INTEGRATED AND PREDICTIVE SMART SHOE INSOLE

Abstract

A smart insole system and device that integrates advanced sensor technologies and predictive analytics to enhance user comfort, optimize biomechanics, and prevent injuries. The smart insole device has a sensor membrane layer fixed between a cushion insole and an insole frame. The sensor membrane layer communicates with a module and a network, sending data regarding a user's biomechanics for processing. The system is compatible with applications and cloud-based ecosystems, for full integration with a user's care plan.

Claims

1. A smart insole system for monitoring biomechanical and biometric parameters, the system comprising: a force sensing resistor (FSR) assembly; an insole frame; a biometric smart module (BSM); and a biometric sensor network (BSN) configured to communicate with a cloud-based analytics platform.

2. The smart insole system of claim 1, wherein the force sensing resistor assembly comprises: a fabric layer comprising a hydrophobic coating and an adhesive layer, and wherein the fabric layer is configured to conform to the contours of a user's foot; a substrate layer comprising a plurality of segments and force concentrators, wherein each segment is anatomically contoured and flexible; and a sensor membrane layer comprising a plurality of force-sensing resistors (FSRs), wherein each of the FSRs are positioned to capture pressure data from a specific anatomical region of the foot.

3. The smart insole system of claim 1, wherein the insole frame comprises a protective cavity configured to house the BSM and a plurality of shock vibration and absorption mounts.

4. The smart insole system of claim 1, wherein the BSM comprises: a microprocessor; a memory; a 9-axis inertial measurement unit; at least one wireless communication module; a zero insertion force connector configured to interface with the FSR assembly.

5. The smart insole system of claim 4, wherein the 9-axis inertial measurement unit comprises a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer and wherein the 9-axis inertial measurement unit is configured to provide motion tracking to measure angular velocity, acceleration, and magnetic field orientation.

6. The smart sole insert system of claim of claim 1, wherein the BSN is configured to collect biomechanical data from the FSR assembly and the BSM, including pressure distribution, gait patterns, and balance metrics.

7. The smart sole insert system of claim 1, wherein the BSM is integrated with a machine learning module or at least one artificial intelligence algorithm, or a combination thereof.

8. The smart sole insert system of claim 1, wherein the cloud-based analytics platform is configured to aggregate, analyze, and store biomechanical data such that the system can make personalized injury recommendations and integrate with external biometric feedback control systems.

9. A method for monitoring and improving user biomechanics, the method comprising: collecting biomechanical data from a force sensing resistor (FSR) assembly in a smart insole system; capturing motion data from a 9-axis inertial measurement unit (IMU); processing the biomechanical and motion data on a biometric smart module (BSM) housed in the smart insole system; determining if the biomechanical and motion data are outside of a predetermined parameter; transmitting the biomechanical and motion data outside of the predetermined parameter to an analytics platform via wireless communication modules; and generating real-time alerts to indicate the user biomechanics are outside of the predetermined parameter.

10. The method for monitoring and improving user biomechanics of claim 9, wherein the predetermined parameter is a user-specific biometric wellness profile comprising parameters defining the user's ordinary performance, a recovery protocol, or injury parameters, or any combination thereof.

11. The method of monitoring and improving user biomechanics of claim 9, wherein the BSM is configured to amplify and digitize analog signals from the FSR assembly and the IMU and analyze the biomechanical data using machine learning or artificial intelligence algorithms, or a combination thereof.

12. The method of monitoring and improving user biomechanic of claim 9, the method further comprising providing feedback to the user via a biometric feedback control system (BFCS), wherein the feedback comprises real-time alerts for a corrective action or personalized recommendations for injury prevention, recovery, and performance optimization, or any combination thereof.

13. The method of monitoring and improving user biomechanics of claim 9, the method further comprising updating a user-specific profile with historic and/or real-time data to modify the predetermined parameter.

14. The method of monitoring and improving user biomechanics of claim 9, wherein the 9-axis IMU comprises a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer.

15. A smart insole, the insole comprising: a fabric layer, wherein the fabric layer is treated with a hydrophobic coating for moisture management and durability; a substrate layer segmented into a plurality of anatomically contoured flexible sections; a sensor membrane layer comprising a plurality of force sensing resistors (FSRs), wherein each FSR is positioned on one of the plurality of anatomically contoured flexible sections; an insole frame, comprising a protective cavity, wherein the protective cavity comprising a plurality of shock and vibration absorption mounts; a biometric smart module (BSM) configured to be removably inserted into the protective cavity; and a comfort layer configured to be positioned on a top surface of the insole frame.

