A wearable device with a sensor that measures edema.

Abstract

The invention relates to a wearable medical device for monitoring edema in the limbs via sensors, evaluating the measurement data digitally, and applying electrical stimulation based on this data;The device consists of a smart sensor area (1) that can be worn or wrapped around the limb, several pressure sensors (2) positioned on the smart sensor area (1) to receive pressure data from different areas on the limb, an Arduino nano (3) that processes the data received from the pressure sensors (2) and converts it into digital measurement data, a Bluetooth module (4) that enables the wireless transmission of the data processed by the Arduino nano (3), at least one electrode (5) that provides electrical stimulation on the limb, a mobile application (6) that allows the display and recording of the measurement data transmitted via the Bluetooth module (4), and a TENS device (7) that provides electrical stimulation via the electrodes (5).

Description

1 TARIFF A wearable device with a sensor that measures edema. Technological Field: 5 The invention enables the monitoring and measurement of edema occurring in the limbs through sensors. the digital evaluation of data and electrical processes based on this data It relates to a wearable medical device for applying stimulation. State of the Art: Edema in the limbs is the accumulation of fluid in the affected area as a result of fluid buildup in the tissue spaces. This is a significant clinical condition that can cause swelling, tightness, tenderness, and limited movement. This is a problem. Especially trauma, surgical intervention, orthopedic injuries, circulatory problems. 15 problems and proper management of edema in post-amputation rehabilitation processes It is of great importance to follow up. Timely and accurate payment. The inability to assess the situation makes it difficult to monitor the healing process, and the prosthesis... This can delay proper socket preparation in the applications and affect the treatment plan for the individual. This makes it difficult to regulate it accordingly. 20 In common practice, edema assessment is mostly done through observation, palpation, and measuring tape. This is done through methods such as environmental measurement and observation and palpation methods. The evaluation largely depends on the practitioner's experience. Therefore, the same Variability between assessments made by different people in the patient 25 Mild increases in edema or regional differences can be observed. It cannot be reliably determined. Circumference measurement with a tape measure is impractical and inexpensive. Although it is a costly method, the measurement point is always from the same location. Measurements must be taken and measured with the same frequency. In practice, this standard is not always followed. Because it cannot be protected, there may be a margin of error in the measurement results. Also, the 30 measurements taken with a tape measure... The measurement shows the circumference change in a specific cross-section of the limb; however, the edema of the limb... 2 detailed information on which local areas it is concentrated in or how its distribution changes He cannot present it in that way. In some cases, the flooding method, volume measuring devices, and imaging systems may be used. from more advanced methods such as ultrasonography or magnetic resonance imaging 5 These methods can be utilized. However, a significant portion of these methods are not suitable for clinical settings. It is dependent, costly, time-consuming, or impractical for daily tracking. This Therefore, regular monitoring, especially at home, frequent measurements, and rehabilitation are essential. Current solutions do not provide sufficient ease of record keeping. Known techniques for measuring edema and applications aimed at reducing edema. They are mostly carried out as separate processes. For example, compression. treatments include exercise, cold application, manual therapy, or electrical stimulation. Supportive practices are implemented individually; however, which of these practices The area, the intensity or timing of the action is often instantaneous and 15 It is not based on objective measurement data. This situation affects the treatment process depending on the individual and This limits the precise adaptation to the regional distribution of the edema. For these reasons, the technique allows for the collection of data from different points on the limb, and the regional assessment of edema. able to evaluate its distribution and intensity more objectively, and digitally display the measurement results. capable of recording and monitoring in the environment and targeting the area based on the data obtained. an integrated system is needed that allows for the application of electrical stimulation It is located. Description of the invention: 25 The main purpose of the invention is to determine the diagnosis of edema in the limbs solely through observation and palpation. or evaluation using methods dependent on the practitioner, such as measuring the circumference with a tape measure Instead, a more objective, quantitative, and trackable