Insole and system comprising an insole

Abstract

A system comprising: (a) an insole having a plurality of sensors and a plurality of adjustment mechanisms disposed thereon at a plurality of locations, each sensor providing a data output signal; (b) a data processor receiving the data output signals from the sensors, analyzing data from the output signals and outputting a response plan; and (c) an execution module receiving the response plan, converting it to a plurality of response signals, and transmitting each of the plurality of response signals to a particular one of the plurality of adjustment mechanisms. Additional systems and related insoles are also disclosed.

Description

Technical Field

[0001] This application pertains to the field of orthopedics. Background Technology

[0002] Insoles are typically found in commercially produced footwear and / or sold separately for addition to shoes. A typical insole is a general-purpose device made of foam rubber and / or fabric.

[0003] There are also commercially available, unchanging "off-the-shelf" insoles characterized by foam and / or gel and / or air cushioning, which can increase comfort if installed in shoes sold separately from the insoles. These fixed, passive insoles are generic devices and cannot be tailored to a user's individual anatomy or medical condition.

[0004] In addition, orthopedic surgeons, podiatrists, physical therapists, and other healthcare professionals use a variety of different types of personalized, fixed passive insoles to diagnose, plan, and treat a range of symptoms, often related to pain and discomfort in the feet and / or lower extremities. Symptoms such as arthritis, back pain, foot deformities, plantar fasciitis, heel injuries, Achilles tendon injuries and ruptures, bone spurs, bunions, bursitis, pronation (flat feet), high arches, fractures, hammer toes, sarcopenia, balance disorders, falls in older adults, foot inflammation, neuromas, lesions, osteoporosis, diabetic foot ulcers, and tendinitis can all cause pain. Patients with these conditions cannot be treated with ordinary insoles because they require solutions tailored to their individual foot structure and / or symptoms.

[0005] Treatment plans in the medical field (e.g., orthopedic surgery) or sports training are typically based on professional assessments, manuals, and / or digital methods. In addition to physical observation, assessments may include video and / or computer monitoring of certain movements, such as standing, running, or walking, in a static or dynamic manner (e.g., in a gait laboratory). Alternatively or additionally, assessments may include evaluations of biomechanical function, foot and / or ankle and / or muscle and / or knee and / or hip mobility. Muscles are typically assessed based on tightness and / or range of motion. Alternatively or additionally, the range of motion of each joint may be assessed.

[0006] Capturing reliable information about human gait in real-life environments remains challenging. Standard gait analysis techniques, such as camera-based motion capture systems and force plates, are expensive and only usable in laboratories, thus offering limited insights into people's biomechanical movements in the real world. However, existing insole products fail to provide accurate gait data, nor do they offer precise foot fit and therapeutic efficacy. Based on evaluation, a treatment plan may be proposed, including orthotic shoes and / or custom insoles and / or orthotics (braces).

[0007] Unfortunately, custom orthotics have drawbacks. Because the result is a single, unchanging passive insole, it's impossible to monitor the solution's compatibility and quality online, let alone dynamically adjust it. While fit and compatibility are crucial, orthotics don't always fit reliably. Furthermore, they don't adapt to changes in fit due to different physical activities, different footwear, foot trauma, or natural bodily changes over time (such as weight gain or loss, pain, or other conditions affecting our biomechanics), leading to decreased fit accuracy and resulting in insole ineffectiveness and / or shortened product lifespan that may not be apparent to both patients and professionals.

[0008] Diabetic foot ulcers (DFU) and associated lower extremity complications are among the most vulnerable and costly sequelae of diabetes in both developed and developing countries. Custom-made orthotic insoles have been shown to reduce plantar pressure in patients at risk of plantar ulcers. Repeated trauma to pressure points on the sole increases the risk of local inflammation, which manifests as elevated temperature at the affected site. Currently, temperature at different locations on the foot is measured manually.

[0009] Randomized controlled trials (RCTs) and meta-analyses have shown that DFU can be prevented by controlling key reversible risk factors (such as elevated local temperature indicating inflammation) and implementing appropriate medical management.

[0010] Unfortunately, in many cases, DFU assessment is only performed after the disease has progressed to the point of causing serious damage. Summary of the Invention

[0011] A broader aspect of some embodiments of the present invention relates to the early detection and / or intervention of a variety of foot and / or gait abnormalities.

[0012] One aspect of some embodiments of the present invention relates to an insole for diagnosing, analyzing, and correcting problems. In some embodiments, the insole includes multiple sensors to collect data. According to various exemplary embodiments of the invention, the sensors include one or more of pressure sensors, motion sensors, level sensors, gyroscopes, shear stress sensors, humidity sensors, temperature sensors, and accelerometers. Alternatively or additionally, in some embodiments, the insole includes a processing module and / or a wireless data transmission module and / or a memory and / or a battery and / or a system-on-a-chip. In some embodiments, data generated by the sensors is transmitted and / or analyzed by an application that enables users and / or remote experts to provide and / or activate response plans. According to various exemplary embodiments of the invention, the analysis is performed by a data processor in the insole and / or by a data processor worn or carried by the user of the insole (e.g., a smartphone, smartwatch, or dedicated wearable device) and / or via a remote server. In some embodiments, the insole includes an adjustment mechanism adapted to implement a response plan and to customize the shape of the insole by extending in a vertical direction. According to various exemplary embodiments of the invention, the adjustment mechanism includes one or more of a plunger, piezoelectric material, motor, gear, bevel gear, worm gear, spring-loaded mechanism, and hydraulic actuator. In some embodiments, the insole is configured to perform autonomous, proactive, online, bidirectional diagnostic and therapeutic activities in real time.

[0013] Another aspect of some embodiments of the present invention relates to a system that receives timestamped data output from multiple sensors mounted on an insole and stores the data in a database along with the user's UID (Unique Identifier). In some embodiments, the system also receives a timestamped response plan and associates it with the UID. In some exemplary embodiments of the present invention, analyzing changes in sensor output over time in conjunction with the intervention response plan allows for the assessment of the therapeutic efficacy of the response plan.

[0014] Another aspect of some embodiments of the present invention relates to a system that receives user input defining a problem area on the sole of the foot. In some embodiments, the user input is provided via a touchscreen (e.g., on a smartphone and / or tablet and / or smartwatch). In some embodiments, the user input is translated into a response plan by a data processor. According to various exemplary embodiments of the invention, the translation is performed by a data processor in the insole, a data processor worn or carried by the user of the insole (e.g., a smartphone, smartwatch, tablet, or dedicated wearable device), and / or via a remote server. In some embodiments, the insole includes a dynamic, online, and / or real-time adjustment mechanism adapted to implement the response plan.

[0015] Another aspect of some embodiments of the invention relates to a system that is reliable in long-term operation and easily switches between and / or uses an automatic adjustment / calibration mode that is controlled by programmable input from a paired smart device (e.g., a mobile phone). In some embodiments, an advantage of such a system is that it reduces the need for more than one pair of expensive custom orthotics for different types of footwear.

[0016] According to various exemplary embodiments of the present invention, the adjustment mechanism includes one or more of the following: plunger, piezoelectric material, motor, gear, bevel gear, worm gear, screw, spring loading mechanism, and hydraulic actuator.

[0017] Alternatively or additionally, according to various exemplary embodiments of the invention, the regulating mechanism and / or sensor are made of various polymers and / or electroactive polymers and / or materials having convertible and / or conductive properties.

[0018] Some exemplary embodiments of the present invention offer advantages in the medical field, such as significantly simplifying the daily lives of people with diabetes. Alternatively or additionally, in some embodiments, patients are empowered to care for themselves. In some embodiments, empowering patients helps improve patient adherence. Alternatively or additionally, in some embodiments, the efficient delivery of data from at-risk patients for remote monitoring helps reduce the access disadvantages of remote areas.

[0019] For example, by continuously monitoring abnormal plantar parameters (such as pressure distribution and / or foot temperature and / or skin moisture), the system can also relieve pressure by reducing the load, responding to early signs of potential ulcers and / or aiding healing and maintaining mobility in the post-diabetic foot ulcer (DFU) stage. Therefore, eliminating abnormal pressure points through dynamic and / or self-customized insole fit to promote healing or prevent ulceration can be a therapeutic approach, thereby enabling early detection and / or prevention and / or delay of foot ulcer wounds and / or recurrence in diabetic foot ulcers (DFU) in diabetic patients.

[0020] Another aspect of some embodiments of the present invention relates to a manually adjustable height adjustment mechanism mounted in an insole. In some embodiments, a plurality of such mechanisms are distributed over a region of the insole. According to various exemplary embodiments of the invention, the mechanism is positioned below the medial arch, metatarsals, and / or heel of the insole. According to various exemplary embodiments of the invention, the mechanism employs a clamping nut and / or screw and / or a bevel joint rotating lifting element and / or a bayonet mounting element (hereinafter referred to as the "height adjustment mechanism").

[0021] Another aspect of some embodiments of the present invention relates to sensors arranged in insoles. According to various exemplary embodiments of the invention, the sensors include pressure sensors and / or temperature / climate sensors and / or level sensors and / or gyroscopes and / or accelerometers.

[0022] Another additional aspect of some embodiments of the invention relates to a data processor that receives output signal data from sensors in the insole and provides user warnings and / or suggestions in response to the data. According to various exemplary embodiments of the invention, the data processor is incorporated into the insole or located externally. In some embodiments, internal and external data processors operate collaboratively. In some embodiments, user suggestions include instructions for manual adjustment of various height adjustment mechanisms in the insole. Alternatively or additionally, in some embodiments, user suggestions include alerts regarding primary foot ulcers and / or orthopedic and / or biomechanical problems. In some exemplary embodiments of the invention, diagnostics and / or alerts and / or user suggestions are presented on a digital user interface (UI) of a smartphone, smartwatch, tablet, or PC.

[0023] In some embodiments of the invention, the correction and / or adjustment plan can be initiated and / or implemented manually by means of a “height adjustment mechanism”, either individually or by machine learning algorithms that suggest plans based on diagnostics inferred from data collected from sensors arranged in the insole.

[0024] It should be understood that the above aspects relate to solutions to technical problems related to the early diagnosis and intervention of various gait-related and / or mobility and / or medical disorders.

[0025] Alternatively or additionally, it should be understood that the foregoing aspects relate to solutions to these technical problems: technical problems related to providing symptom relief for foot pain and / or knee pain and / or hip pain and / or back pain and / or lower extremity neuropathic pain (e.g., diabetic foot ulcers).

[0026] Alternatively or additionally, it should be understood that the foregoing aspects relate to the early diagnosis and / or assessment and / or treatment of chronic foot diseases and pain (e.g., diabetic foot ulcers).

[0027] Alternatively or additionally, it should be understood that the above aspects relate to solutions to technical problems associated with the customization of orthotics.

[0028] Alternatively or additionally, it should be understood that the foregoing aspects relate to solutions to technical problems related to the early detection of initial foot ulcers and / or other medical conditions and / or the improvement of gait and / or mobility.

[0029] In some exemplary embodiments of the present invention, a system is provided, comprising:

[0030] (a) an insole having multiple sensors and multiple adjustment mechanisms disposed thereon at multiple locations, each sensor providing a data output signal; (b) a data processor receiving the data output signals from the sensors, analyzing the data from the output signals, and outputting a response plan; and (c) an execution module receiving the response plan, converting it into multiple response signals, and transmitting each of the multiple response signals to a specific one of the multiple adjustment mechanisms. In some embodiments, the data processor outputs an alarm signal. Alternatively or additionally, in some embodiments, the sensors include at least one of the group consisting of a pressure sensor, a temperature sensor, a motion sensor, a transducer, a level sensor, a gyroscope, and an accelerometer. Alternatively or additionally, in some embodiments, the data processor is located at at least one of the group consisting of an insole / on the insole, worn or carried by the user of the insole (e.g., a smartphone, smartwatch, or dedicated wearable device), or located on a remote server. Alternatively or additionally, in some embodiments, the adjustment mechanism includes at least one of the group consisting of a plunger, a piezoelectric material, a motor, a gear, a bevel gear, a worm gear, a spring-loaded mechanism, a hydraulic actuator, a polymer, and an electroactive material. Alternatively or additionally, in some embodiments, the system includes a stimulation module under the control of the execution module, wherein the response plan includes stimulation signals. According to various exemplary embodiments of the invention, the stimulation module includes at least one from the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0031] In some exemplary embodiments of the present invention, a system is provided, comprising: (a) a plurality of insoles equipped with sensors that generate timestamped data output signals labeled with UIDs (Unique Identifiers) for a user; and (b) a database that receives and stores the timestamped data output signals labeled with UIDs. In some embodiments, the system includes one or more data processors that receive data output signals from sensors, analyze data from output signals associated with a specific UID, and output a timestamped and stored response plan for that specific UID; and a response plan transmission module that transmits the specific UID response plan to the insole associated with that UID.

