A DEVICE FOR LYMPHEDEMA TREATMENT

Abstract

The invention comprises at least one body (1.1) that is tightened like a belt and encircles a limb such as an arm or leg, at least one digital display (1.1.1) positioned on the body (1.1) that acts as a user interface for selecting the treatment mode and displays at least one therapy value data such as vibration, negative pressure, temperature according to the selected mode, and allows the adjustment of these values ​​according to the patient, and initiates treatment after these values ​​are adjusted and displays the post-application data; at least one vacuum applicator unit (1.1.2) that applies vacuum at negative pressure values ​​ranging from -40 mmHg to -80 mmHg as needed to reduce edema and support circulation; at least one voice detection unit (1.1.3) to operate the device (1), preferably with at least one voice command; and at least one wireless data transmission unit (1.1.1) to transmit data to an electronic device.4), preferably a hot / cold application unit (1.1.5) enabling the application of heat or cold as needed, at least one energy storage unit (1.1.6) small enough to allow the device (1) to operate with power and to ensure its portability, at least one length adjustable belt (1.1.7) positioned on the body (1.1) and which, when attached to a limb, ensures that it remains fixed on the limb and thus delivers the therapeutic effect to the correct area, at least one biometric sensor (1.1.8) for monitoring circulation level and edema status during treatment via the digital screen (1.1.1) or a mobile application, at least one data storage unit (1.1.9) enabling the storage of data, preferably at least one vibration application unit (1.1.10) enabling the application of vibration, to the digital screen (1.1.1)1) refers to a portable / ergonomic form lymphedema treatment device (1) containing the said body (1.1) which includes at least one microcontroller unit (1.1.11) that enables the operation of the device (1) after the entered modes are entered by the user and / or enables the operation of the device (1) by detecting the voice command.

Description

1 TARIFF A DEVICE FOR LYMPHEDEMA TREATMENT Technical Area The invention supports the lymphatic system (actiwave-lymphatic system) of patients and treats lymphedema 5 It relates to a device developed for its treatment. State of the Art Lymphedema is the abnormal accumulation of protein-rich fluid and persistent swelling in an extremity. It is a condition characterized by lymphatic dysfunction. Lymphatic 10 There are three mechanisms that explain the pathophysiology. These are obstruction, reflux, and lymphatic fluid. It is the overproduction of lymphatic drainage. Obstruction in lymphatic circulation is the most common cause. Lymphedema can occur in many cases. It occurs in both sexes and at all ages, but is more common in women. Usually singular. It is biased. According to etiology, it is divided into two types: primary and secondary lymphedema. Secondary The causes can include infection, inflammation, cancer, surgery, trauma, and radiation. 15 Primary lymphedema can be congenital (from birth to the first year), precocious (1-35 years), or tarda (35 years and older). It is divided into three types (and subsequently). Lymphedema most commonly occurs in the lower extremities (80%). Although commonly seen, it can also appear on the arm, face, neck, and external genital area. Extremity lymphedema: swelling, heaviness, tightness, pitting, pain, numbness, skin problems It can present with symptoms such as these. 20 Toktaş, H., Çevik, H., Dündar, Ü., & Güleç, Ö. (2015). Lymphedema treatment. Kocatepe Medical Faculty. Journal, 16(4), 269-272. Fife, C.E., Davey, S., Maus, E.A., Guilliod, R., & Mayrovitz, H.N. (2012). A randomized controlled trial comparing two types of pneumatic compression for breast cancer-related lymphedema treatment in the home. Supportive Care in Cancer, 20, 3279-3286. 25 Morgan CL, Lee BB. Classification and staging of lymphedema. In: Tretbar LL, Morgan CL, Lee BB, Simonian SJ, Blondeau B. Lymphedema Diagnosis and Treatment. 1st edition, London. Springer, 2008:21-30. Öz BS, Sargın M, İyem H et al. Frequency and influencing factors of lymphedema in the lower extremity. Turkish Journal of Thoracic Cardiovascular Surgery 2005;14(4):304-7 30 2 Lipodema is a condition that typically affects women and is characterized by the abnormal accumulation of subcutaneous fat tissue. It is a chronic condition characterized by swelling, particularly in the hips, thighs, and legs. It manifests as symmetrical fat accumulation and is often accompanied by pain, tenderness, and easy bruising. It progresses with symptoms. Although the exact cause of lipedema is not fully known, hormonal changes and 5 Genetic predisposition is thought to play a significant role. The disease usually begins in adolescence, It appears or worsens during periods of hormonal change, such as pregnancy or menopause. Diagnosis is based on the patient's history and physical examination findings. Treatment options include: Treatment options include manual lymphatic drainage, compression therapy, exercise, and in some cases, liposuction. There are surgical interventions such as these. Early diagnosis and appropriate treatment can slow the progression of the disease. It is critical in slowing down and alleviating symptoms. Kruppa P, Georgiou I, Biermann N, Prantl L, Klein-Weigel P, Ghods M. Lipedema- Pathogenesis, Diagnosis, and Treatment Options. Dtsch Arztebl Int. 2020 Jun 1;117(22- 23):396-403. doi: 10.3238 / arztebl.2020.0396. PMID: 32762835; PMCID: PMC7465366. Poojari A, Dev K, Rabiee A. Lipedema: Insights into Morphology, Pathophysiology, and 15 Challenges. Biomedicines. 