EXTRAVASATION EARLY DETECTION PLASTER

Abstract

The invention relates to a patch (1) equipped with a pressure sensor (2) and an optical sensor (3) to provide early warning in case of possible subcutaneous infiltration (swelling) when intravenous drug is administered to the patient, to detect extravasation early and prevent the formation of tissue necrosis.

Description

1 TARIFF EXTRAVASATION EARLY DETECTION PLASTER Technical Area The invention addresses the possibility of subcutaneous infiltration (swelling) in a patient during intravenous drug administration. Equipped with a pressure sensor and an optical sensor to provide early warning of extravasation in the early 5 It is related to the adhesive tape that detects and prevents tissue necrosis. Previous Technique The most important findings during intravenous chemotherapy, a commonly used treatment in cancer therapy One complication is extravasation. Extravasation occurs when chemotherapy drugs leak outside the blood vessel. This occurs as a result of the drug seeping and spreading into the subcutaneous tissues, and depending on the properties of the drug, 10 serious consequences such as tissue necrosis, ulceration, loss of function, and disruption of the treatment process It can cause complications. Therefore, extravasation should be treated as early as possible. Detection at this stage is of great importance in terms of timely intervention for the patient. It carries. Detection of extravasation is usually made by healthcare personnel at a specific 15-minute interval at the vascular access site. Periodic visual inspections to monitor the patient's complaints such as pain, burning, or swelling. It is based on reporting and evaluating clinical findings. In addition, vascular Some sensor-based wearable systems also monitor changes in their environment. These systems have been developed using pressure sensors to detect changes in tissue pressure, and optically. With sensors, changes in blood flow or vessel filling within the vessels can be detected. 20 This can be monitored. Additionally, wearable patches that measure temperature and hydrogel-based sensors are available. and different detection technologies, such as color-changing warning layers, are also used for detection. It is used. In the current systems; • Healthcare personnel need to monitor continuously or at frequent intervals. 25 It is heard. • Extravasation is often only noticed after clinical symptoms have developed. 2 • Different parameters such as pressure, optics, temperature, and liquid infiltration together It cannot be evaluated. • An integrated system that brings together different sensor technologies in the same adhesive strip. It is not available. • Early warning cannot be supported by remote monitoring systems. 5 In document WO2009042562A1, to determine the condition of a vein during an injection In order to obtain swelling and leakage data, a patch is applied along the vascular access or an extravasation detection system and its effectiveness that includes sensors integrated into the structure as a module It has been mentioned. Document WO2024023097A1 describes 10 devices adapted to be worn around a patient's limb. a cuff made of elastic material and sensors placed on the cuff to monitor the blood vessel A structure that controls the situation and its effectiveness have been mentioned. Lu HC, Liao YC, "Transparent Wearable Sensor for Early Extravasation Detection", In his article in Proceedings, Vol. 56, No. 8, 2020, he discusses sensors to be placed on transparent adhesive tape. By evaluating the pressure status of the vessels, it is an early detection method for extravasation. 15 It has been mentioned. Document US20150050196A1 describes a disposable medical device that will be functionally connected to another device. It includes a colorimetric layer structured in this way. The colorimetric time display is one or more. when exposed to more external stimuli, through one or more visual indicators It is structured to demonstrate time specificity. 20 In document WO2020000062A1, application number [number] describes pH and humidity sensors based on hydrogels. or its use in detecting chemical changes is described in this document. Conductivity Thanks to modified hydrogel materials, the presence of liquid in the environment or Detection of biochemical parameters and conversion of these changes into electrical signals The study focused on monitoring the hydrogel layers after their transformation. The aim of the study was to monitor the hydrogel layers after their transformation. Integration with biosensors for humidity / liquid detection and monitoring of biological environments. to provide. WO2018022117 document describes a wearable thermometer for accurate measurement of human skin temperature. The patch and its effectiveness have been discussed. It is applied to human skin and provides high accuracy and more. 3 current announced wearable wireless devices that can perform temperature measurements with a fast response time The thermometer patch has been explained. Therefore, current technical solutions cannot reliably detect extravasation early. This prevents us from fully ensuring its implementation, increases the workload of healthcare personnel, and causes delays. Depending on the intervention, it can lead to tissue damage, treatment delays, and decreased patient comfort. 5 This is possible with pressure sensors, optical sensors, temperature sensors, and hydrogel-based sensors. The sensor, visual warning layer, and wireless communication module are all in a single adhesive strip. by combining them, a new early detection system that can monitor extravasation in a multi-parameter manner. It reveals the need that is felt. Purposes and Brief Description of the Invention 10 The aim of this invention is to prevent possible subcutaneous infiltration (swelling) during intravenous drug administration to a patient. Equipped with a pressure sensor and an optical sensor to provide early warning in such situations. A plaster that enables early detection of extravasation and prevents tissue necrosis. It is the development of. Another aim of this invention is to reduce the pressure and blood flow occurring around the blood vessel. By simultaneously monitoring the changes, the clinical symptoms of extravasation signs The goal is to detect it before it occurs. Another aim of this invention is to prevent tissue damage that may occur due to drug leakage outside the bloodstream. The goal is to prevent complications such as ulceration and necrosis through early intervention. Another aim of this invention is to provide healthcare personnel with real-time data from the sensors. The goal is to create a monitoring system that enables remote tracking and rapid intervention by facilitating transmission of information. Detailed Description of the Invention This invention is designed to achieve its objectives and includes an extravasation early detection patch. This is shown in the figures. Figure 1: Schematic view of an early detection plaster for extravasation. 4 Figure 2: Perspective view of the extravasation early detection plaster. Figure 3: Cross-sectional view of an early detection plaster for extravasation. The parts shown in the figures are individually numbered, and their corresponding numbers are given below. 5 It has been given. 