[0032] In some exemplary embodiments of the present invention, a system is provided comprising: (a) a user interface (UI) adapted to receive user input defining a problem area on the sole of the foot; and (b) a data processor including a conversion module adapted to convert the user input into a response signal. In some embodiments, the UI is provided by a touchscreen. Alternatively or additionally, in some embodiments, the data processor is located at at least one location selected from the group consisting of a user-wearable / carrying device for the insole and a remote server. Alternatively or additionally, in some embodiments, the system includes an insole comprising an adjustment mechanism adapted to respond to a response signal; and a response signal transmission module adapted to transmit the response signal to the insole. Alternatively or additionally, in some embodiments, the adjustment mechanism includes at least one of the group consisting of a plunger, a piezoelectric material, a motor, a gear, a bevel gear, a worm gear, a spring-loaded mechanism, a hydraulic actuator, a polymer, and an electroactive material. Alternatively or additionally, in some embodiments, the system includes a stimulation module responsive to the response signal. Alternatively or additionally, in some embodiments of the invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0033] In some exemplary embodiments of the present invention, an insole is provided, comprising: (a) a plurality of adjustment mechanisms integrated over at least a portion thereof; and (b) a manual adjustment interface for each height adjustment mechanism. In some embodiments, each height adjustment mechanism is independently selected from the group consisting of a screw, a bevel joint swivel lifting element, and a bayonet mounting element. Alternatively or additionally, in some embodiments, the insole includes one or more sensors. Alternatively or additionally, in some embodiments, each sensor is independently selected from the group consisting of a pressure sensor, a temperature / climate sensor, a level sensor, a gyroscope, and an accelerometer. Alternatively or additionally, in some embodiments, the insole includes a data channel configured to transmit output signals from one or more sensors to a data processor. Alternatively or additionally, in some embodiments, the insole includes the data processor. Alternatively or additionally, in some embodiments, the insole includes a stimulation module and a manual activation interface for the stimulation module. Alternatively or additionally, in some embodiments of the present invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0034] In some exemplary embodiments of the present invention, a system is provided comprising: (a) one or more insoles having a plurality of height adjustment mechanisms integrated on at least a portion thereof and a manual adjustment interface for each height adjustment mechanism; (b) one or more sensors in the one or more insoles providing one or more output signals; (c) a data processor designed and configured to convert the output signals into recommendations; and (d) an interface presenting diagnoses and / or the recommendations. In some embodiments, the data processor is located in a device external to the insole. Alternatively or additionally, in some embodiments, the device external to the insole is selected from the group consisting of smartphones, smartwatches, PCs (personal computers), and tablets. Alternatively or additionally, in some embodiments, the system includes a wireless communication link between the sensors and the data processor. Alternatively or additionally, in some embodiments, the user recommendations include a set of instructions for manually adjusting each height adjustment mechanism. Alternatively or additionally, in some embodiments, the user recommendations include an alert regarding primary foot ulcers. Alternatively or additionally, in some embodiments, the collected clinical data is used to measure patient compliance and enable remote continuous monitoring and / or connected care. With this continuity of care and the ability to review complete, real-time results, clinicians can improve patient adherence, flag risks, and intervene before problems become severe. Alternatively or additionally, in some embodiments, the system includes a stimulation module in each of the one or more insoles and a manual activation interface for the stimulation module. Alternatively or additionally, in some embodiments of the invention, the stimulation module includes at least one from the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0035] In some exemplary embodiments of the present invention, a system is provided comprising: (a) a data processor designed and configured to receive one or more output signals from sensors in an insole and convert the output signals into user suggestions; and (b) a user interface for presenting the user suggestions. In some embodiments, the data processor is located in a device selected from the group consisting of smartphones, smartwatches, PCs (personal computers), and tablets. Alternatively or additionally, in some embodiments, the system includes a wireless communication link between the sensors and the data processor. Alternatively or additionally, in some embodiments, the user suggestions include a set of instructions for manually adjusting individual height adjustment mechanisms in the insole. Alternatively or additionally, in some embodiments, the user suggestions include an alert regarding primary foot ulcers. Alternatively or additionally, in some embodiments, the collected clinical data is used to measure patient compliance and enable remote continuous monitoring. With this continuous monitoring and the ability to review complete, real-time results, clinicians can improve patient compliance, flag risks, and intervene before problems become serious.

[0036] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. Although suitable methods and materials are described below, similar or equivalent methods and materials may be used to practice this invention. All materials, methods, and examples are illustrative only and not limiting.

[0037] As used herein, the terms “comprising” and “including” or their grammatical variations shall be construed as indicating that the stated feature, integral, action, or component is covered, without excluding the addition of one or more additional features, integrals, actions, components, or groups thereof. This term is broader than and covers the terms “consisting of” and “substantially consisting of” as defined in the U.S. Patent and Trademark Office Patent Examination Procedure Manual. Therefore, any statement that an embodiment “comprising” or “including” a feature specifically states that the sub-embodiment is “substantially consisting of” and / or “consisting of” the stated feature. When used herein, the phrase “substantially consisting of” or its grammatical variations shall be construed as specifying the stated feature, integral, step, or component, without excluding the addition of one or more additional features, integrals, steps, components, or groups thereof, provided that the additional features, integrals, steps, components, or groups thereof do not materially alter the essential and novel characteristics of the claimed composition, apparatus, or method.

[0038] The phrase "suitable" as used in this specification and the appended claims imposes additional structural limitations on the previously described components. The term "method" refers to the manner, means, techniques, and procedures for accomplishing a given task, including but not limited to those known manner, means, techniques, and procedures, or those easily developed by practitioners of architecture and / or computer science from known manner, means, techniques, and procedures. The implementation of methods and systems according to embodiments of the invention involves selected tasks or steps performed or completed manually, automatically, or in combination thereof. Furthermore, in practical instruments and devices according to exemplary embodiments of the methods, apparatus, and systems of the invention, several selected steps may be implemented by hardware, or by software on any operating system with any firmware, or by a combination thereof. For example, as hardware, selected steps of the invention may be implemented as a chip or circuit. As software, selected steps of the invention may be implemented as a plurality of software instructions executed by a computer using any suitable operating system. In any case, selected steps of the methods and systems of the invention can be described as being executed by a data processor, such as a computing platform for executing multiple instructions. Attached Figure Description

[0039] To understand the invention and how to practice it, embodiments will now be described by way of non-limiting example only with reference to the accompanying drawings. In the drawings, identical or similar structures, elements, or portions thereof appearing in more than one figure are generally labeled with the same or similar reference numerals in the figures in which they appear. The dimensions of components and features shown in the figures are chosen primarily for ease of presentation and clarity, and are not necessarily drawn to scale. The drawings are as follows:

[0040] Figure 1A This is a schematic diagram of the sensor layer of an insole according to an exemplary embodiment of the present invention;

[0041] Figure 1B This is a schematic diagram of the electronic device layer of an insole according to an exemplary embodiment of the present invention;

[0042] Figure 2 This is a schematic diagram depicting a worm gear plunger suitable for use as part of an insole adjustment mechanism according to an exemplary embodiment of the present invention;

[0043] Figure 3A This is a schematic cross-sectional view of a cylinder-based lifting system according to an embodiment of the present invention, used to push and / or pull a lifting blade-shaped member suitable for use as part of an insole adjustment mechanism;

[0044] Figure 3B According to an exemplary embodiment of the present invention, a plurality of [facilities] are provided. Figure 3A A schematic top view of the insole with an insole adjustment mechanism;

[0045] Figure 3C It is in the open position according to an exemplary embodiment of the present invention. Figure 3A A perspective view of the adjustment mechanism;

[0046] Figure 3D yes Figure 3C A perspective view of the adjustment mechanism in the closed position;

[0047] Figure 4 This is a schematic system diagram illustrating data flows according to various exemplary embodiments of the present invention;

[0048] Figure 5A This is a diagram illustrating a system layer according to an exemplary embodiment of the present invention;

[0049] Figure 5B This is a diagram illustrating a system layer according to another exemplary embodiment of the present invention;

[0050] Figure 6 These are simplified schematic diagrams of a system according to some embodiments of the present invention;

[0051] Figure 7These are simplified schematic diagrams of a system according to some embodiments of the present invention;

[0052] Figure 8 These are simplified schematic diagrams of a system according to some embodiments of the present invention;

[0053] Figure 9A This is a schematic diagram of the arrangement of the height adjustment mechanism inside the insole according to an exemplary embodiment of the present invention;

[0054] Figure 9B This is an exploded view showing the insole layer of an integrated height adjustment mechanism according to an exemplary embodiment of the present invention;

[0055] Figure 9C This is a top perspective view of an insole showing additional features according to an exemplary embodiment of the present invention;

[0056] Figure 10A This is a cross-sectional view of an exemplary height adjustment mechanism using screws according to some exemplary embodiments of the present invention;

[0057] Figure 10B yes Figure 10A A side view of a portion of an exemplary height adjustment mechanism;

[0058] Figure 10C yes Figure 10A A bottom view of a portion of an exemplary height adjustment mechanism, showing the manual adjustment interface;

[0059] Figure 10D This is a side view of an exemplary slanted joint rotary lifting member height adjustment mechanism in a closed (retracted) operating state according to some exemplary embodiments of the present invention, wherein the illustration depicts a bottom perspective view of the mechanism with the upper part separated from the lower part.

[0060] Figure 10E It is in the open (extended) operation state. Figure 10D One side of the height adjustment mechanism;

[0061] Figure 10F This is a side view of an exemplary bayonet-mounted height adjustment mechanism according to some exemplary embodiments of the present invention;

[0062] Figure 10G yes Figure 10F The bayonet mounting type height adjustment mechanism is relative to Figure 10F Side view rotated 90°;

[0063] Figure 10H yes Figure 10F and Figure 10G A bottom view of a portion of an exemplary height adjustment mechanism, showing the manual adjustment interface;

[0064] Figure 11 This is a schematic diagram of a data acquisition layer for an insole according to some exemplary embodiments of the present invention;

[0065] Figure 12 These are screenshots depicting exemplary user interfaces according to some exemplary embodiments of the present invention;

[0066] Figure 13 These are screenshots depicting exemplary user interfaces according to some exemplary embodiments of the present invention; and

[0067] Figure 14 These are screenshots depicting exemplary user interfaces according to some exemplary embodiments of the present invention. Detailed Implementation

[0068] Embodiments of the present invention relate to adjustable insoles and systems including or communicating with them. Specifically, some embodiments of the invention can be used to adjust insoles to various static and / or dynamic conditions for different users and / or adjust insoles to accommodate different activities of the same user. Alternatively or additionally, some embodiments of the invention detect and / or diagnose and / or warn users of emerging foot ulcers and / or other foot conditions and / or initiate and enable corrective and / or adjustment and / or treatment plans. According to various exemplary embodiments of the invention, treatment plans are implemented manually and / or automatically.

[0069] The principles and operation of the insoles and / or systems according to exemplary embodiments of the present invention can be better understood by referring to the accompanying drawings and description.

[0070] Before explaining at least one embodiment of the invention in detail, it should be understood that the application of the invention is not limited to the details set forth in the following description or illustrated by examples. The invention can have other embodiments or can be practiced or performed in various different ways. Furthermore, it should be understood that the wording is not restrictive.

[0071] Overview

[0072] Many exemplary embodiments of the present invention employ insoles. Exemplary insoles are described herein to avoid repeating details when explaining specific embodiments of the invention below.

[0073] Figure 1A and Figure 1B An insole, typically designated 10, is shown and is suitable for use in many embodiments of the invention. The exemplary insole 10 shown comprises two layers. In the depicted embodiment, these layers are a sensor layer 11 (…). Figure 1A ), Electronic components / adjustment layer 12 ( Figure 1B ).

