SMART WEARABLE INJECTION DEVICE WITH CONTROLLED VIBRATION, PRESSURE, AND HEAT APPLICATION.
Patent Information
- Application Number
- TR202613585
- Authority / Receiving Office
- TR · TR
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-08-11
- Publication Date
- 2026-09-21
Smart Images
Figure 00000014_0000
Abstract
Description
1 TARIFF SMART WEARABLE WITH CONTROLLED VIBRATION, PRESSURE AND HEAT APPLICATION. INJECTION APPARATUS TECHNICAL AREA 5 The invention falls within the technical field of medical devices and neonatal care technologies. It relates to the invention, specifically concerning the thigh region of a newborn or injection. a device that can be temporarily fixed to the anatomical region to be treated; controlled vibration, Combining controlled pressure and controlled heat applications on the same structure; The application parameters are regulated via sensors and a microcontroller. It relates to a smart wearable injection device. STATE OF THE ART Intramuscular injections, vaccination, and vitamin K in newborns. Pain can occur during routine procedures such as those mentioned above. Newborn 15 physiological stress responses to repetitive painful procedures performed during that period and It is known to have neurodevelopmental effects. Therefore, the aforementioned Various pharmacological and other methods are used to reduce pain during procedures. Non-pharmacological applications have been developed. In the known state of the technique, breastfeeding is used for pain control in newborns, 20 oral sucrose administration, kangaroo care, swaddling, pacifier use, music, from non-pharmacological applications such as white noise, massage and skin contact These practices are utilized. Some of these practices are performed by healthcare professionals or This requires the active participation of an assistant throughout the process and implementation. It can vary depending on the duration and method of application. Also, the word 25 The subject of these applications is that the injection is administered directly in the anatomical region and It does not generate a controlled physical stimulus. Vibration and pressure are used to reduce pain during injections. Devices that utilize cold or heat stimuli are also known. Vibration Mechanical vibration near the injection site in robust devices 30 is being created; in pressure-based structures, the area around the injection zone Mechanical pressure is applied to the skin surface. Includes thermal application. These devices create a temperature change on the skin's surface. 2 Patent document number US6902554B2 describes the application of injection. A pressure element that makes contact with the skin around the area is described. The protrusions on the pressure element apply mechanical pressure to the skin surface. It is applied and the injection process is carried out through the opening in the pressure element. This is implemented using modules that apply vibration and controlled heat. 5 the subject is regulating the operating parameters of the modules according to sensor data. It does not include a common control system. Patent document EP2131896B1 describes a device that can be bonded to the skin surface and a structure with an access opening that allows the passage of an injection needle This is explained. In this structure, electrical and vibrational stimuli are combined. 10 It is used and the operating parameters of the stimuli are controlled through a control unit. It can be regulated. However, this structure is applied to the skin surface in a controlled manner. a pressure module that applies pressure and generates low-level controlled heat It does not include the heating module. In patent document number US2013197409A1, vibration and thermal effect 15 A device that creates and adapts to the body surface is described. The device can apply cold or heat in conjunction with vibration. However, the device in question is not anatomically suitable for administering injections to the newborn. controlled on a soft and flexible body temporarily fixed to the area A 20-inch sensor containing a pressure module along with temperature, pressure, and motion sensors. It does not have a structure. In patent document number WO2011159317A1, injections and small a temperature-controlled surface for use during surgical procedures, handheld device featuring tactile stimulation elements and multiple vibration motors A device is being described. This device is related to temperature variation, surface texture, and 25... It can generate different types of vibrations. However, the device's injection... a wearable structure that is temporarily fixed to the anatomical region to be treated This is achieved by applying pressure to elastic support elements or micro-inflatable structures. implementation through and monitoring of operating parameters such as temperature, pressure, and motion. The arrangement based on data from the sensors is not explained. 30 A significant portion of the devices in known technology are for adults or older. It is designed for children and takes into account the anatomical and physiological needs of newborns. It does not have a body structure arranged according to its features. It is held in the hand. The devices used require the healthcare professional to position one hand on the device. 