ORAL PHASE SWALLOWING PRESSURE SIMULATION SYSTEM

Abstract

The invention relates to a swallowing pressure simulation system and its operating method for testing intraoral dental prostheses, implant-supported structures, orthodontic appliances, and similar medical / dental materials in a laboratory environment under moist intraoral conditions and with respect to positive and negative pressure changes in the oral cavity during swallowing.

Description

1 TARIFF ORAL PHASE SWALLOWING PRESSURE SIMULATION SYSTEM Technical Field to Which the Invention Relates The invention relates to intraoral dental prostheses, implant-supported structures, and orthodontic appliances. and similar medical / dental materials, the substances that form in the oral cavity during swallowing laboratory under moist oral conditions with positive and negative pressure changes with a swallowing pressure simulation system for testing in the environment It is related to the pressure cycles that occur during the oral phase of swallowing. By enabling controlled, repeatable and adjustable creation, intraoral 10 durability, retention and long-term performance of devices and materials It provides an opportunity for evaluation. State of the Art Swallowing is the process by which food, liquids, and oral secretions pass from the oral cavity through the pharynx and 15 numerous anatomical features that enable the transport of food through the esophagus to the stomach complex requiring the harmonious functioning of structure and physiological movement It is a biomechanical process. Swallowing function generally consists of a preparatory phase and an oral phase. the stage consists of different phases: pharyngeal stage and esophageal stage. is being evaluated. Each of these phases involves the tongue, palate, cheek muscles, and soft tissues. coordinated action of many structures including the palate, pharyngeal muscles, laryngeal structures, and esophagus. This occurs through movement. Specifically, the oral phase involves food and liquids present in the mouth. or the backward redirection of saliva with the help of the tongue and surrounding muscle structures, During this process, certain pressure changes occur within the oral cavity, and swallowing... 25 This is why pressure changes occurring during the oral phase are only... not only in terms of understanding the physiology of swallowing, but also in the mouth. dental prostheses, implant-supported structures, orthodontic appliances, aligners, oral hygiene products used internal medical devices and similar structures are exposed to during clinical use It is also important in terms of evaluating forces and environmental conditions. 30 It carries. Today, videofluoroscopic imaging is used to study the swallowing mechanism. swallowing studies, dynamic magnetic resonance imaging, fiber optic endoscopic 2 different methods such as swallowing assessment, manometric measurements, and intraoral pressure sensors These methods are used. These methods involve swallowing in live individuals. anatomical movements that occur, bolus passage, pharyngeal pressures, or It allows for the measurement of changes in intraoral pressure. However, the word Most of the methods in question are performed directly on patients or volunteer individuals. 5 It is based on in vivo measurements. In vivo measurement techniques reflect physiological reality. While providing high-quality data, it also offers test conditions that can be replicated in a laboratory environment. creation, accelerated assessment of long-term use effects, different comparing dental materials and devices under the same conditions or swallowing Variables such as frequency, pressure level, pressure duration, and humidity are independent of each other. It has limitations in terms of being able to control it in this way. Also, on a living individual... The measurements taken revealed anatomical and physiological differences between individuals, age, gender, swallowing habits, saliva volume, muscle activity, disease status, and measurement. Numerous variables, such as the placement of equipment used during the process, affect the results. This can affect the swallowing of intraoral products. Therefore, current measurement techniques do not affect the swallowing of oral products. the conditions they are exposed to during the process are standardized and repeatable. Rather than simulating, it involves observing the current physiological state and It is aimed at measurement. 20 studies examining pressure profiles generated during swallowing in the known state of the art. There are academic studies on this subject, and these studies show that the mouth during swallowing... time-dependent changes in pressure values ​​occur in the intrapharyngeal or pharyngeal region. It has been shown that swallowing is not a static event. These studies have revealed that... conversely, involving short but recurring positive and / or negative pressure phases This shows that it is a dynamic process. However, such studies 25 mostly used to measure blood pressure, determine physiological profile, or to assess health and well-being. It is aimed at comparing swallowing parameters in patient individuals. Another In other words, the current literature describes the pressure changes that occur inside the mouth, but by recreating these pressure changes in a controlled experimental chamber An integrated 30 that enables testing of dental materials or intraoral devices. It does not offer a system. However, in dental and medical material testing, it is generally... chewing simulators, thermal aging devices, humidification media, artificial saliva baths, static or periodic load application systems, and mechanical systems. Strength testing devices are used. These systems test the chewing function of intraoral devices. 3 resistant to forces, temperature changes, humid environments, or chemical effects While useful for assessing endurance, swallowing It does not directly represent the oral pressure cycles that occur during chewing. simulators focus more on occlusal forces and mechanical contact loads. ...is concentrating, while artificial saliva or moist environments improve oral environmental conditions. It only mimics the chemical or hygienic aspect. Static pressure or constant The devices that apply the load cause a short-lived, sudden shock during swallowing. It cannot realistically accommodate cyclical and bidirectional pressure changes. Therefore, in current dental testing systems, intraoral materials and prostheses only evaluation in terms of chewing, temperature, humidity or chemical environment 10 It is possible; however, the pressure that occurs in the oral phase during swallowing... It is possible to implement these changes in a long-term, iterative, and adjustable manner. It is not possible. In the current state of the art, some systems for swallowing simulation are also available at 15. It has been developed, for example, to model specific phases of human swallowing. Systems that utilize anatomical or robotic structures exist. Such systems... generally refers to the movement of the bolus during swallowing, mechanically in the pharyngeal phase. simulate behaviors or movements of anatomical structures in the head and neck region It aims to do so. In this context, some known robotic or anatomical 20 Simulation systems can mimic the pharyngeal phase of swallowing or food intake. It aims to analyze how these products behave during ingestion. However, this These systems mostly utilize positive and negative pressure occurring in the mouth during the oral phase. controlled creation of pressure changes and testing of these pressure changes It is not designed for application to samples. Specifically, Swall-E as 25 The known robotic in vitro swallowing simulation device simulates specific swallowing mechanisms. It is known as a system that attempts to model its aspects in a laboratory environment. Together, the primary focus of this device is the simulation of the pharyngeal phase of swallowing. Therefore, this type of system uses the pressure created within the oral cavity during the oral phase. changes in dental materials, prostheses or intraoral devices 30 It is not directly sufficient to assess the effects it creates. Similarly, Some patent documents in the known state of the art describe the swallowing process. numerical modeling of the liquid or food bolus passing through the mouth and throat analysis using particle method or movements of head and neck anatomy 4 Approaches such as simulation are explained. Swallowing behavior in these systems is discussed. computer-aided analyses, particle-based modeling, or anatomical models can be evaluated through this method, but pressure differences occurring in the oral phase The physical production involves applying positive and negative pressure to samples inside a chamber. application in phases and simultaneously maintaining a moist oral environment 5 There is no integrated solution for controlling it. Some known training systems on anatomical structures related to the oral cavity, throat, or human body They are being modeled for purposes such as intubation or medical intervention training. Anatomical mannequins are used. However, these types of educational models also have oral features. phase swallowing pressure, intraoral moisture conditions and long-term swallowing cycles 10 It is not capable of reproducing this in experimental samples. Another shortcoming of current technical solutions is the frequency of swallowing and swallowing difficulties. The long-term effects of cycles accelerated in a laboratory setting. The reason is that it cannot be simulated. People swallow many times a day. 15 This is how intraoral devices perform these repetitive pressure changes and constantly adapt to them. They are exposed to this effect repeatedly. This repeated effect particularly affects the retention of prostheses and the connection. the stability of the components, the strength of the adhesives, the mechanical properties of the implant-supported structures behavior, deformation of orthodontic appliances or long-term use of intraoral materials It is important in terms of period performance. Nevertheless, the current laboratory 20 positive and negative pressure cycles corresponding to the number of swallows in the tests automatic application over a specific period, tracking of total cycle count the real-time monitoring of pressure levels and humidity levels during the experiment It is not commonly possible to keep it under control throughout the process. This situation, 25 in product development and quality control processes This leads to inaccurate representation. Furthermore, in existing systems... Even if pressure can be applied, it is often only positive pressure or Only a vacuum effect is created; bidirectional shock that may occur during swallowing The pressure character cannot be applied simultaneously and in successive phases. However, oral In order to more realistically simulate the swallowing behavior in the phase, both 30 positive pressure and negative pressure at specific times, levels, and repetitions It needs to be controlled within this scope. In addition, the oral environment alone It is not limited to mechanical pressure, but also includes humidity, temperature, the presence of saliva, and the enclosed environment. Factors such as conditions also affect the behavior of intraoral materials. Moist Pressure tests where the environment is absent or humidity is not controlled, intraoral conditions It cannot represent it with sufficient accuracy. Current sensor systems for measuring oral pressure rely on swallowing behavior. numerical simulations modeling, robotic devices focusing on the pharyngeal phase, 5 Various aging methods are used for anatomical training mannequins and dental materials. Although mechanical testing devices are available separately, none of them are suitable for the oral phase. physically creating swallowing pressure in the form of positive and negative pressure phases, applying these pressures to samples inside a sealed test chamber, monitoring pressure values ​​with real-time sensors, counting swallowing cycles, 10 It allows you to adjust the positive and negative pressure times, and also the reservoir. an integrated simulation system that can control the humidity conditions inside It does not offer this. Therefore, current technical, dental and medical intraoral devices laboratory tests of oral phase pressure changes experienced during swallowing Evaluation in a repeatable, controlled and accelerated manner in the environment 15 In terms of technology, intraoral devices and... materials only under chewing forces, static loads or in a humid environment No, it is also tested under dynamic pressure cycles that occur during swallowing. oral phase-specific, controlled, adjustable and repeatable, allowing for A swallowing pressure simulation system is needed. 