MULTI-SENSOR BASED SMART INSULIN VALVE SYSTEM

Abstract

The invention relates to insulin pens and ink cartridge systems used in the treatment of diabetes and encompasses an integrated decision support and warning system with a multiple validation algorithm that analyzes the risk of loss of efficacy of the drug before use by considering temperature, UV / light exposure, freeze-thaw cycles, shock / impact, and changes in optical turbidity / transmittance within the cartridge contents.

Description

1 TARIFF MULTI-SENSOR BASED SMART INSULIN VALVE SYSTEM TECHNICAL FIELD The invention relates to insulin pens and cartridge drug delivery systems used in the treatment of diabetes, and is numbered 5. Factors that can cause the drug to lose effectiveness before use include: temperature, UV / light exposure, freeze-thaw cycles, Analyzing both shock / impact damage and changes in optical turbidity / transmittance within the cartridge contents It includes an integrated decision support and alert system with multiple validation algorithms. The invention is particularly in the field of medical device accessories and biomedical sensor systems, and applies to diabetes 10. Storage and use of insulin pens or cartridge medication systems used in treatment. An innovative smart cover system aimed at increasing security during the preparation phase. It offers. In current practices, insulin storage safety is mostly determined solely by the environment. It relies on monitoring the temperature and UV / light that causes physical degradation of the drug. exposure, freeze-thaw cycles, shock during transport, and optical 15 in protein structure Other important parameters, such as variations, are disregarded. This invention, with all its technical aspects... The problems are addressed by integrating a temperature sensor, UV / light sensor, into a carrier cover / module housing. exposure sensor, optical transmittance / turbidity analysis module, motion / vibration sensor, freeze- a disintegration risk assessment module and a microprocessor that processes data from these modules It solves the problem through a multi-sensor system. The system runs on a microprocessor and consists of 20 Not making decisions based on any single sensor data point, but solely on temperature history, optical data. turbidity / transparency change, UV exposure and mechanical stress data were predetermined. An advanced decision system that, when validated with threshold values, generates a risk score. It includes an algorithm. Thanks to this multi-factor authentication logic, false alarms are filtered out and The drug's status is classified as "usable", "risky use" or "should not be used". 25 With various user interfaces such as LED, audible alert, vibration or mobile application integration. It provides a safety statement. The system also records all environmental conditions to which the drug is exposed over a specific period. a data storage memory and a rechargeable battery or replaceable low-power power supply It includes a feeding module, allowing the user to view their medication storage history via the mobile application. and allows for the visualization of the risk level. Thus, the invention enables insulin to be administered in just 30 days. It not only monitors storage temperature but also assesses the possibility of physical deterioration of the drug using multiple sensors. an integrated system that evaluates data and combined risk assessment algorithms before use. This system represents a significant technical advancement in terms of drug safety and efficacy in diabetes treatment. It provides. 35 PREVIOUS TECHNIQUE 2 In insulin therapy, one of the cornerstones of diabetes treatment, the effectiveness of the medication and protecting safety, regulating blood glucose levels and long-term This is critically important in terms of preventing complications. Today, insulin therapy... One of the most commonly used tools in its application is providing the user with dose adjustment and injection instructions. These are portable insulin pens and cartridge systems that provide convenience. In current applications, these 5 Safety in the process of storing and preparing medicines for use is often a passive responsibility. by the method, that is, within the temperature range specified by the manufacturer (usually +2°C to +8°C) It is based on the principle of preserving (between) the layers. The smart cover developed in line with this principle. The systems integrate sensor technologies for monitoring various environmental parameters. These systems have started to reduce the ambient temperature to which insulin is exposed by 10. temperature sensors that record this data and, based on this data, alert the user on a time-based basis or It includes interfaces that display the drug's temperature history. However, when current techniques are examined, these approaches to insulin safety... 15 that focuses on monitoring only a single variable and threatens the physical integrity of the drug It appears to disregard other critical factors. Insulin has a complex protein structure. It is a biological product, and its effectiveness is due not only to temperature changes but also to ultraviolet radiation. Exposure to (UV) and visible light, freeze-thaw cycles, physical impact, and continuous vibration, etc. It is also significantly affected by mechanical stresses. For example, insulin is affected by direct sunlight. or prolonged exposure to artificial light sources, protein molecules 20 This leads to photooxidation and aggregation, causing it to lose its biological activity. This can happen. Similarly, sudden impacts or heavy loads during the transportation of the drug can also cause damage. Vibrations cause the weak bonds in the protein structure to break down, forming insoluble aggregates. This prepares the ground for its formation. Furthermore, insulin at temperatures below its freezing point... Exposure to and subsequent thawing (freeze-thaw cycle) reduces the protein's 25% the most critical factor causing denaturation and irreversible loss of effectiveness It is one of the factors. Current smart cover systems can detect this multidimensional degradation simply by monitoring ambient temperature. They are unable to assess the risks, and this situation reduces or completely eliminates user effectiveness. 