 may be a circuit board such as a flexible printed circuit (FPC) or a rigid-flex board. Examples of the circuit board 130 include a single layer PCB, double layer PCB, multi-layer PCB, rigid PCB, flex PCB, or rigid-flex PCB. In one embodiment, the flexible circuit includes both rigid sections and flexible sections. Thus, the flexible circuit may also be referred to as a rigid-flex circuit. The rigid sections may be reinforced and are configured not to bend or flex to any significant degree. In one embodiment, the connector 116 is configured to have flexibility such that it does not induce upward tension on the first and second printed circuit board (112, 114) that would cause disengagement from the skin. In one embodiment, the connector 116 and the first and second printed circuit board (112, 114) are sections of a single, hybrid printed circuit board 130. In one embodiment, the hybrid printed circuit board is a rigid-flex printed circuit board. In one embodiment, the connector within the rigid-flex printed circuit board provides flexibility between the first and second printed circuit board sections of the rigid-flex printed circuit board.

[0036] In general, a rigid-flex printed circuit boards (such as Rigid-Flex by FlexibleCircuit Technologies, Minneapolis, MN) is a printed circuit board (PCB) comprised of a flexible circuit board and a rigid circuit board, which has both flexibility of the flexible circuit board and strength of the rigid circuit board. Under circumstances that internal space of electronic products is rapidly reduced, the rigid-flex board provides the maximum flexibility in component connection and assembly space. Thus, rigid-flex boards are often adopted as carriers for components in electronic products. Additional advantages of rigid-flex printed circuit boards are dynamic and mechanical stability, the resulting 3-dimensional freedom of design, simplified installation, space savings, and maintenance of uniform electrical characteristics. In one embodiment, each polymer layer of the device 100 is formed of polyimides, polyurethane, polyethylene, and / or silicone. For making such boards, a number of standardized materials have come into use in the field, including among other things, insulating film material such as the polyimide film sold under the trademark KAPTON acrylic adhesive used for bonding the film to portions of a board, special copper clad KAPTON film or epoxy glass sheets used for forming circuit layers, where the copper is typically a rolled beryllium copper or other rolled annealed high tensile strength metal, and a number of materials for making rigid boards or laminating them together to form multilayer boards. The principal materials of this latter type are prepreg, a pre-impregnated fiberglass epoxy sheet spacer or bonding material, and various polyimide or epoxy / glass copper-clad laminates. See, for example, in U.S. Pat. No. 4,800,461; U.S. Pat. No. 5,144,742; and U.S. Pat. No. 5,004,639.

[0037] In one embodiment, the battery 118 has a 12mm diameter x 2.4mm and is mounted to the top side of the digital section or second PCB 114. In one embodiment, the battery 118 is a lithium-ion battery. The second PCB 114 provides short-circuit, overcharge, and undercharge protection. This design also allows for wireless and cabled charging of the battery 118, although the wireless receiving coil is not included on the PCB (112, 114).

[0038] In another embodiment, the flexible patch device 100 may require replaceablebattery packs to ensure continued monitoring with limited interruption. For example, and without limitation, the battery may be sized to ensure seven-day operation between charges and may have a charge life of 200 cycles minimum. Also for example, and without limitation, the battery pack may include all necessary charging circuitry and may be configured to electrically connect to the USB charger using the mini -USB. When installed in the flexible patch device 100, the charging connector may be protected from water ingress such that the flexible patch device 100 may meet ingress protection (IP) requirements.

[0039] The user interface comprises a micro pushbutton and one or more LED indicators. The at least one LED indicator is configured along a target area for connecting a power management and programming module to the PCB 130. In one or more embodiments, the programming module has conductive springs (not shown), which make electrical contact with conductive pads (not shown) on PCB 130, eliminating the need for a board-mounted connector on PCB 130. In one or more embodiments, the electrical connection comprises using conductive bonding materials, e.g., conductive epoxy, soldering pastes, solder balls, or anisotropic conductive films. In one or more embodiments, the electrical connection comprises using conductive elastomer pads, spring-loaded pins, land grid arrays, ball grid arrays, pin grid arrays, silver buttons, silver balls, or other physical means to make ohmic contact. Optionally, alternate versions of the device 100 may incorporate a micro USB connector in the same area for applications where reusability is desired. Furthermore, the hardware design of the device 100 enables seamless transition and interoperability. Moreover, the introduction of application and firmware updates allows for significantly more advanced operational modes and features, enhancing the versatility and longevity of the device 100.

[0040] The present invention further discloses a method for monitoring and collecting physiological data using a flexible patch device 100. The method comprises a step of providing a flexible patch device 100 comprising: the flexible patch 102 comprising afirst layer 104 configured to be attachable to skin of a user, a plurality of electrode plates 120 embedded on the first layer 104 to provide conformal contact with the skin of the user, and an electronic package disposed within the patch 102 in electrical contact with the electrode plates 120. The method further comprises the step of applying the flexible patch device 100 to the user to establish a direct contact with a skin surface of the user, and collecting physiological data of the user.

[0041] The flexible patch 102 may provide electrical connection to some number of electrodes wherein one or more electrode plates 120 conducts to a portion 108 of one or more conductive targets 110. The one or more conductive targets 110 are configured to make electrical contact with the skin of a user and may be coated in an electrically- conductive material (e.g., silver-silver chloride). In one embodiment, the one or more electrode plates 120 are formed of a metal including gold, platinum, palladium, platinum iridium, or an alloy thereof.

