APPARATUS AND METHOD FOR ADAPTIVE ELECTROTHERAPY CONTROL FOR DEEP VEIN THROMBOSIS (DVT) PREVENTION

Abstract

The present disclosure relates to an apparatus (100) for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention, the apparatus includes a pair of conductive socks (102) configured to be worn by a user. A set of electrodes (104) strategically accommodated within the pair of conductive socks for targeting gastrocnemius muscle and soleus muscle of calf muscle groups of the user. A microcontroller unit (106) operatively coupled to the set of electrodes and the set of biofeedback sensors, the microcontroller unit configured to receive the set of data from the set of biofeedback sensors, generate electrical stimulation signals based on the received set of data and deliver low-intensity electrical stimulation to the calf muscle group of the user through the set of electrodes to mimic natural muscle contractions and promote blood circulation so as to prevent DVT formation

Specification

Description:TECHNICAL FIELD
[0001] The present disclosure relates, in general, to adaptive electrotherapy systems for the prevention of deep vein thrombosis (DVT), and more specifically, relates to an apparatus incorporating conductive socks with integrated electrodes, biofeedback sensors, and a microcontroller unit for delivering personalized electrical stimulation to promote blood circulation and prevent DVT formation.

BACKGROUND
[0002] Deep vein thrombosis (DVT) is a serious medical condition characterized by the formation of blood clots in one or more deep veins in the body, typically in the lower extremities. DVT poses a significant health risk, particularly for individuals with limited mobility or those engaged in prolonged travel, where inactivity contributes to venous stasis and clot formation. Despite the availability of various preventive measures for DVT, existing technologies present several limitations that impact user compliance, comfort, and overall effectiveness.
[0003] Pharmacological prophylaxis, such as the use of blood-thinning medications, is a widely used method to prevent DVT. However, these medications carry inherent risks, including an increased likelihood of bleeding, and require continuous monitoring and medical supervision, which may reduce their suitability for long-term or widespread use. Mechanical prophylaxis, such as compression stockings and intermittent pneumatic compression (IPC) devices, offers an alternative to pharmacological treatments. Compression stockings apply gentle pressure to the legs to promote blood flow, but they are often uncomfortable, difficult to put on and remove, and may not be effective for all users. Similarly, IPC devices, which use inflatable sleeves to intermittently compress the limbs and stimulate circulation, are bulky, uncomfortable for extended use, and typically require professional assistance for proper application. Furthermore, IPC devices are not portable and often necessitate visits to medical facilities, limiting their practical utility in daily life.
[0004] The limitations of these existing DVT prevention technologies highlight the need for an improved, user-centric approach that enhances compliance, comfort, and adaptability to individual needs. Specifically, the challenges presented by these technologies include poor compliance due to the inconvenience and discomfort of medications and mechanical devices, limited comfort for long-term use, restricted accessibility due to the need for professional assistance, lack of adaptability to individual risk factors, and the absence of portability in bulky devices such as IPC systems.
[0005] Therefore, it is desired to overcome the drawbacks, shortcomings, and limitations associated with existing solutions, and develop a cost-effective, adaptive electrotherapy control system designed to prevent DVT by addressing the limitations of existing technologies in terms of compliance, comfort, accessibility, adaptability, and portability. Through its adaptive electrotherapy control system, the present disclosure offers a proactive and effective solution for individuals at risk of DVT, enhancing preventive care and reducing the incidence of blood clot formation associated with prolonged inactivity.

OBJECTS OF THE PRESENT DISCLOSURE
[0006] An object of the present disclosure relates, in general, to adaptive electrotherapy systems for the prevention of deep vein thrombosis (DVT), and more specifically, relates to an apparatus incorporating conductive socks with integrated electrodes, biofeedback sensors, and a microcontroller unit for delivering personalized electrical stimulation to promote blood circulation and prevent DVT formation.
[0007] Another object of the present disclosure is to provide an apparatus that is non-invasive and user-centric, as electrical stimulation avoids the need for needles or medications, thereby promoting user comfort and potentially improving compliance.
[0008] Another object of the present disclosure is to provide an apparatus that is adaptable and personalized, featuring optional integration of electromyography (EMG) sensors that allow for personalized stimulation patterns based on real-time muscle activity, catering to individual needs.
[0009] Another object of the present disclosure is to provide an apparatus that offers a comfortable and convenient wearable sock design that integrates seamlessly into daily activities.