[0074] In the depicted embodiment, the insole 10 includes a diagnostic layer 11 ( Figure 1A Multiple sensors 111 are deployed on the diagnostic layer 11. In some embodiments, layer 11 is flexible. In some embodiments, the sensors 111 include pressure sensors and / or temperature sensors and / or shear force sensors and / or humidity sensors. In some embodiments, the diagnostic layer 11 is composed of a polyester film with mechanical properties, a highly conductive fabric, and nanoscale sensing materials. In some exemplary embodiments of the invention, layer 12 includes a stimulation source (e.g., a vibrator). In some embodiments, the vibrator is integrated into the data processor 14.

[0075] In some embodiments, the diagnostic layer 11 includes a flexible film adhered to a conductive layer, which transmits the output from the sensor 111 to the electronic circuit layer 12. Figure 1B ).

[0076] In some embodiments, the diagnostic layer 11 and the electronic circuitry layer 12 are bonded together with a double-sided adhesive. When pressure is applied to layer 11 by the foot, layers 11 and 12 form an electrical contact and are switched to a sensing mode. In sensing mode, the output resistance of the sensing area changes with pressure.

[0077] For illustrative purposes only, electronic circuit layer 12 includes contact pads and / or wireless communication modules (e.g., Bluetooth or infrared) and / or one or more batteries 15 and / or wireless charging components and / or internal memory and / or wireless synchronization connectivity and / or a microcontroller and / or a data processor 14 and / or a printed circuit board and / or a USB connector and / or a charging port and / or a connection cable 16 and / or an accelerometer and / or a gyroscope. In some exemplary embodiments of the invention, one or more of these components are provided as part of a printed circuit board or a microcontroller.

[0078] Regulation / Electronic Device Layer 12 ( Figure 1B The insole 10 includes multiple adjustment mechanisms 20 adapted to alter the shape of the top surface (in contact with the user's foot). In some embodiments, the adjustment mechanisms 20 move in a coordinated manner, as will be explained in more detail below. Alternatively or additionally, in some embodiments, the mechanisms 20 are covered by padding blocks.

[0079] According to various exemplary embodiments of the present invention, the adjustment mechanism 20 includes a plunger and / or piezoelectric material and / or a motor (e.g., a stepper motor), gears (e.g., bevel gears, worm gears, etc.) and / or a spring-loaded mechanism and / or a hydraulic actuator. In some embodiments, the adjustment / electronics layer 12 includes any combination of these mechanisms.

[0080] By way of example only, cushioning and support materials on all insole layers may include: memory foam, foam, silicone, butyl rubber, neoprene rubber, polyurethane, ethylene-vinyl acetate copolymer (EVA), sponge, gel, leather, polymers and synthetic materials.

[0081] Figure 2 This is a schematic top view of a worm gear drive plunger head with a worm wheel 1, a worm 2, and a worm shaft 3, generally indicated by 20. According to some embodiments of the invention, the adjustment / electronics layer 12 includes, as... Figure 1B The diagram schematically illustrates multiple worm gear plunger heads 20 arranged therein. For example, each individual worm gear plunger head 20 is configured to move a corresponding cover pad to a specific horizontal height, resulting in controlled deformation of the insole 10. In some exemplary embodiments of the invention, the illustrated mechanism has a thickness of 4 mm or less when oriented in the insole. The insole itself may have a thickness of 5 to 50 mm.

[0082] Figure 3A This is a schematic cross-sectional view of another adjustment mechanism, generally represented as 30, applicable to... Figure 1B The situation pertains to the adjustment / electronics layer 12. In the described embodiment, the adjustment mechanism 30 includes a movable blade 32, a pad 31, and a motor assembly 33, as well as a coupling 36 configured to pivot the blade 32 relative to an axis 34. In some embodiments, the pivoting movement of the blade 32 changes the height of the pad 31. In the depicted embodiment, the motor assembly 33 rotates a screw 37 and pulls or pushes a lifting member 35 to apply a force on the bottom surface of the blade 32 via the lifting member 35, causing the blade 32 to pivot relative to the pivot 34 to raise the pad 31. The coupling 36 connects the screw 37 to the motor 33 and transmits the motion of the motor 33 to the screw 37, causing the position of the lifting member 35 to change to raise / lower the blade 32.

[0083] Figure 3B This is a top view of an exemplary insole layer according to an embodiment of the present invention, schematically showing... Figure 3A The arrangement of multiple adjustment mechanisms 30. In some embodiments, Figure 3A The regulating mechanism 30 is replaced Figure 1B Organization 20 in the middle.

[0084] Figure 3C yes Figure 3A The perspective view of the adjustment mechanism depicts the lifting of the pad 31 by the rotation of the screw 37 when the lifting member 35 retracts. Figure 3D yes Figure 3C A three-dimensional perspective view of the central adjustment mechanism in the closed position.

[0085] Exemplary application scenarios

[0086] Figure 4 This is a schematic diagram of the system, generally represented as 2400. According to various exemplary embodiments of the present invention, system 2400 either provides instructions for manually adjusting the individual height adjustment mechanisms in the insole, or sends digital signals to the height adjustment mechanisms to automatically perform adjustments in response to the signals.

[0087] In the depicted embodiments, the insole device 2410 is synchronized with the analysis and assessment tool 2420 via Bluetooth 2416, and each is primarily controlled by the user 12010. In various embodiments, data transmission and reception occur continuously or periodically. In the case of periodic transmission / reception, data is stored in computer memory within devices 2410 and / or 2420 and / or 2440 and / or cloud storage 2430. In the depicted embodiments, data is continuously compiled or presented in summary or periodic reports and displayed to the user 12010 and / or healthcare professional 12020 via displays 2422 of devices 2420 and 2440, respectively. In some embodiments, when 12010 is flagged as being at risk, healthcare professional 12020 receives an online alert via dashboard platform 2440. Alternatively or additionally, in some embodiments, healthcare professional 12020 remotely reviews real-time results, monitors, and treats patient 12010 via tools 2440 and / or 2420 according to treatment plan modification 2410. Alternatively or additionally, in some embodiments, data is stored on a cloud server 2430 with artificial intelligence (AI) and / or big data and / or machine learning capabilities. In some embodiments, server 2430 uses comparative science and / or personal historical data to build personalized models and / or make predictions and / or provide feedback and / or provide treatment recommendations and / or stress reduction and / or serve as early warning indicators of harm and / or request personal input. Alternatively or additionally, in some embodiments, medical recommendations 2414 are autonomously generated by algorithmic instructions from digital processor 2420 and / or cloud-based AI and / or machine learning (ML) and / or data science algorithms of 2430.

[0088] The depicted exemplary embodiment 2400 includes one or more insoles 2410 having a plurality of height adjustment mechanisms integrated on at least a portion of their area.

[0089] In some embodiments, an automatic adjustment interface is provided and the process is carried out from device 2420 to height adjustment mechanism in insole 2410 via relay 2412.

[0090] In other exemplary embodiments of the invention, each height adjustment mechanism has a manual adjustment interface. Exemplary height adjustment mechanism types and manual adjustment interfaces are described below. Furthermore, the insole 2410 includes one or more sensors that provide one or more output signals 2412.

[0091] In the depicted embodiments, system 2400 includes a data processor 2420 (described herein as a smartphone) designed and configured to convert output signals 2412 into alarms and / or user suggestions 2414, and a user interface 2422 (described herein as a smartphone screen) that presents the user suggestions 2414 and / or analyzed data. In some embodiments, the user suggestions 2414 originate from a diagnostic process, with their wireless connection 2418 to a cloud network 2430 for comparing scientific data and / or saving data and / or running AI, ML algorithms. User 12010 receives alarms and / or user suggestions 2414 from interface 2422 and performs manual adjustments 2450 on each of a plurality of height adjustment mechanisms based on the suggestions 2414. In some embodiments, a health expert 12020 remotely monitors real-time results and / or alarms and / or treatments and / or manages a patient's foot health from interface 2440, thereby reducing the need for clinic visits and, if necessary, interventions can be made through a medical orthopedic program 2414.

[0092] In the depicted embodiment, the data processor 2420 is located in a device outside the insole. According to various exemplary embodiments of the invention, the device outside the insole 2410 is, as illustrated, a smartphone, PC (personal computer), smartwatch, or tablet computer. Alternatively or additionally, in some embodiments, the system includes a wireless communication link (e.g., Bluetooth 2416) between the insole 2410 and the data processor 2420.

[0093] In other exemplary embodiments of the invention, the data processor 2420 is located in the insole 2410. According to these embodiments, user suggestion 2414 is transmitted from the insole 2410 and presented to the user 12010 via the interface 2422.

[0094] In some exemplary embodiments of the present invention, user suggestion 2414 includes a set of instructions for manually adjusting each height adjustment mechanism.

[0095] In some embodiments, sensors always collect data and perform gait analysis and / or pressure distribution mapping and / or temperature mapping for the user, which is then transmitted to the user interface (patient and / or healthcare professional). Using different algorithms and machine learning, current information can be cross-referenced, and various pathological patterns can be identified over time, thereby prompting action.

[0096] In some embodiments, a healthcare professional can manually adjust each height adjustment mechanism based on their knowledge and physical examination. The healthcare professional or user can determine the adjustment position based on a diagnosis (e.g., a pressure graph) displayed in the user interface by viewing high pressure and / or temperature zones in a graph, and can intuitively perform the adjustment based on software suggestions (e.g., "High pressure detected in the medial left arch. Change x1y1, x2y2 height adjustment mechanism +2mm") or remotely by the user but under the guidance of a healthcare professional. The healthcare professional can also directly send a clinic invitation to the patient for further observation and / or treatment and / or adjustments. According to these embodiments, the user 12010 manually implements the treatment recommendations 2450 via the height adjustment mechanisms in the insole 2410 based on the height adjustment recommendations.

[0097] Alternatively or additionally, in some embodiments, user suggestion 2414 includes an alert regarding primary foot ulcers. In some embodiments, the alert includes decompression instructions and / or correction of the user's gait and / or orthopedic disorders when abnormal pressure and / or foot temperature are detected.

[0098] In some embodiments, system 2400 includes a stimulation module (e.g., in each insole 2410) Figure 5B (539) and a manual and / or automatic activation interface for the stimulation module. In some embodiments, the manual activation interface is provided on the screen 2422 of the mobile phone 2420. According to various exemplary embodiments of the invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0099] Figure 5A This is a more detailed illustration of the information flow of the intelligent diagnostic layer 510, including a pressure sensor array 512 and / or a level sensor 514 and / or a gyroscope 516 and / or an accelerometer 518 and / or internal memory firmware and a connectivity module 519. In some exemplary embodiments of the invention, the accelerometer 518 and / or the gyroscope 516 are inertial sensors and measure the motion of an object, such as acceleration and angular velocity. In some exemplary embodiments of the invention, the gyroscope 516 and / or the accelerometer 518 are triaxial sensors. In some embodiments, the level sensor 514 (compass) provides a baseline when the inertial sensors (accelerometer and gyroscope) are calibrated. Alternatively or additionally, in some embodiments, the pressure sensor array 512 provides a high-resolution pressure map of the sole of the foot.

[0100] Data from the diagnostic layer 510 is fed to a software algorithm layer 520, which includes one or more data processors 522. In some embodiments, the algorithm layer 520 provides gait feature analysis. In some embodiments, the processor 522 unit has artificial intelligence capabilities and / or big data analytics capabilities and / or machine learning capabilities. The data processor 522 provides output signals to an adaptive autonomous layer 530, which includes an optimization module 532, an instruction card 534, a driver card 536, and a motor 538 that operates the adjustment mechanism in the insole as described above.

[0101] Figure 5B This is another detailed illustration of the information flow suitable for detecting and / or treating diabetic foot and / or neuro-orthopedic motor disorders (e.g., Parkinson's disease). In the depicted embodiment, the diagnostic layer 510 also includes a shear force sensor 513 and / or a temperature sensor and / or a climate control sensor 515. The purpose of foot temperature monitoring and / or in-shoe pressure and / or shear force is to identify impending inflammatory foot symptoms, such as DFU, infection, and acute Charcot neuroarthropathy attacks. Data from the diagnostic layer 510 is collected and fed to a software algorithm layer 520 for processing in one or more data processors 522. In some embodiments, the data processor 522 has artificial intelligence capabilities and / or big data analytics capabilities and / or machine learning capabilities. The data processor 522 provides an output signal to an adaptive autonomous layer 530, which includes an optimization module 532, an instruction card 534, a driver card 536, and a motor 538 that operates the adjustment mechanism in the insole as described above.