30 This can lead to the unwitting use of defective insulin. More importantly, the existing Single-sensor systems provide an alarm directly at any short-term temperature deviation. This leads to false alarms, which in turn causes alarm fatigue in the user. This reduces confidence in the system and can lead to carelessness in critical situations. The systems detect physical deterioration of the drug in advance and inform the user only of the storage requirements. 35 not conditional information, but clear decision support regarding the safety of the drug before use. It lacks a holistic structure. These comprehensive deficiencies lead to a loss of glycemic control and hyperglycemia. 3 attacks and, in the long term, serious microvascular and macrovascular complications associated with diabetes It emerges as a significant risk factor that paves the way for its development. This invention aims to fill all these critical gaps and limitations in existing technologies. It aims to analyze not only temperature data, but also the level of UV / light exposure simultaneously. freeze-thaw cycles, shock and impact data, and optical cloudiness in the cartridge contents. By offering an advanced sensor network that analyzes permeability changes together, it reduces the loss of drug efficacy. It presents a system that assesses the risk in a multifaceted way. This is a multi-faceted validation system. This approach rejects making decisions based solely on any single sensor data point and relies only on that data. Simultaneous verification of multiple indicators of deterioration and predetermined threshold values ​​of 10 If both are exceeded, the user is given a message indicating "usable", "risky use" or "should not be used". By providing clear decision support in this way, it minimizes the risk of false alarms. In this way, the invention, Improving treatment safety for diabetic patients and significantly increasing the predictability of insulin therapy. It offers an innovative solution aimed at significant improvement. Patent document CN114028646A describes a network-based wireless insulin pump. The text refers to an information monitoring system. The invention is in the field of insulin pump technology and is a The pump housing includes an electrical control unit, a blood glucose statistics module, and insulin. It offers a system equipped with injection quantity monitoring features. The system has a communication network. By transmitting the patient's blood sugar data and insulin injection information to the central unit, 20 It provides remote monitoring capabilities. This system primarily monitors the operation of the insulin pump. It focuses on the wireless transmission of parameters and patient biometric data. any assessment of the risk of the drug itself deteriorating due to environmental factors It does not include a sensor system. In the present invention, however, data transmission over a communication network is performed. Furthermore, temperature, light, mechanical impact, and optical 25 threaten the physical integrity of insulin. Multiple parameters such as changes are monitored simultaneously, and the risk of loss of drug effectiveness is assessed. It is evaluated using a holistic approach. Patent document CN119785523A describes a wireless technology-based insulin pump. The text refers to a safety reminder system. The invention is in the field of medical equipment technology and is 30 years old. It consists of an insulin pump end module and a chamber end module. The system delivers insulin. the pump's suitability for challenging environments such as strong magnetic fields, strong radiation, and high-pressure environments. It aims to solve security issues in its use under these conditions and through automated monitoring. It provides timely warning. This invention addresses the effects of external environmental conditions on the pump. While focusing on this, the current invention addresses a much broader range of 35 issues that cause the insulin medication itself to degrade. a range of environmental and mechanical factors (UV exposure, freeze-thaw cycles, 4 It analyzes (shaking, optical blurring) and not only gives a warning but also indicates the drug's It provides a decision support mechanism regarding its usability. Patent document CN116350882A describes an insulin capable of precise drug delivery. The invention describes a pump and its method of use. The invention includes a monitoring sensor and 5 via a catheter system in which an air tube and a drug tube are arranged side-by-side, wirelessly enabling real-time monitoring of the insulin pump through its components and pipeline. It offers a system capable of detecting blockages. The invention relates to the mechanical functionality of the pump and While focusing on detecting physical obstructions in the drug delivery pipeline, the current invention enables insulin delivery. chemical and physical deteriorations occurring in it (protein