16. The smart insole of claim 15, wherein the plurality of FSRs are configured measure pressure and force distribution across specific anatomical regions of a user's foot.

17. The smart insole of claim 15, wherein the substrate layer further comprises a plurality of force concentrators configured to enhance the responsiveness of the plurality of FSRs.

18. The smart insole of claim 15, wherein the BSM comprises: a microprocessor configured to process data from the FSRs and execute machine learning or artificial intelligence algorithms; a memory module configured to store biomechanical data and a user-specific profile; a wireless communication module; and a zero insertion force (ZIF) connector configured to interface the BSM with the sensor membrane.

19. The smart insole of claim 15, wherein the BSM further comprises a 9-axis inertial measurement unit (IMU) configured to capture motion data, including acceleration, orientation, and balance, wherein the IMU comprises a 3-axis accelerometer, a 3-axis gyroscope, and a 3-axis magnetometer.

20. The smart insole of claim 15, wherein the comfort layer comprises open-cell polyurethane.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Subject matter hereof may be completely understood in consideration of the following detailed description of various embodiments in connection with the accompanying figures, in which:

[0009] FIG. 1 is an exploded side angle view of an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0010] FIG. 2 is a schematic of a sensor assembly layer of a smart sole insert, according to an exemplary embodiment;

[0011] FIG. 3 is a cross-section of a sensor assembly layer of a smart sole insert, according to an exemplary embodiment;

[0012] FIG. 4 is cross-section of a sensor membrane of a smart sole insert, according to an exemplary embodiment;

[0013] FIG. 5A is a perspective view of an internal cavity of an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0014] FIG. 5B is a perspective view of an internal cavity of an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0015] FIG. 6 is a side angle view of an internal cavity of an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0016] FIG. 7 is a side angle view of an internal cavity of an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0017] FIG. 8 is a schematic view of an integrated and predictive smart sole insert in communication with an application and a server, according to an exemplary embodiment;

[0018] FIG. 9 is a schematic view of an application for an integrated and predictive smart sole insert, according to an exemplary embodiment;

[0019] FIG. 10 is schematic view of an integrated and predictive smart sole insert in communication with a wellness system and application, according to an exemplary embodiment.

[0020] While various embodiments are amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the claimed inventions to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the subject matter as defined by the claims.

DETAILED DESCRIPTIONS

[0021] Embodiments and methods disclosed herein can include an integrated and predictive smart sole insert. The smart sole insert can comprise a biometric smart module (BSM) and two subassemblies: a force sensing resistor (FSR) assembly and an insole frame. The FSR assembly can comprise several layers, including an outer layer of fabric, a substrate segmented into a plurality of anatomically contoured flexible sections, a set of force concentrators, and a sensor membrane. The insole frame can comprise a protective cavity, where the protective cavity is waterproof and dustproof and can further comprise shock and vibration absorption mounts. The BSM can be removably housed within the protective cavity and is configured to be in communication with a biometric sensor network (BSN).

[0022] According to an exemplary embodiment, such as the embodiment depicted in FIGS. 1-7, the FSR assembly can be constructed as follows. An outermost layer of specialized fabric can be treated with a hydrophobic coating for moisture management and durability. The outermost layer of the smart shoe insole is meticulously crafted from a specialized felt fabric engineered to deliver superior moisture management and durability. Composed of high-performance synthetic fibers such as polyester or nylon, this fabric undergoes a proprietary hydrophobic treatment process to repel moisture and facilitate rapid evaporation, thereby preventing microbial proliferation and maintaining a dry and hygienic environment for the user's foot. Additionally, the fabric features a finely textured surface pattern optimized for enhanced grip and traction within the shoe, ensuring minimal slippage during dynamic movements. Rigorous testing and quality control measures are employed to validate the fabric's performance characteristics, including tensile strength, abrasion resistance, and colorfastness, thereby guaranteeing long-term reliability and aesthetic appeal.