3 This may require the use of devices fixed to the skin surface; however, this is mostly the case with devices fixed to the skin surface. A single physical stimulus or two different physical stimuli are applied together. In addition, vibration frequency, vibration intensity, and pressure level in known structures, temperature value and application time are controlled together by the same control system. Its regulation is limited. Temperature, pressure and motion values are measured by sensors 5 In structures where it is not monitored via this method, the pressure measurement value exceeds the upper pressure threshold. the upper temperature threshold of the temperature measurement value or the upper limit of the motion measurement value If the movement threshold is reached, the operation of the relevant module will automatically stop. It is not possible to stop it. Therefore, in the known technique; the newborn will be given the injection at 10 a device that can be temporarily fixed to the anatomical region, providing access to the injection site. open, controlled vibration, controlled pressure and controlled heat modules in the same combining the modules on a soft and flexible body and their operation parameters based on data from temperature, pressure and motion sensors A regulating injection device is needed. 15 THE TECHNICAL PROBLEM WE AIM TO SOLVE The technical problem that the invention aims to solve is in newborns. Existing pain reduction methods used during intramuscular injections The dependence of these practices on healthcare professionals, physical stimuli 20 the inability to implement it in a standard and controlled manner and the existing devices for newborns It does not offer a wearable structure that is anatomically appropriate. The invention also involves the application of vibration, pressure, and heat stimuli within the same apparatus. inability to be applied together; vibration intensity, pressure level, temperature value and The inability to regulate the implementation period by a common control system; 25 inability to monitor application conditions with sensors and exceeding safety limits technical problems such as the inability to automatically stop the operation It provides a solution. BRIEF DESCRIPTION OF THE INVENTION 30 The invention relates to the administration of injections to the thigh area of newborns. a smart wearable and portable device that can be temporarily fixed to an anatomical region It is an injection device. The device leaves the skin surface open where the injection will be administered. 4 with a soft and flexible body and the vibrations, pressure and It includes controlled heating modules. The device is also equipped with a temperature sensor, a pressure sensor, and a motion sensor. the subject is a microcontroller that processes measurement values received from sensors It includes. The microcontroller stores the pressure measurement value in the microcontroller's memory. The microcontroller stores the temperature measurement value in its memory, along with the recorded upper pressure threshold. The microcontroller records the lower and upper temperature thresholds and the motion measurement value. It compares the relevant measurement value with the upper movement threshold stored in its memory. if it reaches or exceeds the upper threshold associated with it The microcontroller disables the module associated with the measurement value in question. 10 It stops when the motion measurement value reaches the upper motion threshold or this If the threshold is exceeded, the vibration, pressure, and controlled heat modules are deactivated simultaneously. is being left behind. The smart wearable injection device developed within the scope of this invention is as follows: It provides technical advantages: 15 Vibration, pressure, and controlled heat applications are combined within the same apparatus. by bringing together multiple physical structures around the injection site the possibility of generating the stimulus within the same application period It provides. The frequency of the driving signal applied to the vibration module, driving signal 20 the level and duration of operation are recorded in the microcontroller memory Adjustment according to operating values, each vibration module This allows the application to be run with the same performance values. Data from temperature, pressure, and motion sensors The operating conditions of the apparatus are monitored by the microcontroller. This allows for monitoring throughout the implementation period. The upper limits of pressure, temperature, and motion measurement values related to themselves comparison with thresholds and reaching the relevant upper threshold or the upper threshold If this is exceeded, the relevant module is disabled by the microcontroller. The modules are stopped depending on the sensor data. It makes it possible. The soft and flexible body should be placed on the newborn's thigh area or newborns by adapting to the anatomical region where the injection will be administered It offers a placement that is suitable for its anatomy. The device is temporarily placed in the anatomical area where the injection will be administered. It can be fixed in place, allowing the healthcare professional to manually operate the device during the procedure. 5 eliminates the need for holding and provides both for the injection process. It allows the hand to be used. The skin surface where the injection will be administered must have an injection access point on the trunk. leaving the opening open, the apparatus on the anatomical region This allows the injection procedure to be performed while they are present. 10 Elastic support elements or micro-inflatable structures for the pressure modulus It contains a light and homogeneous compression around the injection site. It allows for its creation. The controlled heating module works in conjunction with the temperature sensor, ensuring cold conditions. Pre-cooling and cold 15 required in application-based devices temperature value without the need for preservation processes It allows for monitoring. The device has a working structure based on non-drug physical stimuli. having, injection site without the use of a pharmacological component It enables the creation of controlled sensory stimulation in its surroundings. 