20 Brief Description and Objectives of the Invention The invention includes intraoral dental prostheses, implant-supported structures, and orthodontic appliances. and similar medical / dental materials, the substances that form in the oral cavity during swallowing Laboratory 25 under moist oral conditions with positive and negative pressure changes a swallowing pressure simulation system and word for testing in the environment The topic explains how the system works. The purpose of the invention is to analyze the positive and negative signals generated in the mouth during the oral phase of swallowing. The aim is to simulate pressure changes in a laboratory environment, and for this purpose, a leak-proof 30 The process is carried out using a sample tank, pump, and pressure control valves. One purpose of the invention is to develop intraoral dental prostheses, implant-supported structures, and orthodontics. testing of devices and similar products under conditions that closely resemble real-world usage conditions. 6 The aim is to ensure that the samples to be tested are placed in a closed container. by placement and application of controlled pressure cycles to the reservoir is provided. One aim of the invention is to simulate the bidirectional pressure effect that occurs during swallowing. 5 The aim is to create it in successive phases. This is used for air pressure input. solenoid valve used for air vacuum, in sequence This is achieved through its operation. One aim of the invention is to replicate and controllably simulate oral phase swallowing conditions. The aim is to create a positive pressure period and negative pressure. This is achieved thanks to the fact that its duration is adjustable. One aim of the invention is to quickly determine the effects of long-term oral use in the laboratory. The aim is to enable it to be examined in this environment, and for this purpose a positive pressure phase and a 15 negative pressure phase counted as one swallowing cycle and total swallowing This is done by the system monitoring the number. One aim of the invention is to reliably determine the applied pressure values ​​throughout the experiment. The purpose is to enable monitoring, and for this purpose, a positive pressure sensor and a negative pressure sensor are used. This is accomplished using a sensor and an analog manometer. Another aim of the invention is to control the target pressure levels during the experiment. The aim is to ensure that data from pressure sensors is obtained in this way, and this purpose is to achieve this by using the data received from pressure sensors. evaluation by the microcontroller and phase transitions at the appropriate moment. This is achieved by doing it. Another aim of the invention is to improve the oral cavity not only in terms of pressure but also in terms of humidity. The aim is to ensure that it is also represented in terms of conditions, and for this purpose, a leak-proof chamber. a humidity sensor that detects changes in humidity inside and 30 that activates when necessary This is achieved with a humidification unit. 7 One aim of the invention is to allow the user to easily monitor the experimental conditions. The goal is to provide instantaneous pressure value, humidity level, total number of swallows, and system. The status is communicated to the user via the LCD screen. One aim of the invention is to make the system's start, stop and reset operations practical. The aim is to ensure that it is done in this way. The user controls the button and the microcontroller-based system. The basic control operations of the system are performed thanks to the control unit working together. It is easily accomplished. One aim of the invention is to create positive pressure and vacuum separately using complex 10 The aim is to prevent the need for mechanical devices. A single pump and valves. The system can be used in both the pressure phase and the vacuum phase through this method. This allows it to operate in a more compact and simpler structure. Another purpose of the invention is to prevent pressure build-up in the unused line of the pump. The aim is to ensure the stable operation of the system by preventing pressure relief port and vacuum. The unused port is directed to the atmosphere via the discharge port, and this This ensures more balanced pressure transfer. Another aim of the invention is to create a swallowing device that can be adapted to different test scenarios. The aim is to provide a simulation platform. Pressure level, pressure duration, humidity percentage, and The fact that the number of swallowing cycles is adjustable and monitorable allows the system to be used in different experiments. This makes it possible to adapt to the conditions. Another purpose of the invention is to contribute to dental and medical product development, quality control, and academic research. integrated systems that can be used in research and accelerated aging studies The aim is to provide a testing infrastructure. Leak-proof chamber, controlled pressure-vacuum system, sensors, humidity control, microcontroller, and user interface working together. This test infrastructure is created in an integrated manner through its use. Explanation of the Figures Figure 1. Front view of the system that is the subject of the invention. Figure 2. Rear view of the system described in the invention. Figure 3. Top view of the system described in the invention. 8 Figure 4. Left view of the system described in the invention. Figure 5. Right-hand view of the system described in the invention. Explanation of References in Figures 1. Sample container 5 2. Positive pressure sensor 3. Negative pressure sensor 4. Positive pressure valve 5. Negative pressure valve 6. Positive pressure hose 10 7. Negative pressure hose 8. Circuit box 9. LCD screen 10. Button 11. Power supply (DC / Brain power supply) 15 12. Power supply (AC / Motor-valve power supply) 13. Cover 14. Cover clip 15. Vacuum relief port 16. Pressure relief port 20 17. Analog pressure gauge 18. Humidity sensor 19. Ultrasonic humidification unit Detailed Description of the Invention 25 The invention relates to dental prostheses used in the mouth, implant-supported structures, and orthodontics. appliances and similar medical / dental materials; mouth during swallowing positive and negative pressure changes occurring in the environment, and the moist oral cavity a swallowing pressure that allows testing in a laboratory environment under certain conditions This relates to the simulation system and its working method. 30 The system described in the invention simulates the positive wave that occurs in the mouth during human swallowing. and controlled, repeatable negative pressure changes in a laboratory environment. 9 a swallowing pressure simulation that allows for adjustable simulation It is a system. The system generally consists of a sample in which the sample to be tested is placed. the reservoir (1), monitoring the pressure and humidity changes inside the sample reservoir (1) positive pressure sensor (2) and negative pressure sensor (3), pressure and vacuum positive pressure valve (4) and negative pressure valve (5) which provide its direction, these 5 The positive pressure hose (6) and negative pressure hose (7) connected to the valves, the system circuit box (8) that manages its operation, LCD screen (9) that forms the user interface DC / Brain power supply (11) and AC / which provides power supply with button (10). The motor-valve power supply consists of power sources, including (12). In the invention, positive and negative pressure phases created inside the sample chamber (1) are used for oral 10 The phase will represent the pressure changes that occur inside the mouth during swallowing. It is implemented in this way. The sample chamber (1) constitutes the experimental test chamber of the system, and swallowing Dental prosthesis, implant-supported structure, orthodontic 15 to be examined under the influence of pressure an appliance is a closed volume into which an intraoral medical device or material sample is placed. It is structured as follows: Sample chamber (1), positive pressure and vacuum during the experiment. For applications where effects can be achieved with no loss or with controlled loss, it must be airtight. It is arranged in a way that is suitable for the upper part or opening area of ​​the sample container (1). There is a lid (13) that separates the internal volume of the reservoir from the external environment. The lid (13) is 20 The sample container (1) is connected to the sample container in an open-close manner, before the experiment the sample is placed inside the container, and after the experiment, the sample is removed. It allows it to be removed from the container. The sample chamber (1) in the system subject to the invention is subject to controlled pressure during the experiment, 25 creating temperature and relative humidity conditions and maintaining those conditions It is structured in a way that will allow it to be preserved at the specified values. In a preferred application of the invention, the sample container (1) has an internal volume of 1.5 litres. and the reservoir body is made of transparent plexiglass, in other words, acrylic material. It is manufactured. Plexiglas material withstands positive and negative pressures generated during the experiment for 30 degrees. providing sufficient mechanical strength, being resistant to corrosion, and being an example The sample positioned inside the container (1) is visually inspected from the outside during the experiment. It is preferred because it allows monitoring. Sample container (1), It has a rectangular cross-section prismatic geometry in the preferred application. suitable for the placement of the sample and system components It is sized. The positive pressure hose (6) and on the sample container (1) pressure inlet and outlet for connecting the negative pressure hose (7) connections, positive pressure sensor (2), negative pressure sensor (3) and humidity sensor (18) The connection points of the sensors and the sample inside the chamber 5 There is at least one opening for insertion. That opening is the lid. (13) is closed by means of at least four cover clips (14). It is fixed. The pressure on the sample container (1) is fixed by the sensor and lid connection. gaskets, sealing rings and / or similar sealing elements at points using controlled pressure and ambient conditions inside the sample chamber (1) 10 This ensures protection. The preferred 1.5-liter internal volume allows for proper swallowing behavior. positive and negative pressure changes to be created during the simulation generated in a controlled manner, within appropriate timeframes to achieve target pressure values. achieving and reproducibly applying the experimental parameters is taken into consideration This was determined by taking into account that the sample container (1) has a capacity of approximately 1.5 liters. not limited to having volume or rectangular cross-sectional prismatic geometry different volumes that provide the same working principle and controlled experimental environment, manufactured from materials with appropriate dimensions, geometries, and suitable mechanical properties It can also be implemented with sample containers. In order to maintain the airtightness between the lid (13) and the sample container (1), the most At least four cover clips (14) are used. Cover clip (14), cover (13) closed When the lid is brought to the position, press down on the sample container (1) and experiment the lid should not detach despite the pressure differences that occur during the process This ensures that in the positive pressure phase, the air inside the chamber escapes. escape, or in the negative pressure phase, the uncontrolled entry of outside air into the chamber. Entry is prevented. Lid clips (14) are preferably placed opposite each other around the lid (13). positioned so that there is a balance between the lid (13) and the sample container (1). It is designed to generate compressive force. There is a positive correlation between the sample chamber (1) and the pressure generation and guiding elements. There is a positive pressure line and a negative pressure line. The positive pressure line is the positive pressure line. through valve (4) and positive pressure hose (6) into sample chamber (1) It is connected. The positive pressure valve (4) opens in the positive pressure phase of the system. 