Multimodal analgesia device for pediatric injections.

Abstract

The invention specifically relates to a multimodal analgesia device that helps overcome needle phobia in pediatric injection procedures and minimizes acute pain through a simultaneous combination of tactile, thermal, visual, and auditory stimuli. Figure 1

Description

1 TARIFF Multimodal analgesia device for pediatric injections. TECHNICAL AREA 5 The invention has implications for biomedical device technologies in general, pediatrics, anesthesiology, and hospitals. It is related to the fields of infection control and multimodal pain management. The invention is particularly designed to overcome needle phobia in pediatric injection procedures and 10 Acute pain is perceived simultaneously with tactile, thermal, visual, and auditory stimuli. It relates to a multimodal analgesia device that enables minimizing pain through combination of these methods. STATE OF THE ART Today, medical injections, vaccinations, and blood draws are performed on pediatric patients. The pain experienced during the procedure and the resulting fear of needles (trypanophobia) affect both the patient and the patient. Pain is one of the most significant factors that complicates the procedure for healthcare professionals. various traditional and mechanical methods in medical applications for reduction It is used. 20 The first of the current technical applications is a topical medication containing the active ingredients lidocaine and prilocaine. These are (local) anesthetic creams (EMLA, Ametop, etc.). After these creams are applied to the skin... They then need a waiting period of approximately 30 to 60 minutes to take effect. This is heard. This situation occurs in the intense clinical flow, in emergency room interventions, or 25 This makes its practical use in mass vaccination campaigns impossible. Furthermore, topical application... Allergic reactions, methemoglobinemia risk, and high risk of allergic reactions when using anesthetics. There are technical and clinical disadvantages, such as the cost of medication. Another approach is based on the principle of "Gate Control Theory". These are mechanical devices that rely on, are held manually, and have vibrating and ice packs (Buzzy, (VibraCool, etc.). These devices are placed above the injection site to provide coolness. and transmission of pain signals at the spinal cord level through a combination of vibration. 2 It aims to prevent this. However, in the current state of technology, these devices have the following characteristics: There are technical shortcomings and unresolved problems: - Operator Dependence and Clinical Workflow Issues: Operation of Existing Devices manually on the skin by a healthcare professional or a patient's relative throughout It is necessary to keep this in mind. This situation requires the healthcare personnel administering the injection to be 5 years old. keeping one hand constantly busy, disrupting clinical workflow, and fidgeting. It poses a safety risk for pediatric patients. - Rapid Energy Consumption and Limited Battery Life: Due to the active cooling element. The Peltier thermoelectric modules used have high electrical power consumption. It has. In compact medical devices, this high power draw extends battery life by 10. limiting it to minutes, in clinics that continuously see patients throughout the day this prevents uninterrupted use and requires the device to be charged frequently. This requires. In the initial moments when Peltier modules begin to operate. High instantaneous current draw also rapidly depletes the lifespan of lithium batteries. - Neural Adaptation (Habitation) Problem: 15 producing vibrations at a constant frequency due to existing actuators in the peripheral nervous system (especially Meissner and Pacinian bodies adapt rapidly to vibration. This situation, The numbness and analgesic effect initially obtained rapidly during the procedure. This leads to a decrease; especially with multiple vaccinations or prolonged periods. This leads to the device losing its effectiveness in the processes. 20 - Insufficient Mechanical Transmission and Energy Dissipation: Lack of a flat and smooth contact surface. The current devices that have this feature deliver vibration and cold energy to a wide range of skin surfaces. It is distributed throughout the area; reaching the target nerve endings with sufficient density. This cannot be delivered. This makes it difficult to reach the arousal threshold. and unnecessarily prolongs the device's operating time. 25 - Limitation of Monomodal Analgesia: Products on the market only offer monomodal analgesia. It is based on tactile (vibration) or thermal (cold) stimuli. Pediatric as evidenced in the literature, in the management of injection pain in children A multimodal approach that includes auditory and visual distraction, statistically significantly more than the single-mode approach 30 It achieves high success. Current devices have an integrated auditory system. or does not contain a visual distraction mechanism, external device Mandatory use creates hygiene and cost problems. 3 - Risk of Cross-Contamination and Hospital Infection: Existing vibration The devices are used repeatedly among patients, and their surfaces are only The surface is disinfected with alcohol wipes. The active disinfectant on the device surface... or lack of passive antimicrobial properties, especially in newborns units, pediatric oncology and intensive care units, MRSA, 5 This creates a serious risk of cross-contamination from bacteria such as Acinetobacter. - Lack of Personalized Treatment: All pediatric patients have different age, skin types Despite having thickness, bio-impedance and pain threshold, it is currently available. devices operate at constant parameters (constant vibration and cooling level) It is working. This situation, especially in very young babies, is due to the device being inadequate. 