20 Modules and control components on the same wearable body Its availability means the device is portable and ready for use in different clinical settings. It allows for its use as a whole. The execution time is automatically determined by the microcontroller. termination reduces user-dependent time variations and every 25 It ensures the maintenance of the work period determined in the application. In conclusion, the invention provides effective pain control and ease of use. its presentation, standardization, newborn-specific design, and multiple Because it combines analgesic mechanisms in a single system, it is superior to existing technologies. It provides significant advantages over others. 30 LIST OF FIGURES Figure 1. General view of the smart wearable injection device. 6 The Definitions of the Numbers in the Figures 1. Soft and flexible body 2. Vibration module 3. Pressure module 4. Controlled heat module 5 5. Temperature sensor 6. Pressure sensor 7. Motion sensor 8. Microcontroller DETAILED DESCRIPTION OF THE INVENTION The invention is for use during intramuscular injection in newborns. It is a smart wearable injection device developed for this purpose. The device in question; soft and flexible body (1), vibration module (2), pressure module (3) and controlled The appliance includes a heat module (4). In the preferred application form of the invention, the appliance is 15 also temperature sensor (5), pressure sensor (6), motion sensor (7) and It contains a microcontroller (8). The soft and flexible body (1) is placed on the thigh area of the newborn or a device that can be temporarily fixed to the anatomical area where the injection will be administered It is structured. Soft and flexible body (1), anatomical 20 where injection will be applied. It has been designed with the flexibility to adapt to the topography of the region. Soft and flexible body (1), biocompatible, skin-friendly and sterilizable. It is made of suitable material. Soft and flexible body (1) with skin surface The contact area is soft enough to suit the delicate skin of a newborn. is being created. 25 Soft and flexible body (1), the area to be injected will surround it and not interfere with the healthcare professional's injection procedure. It is arranged in this way. That is, the soft and flexible body (1), injection It includes an injection access opening that leaves the skin surface exposed for injection. Thus, the device is placed in the newborn's thigh area or 30°C where the injection will be administered. The injection can be performed while located in the anatomical region. The wearable structure of the soft and flexible body (1) is made of injection molded material. This structure allows it to remain on the anatomical region throughout the procedure. 7 thanks to the healthcare professional holding the device with their hand during the procedure. It is not necessary. The vibration module (2) is inside or on a soft and flexible housing (1). The vibration module (2) is located around the area where the injection will be applied. It creates micro-vibrations. Micro-vibrations created by the vibration module (2) Vibration is transmitted to the skin surface via the soft and flexible body (1). Vibration frequency and vibration intensity of the vibration module (2) of newborns predetermined limits taking into account anatomical and physiological characteristics It is arranged inside. The vibration module (2) is arranged before the injection process. It can be operated for the specified period and during the injection process 10 They are able to continue working. The mode of operation of the vibration module (2) is determined by the microcontroller (8). It is regulated according to the driving signal transmitted to the vibration module (2). The microcontroller (8) stores the driving signal frequency in the microcontroller memory. change the driving signal level and operating time to the vibration module (2) 15 It applies. In continuous operation mode, the microcontroller (8) vibrates module (2) during the application time recorded in the microcontroller memory It operates continuously. In intermittent operation mode, the microcontroller (8), vibration module (2) throughout the operating range recorded in the microcontroller memory It activates and deactivates during the recorded shutdown interval. 20 Pressure module (3), injection on soft and flexible body (1) It is located in a position corresponding to the surrounding area of the region where it will be implemented. Pressure modulus (3), a light and homogeneous compression on the skin surface It is implementing. In one application form of the invention, the modulus of pressure (3), elastic support 25 It includes the following elements: Elastic support elements, soft and flexible body (1) to create light and even pressure between the skin surface It is being organized. In another application form of the invention, the pressure module (3) is micro-inflatable It includes structures. The pressure modulus (3) of the micro-inflatable structures is 30 It applies pressure to the skin surface depending on its level. Micro-inflatable. By altering the swelling level of the structures, the level of pressure applied to the skin surface is adjusted. It is being organized. 