11 pressurized air through positive pressure hose (6) into sample chamber (1) It ensures the transmission of the sample. Positive pressure hose (6), positive pressure valve (4) It functions as a flexible or rigid line that establishes a flow connection between the reservoir (1). This allows for a controlled pressure within the reservoir volume during the positive pressure phase. an increase is being created. 5 The negative pressure line consists of a negative pressure valve (5) and a negative pressure hose (7) It is connected to the sample chamber (1) via the negative pressure valve (5), vacuum opening in phase and air inside sample chamber (1) through negative pressure hose (7) It enables the negative pressure hose (7) to be pulled through. Negative pressure 10 It establishes a flow connection between the valve (5) and the sample chamber (1) and inside the chamber This structure allows for a reduction in pressure. Thanks to this design, the system only It ceases to be a mechanism that applies pressure and the double pressure that occurs during swallowing both positive and negative pressure, representing directional pressure characteristics. It can implement its phases. 15 Positive pressure valve (4) and negative pressure valve (5) determine the pressure direction of the system. These are the basic control elements. In the positive pressure phase, the positive pressure valve (4) is open. While the negative pressure valve (5) is brought to this position, it is kept in the closed position. Negative In the pressure phase, the negative pressure valve (5) is opened, and the positive pressure is 20 The valve (4) is kept in the closed position. With the sequential and controlled operation of these valves a positive pressure phase and a negative pressure phase are created sequentially, and this The completion of the two phases is considered a swallowing cycle. The invention... In this system, the target maximum pressure value for the positive pressure phase is +50 mbar. The target minimum pressure value for the negative pressure (vacuum) phase is -120 mbar. It has been determined that the cycle / day value for daily swallowing simulation is 585, totaling... In each swallowing cycle, which lasts 3 seconds, the positive pressure phase lasts 1 second, and the negative pressure phase lasts 1 second. The pressure phase lasts for 2 seconds. The positive and negative pressure profiles generated in the preferred application of the invention are 30. swallowing cycle durations, occurring during the oral phase of human swallowing. Clinical manometric analysis describing physiological and subpalatal pressure changes. The determinations are based on measurements, sensor data, and biofunctional models. In a sample application, the target positive pressure value of the system is approximately +50 mbar and 12 The target negative pressure value can be set at approximately -120 mbar. The subject is pressure values ​​and the durations of pressure phases, related to human swallowing physiology. taking into account the pressure ranges and timing data described in the relevant literature theoretically validated and corresponding to the physiological swallowing pressure profile It is applied in this way. However, the invention refers to the sample pressure 5 not limited by their values ​​but also encompassing different individuals, age groups, clinical conditions, and Different positive and negative pressures were used to simulate the experimental protocols. It can be implemented using different phase and cycle times with varying values. In the system described in the invention, the positive and negative pressure inside the sample chamber (1) is 10 The generation processes are carried out using a single pump / motor unit. This is being carried out in order to create positive pressure in the system. a separate air pump and a separate vacuum to create negative pressure The pump is not needed. The suction of the pump / motor unit. line and discharge line, negative pressure valve (5) and 15 managed by the control unit Selectively fluid into the sample chamber (1) via positive pressure valve (4) It is designed to establish a connection. Pump / motor in negative pressure phase. The suction side of the unit is connected to the negative pressure hose by opening the negative pressure valve (5). (7) connects to the sample container (1) and inside the sample container (1) a pressure below atmospheric pressure by removing air 20 is created. In the positive pressure phase, the discharge side of the pump / motor unit, Sample through positive pressure hose (6) by opening positive pressure valve (4) connected to the reservoir (1) and atmosphere by transmitting air to the sample reservoir (1) A pressure above the normal pressure is being created. The control unit detects swallowing. Depending on the active pressure phase of the cycle, the positive pressure valve (4) and the negative pressure 25 to determine the appropriate working combinations of the valve (5) and the same pump / motor the unit can be selectively powered by either a vacuum source or a pressure source. It enables its use. The pressure value in the sample chamber (1) is positive pressure. feedback data from sensor (2) and negative pressure sensor (3) It is monitored via; the measured pressure values ​​are the target positive or negative pressure 30 The values ​​are compared. The control unit performs this comparison. According to the result, the operating times of the pump / motor unit and related valves and / or By adjusting the activation conditions, target pressure values ​​are created and This structure ensures that it is protected within predetermined tolerance limits. 13 Thanks to this, the number of pressure-generating components used in the system is reduced, The system's production and maintenance costs are reduced, and its control structure is simplified. and repeatable positive and negative pressure through the same pump / motor unit. It is possible to create cycles. In the system described in the invention, positive pressure and negative pressure redirection processes are performed. This is accomplished through electrically controlled solenoid valves. In this context, the positive pressure valve (4) and the negative pressure valve (5), control unit will open or in accordance with the electrical control signals produced by It is configured to close. These valves are selectively activated at 10:00 AM. With this, the suction line or discharge line of the pump / motor unit becomes negative, respectively. through pressure hose (7) or positive pressure hose (6) to sample chamber (1) It is connected. Thus, in the negative pressure phase of the swallowing simulation The suction line of the pump / motor unit is directed to the sample chamber (1) and the sample The air inside the reservoir (1) is removed, and in the positive pressure phase 15 The sample is directed to the sample chamber (1) by the discharge line of the pump / motor unit. Air is transferred into the reservoir (1). The control unit is predefined. working scenario, pressure application times, phase transition times and target positive pressure valve (4) and negative pressure valve (5) according to the pressure values to be commissioned at specified times and in appropriate combinations of operations or 20 It disables it. In this way, negative pressure, transition, neutralization and positive Transitions between pressure phases are managed automatically. Positive pressure. feedback data from sensor (2) and negative pressure sensor (3) It is evaluated by the control unit and depends on the measured pressure values. as well as the opening and closing states of the relevant solenoid valves and the pump / motor 25 The operating time of the unit is adjusted. Thus, the sample inside the sample container (1) bringing the pressure to the target positive or negative pressure value, the value is maintained within the specified tolerance limits and pressure phases the transitions between them are carried out in a controlled, automatic and repeatable manner. is provided. 30 In the system, pressure build-up or air in the pump's line that is not in use at the moment may occur. To prevent obstruction of the flow, a vacuum relief port (15) and pressure There is a discharge port (16). The vacuum discharge port (15) is located in the vacuum line. 14 when not in use or when transitions to the negative pressure phase need to be balanced In certain situations, it allows the relevant line to be opened to the atmosphere. Pressure relief port (16) is used during positive pressure generation or when the pressure line is not in use. directing the unused output of the pump to the outside environment in the phases These relief ports prevent the pump from being strained, 5 Unwanted pressure build-up in the lines is reduced, and positive / negative pressure phases are minimized. A more stable transition can be achieved between them. In the system described in the invention, vacuum evacuation is used. port (15) and pressure relief port (16) are controlled by the control unit during operation. It is configured to be managed automatically. These discharge ports... 10 in a continuously open state or to form a stable fluid connection not used; active pressure phase of the swallowing cycle, target pressure value, feedback from the positive pressure sensor (2) and the negative pressure sensor (3) Selective based on feed data and a predefined operating scenario. It is activated or deactivated in this way. This is automatic control. Thanks to its structure, positive or negative pressure 15 inside the sample chamber (1) creation, the created pressure value within the specified tolerance and / or hysteresis preservation within its boundaries and transitions between pressure phases This is accomplished without requiring user intervention. In this way, controlled, safe and repeatable working conditions are obtained throughout the experiment. is being done. 20 The system in question includes a vacuum relief port (15) and a pressure relief port (16). connected airflow paths, depending on the active pressure phase of the swallowing cycle It is managed by the control unit. In the negative pressure phase, the control unit, By activating the negative pressure valve (5), the suction side of the pump / motor unit and sample 25 Fluid connection between reservoir (1) via negative pressure hose (7) This ensures the establishment of the flow path associated with the vacuum relief port (15) at this stage. When opened, the positive pressure valve (4) and the positive pressure line are closed. Thus, the air pump / motor unit inside the sample chamber (1) is retained. It is drawn towards the suction side and the target negative pressure is 30 inside the sample chamber (1). The value is generated. Feedback received from the negative pressure sensor (3) Operation of the pump / motor unit and negative pressure valve (5) according to the data by checking the target negative pressure value within the specified tolerance and / or hysteresis It is ensured that it is maintained within its limits. In the positive pressure phase, control is maintained. unit activates positive pressure valve (4) on the discharge side of pump / motor unit fluid through positive pressure hose (6) between sample chamber (1) and sample chamber (1) It ensures that a connection is established. At this stage, the pressure relief port (16) negative pressure valve (5) and negative pressure line when the associated flow path is opened It is kept in the closed position. In this way, the discharge side of the pump / motor