10 This causes it to remain or to become overstimulated. The current technical document numbered US2008086063A1 concerns vibration, cold, and caution. It relates to devices and methods aimed at reducing pain using dispersing elements. This In addition to vibration and cold, the device mentioned in the document has 15 distracting elements. The outer casing of the device can have various shapes such as geometric patterns, animal designs, etc. This has been stated. However, this situation has not had a sufficient effect in pediatric applications. It does not create. Document number CN211584595U concerns infusion pain relief wristbands for children, 20 This document is related to the vibration and cooling systems that are subsequently installed on the product. In addition to the parts, the device's casing is designed with cartoon characters. This device is also seen to be inadequate for pediatric applications. In conclusion, improvements in analgesia devices used in pediatric applications number 25. This is being done to eliminate the disadvantages mentioned above and New structures are needed to provide solutions to the existing systems. THE PURPOSE OF THE INVENTION The present invention meets the aforementioned requirements and overcomes all the disadvantages. This relates to a multimodal analgesia device that eliminates the need for analgesia and offers some additional advantages. 4 The main purpose of the invention is to overcome needle phobia in pediatric applications and invasive medical procedures such as injections, blood draws, intravenous access, or vaccinations The aim is to minimize the acute pain felt during the procedure. For this purpose, tactile, a wearable device that combines thermal, auditory, and visual modalities The goal is to present the analgesic device. 5 One aim of the invention is to convert cooling energy into latent heat by hybridizing the Peltier module. storing it in this form and eliminating the need for continuous operation of the Peltier element, thus saving the battery. The goal is to extend its lifespan by up to 300%. Additionally, the instantaneous Peltier element... By meeting high current draws externally from the battery, the battery is protected from high current pulses by 10 The aim is to ensure its protection. Another purpose of the invention is to eliminate bacteria and microorganisms on the skin contact surface. The goal is to passively prevent its formation by 99%. Furthermore, this contact... by allowing the vibration energy to concentrate at small contact points with the surface 15 By transmitting direct and high-intensity signals to Meissner and Pacinian bodies. The goal is to achieve more effective analgesia with lower power. Another objective of the invention is to achieve continuous frequency modulation in the 40-250 Hz range. It produces tactile vibrations. With this variable frequency structure, the nervous system... By inhibiting the habituation (adaptation) response, the analgesic effect is maintained throughout the entire process. The aim is to ensure its continuation throughout this period. Another purpose of the invention is to create simultaneous colorful light animations and a child-friendly design. Sensory / cognitive distraction through door control theory by broadcasting music / lullabies 25 The goal is to enable the combination of (distraction) mechanisms in a single device. Another aim of the invention is to provide a biocompatible hypoallergenic solution to the injection site. Secured with medical adhesive disposable pads to ensure hygienic use and The aim is to eliminate the risk of cross-contamination. At the same time, this also improves health. 30 It also aims to ensure that personnel have completely hands-free access. Another purpose of the invention is to measure the skin resistance value of a pediatric patient. According to the data, vibration amplitude, cooling intensity, music volume, and light brightness. The goal is to ensure that the values ​​are adjusted individually for each patient. This allows each patient to... Personalized multimodal analgesia parameters can be obtained. Another purpose of the invention is to display device temperature, vibration mode, and music / song on the device. Name, volume, light animation mode, battery status, and remaining operating time. 5 The goal is to provide real-time display of information. All the advantages mentioned above and explained in detail below. The present invention aims to achieve vaccination in pediatric injection applications. and to reduce pain and eliminate needle phobia during blood sampling procedures 10 Multimodal analgesia with cooling module and battery, used for this purpose. is a device; • contains the mechanical and electronic components of the device and is the main component of the device. its load-bearing structure consists of an upper body and a lower body. incoming main body, 15 • The battery located inside the main body that provides the necessary energy for the device. • lights located inside the main body and intended for visual distraction The light source that enables the animations to be created. • located inside the main body and designed to distract auditory attention by controlling the output of sounds. sound source providing, 20 • located inside the main body and producing variable frequency tactile vibrations inhibiting the habituation response of the nervous system and the processing of the analgesic effect. variable frequency actuator that ensures its maintenance throughout the process, • located inside the main body and forming the central control unit of the device, microcontroller that enables all operations to be performed, 25 • Connected to the lower part of the main body and activated by the energy from the battery. cooling that reduces the sensation of pain by converting it to cooling. module, • Connects to the bottom of the cooling module and makes contact with the patient's skin. a skin contact layer with antimicrobial properties, 30 • The analgesic device connects to the patient via a layer of skin contact that attaches to the lower part of the skin. hypoallergenic medical adhesive that ensures it is fixed in place by sticking, and single-use. disposable adhesive element, A structure containing these elements has been obtained. 