aggregation, optical 10 by sensing (such as changes in density) directly through the cartridge containing the drug, and thus monitoring delivery. It assesses the risk of drug efficacy loss, independently of the system. Patent document CN106362238A describes a new cloud-based smart insulin pump system. It is mentioned that the invention consists of a smart insulin pump body, a cloud storage station, and a 15 It includes a remote monitoring terminal, a smart insulin pump body, a controller, and an enzyme. electrode sensor, a wireless module, a keypad module, a liquid crystal module, and an alarm module It includes a system that transmits the patient's physiological data via the cloud and enables remote monitoring. This system focuses on blood glucose measurement and data transmission, while offering the possibility of... The invention directly detects environmental stressors to which the drug itself is exposed using multiple sensors. by sensing whether the biological activity of the drug is preserved based on objective criteria. It identifies and provides the user with actionable decision support. Patent document CN121534255A describes a smart insulin closed-loop system for type 1 diabetes. The infusion system is being discussed. The invention is in the field of diabetes treatment equipment technology and is 25 years old. It includes a blood glucose monitoring module, a control module, an insulin infusion module, and a user module. The interaction module includes a wireless communication module and a power module, and the insulin is switched off. The circuit performs precise infusion. The invention automates insulin delivery and While building upon its sensitivity, the current invention focuses on the stage before insulin delivery, where the drug is released. the risk of deterioration due to factors to which it is exposed during storage and transportation 30 by analyzing it, the aim is to ensure the safety of the drug before infusion, and this It offers a layer of protection that sets it apart from existing systems. Patent document number CN215690561U describes a remote control for an insulin pump. It is mentioned. The invention is in the field of remote-controlled insulin pump technology and is 35. It includes a pump housing and a sensing platform connected wirelessly; the pump body, a power supply module, a treatment mechanism, blood glucose detection equipment and It includes a control unit. While the invention aims to solve the data monitoring problem, the present invention... Rather than monitoring blood sugar levels, the physicochemical properties of the insulin medication itself... monitoring whether protection is maintained and, in this context, whether the drug is directly used by the user. changes in the optical and physical properties (such as blurring and color change) that can be seen in the lens. It offers an advanced system that detects using sensor data. 5 Patent document number CN121490185A describes a closed-loop, non-invasive insulin detection system. The invention refers to a precision infusion system. It is a blood glucose monitoring regulator and... It includes a non-invasive syringe, and provides trend prediction and individualized dose determination through blood. It improves the accuracy of blood sugar monitoring and the timing of insulin administration; wireless 10 By providing data transmission, remote monitoring and intelligent management, it helps diabetic patients monitor their blood sugar levels. This system enhances the convenience, accuracy, and reliability of its management. This non-invasive system... While focusing on monitoring and dose optimization, the present invention delivers the drug using a non-invasive method. It detects physical deterioration (protein denaturation, aggregation) with optical and thermal sensors. By analyzing directly and simultaneously, it is determined whether the drug is "usable" before deciding on the dosage. It provides crucial background information indicating that it is not the case. Patent document CN121401540A describes an alarm system and alarm for an insulin pump. The method is being discussed. The invention is in the field of medical device monitoring technology and concerns insulin. located inside the pump and wirelessly connected to the user via a Bluetooth module 20 It includes a microprocessor that communicates with the system. The system provides alerts regarding the pump's operating status. This invention focuses on operational warnings of the pump, while the present invention is singular. It operates with a multi-validation logic that filters out false alarms caused by sensor errors. and only if multiple degradation criteria come together, the user By providing information, it offers a much more reliable and clear warning mechanism regarding drug safety. 25 Patent document US2012302991A1 (B2) describes an infusion with additional modules. The invention refers to a pump designed to convey a liquid. a wireless communication port and an open standard wireless communication protocol It offers a device that communicates using a sliding mechanism. The housing slides into place with a second device, 30 inches. It involves a mechanical connection for interlocking, and this connection is the first and second communication. It enables the positioning of the connection points. This invention allows the pump to be modular. While focusing on expandability and communication protocols, the present invention is fixed or modular. Regardless of the structure, it directly delivers the drug through its integrated multiple sensors (optical, temperature, acceleration). By collecting data from the cartridge in which it is located, the total environmental load to which the drug is exposed is analyzed. 