unit is 5 The supplied air is conveyed to the sample chamber (1) and the target is inside the sample chamber (1). A positive pressure value is generated. The feedback received from the positive pressure sensor (2) Based on the supply data, the pump / motor unit and the positive pressure valve (4) The operation is checked to ensure the target positive pressure value is within the specified tolerance and / or Hysteresis is maintained within certain limits. Negative and positive pressure 10 During the transition between phases, the control unit connects the positive pressure line to the negative pressure line. a positive pressure valve to prevent the pressure line from becoming active simultaneously (4) and negative pressure valve (5) are managed sequentially. Preferably, active pressure after the valve relating to the first pressure phase is closed, before the valve relating to the other pressure phase is opened A predetermined security waiting period applies. The required 15 days. In such cases the pressure inside the sample chamber (1) is controlled to the atmosphere a transition, equalization and / or neutralization phase where the pressure is brought close to a certain level is being applied and the next pressure after the completion of that phase. The phase is being entered. Associated with the vacuum relief port (15) and pressure relief port (16). Flow path activation and deactivation times; user-defined 20 The defined target positive and negative pressure values, positive pressure sensor (2) and Instantaneous pressure values ​​measured by the negative pressure sensor (3), pressure application times, phase transition and / or waiting times, and in the control unit This is determined automatically according to the control algorithm being implemented. Thus Transitions between pressure phases must be safe, controlled and repeatable. 25 This is ensured. In order to monitor the pressure changes inside the sample chamber (1) The system includes a positive pressure sensor (2) and a negative pressure sensor (3). Positive pressure sensor (2), inside sample chamber (1) or positive pressure 30 It is positioned to measure the positive pressure value in the line. Negative pressure The sensor (3) detects the vacuum inside the sample chamber (1) or in the negative pressure line. It is designed to monitor its value. Positive pressure sensor (2) and negative pressure The sensor (3) displays the pressure values ​​it measures inside the circuit box (8). 16 It transmits the information to the microcontroller-based control unit. Thus, the system controls the implemented... It is possible to monitor pressure levels in real time and the target pressure When the specified values ​​are reached, the position of the relevant valves is changed to proceed to the next phase. It is possible to pass. The positive pressure sensor (2) and negative pressure sensor used in the system that is the subject of the invention The sensor (3) is not inside the sample chamber (1), but in the system housing and / or circuit The pressure sensors (2, 3) are located on the box (8). It operates according to the differential pressure measurement principle. Each pressure sensor... (2, 3) a pressure inlet end, through the relevant hose line, the internal volume of the sample chamber (1) 10 While one end is designed to establish a fluid connection with the other, the other pressure inlet end is at atmospheric pressure. It is left open to the environment. Thus, the positive pressure sensor (2) and the negative pressure The sensor (3) detects the difference between the pressure inside the sample chamber (1) and the atmospheric pressure. measuring the difference and controlling the electrical signals corresponding to the measured pressure difference. It transmits to the unit. Thanks to this structure, the positive and 15 inside the sample container (1) Negative relative pressure values ​​can be determined in real time. The system also includes an analog manometer (17). Analog manometer (17), Enables visual and direct monitoring of pressure values It functions as a mechanical / analog measuring element. Analog manometer 20 (17), preferably on a pressure line connected to the sample container (1) or the user It is positioned on a surface that can be seen by the system. This element is part of the system. Checking initial pressure values, comparing sensor measurements. and serves as a reference point in the calibration process. Thus 25 via analog pressure gauge and values ​​obtained from electronic sensors It is possible to make a match between the monitored values. The analog manometer (17) in the system is an active control during normal operation. as an element or a reference sensor providing continuous feedback is not used. Analog manometer (17) is mainly used for system setup, 30 in initial verification, calibration and recalibration processes when necessary It is an auxiliary measuring equipment used. During the calibration process, the sample A specific reference pressure value created in the reservoir (1) is analogous within the working range in which the manometer (17) provides high measurement accuracy 17 is selected and obtained from the positive pressure sensor (2) and the negative pressure sensor (3) The measured values ​​are compared with the reference pressure value. After the calibration process is complete, the system will operate normally. During the process, no data is received from the analog manometer (17) and the analog manometer (17) The values ​​shown are not used in the control algorithm. Normal 5 pressure control, feedback processes and pressure phases during operation The transitions between the positive pressure sensor (2) and the negative pressure sensor (3) This is carried out based on the measurement data obtained. Analog manometer (17) with positive pressure sensor (2) and negative pressure sensor (3) 10 The calibration and matching process between them is not done automatically by the system, Comparative measurements performed during the installation and verification phases. This is done via. During calibration, positive and negative pressure is applied to the pump / motor unit. using pressure valve (4) and negative pressure valve (5) inside sample chamber (1) Different predetermined pressure levels are created. The created pressure is 15 levels are simultaneously measured by analog manometer (17) and positive pressure sensor (2) and / or negative pressure sensor (3) is measured. Electronic pressure Analog electrical signals obtained from sensors (2, 3) control unit These signals are read by and the corresponding measurement values ​​are converted into analog signals. Compared with reference measurement values ​​obtained from the manometer (17). 20 According to the comparison results, the positive pressure sensor (2) and the negative conversion coefficients, slope values ​​and / or offsets relating to the pressure sensor (3) The values ​​are determined and defined in the system software. Thus, from the sensors... converting the received electrical signals into actual pressure values Analog manometer (17) is provided. 25 days after the completion of the calibration process. then verification and recalibration to be performed only when necessary. It is used as a reference measurement tool in processes. In the sample chamber (1), not only pressure changes but also the oral environment In order to monitor the humidity conditions representing the humidity sensor (18) 30 The humidity sensor (18) is located in contact with the internal volume of the sample chamber (1) or It is positioned to detect the relative humidity inside the reservoir. Additionally, the humidity... The sensor (18) can also measure the temperature. The humidity sensor (18) measures the temperature of the reservoir during the experiment. It measures the moisture content inside and transmits this data to the control unit. In this way... 18 whether the test environment was kept under conditions closer to the physiological oral environment It can be monitored; the humidification unit can be activated when necessary to fill the reservoir. The humidity level inside can be maintained within the specified range. The humidity sensor (18) directly measures the relative humidity conditions inside the sample chamber (1). in contact with the internal volume of the sample container (1) in such a way that it can be measured It is positioned. In a preferred application of the invention, the humidity sensor (18), It is mounted on one wall of the sample chamber (1) and performs moisture measurement. The sensing surface is positioned to face the interior of the sample chamber (1). Thus, the actual relative humidity formed in the sample container (1) during the experiment was 10 values ​​continuously or at predetermined time intervals It can be measured. Ultrasonic when determining the position of the humidity sensor (18). The humid aerosol that comes out through the humidification unit (19) directly to the sensor by reaching the sensing surface, a measurement that differs from or is inaccurate compared to the actual ambient humidity. This prevents its formation. For this purpose, the humidity sensor (18), ultrasonic 15 positive and negative pressure from the aerosol outlet area of ​​the humidification unit (19). from air inlet and outlet points and where condensation is likely to occur They are located at a certain distance from the areas. Physiological oral environmental conditions and a high-humidity or saliva-saturated environment 20 In order to simulate in laboratory conditions, the sample container (1) contains The target relative humidity value is preferably set between 70% RH and 100% RH. However, the user will need the experimental protocol to be implemented, the protocol to be tested. depending on the characteristics of the sample and the physiological or clinical conditions that are to be simulated depending on a different target relative humidity value or relative humidity range 25 It can identify the relative humidity value in the sample container (1) using the humidity sensor. (18) is monitored in real time and the measured humidity values ​​are controlled. The data is transmitted to the control unit. The control unit, according to the received feedback data... By managing the humidification unit, the target relative humidity value can be maintained throughout the experiment. This ensures that it is kept within the specified tolerance and / or hysteresis limits. 30 The circuit box (8) houses the electrical and electronic control elements of the system. It is structured as a section. Microcontroller based inside the circuit box (8) control unit, power connections, sensor connections, valve drivers and user 19 Interface connections are included. Positive pressure sensor (2), negative pressure sensor (3), humidity sensor (18), positive pressure valve (4), negative pressure valve (5), LCD The screen (9) and button (10) are electrically connected to the control unit inside the circuit box (8). It is interconnected in this way. Thus, the system's measurement, control, user information and Phase transition operations are carried out through a central control structure. 