2022 Nov 30;10(12):3081. doi: 10.3390 / biomedicines10123081. PMID: 36551837; PMCID: PMC9775665. Herbst KL, Kahn LA, Iker E, Ehrlich C, Wright T, McHutchison L, Schwartz J, Sleigh M, Donahue PM, Lisson KH, Faris T, Miller J, Lontok E, Schwartz MS, Dean SM, Bartholomew JR, Armor P, Correa-Perez M, Pennings N, Wallace EL, Larson E. 20 Standard of care for lipedema in the United States. Phlebology. 2021 Dec;36(10):779-796. doi: 10.1177 / 02683555211015887. Epub 2021 May 28. PMID: 34049453; PMCID: PMC8652358. In its current state, the technique is used for the treatment of lymphedema and resolution of circulatory system problems. Different methods are used for this. These methods generally include manual therapy techniques, 25 clinical application is needed, such as pneumatic compression or negative pressure devices. It is based on mechanical devices that are heard. In lymphedema treatment, manual lymphatic drainage is a special massage performed manually by therapists. The techniques aim to increase the flow of lymphatic fluid. Problems related to the lymphatic system. In surviving patients, regular lymphatic drainage should continue even after therapy. 30 It is recommended, but patients are generally reluctant to perform lymphatic drainage on their own. 3 They are experiencing problems, which can lead to increased swelling and skin lesions in the tissue. problems such as changes, increased risk of infection and having to restart the therapy process This brings with it a time-consuming, laborious implementation process that requires constant expertise. It requires support. In patients with lymphedema and lipedema, in addition to regular use of compression stockings, 5 Regular lymphatic drainage is recommended. This procedure helps control edema in the patient. This is the goal. In cases of increased edema, multiple layers of bandages will make things even more difficult for the patient. These practices are reinstated. Furthermore, these passive methods are generally used over a long period. This requires attention and the effectiveness of the treatment may be limited. Devices that apply negative pressure are believed to increase the movement of the lymphatic system. These are devices that are generally large and expensive, but are typically used in clinical settings. These are devices. Therefore, their use has not become widespread enough. Devices specifically developed for the treatment of lymphedema are rare. Most studies in the literature focus on applying vibrations to the entire body. devices were used; however, this method has a product diversity of 15 in regional applications. It has been observed that it does not provide sufficient support. In addition, the current devices are mostly single-use. focusing on a treatment method and offering customization options for individual needs. It remains quite limited. In conclusion, the methods used in current techniques generally require clinical settings. hearing, not meeting the needs in individualization or local applications, more than 20 These are solutions that require sessions, are not user-friendly, and have limited portability. Disadvantages of devices used in the treatment of lymphedema in the current state of the art. They can be listed as follows: 1) Constant Pressure Application: Pneumatic compression pumps apply constant pressure. This also means it cannot be customized to the needs of every user. This situation means the treatment process takes 25 days. This prevents personalization. These pumps remove edema from the tissue. It does not activate the lymphatic system or increase lymphatic circulation while working. It varies from person to person. It cannot be individualized and adapted to each individual limb. 2) Limited Personalization: Personalized vibration or pressure settings on existing devices. It is difficult to do so. The inability to adjust treatment settings according to the different needs of users, 30 This may limit treatment effectiveness. 4 3) Non-ergonomic Designs: Some devices are not suitable for users' body structures. It is not adaptable, which can cause discomfort during prolonged use. Also, portability... It offers limited flexibility in this regard. 4) Lack of Digital Control and Mobile Application: Most current devices have digital displays. or there is no mobile application support. This makes monitoring the treatment process and settings remote. 