[0102] In some embodiments, the adaptive layer 530 includes a micromechanical module 539 for active, non-invasive stimulation of the user's lateral plantar surface. In some embodiments, non-invasive stimulation is part of a treatment plan and / or helps in the early prevention of DFU to reduce target symptoms and / or improves the mobility of outpatients in real-world rehabilitation in terms of both quality and function. In some embodiments of the invention, module 539 includes one or more tactile vibration motors and / or actuators, vibrators and / or wireless functional electrical stimulators.

[0103] The benefits of stimulating plantar fasciitis and / or flexor muscles to reduce gait and balance disorders and / or improve plantar sensation in patients with neuropathy are known.

[0104] Exemplary sensor response system

[0105] Figure 6This is a simplified schematic diagram of a responsive insole system according to some embodiments of the present invention, generally indicated as 600. In the depicted embodiment, system 600 includes a plurality of sensors 612 (612A, 612B, and 612C are depicted for clarity, although a much larger number is typically provided in actual use) and a plurality of adjustment mechanisms 614 (614A, 614B, and 614C are depicted for clarity, although a much larger number is typically provided in actual use). Each of the sensors 612A, 612B, and 612C provides a data output signal 618 (only 618B is depicted in the figure for clarity).

[0106] The illustrated exemplary system 600 also includes a data processor 620, which is designed and configured to receive data output signals (e.g., 618B) from sensors 612 (e.g., 612A, 612B, and 612C as depicted) and analyze the data from the output signals. Based on this analysis, the data processor 620 provides a response plan 622 as output.

[0107] In the depicted embodiment, system 600 includes an implementation module 630 that receives a response plan 622 and converts it into a plurality of response signals 632 (632B is depicted only for clarity), and transmits each of the plurality of response signals to a specific one of a plurality of adjustment mechanisms. Each adjustment mechanism responds to its received response signal to adjust its height.

[0108] Specifically, in the depicted embodiment, sensor 612B provides output 618B, which generates a response signal 632B and operates adjustment mechanism 614B. Simultaneously (though not depicted), sensor 612A provides output 618A, which generates a response signal 632A and operates adjustment mechanism 614A. Simultaneously (though not depicted), sensor 612C provides output 618C, which generates a response signal 632C and operates adjustment mechanism 614C.

[0109] Because the data processor 620 analyzes the output signals 618 as a set, the response plan 622 is a coordinated response plan based on the sensors in different areas of the insole. As a result, each of the response signals 632 is influenced by the data collected by all the sensors.

[0110] According to various exemplary embodiments of the present invention, sensors 612A, 612B and 612C are each independently selected from the group consisting of a pressure sensor, a temperature sensor, a level sensor, a gyroscope and an accelerometer.

[0111] According to various exemplary embodiments of the present invention, the data processor 620 is located in or on the insole 610 and / or worn or carried by the user of the insole (e.g., in a smartphone, smartwatch, or dedicated wearable device) and / or on a remote server.

[0112] According to various exemplary embodiments of the present invention, each adjusting mechanism 614A, 614B and 614C is independently selected from the group consisting of a plunger, a piezoelectric material, a motor, a gear, a bevel gear, a worm gear, a spring loading mechanism and a hydraulic actuator.

[0113] In some exemplary embodiments of the present invention, system 600 includes a stimulation module under the control of execution module 630. Figure 6 Not depicted in the text; see also Figure 5B (539 in the example). According to these embodiments, the response plan 622 includes a stimulation signal 632. According to various exemplary embodiments of the invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0114] Exemplary multi-user system

[0115] Figure 7 This is a simplified schematic diagram of a multi-user system according to some embodiments of the present invention, generally designated 700. In the depicted embodiment, system 700 includes a plurality of insoles 710 equipped with sensors 712 (only one is depicted for clarity), generating a timestamped data output signal 718 labeled with a UID (Unique Identifier) ​​for a user of a particular insole. In some embodiments, a single data output signal reflects data from a large number of sensors 712 distributed on the insole 710. In some embodiments, each sensor has a sensor ID indicating its position on the insole 710, and this position information is stored in the output signal 718.

[0116] In the depicted embodiments, timestamped output signals 718 are received and stored in a database with their UIDs as labels. In some embodiments, database 720 contains digital medical records (DMRs) of patients associated with their UIDs or communicates with other databases containing DMRs to retrieve data related to foot or gait-related issues of specific individuals in different scenarios.

[0117] Alternatively or additionally, in some embodiments, system 700 includes one or more data processors 730 that receive data output signals 718 from sensor 712. In some embodiments, processor 730 analyzes data from the output signal 718 associated with a specific UID and outputs a timestamped, stored response plan 732 for that specific UID. Alternatively or additionally, in some embodiments, processor 730 relays the response plan 732 to a response plan delivery module 740, which delivers the specific UID response plan 732 to the insole associated with the UID.

[0118] Alternatively or additionally, in some embodiments, analyzing changes in sensor output 718 over time in conjunction with the intervention response plan 732 will allow for the assessment of the therapeutic efficacy of the response plan. Alternatively or additionally, in some embodiments, the response strategy 732 is prepared based on DMR stored in database 720.

[0119] Although system 700 is presented simply here, the implementation of a system with a large number of users with various medical conditions is helpful for the large amount of sensor data 718 in database 720 before and after the implementation of response plan 732. In some embodiments, implementing machine learning algorithms on database 720 can help improve the effectiveness of future response plans.

[0120] Exemplary User Input Driven System

[0121] Figure 8 This is a simplified schematic diagram of a user input-driven system according to some embodiments of the present invention, generally designated 800. In the depicted embodiments, system 800 includes a user interface (UI) 810 adapted to receive user input defining a problem area 812 on the sole 814 and a data processor 820 including a conversion module adapted to convert the user input (problem area 812) into a response signal 822. In the depicted embodiments, UI 810 is provided by a touchscreen 813. According to various exemplary embodiments of the present invention, touchscreen 813 is part of a smartphone, tablet, or smartwatch. Alternatively or additionally, in various embodiments, UI 810 displays the sole 814 as an illustration or photograph of the user's foot.

[0122] According to various exemplary embodiments of the present invention, the data processor 820 is located at at least one location selected from the group consisting of an insole, a device worn / carried by a user of the insole, and a remote server. According to various exemplary embodiments of the present invention, the device worn / carried by the user represents a smartphone, smartwatch, tablet computer, or dedicated wearable device.

[0123] Alternatively or additionally, in some embodiments, system 800 includes an insole 830, which includes an adjustment mechanism (not depicted) adapted to respond to a response signal 822 and a response signal transmission module 840 adapted to transmit the response signal 822 to the insole 830. According to various exemplary embodiments of the invention, the adjustment mechanism includes at least one of the following: a plunger, a piezoelectric material, a motor, a gear, a bevel gear, a worm gear, a spring-loaded mechanism, a blade, and a hydraulic actuator. In other exemplary embodiments of the invention, the adjustment command is controlled by a health monitor or foot care professional and is remotely triggered by an outpatient, providing real-time monitoring in a real-life environment.

[0124] The placement and operation of the adjustment mechanism are as described above and / or below.

[0125] In some exemplary embodiments of the present invention, system 800 includes a stimulation module (not depicted here; see also) responsive to response signal 822. Figure 5B (539 in the original text). According to various exemplary embodiments of the present invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0126] Exemplary insole

[0127] Figure 9A This is a schematic diagram of the arrangement of the height adjustment mechanism 93 in the insole 911 according to an exemplary embodiment of the present invention; in the illustrated embodiment, the height adjustment mechanism is distributed under the heel, under the arch of the foot, and under the ball of the foot.

[0128] Figure 9B This is an exploded view showing an insole layer with an integrated height adjustment mechanism according to an exemplary embodiment of the present invention, the insole layer generally indicated by 2100; in Figure 9B In this context, layer 2160 is the substrate layer. In some embodiments, layer 2160 is made of polypropylene. In the depicted embodiment, layer 2150 is a flexible overlay layer. In some embodiments, layer 2150 is made of a thin plastic material that isolates the adjustment mechanism from the top layer and / or improves comfort. In the depicted embodiment, layer 2110 is the upper insole layer. According to various exemplary embodiments of the invention, layer 2110 is made of foam and / or gel and / or polyurethane and / or other fabrics. Each hole in layer 2160 is fitted with a height adjustment mechanism (shown in the illustration), as described below. Figure 10A The situation is described in the text. In some embodiments, each height adjustment mechanism includes a manual adjustment interface. According to various exemplary embodiments of the invention, each height adjustment mechanism is independently selected from the group consisting of a screw, a diagonal joint rotating lifting member, and a bayonet mounting member.

[0129] Figure 9CThis is a top perspective view of an insole, generally designated 2101, illustrating additional features according to an exemplary embodiment of the invention. In this view, the height adjustment mechanism 2130 is visible. In the depicted embodiment, the insole 2101 includes a magnetic connector 2142 and a battery 2152. According to this embodiment, the battery 2152 powers monitoring, analysis, and connectivity capabilities, and the connector 2142 facilitates connection to an external power source for charging. The magnetic connector 2142 facilitates charging without removing the insole 2101 from the shoe. In some embodiments using a magnetic charging cable (not depicted), two insoles can be charged using a dedicated cable. Alternatively or additionally, the magnetic connector 2142 may be moisture-proof and / or waterproof. In other exemplary embodiments of the invention, wireless charging is employed (e.g., using a dedicated charging pad on which the shoe containing the insole is placed). In other exemplary embodiments of the invention, a kinetic charging system is embedded in the insole.

[0130] According to various exemplary embodiments of the invention, battery 2152 supplies power to sensors (e.g., 2112 and / or 2162) and / or microprocessor 2164 and / or inertial measurement units (IMUs) and / or systems-on-chips (SOCs) and / or onboard memory and / or connectivity modules and / or stimulation hardware (e.g., vibration motors and / or haptic engines and / or micro piezoelectric actuators). In some embodiments, insole 2101 records data for several hours or other time periods in "offline mode" without connection to a smart device. According to these embodiments, battery 2152 provides power to operate monitoring, diagnostic, and vibration capabilities. In the depicted embodiments, vibration motor 2122 applies low-level vibration. According to various exemplary embodiments of the invention, low-level vibration contributes to improved neurological function.

[0131] Improvements in neurological function can potentially benefit the health and / or performance of many different types of wearers. For example, low-level vibration may be beneficial for stroke or diabetes-related nerve damage and / or improve balance and / or gait. Alternatively or additionally, low-level vibration can prevent injury and / or falls and / or help assess nerve damage and / or decreased plantar sensation. In some exemplary embodiments of the invention, imperceptible mechanical vibrations are delivered to the foot to enhance neurosensory performance—which in turn improves a person's balance, gait control, and sense of spatial position and movement of different parts of the body. In some embodiments, the operation of the vibration motor 2122 is performed via signals transmitted from a smartphone or third-party connected device or remote care management platform. In the depicted embodiment, the pressure sensor 2112 is located at key points where ulcers and / or high pressure are most commonly observed. In the depicted embodiment, the temperature sensor 2162 (one is shown for clarity, but in other embodiments there are 3, 5, 7, 9, or an intermediate or greater number) is located in one or more areas that are statistically and medically at high risk of ulcers and other conditions.

[0132] Figure 10A This is a cross-section of an exemplary screw-based height adjustment mechanism according to some exemplary embodiments of the present invention. In the described embodiment, the base 2210 includes a screw 2212 with a screwdriver slot 2214. Figure 10C Screw 212 rises or falls within base 210 in response to rotation of slot 2214. Figure 10B This is a side view of screw 2212. Figure 10C This is a bottom view of screw 2212, showing a manual adjustment interface in the form of a screwdriver slot 2214. Manually rotating slot 2214 with a screwdriver causes screw 2212 to rise or fall within the internal channel of base 2210.

[0133] Figure 10D This is a side view of an exemplary angled joint rotary lifting height adjustment mechanism in a closed (retracted) operating state according to some exemplary embodiments of the present invention, wherein the illustration depicts a bottom perspective view of the mechanism with the upper and lower parts separated. According to the depicted embodiment, rotation of the shaft 2224 causes a change in the orientation of the upper cover 2222 relative to the lower cover 2226 along the contact surface 2225. As a result, as... Figure 10E As shown, the top surface 2220 rises. The rotation of the shaft 2224 in the opposite direction lowers the top surface 2220.