5 The LCD screen (9) is used to monitor the experimental conditions in real time. It is located on the box (8), preferably on the front surface facing the user. Instantaneous pressure value, negative or positive pressure phase information is displayed via the LCD screen (9), humidity level, total number of swallowing cycles, system run / stop status, and 10 Calibration information can be displayed. This allows the user to see the calibration information during the experiment. which phase the system is in, the pressure and humidity conditions inside the tank, and It can directly track the total number of swallowing cycles completed. Button (10) is used to start, stop and / or 15 the system by the user. It is the control element used for resetting. The button (10), preferably with the LCD screen (9). easily accessible on the same user access surface or circuit box (8) It is located in this position. The user can operate the system via button (10), The system can be stopped during the experiment or restarted if necessary. It can be recalibrated by resetting. Button (10) 20 The given commands are sent to the microcontroller-based control unit inside the circuit box (8). It is detected by the system, and the relevant operating mode is determined accordingly. The system has a DC power supply (11) for the electronic control circuits. Brain DC power supply (11) is used to power the microcontroller-based control unit, sensors, 25 Power supply for the LCD screen (9) and low voltage electronic components The motor-valve AC power supply (12) provides power to pumps, motors and / or valves. It is used to power components that require higher power. Brain DC power supply (11) and motor-valve AC power supply (12) within the system Because they are functionally separated, the control circuits operate stably and the power is 30. It is possible to supply the energy needed by the components through a separate line. is becoming. The sample to be tested during the study of the invention is placed inside the sample container (1). is installed and the lid (13) is sealed by means of the lid clips (14) is being shut down. When the user starts the system with button (10), the control unit It takes initial values, reads data from sensors, and calculates the necessary zeros. It performs its calibration. Positive pressure valve (4) 5 in positive pressure phase air is drawn into the sample chamber (1) through the positive pressure hose (6) by opening is being sent; meanwhile, the positive pressure sensor (2) and analog manometer (17) The pressure value is monitored via this method. The target is a positive pressure value. or when the specified positive pressure duration is reached, the system enters the relevant phase. It concludes. 10 During the negative pressure phase, the negative pressure valve (5) is opened and the negative pressure Air is drawn out of the sample container (1) through the hose (7). In this stage, the negative pressure sensor (3) measures the vacuum value that is formed and the measured The values ​​are evaluated by the control unit. Vacuum phase 15 When completed, the system considers that a swallowing cycle has been completed and It increases the number of cycles. This number of cycles is displayed to the user on the LCD screen (9). The vacuum relief port (15) and the pressure relief port (16) are shown. By directing the unused line between them into the atmosphere, the system becomes more efficient. It contributes to his determined and efficient work. 20 Throughout the experiment, the humidity sensor (18) monitored the relative humidity inside the sample container (1). It is being monitored. If the humidity level falls below the specified threshold values, the system will be checked. The unit activates the humidification unit integrated into the system, thereby filling the reservoir. It ensures that the humidity level inside is maintained within the desired range. Thus, 25 The samples were subjected not only to pressure changes but also to the humid mouth environment. It is also exposed to environmental conditions that represent it. Thanks to this structure, the invention subject system, sample container (1), lid (13), cover on a single experimental platform clip (14), positive pressure valve (4), positive pressure hose (6), negative pressure valve (5), negative pressure hose (7), vacuum relief port (15), pressure relief port (16), positive 30 pressure sensor (2), negative pressure sensor (3), humidity sensor (18), analog pressure gauge (17), LCD screen (9), button (10), control unit DC power supply (11), motor-valve It brings together the AC power supply (12) and the circuit box (8). Thus, the human with the positive and negative pressure changes that occur in the oral phase during swallowing 21 Moist oral environment conditions, controlled, repeatable in a laboratory setting, and It is simulated in a way that can be observed. Humidification of the sample chamber (1) by ultrasonic humidification unit (19) This is done via. Moisture is added to the sample container (1) using a wet pad or 5 not in the form of hot water vapor created with the help of a resistance, but ultrasonically. micrometer-sized fine water particles produced as a result of the atomization process It is delivered in the form of droplets. Located in the ultrasonic humidification unit (19) At least one piezoelectric transducer generates high-frequency mechanical vibrations. It separates the water into fine droplets, thereby creating a moist aerosol or mist. 10 It brings about a moist aerosol created by natural or forced airflow. By transporting it to the sample container (1) with the help of the relative humidity inside the sample container (1) It increases the level of relative humidity measured by the humidity sensor (18). its value falling below the user-defined lower threshold value In this case, the ultrasonic humidifier unit (19) is activated by the control unit. is taken; the measured humidity value is adjusted to the target humidity level or upper threshold value. If it reaches this level, it is deactivated. Thanks to this control structure... high humidity conditions representing the oral environment in the sample container (1) It can be generated in a controlled and repeatable manner. The system provides data on the operating conditions to which the sample was exposed during the experiment. It can be recorded by the control unit. The control unit records positive results throughout the experiment. pressure values ​​obtained from the pressure sensor (2) and the negative pressure sensor (3), relative humidity values ​​obtained from the humidity sensor (18) and relative humidity values ​​obtained from the temperature sensor The study on the obtained temperature values ​​and the swallowing cycles performed is 25. It collects information continuously or at predetermined time intervals. The collected data is transferred to a data recording and storage unit within the system, preferably an SD card. The data is recorded on the card. The recorded data includes the measurement date and time, and the instantaneous information. positive or negative pressure value, relative humidity value, temperature value, active operation phase, target pressure value, number of completed and / or remaining swallowing cycles, phase 30 This log structure can include duration, system status, and error or warning information. Thanks to this, the experimental conditions can be examined retrospectively, and different experiments can be conducted. Comparing the results, verifying system performance, and conducting experiments It becomes possible to document it. 22 The experimental data was recorded onto the SD card after the experiment was completed. It can be transferred to an external computer, memory device, or data processing software. In the preferred application of the invention, data transfer occurs when the SD card is removed from the system. and by connecting it to an external computer via a suitable card reader 5 This is carried out. Pressure, relative humidity, temperature, time, and are transferred to the external environment. swallowing cycle data; spreadsheet, data analysis, graphing and / or This can be analyzed through statistical evaluation software. It can be archived and reported. This allows for comparison of different tests. Long-term monitoring of experimental results and testing conditions 10 Verification can be ensured. However, the invention only allows data transfer. It is not limited to being performed via SD card. The invention's operation USB connection, serial communication protocols, wired, without deviating from the principle. or wireless network connection, Bluetooth, Wi-Fi and / or similar data transfer One or more of these methods can be used. 15 The system described in the invention is intended for use in dental prostheses, implant-supported structures, and orthodontics. appliances, dental connectors and / or suitable for use in the mouth medical materials with repeated positive and negative swallowing pressures and high This allows for the examination of their behavior under humid environmental conditions. 20 Following simulations performed through the system, the long-term results of the samples... prolonged fatigue behavior, retention, adhesion or bonding strength, such as leak tightness, tendency to microleakage, fracture resistance, and structural deformation resistance. Technical specifications can be evaluated. However, the system being tested... An analysis that automatically determines whether a sample is successful or unsuccessful. 25 It does not operate as a system. The system operates under user-defined pressure. until relative humidity, temperature, phase duration, and swallowing cycle count are complete It automatically runs and controls the simulation process and processes the experimental data. It records the retention that occurs in the sample after the test is completed. loss, microleakage, fracture, abrasion, deformation, surface change and / or 30 biochemical changes outside the sample container (1) by the researcher mechanical, physical, chemical, microscopic and / or biochemical tests performed and are evaluated through analytical methods. 23 The working principle of the system described in the invention is as follows: i. the system's power supply, control unit and electronic components DC power supply (11) which provides power to the motor and valves AC power supply (12) 5 which feeds the DC transformer that provides the power supply provided through, ii. When the system is started, the circuit box (8) located inside the sensors and actuators within the system by the control unit performing initial checks, iii. from the positive pressure sensor (2), from the negative pressure sensor (3) and humidity 10 Verification of measurement data received from sensor (18) and initial Determining reference values, iv. By pressing and holding button (10), zero will appear on the LCD screen (9). Displaying the calibration interface during the zero calibration process. The pressure value available in the sample chamber (1) is the initial pressure 15 and the initial pressure value in question should be accepted as such. positive pressure sensor (2), negative pressure sensor (3) and control unit being recorded as a reference value by, v. by the user via the LCD screen (9) and at least one button (10) target negative pressure value, target positive pressure value, negative and 20 positive pressure application times, waiting periods between pressure phases durations, total number of swallowing cycles, target temperature value and defining the target relative humidity value in the system, vi. User-defined operating parameters control unit the data is stored in memory by and the relevant operating parameters are 25 The experimental initial data is stored in a data recording unit, preferably an SD card. to be recorded on it, vii. closed by means of the cover (13) and with the help of at least four cover clips (14) Relative humidity inside the leak-proof sample container (1) The value of 30 is continuously or predetermined via the humidity sensor (18) measuring the relative humidity at time intervals and providing the measured relative humidity value to the user. the target relative humidity value or lower threshold value determined by if it is below the control unit of the ultrasonic humidifier commissioning by, 24 viii. Piezoelectric transducer located within the ultrasonic humidifier by converting water into micrometer-sized droplets and by transferring the formed water droplets to the sample container (1) Increasing the relative humidity value in the sample container (1), ix. The relative humidity value measured by the humidity sensor (18) is the target relative humidity 5 reaching its value or a predetermined upper threshold value In this case, the ultrasonic humidifier is deactivated by the control unit. by leaving it as is and thus the ultrasonic humidifier detects small humidity changes. to prevent it from opening and closing continuously, x. The environmental conditions inside the sample container (1) are determined by the user. after reaching the defined temperature and relative humidity values The swallowing simulation cycle is started by pressing the button (10). initiation, xi. instantaneous positive pressure value in sample chamber (1) positive pressure by sensor (2) and instantaneous negative pressure value negative pressure 15 continuously or at a predetermined time by the sensor (3) measured within the ranges, corresponding