[0010] Yet another object of the present disclosure is to provide a portable apparatus, with a lightweight design that enables use throughout the day, regardless of location.

SUMMARY
[0011] The present disclosure relates in general, to adaptive electrotherapy systems for the prevention of deep vein thrombosis (DVT), and more specifically, relates to an apparatus incorporating conductive socks with integrated electrodes, biofeedback sensors, and a microcontroller unit for delivering personalized electrical stimulation to promote blood circulation and prevent DVT formation. The main objective of the present disclosure is to overcome the drawbacks, limitations, and shortcomings of the existing system and solution, by providing an adaptive electrotherapy control system for the prevention of deep vein thrombosis (DVT), comprising conductive socks embedded with electrodes configured to deliver targeted electrical stimulation to calf muscles, wherein the system is governed by a microcontroller programmed to control the stimulation based on user input and pre-programmed algorithms. The system further includes electromyography (EMG) sensors to enable personalized stimulation patterns, adjustable intensity parameters to ensure user comfort, and safety features such as automatic shut-off mechanisms. The system simulates muscle movement without requiring actual physical motion from the user, thereby reducing the risk of clot formation due to prolonged inactivity.
[0012] The present disclosure provides an apparatus for adaptive electrotherapy control for the prevention of deep vein thrombosis (DVT). The apparatus comprises a pair of conductive socks configured to be worn by a user. The conductive socks accommodate a set of electrodes, which are strategically positioned to target the gastrocnemius and soleus muscles of the calf muscle groups. The apparatus further includes a set of biofeedback sensors that detect a set of data from the user, wherein the set of data pertains to any combination of muscle activity, muscle contractions, and blood oxygen levels. A microcontroller unit is operatively coupled to both the set of electrodes and the set of biofeedback sensors. The microcontroller unit is configured to receive the set of data from the biofeedback sensors, generate electrical stimulation signals based on the received data, and deliver low-intensity electrical stimulation to the calf muscle groups via the electrodes. This stimulation is designed to mimic natural muscle contractions and promote blood circulation, thereby preventing DVT formation.
[0013] Various objects, features, aspects, and advantages of the inventive subject matter will become more apparent from the following detailed description of preferred embodiments, along with the accompanying drawing figures in which like numerals represent like components.

BRIEF DESCRIPTION OF THE DRAWINGS
[0014] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.
[0015] FIG. 1A illustrates an exemplary view of an apparatus in accordance with an embodiment of the present disclosure.
[0016] FIG. 1B illustrates an exemplary functional components of an apparatus in accordance with an embodiment of the present disclosure.
[0017] FIG. 2 illustrates an exemplary flow chart outlining the overall schematic workflow for the system related to the prevention of deep vein thrombosis (DVT) in accordance with an embodiment of the present disclosure.
[0018] FIG. 3 illustrates an exemplary flow chart workflow related to the Primary Care Physician (PCP) and the muscle stimulation system in accordance with an embodiment of the present disclosure.
[0019] FIG. 4 illustrates an exemplary flow chart of user safety features for the system, in accordance with an embodiment of the present disclosure.
[0020] FIG. 5 illustrates an exemplary flow chart of a method for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention, in accordance with an embodiment of the present disclosure.

DETAILED DESCRIPTION
[0021] The following is a detailed description of embodiments of the disclosure depicted in the accompanying drawings. The embodiments are in such detail as to clearly communicate the disclosure. If the specification states a component or feature "may", "can", "could", or "might" be included or have a characteristic, that particular component or feature is not required to be included or have the characteristic.
[0022] As used in the description herein and throughout the claims that follow, the meaning of "a," "an," and "the" includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of "in" includes "in" and "on" unless the context clearly dictates otherwise.
[0023] The system offers a non-invasive, wearable solution in the form of conductive socks with integrated electrodes that deliver electrical stimulation to calf muscles, simulating muscle movement without requiring user-initiated motion. The system is controlled by a microcontroller and is configured to adapt stimulation patterns based on real-time data, such as electromyography (EMG) signals, allowing for personalized treatment that is tailored to the specific needs of each user. Adjustable intensity parameters ensure optimal user comfort, while safety features, such as automatic shut-off mechanisms, enhance usability.