[0134] Now for reference Figure 10DThe illustration shows that the extension (or retraction) of the shaft 2224 is achieved by rotating the manual adjustment interface 2229, which is depicted here as a hexagonal socket that can be rotated by an Allen wrench. Rotation of the interface 2229 causes the teeth 2227 on the bottom side 2221 of the contact surface 2225 of the upper 2222 to be positioned relative to the top side 2223 of the contact surface 2225 of the lower 2226. Figure 10E The corresponding teeth (not depicted) on 2221 move. Without the rotational force provided by the manually adjusting interface 2229, the engagement of the corresponding sets of teeth at 2221 and 2223 prevents 2222 from rotating relative to 2226.

[0135] Figure 10F This is a side view of an exemplary bayonet-mounted height adjustment mechanism according to some exemplary embodiments of the present invention. Figure 10G yes Figure 10F The bayonet mounting type height adjustment mechanism is relative to Figure 10F Side view rotated 90°.

[0136] Figure 10H yes Figure 10F and 10G A bottom view of a portion of an exemplary height adjustment mechanism shows a manual adjustment interface in the depicted embodiment, whereby inserting a square rod into a square hole 2236 allows the shaft 2234 to rotate relative to a rectangular hole 2238.

[0137] In the depicted embodiment, the shaft 2234 is fitted with rectangular protrusions 2232. When these protrusions are aligned with the bore 2238 (e.g. Figure 10G As shown, shaft 2234 can freely rise / fall through hole 2238. Rotation of shaft 2234 in either direction causes protrusion 2232 to misalign with hole 2238 and prevents shaft 2234 from rising / falling through hole 2238. In this way, square hole 2236 rotates 90° to unlock the mechanism and immediately relocks it when protrusion 2232 misaligns with hole 2238.

[0138] Alternatively or additionally, in some embodiments, the insole 2100 includes one or more sensors. Figure 11 This is a schematic diagram of a data acquisition layer for an insole according to some exemplary embodiments of the present invention, generally indicated as 2300. According to various exemplary embodiments of the present invention, sensors include pressure sensors 2312 and / or sensors 2314 to obtain foot temperature microclimate temperature and humidity data within the insole, and / or include level sensors 2315 and / or gyroscopes 2316 and / or accelerometers 2318. Various types of sensor groups are present in… Figure 11The layer is referred to as intelligent diagnostic layer 2310. In the depicted embodiments, layer 2310 also includes a battery 2320 and a system-on-a-chip (SOC) 2360. In some embodiments, SOC 2360 includes integrated Wi-Fi and Bluetooth modules. In the depicted embodiments, data acquisition layer 2300 includes a data channel 2362 configured to transmit output signals from one or more sensors to data processor 2340. In the depicted embodiments, data processor 2340 is equipped with software algorithm 2330 and / or communicates with analysis software via network 2350. In some exemplary embodiments of the invention, the analysis software is cloud-based. In some exemplary embodiments of the invention, data processor 2340 is physically present in insole 2100.

[0139] In some embodiments of the invention, the pressure sensor 2312 is woven into a conductive fabric / textile as a single layer. Single-layer pressure sensors offer higher performance and are thinner than multi-layer sensors.

[0140] Alternatively or additionally, in some embodiments, the insole 2100 includes a stimulation module (e.g., Figure 5B The manual activation interface of the stimulation module (539) and the stimulation module. According to various exemplary embodiments of the present invention, the stimulation module includes at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

[0141] Additional Exemplary System

[0142] Refer again Figure 4 The system 2400 can also be described as a data processor 2420, which is designed and configured to receive one or more output signals 2412 from sensors in the insole 2410, convert the output signals into user suggestions 2414, and a user interface 2422 that presents the user suggestions 414.

[0143] System 2400 can perform continuous monitoring of plantar pressure and / or temperature and / or user gait for diagnosing early foot ulcer formation, and thus dynamically output alerts and / or medical advice (using the unloading treatment plan of the regulating mechanism) 2414 to the user interface 2422 and / or via the user interface 2440 to a health expert 12020. Therefore, system 2400 can reduce the recurrence of diabetic foot ulcers.

[0144] According to various exemplary embodiments of the present invention, the data processor 2420 is located in a device selected from the group consisting of smartphones, smartwatches, PCs (personal computers), and tablet computers. Alternatively or additionally, in some embodiments, the system includes a wireless communication link 2416 between the sensor and the data processor 2420.

[0145] According to various exemplary embodiments of the invention, user suggestion 2414 includes a set of instructions for manually adjusting the various independent height adjustment mechanisms in the insole (e.g., as part of a weight-reduction treatment plan) and / or user suggestion 2414 includes an alert regarding primary foot ulcers.

[0146] Exemplary network implementation.

[0147] Refer again Figure 4 In some embodiments, data processor 2420 uses an available network connection (e.g., Wi-Fi 2418) to evaluate output signal 2412 relative to comparative scientific data 2430 when making recommendation 2414. Alternatively or additionally, in some embodiments, data processor 2420 uses an available network connection (e.g., Wi-Fi 2418) to send a query to health expert 12020 via device 2440 belonging to a health expert when making recommendation 2414. Health expert 12020 can monitor and perform remote diagnoses and develop care plans to send medical advice (e.g., treatment recommendations) to user 12010 via interface 2440, which will be presented to user 12010 via user interface 2422.

[0148] Exemplary use cases

[0149] The various embodiments of the invention described above will find practical applications in a variety of situations, including orthopedic problems, neuro-orthopedic problems, diabetic heel, diabetic foot (ulcers, infections, peripheral neuropathy), rehabilitation, early diagnosis of Parkinson's disease and Alzheimer's disease, stroke, obesity, falls in the elderly, various musculoskeletal disorders and movement-related diseases, and are expected to reduce pain, increase comfort, increase independence in daily living activities and alleviate various symptoms.

[0150] Alternatively or additionally, the various embodiments of the invention described above are expected to have practicality for sports training and / or fitness and / or as part of rehabilitation and / or physical therapy and / or in outpatient or home settings.

[0151] Alternatively or additionally, it is expected that the various embodiments of the invention described above will provide warnings of excessive stress that may cause injury and / or encourage gait correction and / or provide internal / external stimulation and / or provide biofeedback.

[0152] Alternatively or additionally, it is anticipated that the various embodiments of the invention described above will eliminate the need for gait analysis laboratories for certain subjects. By doing so, it will allow for real-time diagnosis and / or monitoring and / or training and / or treatment of outpatients and / or various living environments. Such embodiments can be fitted into everyday shoes, making them lightweight and inconspicuous.

[0153] Alternatively or additionally, it is anticipated that the various embodiments of the invention described above will be provided in the sole, rather than in the insole. According to these embodiments, adjustments include changing the stiffness of the sole.

[0154] Exemplary data structures

[0155] Now refer to Figure 9C and Figure 4 According to various exemplary embodiments of the present invention, sensor data signals and / or treatment plan data signals (such as...) are processed in different ways. Figure 4 (As shown by the double-headed arrow in 2412).

[0156] In some embodiments, each sensor 2112 ( Figure 9C Each sensor 2400 is equipped with a unique identifier (UID). The sensor UID helps system 2400 distinguish data output signals from different sensors 2112. Alternatively or additionally, in some embodiments, the processor at processor 2164 and / or 2420 stores a sensor location map, where each sensor UID is assigned to a discrete location. This map helps system 2400 associate data from a specific sensor with a specific location in insole 2410, which corresponds to a matching location on the sole of user 12010's foot. Alternatively or additionally, in some embodiments, system 2400 is equipped with a date / time module that associates time information with each data output signal from a specific sensor 2112. According to various exemplary embodiments of the invention, the date / time module is provided in each individual sensor 2112 and / or processor 2164.

[0157] Alternatively or additionally, in some embodiments, each of the height adjustment mechanisms 2130 is assigned a unique identifier (UID). In some embodiments, a height adjustment mechanism location map is stored at the processor at 2420, wherein each height adjustment mechanism UID is assigned to a discrete location. The height adjustment mechanism UIDs contribute to the system 2400's ability to implement location-based treatment plans.

[0158] Regardless of the exact configuration, the data output signal 2412 from the insole 2410 to the data processor at 2420 carries a set of independent signals from different individual sensors 2112, where each individual sensor signal is associated with a UID, physical location within the insole 2410, and time information. This data is analyzed by the data processor at 2420, which responds by displaying the data 2412 on a screen 2422 to the user 12010 (e.g., as a map) and / or by developing a treatment plan that includes instructions for adjusting the different individual height adjustment mechanisms 2130. According to some exemplary embodiments of the invention, the treatment plan is displayed 2414 on the screen 2422 to the user 12010 for manual execution 2450. In other exemplary embodiments of the invention, the treatment plan is transmitted directly from 2420 to the insole 2410 as a digital signal 2412 for automatic execution. The treatment plan digital signal 2412 carries a set of independent execution signals for different individual height adjustment mechanisms 2130, wherein each individual execution signal is associated with a UID of a specific height adjustment mechanism 2130.

[0159] When the treatment plan digital signal 2412 arrives at the insole 2410, the processor 2164 uses the adjustment mechanism unique identifier (UIDS) to resolve it into an individual signal for the individual height adjustment mechanism 2130. In some embodiments, the processor 2164 stores a list of unique identifiers (UIDS) for the height adjustment mechanism 2130.

[0160] Exemplary data output from shoe insoles

[0161] According to various exemplary embodiments of the present invention, one or more types of sensors in the insole provide one or more types of data.

[0162] In some embodiments, the pressure sensor provides an output including a unique identifier sensor and / or a unique identifier insole and / or sensor position and / or pressure (e.g., in N / cm2 or kPa) and / or a timestamp.

[0163] Alternatively or additionally, in some embodiments, the temperature sensor provides an output including a unique identifier sensor and / or a unique identifier insole and / or sensor location and / or temperature and / or timestamp.

[0164] Alternatively or additionally, in some embodiments, the shear force sensor provides an output including a unique identifier sensor and / or a unique identifier insole and / or sensor location and / or resistance measurement (e.g., in kPa) and / or a timestamp.

[0165] Alternatively or additionally, in some embodiments, the humidity sensor provides an output including a unique identifier sensor and / or a unique identifier insole and / or sensor location and / or relative humidity (RH) measurement (e.g., degrees Celsius) and / or measurement resolution and / or timestamp.

[0166] Alternatively or additionally, in some embodiments, the system records temporal gait characteristics, such as heel strike time and / or toe lift-off time. Alternatively or additionally, in some embodiments, accelerometer and gyroscope outputs allow the system to record spatial gait measurements, such as stride length and / or stride speed and / or cadence and / or stance and / or swing duration and / or stride duration and / or asymmetry.

[0167] Alternatively or additionally, in some embodiments, the system records data about the height adjustment mechanism, such as its position and / or activity status and / or the most recent height setting and / or the new height setting and / or the default height value and / or the maximum height and / or the minimum height and / or the new adjustment value in millimeters. In some embodiments, the automatic height adjustment mechanism provides a data output signal. In other exemplary embodiments of the invention, the system records data based on the last instruction issued to each height adjustment mechanism, regardless of whether the mechanism is manually or automatically operated.

[0168] It is anticipated that many regulating mechanisms and / or communication protocols will be developed during the life of this patent, and the scope of this invention is intended to include all such new technologies a priori.

[0169] Although the invention has been described in conjunction with specific embodiments thereof, it will be apparent to those skilled in the art that many alternatives, modifications, and variations will be readily apparent. Therefore, it is intended to cover all such alternatives, modifications, and variations that fall within the broad scope of the appended claims.

[0170] Specifically, various numerical indicators have been used. It should be understood that these numerical indicators can be further varied based on various engineering principles, materials, intended uses, and designs incorporated into the various embodiments of the invention. Furthermore, components and / or actions that pertain to exemplary embodiments of the invention and are described as single units can be divided into sub-units. Conversely, components and / or actions that pertain to exemplary embodiments of the invention and are depicted as sub-units / individual actions can be combined into a single unit / action having the described / depicted function.

[0171] Alternatively or additionally, features used to describe a method may be used as device features, and features used to describe a device may be used as method features.

[0172] Exemplary User Interface

[0173] Figure 12, Figure 13 and Figure 14 It's a screenshot depicting something like... Figure 4 An exemplary user interface associated with the operation of the system 2400 is shown.