35 It is a holistic system. 6 Patent document number JP2017192760A (B2) describes a pen-type injection device and for this purpose. An electronic clip-on module is being described. The invention allows the patient to receive their next injection. This invention includes a system that can suggest the type and / or dosage of insulin. This invention provides dose reminder and... While focusing on the proposition function, the present invention addresses not only dose management but also the use of the drug. Direct decision support regarding suitability such as "usable", "risky" or "should not be used" 5 An advanced risk assessment that provides warnings and bases these decisions on data from multiple sensors. It has a system. In patent document CA3025902A1 (C), control safety measures according to a range (Control-to-Range Failsafes) is mentioned. The invention relates to a continuous glucose monitoring system, 10 taking into account changes in insulin sensitivity or inaccurate glucose measurements in a person with diabetes Methods and systems for determining basal insulin rate adjustment to include This invention encompasses the adjustment of dose dynamics based on blood glucose data. While focusing on the current invention, the study examines not the effect of insulin within the body, but the structural characteristics of the drug itself. whether it maintains its integrity and biological activity, and external factors during storage and transport. It evaluates factors based on various factors and uses a different technique that focuses on the safety of the drug itself. It targets the area. Patent document US2015246179A1 describes integration, particularly with smartphone applications. 20 devices and methods for drug dosing with insulin pen application monitoring. The invention is described as comprising a controller, sensors, a wireless transceiver, and a memory unit. It includes a handheld drug delivery unit. This system facilitates the administration of the drug. While focusing on monitoring and dose recording, the present invention aims to track the drug before it is administered. The drug's exposure to parameters such as temperature, light, impact, and optical changes in the environment where it is stored 25 that evaluates its stability and provides this evaluation to the user with clear decision support messages. It is a protective system that goes beyond application monitoring. In patent document CA3025906A1, control-to-aggressiveness is described as varying according to range. Range Aggressiveness is mentioned. The invention concerns basal glucose monitoring in a continuous glucose monitoring system. This invention presents a method and system for determining insulin rate regulation. This invention applies to glucose 30 how aggressive insulin delivery needs to be in order to keep the level within the target range While focusing on algorithms, the current invention, regardless of the drug's delivery parameters, allows the drug to be delivered. by detecting its physical degradation level through multiple verification processes, thus enabling pre-transmission. It ensures drug safety and introduces a complementary and unique innovation. 35 Investigations revealed that insulin pens and cartridge systems used in the treatment of diabetes... Existing smart capping and monitoring systems for this purpose largely depend on the storage temperature of the drug. 7 It is limited to the principle of passive monitoring and time-based alerts based on this data. It appears that these systems mostly consist of only a sensor that measures ambient temperature. This includes UV / light exposure and freeze-thaw cycles, which can cause a loss of effectiveness of the drug. other critical environmental factors such as mechanical shocks and vibrations that occur during transportation This completely ignores the physical aspect of insulin. This one-dimensional approach in current systems completely disregards the physical aspect of insulin. This leads to the failure to evaluate numerous parameters that threaten its integrity; for example, Photooxidation caused by direct exposure of the drug to sunlight, repeated freeze-thaw cycles protein denaturation occurring through cycles or aggregation caused by intense vibration Such degradation mechanisms cannot be identified. However, these systems, By giving an alarm directly in case of any short-term temperature deviation, it prevents false alarms. This causes alarm fatigue in the user, which in turn undermines the system's reliability and user experience. This undermines trust. Furthermore, these systems only provide information on the storage conditions of the medication. The user is provided with information regarding the safety of the drug before use, such as "usable," "risky use," or... It fails to provide a clear decision support mechanism such as "should not be used". This invention, To eliminate all these technical shortcomings and limitations of existing systems, 15 It has been improved and takes into account not only temperature data, but also UV / light exposure level, freezing- Dissolution cycle, shock and impact data, and optical turbidity and transmittance in the cartridge contents. The invention presents a multi-sensor based integrated system that analyzes changes together. Not making decisions based on any single sensor data, but only on multiple disturbances. Simultaneous verification of the indicator and simultaneous exceeding of predetermined threshold values ​​20 In this case, the user is given a classification of "usable", "risky