[0024] The present disclosure provides an apparatus for adaptive electrotherapy control for the prevention of deep vein thrombosis (DVT). The apparatus comprises a pair of conductive socks configured to be worn by a user. The conductive socks accommodate a set of electrodes, which are strategically positioned to target the gastrocnemius and soleus muscles of the calf muscle groups. The apparatus further includes a set of biofeedback sensors that detect a set of data from the user, wherein the set of data pertains to any combination of muscle activity, muscle contractions, and blood oxygen levels. A microcontroller unit is operatively coupled to both the set of electrodes and the set of biofeedback sensors. The microcontroller unit is configured to receive the set of data from the biofeedback sensors, generate electrical stimulation signals based on the received data, and deliver low-intensity electrical stimulation to the calf muscle groups via the electrodes. This stimulation is designed to mimic natural muscle contractions and promote blood circulation, thereby preventing DVT formation.
[0025] In an aspect, the set of integrated electrodes is fabricated from a biocompatible conductive material that ensures safe and effective transmission of electrical stimulation. The conductive socks are made of breathable and moisture-wicking material to enhance user comfort and ensure wearability throughout the day. Additionally, the biofeedback sensors may include electromyography (EMG) sensors for detecting muscle activity and optional blood oxygen sensors for monitoring blood oxygen levels in the user's lower extremities.
[0026] In another aspect, the microcontroller unit is operatively coupled to a stimulation module equipped with adjustable intensity settings, allowing the user to modify the strength of stimulation for optimal comfort. The stimulation module is further configured to deliver electrical stimulation that mimics natural muscle movement, promoting blood flow and reducing the risk of clot formation. Furthermore, the microcontroller unit is configured with an automatic deactivation mechanism to prevent overstimulation during prolonged use, thereby ensuring user safety.
[0027] In another aspect, the microcontroller unit is operatively coupled to a user interface integrated into a mobile application, allowing enhanced user interaction through a computing device. Alternatively, the user interface may comprise a control button located directly on the conductive socks. The microcontroller unit is also operatively coupled to a power source, such as a rechargeable battery, to supply power to the apparatus, ensuring portability and continuous usage throughout the day. The present disclosure can be described in enabling detail in the following examples, which may represent more than one embodiment of the present disclosure.
[0028] The advantages achieved by the structure of the present disclosure can be clear from the embodiments provided herein. The adaptive electrotherapy control system provides several key advantages over existing DVT prevention methods. Its non-invasive design eliminates the need for medications or needles, improving user comfort and acceptance. The system's adaptability allows for personalized treatment based on real-time physiological data, ensuring that the device can cater to individual risk factors and conditions. The wearable sock design is lightweight, compact, and easy to use, promoting accessibility and eliminating the need for professional assistance. Additionally, the system's portability allows users to integrate it into their daily routines without disruption, overcoming the limitations associated with bulky mechanical devices. The description of terms and features related to the present disclosure shall be clear from the embodiments that are illustrated and described; however, the invention is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents of the embodiments are possible within the scope of the present disclosure. Additionally, the invention can include other embodiments that are within the scope of the claims but are not described in detail with respect to the following description.
[0029] FIG. 1A illustrates an exemplary view of an apparatus in accordance with an embodiment of the present disclosure.
[0030] Referring to FIG. 1A, the thrombostop socks 100 (also referred to as apparatus 100, herein) for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention. The apparatus includes a pair of conductive socks 102, integrated electrodes 104 (also referred to as a set of electrodes 104, herein), a microcontroller unit 106, biofeedback sensors 108, a stimulation module 110, and protective case 114.
[0031] The conductive socks 102 are configured to be worn comfortably for extended periods and are fabricated from a breathable, moisture-wicking material to enhance user comfort and hygiene. The socks 102 provides the primary wearable platform for the components, ensuring ease of use and wearability throughout daily activities. The integrated electrodes 104 are strategically embedded within the conductive socks 102, positioned to target key calf muscle groups. These electrodes are made of a biocompatible conductive material to ensure the safe and effective transmission of electrical stimulation to the muscles, promoting blood flow and mimicking natural muscle movement to reduce the risk of clot formation.
[0032] FIG. 1B illustrates an exemplary functional components of an apparatus in accordance with an embodiment of the present disclosure.The microcontroller unit 106, serves as the central processing hub for the apparatus. In an exemplary embodiment, the apparatus 100 can include an Arduino Nano microcontroller or equivalent. It is programmed to receive and process user input and sensor data, subsequently controlling the delivery of electrical stimulation to the integrated electrodes. The microcontroller 106 is configured to execute pre-programmed algorithms that modulate stimulation patterns based on real-time data, thereby personalizing the therapy to meet individual user needs.