[0174] Figure 12 It is when user 12010 ( Figure 4 Log in to device 2420 ( Figure 4 This is an exemplary main user interface that will be presented when using an insole management application on a shoe insole. The main user interface has a tab bar menu 2510 to select the data type to be displayed. In the depicted embodiment, tabs for pressure graphs and temperature graphs are present. In other exemplary embodiments of the invention, other types of displays may be used, depending on the type of sensors deployed in the insole. A second set of tab bar buttons 2512 allows the user to select the type of data to be displayed. The current selection is "Real-time," indicating that the current sensor output data is displayed on map 2518. In the described embodiment, other available scenarios are walking straight and standing. In other exemplary embodiments of the invention, scenarios such as running and climbing stairs are presented. Panel 2514 is an alert for user 12010 (see...). Figure 4 (2414 in the text). Button 2516, labeled "Adjust Now," allows the user to enter a command.

[0175] Figure 13 An exemplary pop-up screen is depicted that appears when a user clicks the "Adjust Now" button 2516 from the home screen. The depicted exemplary pop-up screen includes buttons for controlling the operation of the adjustment mechanism. The depicted exemplary pop-up screen includes a foot selection menu 2610 for indicating which insole to operate and a target area selection menu 2612 that allows the user to select the foot area to be adjusted for height. In the depicted embodiment, the target area selection menu 2612 includes the metatarsal strip; distal arch, arch 2, and proximal arch.

[0176] In some embodiments, the user uses slider 2614 to select the magnitude and direction of the change, which is then displayed 2616 on the relevant foot in menu 2612. In other exemplary embodiments of the invention, the system indicates a suggested magnitude and direction of change, which is then displayed 2616 on the relevant foot in menu 2612. In either case, the user makes the change by clicking the Submit Changes button 2618.

[0177] In the depicted embodiment, the stimulation button 2620 provides the user with the possibility of applying stimulation, either as an addendum to or in lieu of height adjustment.

[0178] Figure 14 An exemplary pop-up screen is depicted when a user clicks the stimulation button 2620.

[0179] Figure 14 The illustrated exemplary pop-up screen includes a foot selection menu 2710, a target area selection menu 2712, and a duration selection menu 2714. In the depicted embodiment, the target area selection menu 2712 includes a metatarsal strip; the distal arch and the proximal arch (foot arch number 2 is used for illustrative purposes). In the depicted embodiment, the time selected at 2714 is superimposed 2715 on the relevant location menu 2712. In other exemplary embodiments of the invention, the system indicates the suggested location and duration of the stimulus superimposed at the relevant location 2715 on the menu 2712. In any case, the user applies the stimulus by clicking the start button 2718.

[0180] The various features described above and presented in the examples below can be combined in all possible combinations and sub-combinations to produce additional embodiments of the invention. The information given in the examples above and below is illustrative in nature and does not limit the scope of the invention as defined solely by the appended claims.

[0181] Each description of an embodiment of the invention that includes a specific feature, part, component, module, or process covers explicit statements of additional embodiments of the invention that do not include the described feature, part, component, module, or process.

[0182] Alternatively or otherwise, several exemplary embodiments of the present invention exclude any particular feature, portion, component, module, process, or element not specifically disclosed herein.

[0183] All publications, references, patents, and patent applications mentioned in this specification are incorporated herein by reference in their entirety as if each individual publication, patent, or patent application were specifically and individually indicated to be incorporated herein by reference. Furthermore, any reference or identification in this application should not be construed as an admission that such reference is used as prior art in this invention.

[0184] Additional objects, advantages, and novel features of the various embodiments of the present invention will become apparent to those skilled in the art upon examination of the following non-limiting examples. Furthermore, each of the different embodiments and aspects of the invention as described above and claimed in the following claims section can be experimentally supported in the following examples.

[0185] Example

[0186] The invention is now illustrated in a non-limiting manner with reference to the following examples, which, together with the foregoing description, illustrate the invention.

[0187] Example 1:

[0188] youth athletes

[0189] A 20-year-old male (e.g.) Figure 4 User 12010, who is in good physical condition except for slightly flat feet, will be running on level ground. Data is collected using sensors in insole 2410 for preliminary diagnosis.

[0190] According to various exemplary embodiments of the invention, the diagnosis is performed by input from a healthcare professional 12020 via a data processor smartphone 2420 and / or a remote analysis module in a cloud 2430 and / or via a computer 2440. Based on this diagnosis, the insole appears to provide sufficient support, therefore no changes will be made to the insole. The system will set a separate threshold for subsequent analysis based on individual data and observed history (if one or more parameters are met or exceeded; not necessarily a complete analysis). For example, in some embodiments, the system sets a threshold of 200 kPa for vertical plantar pressure and / or a temperature rise threshold exceeding 2.2 degrees Celsius.

[0191] Threshold parameters and values ​​are discussed in, for example, in "The role of foot pressure measurement in the prediction and prevention of diabetic foot ulcers - a comprehensive review" (Chatwin et al., Diabetes Metab Res Rev (2019)).

[0192] 36(4):e3258) and / or described in Beach, Christopher & Cooper, Glen & Weightman, Andrew & Hodson-Tole, Emma & Reeves, Neil & Casson, Alex. (2021) (Basel, Switzerland). 21.10.3390 / s21051717; each is fully incorporated herein by reference.

[0193] In this example, vertical foot pressure will be measured by a force-sensing resistor (FSR), a pressure sensor matrix from a conductive fabric (such as VELOSTAT), or a sensor based on a graphene hybrid material.

[0194] In this example, pressure sensors will collect cumulative pressure data and / or peak pressure data and / or pressure-time integral data. Alternatively or additionally, in this example, gait analysis during activity will be generated from accelerometer and / or gyroscope data. In some embodiments, the system algorithm will compare peak plantar pressure data, gait parameters, and the center of pressure (COP) path between a normal foot model and the patient's foot. If this comparison reveals significant changes in overthreshold pressure and / or gait parameters affecting the COP, the system-generated diagnosis will indicate flat foot, and based on a comparison between the current foot pressure distribution map and the normal foot pattern model, the algorithm will determine which modulators should be activated and the speed and / or magnitude of the modulation. (See Huang et al., PLoS One (2020) 15(8):)

[0195] e0237382.doi) "Arch support insoles are beneficial for standing time, rhythm, plantar pressure and contact area in patients with flat feet" and / or Han et al., Journal of Physical Therapy Science (2011) 23(4):683-685 "Differences in plantar pressure and COP between flat feet and normal feet during walking"; each is fully incorporated herein by reference.

[0196] For example, after running for 15 minutes and an additional distance of 2.5 kilometers, the additional system 200 will recalculate whether the individual threshold has been reached. This recalculation will identify increased stress and plantar pressure in the left arch region, as well as foot joint motion parameters. The system will determine the risk of injury due to improper foot placement during the activity. The algorithm will calculate that additional support for both feet in the arch region will improve the user's biomechanics and / or balance and / or movement. This calculation will be performed by AI and / or ML algorithms implemented at 2420 and / or 2430. In this case, the autonomously generated treatment plan would include increasing the height of the left proximal arch region of the insole by 3 mm and the height of the right medial arch region of the insole by 5 mm.

[0197] In some embodiments, sensor data will be collected and stored in a database (e.g., Figure 7 In the 720), the algorithm calculates a treatment plan based on a comparison between a set of clinical roles and various known clinical foot patterns, using machine learning (ML) or other pattern recognition analysis for DFU prediction or treatment.

[0198] Based on a human gait database (e.g., stored in) that will be trained using artificial intelligence (AI) and / or ML algorithms. Figure 7With 720 digital medical records in the database, the system's ability to diagnose patients and / or develop treatment plans will improve over time as the number of records in the database increases (e.g., 720).

[0199] Alternatively or additionally, the sensor output data will be visualized as a map so that healthcare professionals can train the ML algorithm for treatment plans and / or changes / adjustments that should be implemented.

[0200] In some exemplary embodiments of the invention, the treatment plan is transmitted from a smartphone 2420 to the insole 2410 as digital instructions 2412 (e.g., via Bluetooth 2416). According to these embodiments, the digital instructions 2412 are parsed by a processor in the insole 2410 to separate digital signals for each individual height adjustment mechanism in the insole 2410, and each individual height adjustment mechanism automatically responds to its received digital signal. In some exemplary embodiments of the invention, changes in the height adjustment mechanism occur when the force applied to the foot is minimal, such as when the foot is moving in the air. Alternatively or additionally, in some embodiments, changes in the height adjustment mechanism are implemented incrementally over time.

[0201] In other exemplary embodiments of the invention, the treatment plan is provided to user 12010 as user suggestion 2414 on display 2422 of smartphone 2420. User 12010 then manually implements 2450 the treatment plan by manually adjusting each height adjustment mechanism in insole 2410.

[0202] In some embodiments, user suggestions 2414 on display 2422 will guide user 12010 with visual guidance of the precise position and rate and / or magnitude of change of the adjustment mechanism using a diagram of the sole of each foot. Each adjustment mechanism will be numbered and have a visual and / or audible indicator to indicate the degree of change (e.g., the user will feel a click sound for every 1 mm of change as they turn).

[0203] Following the implementation of the treatment plan, the assessment described above will demonstrate its effectiveness. If necessary, supplementary treatments will be developed and implemented. This cycle will then be repeated periodically and / or in response to threshold triggers.

[0204] Example 2:

[0205] Diabetic men

[0206] For a 49-year-old male with diabetes who has no signs (or early signs of neuropathy), accurately diagnosing or predicting the risk of diabetic foot ulcers is difficult, especially for those with poor self-care management. This system will measure patient adherence (e.g., hours / day of insole use) and monitor healthcare professionals 12020 ( Figure 4 The required clinical indicators are used to remotely manage patients during their daily activities.

[0207] In this example, the relevant primary clinical indicators will be plantar pressure data and / or dynamic foot temperature parameters at different sites and / or gait indicators. Some embodiments will also use supportive clinical indicators, such as plantar shear stress (friction) distribution data at various sites and plantar humidity.

[0208] Healthcare professional 12020 will access the data through a dedicated secure network portal (e.g., 2440). System 2400 will collect, analyze, and display for healthcare professional 12020 the output from sensors in insole 2410, including historical sensor output data for the patient. The cumulative output from sensors in insole 2410 will help healthcare professional 12020 detect and address inflammation before diabetic foot ulcers (DFU) actually form. This early detection will help reduce the risk of amputation. According to these embodiments, insole 2410 will embed multiple sensors that will measure and detect differences in stress and / or pressure and / or foot temperature and / or shear force and / or humidity and / or climate in the foot in real time. In some embodiments, foot climate will be measured by an array of one or more microclimate sensors capable of measuring microclimates including temperature, pressure, and humidity.

[0209] In some embodiments, if a trigger threshold is exceeded, the sensor data output 2412 of the data processor relayed to the smartphone 2420 will trigger an alarm to the patient 12010 and / or the healthcare professional 12020.

[0210] In some embodiments, the peak pressure threshold (the maximum physical force applied to the area) will be 200 kPa. Alternatively or additionally, in some embodiments, the temperature threshold will be a temperature rise of 2.2 °C. Alternatively or additionally, in some embodiments, measurements of temperature asymmetry between the feet and / or combined contralateral and average temperature analyses will be used as the temperature threshold.

[0211] Shear stress occurs when two forces are applied in opposite directions, causing tissue deformation parallel to the surface. Subsequent studies have shown that the local peak shear stress in diabetic patients (mean 82.0 ± 26.4 kPa) is higher than that in healthy controls (64.6 ± 15.7 kPa), and even higher in patients with diabetic neuropathy (86.4–91.3 ± 29.0–30.3 kPa) and in individuals with a history of DFU neuropathy (135.3 ± 60.6 kPa) (Jones et al., “Prediction of diabetic foot ulcers: the value of using microclimate sensor arrays” J Diabetes Sci Technol (2020) 14(1):55–64; which is incorporated herein by reference in its entirety).

[0212] In some embodiments, a humidity sensor and / or mean skin resistance (which indicates hydration levels) will be employed. Both under- and over-hydration can affect foot health, especially in patients with diabetic neuropathy. Although there are studies on the correlation between DFU and foot humidity, no clear clinical threshold has been established. The insole according to an exemplary embodiment of the invention provides an important tool for data collection and for correlating data with disease progression and / or treatment outcomes.