[0023] The felt fabric layer is meticulously designed to conform to the contours of the user's foot, providing a snug and comfortable fit while minimizing friction and pressure points. Through advanced patterning and cutting techniques, the fabric layer is tailored to accommodate the unique biomechanics and anatomical features of different foot shapes and sizes, ensuring universal compatibility and optimal user experience. Furthermore, the fabric undergoes rigorous biomechanical testing to assess its impact on gait dynamics, stability, and comfort. By seamlessly integrating with the underlying components of the smart shoe insole, the outer felt fabric layer serves as a versatile and adaptive interface, facilitating efficient transmission of pressure and motion data while enhancing overall user comfort and performance.

[0024] The bottom side of the felt fabric layer is treated with a medical-grade adhesive, meticulously applied using precision spraying techniques. The adhesive exhibits exceptional bonding strength and durability, ensuring secure attachment to the underlying components of the smart shoe insole, including the Plexiglass layer and sensors layer. Prior to application, the adhesive undergoes stringent quality control checks to verify its compatibility with various substrate materials and environmental conditions. Additionally, the adhesive layer comprises a release liner to protect its tackiness during storage and handling, facilitating effortless installation and minimizing the risk of premature adhesion.

[0025] Below the fabric, a precisely engineered Plexiglass substrate can be affixed to the fabric layer using LSE adhesive. The adhesive-coated felt fabric layer is meticulously aligned and affixed to the Plexiglass layer using advanced lamination techniques. Through controlled pressure and temperature settings, the adhesive achieves optimal bond strength and uniform coverage, creating a seamless interface between the outer felt fabric layer and the underlying components. The resulting bond is resistant to shear, peeling, and delamination, ensuring long-term reliability and performance in diverse usage scenarios. It is contemplated that other materials can be suitably engineered to form the substrate.

[0026] In the exemplary embodiments, the substrate can be segmented into eight anatomically contoured flexible sections to accommodate natural foot movements. Fabricated from transparent acrylic material utilizing precision machining techniques, this layer features a sophisticated design comprising eight anatomically contoured flexible sections, strategically positioned to coincide with key pressure points on the foot. Each flexible section undergoes a meticulous molding process, meticulously calibrated to achieve the desired mechanical properties, including elasticity, modulus of elasticity, and tensile strength. Furthermore, advanced finite element analysis (FEA) simulations are employed to optimize the structural geometry and material distribution, ensuring uniform stress distribution and minimizing the risk of material fatigue or deformation over time. The resulting Plexiglass layer serves as a resilient and adaptive platform, providing unparalleled support and comfort while accommodating the natural biomechanics of the foot during various activities. In other embodiments, it is contemplated that the substrate may be segmented into a different number of anatomically contoured flexible sections, such as six sections or ten sections.

[0027] A set of force concentrators, aka pucks, designed to enhance the sensitivity and responsiveness of the FSR sensors, can be placed at optimal locations on each of the eight flexible sections of the Plexiglass layer. (See FIG. 3). The force concentrators ensure precise, and repeatable, measurement of pressure distribution and dynamic changes during gait.

[0028] The next layer can comprise a sensor membrane layer comprising a plurality of force-sensing resistors (FSRs) strategically positioned under specific anatomical regions of the foot and comprising part of the biometric sensor network (BSN). In the exemplary embodiment, the sensor membrane layer comprises eight FSRs. Each FSR sensor is engineered using state-of-the-art thin-film deposition techniques, resulting in a lightweight and ultra-thin sensor element with exceptional sensitivity and responsiveness. The conductive polymer matrix of each FSR sensor is formulated to exhibit consistent electrical properties across a wide range of pressure levels, ensuring accurate and reliable measurement of foot pressure distribution and dynamic changes during gait. (See FIG. 4). The FSR sensors membrane layer features a precisely engineered layout, with each FSR sensor strategically positioned to capture pressure data from specific anatomical regions of the foot, including the medial heel, lateral heel, lateral longitudinal arch, lateral metatarsal heads, mid-metatarsal heads, medial metatarsals heads, distal 1st and 2nd toes, and distal 3rd, 4th, and 5th toes. The FSR sensor membrane connects to the advanced signal conditioning circuitry on the BSM to amplify and digitize the analog signals generated by the FSR sensors, facilitating seamless integration with the BSM's onboard processing unit (discussed below). Additionally, the FSR sensor membrane layer undergoes extensive calibration and validation procedures to ensure accurate and repeatable performance under varying loading conditions and environmental factors.