[0033] The biofeedback sensors 108 may include electromyography (EMG) sensors and optional blood oxygen sensors. The EMG sensors are embedded in the apparatus to detect muscle activity and provide real-time data on muscle contractions. The microcontroller unit 106 processes this data to tailor electrical stimulation patterns that mimic natural muscle movement or adjust based on the user's specific requirements. Optionally, blood oxygen sensors may be included to monitor blood oxygen levels in the lower extremities. The microcontroller 106 can adjust the intensity of stimulation based on blood oxygen readings, further enhancing the effectiveness of DVT prevention.
[0034] The stimulation module 110 is responsible for generating and delivering controlled electrical pulses to the electrodes 104. The module is equipped with adjustable intensity settings, allowing the user to modify the strength of stimulation for optimal comfort. Additionally, safety features such as automatic shut-off mechanisms are integrated into the stimulation module 110 to prevent overstimulation and ensure user safety during extended use.
[0035] The power source can include a rechargeable battery, preferably a lightweight lithium-ion (Li-ion) battery, designed to power the entire apparatus 100. The battery is selected for its sufficient capacity, ensuring extended periods of operation between charges. Its compact form factor enhances the portability and convenience of the thrombostop socks, allowing users to wear the apparatus throughout the day without the need for frequent recharging.
[0036] In an embodiment, the apparatus 100 includes a user interface that enables users to interact with the apparatus 100 by initiating and terminating electrical stimulation, adjusting stimulation intensity for optimal comfort, and optionally selecting pre-programmed stimulation modes based on activity levels, such as sitting or light walking. The user interface may be integrated into a mobile application or provided as a simple control button on the socks.
[0037] The apparatus 100 includes a protective case 114 designed to securely house the electronic components of the apparatus, including the microcontroller unit 106, stimulation module 110, and power source. The protective case 114 is fabricated from a lightweight, durable material such as ABS plastic or a composite material that provides impact resistance and protects the internal electronics from environmental factors such as moisture, dust, and physical damage during daily use.
[0038] The protective case 114 is designed to be compact and ergonomic, ensuring that it can be comfortably attached to the user's footwear or clothing without causing discomfort. The case includes a series of ventilation slits to allow for heat dissipation from the internal components, preventing overheating during prolonged use. Additionally, the case features an integrated charging port that allows the user to easily recharge the power source without needing to remove the electronics from the case.
[0039] In an embodiment, the protective case 114 includes a snap-fit closure mechanism that securely holds the case together while allowing for easy access to the internal components for maintenance or upgrades. The case also incorporates a Velcro strap or similar fastening system (e.g., clips or magnets), enabling users to attach it to their socks, shoes, or clothing for convenient portability and ensuring that the system remains securely in place during physical activity.
[0040] For added user convenience, the protective case 114 may also feature an LED indicator panel that displays the system's operational status, such as power level, stimulation mode, and connectivity status with the mobile application (if applicable). This visual feedback ensures the user is informed of the apparatus's status at all times without needing to check the mobile app.
[0041] The protective case 114 is also designed to support wireless communication protocols, such as Bluetooth, ensuring that users can interact with the apparatus 100 through the mobile application without obstruction, even when the case is secured to a less accessible part of the body. This ensures seamless remote control and monitoring of the system, further enhancing user experience and flexibility.
[0042] In another embodiment, the apparatus 100 includes biofeedback sensors 108 for data acquisition. The apparatus 100 may incorporate electromyography (EMG) sensors to detect electrical activity in the calf muscles and, if included, blood oxygen sensors to monitor blood oxygen levels in the lower extremities, allowing for real-time physiological monitoring and adjustment of the stimulation parameters based on the acquired data.
[0043] The microcontroller unit 106 is configured to process user input and, if applicable, sensor data according to pre-programmed algorithms. Based on the processed information, the MCU sends control signals to the stimulation module 110, which delivers targeted electrical pulses to the designated muscle groups through the integrated electrodes 104, ensuring effective muscle stimulation for DVT prevention.