use" or "should not be used". It includes an advanced multi-factor authentication algorithm that provides a security notification. This allows... The risk of false alarms is minimized, errors originating from individual sensors are filtered, and the physical characteristics of the drug are assessed. The risk of deterioration, environmental and mechanical factors are evaluated holistically before the drug is presented to the user. Accurate and actionable decision support is provided regarding suitability for use. 25 Ultimately, the problems mentioned above, which cannot be solved with the current technology, are related to the technical aspects. This has made it necessary to make an innovation in the field. BRIEF DESCRIPTION OF THE INVENTION 30 The present invention is a multi-faceted system developed to eliminate the aforementioned technical shortcomings. It relates to sensor-based smart insulin capping systems. The main purpose of the invention is to improve insulin pens and cartridge medications used in the treatment of diabetes. in systems that assess the risk of drug efficacy loss before use, using multi-sensor technology. The aim is to offer an integrated security system. This will eliminate the traditional 35-bit security system that relies solely on temperature data. Unlike monitoring methods, UV / light exposure threatens the physical integrity of insulin. 8 Numerous parameters such as freeze-thaw cycles, mechanical shock, and optical opacity are compared. By analyzing the drug over time, the risk of drug degradation is assessed using a holistic approach, and Thus, unknowingly using insulin with reduced effectiveness can lead to loss of glycemic control and serious consequences. The risk of health complications is minimized. Another aim of the invention is to improve decision-making based on individual sensor data in existing systems. The false alarm problem caused by this principle can be solved with an advanced multi-verification algorithm. The aim is to eliminate this. In this way, any short-term temperature fluctuation or single-term deviation is avoided. The temporary change in the parameter does not directly translate into a warning; only the temperature history, optical turbidity, UV exposure and mechanical stress data together with predetermined threshold values. If verified, a security notification will be generated for the user, preventing alarm fatigue. This improves the system's reliability. Another aim of the invention is to protect the environmental and other factors to which the drug is exposed during storage and transportation. By analyzing mechanical factors together, the user is informed about the suitability of the drug for use. Clear and actionable decision support in the form of "usable", "risky use" or "should not be used". This is to provide the user with only raw sensor data or storage condition information. 15 It is not left unattended; a definitive warning regarding the safety of the drug has been interpreted and classified. By doing so, they can make more informed and safer treatment decisions. Another aim of the invention is to address protein aggregation, which causes the physical degradation of insulin, and chemical changes such as denaturation, optical transmittance and turbidity in the cartridge contents This involves indirectly detecting the change through a sensor module that analyzes it. In this way, 20 Microscopic alterations in the drug's structure are invisible to the user's naked eye. Even at these stages, the drug's biological activity is preserved by detection by sensors. It is determined based on objective criteria that it is not protected, and thus has suffered a loss of effectiveness. The use of insulin is prevented beforehand. Another aim of the invention is to detect sudden vibrations (shocks) that occur during transport using a motion / vibration sensor (accelerometer). mechanical stress by monitoring the risk of protein degradation caused by impacts, falls, or intense vibration. The aim is to evaluate the negative effects on drug stability. This is especially important for those traveling or using medication. insoluble insulin caused by physical trauma during daily transport. By identifying the risk of aggregate formation and loss of activity, the user is informed that the drug is susceptible to such mechanical factors. They are warned to be careful in situations where they are exposed to such things. 30 Another objective of the invention is to assess the risk of sudden temperature drops and freeze-thaw cycles using a freeze-thaw risk assessment module. By analyzing the history of recurrent thermal stress, insulin levels below freezing were determined. the reaction that occurs when exposed to high temperatures and then thawed again 9 The aim is to determine the risk of irreversible protein denaturation. This allows us to identify such risks, especially during winter months or... due to the freeze-thaw cycles that insulin may be subjected to when transported in cold weather conditions By detecting the loss of efficacy in advance, the use of such thermally stressed medication is prevented. Another purpose of the invention is to detect direct sunlight or harmful light using a UV / light exposure sensor. By sensing the exposure time, it leads to photooxidation and aggregation of insulin proteins. 