5 It makes it more difficult to do. 5) Lack of Cold / Hot Therapy Integration: Existing devices are generally inadequate. It only applies pressure and does not offer cold / hot therapy integration. It prevents excessive tissue temperature. An increase in swelling causes an increase in edema, while an excessive decrease reduces the mobility of the lymphatic system. Edema can also limit the effectiveness of the treatment process. 10 6) Lack of Language Support: Current devices do not provide support for use in different languages. This can limit the user experience. 7) Difficulty of Home Use: Most treatment devices are not suitable for home use. It may not be possible, or it may require complex installations and high energy consumption. 8) Technological Deficiencies: Existing devices generally lack wireless connectivity and sensors. It does not have modern technologies such as technology, which makes treatment monitoring and personalized This complicates the settings and can also limit the therapist's effectiveness in the therapy process. 9) User Independence: In lymphedema treatment or circulatory system support, The patient usually needs the therapist's continuous guidance. The therapist needs to be there for them at all times. Failure to locate it may cause disruptions in the treatment process. 20 10) Lack of Remote Control: Most treatment devices require manual control and Remote use options are limited. This leads to a waste of time for the patient or therapist. It can open. 11) Lack of Personalization in the Treatment Process: Each patient's treatment needs... The difference is not enough because existing devices offer a single, uniform solution. 25 It cannot be met. The patent numbered D1-US20210290482A1, which is included in the known state of the art, The device is wearable and can be attached to the patient's body (arm, leg, etc.). Vibration commands are given via the control module. The vibration module, given 30 It generates vibrations according to commands. The vibration sensor measures the generated vibration and controls it. It provides feedback to the module. Harness (binding mechanism) and compression. Thanks to its sensor, the device is secured to the patient. The device can be accessed via a mobile application or an external device. It can be controlled via this device. The device provides focused vibration therapy. It can be used in rehabilitation and pain management. However, despite having the aforementioned features, This device offers only vibration therapy; it does not offer negative pressure (pneumatic compression) or other forms of therapy. It does not have hot / cold therapy features. It monitors circulation or edema using biometric sensors. It doesn't. It doesn't have the feature to graph treatment data or record long-term data. Automatic. It does not have a shut-off feature; continuous manual control is required. Multiple therapy protocols 5 Its adaptability to different patient needs is limited because it does not offer these options. D2: US 10912704 B2, which is included in another known case of the art. The device mentioned in the patent document is specifically designed for deep vein thrombosis (DVT) and peripheral vein thrombosis. To prevent vascular complications such as edema, apply the injection to the leg area at intervals of 10 minutes. It is designed to apply pneumatic compression. The device works by bypassing air leakage. It aims to increase treatment effectiveness by controlling compression. Its tubeless design and battery... Thanks to its design, it offers portability, thus providing the patient with freedom of movement. There are no restrictions. However, only intermittent pneumatic compression application is available. Advanced treatments such as vibration, hot / cold therapy, biometric tracking and digital data management and 15 Tracking systems are not integrated into the device. Mobile application support and real-time tracking are available. Data tracking is not offered. Detailed data recording and analysis of the treatment process is not possible. It is not available. In addition, the device in question has automatic shutdown and treatment results display. User-friendly features such as systematic logging are not available. Brief Description of the Invention The aim of the invention is to support the lymphatic system (actiwave-lymphatic system) of patients and to treat lymphedema. The goal is to develop a device for its treatment. With the invention of this device, the patient's lymphatic drainage is performed spontaneously. This is the goal. This also reduces the patient's need for bandaging. 