[0044] The apparatus 100 incorporates safety features, including automatic shut-off mechanisms to prevent overstimulation, user-controllable intensity settings to ensure optimal comfort, and a design that adheres to established safety guidelines for electrotherapy devices to ensure safe and reliable operation during use.
[0045] In an implementation of an embodiment, a user at risk of deep vein thrombosis (DVT) due to prolonged sitting, such as an office worker, wears the Thrombostop Socks 100 and activates the apparatus 100 via the user interface, either through a mobile application or a control button. Upon activation, the apparatus 100 delivers low-intensity electrical stimulation to the calf muscles at a pre-programmed frequency and pattern, simulating natural muscle contractions to promote blood circulation. The user can adjust the stimulation intensity for comfort throughout the day as needed.
[0046] In another implementation of an embodiment, a user with a higher risk of deep vein thrombosis (DVT) due to limited mobility activates the apparatus 100 with integrated electromyography (EMG) sensors. The EMG sensors detect weak muscle activity in the calf muscles, and the microcontroller unit 106 analyzes the sensor data to personalize the stimulation pattern, encouraging stronger muscle contractions to potentially improve blood flow compared to the basic use case. The user retains the ability to adjust the stimulation intensity for optimal comfort.
[0047] The apparatus 100 for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention can include conductive socks 102 made from conductive fabric to facilitate electrical signal transmission while ensuring comfortable wear. The EMG sensor electrodes 108 attached to the socks 102 for detecting muscle activity through electrical signals. The microcontroller 106 that processes sensor data and controls the stimulation output. An optional EMG processing unit designed for advanced signal processing and feature extraction from the EMG data if necessary. An EMS stimulator module 110 generates electrical pulses based on user-defined settings or processed EMG data. The EMS electrodes 104 are attachable to the conductive socks 102 to deliver electrical stimulation to targeted muscle groups.
[0048] In another embodiment, a DHT sensor 116 for monitoring the temperature within the apparatus enclosure to ensure safety during operation. The user control switch 112 on the protective case 114 allows for manual activation and deactivation of the stimulation by the user, where an optional mobile application provides a user interface for adjusting settings, displaying data, and controlling functionalities.
[0049] The breadboard functions as a solderless prototyping platform to connect electronic components with wires. A Li-Ion battery that powers the entire apparatus 100 and an enclosing box 118 that securely houses the Arduino Nano, EMS module, and other electronic components, attached to the user's shoe with Velcro 120 for easy access and portability. The apparatus 100 operates by first enabling user activation when the user puts on the Thrombostop Socks 100 and activates the apparatus 100 via the mobile app or the physical switch. The EMG signal acquisition is achieved through the continuous capture of electrical signals generated by muscle activity via the EMG sensor electrodes. If an EMG processing unit is included, advanced signal processing is performed to enhance the EMG signal for accurate muscle movement detection. The Arduino Nano analyzes either the raw or processed EMG signal to detect muscle activity based on pre-defined criteria established through clinical trials or user studies.
[0050] When muscle movement is detected, the apparatus 100 continues to monitor muscle activity; if no muscle movement is detected for a specified duration, the Arduino Nano triggers the EMS stimulator module. EMS stimulation involves delivering electrical pulses with a waveform customized to meet patient needs and safety limits, featuring a ramp-up and ramp-down of stimulation intensity for a more natural feel. Safety monitoring is ensured through the DHT sensor, which continuously checks the system's internal temperature and automatically shuts down all processes if safety limits are exceeded or if the sensor detects rain or other potential hazards. Overuse prevention is implemented by tracking usage time, with the system automatically powering off if the usage exceeds a pre-defined limit. The optional mobile app connects to the Arduino Nano via Bluetooth or another wireless protocol, providing functionalities such as real-time display of muscle activity levels detected by the EMG sensors, stimulation settings control, usage time monitoring, and optional data logging for analysis and consultation with healthcare providers.
[0051] FIG. 2 illustrates an exemplary flow chart outlining the overall schematic workflow for the system related to the prevention of deep vein thrombosis (DVT) in accordance with an embodiment of the present disclosure.
[0052] Referring to FIG. 2, the method 200 includes at block 202, the patient consults a primary care physician (PCP) to perform required scans and tests, obtaining data on the current health condition. At block 204, the PCP determines whether the patient is susceptible to DVT based on the collected data.