6 The structural and characteristic features and all the advantages of the invention are given in the figures below. And thanks to the detailed explanation written with references to these figures, it becomes clearer. This will be understood as such. Therefore, the evaluation should also be based on these forms and details. This should be done taking the explanation into consideration. 5 BRIEF DESCRIPTION OF THE FIGURES The best way to utilize the advantages of the existing invention, together with its structure and additional elements. For understanding, it should be evaluated together with the figures explained below. It is necessary. 10 Figure 1 shows a disassembled view of the analgesia device that is the subject of the invention. REFERENCE NUMBERS 1. Main body 1.1. Upper body 15 1.2. Lower body 2. Screen 3. Light source 4. Sound source 5. Supercapacitor bank 20 6. Microcontroller 7. Battery 8. Memory and connectivity module 9. Variable frequency actuator 10. Cooling module 25 11. Phase change layer 12. Skin contact layer 12.1. Contact surface 13. Impedance sensor 14. Adhesive element 30 7 DETAILED EXPLANATION OF THE INVENTION This detailed description outlines the preferred configurations of the analgesia device that is the subject of this invention. purely for the purpose of better understanding the subject and without any limiting influence. It is explained in a way that will not create. 5 The invention relates to pediatric injection applications during vaccination and blood sampling procedures. Cooling agents are used to reduce pain and alleviate needle phobia. It is a multimodal analgesia device with module (10) and battery (7); • Contains the mechanical and electronic components of the device and is the main component of the device. forming the load-bearing structure, consisting of an upper body (1.1) and a lower body (1.2) the main body that was formed (1), • battery located inside the main body (1) and providing the necessary energy for the device (7), • located inside the main body (1) and for the purpose of visual distraction light 15 light source (3) that enables the animations to be made, • located inside the main body (1) and used for auditory distraction purposes sound source (4) that provides its output, • variable frequency tactile vibration located inside the main body (1) by producing and inhibiting the habituation response of the nervous system, the analgesic effect is 20 variable frequency actuator (9) which ensures that the process is maintained throughout the process, • located inside the main body (1) and forming the central control unit of the device and microcontroller (6) that enables all operations to be performed. • connected to the bottom of the main body (1) and receiving energy from the battery (7) Cooling that reduces pain sensation by converting to active cooling 25 module (10), • connected to the bottom of the cooling module (10) and in contact with the patient's skin skin contact layer with antimicrobial properties (12), • skin contact layer (12) connected to the lower part of the analgesia device and to the patient Hypoallergenic medical adhesive that allows it to be fixed by sticking, single 30 reusable adhesive element (14), It includes. 8 Figure 1 shows a general view of the analgesia device, the subject of the invention, in its disassembled state. The invention concerns an analgesia device whose carrier structure is biocompatible. Made of medical grade polycarbonate material, consisting of an upper body (1.1) and a lower body. The main body (10) consists of the body (1.2). In the analgesia device Mechanical and electronic components are located inside the main body (1) and in contact with the skin 5 It is located at the bottom, that is, under the lower body (1.2). Main body (1) inside There is a battery (7) in this part that provides energy to the device. The mentioned battery (7) is the portable main power supply of the device, preferably a lithium-polymer rechargeable is a battery (7). Inside the main body (1) there is a battery to provide visual distraction. There is a light source (3). Preferably on the top surface inside the main body (1) 10 placed and circular in order to illuminate the edge regions of the main body (1). or a light source of similar structure (3), soft transition color light animations (producing star effects, rainbow effects, breath effects, synchronized with the music rhythm) for children This helps to divert the patient's visual attention away from the injection. Light To provide its appearance, the main body (1) has a light-transmitting structure. Main 15 sound source (4) to provide auditory distraction inside the body (1) There is a sound source (4) which is a speaker and plays songs suitable for children. Attracting attention by playing lullabies or nature sounds, and then administering injections. The process is made to be forgotten. The sounds that the sound source (4) will play are the main body (1) is taken from the memory and connection module (8) located inside. Memory and connection 20 module (8) can play the sounds stored within it via its memory or Thanks to its wireless connectivity feature, you can connect to an external phone and play the desired audio files. It can enable the theft. To enable this, the memory and