[0213] In some embodiments, the threshold is set individually for a specific patient 12010. In some embodiments, the healthcare specialist 12020 will decide whether to summon the patient 12010 to the clinic and / or provide a treatment plan.

[0214] If a healthcare expert 12020 provides a treatment plan, it will be implemented manually or automatically, as described in Example 1.

[0215] In some embodiments, the data is presented to the healthcare professional 12020 in the form of, for example, temperature and / or pressure maps. In some embodiments, the healthcare professional 12020 compares the data over a period of time to identify trends and make a diagnosis. In therapeutic plantar pressure reduction systems, the system minimizes or removes the weight applied to the foot to help prevent and heal ulcers, particularly those caused by poor blood circulation in the foot, and avoid dangerous secondary infections that are indicators of inflammation that can lead to debilitating foot ulcers or even amputation. For example, if there is an ulcer or risk of ulceration under the metatarsal head, the height adjustment mechanism of the midfoot portion of the foot raises it more from the top of the insole before the vulnerable area and / or arch, suspending the metatarsal head above the insole surface, reducing plantar pressure at risk areas by redistributing pressure (within safe limits) to other areas of the foot (increasing the total contact area). Evaluations have shown that custom-made foot orthotics can increase the total contact area (redistribute force) and are able to reduce plantar pressure. Therefore, the insole according to an exemplary embodiment of the present invention should be able to reduce the risk of diabetic neuropathy foot ulcers.

[0216] According to this embodiment, the sensor monitors foot health as long as the insole 2410 is worn. In some embodiments, the treatment plan implemented by the system 2400 will include activating a stimulation mechanism (see...). Figure 5B (539) to improve nerve sensitivity in the sole of the foot. In some embodiments, an external monitoring device (e.g., a smartphone 2420) will alert the user 12010 or a healthcare professional 12020 regarding the detection of abnormal pressure and potential risks of DFU. According to these embodiments, treatment and / or response plans will be automatically activated by the user and / or remotely activated by a healthcare professional.

[0217] In some embodiments, user 12010 will manually activate the stimulation mechanism in insole 2410. In some embodiments, this manual activation will be initiated by the user in response to a medical suggestion 2414 provided by the system. In other exemplary embodiments of the invention, the data processor of telephone 2420 will send a signal 2412 to insole 2410 to activate the stimulation mechanism in response to sensor output data 2412. In any case, the stimulation mechanism will assist in the diagnosis and / or treatment and / or rehabilitation of patients with neurogenic diabetes and / or neuromuscular diseases and / or post-stroke patients. In some embodiments, the stimulation mechanism employs transcutaneous electrical nerve stimulation and / or functional electrical stimulation (FES). Alternatively or additionally, in some embodiments, the stimulation mechanism will serve to provide foot electromyography (EMG) biofeedback and / or other biofeedback to assist patient 12010 without foot lesions in performing foot arching exercises.

[0218] In some embodiments, diagnosis and treatment will be determined by a clinic healthcare specialist 12020 through a physical examination of the foot and manual adjustments made on-site. Alternatively or additionally, in some embodiments, digital assessment based on sensor data 2412 may aid in the decision-making process and / or help the specialist 12020 determine the nature of the treatment plan as appropriate. Alternatively or additionally, the treatment plan may also be determined by the specialist 12020 via a dashboard presented as a user interface (UI) at 2440. According to these embodiments, the specialist 12020 will send the digital treatment plan to a mobile phone 2420 via network 2418, which will then forward it as treatment plan 2412 to the insole 2410.

[0219] Example 3:

[0220] A 35-year-old woman receives a customized orthodontic prescription.

[0221] A 35-year-old woman with high arches causing lower limb pain, resulting in instability and / or gait problems, will wear insoles 2410 ( Figure 4The height adjustment mechanism in insole 2410 will redistribute pressure on her foot and / or provide support.

[0222] Installing the insole 2410 will be simple and can be completed during a single outpatient visit by selecting an off-the-shelf product with the appropriate shoe size. During the visit, it will be paired with a smart device (such as a mobile phone 242) via Bluetooth 2416. Once the initial setup process is complete and the patient 12010 begins walking, sensor output data 2412 will be transmitted from the insole 2410 to the smartphone 2420. The data processor in 2420 will analyze the sensor output data to complete a “foot ID” based on gait indicators and / or medical analysis and / or sensor data.

[0223] "Medical analysis" refers to the initial clinical judgment, foot shape, and initial personal medical condition and / or their BMI used to assess patient risk if the patient has a history of DFU attacks when prescribing insoles.

[0224] "Gait metrics" originate from motion analysis using data output from accelerometers and gyroscopes. Gait metrics include dynamics and gait parameters such as stance, rhythm, balance, and stride length (r / l). Each parameter can be plotted as a function of time and displayed together on the same timeline.

[0225] Sensor data includes, but is not limited to, output signals from pressure sensors and / or temperature sensors and / or shear force sensors and / or humidity sensors. This sensor data aids in medical analysis and prediction for patients at risk of ulceration. Pressure sensor data is useful for all types of patients.

[0226] Foot IDs, based on gait metrics and / or medical analytics and / or sensor data, contain a "map" for clinical diagnosis.

[0227] In some embodiments, device 2420 relays data to digital medical records (DMRs) (e.g., in the cloud 2430 and / or at a remote server 2440). According to these embodiments, DMRs can be retrieved for further analysis and / or investigation.

[0228] Alternatively or additionally, in some embodiments, the treatment plan will be prepared by a data processor at 2420 and / or 2430 and / or 2440, optionally with input from a healthcare expert 12020, as described in Example 1. As described in Example 1, the treatment plan will be implemented manually or automatically.

[0229] In this example, pressure sensors, accelerometers, and gyroscopes will be used to extract gait data and determine the mean peak pressure and whether the patient exceeds a predetermined threshold. Analysis using machine learning algorithms and deep learning will attempt to find a recognizable pattern in the platform's database (e.g., 720) containing an appropriate treatment plan for the problem, alerting expert 12020 and / or patient 12010, and, if permitted, implementing the treatment plan in a completely autonomous manner.

[0230] Example 4:

[0231] Diabetic neuropathy in women with foot deformities

[0232] High blood sugar levels over many years in diabetic patients lead to progressive damage to nerve fibers and blood vessels, causing peripheral neuropathy and peripheral vascular disease (PVD), respectively. Both conditions are common in diabetic patients. In a 54-year-old female diabetic subject, insoles 2410 ( Figure 4 This will be able to provide physical stimulation and / or laser and / or vibration and / or functional electronic stimulation (e.g., to the foot) Figure 5B Stimulation module 539 in the middle.

[0233] Due to neuropathy, damaged motor nerves can lead to atrophy and weakness of the intrinsic foot muscles. In some embodiments, the stimulation will be used for diagnosis, as well as for assessing nerve damage and / or its progression. Alternatively or additionally, in some embodiments, the stimulation will be used to improve balance and / or stability and / or blood flow to the foot and associated nerves.

[0234] Neuropathy progresses over time and is associated with loss of sensation in the foot. In some embodiments, the patient's response to stimulation is used to detect and / or measure loss of sensation over time (e.g., by testing with different low levels of electrical stimulation of the foot) and / or to treat weak, damaged, or paralyzed muscles. In some embodiments, transcutaneous electrical nerve stimulation (Tens) can aid in the final stages of wound healing in patients with diabetic foot ulcers.

[0235] Alternatively or additionally, when high pressure and / or high temperature, indicative of a pre-ulcer stage, occur, the height adjustment mechanism will function in a stress-relief treatment plan. Thus, exemplary embodiments of the present invention will function in the preventative treatment of diabetic foot ulcers.

[0236] In summary, physical stimulation is not part of a burden reduction treatment plan, but rather an alternative or supplementary treatment plan or assessment tool.

[0237] The patient will receive physical stimulation. According to various exemplary embodiments of the invention, physical stimulation will promote healing and / or slow disease progression. Alternatively or additionally, in some embodiments, physical stimulation will be administered as part of a field of examination. Alternatively or additionally, in some embodiments, physical stimulation will be used as an assessment tool for decision-makers (e.g., healthcare professionals 12020).

[0238] In addition to the patient's motor nerve damage, chronic hyperglycemia also restricts joint mobility and reduces tissue elasticity. These factors combined lead to foot stiffness and instability, and alters weight-bearing areas and gait patterns. This increases plantar pressure, leading to DFU formation. Furthermore, protective sensory loss due to sensory nerve damage also contributes to increased plantar pressure. For example, a healthy person will feel discomfort and change posture after standing for too long, transferring the pressure to other parts of the foot. However, in this case, the neuropathyd woman did not feel this discomfort, and prolonged pressure on the same area can lead to foot ulcers in the long run. Additionally, damage to the autonomic nervous system can cause reduced or absent sweating, which can be monitored and diagnosed by humidity and / or climate sensors in insole 4210.

[0239] Furthermore, implementing a treatment plan based on pressure sensor data will reduce pressure in the area where pressure ulcers develop and / or reduce pressure by adding additional support to the deformed area. According to various exemplary embodiments of the invention, the implementation of the treatment plan from 2420 and / or 2430 will be carried out manually or automatically, as described in Example 1.

[0240] The decompression treatment program provides additional support, in which pressure at peak points is relieved and redistributed to other areas. This occurs when the adjusting mechanism alters the shape of the insole 2410 by increasing or decreasing the total contact area between the foot and the insole. The additional support does not increase pressure but relieves pressure in problem areas by increasing the height of the surrounding area (within a predetermined safe range). As a result, after the treatment program is implemented, the insole will have reduced contact with the previously detected areas of increased pressure, leaving those areas with virtually no pressure.

[0241] In this case, subject 12010 was diagnosed with Charcot disease, so clinical weight-bearing treatment will involve increasing the insole surface height adjustment (e.g., from 20 mm to 30 mm) in the medial arch and / or boat area. The collected data will also be accessed by patient 12010 and shared with family, healthcare professional 12020, or others to determine if surgical intervention or other treatments are needed.

[0242] Example 5:

[0243] Flat-footed amateur male

[0244] A 33-year-old male subject with mild foot deformity who had never been diagnosed or prescribed a custom orthotic device would use his smart device (e.g., a smartphone 2420). Figure 4 The system (or a smartwatch) is paired with the insole 4210 (e.g., via Bluetooth 2416). Following the instructions on screen 2422, user 12010 will perform a gait and balance assessment for analysis. In this case, mild overpronation of the right foot and moderate overpronation of the left foot will be diagnosed. Because the severity of the problem varies for each foot, the system's actions for each foot will also differ, but overall, appropriate flexibility and balance will be maintained. The system will use the paired smart device to prepare and execute an automated corrective and / or therapeutic response plan, as described in Example 1.

[0245] Sensor data from the insole 4210 will be used to generate a pressure map for each foot. Gait patterns will be compared with personal data parameters such as the user's age, weight, and height. The comparison and evaluation are based on appropriate clinical and biomechanical guidelines to identify differences and asymmetries in gait patterns and areas of above-average foot pressure.

[0246] Gait patterns will be derived from accelerometer and gyroscope data, which provide information about spatial motion and orientation. A set of force sensors will simultaneously detect plantar pressure. Measurements will be performed in real time at a rate of hundreds of times per second, and various gait tests will be conducted in the real world (e.g., short periods of walking in a horizontal straight line, climbing stairs, walking uphill). Measurement data from several features will be processed by algorithms (e.g., AI) to quickly extract gait parameters such as gait speed, swing, and duration, and / or detection time events. According to various exemplary embodiments of the invention, the algorithms operate on data processors in insole 2420 (and / or 2440) and / or data processors in link device 2420 and / or cloud 2430. For example, the algorithm will use data from pressure sensors in insole 2410 to identify gait phases such as heel strike and / or toe lift. The processed data will be stored for gait analysis and / or clinical evaluation.

[0247] In some embodiments, database 720 ( Figure 7The system 2400 will reside in the platform cloud 2430. This database will be updated over time with multi-ethnic gait analyses collected in various real-life settings using the insole 2410 according to embodiments of the invention. The database will also store clinical data regarding pathological patterns and potential risks, which will be provided to the AI ​​algorithm for searching based on patient demographics and / or clinical data (e.g., BMI and / or DFU history and / or foot condition (e.g., flat feet or pronation) and / or lower extremity condition). Based on similar patterns identified and tagged as successful treatments performed in similar patients using the insole 2410, the system 2400 will be able to quickly recommend treatment plans with a high probability of success. The algorithm will consider user feedback on the initial treatment plan results and / or time-related sensor data in the development of updated treatment plans. Thus, the system 2400 will adjust according to the patient 12010's needs, foot condition, and capabilities.