[0053] At block 206, if the patient is deemed DVT susceptible, the apparatus assesses whether the patient has a sedentary lifestyle. At block 208, if the patient leads a sedentary lifestyle, the EMG sensor reads electrical activity from the muscles, and the apparatus defines stimulation parameters. At block 210, the apparatus checks if the safety threshold values of the conductive socks have been crossed. At block 212, if the safety threshold values have not been exceeded, the apparatus verifies if the patient has been sedentary for too long.
[0054] At block 214, if the patient has been sedentary for an extended period, the apparatus sends a signal to the Electrical Muscle Stimulation (EMS) module to initiate stimulation. At block 216, the EMS module delivers electrical stimulation via attachable electrodes to the target muscle groups. At block 218, the apparatus monitors whether the stimulation time has been completed.
[0055] At block 220, if the stimulation time is not completed, the apparatus returns to step 210 to check for any safety threshold violations. At block 222, if any safety threshold values have been crossed at any point in the process, the system may terminate the stimulation process immediately.
[0056] FIG. 3 illustrates an exemplary flow chart workflow related to the Primary Care Physician (PCP) and the muscle stimulation system in accordance with an embodiment of the present disclosure.
[0057] The method 300 includes at block 302, user activation occurs either through a mobile app control (optional) or by using a user switch. At block 304, upon user activation, the microcontroller processes the EMG data received from the EMG sensor. At block 306, the apparatus triggers the EMG sensor to begin capturing muscle electrical activity.
[0058] At block 308, the EMG sensor is activated and begins sending EMG data to the microcontroller (MC). At block 310, a timer (Timer 1) is initiated, during which the apparatus monitors for muscle movement.
[0059] At block 312, if muscle movement is detected, the apparatus returns to monitoring muscle activity. At block 314, if no muscle movement is detected for a predetermined duration for X minutes, the microcontroller triggers the EMS module. At block 316, the EMS module generates electrical stimulation that mimics natural muscle movement. At block 318, the EMS electrodes attached to the conductive socks stimulate the targeted muscle groups, enhancing blood circulation and preventing DVT.
[0060] FIG. 4 illustrates an exemplary flow chart of user safety features for the system, in accordance with an embodiment of the present disclosure.
[0061] The method 400 includes at block 402, timer 3 is initiated to monitor the time of usage from the start of the apparatus operation. At block 404, the apparatus continuously checks if the time of usage exceeds the predefined limit i.e., Z minutes. At block 406, if the usage time exceeds the limit, the apparatus initiates a shutdown sequence to ensure user safety.
[0062] Concurrently, at block 408, the DHT sensor runs to monitor environmental conditions. At block 410, the apparatus checks for the detection of heat or moisture levels above the predefined threshold. At block 412, if heat or moisture above the threshold is detected, the apparatus also initiates a shutdown sequence for user safety.
Mathematical Model For Thrombostop Socks:-
[0063] This document outlines the mathematical model for the Thrombostop Socks, an apparatus designed to prevent DVT through targeted electrical muscle stimulation (EMS). The model serves as a framework for understanding the system's core functionalities and their underlying mathematical relationships. It's important to note that this model is flexible and subject to change based on findings from ongoing clinical trials.
[0064] Model Components and Relationships:
[0065] Effective Stimulation Threshold (ΔA(threshold))
• Muscle Activity: Represented by average EMG signal amplitude (A) in microvolts (μV).
• Stimulation Intensity: Represented by current amplitude (I) in milliamps (mA).
• Response: Represented by a change in muscle activity (ΔA) in μV after stimulation.
Simplified Model:
ΔA = k * I (Equation 1)
• k: This represents the sensitivity of the muscle to electrical stimulation. Its value depends on muscle characteristics, electrode placement, and system design. A value between 0.1 and 0.5 could be a starting point, but it may need adjustment based on experimentation and testing.
[0066] Threshold for Effective Stimulation (ΔA(threshold)):
[0067] This is a reference point to determine the effectiveness of stimulation. If the change in muscle activity (ΔA) falls below this threshold, the stimulation parameters may be adjusted to optimize effectiveness. Clinical trials will help refine this threshold and potentially other aspects of the model.
[0068] User Adjustment and Sensor Integration:
I(user) = m * I(max) (Equation 2)
• I(max): Maximum allowable stimulation intensity.
• I(user): User-adjustable parameter representing the proportion of the maximum intensity.