connection module (8) It has Bluetooth connectivity. The vibration function of the analgesia device is located in the main body. This is provided by the variable frequency actuator (9) located in (1). Variable 25 frequency actuator (9), variable frequency tactile vibration between 40-250 Hz by inhibiting the nervous system's habituation response through frequency modulation It ensures that the analgesic effect is maintained throughout the procedure. The analgesia device Main body (1) to ensure that instantaneous high current demand is met It contains a supercapacitor bank (5). The mentioned supercapacitor bank is 30 (5), especially the cooling module (10) the instantaneous high current requirement of the device extending the battery life by meeting the battery (7) independently. It provides. Preferably, there is a screen (2) inside the main body (1). The mentioned screen (2) is located at the very top inside the main body (1), 9 Device temperature level, battery status, vibration mode, music / song title, volume. Information such as level, light animation mode, and runtime is provided to the user. It is the interface that enables the display of the screen (2) from the outside. The upper surface of the upper body (1) has a transparent and see-through structure. Central control of the analgesia device is done by the microcontroller 5 located inside the main body (1) (6) is provided by the microcontroller (6); PWM control, frequency modulation, sensor data processing, music playback control, RGB LED animation coordination, It is an embedded processor that coordinates energy management and safety outages. The cooling module (10) is connected to the bottom of the main body (1). Cooling 10 The module (10) activates the energy it receives from the battery (7) located inside the main body (1). It converts energy into cooling energy, lowering the temperature on the skin and reducing the sensation of pain. It ensures the reduction. Preferably, a Peltier structure is used as the cooling module (10). The module is used. Phase change layer at the bottom of the cooling module (10) (11) is located. The phase change layer (11) receives 15 from the cooling module (10). to store cold energy and when the cooling module (10) is not working It provides the necessary active cooling. This allows for cooling that consumes a lot of energy. The module (10) is prevented from operating all the time and the battery (7) working life is extended. A high increase is ensured. The phase change layer (11) is placed under the skin. The skin contact layer (12) is in contact with the patient's skin. It forms the main area of ​​contact. The skin contact layer (12) prevents bacterial growth. silver ions to prevent and provide passive protection against infections It is made of reinforced medical-grade silicone material and has antimicrobial activity. The skin contact layer (12) receives the vibration energy from the variable frequency actuator (9). Focusing on Meissner and Pacinian nerve endings to achieve a high level of numbness effect 25 It contains a contact surface (12.1) with a micro-pyramidal structure. Skin contact layer (12) in contact with the skin and according to the skin type of the pediatric patient and Vibration amplitude, cooling power, music volume, and light according to sensitivity. bio-electrical impedance that adaptively adjusts its brightness There are sensors (13). Impedance sensors (13) with this function personalized 30 It provides multimodal analgesia. The device is placed under the skin contact layer (12). adhesive element that ensures fixation to the patient’s skin (14) It is connected. The adhesive element (14) is hypoallergenic medical adhesive and single. It has a usable structure. Thanks to the adhesive structure of the adhesive element (14) The operator does not need to hold the device and can comfortably use it. It can work. The hypoallergenic and disposable nature of the adhesive element (14) with the aim of reducing the risk of cross-contamination to zero and ensuring hygienic use. is provided. The application and operating principles of the multimodal analgesia device that is the subject of this invention are as follows: It is as follows; Initially, in the clinical application process, healthcare personnel will use disposable, biocompatible materials. Remove the protective foil from the medical adhesive element (14) and apply the adhesive. He attaches the element (14) to the patient's skin and the main body (1) of the analgesia device. It fixes to the adhesive element. When the device is switched on, the leather impedance sensors (13) It measures the instantaneous skin resistance and transmits the data to the microcontroller (6). The microcontroller (6), Depending on the patient's skin type, the vibration intensity of the variable frequency actuator (9) can be adjusted to the cooling intensity. It adjusts the cooling target of the module (10) and the brightness of the light source (3). In the cooling cycle, the supercapacitor bank (5) cools the module (10) instantaneously 15 It meets the high current; the cooling is loaded onto the phase change layer (11). The module (10) periodically shuts down to perform the cooling task. Phase change layer (11) It is continued through. Simultaneously, the variable frequency actuator (9) 40-250 Hz by generating modulated oscillation through the micro-pyramidal contact surface (12.1) It stimulates Meissner and Pacinian nerve endings. Memory and connection module (8) and sound 20 While the melody is broadcast from the source (4), the light source (3) synchronizes the color with the music. It presents animations. When the process is complete, a disposable adhesive element is used. (14) is removed and discarded; antimicrobial skin contact layer (12) silver ions (Ag+) Thanks to this, it maintains passive protection.