8 The pressure sensor (6) is applied to the skin surface by the pressure module (3). It produces a pressure measurement value corresponding to the pressure level and the said It transmits the pressure measurement value to the microcontroller (8). Application in which the pressure module (3) contains micro-inflatable structures In this way, the inflation level of micro-inflatable structures is measured from the pressure sensor (6) 5 control by microcontroller (8) according to the received pressure measurement value The microcontroller (8) takes the pressure measurement from the pressure sensor (6). its value, the upper pressure threshold stored in the microcontroller memory. It compares the pressure measurement value to the upper pressure threshold or the upper limit. If the pressure threshold is exceeded, the microcontroller (8) transmits 10 to the pressure module (3). interrupting the inflation process of micro-inflatable structures It stops the upper pressure threshold of the inflation function of the pressure module (3). the pressure value that triggers the shutdown is stored in the microcontroller's memory It is hidden. Controlled heat module (4), inside a soft and flexible housing (1) or 15 on it, thermally in contact with the skin surface surrounding the area where the injection will be administered. It is located in a way that will interact. The controlled heat module (4) is on the skin surface. It generates low-level local heat. The temperature level created by the controlled heat module (4) is applied to the newborn's skin. It is kept within appropriate limits. Controlled heat module (4), injection 20 in the relevant part of the soft and flexible body (1) surrounding the area to be applied It applies local heat. The temperature sensor (5) corresponds to the temperature value on the skin surface. It produces the temperature measurement value and the said temperature measurement value transmits to the microcontroller (8). 25 The temperature level created by the controlled heat module (4) is the temperature Based on the temperature measurement value received from the sensor (5), the microcontroller (8) It is controlled by the microcontroller (8), temperature sensor (5) The measured temperature value is stored in the microcontroller's memory as the lower temperature threshold. and compares it with the upper temperature threshold. The lower temperature of the temperature measurement value is 30. If it is below the threshold, the controlled heat module (4) is activated; the temperature measurement value reaching the upper temperature threshold or exceeding the upper temperature threshold If it exceeds this limit, the operating signal transmitted to the controlled heat module (4) is interrupted. 9 Controlled heat module (4), temperature measurement value at upper temperature threshold or above It is deactivated as long as the temperature remains above the threshold. Motion sensor (7), injection molding of soft and flexible body (1) It generates data regarding the movement of the device over the anatomical region where it will be applied. Data generated by the motion sensor (7) is transmitted to the microcontroller (8). 5 Motion sensor (7), injection molding of soft and flexible body (1) a movement corresponding to the movement over the anatomical region to be applied It generates a measurement value and sends that motion measurement value to the microcontroller. (8) transmits. The microcontroller (8) receives the motion from the motion sensor (7). The measured value is stored in the microcontroller's memory along with the upper movement threshold of 10. It compares the motion measurement value to reach the upper motion threshold or If the upper movement threshold is exceeded, the microcontroller (8); vibration module (2), pressure module (3) and controlled heat module (4) are stopped. Microcontroller (8); vibration module (2), pressure module (3), controlled heat module (4), temperature sensor (5), pressure sensor (6) and motion sensor (7) with 15 It is connected. The microcontroller (8) takes pressure measurement from the pressure sensor (6). its value is the upper pressure threshold stored in the microcontroller memory, temperature The temperature measurement value received from the sensor (5) is recorded in the microcontroller memory. lower and upper temperature thresholds and motion measurement from the motion sensor (7) Its value is 20, the upper limit of movement stored in the microcontroller's memory. It compares them. The pressure measurement value reaching or exceeding the upper pressure threshold. in this case the pressure module (3) reaches the upper temperature threshold of the temperature measurement value or if it exceeds this threshold, the controlled heat module (4) is deactivated. The motion measurement value reaching or exceeding the upper motion threshold is 25. in the case of vibration module (2), pressure module (3) and controlled heat module (4) together It is being disabled. The microcontroller (8) stores the vibration module (2) in the microcontroller memory. via recorded driving signal frequency, driving signal level and operating time It operates. Vibration module (2), pressure module (3) and controlled heat module 30 (4) simultaneously put into operation at the beginning of the same application period is received and the elapsed application time is recorded in the microcontroller (8) memory. It is disabled when the application duration reaches its limit. During the use of the apparatus, the soft and flexible body (1), injection to be applied to the newborn's thigh area, in a way that surrounds the area to be treated, or It is temporarily fixed to the anatomical area where the injection will be administered. Before the injection process, the vibration module (2), pressure module (3) and 5 controlled heat module (4), predefined by microcontroller (8) It is operated according to the protocol. During the injection process, the following occurs: The modules can continue to function. The microcontroller (8) includes the vibration module (2), the pressure module (3) and The application time elapsed with the commissioning of the controlled heat module (4) The microcontroller (8) determines the elapsed application time. It compares it with the elapsed application duration value stored in memory. the application period reaching the registered application period value or this value If it exceeds the limit, the microcontroller (8), vibration module (2), pressure module (3) and disables the controlled heat module (4). The application after completion, the soft and flexible body (1) from the anatomical region 15 They are leaving. 25