• m: User-adjustable parameter representing the proportion of the maximum intensity (0 to 1).
o 0 = No stimulation
o 1 = Maximum allowable intensity
stimulation_intensity = f (EMG reading) (Equation 4)
• f(x): Calibration function with x as the sensor reading and a, b as calibration constants.
• a, b: Calibration constants adjusted according to need and experimentation. Starting values: a = 1, b = 0.
[0069] These equations allow for user control and real-time adjustments based on sensor readings. Clinical trials will guide the calibration of these functions to achieve optimal stimulation for various user profiles.
[0070] Physiological Modelling (Optional):
Blood Flow = k1(stimulation intensity) + k2(muscle activity) (Equation 3)
• k1, k2: Constants representing the influence of stimulation intensity and muscle activity on blood flow. Their values depend on the specific physiological response and units used. Starting values like k1 = 0.2 and k2 = 0.5 can be adjusted based on research or experimentation.
[0071] This equation represents a potential physiological model for blood flow. Including it depends on the desired level of model complexity and the data collected during trials.
[0072] Safety Mechanisms:
a) Shut Down:
• Implemented based on temperature: temperature > threshold1
• Threshold temperature (threshold1) = 40°C
This is a crucial safety feature to prevent overheating.
b) Alert Mechanism:
• Alerts users to seek medical help if stimulation time exceeds a threshold: stimulation time > threshold2
• Threshold time (threshold2) = 2 hours
This helps ensure user safety by prompting medical attention for extended use.
c) DHT Sensor and Usage Timer:
• DHT Sensor: Continuously monitors the system's temperature for safety.
• Timer: Tracks total stimulation time.
[0073] These sensors along with the existing safety mechanisms provide a comprehensive safety system. The system shuts down if the temperature exceeds the threshold or alerts the user to seek medical help if stimulation time exceeds the threshold.
[0074] Customization based on Patient Biomarkers:
[0075] The model can be further customized based on patient-specific factors like blood cholesterol levels or other relevant biomarkers. This customization can potentially involve adjusting parameters within the model or incorporating additional equations based on future research and clinical trial findings.
[0076] Adaptability and Future Development:
[0077] The mathematical model presented here serves as a foundation for the thrombostop socks system. Clinical trials will play a vital role in refining the model's parameters and potentially its structure. The adaptability of the model allows for incorporating new findings and potentially including additional functionalities based on patient-specific data and ongoing research.
[0078] FIG. 5 illustrates an exemplary flow chart of a method for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention, in accordance with an embodiment of the present disclosure.
[0079] The method 500 for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention. The method includes at block 502, the method involves providing a pair of conductive socks configured to be worn by a user. The conductive socks are designed to accommodate the necessary components for adaptive electrotherapy, including electrodes and biofeedback sensors, ensuring comfort and wearability during extended use. At block 504, the method includes positioning a set of electrodes within the conductive socks. These electrodes are strategically placed to target the gastrocnemius muscle and soleus muscle of the user's calf muscle groups, allowing for effective electrical stimulation of these key areas.
[0080] At block 506, the method involves detecting a set of data related to the user's physiological parameters through a set of biofeedback sensors. The set of data pertains to any combination of muscle activity, muscle contractions, and blood oxygen levels, providing real-time feedback on the user's condition. At block 508, the method includes receiving the set of data at a microcontroller unit. The microcontroller processes the data from the biofeedback sensors to tailor the electrical stimulation based on the user's muscle activity and blood oxygen levels.
[0081] At block 510, the method involves generating electrical stimulation signals by the microcontroller unit. These signals are modulated based on the data received from the biofeedback sensors to ensure personalized and effective stimulation of the calf muscles. At block 512, the method includes delivering low-intensity electrical stimulation through the set of electrodes to the calf muscle groups of the user. The stimulation is designed to mimic natural muscle contractions, promoting blood circulation and aiding in the prevention of deep vein thrombosis (DVT).
[0082] Thus, the present invention overcomes the drawbacks, shortcomings, and limitations associated with existing solutions, and provides a non-invasive and user-centric apparatus, wherein electrical stimulation is employed to avoid the need for needles or medications, thereby enhancing user comfort and potentially improving compliance. The apparatus is adaptable and personalized, incorporating optional integration of electromyography (EMG) sensors, which facilitate the generation of personalized stimulation patterns based on real-time muscle activity, thereby catering to the specific needs of individual users. Furthermore, the apparatus offers a comfortable and convenient wearable sock design, allowing it to integrate seamlessly into daily activities. Additionally, the apparatus is portable, featuring a lightweight design that enables continuous use throughout the day, irrespective of the user's location.
