SMART WEARABLE TECHNOLOGIES IN SHOES AND SOCKS FOR THE PREVENTION OF DIABETIC FOOT ULCERS.

Abstract

The invention relates to an intelligent wearable monitoring system in the field of health technologies, biosensor systems, and smart wearable medical devices, designed for the prevention of diabetic foot ulcers. It is structured in the form of a shoe or sock and continuously and simultaneously collects pressure distribution, temperature, and humidity parameters through pressure sensors placed inside the shoe and temperature and humidity sensors placed inside the sock. This data is processed via an electronic control unit, embedded software, and a risk algorithm. Based on risk assessment, it transmits warnings to the user and / or healthcare professional and presents the collected data for viewing and clinical integration via a mobile application and a digital health platform integration interface.

Description

1 TARIFF SMART WEARABLE DEVICES FOR THE PREVENTION OF DIABETIC FOOT ULCERS. TECHNOLOGIES FOR SHOES AND SOCKS Technical Area The invention relates to health technologies, biosensor systems, and smart wearable medical devices. in the field of shoes and equipment for the prevention of diabetic foot ulcers. pressure sensors structured in the form of a sock and placed inside the shoe 10 pressure is measured via temperature and humidity sensors placed inside the sock. It continuously and simultaneously collects distribution, temperature and humidity parameters, the data in question is processed by an electronic control unit, embedded software, and a risk algorithm. operating through, according to risk assessment, user and / or health It communicates warnings to professionals and shares the collected data digitally via a mobile application. Imaging and clinical via health platform integration interface It relates to a smart wearable tracking system offered for integration purposes. State of the Art Prevention of diabetic foot ulcers and monitoring of diabetic foot risk. In current practices, patients undergo clinical examinations at specific intervals. undergoing a visual examination of the feet, regarding general foot care recommendations such as the use of standard orthopedic shoes various methods are used. 25 Current practices may be associated with the development of diabetic foot ulcers. biomechanical and environmental parameters are monitored continuously, simultaneously, and objectively. There is no monitoring method available for measuring this, especially on the foot. Pressure distribution and temperature and humidity changes during daily use 30 The inability to continuously monitor the situation and identify risky situations at an early stage. and consequently, timely intervention It makes things more difficult. 2 Therefore, pressure is an important factor in the development of diabetic foot ulcers. Temperature and humidity parameters are monitored continuously and simultaneously during daily use. There is a need for a wearable tracking system to monitor this. Purpose of the Invention 5 The invention introduces a new approach to this field, unlike the structures currently used in the technology. the creation of a structure with different technical features that brings about innovation It aims to... The primary purpose of the invention is to highlight its importance in terms of the development of diabetic foot ulcers. the pressure, temperature and humidity parameters carried continuously and simultaneously The goal is to offer a smart wearable system that enables monitoring. Another purpose of the invention is to integrate pressure sensors, temperature sensors, and humidity sensors. 15 the simultaneous collection of data obtained through and electronic The goal is to ensure that it is processed through the control unit. Another purpose of the invention is to use pressure sensors placed inside the shoe. Temperature and humidity sensors placed inside the sock form a single wearable monitoring system. 20 The goal is to bring them together within the system. Another purpose of the invention is to embed the collected pressure, temperature, and humidity data. analysis using multiple parameters via software and risk algorithms and to enable the calculation of the integrated risk score. 25 Another purpose of the invention is to classify low, medium, and high risk according to defined risk thresholds. the creation of tiered alerts at different levels and the issuance of these alerts The aim is to ensure that it is communicated to the user and / or healthcare professional. Another purpose of the invention is to analyze the obtained pressure distribution, temperature, and humidity data. visualization via mobile application and historical data The aim is to enable comparison. 3 Another purpose of the invention is to utilize the data obtained by the system for digital health. Clinical support systems, electronic systems via platform integration interface The aim is to ensure that health records are shared with remote monitoring platforms. The structural and characteristic features and all the advantages of the invention are given below in 5. a detailed explanation written with figures and references to these figures This will make it clearer, and therefore the evaluation will also be based on this. This should be done taking into account the figures and detailed explanations. Technical Effects Provided by the Invention 10 Thanks to the invention; • Continuous and simultaneous monitoring of pressure, temperature, and humidity parameters. by enabling the collection of data on these parameters together It allows for evaluation. 