information regarding the location and severity of the edema is needed. The aim is to ensure that the localization of the edema can be determined in a way that is easily ascertainable. This will allow for the identification of the 30-degree localization of the edema. inability to detect precisely, small changes being overlooked, measurements 3 It varies from person to person and the response to treatment is consistent. A technical solution is offered for existing problems such as the inability to monitor. One of the key advantages of the invention is the multi-point placement on the smart sensor area. Thanks to pressure sensors, the edema on the limb can be measured not with a single overall value, but with 5 It involves evaluating the edema using data from different regions. This allows for an assessment of the edema on the limb. It can be more clearly determined in which region it is concentrated. This situation, especially Rehabilitation, orthopedic follow-up, and prosthetics should be performed to monitor regional swelling. This allows for a more meaningful evaluation during the implementation processes. The invention enables the digital recording of measurement results and their comparison with previous measurements. It also makes comparison possible. Data obtained through the mobile application. being able to monitor it over time, observing whether the edema is increasing or decreasing This provides the system with more than just a device that takes instantaneous measurements. exiting; the user or healthcare professional can review the process retrospectively 15 It provides a monitoring infrastructure that allows for evaluation. Another advantage of the invention is that the measurement and electrical stimulation functions are within the same system. It is related to the fact that the edema is based on data obtained from pressure sensors. by determining the region where it is concentrated and through the electrodes corresponding to that region 20 The ability to apply electrical stimulation with a TENS device is due to the device's data-driven and targeted nature. This ensures that it has a working structure. In this way, the stimulus reaches the entire region. Instead of applying it in a standard way, it is applied to the area where it is needed based on the measurement results. It becomes possible to direct it. The system also contributes to personalized monitoring and implementation. Each The user's limb structure, edema distribution, and changes throughout the process are different. Because of this, the data obtained from the pressure sensors should be evaluated separately. It offers a more personalized user experience. Thus, the same device architecture can be used in different ways. It is becoming adaptable for users and different limb regions. 30 4 The invention also provides decision support for physiotherapists, orthopedists, and prosthetic and orthotic specialists. It produces data of a qualitative nature. Obtaining measurements numerically facilitates treatment or The impact of the practices applied during the rehabilitation process can be more objectively examined. It helps in the evaluation. Thus, clinical decisions are not based solely on visual assessment. It can move beyond being based on observation or manual examination and be supported by measurable data. 5 In conclusion, the invention enables the regional perception of payment and the digital processing of measurement data. Monitoring in the environment, targeted electrical stimulation based on the measurement result. It can be made and offers a wearable structure that can be adjusted according to the user's needs. In this respect, it offers significant advantages compared to existing approaches. This integrated 10 The structure makes payment tracking more objective, organized, customizable, and practical. It makes it so. Explaining the Figures: The invention will be described by referring to the attached figures, so that the features of the invention can be explained. It will be understood and appreciated more clearly, but the purpose of this invention is this obvious It is not about limiting it with regulations. On the contrary, the invention is defined by the accompanying claims. all alternatives, modifications, and options that could be included within the defined area The aim is to cover their equivalences. The details shown are only for 20 of the present invention. It is shown to illustrate the preferred arrangements and both the methods shaping, as well as the most useful and conceptual features of the invention's rules and principles It should be understood that these drawings are presented to provide an easily understandable definition. In these drawings; Figure 1 shows the application of the edema measuring device, the subject of the invention, to the leg. 25 It is the appearance. Figure 2 is a schematic view illustrating the operation of the device described in the invention. Illustrations that will help understand this invention are shown in the attached image. They are numbered and listed below with their names. 