[0248] According to various exemplary embodiments of the present invention, the implementation of the treatment plan can be manual or automatic, as described in Example 1. System 2400 will continue to monitor the user's gait and balance in different living environment settings in real time and provide new and improved adjustment solutions when needed. For example, if the user changes or switches to different shoes, the system will dynamically adjust the insole 4210 to improve the fit and support of each foot by adjusting the height in the vertical direction.

[0249] Example 6:

[0250] Diabetic patients at risk of recurrent foot ulcers

[0251] Diabetic foot ulcer (DFU) is associated with increased morbidity, mortality, and resource utilization. A 50-year-old diabetic patient with a history of DFU is therefore at high risk for diabetic foot ulcer. Current standards of care offer little protection against the occurrence and recurrence of foot ulcers. One reason is the difficulty in measuring patient adherence to treatment plans. Various exemplary embodiments of the present invention will facilitate daily monitoring of risk factors associated with DFU. This will help empower patients with self-care and / or enable patients using insoles 2410 to receive effective, coordinated care from specialists 12020.

[0252] Patient 12010 will use insoles 4210 daily with telemedicine support from healthcare expert 12020. Figure 4 The insole 4210 will have the sensing and monitoring components described above. The insole 4210 will output sensor data 2412 to data processors 2420 and / or 2430 and / or 2440. These data processors will generate reports and / or treatment plans.

[0253] The goal for this patient is early detection of inflammation. Temperature data will be collected by a temperature sensor in the insole 2410 and automatically analyzed for temperature differences or asymmetries between the left and right feet in different locations, such as the heel; arch; first, third, and fifth metatarsal heads; and big toe.

[0254] For example, if a patient experiences temperature asymmetry exceeding a 2.2°C threshold twice or more consecutively at the same location, insole 4210 will send an alert 2414 to the patient (12010) and / or healthcare professional 12020. Upon issuing alert 2414, the patient is considered to be in an acute phase. If patient 12010 also experiences pressure spikes at the same location exceeding the patient's historical average pressure, this reinforces the clinical diagnosis of pre-DFU inflammation, typically occurring several weeks prior to clinical manifestation. The system may decide to more aggressively monitor the patient and flag them as high-risk. Healthcare professional 12020 may decide how to provide care and / or use telemedicine capabilities to send personalized stress relief plans, and / or the system insole may autonomously determine and initiate effective DFU prevention protocols and non-invasive stress relief plans according to exemplary embodiments of the present invention, based on predictive AI algorithms.

[0255] When a digitally customized weight-reduction treatment plan is initiated, the insole 2410 dynamically adjusts its shape by changing the vertical height at different coordinates to reduce pressure from the problematic area of ​​the foot. This personalized weight reduction calculation is based on past and current clinical data collected from sensors (e.g., temperature maps, pressure maps, foot humidity, gait) and de-identified according to best practices and other similar events indexed in the platform. The data is stored and accumulated long-term to improve clinical decision-making. Thus, in this example, for a patient with a history of DFU under the second metatarsal, based on the current sensory diagnosis of inflammation in the same area of ​​the foot, the system initiates a weight-reduction plan. This plan actively reduces pressure (and thus temperature) from the problematic area of ​​our patient by elevating adjacent areas, so that no load is applied to the same area when the foot is pressed down. The insole's dynamic weight reduction begins to take effect when the insole feels minimal or even no force applied to it (e.g., when that part of the foot is in the air during walking).

[0256] In some embodiments, the system 2400 provides an autonomous feedback loop for DFU preventative treatment by automatically developing and implementing treatment plans in response to data output signals from sensors in the insole 2410.

Claims

1. A system for providing early diagnosis, assessment, and treatment of chronic foot diseases and pain, comprising: (a) At least one insole, comprising: i) A plurality of height adjustment mechanisms arranged at multiple locations on the insole, wherein each of the plurality of height adjustment mechanisms is provided with a unique identifier; and ii) A plurality of sensors arranged at multiple locations on the insole, wherein each of the plurality of sensors is provided with a unique identifier and configured to provide a data output signal; (b) A data processor, comprising at least one software algorithm configured to receive the data output signal from at least one of the plurality of sensors, wherein each data output signal from each of the plurality of sensors is associated with the sensor's unique identifier, a physical location within the insole, and time information; the software algorithm is configured to analyze the data from the data output signals from the plurality of sensors and provide a response plan; and (c) The response plan is configured to be compatible with at least one of the following: (i) An autonomous implementation module, configured to autonomously receive the response plan, convert the response plan into a set of independent execution signals, wherein each of the independent execution signals is associated with a unique identifier of a height adjustment mechanism among the plurality of height adjustment mechanisms; the autonomous implementation module is configured to transmit each of the set of independent execution signals to a height adjustment mechanism among the plurality of height adjustment mechanisms that has the unique identifier associated with that independent execution signal; and (ii) A healthcare professional, trained to receive the response plan, convert the response plan into a set of independent execution signals, wherein each of the set of independent execution signals is associated with a unique identifier of a height adjustment mechanism among the plurality of height adjustment mechanisms, transmits each of the set of independent execution signals to a height adjustment mechanism among the plurality of height adjustment mechanisms having the unique identifier associated with the independent execution signal, and automatically activates the height adjustment mechanism; Its features are, (A) Each of the plurality of height adjustment mechanisms is configured to be activated independently of the other height adjustment mechanisms in the plurality of height adjustment mechanisms to increase or decrease its own height, thereby changing the height of the insole at the location of the height adjustment mechanism; (B) Activate at least two of the plurality of height adjustment mechanisms to change the shape of the insole surface that contacts the user's foot, thereby reducing the burden; (C) The insole is configured to be inserted into everyday shoes, thereby allowing at least one of real-time diagnosis, monitoring, training and treatment of outpatients in various living environments; (D) The unique identifiers of the plurality of height adjustment mechanisms and the unique identifiers of the plurality of sensors enable the system to be configured for integration with mobile phones and remote monitoring platforms; and (E) The plurality of sensors include a pressure sensor and at least one of the group consisting of a temperature sensor, a motion sensor, a gyroscope and an accelerometer.

2. The system according to claim 1, wherein, The data processor is located in one or more of a group consisting of insole, on insole, configured to be worn by a user of the insole, configured to be carried by a user of the insole, and located on a remote server.

3. The system according to claim 1, wherein, Each of the plurality of height adjustment mechanisms comprises at least one of the group consisting of a plunger, a piezoelectric material, a motor, a gear, a bevel gear, a worm gear, a screw, a spring-loaded mechanism, a hydraulic actuator, an exciter, a polymer, and an electroactive material.

4. The system according to claim 1, wherein, The data processor is configured to automatically track the user's gait behavior, physiological activity, and foot parameters to generate at least one of the following: risk prediction and alerts regarding at least one of gait abnormalities and foot pathologies.

5. The system of claim 1, wherein the system includes a stimulation module under the control of an execution module, wherein the response plan includes stimulation signals; Its features are, The response signal is configured to activate the stimulation module to perform at least one of the following functions: managing pain, promoting blood circulation, improving gait disturbances, and providing treatment to the patient.

6. The system of claim 5, wherein the stimulation module comprises at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

7. The system according to claim 1, wherein: (a) At least one of the plurality of sensors is configured to generate a timestamped data output signal labeled with a UID (Unique Identifier) ​​for the user; and (b) The data processor includes a database configured to receive and store timestamped data output signals labeled with UIDs.

8. The system according to claim 1, wherein: At least one of the data processor and the implementation module includes at least one artificial intelligence algorithm and / or machine learning algorithm, the artificial intelligence algorithm and / or machine learning algorithm being configured to improve the system’s ability to: provide feedback, diagnose patients, and develop treatment plans.

9. The system according to claim 1, comprising: (a) User interface (UI) configured to receive user input defining a problem area on the sole of the foot; and (b) A data processor, including a conversion module configured to convert the user input into a response signal; The characteristic feature is that the response signal is configured to activate each of the plurality of height adjustment mechanisms located in the problem area to alleviate the problem in the problem area.

10. A system configured to provide early diagnosis, assessment, and treatment for chronic foot diseases and pain, comprising: (a) One or more insoles, including: (i) A plurality of manual height adjustment mechanisms integrated over at least a portion of its area, wherein each of the plurality of manual height adjustment mechanisms is provided with a unique identifier; (ii) The manual adjustment interface of each of the plurality of manual height adjustment mechanisms; (iii) A plurality of sensors located in the one or more insoles, configured to provide one or more output signals, wherein each sensor is provided with a unique identifier; (b) wherein the one or more output signals are configured to be compatible with at least one of the following: (i) A data processor, designed and configured to convert the output signal into user suggestions; (ii) The output signal is translated into user suggestions by trained healthcare professionals; and (c) Present the interface that is suggested; Its features are, (A) Each of the plurality of manual height adjustment mechanisms is configured to be activated independently of all other manual height adjustment mechanisms in the plurality of manual height adjustment mechanisms to change the height of the insole at the location of the manual height adjustment mechanism. (B) The plurality of manual height adjustment mechanisms are configured to customize the morphology of the insole surface that contacts the user's foot. (C) The user-suggested configuration includes instructions for the user to manually adjust one of the plurality of manual height adjustment mechanisms in the insole; and (D) The insole is configured to be inserted into everyday shoes, thereby allowing for at least one of real-time diagnosis, monitoring, training, and treatment of outpatients in various living environments; and (E) The plurality of sensors include a pressure sensor and at least one of the group consisting of a temperature sensor, a motion sensor, a gyroscope and an accelerometer.

11. The system of claim 10, wherein the user suggestion includes a set of instructions for manually adjusting one of the plurality of manual height adjustment mechanisms.

12. The system of claim 10, wherein the data processor is configured to automatically track the user’s gait behavior, physiological activity, and plantar parameters to generate at least one of the following: risk prediction and alerts regarding at least one of gait abnormalities and foot pathology.

13. The system according to claim 10, comprising: Stimulation module in each of the one or more insoles; and A manual activation interface for the stimulation module, wherein the stimulation module comprises at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

14. The system of claim 10, wherein the data processor is located at at least one of the following groups: in an insole, on an insole, configured to be worn by a user of the insole, configured to be carried by a user of the insole, and located on a remote server.

15. The system of claim 14, comprising: (a) User interface (UI) configured to receive user input defining the plantar problem area; as well as (b) The data processor includes a conversion module configured to convert user input into a response signal.

16. The system of claim 10, wherein the data processor comprises at least one artificial intelligence algorithm and / or machine learning algorithm, the artificial intelligence and / or machine learning algorithm being configured to enhance the system's ability to: provide feedback, diagnose patients, and develop treatment plans.

17. An insole, comprising: (a) A plurality of manual height adjustment mechanisms integrated on at least a portion thereof, wherein each of the plurality of manual height adjustment mechanisms is provided with a unique identifier; and (b) The manual adjustment interface of each of the plurality of manual height adjustment mechanisms; (c) Multiple sensors configured to provide one or more output signals, wherein each sensor is provided with a unique identifier; Its features are: (A) Each of the plurality of manual height adjustment mechanisms is provided with a manual adjustment interface and is configured to be manually activated independently of all other manual height adjustment mechanisms in the plurality of manual height adjustment mechanisms, so as to change only the height of the insole at the location of the manual height adjustment mechanism. (B) The plurality of manual height adjustment mechanisms are configured to change the morphology of the insole surface that contacts the user's foot, thereby achieving a weight-reducing treatment; (C) The insole is configured to be inserted into everyday shoes, thereby allowing for at least one of real-time diagnosis, monitoring, training, and treatment of outpatients in various living environments; and (D) The plurality of sensors include a pressure sensor and at least one of the group consisting of a temperature sensor, a motion sensor, a gyroscope and an accelerometer.

18. The insole of claim 17, wherein each manual height adjustment mechanism is independently selected from the group consisting of a screw, a bevel joint rotating lifting element, and a bayonet mounting element.

19. The insole of claim 17, configured for use in the system of claim 10.

20. The insole of claim 17, comprising a stimulation module and an activation interface for the stimulation module.

21. The insole of claim 20, wherein the stimulation module comprises at least one of the group consisting of a physical stimulator, a laser, a vibrator, and a current source.

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