[0042] The one or more electrode plates 120 may have electrically-conductive coatings, e.g., plating of Electroless Nickel Electroless Palladium Immersion Gold (ENEPIG), Organic Solderability Preservative (OSP), Electroless Nickel Immersion Gold (ENIG), Direct Immersion Gold (DIG), or the like. Also for example, and without limitation, device 100 may be secured to the user's skin using adhesives applicable for the situation. An adhesive may be employed based on an ability to advantageously hold the total device weight during a long-term wear period (defined as up to seven days). For example, and without limitation, the adhesive may comprise a non-woven material, the application of which may extend a few millimeters beyond the contour of the flexible patch device 100 in order to advantageously hold the patch weight for a longer period of time without de-adhering from the user's skin.

[0043] The device 100 provides a direct-to-skin interface through one or more conductive targets 110. In one embodiment, PCB 130 is a hybrid printed circuit board.In one embodiment, the device 100 weighs about 3 grams and measures about 25mm x 10mm. In one embodiment, the thickness of the device 100 is about 4mm. In one embodiment, the second PCB 114 is about 20mm x 20mm in dimension.

[0044] Further, the dimension of the device 100 could have any other dimensions. In one embodiment, PCB 130 has a waterproof coating formed thereon. The waterproof coating may be selected from a polymer such as a para-xylylene polymer or chlorinated poly (para-xylylene) polymer (e.g., PARYLENE C®). Other waterproof polymers such as acrylics, silicones, urethanes may also be used. In one or more embodiments, PCB 130 is protected with a biocompatible conformal coating. In one embodiment, the side of the PCB 130 with electronic components is protected with biocompatible conformal coating. The coating obscure part identifiers while being selected to have minimal impact on the flexibility of this section of the board, preserving its mechanical properties. The digital section of the PCB (112, 114, 116) is coated to cover all electronic components so there are no exposed electronic components. Furthermore, the battery 118 is coated to a sufficient extent to mitigate the risk of short-circuit hazards, ensuring safe operation of the device 100.

[0045] The PCB 130 is an all-inclusive hybrid circuit board that incorporates multiple layers or regions with different thicknesses within a single board structure. This design approach allows for the integration of diverse functionalities and components while optimizing the overall performance, reliability, and cost-effectiveness of the PCB 130.

[0046] Advantageously, the device 100 has a flexible configuration and configured to adhere to the body surface during use. The device 100 seamlessly conforms to a curvature of the monitored body part, ensuring comfort and ease of use. The device 100 could be used in tracking, electroencephalogram (EEG), electromyography (EMG), electrooculography (EOG), electrocardiogram (ECG) and spatial data, making it a fullbody platform for physiological monitoring and a versatile tool for research and industry applications. In one embodiment, the device can be used for assistivetechnology, rehabilitation, physical sports performance, and other uses. The device 100 provides a direct-to-skin electrode interface that allows designers and researchers to access the body’s “signal highway” with heretofore unimaginable signal fidelity, opening doors to new possibilities in understanding human physiology. The device 100 is designed to be lightweight, compact, and non-intrusive.

[0047] Although the features, functions, components, and parts have been described herein in accordance with the teachings of the present disclosure, the scope of coverage of this patent is not limited thereto. On the contrary, this patent covers all embodiments of the teachings of the disclosure that fairly fall within the scope of permissible equivalents.

[0048] Many modifications and other implementations of the disclosure set forth herein will be apparent having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the disclosure is not to be limited to the specific implementations disclosed and that modifications and other implementations are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.

Claims

WHAT IS CLAIMED IS:

1. A method for monitoring and collecting physiological data, comprising: providing a flexible patch device comprising: a flexible patch comprising a first layer configured to be attachable to skin of a user, a plurality of conductive targets embedded on the first layer to provide conformal contact with the skin of the user, and an electronic package disposed within the patch; wherein the electronic package comprises one or more electrode plates in electrical contact with the conductive targets; applying the flexible patch device to the user to establish a direct contact with a skin surface of the user, and collecting physiological data of the user.

2. The method of claim 1, wherein the physiological data includes at least one of electroencephalogram (EEG) signal, electromyography (EMG) signal, electrooculography (EOG) signal, and electrocardiogram (ECG) signal.

3. The method of claim 1, wherein the patch device comprises a second layer opposite to the first layer and an internal portion formed between the first layer and the second layer.

4. The method of claim 3, wherein the electronic package comprises a first printed circuit board comprising the microcontroller and a second printed circuit board comprising a digital assembly disposed at the internal portion.

5. The method of claim 4, wherein the first printed circuit board and the second printed circuit board are connected via a digital connector.

6. The method of claim 4, wherein the first printed circuit board is a flexible printed circuit board.

7. The method of claim 4, wherein the first printed circuit board is configured to conform to a curvature of a body part of the user.

8. The method of claim 4, wherein the first and second printed circuit boards arecoated with a biocompatible conformal coating.

9. The method of claim 4, wherein the first printed circuit board comprises a plurality of electronic components, wherein the electronic components are arranged at a side of the first printed circuit board adjacent to the second layer to ensure unobstructed contact of the electrode plates disposed at the first layer with the user.

10. The method of claim 4, wherein the digital assembly comprises at least one battery.

11. The method of claim 10, wherein the battery is a lithium-ion battery.

12. The method of claim 10, wherein the battery is configured for wireless charging and wired charging.

13. The method of claim 4, wherein the digital assembly comprises a user interface module.

14. The method of claim 13, wherein the user interface module includes one or more LED indicators and a push button.

15. The method of claim 4, wherein the digital assembly comprises a programming port.

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