15 • Mechanical load occurring in different anatomical regions of the sole of the foot and enables continuous measurement of pressure changes. • Temperature and humidity are monitored via temperature and humidity sensors that come into contact with the skin of the foot. It allows for continuous monitoring of humidity changes. • Pressure, temperature and humidity data are electronically controlled by the unit, embedded software 20 and processing through a risk algorithm and in a multi-parameter manner. It allows for evaluation. • Pressure and temperature that do not exceed the determined thresholds when evaluated individually. Risk algorithm for risky situations created by changes in humidity and moisture levels. evaluation by and calculation of integrated risk score 25 provides. • Low, medium, and high risk levels according to the calculated risk score. Creating tiered alerts and providing them to the user based on the risk level. or ensures that a notification is sent to a healthcare professional. • The obtained pressure distribution, temperature and humidity data can be used in the mobile application 30 visualization and comparison with historical data provides. 4 • In case the communication connection is interrupted, the data is temporarily stored in the memory unit. the data is stored and the connection is re-established. It enables automatic transfer. • Integration of data obtained by the system into a digital health platform. Clinical decision support systems via interface, electronic health records 5 and enables sharing with remote monitoring platforms. • The sensor structure in the form of a shoe or sock during daily use It enables it to be used as a wearable monitoring system. Figures to Help Understand the Invention 10 Figure 1 shows a general overview of the smart shoe, the subject of the invention. Figure 2 shows a general view of the wrist module, which is the subject of the invention. Figure 3 shows a disassembled view of the components of the wrist module, which is the subject of the invention. Figure 4 shows the separated 15 components of the sole layer of the smart shoe that is the subject of the invention. It is the appearance. Figure 5 shows the structure of the smart sock, which is the subject of the invention. Figure 6 shows how the smart sock and smart shoe, which are the subject of the invention, are used. It is the appearance. Drawings do not necessarily need to be scaled and are useful for understanding the existing invention. Details that are not necessary may have been omitted. Furthermore, the most important... functions that are at least substantially identical or at least substantially identical The elements that exist are indicated by the same number. Explanations of Figure References 1. Smart Shoe Body 2. Wrist Module 3. Outer Cover 30 4. Electronic Control Unit 5. Wireless Communication Module 6. Memory Unit 7. Power Supply (Rechargeable Battery) 8. Silicone Cushioning (Shock Absorbing) 9. Inner Textile Cover (Skin-Friendly) 10. Top Textile Layer 11. Silicone Insole 12. Sensor Base 5 13. Pressure Sensor Layer 14. Silicone Base 15. Outsole 16. Smart Socks 17. Temperature Sensors 10 18. Humidity Sensors 19. Sock Ankle (Cuff) Section 20. Flexible Conductive Yarns 21st Connection Point Detailed Description of the Invention In this detailed description, the preferred configurations of the invention are presented, only in relation to the subject matter. for a better understanding and without creating any limiting effects. This is explained as follows. 20 The invention analyzes the continuous and intrinsic risk factors leading to the development of diabetic foot ulcers. As a solution to the problem of not being able to monitor them simultaneously; shoes and socks It is a smart, wearable tracking system designed in this form. Within the scope of the invention, pressure sensors (13) integrated into the sole of the foot and tissue load distribution on it, temperature sensors (17) and local inflammation indicator possible increases in temperature and humidity sensors (18) negatively affect skin integrity The influencing environmental conditions are measured simultaneously. The collected data, predefined risk 30 analyzed by electronic control unit (4) They are compared with threshold values. 6 The system can identify parameters that may pose a risk for ulcer development in the measured parameters. If any changes are detected, inform the user or healthcare professional. It is structured to provide a warning. The elements that provide the technical solution for the invention are; integration of multiple biosensors, 5 continuous data collection infrastructure, real-time analysis capability and daily use suitable wearable design features. In the invention, the sensor base (12) measures the pressure distribution inside the foot, temperature (17) and humidity. (18) continuously collects data; sensor data on the sock is flexible 10 via conductive threads (20) and connection point (21) to the wrist module (2) The data is transmitted to the electronic control unit (4) in the wrist module (2). is processed and applied to the mobile application (24) via the wireless communication module (5) is being transferred. Smart socks (16) carry temperature (17) and humidity (18) sensors to the skin surface; The smart shoe body (1) consists of a sensor sole (12), silicone insole (11), silicone It houses the sole (14) and outsole (15). Components in the ankle module (2) It is protected by an outer cover (3), silicone cushioning (8) and an inner textile cover (9). Memory Unit (6) allows temporary storage of data in case of connection interruptions. It provides. Embedded software (22) performs sensor reading and preprocessing operations; risk algorithm (23) analyzes pressure, temperature and humidity data with multiparameter analysis It determines the ulcer risk level by evaluating the results. The results obtained are digital 25 through the health platform integration interface (25) with clinical systems It is being shared. Smart shoe body (1), sensor sole (12), silicone insole (11), silicone It incorporates a sole (14) and an outsole (15). Suitable for daily use. 30 It has a suitable ergonomic design. 