30 Explanation of References: 1. Smart sensor area 1.1. Neoprene fabric 1.2. Compression structure 1.3. Velcro 5 2. Pressure sensors 3. Arduino Nano 4. Bluetooth module 5. Electrode 6. Mobile application 10 7. TENS device Detailed Description of the Invention: The terminology used here is intended solely to describe specific applications. 15 and does not limit the scope of the invention. Used here The term "and / or" refers to any of the items listed as related. It includes one and all combinations thereof. Also, the singular "one" used here, "one" The terms "number" and "specified" are used in their plural forms unless the context explicitly indicates otherwise. It is designed to include singular forms such as these. Furthermore, the 20 used in this specification... The terms "includes" and / or "contains" refer to the specified features, steps, processes, It indicates the presence of elements and / or components, but one or more other features, steps, processes, elements, components and / or groups thereof It will be understood that this does not exclude its existence or addition. Unless otherwise noted, all terms used herein (including technical and scientific terms), in the sense that a person with general knowledge in the field to which this invention belongs would generally understand it They have the same meaning. Furthermore, as defined in commonly used dictionaries... The terms will have a meaning consistent with the context of the relevant field and this explanation. it should be interpreted as such, unless otherwise explicitly defined here, idealized 30 or it will be understood that it will not be interpreted in an overly formal sense. 6 The description of the invention will reveal a series of techniques and steps involved. These are: Each of them provides benefits individually, and at the same time, one or more of them together or In some cases, all of the other techniques described may be used in combination. Accordingly, To ensure clarity, each step in the disclosure of the invention should be presented as accurately as possible. All combinations will be avoided by unnecessarily repeating them. With this 5 Together, the specification and claims, such combinations fully constitute an invention and claims. It should be read with the understanding that it falls within its scope. The invention enables the localized detection of edema occurring in the limbs, and the measurement of edema. Obtaining numerical data regarding the intensity, monitoring the obtained data in a mobile environment 10 electrical stimulation to the targeted area based on the data in question. a sensor-equipped edema monitoring and stimulation device that enables its application It is related. The device developed within the scope of the invention is essentially a wearable device that can be placed on a limb or 15 a wrapable smart sensor area (1), the smart sensor area (1) pressure sensors (2) located on it, data received from the pressure sensors (2) A working Arduino Nano (3) enables the wireless transmission of processed data. a Bluetooth module (4), electrodes that mediate the application of electrical stimulation (5), a mobile application that enables data monitoring and recording (6) and 20 It includes a TENS device (7) that provides stimulation via electrodes (5). The smart sensor area (1) is where the device makes contact with the limb and monitors edema. It forms the main body section where the smart sensor area is implemented. (1), preferably fits a knee, leg, ankle, arm or similar extremity area 25 It is arranged in a flexible structure to provide smart sensor area (1), The sensors will take measurements when the device is wrapped around or worn on the user's limb. It is structured to ensure stable contact with the surface. Smart sensor area (1), neoprene fabric (1.1), compression structure (1.2) and Velcro 30 Includes a band (1.3). Neoprene fabric (1.1) ensures the device fits comfortably on the limb. It is the flexible main support surface that allows it to sit. Neoprene fabric (1.1), pressure 7 a suitable surface for carrying sensors (2), electrodes (5) and connecting lines It also adapts to different limb diameters thanks to its flexible structure. It helps the sensors maintain their position within the measurement area. Compression structure (1.2) ensures that the smart sensor area (1) exerts a certain pressure on the limb. It is the structure that enables the creation of compression sensors (1.2). (2) The continuity of contact with the skin surface or the area to be measured is increased. In this way Circumferential expansion due to edema, local pressure change, or tissue Changes on its surface can be detected more stably. The compression structure (1.2) is the same by preventing the device from slipping during use, the measurements are 10 It increases its repeatability. The Velcro strap (1.3) allows the smart sensor area (1) to be fixed to the user's limb. It is an adjustable fastening element that provides Velcro strap (1.3) for the device to be different It can be used with adjustable tightness according to limb circumference. User or 15 Healthcare personnel can adjust the position of the device on the limb via Velcro strap (1.3). and can adjust the compression level. Thus, the measuring surface of the pressure sensors (2) It is ensured that it remains in proper contact. Pressure sensors (2) will be placed in a multi-point configuration on the smart sensor area (1) 20 Pressure sensors (2) are positioned to detect the formation of edema or swelling on the limb. to detect local pressure changes resulting from changes in intensity It is arranged in such a way that pressure changes detected by pressure sensors (2) These signals are converted into electrical signals. These signals indicate that the edema is only generally... 