to the measured pressure values the transmission of electrical signals to the control unit and the electrical signals in question signals are calibrated by a predefined calibration control unit. Converting pressure values ​​using coefficients, 20 xii. Analog manometer (17) of the pressure inside the sample chamber (1) mechanical observation via and positive pressure sensor (2) pressure values ​​measured by the negative pressure sensor (3) Checking via analog manometer (17) when necessary, xiii. Depending on the pressure phase to be created, the positive pressure valve (4), negative 25 pressure valve (5) is suitable by the air pump control unit activation in the operating configuration, xiv. Opening of the negative pressure valve (5) in the negative pressure phase and negative air inside sample container (1) through pressure hose (7) The sample container is 30 by moving it away in the direction of the vacuum relief port (15). (1) reducing the pressure inside to below atmospheric pressure, xv. Feedback data obtained by the negative pressure sensor (3) continuously evaluated and measured by the control unit negative pressure value is the target negative pressure defined by the user. until the negative pressure valve (5) and air pump reach the value keeping it in active state xvi. The measured negative pressure value reaching the target negative pressure value in this case a predefined hysteresis by the control unit application of the interval and thus the small 5 inside the sample container (1) negative pressure valve (5) and air due to pressure fluctuations preventing the pump from switching on and off unnecessarily, xvii. Pressure inside the sample chamber (1) during the negative pressure phase lower and upper tolerance limits of the target negative pressure value the pressure value must be maintained between these limits and the measured pressure value must be within the specified tolerance of 10. If it goes outside its limits, the negative pressure valve (5) and / or reactivation of the air pump by the control unit by correcting the pressure value, xviii. After the completion of the negative pressure phase, the system undergoes a transition or transition to neutralization phase, negative pressure valve (5) and / or positive 15 by operating the pressure valve (4) in a controlled manner, the sample chamber (1) bringing the pressure inside closer to atmospheric pressure, 19. Positive pressure after completion of the transition or neutralization phase. opening of valve (4) and pressurized by air pump air through positive pressure hose (6) into sample chamber (1) 20 by transmitting atmospheric pressure inside the sample container (1). putting pressure on it, feedback data obtained by the xx. positive pressure sensor (2) continuous evaluation and measurement by the control unit and positive pressure value user-defined target positive pressure 25 until the value is reached, the positive pressure valve (4) and the air pump keeping it in active state XXI. The measured positive pressure value reaching the target positive pressure value. in this case, the application of a predefined hysteresis range, During the positive pressure phase, the pressure value is 30 degrees above the target positive pressure value. and the pressure value should be kept within the lower and upper tolerance limits. positive pressure if it exceeds the aforementioned tolerance limits by reactivating the valve (4) and / or the air pump Correction of the pressure value, 26 xxii. After the completion of the positive pressure phase, the sample chamber (1) pressure relief port (16) of the compressed air inside and / or related sample reservoir by controlled discharge through valves (1) bringing the pressure inside closer to atmospheric pressure, xxiii. a negative pressure phase, a transition or neutralization phase, and a positive 5 The completion of the pressure phase is considered a swallow cycle. being done, xxiv. until the number of swallowing cycles programmed by the user is reached up to the negative pressure phase, the transition or neutralization phase, and the positive The pressure phase is repeated sequentially by the control unit. 10 By creating repeatable swallowing scenarios, During the xxv. operation, the positive pressure sensor (2) and the negative pressure sensor (3) pressure values ​​measured by the humidity sensor (18) measured relative humidity value, temperature value, completed swallowing cycle count, time information, active operating phase, and system status 15 the information is sent to the data recording unit at predetermined time intervals, preferably saved to an SD card, xxvi. Instantaneous positive or negative pressure value inside sample chamber (1), temperature value, relative humidity value, active working phase, completed and / or the remaining swallow cycle count and system alerts on LCD 20 to be shown to the user via the screen (9) xxvii. Reaching the number of swallowing cycles programmed by the user. in case of positive pressure valve (4), negative pressure valve (5), air safe by the control unit of the pump and other actuators Stopping by switching to working status, sample container (1) 25 Bringing the pressure inside closer to atmospheric pressure, the final measurement and recording the study data into the data logging unit and the experiment information that it is completed is displayed on the LCD screen (9) It includes the steps involved in the process. In a preferred application of the invention, the positive pressure phase transitions to negative pressure. the transition from phase to phase or from negative pressure phase to positive pressure phase, is just an example. based on the principle of reaching the target pressure value inside the reservoir (1) This is not being implemented. The control unit primarily uses the user at the relevant pressure phase. 27 It enables the creation of the target pressure value defined by and the word The subject is whether the target pressure value has been reached from the positive pressure sensor (2) or via feedback data received from the negative pressure sensor (3) This confirms that after the target pressure value is reached, the said pressure... The value is 5 for the duration of the application period determined by the user for the relevant phase. It is maintained within predefined hysteresis and / or tolerance limits. The control unit confirms both that the target pressure value has been reached and that the relevant pressure phase has been entered. by jointly assessing that the defined implementation period has been completed It then decides on the transition to the next phase. Thus, the phase transition reaches the target pressure value. reaching and maintaining the specified pressure value for the specified period 10 It is carried out depending on the simultaneous fulfillment of these conditions. together, within a predetermined maximum time to reach the target pressure value If it cannot be reached, an error message is displayed by the control unit. can be created, the user via LCD screen (9) and / or a warning unit can be warned, the experiment can be terminated, or the system can be set to a predefined 15 It can be put into a security procedure. One of these security measures is... or several of them, selected by the user before the start of the experiment It can be activated. Thanks to this control structure, only each pressure phase can be activated. not only reaching a certain pressure value, but also the pressure in question by ensuring that its value remains stable for the specified period, the true 20 pressure profiles that are closer to and more repeatable than swallowing conditions is being created. In a preferred application of the invention, it will be carried out as part of a test. The total number of swallowing cycles can be adjusted by the user. The user can set it to 25. the user interface which includes an LCD screen (9) and at least one button (10) displaying the experimental parameters When defining it, also enter the target total swallowing cycle count into the system. It can input. The target number of cycles entered by the user is controlled by the control unit. The swallowing cycles performed during the experiment are memorized by the system. It is used as a reference value in the control process. A 30 is given by the system. the negative pressure phase, the positive pressure phase, and that make up the swallowing cycle preferably a transition, neutralization and / or waiting period applied between these phases. The cycle counter is updated after the completion of the phases. Control The unit counts the number of completed swallowing cycles according to a user-defined target. 28 total number of swallowing cycles and continuous or completion of each cycle It then compares the number of completed cycles to the target total cycles. If the required number is reached, the control unit will automatically start the experiment. terminating; positive pressure valve (4), negative pressure valve (5), air pump and bringing other active components to a safe working state; sample container (1) 5 by bringing the pressure inside closer to atmospheric pressure and obtaining it during the experiment The collected measurement and study data are recorded on a data logging unit, preferably an SD card. It records the information that the experiment is complete via the LCD screen (9). This structure allows different clinical scenarios and / or to be displayed to the user. To simulate laboratory conditions, different numbers of repeated swallows were performed. 10 Cycles can be created and experimental protocols are flexible according to user needs. and can be arranged in a repeatable manner. In a preferred application of the invention, the frequency of swallowing is determined by the user. It can be adjusted. The swallowing frequency is the frequency of swallowing performed per unit of time. It represents the number of swallowing cycles and is set to 15 via the system software. It is a definable operating parameter. The user can detect the LCD screen (9) and at least one Through the user interface containing button (10), the duration of the negative pressure phase, positive the duration of the pressure phase and the transition to be applied between those pressure phases, It is possible to specify neutralization and / or waiting times separately. Control The unit uses the user-defined timing parameters 20 By evaluating this, we determine the total duration of each swallowing cycle and... Depending on the situation, it helps to create the targeted swallowing frequency. Furthermore... negative and positive pressure to simulate frequent swallowing behavior Implementation periods for the phases and transitions and / or waiting periods between phases The durations can be reduced; simulating a less frequent swallowing behavior. 25 For this purpose, these periods can be extended. Thus, the system can provide different individuals with different corresponding to age groups, physiological characteristics and / or clinical conditions It can be programmed to create specific swallowing frequencies. The control unit, sequentially by applying the timing parameters defined during the experiment swallowing cycles are performed at specified intervals and user 30 This ensures that the swallowing frequency selected by the user is maintained throughout the experiment. In this way, experimental scenarios with different swallowing frequencies are standardized, controlled, and It can be generated in a repeatable manner. 29 Industrial Applicability of the Invention The invention relates to dental prostheses used in the mouth, implant-supported structures, and orthodontics. appliances and similar medical / dental materials; mouth during swallowing positive and negative pressure changes occurring in the environment and the moist oral cavity 5 a swallowing pressure that allows testing in a laboratory environment under certain conditions This relates to the simulation system and its working method, and to the industry. It is feasible. The invention is not limited to the above descriptions; a person skilled in the field can easily create 10... It can demonstrate different applications of the invention. These are the claims and demands of the invention. It should be evaluated within the scope of the protection granted. 20 30