7 Wrist module (2); electronic control unit (4), wireless communication module (5), memory that combines the unit (6) and the power supply (7) in a single carrier body and is smart It is a wearable module that is fixed to the ankle part of the sock (16). The wrist module (2) is designed to protect the electronic components from external factors. 5 positioning electronic components in the ankle area instead of the sole of the foot provides. The outer cover (3) forms the outer surface of the wrist module (2) and contains the electronic components. It is a lid that protects against external factors such as moisture, dust, and impact. It opens and closes 10 Its closable structure allows for maintenance and replacement of components within the module. It provides access. Electronic control unit (4), pressure sensors (13), temperature sensors (17) and collect raw analog signals from humidity sensors (18), analog-15 digital transformation, embedded software (22) and risk algorithm (23) processes the data and analyzes the results via wireless communication. It redirects to module (5). The electronic control unit (4) uses a low power consumption microcontroller architecture. It has. Wireless communication module (5) transmits the processed data to the mobile application (24) and digital via low-power wireless protocols to the healthcare platform It is conveying. 25 The memory unit (6) provides temporary storage of sensor data. It is used to prevent data loss during connection interruptions and automatic data transfer after the connection is re-established It provides. 30 The power supply (7) provides energy for the operation of the electronic components within the system. The power supply (7) is located inside the wrist module (2) and charging It is designed to be usable. 8 Silicone cushioning (8) protects the electronic components located inside the wrist module (2) It is the shock-absorbing layer located in the compartment. The inner textile cover (9) is the textile located on the surface of the wrist module (2) that comes into contact with the skin. It is a structure. 5 The upper textile layer (10) is located in the upper layer of the shoe body (1) and It is in contact with the sole of the sock. It allows sweat and moisture to be transferred to the lower layers and It contributes to supporting the microclimate during use. The silicone insole (11) provides shock absorption and wearing comfort, and moisture contributes to the management and the pressure between the foot and the sensor base (12) It plays a role in the distribution. The sensor base (12) is a semi-flexible structure in which the pressure sensors (13) are placed. 15 Pressure sensors (13); heel, first metatarsal head, fifth metatarsal head, middle at anatomically defined points such as the foot / arch and toes It is located. Pressure sensors (13) detect what happens during walking, standing and sitting. It continuously measures the incoming mechanical load and pressure changes. Silicone base (14) for cushioning, vibration damping and structural support. It is located in the sole structure of the shoe body (1). 25 The outsole (15) is the outermost layer of the shoe that comes into contact with the ground and provides grip. It includes durability features. Smart socks (16) have a flexible, biocompatible and breathable textile structure. 30 Temperature sensors (17) and humidity sensors (18) are in direct contact with the skin surface. It is integrated onto the smart sock (16) in such a way as to do so. 9 Temperature sensors (17) measure local skin temperature. Especially the opposite side or Detecting regional temperature differences of 2°C or more. It is used in its production. Humidity sensors (18) continuously measure humidity values. The obtained humidity is 5 data, along with pressure and temperature data, are used in risk assessment. It is used. The ankle (cuff) part of the sock (19), the ankle module (2) on the smart sock (16) This is the part that ensures it is secured. 10 Flexible conductive yarns (20), temperature sensors (17) and humidity sensors (18) It carries the data lines through the sock fabric to the connection point (21). Connection point (21) connects the sensor data lines on the sock to the wrist module (2) 15 It is the electrical interface element that transmits to the electronic control unit (4). Embedded software (22) runs on the electronic control unit (4); sensor read cycle, analog-to-digital conversion parameters, signal filtering, data normalization, calibration, data exchange with memory unit (6), wireless communication 20 It manages data transfer and low power consumption modes with module (5). Risk algorithm (23) uses pressure, temperature and humidity data as a multi-parameter It cross-evaluates the correlation, calculates the risk of ulcer development, and It determines the tiered alert level. 25 The risk algorithm includes thresholds for low risk, medium risk, and high risk levels. Intervals and triggering conditions are defined. The mobile application (24) receives data via the wireless communication module (5) 30 visualization, monitoring of historical data and risk algorithm (23) the generated alert notifications to the user and / or healthcare professional It enables transmission. Digital health platform integration interface (25), collected data clinical decision with support systems, electronic health records and remote patient monitoring platforms It is a software-based linking element that enables sharing. The production of the invention consists of the following steps; 5 1. Production of Sensor Base (12) and Integration of Pressure Sensors (13) The sensor base (12) is a semi-molded base designed to conform to the anatomy of the sole of the foot. It is manufactured from flexible polymeric material. Pressure sensors (13), heel, first metatarsal head, fifth metatarsal head, midfoot / arch, and toe tips They are placed in pre-formed nests corresponding to their respective regions. 