[0029] The sensor membrane layer can be then attached to the second subassembly, the 3D printed insole frame. In some embodiments, the insole frame can be manufactured by other means, such as injection molding. The insole frame comprises a watertight and dustproof sealed protective cavity and a plurality of shock and vibration absorption mounts beneath the arch region to house a biometric smart module (BSM). (See FIG. 5). The protective cavity can also contain rechargeable battery components and connections to the sensor membrane. The cavity geometry is optimized using advanced CAD modeling and simulation tools to maximize space utilization while minimizing weight and bulk. The cavity walls feature integrated mounting features and retention clips, which enables efficient and effecting routing and connections for power sources, batteries and the sensor membrane, while also providing secure attachment with shock and vibration absorbing properties, preventing component damage and/or displacement during dynamic loading and movement. The protection cavity incorporates sealing gaskets and O-rings at critical external interfaces to ensure a watertight and dustproof seal, safeguarding the internal electronics from moisture ingress and environmental contaminants. The cavity cover is secured using tamper-resistant fasteners or locking mechanisms, further enhancing the security and integrity of the internal components.

[0030] Placing the BSM in the easily accessible, but waterproof and dust proof protective cavity with shock and vibration mitigation features allows the BSM to be replaced, repaired, and recycled. This can prolong the reliability and usable lifetime of this insole. This characteristic separates it from all other smart insoles on the market that are often hard mounted, potted or have their sensor and processing electronics in a separate housing that is attached via cabling. This latter smart insole approach is the most problematic as the cabling is prone to chafing the body or being caught and damaged, and is also the most intrusive and conspicuous, making it far less user friendly and desirable.

[0031] The BSM comprises a printed circuit board (PCB). Within the protective cavity, mechanical fasteners such as self-tapping screws or snap-fit connectors secure the PCB to the insole frame. The attachment points are strategically located to ensure uniform load distribution and prevent stress concentrations. Compliant elastomeric pads are interposed between the PCB and insole frame to dampen vibration and shock forces, enhancing component, and overall product reliability and longevity. The mechanical fasteners undergo stringent torque testing and reliability validation to ensure consistent clamping force and resistance to loosening over time. Advanced surface treatments, such as chemical passivation or corrosion-resistant coatings, may be applied to the fasteners to enhance their durability and resistance to environmental degradation. Additionally, the attachment points are designed to facilitate case of assembly and disassembly, enabling efficient maintenance and serviceability of the smart shoe insole.

[0032] A zero insole force (ZIF) connector can also be mounted inside the insole frame on the BSM, such that the ZIF can facilitate the electrical connection between the sensors layer and the BSM located within the protection cavity. The ZIF connector features a spring-loaded mechanism that applies consistent pressure to ensure reliable electrical contact while minimizing mechanical stress on the flexible components. The connector housing can be fabricated from a durable thermoplastic material, selected for its high mechanical strength and chemical resistance.

[0033] The ZIF connector undergoes rigorous testing to verify its electrical and mechanical performance characteristics, including contact resistance, insertion force, and cycle life. Additionally, the connector interface is designed to accommodate repeated insertion and removal cycles without degradation, ensuring case of maintenance and serviceability throughout the product lifecycle. Advanced locking mechanisms, such as cam levers or screw locks, may be incorporated into the connector design to enhance retention and prevent accidental disconnection during use.

[0034] Finally, positioned atop the 3D printed insole frame, is a layer of open cell polyurethane foam that serves as the comfort interface between the user's foot and the rigid components of the smart shoe insole. The open cell polyurethane foam is formulated to exhibit superior cushioning properties, providing shock absorption and pressure relief during dynamic activities. The foam undergoes a thermoforming process to contour to the shape of the user's foot, ensuring a customized fit and optimal comfort. The open cell polyurethane foam layer features a perforated structure to enhance breathability and moisture management, preventing heat buildup and maintaining a dry and comfortable environment for the user's foot. Advanced antimicrobial treatments are applied to the foam to inhibit the growth of odor-causing bacteria and fungi, ensuring long-lasting freshness and hygiene. Additionally, the foam layer undergoes rigorous durability testing to assess its resilience against compression set and fatigue, ensuring consistent performance over extended periods of use.