5 The aim is to minimize the risk of degradation caused by light exposure. This ensures the drug is protected from sunlight or artificial light. Loss of biological activity is detected as a result of prolonged exposure to light sources. And the user is given a clear warning that the medication should not be stored in such environments. Another aim of the invention is to process data from all sensor modules into a central microprocessor. By combining them, it filters out false alarms caused by individual sensor errors and only 10 A decision that informs the user when multiple risk criteria are met simultaneously. The goal is to provide an algorithm. This optimizes the system's specificity and sensitivity, eliminating unnecessary elements. While user dissatisfaction and loss of trust caused by warnings are avoided, a real risk is eliminated. This ensures that timely and accurate intervention is possible in such situations. Another purpose of the invention is to provide a user alert interface with LED, audible alert, vibration or screen 15 By informing the user about the safety status of the drug through different sensory channels The aim is to transmit information effectively and quickly through this medium. In this way, visually impaired or hearing impaired individuals can communicate effectively and quickly. Even individuals can perceive the warnings; moreover, the combined use of audible and vibrating alerts can be critical. In these situations, the user's attention is drawn more effectively. Another aim of the invention is to integrate the user's medication storage history into a mobile application, 20 by enabling users to view risk levels and recommendations through a digital platform, for long-term The aim is to facilitate the long-term management and monitoring of medication. This allows the user to understand the effects of their medication on their condition. We can access the history of environmental conditions, observe trends of deterioration over time, and By sharing data with the treatment team, they can achieve more informed diabetes management. Another purpose of the invention is to record data and historical memory, as well as the environmental conditions to which the drug is exposed. by storing them for a certain period of time, allowing for retrospective review of drug safety when needed. The aim is to provide an opportunity. In this way, in case of any adverse health situation or unexpected events... In the case of glycemic response, the history of environmental conditions to which the insulin used was exposed. By examining the situation, it can be determined whether the problem is related to drug spoilage. Another purpose of the invention is to provide a rechargeable battery or replaceable low-power energy supply. 30 By providing this module, the system ensures uninterrupted and long-term operation, offering the user practical and convenient solutions. The aim is to offer a portable structure. This makes the system suitable for daily use and energy efficient. It is designed as a high-performance device that can be used comfortably in any environment, allowing the user to charge it. or being able to monitor drug safety for extended periods without worrying about battery replacement It allows. Another aim of the invention is to replace existing systems that only monitor temperature or provide dosage reminders. Unlike the caps, the possibility of physical degradation of the drug is assessed using multiple sensor data and combined risk. By offering a system that evaluates before use with an evaluation algorithm, diabetes 5 The goal is to achieve significant technical progress in terms of drug safety and efficacy in drug management. In this way, it reduces false alarms caused by a single sensor, without creating a false sense of security in the patient, and A superior safety mechanism is offered that minimizes the risk of clinical complications. All the purposes mentioned above and those that will emerge from the detailed explanation below. The present invention aims to realize insulin pens and cartridges used in the treatment of diabetes. Multi-sensor based systems for evaluating the risk of drug efficacy loss before use in drug management. It relates to an intelligent decision support system. This system involves at least one insulin injection facility where the medication is located. A carrier body is attached to the pen or medication cartridge and functions as a protective and sensor carrier. the temperature history to which the drug was exposed, located within the aforementioned carrier body. and a Temperature Sensor that measures sudden temperature changes, 15 within the aforementioned Carrier Body. the position and the duration of direct sunlight or harmful light exposure to which the drug is exposed A UV light sensor, which detects insulin, is located within the aforementioned carrier body. changes in protein structure, turbidity, or optical density occurring within it An Optical Analysis Module, which performs the analysis, is located within the aforementioned Carrier Body and 20 a motion sensor, located within the aforementioned carrier body and mentioned Working in conjunction with the temperature sensor, it tracks sudden temperature drops and recurring thermal stress patterns. A Freeze-Thaw Assessment Module analyzes the aforementioned Carrier Body. located within it are the aforementioned Temperature Sensor and UV Light Sensor, The aforementioned Optical Analysis Module, the aforementioned Motion Sensor, and the aforementioned Freeze-Thaw 25 By simultaneously processing data from the Evaluation Module, it is linked to individual sensor data. A Processor Unit that generates a risk score using a non-decisive multi-validation logic, The drug's availability is determined according to the risk score generated by the aforementioned Processing Unit. A Risk Classifier classifies risks as risky to use or should not be used. The drug status determined by the classifier is displayed via LED, audible alert, vibration or screen on 30 a User Interface that communicates to the user, located within the aforementioned Carrier Body and the aforementioned Temperature Sensor, the aforementioned UV Light Sensor, the aforementioned Optical Analysis Module, from the aforementioned Motion Sensor and the aforementioned Freeze-Thaw Assessment Module data and the risk level generated by the aforementioned Risk Classifier over a specific period a Data Storage Unit that stores, 35 drugs stored in the aforementioned Data Storage Unit Allows the user to view storage history, risk level, and recommendations. 