10 Sensor connection lines are routed externally through conductive paths inside the base. is being removed. The mechanical and electrical integrity of the pressure sensors (13) is checked and Calibration tests showed that it gave an accurate response within the specified pressure range. 15 It is confirmed. 2. Production of Smart Socks (16) and Temperature (17) and Humidity Sensors (18) Integration Smart socks (16) are knitted or made from biocompatible, flexible and breathable textile fibers. It is produced by weaving method. Temperature sensors (17) and humidity sensors 20 (18) is integrated into the textile structure. Sensor connection lines are connected to the connection point via flexible conductive threads (20). (21) is directed. The smart sock (16) that has been produced, temperature Verification that the sensors (17) and humidity sensors (18) are working correctly 25 For this purpose, they undergo functional testing. 3. Production and Configuration of the Electronic Control Unit (4) Electronic control unit (4), low power consumption microcontroller core It is built on a printed circuit board (PCB) designed around it. The circuit is 30 microcontroller, analog-to-digital converter (ADC), signal conditioning board Circuits and power management integrated circuits are being installed. 11 from pressure sensors (13), temperature sensors (17) and humidity sensors (18) Multiple input channels are created where simultaneous data can be received. Memory The unit (6) and the wireless communication module (5) are integrated into the circuit board. After production, the electronic control unit (4) electrical test and functional 5 It is undergoing a verification process. 4. Development of Embedded Software (22) and Risk Algorithm (23) and Loading Embedded software (22); sensor reading timing, analog-to-digital conversion 10 parameters, noise filtering, data normalization, calibration corrections, data exchange with memory unit (6), data transfer with wireless communication module (5) and It manages low power consumption modes. Risk algorithm (23), risk defined for pressure, temperature and humidity parameters 15 It performs individual comparisons with threshold values ​​and multiple comparisons of the three parameters. to perform cross-evaluation using correlation analysis method It is structured with threshold ranges for low, medium and high risk levels. Triggering conditions are being defined. The developed software is connected to the microcontroller of the electronic control unit (4). It is installed via the programming interface. For the software to function correctly... Risk algorithm through functional tests using sensor simulation data (23) Warning levels are checked with validation tests. 5. Preparation of the Power Supply (7) Power supply (7) consists of rechargeable lithium polymer battery cells. It is created. Battery capacity is sufficient for the system components to operate for at least one full day. to the extent that it will operate continuously for approximately 12–16 hours. is being calculated. 30 The battery cell comes in a compact module with a protection circuit. It is packaged with a protection circuit against overcharging, over-discharging, short circuits, and overcurrent. It provides security protection against these situations. 12 The charging interface is accessible from the outer surface of the wrist module (2) and is waterproof. It is designed as a connection point. Power supplies have capacity, charge-discharge. It undergoes cycle and safety testing. 6. Production of the Smart Shoe Body (1) and Assembly of Hardware Components Smart shoe body (1) using standard shoe manufacturing techniques is being manufactured and suitable in the base area for the placement of the sensor base (12). A nest is being prepared. Wrist module (2) contains electronic control unit (4), wireless communication module (5), electronic compartment where the memory unit (6) and power supply (7) will be placed It is formed. The outer cover (3), silicone cushioning (8) and inner textile cover (9) are assembled. is being done. Pressure sensors (13) integrated sensor base (12) of the shoe body (1) It is placed in the inner base compartment and the connection lines are connected to the electronic control unit. (4) is connected. Connection between smart sock (16) and wrist module (2) The points are being assembled. The electronic compartment is sealed with insulating gaskets to prevent moisture and dust ingress. The charging port is located in an accessible position on the outer surface of the wrist module (2). are fixed. Electrical connections and mechanical fasteners are made after assembly. and insulation integrity is checked. 7. Mobile Application (24) and Digital Health Platform Integration Development of the Interface (25) The mobile application (24) is being developed for smartphone and tablet platforms. In practice, wearable system pairing and data acquisition, pressure distribution map, Temperature map and trend graph, humidity level indicator and time series graph, 30 Functions include monitoring and comparing historical data with tiered risk alerts. It is located. 13 Digital health platform integration interface (25), mobile application (24) infrastructure It is being developed as a software layer that runs on top of standard healthcare. Data communication protocols are supported, and the collected data is used for clinical decision support. to systems, electronic health records and remote patient monitoring platforms The transfer is ensured. 5 Encryption and authentication mechanisms in data transfer. It is being configured. The software components are integrated end-to-end with the wearable system. Its functionality is verified through integration tests. 