[0083] It will be apparent to those skilled in the art that the apparatus 100 of the disclosure may be provided using some or all of the mentioned features and components without departing from the scope of the present disclosure. While various embodiments of the present disclosure have been illustrated and described herein, it will be clear that the disclosure is not limited to these embodiments only. Numerous modifications, changes, variations, substitutions, and equivalents will be apparent to those skilled in the art, without departing from the spirit and scope of the disclosure, as described in the claims.

ADVANTAGES OF THE PRESENT INVENTION
[0084] The present invention provides an apparatus is non-invasive and user-centric, as electrical stimulation avoids the need for needles or medications, thereby promoting user comfort and potentially improving compliance.
[0085] The present invention provides an apparatus is adaptable and personalized, featuring optional integration of electromyography (EMG) sensors that allow for personalized stimulation patterns based on real-time muscle activity, catering to individual needs.
[0086] The present invention provides an apparatus that offers a comfortable and convenient wearable sock design that integrates seamlessly into daily activities.
[0087] The present invention provides an apparatus that is portable, with a lightweight design that enables use throughout the day, regardless of location.

 
, Claims:1. An apparatus (100) for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention, the apparatus comprising:
a pair of conductive socks (102) configured to be worn by a user;
a set of electrodes (104) strategically accommodated within the pair of conductive socks for targeting gastrocnemius muscle and soleus muscle of calf muscle groups of the user;
a set of biofeedback sensors (108) detects a set of data of the user, the set of data pertains to any or a combination of muscle activity of the user, muscle contractions of the user, and blood oxygen levels of the user;
a microcontroller unit (106) operatively coupled to the set of electrodes and the set of biofeedback sensors, the microcontroller unit configured to:
receive the set of data from the set of biofeedback sensors;
generate electrical stimulation signals based on the received set of data;
deliver low-intensity electrical stimulation to the calf muscle group of the user through the set of electrodes to mimic natural muscle contractions and promote blood circulation so as to prevent DVT formation.
2. The apparatus as claimed in claim 1, wherein the set of electrodes (104) is made of a biocompatible conductive material for electrical stimulation transmission.
3. The apparatus as claimed in claim 1, wherein the set of biofeedback sensors (108) comprise electromyography (EMG) sensors for detecting muscle activity and blood oxygen sensors for monitoring blood oxygen levels in the lower extremities.
4. The apparatus as claimed in claim 1, wherein the microcontroller unit (106) is operatively coupled to a stimulation module (110) that is equipped with adjustable intensity settings for user comfort.
5. The apparatus as claimed in claim 4, wherein the stimulation module (110) delivers electrical stimulation that mimic natural muscle movement to promote blood flow and reduce the risk of clot formation.
6. The apparatus as claimed in claim 1, wherein the microcontroller unit (106) is configured to deactivate mechanism automatically to prevent overstimulation during use.
7. The apparatus as claimed in claim 1, wherein the microcontroller unit (106) is operatively coupled to a user interface that is integrated into a mobile application associated with a computing device for enhanced user interaction.
8. The apparatus as claimed in claim 1, wherein the user interface comprises a control button located on the pair of conductive socks.
9. The apparatus as claimed in claim 1, wherein the microcontroller unit (106) operatively coupled to a power source to supply power to the apparatus.
10. A method (500) for adaptive electrotherapy control for deep vein thrombosis (DVT) prevention, the method comprising:
providing (502) a pair of conductive socks configured to be worn by a user;
positioning (504) a set of electrodes within the pair of conductive socks for targeting gastrocnemius muscle and soleus muscle of calf muscle groups of the user;
detecting (506), through a set of biofeedback sensors, a set of data of the user, the set of data pertains to any or a combination of muscle activity of the user, muscle contractions of the user, and blood oxygen levels of the user;
receiving (508), at a microcontroller unit, the set of data from the set of biofeedback sensors;
generating (510), by the microcontroller unit, electrical stimulation signals based on the received set of data; and
delivering (512), through the set of electrodes, low-intensity electrical stimulation to the calf muscle groups of the user to mimic natural muscle contractions and promote blood circulation to prevent DVT formation.

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