[0035] The insole assembly process involves meticulous alignment and positioning of the FSR assembly layer so it seamlessly integrates within the insole frame, guided by precision jigs and fixtures to maintain dimensional accuracy and alignment. It is securely affixed to the underside of the insole frame using a biocompatible LSE adhesive, ensuring uniform contact and reliable signal transmission. After the FSR assembly is attached to the insole frame, a FSR assembly tail is routed along the contoured guide track in the 3D-Insole frame and through the gasketed opening into the protective cavity for the BSM. It is then connected to the BSM's ZIF connector and locked in place. Once the FSR assembly tail is attached to the ZIF connector, the BSM is fully secured to the internal shock mounts, the protective cavity door with its rubberized sealing gasket is secured to the frame, and the exposed BSM alignment screw lock is covered with a rubberized cap for future serviceability of the BSM The resulting final smart insole is waterproof, dustproof and exhibits robustness and resilience against mechanical shocks, vibrations, and repetitive loading, ensuring long-term performance and reliability in demanding footwear applications.

[0036] The biometric sensor network (BSN) consists of the sensor membrane assembly and a 9-axis Inertial Measurement Unit (IMU) which is populated on the BSM. The sensor membrane assembly consists of a series of embedded biometric sensors in critical anatomical areas of the foot including, but not limited to, the heel post, transverse metatarsal region in the midfoot, first ray extension and fifth ray extension and under the arch. In the exemplary embodiments depicted in FIGS. 2-4, the biometric sensors embedded in the insole on the sensor membrane include those to measure pressure and force levels and imbalances at the extremities as represented by measurements of Center of Force and Center of Gravity parameters. The 9-axis IMU, consisting of a 3-axis Accelerometer, a 3-axis Gyroscope and a 3-axis Magnetometer, will enable the measurement of critical motion parameters, such as acceleration patterns, gait and balance. In the context of the smart shoe insole, the 9-axis IMU motion sensors play a crucial role in capturing detailed motion data during various physical activities, such as walking, running, and jumping. By monitoring changes in foot orientation, velocity, and acceleration, the sensors provide valuable insights into gait patterns, foot strike mechanics, and overall biomechanical performance. Advanced signal processing algorithms on the BSM analyze the sensor data in real-time, detecting subtle deviations from normal movement patterns and identifying potential indicators of injury risk or biomechanical inefficiency.

[0037] Furthermore, the 9-axis sensors enable the smart insole to assess the user's posture, balance, and stability during static and dynamic activities. By detecting shifts in center of mass and body alignment, the sensors can provide feedback on posture correction and weight distribution, helping users optimize their movement patterns and reduce the risk of musculoskeletal injuries. Additionally, the magnetometer sensor facilitates orientation tracking relative to the Earth's magnetic field, enabling the smart shoe Insole to provide context-aware feedback based on the user's geographic location and heading. Through continuous monitoring and analysis of motion data, the smart shoe Insole leverages the capabilities of the 9-axis sensors to offer personalized coaching, performance optimization, and injury prevention strategies. The integration of these advanced sensor technologies enhances the overall functionality and effectiveness of the smart shoe insole, empowering users to achieve their fitness goals, improve athletic performance, and maintain optimal foot health.

[0038] The BSM can include, in addition to the IMU and connections to capture Force and Pressure Sensor data from the sensor membrane assembly, a microprocessor and memory chip to allow for monitoring, processing, and analyzing all of the received electronic sensor data on the insole itself using an edge-based architecture that enables real-time decisions. The BSM can have wireless communication capabilities via Low Energy Bluetooth (BLE), ANT+, Wi-Fi or Cellular, and the ability to utilize USB or wireless inductance for battery recharging. BLE advantageously has a lower level of battery usage, extending its life and enabling much higher levels of analysis by the BSM and BSN. The ANT+ communication module is the lowest wireless communication protocol and allows simultaneous communication to multiple sensor networks. Communication with multiple sensor networks can allow other wearable sensors like wearable watches, glucometers, etc. to be integrated into an integrated ecosystem like the IWS Integrated Wellness Ecosystem. The advent of Bluetooth Mesh Networks will further expand the number and types of wearable devices that can be integrated into the IWS Integrated Wellness Ecosystem.

[0039] The BSM can comprise advanced signal conditioning circuitry that is integrated into the BSM to amplify and digitize the analog signals generated by the FSR sensors, facilitating seamless integration with the onboard processing unit. Additionally, the outputs from the FSR sensor membrane layer undergoes extensive calibration and validation procedures to ensure accurate and repeatable performance under varying loading conditions and environmental factors.