Claims

REQUESTS 1. It is an oral phase swallowing pressure simulation system, the feature of which is; • with a flip-open lid (13) in which the sample to be tested is positioned at least one sample container with a sealed, leak-proof internal volume (1); • at least one pump / motor unit with one suction line and one discharge line; 5 • fluid between the discharge line of the pump / motor unit and the sample tank (1) at least one positive pressure hose (6) connecting the connection and positive pressure at least one positive pressure valve (4) located on the hose (6); • fluid between the suction line of the pump / motor unit and the sample chamber (1) at least one negative pressure hose (7) connecting and negative pressure 10 at least one negative pressure valve (5) located on the hose (7); • the internal volume of the sample container (1) and / or the positive pressure hose (6) At least one positive pressure sensor located in a fluid connection (2); • the internal volume of the sample container (1) and / or negative pressure hose (7) At least one negative pressure sensor located in a fluid connection (3); 15 • to measure the relative humidity value in the internal volume of the sample container (1) at least one moisture located in contact with the internal volume of the reservoir (1) sensor (18); • with sample container (1) in such a way as to deliver moist aerosol to sample container (1) at least one connected ultrasonic humidification unit (19); 20 • pump / motor unit, positive pressure valve (4), negative pressure valve (5), positive pressure sensor (2), negative pressure sensor (3), humidity sensor (18) and electrically connected to the ultrasonic humidification unit (19) and from positive pressure sensor (2) and negative pressure sensor (3) According to the measurement data, the positive pressure valve (4) and the negative pressure valve (5) 25 will check sequentially and the measurement taken from the humidity sensor (18) According to the data, it will control the ultrasonic humidification unit (19). at least one control unit configured in this way; • at least one circuit box containing the control unit (8); • at least one LCD screen (9) electrically connected to the control unit, 30 • on the circuit box (8) to transmit user commands to the control unit at least one button located (10) It includes. 31 2. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; The lid (13) located in the opening area of ​​the sample container (1), sample connected to the container (1) in an open-close manner and the lid (13) When in the closed position, the lid (13) must be pressed down on the sample container (1) at least It includes four cover clips (14). 5 3. According to Claim 2, it is an oral phase swallowing pressure simulation system, the feature of which is; at least four cover clips (14) around the cover (13) opposite each other positioned between the lid (13) and the sample container (1) at least one gasket and / or sealing ring at the connection area It is to be found. 10 4. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; sample container (1), positive pressure hose (6) and negative pressure pressure connection points for connecting the hose (7), positive for pressure sensor (2), negative pressure sensor (3) and humidity sensor (18) 15 It must contain at least one statement to that effect.

5. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; positive pressure valve (4) and negative pressure valve (5), control unit open and closed according to electrical control signals produced by It is the presence of solenoid valves that move between positions. 20 6. According to claim 5, it is an oral phase swallowing pressure simulation system, the feature of which is; The control unit must connect the positive pressure valve (4) and the negative pressure valve (5) at the same time. will not open immediately and the active valve will be closed. a predetermined waiting period between the opening of the other valve It is structured in a way that will allow it to be implemented. 25 7. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; a vacuum relief port connected to the suction line of the pump / motor unit (15); and a pressure relief port connected to the discharge line of the pump / motor unit (16) is included.

8. According to Claim 1, it is an oral phase swallowing pressure simulation system, and its feature is; 30 Example of positive pressure sensor (2) and negative pressure sensor (3) outside of its housing (1), on the system body and / or circuit box (8) having positioned differential pressure sensors; each pressure the internal volume of the sample chamber (1) of the pressure inlet end of the sensor and the fluid 32 it must be connected and the other pressure inlet end must be open to the atmosphere. It is structured.

9. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; on a pressure line connected to the internal volume of the sample chamber (1) and at least one analog 5 located in a position visible to the user. It contains a manometer (17).

10. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; The humidity sensor (18) is mounted on one wall of the sample chamber (1). the sensing surface of the humidity sensor (18) is inside the sample chamber (1) positioned to look at its volume and the humidity sensor (18), 10 From the aerosol outlet area of ​​the ultrasonic humidifier (19), positive and negative pressure from air inlet and outlet points and condensation areas It is located at a distance.

11. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; The LCD screen (9) has 15 on the user-facing surface of the circuit box (8). its positioning and the instantaneous pressure value received from the control unit, active pressure phase, relative humidity, completed and / or remaining swallowing It will display the cycle count, system operating status, and system alerts. It is structured in this way.

12. According to Claim 1, it is an oral phase swallowing pressure simulation system, the feature of which is; 20 from positive pressure sensor (2), negative pressure sensor (3) and humidity Measurement data received from the sensor (18), active working phase, swallowing a system that records cycle count, time information, and system status information. It includes a data recording and storage unit.

13. According to claim 12, it is an oral phase swallowing pressure simulation system, the feature of which is; 25 the data recording and storage unit includes an SD card and the system uses the SD card, USB connection, serial communication connection, wired network connection, wireless network connection, transmitting data via Bluetooth and / or Wi-Fi It must contain at least one data transfer interface.

14. According to Claim 1, it is an oral phase swallowing pressure simulation system, and its feature is; 30 control unit, positive pressure sensor (2), negative pressure sensor (3), humidity sensor (18), LCD screen (9) and low voltage powered electronics a DC power supply (11) that feeds the components and the pump / motor unit, positive 33 pressure valve (4), negative pressure valve (5) and high power operating components It includes an AC power supply (12) that feeds it.

15. The working method and characteristic of the system that is the subject of the invention is; i. the system's power supply, control unit and electronics DC power supply (11) which provides power to the components motor 5 via the AC power supply (12) which provides power to the valves ensuring, ii. The circuit box (8) is located inside the system when it is started by the field control unit, the sensors within the system and Performing initial checks of actuators, 10 iii. from the positive pressure sensor (2), from the negative pressure sensor (3) and Verification of the measurement data received from the humidity sensor (18) and Determining the initial reference values, iv. By pressing and holding button (10), zero will appear on the LCD screen (9). Displaying the calibration interface, zero calibration process 15 the pressure value available in the sample chamber (1) during is accepted as the initial pressure value and the aforementioned initial pressure value positive pressure sensor (2), negative reference value by pressure sensor (3) and control unit recorded as, 20 v. LCD screen (9) and at least one button (10) by the user through which the target negative pressure value, target positive pressure the value, the duration of negative and positive pressure application, pressure waiting times between phases, total swallowing cycle the number, target temperature value and target relative humidity value are 25 definition in the system vi. Control of user-defined operating parameters the unit's memory and the work in question parameters as experimental starting data in a data record saving to the unit, preferably to an SD card, 30 vii. closed by means of the cover (13) and at least four cover clips (14) sample container (1) which is fixed leak-proof with the help of the relative humidity value inside is measured by the humidity sensor (18) measurement continuously or at predetermined time intervals and 34 the measured relative humidity value is the target set by the user. relative humidity being below or below the lower threshold value in this case by the ultrasonic humidifier control unit commissioning, viii. piezoelectric 5 located within the ultrasonic humidifier through the transducer, the micrometer-sized particles of water the transformation into droplets and the water droplets formed by transferring to the sample container (1) increasing the relative humidity inside, ix. The relative humidity value measured by the humidity sensor (18) is the target 10 relative humidity value or a predetermined upper threshold value if it reaches the control unit of the ultrasonic humidifier by disabling it and thus ultrasonic the moisturizer constantly due to small humidity changes preventing it from opening and closing, 15 x. The environmental conditions inside the sample container (1) are determined by the user. temperature and relative humidity values ​​defined by swallowing by pressing the button (10) after reaching it initiating the simulation cycle, xi. instantaneous positive pressure value inside sample chamber (1) positive 20 by the pressure sensor (2) and the instantaneous negative pressure value continuously or in advance by the negative pressure sensor (3) measured pressure at specified time intervals electrical signals corresponding to their values ​​are sent to the control unit transmission and control of the electrical signals in question to the control unit 25 calibration coefficients predefined by Converting into pressure values ​​using xii. Analog manometer (17) of the pressure inside the sample chamber (1) mechanical observation through and positive pressure Pressure measured by sensor (2) and negative pressure sensor (3) 30 values ​​can be measured via an analog manometer (17) when necessary. to be checked, 35 xiii. depending on the pressure phase to be created, the positive pressure valve (4), negative pressure valve (5), air pump control unit commissioning by in the appropriate operating configuration, xiv. Opening of the negative pressure valve (5) in the negative pressure phase and through the negative pressure hose (7) into the sample container (1) 5 air is removed towards the vacuum release port (15) by means of the pressure inside the sample chamber (1) in atmosphere lowering the pressure below xv. Feedback obtained by the negative pressure sensor (3) Continuous evaluation of the data by the control unit 10 and the measured negative pressure value is defined by the user. negative pressure until the target negative pressure value is reached keeping the valve (5) and the vacuum pump active, xvi. measured negative pressure value to target negative pressure value If it arrives, the control unit will pre-warn it 15 by applying a defined hysteresis range and thus small pressure fluctuations inside the sample chamber (1) because of the unnecessary negative pressure valve (5) and air pump preventing it from switching on and off in this way, During the xvii. negative pressure phase, the pressure inside the sample chamber (1) is 20 lower and upper tolerances of the target negative pressure value and the measured pressure value within the specified limits Negative pressure if it exceeds the tolerance limits. by the control unit of the valve (5) and / or air pump Correcting the pressure value by reactivating the system, 25 xviii. After the completion of the negative pressure phase, the system has a transition or neutralization phase, negative pressure valve (5) and / or controlled operation of the positive pressure valve (4) by means of the pressure inside the sample chamber (1) in atmosphere bringing it closer to the pressure, 30 19. Positive after completion of the transition or neutralization phase. opening of the pressure valve (4) and air supplied by the air pump sample of compressed air through positive pressure hose (6) 36 by being conveyed into the sample container (1) inside the sample container (1) creating a pressure above atmospheric pressure, Feedback obtained by the xx. positive pressure sensor (2) continuous evaluation of the data by the control unit and the measured positive pressure value is defined by the user as 5 positive pressure until the target positive pressure value is reached keeping the valve (4) and the air pump active, XXI. The measured positive pressure value versus the target positive pressure value. if reached a predefined hysteresis range its implementation, the pressure value during the positive pressure phase is the target 10 between the lower and upper tolerance limits for positive pressure value and the pressure value within the aforementioned tolerance limits If it goes outside, the positive pressure valve (4) and / or air the pressure value by reactivating the pump correction, 15 xxii. After the completion of the positive pressure phase, the sample chamber (1) pressure relief port of the pressurized air inside (16) and / or controlled discharge via the relevant valves by means of the pressure inside the sample chamber (1) in atmosphere bringing it closer to the pressure, 20 xxiii. a negative pressure phase, a transition or neutralization phase, and a Completion of the positive pressure phase is a swallowing cycle. to be accepted as, xxiv. the number of swallowing cycles programmed by the user. until the negative pressure phase, transition or neutralization 25 the phase and the positive pressure phase are controlled sequentially by the control unit. repeatable swallowing by repeating it creating scenarios, During the xxv. operation, the positive pressure sensor (2) and the negative pressure pressure values ​​measured by sensor (3) humidity sensor 30 (18) the relative humidity value measured by the temperature value, number of completed swallowing cycles, time information, active the work phase and system status information are predetermined 37 data is recorded at time intervals to the data recording unit, preferably on an SD card. recording, xxvi. Instantaneous positive or negative pressure inside the sample chamber (1) value, temperature value, relative humidity value, active work phase, number of completed and / or remaining swallowing cycles and 5 system alerts are displayed to the user via the LCD screen (9) showing, xxvii. number of swallowing cycles programmed by the user If reached, the positive pressure valve (4), negative pressure Control unit of the valve (5), air pump and other actuators 10 being stopped by switching to a safe operating state, the pressure inside the sample chamber (1) to atmospheric pressure bringing the latest measurement and study data closer to the data logging unit. recording and displaying information about the completion of the experiment on the LCD screen. (9) display on 15 It includes the steps of the process. 25

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