8. System Integration Testing and Calibration Verification that all completed components work together. system integration testing and final calibration processes for this purpose. is being carried out. Smart socks (16) and smart shoe bodies (1) are fitted onto a test mannequin, ankle The module (2) is fixed to the wrist and the power supply (7) is activated Initial calibration is performed via embedded software (22). is being carried out. known force values ​​are assigned to pressure sensors (13) and temperature sensors (17) controlled heat sources and humidity sensors (18) controlled humidity environments Measurement accuracy and precision are checked by applying this method. Simultaneous data collection of the electronic control unit (4), data of the memory unit (6) 25 storage and retrieval operations and mobile wireless communication module (5) Data transfer to the application (24) is verified. Risk algorithm (23) high pressure + normal temperature, normal pressure + high 30 predefined parameters such as temperature + high humidity and multiple parameter threshold exceedance. Risk scenarios are being applied. The algorithm needs to generate the correct alert levels. This is checked through validation tests. 14 The mobile application (24) accurately visualizes the data and delivers alert notifications. and end-to-end data transfer of the digital health platform integration interface (25) It is being tested. 9. Final Quality Control and Packaging 5 The final product undergoes quality control processes. The smart shoe body... (1) Mechanical integrity, insulation quality and ergonomic fit are checked. Textile quality, sensor integration integrity and biocompatibility of smart socks (16) Its features are being verified. Mechanical stability of the sensor base (12) and pressure sensors (13) being examined; temperature sensors (17) and humidity sensors (18) measurement Their sensitivities are being verified. Electronic control unit (4), wireless communication module (5), power supply 15 (7) and the electrical and functional status of the memory unit (6) are checked. Current and correct versions of the embedded software (22) and the risk algorithm (23) It is confirmed that the mobile application (24) and the digital health platform are installed. The latest versions of the integration interface (25) are being made available. The product that completed the quality control process; smart shoe body (1), smart sock (16), wrist module (2), charging accessory and user manual included. It is being packaged. In the use of the invention, the smart sock (16) is primarily worn by the user and 25 Temperature sensors (17) and moisture sensors (18) located on the sock interact with the skin. The smart shoe body (1) is positioned to make contact with the user. After being worn, the wrist module (2) is properly secured and the power The source (7) is activated. With the operation of the system, electronic control unit (4) performs initial calibration of sensors via embedded software (22) 30 It is carrying out. When the system is activated, the pressure on the sensor base (12) sensors (13) continuously monitor mechanical load and pressure changes on the foot When measuring, the temperature sensors (17) on the smart sock (16) changes and humidity values ​​from humidity sensors (18) simultaneously It measures. Data obtained from sensors on the smart sock (16) are flexible via conductive threads (20) and connection point (21) to the electronic control unit (4) is transmitted. Thus, pressure, temperature and humidity data are transmitted simultaneously. is being collected. Analog signals received from the sensors are processed by the electronic control unit (4) converted into digital data and preprocessed by embedded software (22) This includes signal noise filtering, signal correction, and 10 Normalization operations are performed. The processed data is stored in the memory unit (6) It can be temporarily stored and may malfunction in the wireless communication connection. Data protection is ensured during potential disruptions to the connection. Data transfer is accomplished through the re-establishment of the system. Pre-processed pressure, temperature and humidity data are transmitted to the electronic control unit (4) Risk is evaluated by the risk algorithm (23) working within it. algorithm (23) takes the obtained multi-parameter data into predetermined clinical compares risk threshold values ​​and analyzes the relationship between the parameters together. It evaluates. Thus, pressure and temperature that alone do not exceed the threshold value 20 or situations created by a combination of humidity levels are also included in the risk assessment. is included and an integrated risk score is provided in each measurement cycle. is being calculated. If the calculated risk score exceeds the specified threshold values, the system will activate 25. Gradual warnings are generated by the system. At the low risk level, the user receives a warning. When notifications are made, additional information is provided to the user at medium and high risk levels. Notifications may also be sent to designated healthcare professionals. Warnings, It is transmitted to the mobile application (24) via the wireless communication module (5). Pressure distribution map, temperature changes and via mobile application (24) Data on humidity levels can be viewed; historical data, Comparisons and trends can be monitored. Obtained with the user's consent. data through the digital health platform integration interface (25) clinical decision 16 support systems, electronic health records and remote monitoring platforms This allows the measurement and risk data obtained by the system to be transferred. Evaluation data by users and healthcare professionals. It can be viewed.