25 The aim of this invention is to increase the effectiveness of the compression products currently in use. The portability, user comfort, and treatment effectiveness offered by this invention are superior to existing devices. It offers a significant innovation and advantage compared to others. The advantages offered by the invention can be listed as follows: 6 1) Customizable Treatment Options: The device can be tailored to the user's needs. Because it offers the possibility to adjust the vibration intensity and patterns, it makes the treatment process easier. It makes it effective and personalized. It supports a specific area in a specific activity. It allows use during the activity. 2) Ergonomic Design and Comfort: The device provides comfort even during prolonged use. 5 and can be adjusted to fit body shape. Its lightweight, portable design and Breathable materials offer convenience to users in daily life. The person is a sports person. It can be used comfortably while working or in daily life. 3) Wireless Connection: Thanks to its wireless connection feature, the device can be used to remotely monitor the treatment process. manageable. 10 4) Monitoring via Mobile Application Support: Integration of the device with a mobile application, allowing users to monitor their treatment progress and make adjustments to their treatment. This feature allows the treatment process to be managed in a more efficient and personalized way. It makes it possible. It also allows the user to exercise independently at home while consulting their doctor. It allows them to stay in contact. 15 5) Voice Command and Control Feature: Voice commands integrated via the mobile application. The command system controls the treatment process without the therapist needing to be present with the patient. It allows you to manage it. For example, "Start the device", "Increase vibration intensity", etc. You can easily change treatment settings with commands. 6) Effective Tracking with Biometric Sensors: The biometric sensors in the device, 20 It analyzes the circulation level and the state of edema. This determines the effectiveness of the treatment process. This enhances and allows for better monitoring of users' response to treatment. 7) Cold / Hot Therapy Integration: The device integrates cold and vibration therapy. It offers heat therapy options. This feature accelerates circulation, thus aiding in the treatment of lymphedema. It supports more effectively. 25 8) Environmentally Friendly and Durable Materials: The device is manufactured with environmentally friendly materials. It is durable for long-term use. 9) Different Modes and Programs: Customized treatment for athletes and other users. It offers different modes and programs. Users can choose a treatment program suitable for their needs. They can choose. 30 10) Language Support: The device offers multiple language options, allowing users to speak different languages. It makes it easier to use. 7 These features highlight the unique aspects of the product that set it apart from existing devices. Similarly... At the time, the device was used not only for lymphedema treatment, but also for muscle growth and muscle development. It can also be used to support retraining and circulatory health. In the prior art, the invention differs from the documents listed below in the following respects: It has advantages: 5 • Multiple therapies such as vibration + negative pressure (pneumatic compression) + hot / cold therapy There are various therapy modes. With its multimodal therapy, it caters to different patient groups. (Lymphedema, circulatory disorders, post-operative edema, etc.) are adaptable. In other words; The device provides intermittent pneumatic compression, as well as vibration therapy and hot / cold applications. It offers a combination of therapy modes. These multiple therapy options provide treatment for 10 increasing its effectiveness and providing the patient with a more comprehensive rehabilitation opportunity. It provides. • It has a wearable design that can be easily attached to the arm or leg. • Provides easy control via digital display and mobile application. Mobile application This enables digital monitoring and communication between patient and therapist. Another 15 In other words, the device is controlled via a digital screen and a mobile application, all Treatment data is systematically recorded and analyzed in detail. This is possible. In this way, both the patient and the therapist can monitor the treatment process. and can plan individualized interventions if needed. • Circulation and edema are monitored using biometric sensors, providing real-time data (20) during treatment. Data is monitored. Personalized treatment plan based on biometric sensor data. It provides the possibility of creating treatment with advanced biometric sensors. In other words, treatment with advanced biometric sensors. During this time, the patient's circulatory status and edema level are monitored in real time. They are being monitored, which allows for immediate intervention in the treatment process. • Progress can be monitored thanks to the recording of treatment data. 25 from the collected data. The generated graphs and analyses provide an objective assessment of the treatment process. This allows for the optimization of the treatment plan and patient outcomes. It contributes to its improvement. • Data is displayed both on the screen and in the mobile application; for graphing and analysis. It is done. 30 • It has the ability to send instant alerts / signals to the therapist when needed. • It has an automatic shut-off and treatment result saving feature. Treatment When complete, the device switches off automatically and the treatment results are recorded. 