11 a Mobile Integration Module and located within the aforementioned Carrier Body, and The aforementioned Temperature Sensor, the aforementioned UV Light Sensor, the aforementioned Optical Analysis Module, The aforementioned Motion Sensor, the aforementioned Freeze-Thaw Evaluation Module, the aforementioned Processor Unit, Risk Classifier mentioned, User Interface mentioned, Data mentioned A Power 5 provides power to the Storage Unit and the aforementioned Mobile Integration Module. It includes the source. The best way to utilize the advantages of the existing invention, together with its structure and additional elements. For it to be understood, it must be considered together with the figures explained below. BRIEF DESCRIPTION OF THE FIGURES 10 Figure 1: Schematic view of a multi-sensor based smart insulin valve system. REFERENCE NUMBERS 1. Carrier Body 11. Temperature Sensor 15 12. UV Light Sensor 13. Optical Analysis Module 14. Motion Sensor 15. Freeze-Thaw Assessment Module 16. Processor Unit 20 17. Risk Classifier 18. User Interface 19. Data Storage Unit 20. Mobile Integration Module 21. Power Supply 25 DETAILED DESCRIPTION OF THE INVENTION This detailed explanation focuses solely on the innovation in the invention to provide a better understanding of the subject matter. This is conveyed without being limited to examples. Accordingly, in the following explanations and figures, Privacy-focused mobile access system with adaptive braille interface for visually impaired individuals 30 It is explained. Figure 1 shows privacy-focused mobile access with adaptive braille interface for visually impaired individuals. This is a schematic view of the system. Accordingly, the system is: 12 • A protective and sensor carrier that attaches to an insulin pen or medication cartridge containing the medication. a Carrier Body (1) which functions as • The temperature to which the drug is exposed, located inside the aforementioned Carrier Body (1) A Temperature Sensor (11) that measures past and sudden temperature changes, • Positioned inside the mentioned Carrier Body (1) and exposed to direct sunlight 5 A UV Light Sensor (12) that detects light or the duration of exposure to harmful light. • Located within the aforementioned Carrier Body (1) and occurring in the insulin content An optical analyzer that analyzes changes in protein structure, turbidity, or optical density. Module (13), • Positioned inside the aforementioned Carrier Body (1) and subjected to excessive impact during transport, 10 A Motion Sensor (14) monitors the risk of malfunction caused by falling or intense vibration, • The mentioned Temperature Sensor (11) is located inside the aforementioned Carrier Body (1) working together to analyze the history of sudden temperature drops and recurring thermal stress a Freeze-Thaw Assessment Module (15), • The mentioned Temperature Sensor 15 is located inside the aforementioned Carrier Body (1). (11), mentioned UV Light Sensor (12), mentioned Optical Analysis Module (13), mentioned From the Motion Sensor (14) and the aforementioned Freeze-Thaw Assessment Module (15) By processing data simultaneously, it creates a multi-sensor system that doesn't make decisions based on single sensor data. A Processor Unit (16) that generates a risk score with verification logic, • According to the risk score generated by the mentioned Processing Unit (16), the status of the drug is 20 A Risk Classifier (17) classifies as usable, risky use or should not be used, • Drug status determined by the aforementioned Risk Classifier (17) is indicated by LED, audible warning, A User Interface (18) that transmits to the user via vibration or screen, • The mentioned Temperature Sensor located inside the mentioned Carrier Housing (1) (11), the mentioned UV Light Sensor (12), the mentioned Optical Analysis Module (13), the mentioned 25 From the Motion Sensor (14) and the aforementioned Freeze-Thaw Assessment Module (15) data and the risk level generated by the aforementioned Risk Classifier (17) for a specific period of time a Data Storage Unit (19) that stores • Drug storage history, risk level and stored in the aforementioned Data Storage Unit (19) A Mobile Integration Module (20) and 30 that allows the user to view the suggestions 13 • Located within the aforementioned Carrier Body (1) and providing electrical energy a Power Supply (21) that makes the system work It includes. The invention relates to the delivery of 5 doses of insulin in insulin pens and cartridge drug delivery systems used in the treatment of diabetes. Multi-sensor based intelligent decision support that assesses the risk of loss of effectiveness before use. It is a system and its working principle is the sensor modules integrated inside the Carrier Body (1). based on the principle of simultaneous data collection and processing of this data using a multi-factor authentication logic. The system is based on the Carrier Body (1) being attached to an insulin pen or drug cartridge. It is