25 It is used. Thanks to the placement of pressure sensors (2) at multiple points. The device is not limited to producing a single environmental measurement or a general pressure value. Rather, By evaluating sensor data from different points together, the edema is determined. A regional assessment of the localization can be made. This will allow for an assessment of the limb's location of the edema. It can be determined whether it is homogeneous or concentrated in certain areas. 30 This structure is particularly important in rehabilitation, postoperative follow-up, and prosthetic fitting processes. It enables regional payment tracking. 8 Arduino nano (3) receives, processes and electrical signals from pressure sensors (2) It acts as a control unit that converts these signals into digital data. Arduino nano (3) reads the data from the pressure sensors (2) at regular intervals It obtains the measurement value for each sensor point. The obtained values ​​are previously set to 5 These can be compared with defined reference values ​​or previous measurement values. Thus, the change in pressure on the limb and the effect of this change over time The course can be followed. The Bluetooth module (4) is processed by Arduino nano (3). communication that enables data to be transferred wirelessly to the mobile application (6) It is the unit. The Bluetooth module (4) enables data communication between the device and the mobile application (6). by establishing a system that allows users or healthcare personnel to monitor measurement results. This allows data transmitted via the Bluetooth module (4) to each pressure sensor. (2) Measurement values, measurement time, change compared to previous measurements and payment It may include assessment data regarding its density. The electrodes (5) are located on or associated with the smart sensor area (1). The electrodes (5) are positioned to come into contact with the user's limb. Transmission of electrical stimulation produced by the TENS device (7) to the target area The position of the electrodes (5) allows the pressure sensors (2) to detect any increase in edema. It can be positioned close to the targeted areas. This ensures that the stimulation reaches the entire limb. Instead of being applied in a standard way, to areas determined by taking measurement data into consideration. It can be directed. The mobile application (6) allows viewing the measurement data from the device, It is a digital interface that allows data to be recorded and compared over time. Mobile 25 The application (6) receives the data from the Bluetooth module (4) and sends the measurement to the user. It can present its results as numerical values, graphs, or regional representations. Mobile through the application (6) the user’s previous measurements and current measurements They can be compared. This allows monitoring whether the edema increases, decreases, or remains stable. The mobile application (6) can also be configured to provide clinical decision support. 30 For example, if the pressure value exceeds the threshold value in certain sensor areas. In this case, the mobile application (6) can inform the user or healthcare personnel. 9 In addition, the mobile application (6) can detect the TENS device according to the sensor data obtained. (7) suggestions regarding which region, what intensity or what duration it will be applied to or it can generate control information. Thanks to this structure, measurement and electrical stimulation can be performed. By transforming processes from independent operations into data-driven monitoring... The system is created. 5 The TENS device (7) provides low-level electrical stimulation through electrodes (5). It is a unit. Within the scope of the invention, the TENS device (7) is obtained by pressure sensors (2). Depending on the data obtained, it is possible to apply electrical stimulation to the targeted area. It gives. The TENS device (7) is connected to the smart sensor zone (1) as a separate device. It can be used as well as in different application forms on the smart sensor area (1). It can also be configured to be integrated with a field control system. The working principle of the invention is that the smart sensor area (1) is attached to the user's limb. It starts with the placement. Neoprene fabric (1.1) conforms to the limb surface, compression 15 Its structure (1.2) supports the operation of the sensors with appropriate contact pressure and Velcro strap. (1.3) ensures the device is fixed on the limb. At this stage, pressure sensors (2), It begins measuring pressure values ​​at different points on the limb. Pressure sensors The measurement signals obtained by (2) are received by Arduino nano (3). Arduino nano (3) processes these signals and takes numerical measurements for each sensor point 20 It produces values. These data are sent to the mobile application (6) via the Bluetooth module (4). is transferred. The mobile application (6) displays, records and transfers the incoming data to the user. It compares the measurements. This allows for the localization, severity, and duration of the edema. The change can be monitored. The system monitors the data received from the pressure sensors (2). It can identify the region or regions where increased edema is detected. 