Claims

17 REQUESTS 1. The invention relates to wearable health devices for monitoring the risk of diabetic foot ulcers. In the field of technology, it is a system consisting of smart shoes and smart socks, Its feature is the sensor sole (12) and 5 located inside the smart shoe body (1). pressure sensors (13), temperature sensors integrated into smart socks (16) (17) and humidity sensors (18), pressure, temperature and humidity sensors (13, 17, 18) Electronic control unit (4) that processes the incoming data, transmits the data wireless communication module (5), embedded that manages data processing software (22) and pressure, temperature and humidity data multi-parameter correlation 10 It includes a risk algorithm (23) which evaluates by analysis.

2. The system according to claim 1, and its feature is; electronic control unit (4), intelligent from temperature sensors (17) and humidity sensors (18) on socks (16) incoming data is transmitted through flexible conductive threads (20) and the connection point (21) It is to receive. 15 3. The system is as per claim 1 and its characteristic is; electronic control unit (4) pressure from sensors (13), temperature sensors (17) and humidity sensors (18) converting analog signals into digital data and embedded software (22) signal filtering and data normalization processes by It is the implementation. 20 4. According to claim 1, the system has the following characteristics; risk algorithm (23), pressure, temperature and compares humidity data with predefined threshold values ​​and these parameters together with multiparameter correlation analysis This is an assessment.

5. The system is according to claim 4 and its feature is that each measurement of the risk algorithm (23) is 25 an integrated risk score calculation in the cycle and the risk in question It determines low, medium, and high risk levels based on the score.

6. The system according to claim 1, its feature is; electronic control unit (4), wireless communication module (5), memory unit (6) and power supply (7) wrist module (2) It is to be included. 30 7. The system is according to claim 1 and its feature is; the sensor base of the pressure sensors (13). (12) on the heel region, the heads of the first and fifth metatarsals, the midfoot and This refers to the positions corresponding to the fingertips. 18 8. The system according to claim 1, and its feature is; smart sock (16), temperature sensors (17) and moisture sensors (18) in direct contact with the skin surface It has a flexible and biocompatible textile structure into which it is integrated.

9. The system is according to claim 1 and its feature is; via wireless communication module (5). Viewing of transferred data by mobile application (24) and risk 5 notifications regarding risk levels determined by the algorithm (23) It is the transmission of information.

10. According to claim 1, the system is characterized by; mobile application (24) and digital health Clinical decision support systems via platform integration interface (25) and data sharing through electronic health records. 10

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