8 This data can be used for subsequent evaluations. This feature allows the user It increases comfort and reduces the risk of errors. • Treatment parameters can be customized according to the patient. Figure Description 5 Figure 1. Representative view of the lymphedema treatment device, the subject of the invention, in operation. It is the appearance. Figure 2. A representative view of the lymphedema treatment device, the subject of the invention, in action. It is the appearance. Figure 3. Block 10 of the units contained within the body of the lymphedema treatment device that is the subject of the invention. It is a diagram. Explanation of References in Figures To better understand the invention, the parts shown in the figures are individually numbered. The corresponding numbers are given below: 1. Device 15 1.1. Body 1.1.1. Digital display 1.1.2. Vacuum application unit 1.1.3. Sound detection unit 1.1.4. Wireless data transmission unit 20 1.1.5. Hot / cold application unit 1.1.6. Energy storage unit 1.1.7. Adjustable belt 1.1.8. Biometric sensor 1.1.9. Data storage unit 25 1.1.10. Vibration application unit 1.1.11. Microcontroller unit Detailed Description of the Invention The subject of the invention is a portable / ergonomic form lymphedema treatment device (1); 30 like a belt at least one trunk (1.1) in the form of a constricted and encircling limb such as arm / leg, the trunk in question 9 (1.1) is positioned on and the treatment mode is selected by the user. Acting as a user interface, it provides vibration, negative pressure, and other functions depending on at least one selected mode. showing at least one therapeutic value data such as temperature, and this is relevant to the patient. It allows the adjustment of the values, and after these values ​​are adjusted, the treatment begins. at least one digital display that initiates and displays post-implementation data 5 (1.1.1), -40 mmHg to -80 as needed to reduce edema and support circulation at least one vacuum that applies a vacuum at negative pressure values ​​varying between mmHg. The implementing unit (1.1.2) shall enable the operation of the device (1) preferably with at least one voice command. at least one sound detection unit (1.1.3), preferably for transmitting data to an electronic device. at least one wireless data transmission unit (1.1.4), allowing for the application of heat or cold as needed 10 preferably a hot / cold application unit (1.1.5) that provides power for the device (1) to operate. and at least one energy storage unit small enough to ensure its portability (1.1.6), positioned on the body (1.1) and fixed to the limb when attached to a limb at least one that ensures it remains there and thus delivers the therapeutic effect to the correct area. The adjustable length belt (1.1.7), the aforementioned digital display (1.1.1) or a mobile 15 The application is used to monitor circulation levels and edema status during treatment. at least one biometric sensor (1.1.8), at least one data storage device that enables data storage. unit (1.1.9), preferably with at least one vibrating unit that enables the application of vibration. (1.1.10) is the mode entered into the digital screen (1.1.1) after it has been entered by the user. then enabling the device (1) to operate and / or enabling the voice command to be detected 20 the device (1) contains at least one microcontroller unit (1.1.11) that enables the operation of the device (1). It includes the housing (1.1). The microcontroller unit (1.1.11) enhances the functionality of the device. enriching the user experience and offering multiple control options (digital display or It enhances the accessibility of the device by offering voice commands. The user can choose the treatment mode via the digital screen (1.1.1) or a mobile application. can select. Post-application data is also available through the mobile application in question. can be displayed to the user. If needed, this data or a signal can be shown to the user. It can also be transmitted to an external therapist's mobile application. How the device (1) works: • The user attaches the device (1) to the arm / leg and the digital display (1.1.1) or mobile app 30 selects the treatment mode via • On the digital display (1.1.1), vibration, negative pressure, hot / cold according to the selected modes. The minimum values ​​of therapy are shown, and these values ​​vary depending on the patient. Treatment is started after adjustment from the digital display (1.1.1). • Biometric sensors monitor circulation levels during treatment via a mobile application. It monitors the payment status. 