[0040] The BSN sensor data can then be interpreted at the BSM and only the data points that need to be addressed immediately would be sent downstream. Machine learning and artificial intelligence (AI) algorithms can determine what data should be transmitted and what data should simply be store. The machine learning and AI algorithms can be configured to identify when a user is operating outside of their customer-specific Biometric Wellness Profile. (See FIG. 9). The Biometric Wellness Profile can be generated from a cloud-based analytical portion of the Continuous. The Biometric Wellness Profile can identify when the user is either not performing at optimum levels, or in the worst case, are in danger of injury. Limiting the amount of potentially superfluous data flowing downstream will limit the bandwidth needed for either the smartphone app/cloud interface, or the cloud directly, if sent via cellular communication. These data transfer volumes can now be as little as 1% of the total available data volume in some cases, unburdening the wireless infrastructure and enabling optimized communication and real-time alerts. Alerts that could mean the difference between injury prevention, and a user's wellness and positive performance, or in the future, even prevent a fall, with a quick warning to the user. For example, FIG. 10 illustratively shows the integration of these machine learning and AI algorithms into the IWS Wellness Improvement Cycle.

[0041] In embodiments, the smart insole can be in communication and compatible with a biometric feedback control system (BFCS), as illustratively depicted in FIG. 9. The BFCS comprises three major elements: 1) the Biometric Sensor Network (BSN) in the insole, 2) the Biometric Smart Module (BSM) that captures data from the BSN to detect, process, and continually transmit to a BFCS smartphone application and 3) the BFCS application which simultaneously communicates to the cloud-based IWS Integrated Wellness Ecosystem, while using a series of proprietary computer algorithms, to sense when the user is performing dangerously outside the parameters of their user-specific Biometric Wellness Profile and/or Wellness Plan. When an out of control condition or trend is discovered that would be detrimental to the user's performance, recovery, or might result in injury, the BFCS will generate real-time haptic (vibration), audio and/or visual alerts. These alerts may be originated from the BFCS application (if in use at this time) or may come via automated communication directly from the cloud-based analytics running on the IWS Integrated Wellness Ecosystem if cellular communications are being used. These alerts may take the form of text messages to the user's cellphone, email to the user, vibration (haptic) of the phone through the BFCS application, or alerts through the BFCS App with the Dashboard interface showing the area and magnitude of the issue. These alerts may also be generated by a Wellness Provider's customer service/concierge help desk that has personnel actively monitoring User Dashboards for potential issues. At the highest control level, this biofeedback will also indicate where the problem is to the user and the corrective action that should be taken to fix the problem or defect. Once again, only the data that is outside the Wellness Profile will be processed allowing for faster processing. That cloud infrastructure provides both user-specific and wellness professional-specific dashboards as part of the IWS Wellness Ecosystem (see FIG. 9), empowering users with actionable insights and personalized recommendations for injury prevention, recovery, and performance optimization.

[0042] A Wellness Improvement Plan can be generated and integrated with the smart insole system, as described supra. The Wellness Improvement Plan follows a general cycling comprising detection, communication, aggregation, analysis, and action. In the detection phase, the wearable technology can detect biomechanical issues before real damage occurs. In the communication phase, real-time critical actionable data is sent to the healthcare ecosystem. In the aggregation phase, the data is compiled into a Wellness Data Summary to enable easier, faster analysis. In the analysis phase, data analytics can be provided to determine the user/client risk level using the proprietary algorithms. In the action phase, a tiered response system based on risk level includes immediate haptic feedback for corrective action.

[0043] The tiered response system can comprise three tiers. Tier 1 can be available to all users. Tier 1 can issue responses localized at the Smartphone through visual, audio and/or haptic feedback when the User/Patient is performing outside of their user-specific Wellness Profile or Wellness Plan. Tier 2 can be available when a Wellness Plan Provider is involved in the user's plan. Tier 2 can issue responses through Telehealth and/or mobile Health monitoring with Text Message Interventions when the User is operating outside of their Wellness Profile for an extending period of time. Tier 3 can be customizable at the highest level when a clinician-level Wellness Plan Provider is involves. Tier 3 can issue responses through Telehealth and/or mobile Health monitoring and direct contact with the Medical Professionals when the User's Operating Conditions is veering into potentially dangerous conditions that could lead to DFUs.