1. Adhesive plaster 2. Pressure sensor 3. Optical sensors 4. Color-changing visual alert layer 10 5. Temperature sensor 6. Hydrogel-based sensor 7. Communication module 8. Acoustic warning unit The invention addresses the possibility of subcutaneous infiltration (swelling) in a patient during intravenous drug administration. Equipped with a pressure sensor and an optical sensor to provide early warning of extravasation. It relates to the adhesive tape that detects and prevents tissue necrosis, - A biocompatible surface on the skin-facing surface that allows the intravenous catheter to be secured to the skin. a flexible plaster containing adhesive material (1), 20 - At least one pressure is applied to the part of the patch (1) that is over the vein. sensor (2), - Optical sensors placed along the area where the vascular access passes (3), - At least one color-changing visual warning layer (4) integrated into the surface of the plaster (1), - Temperature sensor (5) integrated into the surface of the plaster (1), 25 - The hydrogel layer on the surface of the plaster (1) facing the skin, as a result of liquid contact a hydrogel-based sensor (6) that detects the electrical changes that occur, - Data received from the sensors on the plaster (1) to an external user terminal and / or a communication module that transmits to the server (7), It consists of 30 parts. A patch (1) compatible with vascular access measurements, for intravenous drug administration. Designed for application to the entry area, it is flexible, lightweight, hypoallergenic, and biocompatible. Made of material. The plaster (1) is sized to fit standard intravenous access plasters. It has a structure that adheres securely to the patient's skin and remains stable for a long time. The plaster (1) is a carrier that allows the sensors on it to be positioned correctly. It serves as a structural unit and includes all sensing components for the early detection of extravasation. It combines all these features. Furthermore, thanks to its flexible structure, it allows the patient to move freely without restriction. It allows for continuous monitoring of the vascular access area. The pressure sensor (2) is placed on the part of the patch (1) corresponding to the vascular access site. and which occurs in the tissue pressure around the vessel during intravenous infusion. It is structured to detect changes. Preferably based on the principle of bioimpedance. The pressure sensor in question (2) causes edema resulting from fluid leakage outside the vessel, 10 By detecting changes in infiltration and tissue resistance in the early stages, the first signs of extravasation can be identified. It determines the symptoms. The measurement data obtained by the pressure sensor (2) is communicated. It is transferred to external devices via module (7). Optical sensors (3) are placed along the area where the vascular access is located on the plaster (1), Optical measurement of changes in blood flow, vessel occupancy, and perfusion within the vessels. 15 It monitors using this method. Preferably, an optical method operating according to the principles of photoplethysmography (PPG). sensors (3) detect changes in flow within the vessel and thus pressure a second sensing mechanism to verify the data obtained by sensor (2) This creates a false positive effect that can occur in measurements based on only a single sensor. or the reduction of false negative results is ensured. In dual sensor operation, the measurement is 20 Reliability increases, and the sensitivity of early detection improves. The color-changing visual warning layer (4) is integrated into the surface of the plaster (1) and pressure sensor (2), optical sensors (3), temperature sensor (5) and hydrogel-based sensor (6) It is visible if the obtained measurement data satisfies predetermined decision criteria. It is structured to create a color change. The visual warning layer in question (4), 25 preferably using thermochromic, electrochromic or pH-sensitive materials. This can be done without the need for any external imaging device, and health This allows staff or patients to directly observe the risk of extravasation. This ensures that early warning is provided not only through electronic systems but also through other means. It is also possible to provide visual support. 30 6 The temperature sensor (5) is integrated into the surface of the plaster (1) and is located around the vascular access. It continuously measures temperature changes. In the initial stages of extravasation. Thermometers that detect temperature changes caused by fluid leakage outside the blood vessels. supporting data obtained by sensor (5), pressure sensor (2) and optical sensors (3) This creates an additional verification parameter. Thus, extravasation becomes more reliable. 5 This ensures that the information is determined in this way, thus reducing the possibility of false alarms. The hydrogel-based sensor (6) is integrated into the lower surface of the plaster (1) and is in direct contact with the skin. It is positioned in such a way as to detect extravascular leakage. The hydrogel-based sensor (6) in question detects extravascular leakage. to detect changes in moisture, liquid volume, or conductivity caused by the liquid It is structured. 10 changes in the physical or electrical properties of the hydrogel layer. Changes are evaluated by the system, and additional information regarding the presence of extravasation is obtained. Verification is provided. Thus, the pressure sensor (2), optical sensors (3) and temperature sensor Hydrogel-based sensor (6) working together with (5) multiparameter verification mechanism It forms a part of it. Communication module (7), pressure sensor (2) on the plaster (1), optical sensors (3), temperature 15 Data obtained by the sensor (5) and the hydrogel-based sensor (6) can be transmitted wirelessly to the external It is the communication unit that enables the transfer of data to devices. Preferably the communication module (7), Bluetooth It is a Bluetooth module that uses the Low Energy (BLE) communication protocol and transmits sensor data. Relevant healthcare personnel can access the hospital information system via mobile phone, tablet, computer or real-time data. It transmits the information in real time. This allows healthcare personnel to monitor the patient remotely, 20 instantaneous assessment of abnormal situations and rapid intervention when necessary. It is possible to find it. The acoustic warning unit (8) is optionally integrated onto the plaster (1) and the pressure sensor (2), optical sensors (3), temperature sensor (5) and hydrogel-based sensor (6) Based on the data obtained, the risk of extravasation exceeded a predetermined threshold of 25. It is an electronic warning unit that provides an audible alert to the user and / or healthcare personnel in this situation. The acoustic warning unit (8) generates an audible warning via the plaster (1) to provide health This allows personnel to intervene early. In one application of the invention, the plaster (1) has a particularly vesicant or irritant property. intravenous access during intravenous administration of chemotherapy drugs shown It is applied to the region. During the infusion process, pressure sensor (2), optical sensors (3), 7 temperature sensor (5) and hydrogel-based sensor (6) detect physical activity occurring around the vascular pathway. It monitors the changes simultaneously. Data obtained from the sensors are transmitted to the communication module (7) The data is transferred to an external device and evaluated together. Increased pressure, altered intravascular flow, local temperature change, and fluid leakage. A color-changing visual warning layer (4) appears if the data indicates extravasation. 5 It changes color accordingly and the acoustic warning unit (8) generates an audible warning. Thus Healthcare personnel or the patient is informed immediately, even if the extravasation is not yet clinically apparent. Early intervention is ensured by detecting the problem before significant tissue damage occurs. 15