Claims
11 REQUESTS 1. The newborn's thigh area or the anatomical site where the injection will be administered. smart wearable injection device that can be temporarily fixed to the area and its feature is; 5 - the area surrounding the injection site, injection an injection access opening that leaves the skin surface open to be treated containing and the surface of the anatomical region where the injection will be administered soft and flexible, with the flexibility to adapt to its shape body (1), 10 - located in or on the soft and flexible body (1), Micro-vibration around the injection site the micro-vibration generated and created by the soft and flexible body (1) a vibration module (2) that transmits to the skin surface, - 15 to be injected on the soft and flexible body (1) micro Inflatable structures and the inflation of micro-inflatable structures. a pressure that applies pressure to the skin surface depending on its level module (3), - inside or on the soft and flexible body (1), injection 20 thermal interaction with the skin surface surrounding the application area a substance that is positioned to create local heat on the skin's surface controlled heat module (4), - temperature measurement corresponding to the temperature value on the skin surface a temperature sensor (5) that produces its value, 25 - pressure applied to the skin surface by the pressure module (3) a pressure that produces a pressure measurement value corresponding to the level sensor (6), - the soft and flexible body (1) anatomical where the injection will be administered the motion measurement value corresponding to its movement over the region is 30 a motion sensor that produces (7), - vibration module (2), pressure module (3), controlled heat module (4), with temperature sensor (5), pressure sensor (6) and motion sensor (7) a connected microcontroller (8) 12 including and microcontroller (8); - pressure measurement value taken from the pressure sensor (6) compare with the upper pressure threshold stored in the microcontroller memory and the pressure measurement value reaches the upper pressure threshold or the upper If the pressure threshold is exceeded, 5 is transmitted to the pressure module (3) interrupting the inflation process of micro-inflatable structures stop, - temperature measurement value received from the temperature sensor (5) lower and upper temperature thresholds stored in the microcontroller's memory Comparing it with the threshold, the temperature measurement value is 10 times the lower temperature threshold. If it is below, activate the controlled heat module (4), the temperature measurement value reaching the upper temperature threshold or above If the temperature exceeds the threshold, it is transmitted to the controlled heat module (4) interrupt the operating signal and the temperature measurement value is the upper temperature. 15 as long as it is at or above the threshold or upper temperature threshold to disable the controlled heat module (4), - motion measurement value received from the motion sensor (7) with the upper limit of movement recorded in the microcontroller memory compare and determine the upper limit of the motion measurement value If it reaches or exceeds the upper limit of movement, the vibration modulus is set to 20. (2), pressure module (3) and controlled heat module (4) are circuited together. It is characterized by being structured to exclude.
2. It is a smart wearable injection device according to claim 1, and its features are: the driving signal stored in the microcontroller memory (8) frequency, drive signal level and operating time to the vibration module 25 (2) is characterized by being structured to implement.
3. It is a smart wearable injection device according to claim 1, and its features are: the vibration module (2) of the microcontroller (8) in the microcontroller memory to operate continuously for the duration of the registered application period It is characterized by its structured nature. 30 4. It is a smart wearable injection device according to claim 1, and its features are: the vibration module (2) of the microcontroller (8) in the microcontroller memory Activation during the registered operating range and registered shutdown range 13 with the possibility of being configured to disable it throughout It is characteristic.
5. It is a smart wearable injection device according to claim 1, and its features are: microcontroller (8), vibration module (2), pressure module (3) and controlled heat module (4) at the beginning of the same application period equal 5 to commission in a timely manner, from the moment the modules are commissioned the elapsed application time is recorded in the microcontroller memory. compare the duration with the recorded value and the elapsed application time. Vibration occurs if the application time reaches or exceeds this value. module (2), pressure module (3) and controlled heat module (4) together 10 It is configured to be disabled. 20 30