[0044] The entire time that the user/patient is utilizing the smart insole, the BFCS is communicating to the IWS Integrated Wellness Ecosystem, either through the BFCS application or directly to the cloud via an eSIM chip on the smart insole. (See FIG. 10). The eSIM chip allows direct communication to the IoT through the user/patient's cell phone provider. The cloud backend serves as a centralized data repository and computational platform, hosting the AI algorithms and supporting advanced analytics capabilities. By offloading intensive computational tasks to the cloud, the smart shoe Insole can leverage scalable computing resources to perform complex data processing, modeling, and predictive analytics tasks. The information transmitted to the cloud will go to a HIPAA-compliant database for access by the user/patient and/or the Wellness Plan Provider through the appropriate Wellness Dashboards.

[0045] The smart insole can further comprise AI-driven injury prediction models. The smart insole utilizes artificial intelligence (AI) algorithms to analyze data collected from the integrated sensors, including pressure sensors and 9-axis motion sensors, to detect differences in the user's gait patterns. By leveraging machine learning techniques, such as pattern recognition and anomaly detection, the AI algorithms can identify subtle deviations from normal gait patterns that may indicate potential biomechanical issues or injury risks.

[0046] Furthermore, the AI algorithms are trained using, large datasets of gait patterns and injury profiles obtained from diverse user populations, aka Big Data. These datasets encompass a wide range of geographical locations, environmental conditions, and activity levels, allowing the AI models to capture the complex interplay between biomechanical factors and injury susceptibility. Through continuous learning and refinement, the AI algorithms improve their predictive accuracy and generalization capabilities, enabling them to effectively assess injury risks and provide personalized recommendations for injury prevention and performance optimization.

[0047] The smart shoe insole can also leverage AI to connect to large gait datasets worldwide, allowing for the prediction of potential injuries based on a user's geographical location, local terrain, and other environmental factors. For example, in areas with hilly terrain, such as San Francisco, the AI algorithms can analyze historical data to predict the likelihood of specific injuries based on the user's gait patterns and activity levels. By simulating wear and tear similar to a tire or car suspension system, the AI algorithms provide users with valuable insights into the long-term impact of their daily activities on foot health and injury risk.

[0048] Additionally, the cloud backend, the IWS Integrated Wellness Ecosystem, facilitates integration with external data sources, such as global gait databases and environmental databases, to augment the predictive capabilities of the AI algorithms. For example, the smart shoe Insole can access large-scale gait datasets from urban environments with diverse terrain profiles, such as San Francisco, to analyze the impact of hilly terrain on gait dynamics and injury risk. By correlating user-specific gait data with environmental factors and historical injury trends, the AI algorithms can generate personalized injury risk assessments and proactive injury prevention strategies tailored to the user's unique needs and circumstances.

[0049] Persons of ordinary skill in the relevant arts will recognize that the subject matter hereof may comprise fewer features than illustrated in any individual embodiment described above. The embodiments described herein are not meant to be an exhaustive presentation of the ways in which the various features of the subject matter hereof may be combined. Accordingly, the embodiments are not mutually exclusive combinations of features; rather, the various embodiments can comprise a combination of different individual features selected from different individual embodiments, as understood by persons of ordinary skill in the art. Moreover, elements described with respect to one embodiment can be implemented in other embodiments even when not described in such embodiments unless otherwise noted.

[0050] Although a dependent claim may refer in the claims to a specific combination with one or more other claims, other embodiments can also include a combination of the dependent claim with the subject matter of each other dependent claim or a combination of one or more features with other dependent or independent claims. Such combinations are proposed herein unless it is stated that a specific combination is not intended.

[0051] Any incorporation by reference of documents above is limited such that no subject matter is incorporated that is contrary to the explicit disclosure herein. Any incorporation by reference of documents above is further limited such that no claims included in the documents are incorporated by reference herein. Any incorporation by reference of documents above is yet further limited such that any definitions provided in the documents are not incorporated by reference herein unless expressly included herein.

[0052] For purposes of interpreting the claims, it is expressly intended that the provisions of 35 U.S.C. 112 (f) are not to be invoked unless the specific terms means for or step for are recited in a claim.