Claims

8 REQUESTS 1. Early detection of extravasation that may occur during intravenous drug administration. It relates to an extravasation early detection patch that enables this, - A biocompatible surface on the skin-facing surface that allows the intravenous catheter to be secured to the skin. a flexible plaster containing adhesive material (1), 5 - At least one pressure is applied to the part of the patch (1) that is over the vein. sensor (2), - Optical sensors placed along the area where the vascular access passes (3), - At least one color-changing visual warning layer (4) integrated into the surface of the plaster (1), - Temperature sensor (5) integrated into the surface of the plaster (1), 10 - The hydrogel layer on the surface of the plaster (1) facing the skin, as a result of liquid contact a hydrogel-based sensor (6) that detects the electrical changes that occur, - Data received from the sensors on the plaster (1) to an external user terminal and / or a communication module that transmits to the server (7), It is characterized by containing its components. 15 2. An extravasation early detection patch as in Claim 1, with a pressure sensor (2), vein Tissue resistance and / or pressure caused by edema resulting from fluid leakage. It is characterized by being a bioimpedance-based sensor that detects changes in these parameters.

3. An extravasation early detection patch as in Claim 1, with optical sensors (3), vein Changes in blood flow, vessel filling, and perfusion within the vessel are measured using photoplethysmography (PPG). 20 It is characterized by having sensors that monitor using this method.

4. An extravasation early detection patch as in Claim 1, with an acoustic warning unit (8), It is characterized by its optional integration onto the plaster (1).

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