5 • Data is transferred to a digital screen and mobile application, and a signal is sent to the therapist when needed. It will be sent. • At the end of the treatment, the device (1) switches off automatically and the results are recorded. • A chart is created from the data entered into the mobile application during the treatment period. The data and the chart created provide a clearer analysis of the progress in the treatment process. 10 This allows for monitoring and, if necessary, adjustments to the treatment plan. The system enables both the patient and the therapist to make informed decisions regarding treatment. It helps. Industrial Applicability of the Invention The invention relates to a portable / ergonomic form lymphedema treatment device (1) and is intended for industrial use. It is feasible. - Medical Use: Treatment of lymphedema and edema caused by any reason. Supporting the lymphatic circulatory system, supporting the muscle growth process, muscle It enables the support of neural plasticity in re-education. - Occupational therapy: For individuals with special needs (e.g., neurological or orthopedic 20 (problems) supports circulation and muscle function. Activities of daily living. It facilitates and increases mobility. - Physiotherapy and Rehabilitation: Edema and atrophy after injury or surgery. In the cases seen, supporting muscle development and the circulatory system leads to shorter recovery periods. Recovery in a short time, increasing muscle strength with less physical activity 25 - Home Healthcare Services: Easy portability for daily use. - Sports and Recreation: When used during sports, it supports muscle development and promotes well-being. Post-exercise muscle relaxation and circulatory support. Lymphatic system support in post-exercise applications. by supporting the flow of post-exercise metabolic processes more easily from the tissue. It helps to remove it. 30 11 - The invention is also applicable to industry. Treatment of lymphedema, circulatory system. in areas such as support and rehabilitation, clinical, home use and athlete health. It has the potential for mass production and marketing in various sectors. This device can be used for both therapeutic purposes and for general health and comfort. 5 The invention is not limited to the above descriptions; a person skilled in the field can easily create the invention. It can present different applications. These are the claims of the invention and the protection sought. should be evaluated within this context. 15 25

Claims

12 REQUESTS 1. At least one digital display (1.1.1), at least one vacuum applicator unit (1.1.2), , at least one energy storage unit (1.1.6), at least one adjustable belt (1.1.7), wireless data Containing a transmission unit (1.1.4); tightened like a belt and encircling a limb such as an arm / leg. at least one stem in the form (1.1), positioned on the said stem (1.1) and 5 acting as a user interface for the user to select the treatment mode and at least one therapy such as vibration, negative pressure, or temperature, according to at least one selected mode. showing the value data and adjusting these values ​​according to the patient. and at least one digital display (1.1.1) that enables the display of post-implementation data, 10 -40 mmHg to -80 mmHg as needed to reduce swelling and support circulation at least one vacuum that applies a vacuum at negative pressure values ​​varying between The implementing unit (1.1.2) controls the operation of the device (1) preferably with at least one voice command. to provide at least one sound detection unit (1.1.3), preferably an electronic device for data processing. at least one wireless data transmission unit (1.1.4) to transmit to the device, hot or hot if required. preferably a hot / cold applicator unit (1.1.5) that enables the application of cold, the device (1) at least one small enough to operate with energy and to ensure its portability. The energy storage unit (1.1.6) is located on the said shell (1.1) and When attached to a limb, it remains fixed in the limb, thus ensuring the therapeutic effect is delivered to the correct area. at least one adjustable length belt (1.1.7) enabling the transmission of the digital 20 Circulation level during treatment via screen (1.1.1) or a mobile application and At least one biometric sensor (1.1.8) to monitor payment status, data at least one data storage unit (1.1.9) enabling its storage, preferably vibration at least one vibration implementing unit (1.1.10) that enables its implementation, the digital After the modes entered on the screen (1.1.1) are entered by the user, the device (1) 25 enabling the device to function and / or detect voice commands (1) the said body containing at least one microcontroller unit (1.1.11) that enables its operation (1.1) A portable / ergonomic form of lymphedema treatment characterized by containing device (1).

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