automatically activated by plugging it in and at this stage the Power Supply (21) mentioned 10 Temperature Sensor (11), UV Light Sensor (12), located inside the Carrier Body (1), Optical Analysis Module (13), Motion Sensor (14), Freeze-Thaw Evaluation Module (15), Processor Unit (16), Risk Classifier (17), User Interface (18), Data Storage Unit (19) and By supplying electrical energy to the Mobile Integration Module (20), the system can operate. In the activated system, the Temperature Sensor (11) records the temperature history to which the drug has been exposed and 15 When measuring sudden temperature changes, the UV Light Sensor (12) can detect direct sunlight or harmful light. The Motion Sensor (14) detects the exposure time, excessive impact, fall or during transport. It monitors the risk of degradation due to intense vibration and the Optical Analysis Module (13) in the insulin content. It analyzes any changes in protein structure, turbidity, or optical density that occur. Temperature Sensor (11), UV Light Sensor (12), Optical Analysis Module (13) and Motion Sensor 20 Data from (14) are referred to by the Freeze-Thaw Assessment Module (15). By evaluating the Temperature Sensor (11) data together with the sudden temperature drops and recurring The thermal stress history is analyzed and all this sensor data is transmitted to the Processor Unit (16). Processor Unit (16), mentioned Temperature Sensor (11), mentioned UV Light Sensor (12), mentioned Optical Analysis Module (13), the aforementioned Motion Sensor (14) and the aforementioned Freeze-Thaw 25 It processes the data from the Evaluation Module (15) simultaneously and any individual It generates a risk score using a multi-validation logic that does not make decisions based solely on sensor data. This generated risk score is transmitted to the Risk Classifier (17), where the status of the drug is determined beforehand. It can be used if the specified threshold values ​​are exceeded simultaneously, for risky use or It is classified as not to be used. The drug status determined by the Risk Classifier (17) is 30 The information is transmitted to the User Interface (18) and is displayed via LED, audible alert, vibration or screen. The user is notified. Simultaneously, the Temperature Sensor (11), UV Light Sensor (12), Optical Analyzer From Module (13), Motion Sensor (14) and Freeze-Thaw Assessment Module (15) Risk level created by Risk Classifier (17) with data, Data Storage Unit (19) is stored for a certain period of time and the aforementioned Data 35 is transmitted via the Mobile Integration Module (20). The drug storage history, risk level and recommendations stored in the Storage Unit (19) are provided to the user. It allows viewing.

Claims

14 REQUESTS 1. It is a multi-sensor based smart insulin capping system, the feature of which is: • A protective cover and sensor attached to an insulin pen or medication cartridge containing the medication. a Carrier Body (1) which functions as a carrier, • The temperature to which the drug is exposed is 5 located inside the aforementioned Carrier Body (1). A Temperature Sensor (11) that measures past and sudden temperature changes, • Located within the aforementioned Carrier Body (1) and the direct exposure of the drug A UV Light Sensor (12) that detects the duration of exposure to sunlight or harmful light. • Located within the aforementioned Carrier Body (1) and containing insulin. 10 that analyze incoming protein structure changes, turbidity or optical density changes an Optical Analysis Module (13), • Located inside the aforementioned Carrier Body (1) and excessive during transport A motion sensor that monitors the risk of malfunction due to impact, falls, or intense vibration. (14), • Located within the aforementioned Carrier Body (1) and the aforementioned Temperature 15 Working together with its sensor (11), it detects sudden temperature drops and repetitive thermal stresses. A Freeze-Thaw Assessment Module (15) that analyzes its history, • Located within the aforementioned Carrier Body (1) and the aforementioned Temperature Sensor (11), mentioned UV Light Sensor (12), mentioned Optical Analysis Module (13), The aforementioned Motion Sensor (14) and the aforementioned Freeze-Thaw Assessment 20 By processing the data from module (15) simultaneously, it is connected to the single sensor data. A Processor Unit that generates a risk score using a non-decisive multi-validation logic. (16), • The status of the drug according to the risk score generated by the aforementioned Processing Unit (16) Risk 25 classifies usage as usable, risky, or not to be used. Classifier (17), • Drug status determined by the aforementioned Risk Classifier (17) is indicated by LED, audible warning, A User Interface (18) that transmits to the user via vibration or screen, • Located within the aforementioned Carrier Body (1) and the aforementioned Temperature Sensor (11), mentioned UV Light Sensor (12), mentioned Optical Analysis Module (13), 30 The aforementioned Motion Sensor (14) and the aforementioned Freeze-Thaw Assessment Data from Module (15) and by the aforementioned Risk Classifier (17) A Data Storage Unit (19) that stores the created risk level for a certain period of time. • Drug storage history, risk information stored in the mentioned Data Storage Unit (19). Mobile 5 allows the user to view the level and recommendations. Integration Module (20) and • Located within the aforementioned Carrier Body (1) and providing electrical energy a Power Supply (21) that makes the system work It is characterized by its inclusion. 15 25 35

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