Claims

11 REQUESTS 1. During vaccination and blood sampling procedures in pediatric injection applications. Cooling agents are used to reduce pain and alleviate needle phobia. It is a multimodal analgesia device with module (10) and battery (7), and its feature is; 5 • contains the mechanical and electronic components of the device and the device forming the main load-bearing structure, consisting of an upper body (1.1) and a lower body (1.2) the main body (1), • located inside the main body (1) and providing the energy required for the device battery (7), 10 • located inside the main body (1) and for the purpose of visual distraction light light source (3) that enables the animations to be made, • located inside the main body (1) and used for auditory distraction purposes sound source that provides its output (4), • located inside the main body (1) and variable frequency tactile vibration 15 by producing substances that inhibit the habituation response of the nervous system and have analgesic properties. variable frequency that ensures the effect is maintained throughout the process actuator (9), • located inside the main body (1) and the central control unit of the device microcontroller (6), which creates and enables all operations to be performed, 20 • connected to the bottom of the main body (1) and coming from the battery (7) By converting energy into active cooling, it reduces the sensation of pain. cooling module (10), • connected to the bottom of the cooling module (10) and to the patient's skin contact skin contact layer with antimicrobial properties (12), 25 • skin contact layer (12) connected to the lower part of the analgesia device hypoallergenic medical adhesive that secures to the patient's body. adhesive and disposable adhesive element (14), It includes.

2. Multimodal analgesia device conforming to claim 1, and its feature is; main body (1) inside It includes a screen (2) which displays information about the device. 12 3. Multimodal analgesia device conforming to claim 1, its feature is; cooling module (10) and located between the skin contact layer (12) and the cooling module (10) which stores the cold energy it receives and when the cooling module (10) is not working The reason is that it contains a phase change layer (11) which provides coolness in the case.

4. It is a multimodal analgesia device conforming to Claim 1, and its feature is that it has a main body (1) inside. and the instantaneous high current requirement of the cooling module (10) It includes a supercapacitor bank (5) which enables it to meet the requirements.

5. A multimodal analgesia device conforming to Request 1, its feature being; skin 10 of the pediatric patient. Depending on the type and sensitivity, the amplitude of vibration that the device will apply will affect cooling. adaptive adjustment of power, music volume, and light brightness impedance sensors (13) located on the skin contact layer (12) It includes.

6. It is a multimodal analgesia device conforming to Claim 1, and its feature is that it has a main body (1) inside. storing existing and pre-loaded audio files or in a different way It connects to a source and allows the playback of audio files from that source. It includes memory and connection module (8).

7. A multimodal analgesia device conforming to Claim 1, characterized by its skin contact layer. (12) Meissner and the vibration energy taken from the variable frequency actuator (9) By focusing on Pacinian nerve endings, to achieve a high level of numbness. It contains a contact surface (12.1) which has a micro-pyramidal structure.

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