25 corresponding to the identified regions. electrical stimulation via TENS device (7) through incoming electrodes (5) It is feasible. Thus, the device functions as a passive measurement system that only monitors edema. No, it allows for the application of stimulation to the targeted area based on measurement data. It functions as an integrated monitoring and stimulation system. In another application of the invention, the mobile application (6) can collect measurement data for specific purposes. It records the user's rehabilitation at time intervals. Thanks to these records, the user's rehabilitation During this process, the temporal changes in the payment status can be monitored. User, healthcare professional or the prosthetics-orthotics specialist can track the measurement history via the mobile application (6) The treatment or intervention plan can be evaluated accordingly. The number, location and layout of pressure sensors (2) within the scope of the invention are defined in application 5 It can be adjusted according to the limb area to be treated. It's different for the knee area, ankle or... Different sensor placement arrangements can be used for the arm region. Similarly The position of the electrodes (5) also corresponds to the expected density regions or pressure of the edema. The arrangement of the sensors (2) can be changed according to the configuration. Therefore, the invention applies only to the array. It is not limited to use around the limb and can be adapted to different extremity areas. 10 20 30

Claims

11 REQUESTS 1- The invention relates to monitoring edema occurring in limbs and basing it on measurement data. edema monitoring and electrical stimulation developed for the application of electrical stimulation. It is a stimulation system, and its feature is; 5  A smart sensor designed to be worn or wrapped around a limb region (1),  located on the smart sensor area (1) and the limb numerous pressure systems aimed at collecting pressure data from different regions on the surface. sensor (2), 10  by processing the data received from the pressure sensors (2) into numerical measurement data an Arduino nano (3) that converts,  Wireless transmission of data processed by Arduino nano (3) a Bluetooth module (4),  at least one electrode that enables the application of electrical stimulation on the limb (5), 15  Displaying the measurement data transmitted via the bluetooth module (4) and a mobile application that enables recording (6),  A TENS device (7) that provides electrical stimulation via electrodes (5), It includes. 2- The system mentioned in Claim 1 is characterized by its intelligent sensor area (1), flexible and It is characterized by containing a neoprene fabric (1.1) that can adapt to the limb surface. It is done. 3- The system mentioned in Claim 1, its feature is; the smart sensor area (1), pressure 25 to ensure the continuous contact of the sensors (2) with the limb surface, pressure on the limb It is characterized by having a compression structure (1.2) that applies pressure. 4- The system mentioned in Claim 1, its feature is; the smart sensor area (1), different limbs at least one velcro strap (1.3) that allows the tightness to be adjusted according to its surroundings 30 It is characterized by its inclusion. 12 5- The system mentioned in Claim 1, its feature is; on the smart sensor area (1) their spaced-out positioning and different local patterns on the limb having pressure sensors (2) arranged to receive pressure data from regions It is characterized by... 6- The system mentioned in Claim 1 is characterized by the measurement taken from the pressure sensors (2). data compared with previous measurement data and / or predetermined threshold values It is characterized by having the Arduino Nano (3) which is compared. 7- The system mentioned in claim 6, its characteristic is; detecting a pressure increase above the threshold value. 10 The sensor area is identified as the target area to which electrical stimulation will be applied. It is characterized by having an Arduino Nano (3). 8- The system mentioned in Request 1 is characterized by being processed by Arduino nano (3). Bluetooth module (4) 15 which wirelessly transmits the measurement data to the mobile application (6). It is characterized by having 9- The system mentioned in Claim 1, its characteristic feature is; the severity of the edema and / or Data regarding localization is presented as numerical values, graphical representations and / or regional data. 20 characterized by having a mobile application (6) that presents the information to the user in a display format. It is done. 30

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