SMART SHUNT SYSTEM PROVIDING SENSOR-BASED CONTROLLED DRUG RELEASE.

Abstract

The invention encompasses an improved intelligent shunt system incorporating integrated sensor, decision, and drug release modules that detect infection risk early in shunt systems used for cerebrospinal fluid drainage and, based on this risk, deliver controlled local antimicrobial agents within physician approval and safety limits.

Description

1 TARIFF SMART SHUNT SYSTEM PROVIDING SENSOR-BASED CONTROLLED DRUG RELEASE. TECHNICAL FIELD The invention reduces the risk of infection in shunt systems used for cerebrospinal fluid drainage in the early 5 months. Detection during this period and, depending on this risk, controlled access with physician approval and within safety limits. an integrated sensor that performs local antimicrobial release, including decision and drug release modules. It includes an improved smart shunt system. The invention specifically concerns the conventional shunt used in the treatment of hydrocephalus in the field of neurosurgery. due to the passive drainage principle-based working structure of these systems and the infection of these systems solving technical problems arising from insufficient intervention capabilities in the face of development It is an innovative smart implant system aimed at... In current technology, shunt infections are common. Diagnosis is made after the appearance of clinical findings, and this delay leads to biofilm formation. serious clinical consequences such as surgical removal of the device and the need for reoperation 15 This can lead to complications. Currently used antibiotic-impregnated catheters or antimicrobials Coatings, on the other hand, are fixed in effect, but provide real-time data monitoring and situation-specific response capabilities. It does not offer this. This is where the current invention comes in, shunt body or cerebrospinal fluid flow pH, lactate, and inflammation can be monitored via at least one biosensor module integrated into the bloodstream. By continuously or periodically measuring parameters that indicate infection, such as these markers, these 20 It includes a decision unit that processes the data and generates an infection risk level. This decision unit The risk level created by the system is kept off by default. By triggering the microvalve control mechanism, it only activates when the defined risk threshold is exceeded and the same an antimicrobial release that becomes active only after obtaining timely physician approval. It manages the module. The system also handles false positives or physician interventions. It is equipped with a safety architecture that activates when necessary; single dose limit, It incorporates fail-safe mechanisms such as a daily total emission limit and manual interlocking. It contains these features. In addition, the biofilm-preventing surface structure located on the shunt surface is passive. While providing protection, the integrated structure consisting of the aforementioned sensor, decision and release modules is active. 30 by offering an intervention mechanism that combines passive and active protection in the same implant architecture It presents a technical solution. PREVIOUS TECHNIQUE Used in neurosurgical practice to treat hydrocephalus and intracranial pressure disorders. Conventional shunt systems are mechanical implants that operate primarily on the principle of passive drainage. 35 These are devices. These systems generally use biocompatible polymers such as silicone or polyurethane. 2 a network of catheters made of various materials and pressure gauges positioned between these catheters It includes a passive valve mechanism that opens and closes depending on the difference. The ventricular catheter, Cerebrospinal fluid is taken from the ventricular region and transmitted through a distal catheter to the peritoneum, atrium, or It directs pressure to body cavities such as the pleural cavity, and the valve system has a specific pressure threshold. When exceeded, it prevents backflow by ensuring the unidirectional flow of the fluid. However, this passive structure, 5 Any diagnostic, monitoring, or therapeutic intervention capability beyond basic drainage function. It does not offer this. Therefore, shunt infections and the resulting biofilm formation are preventable. Critical complications such as fever, signs of meningeal irritation, or device obstruction can occur. It can only be diagnosed after advanced clinical symptoms such as these appear. Current techniques include various approaches to preventing or treating shunt infections. These have been developed. The most common of these are antibiotic-impregnated or antimicrobial agents-containing. This involves the use of coated catheters. These coatings are applied using rifampicin, clindamycin, or silver ions. It contains substances such as these, which promote the multiplication of microorganisms that adhere to the device surface. It aims to prevent or delay. However, such coatings have a constant effect of 15 They are temporary, but they wear out and lose their effectiveness over time. Furthermore, these coatings are only... It provides passive protection and is not affected by changes in cerebrospinal fluid parameters or a dynamic response depending on early biochemical markers of infection They are unable to produce microorganisms. Surface modifications, however, allow microorganisms to adhere to the device surface. 20 However, these approaches also cannot completely prevent the development of infection and biofilm formation. It becomes ineffective when it starts. Systemic antibiotic prophylaxis or therapy is another approach in managing the infection. This method appears as such, but due to the blood-brain barrier, the brain and spinal cord 25 inability to achieve sufficient therapeutic concentration in the fluid, high dose requirements, and It has significant disadvantages, such as systemic side effects. Local antimicrobial applications, on the other hand... usually a single bolus injection during or after device implantation This is done in this way, and these practices ensure a sustainable drug concentration in the target region. It does not provide protection and does not offer long-term protection where the risk of infection persists. 30 The common thread running through all these approaches is the early detection of infection. They lack a real-time monitoring mechanism. The pH in the cerebrospinal fluid, in biochemical parameters such as lactate, glucose, protein, or specific inflammatory cytokines Although these changes are early indicators of infection development, the current shunt 35 Their systems do not have any integrated sensors that measure these parameters. Therefore, 3 These early signals indicating a risk of infection are not being evaluated, and clinical findings are not emerging. No intervention can be made until it comes out. In this context, the main technical problems encountered in the current technique are as follows: brain and spinal cord. Sensor 5 monitors the liquid parameters on the device in real time or periodically. The absence of a base structure that assesses the infection risk level based on measured data. The lack of decision-making logic means that when the risk of infection arises, a local and controlled antimicrobial response is necessary. The absence of an integrated intervention module that initiates release and the need for physician approval and dose for release The problem is that it is not managed within a fault-tolerant security architecture with limits. Furthermore, passive biofilm... Preventive surface protection and active local intervention together within the same implant system. 10 There is no integrated solution available that it can work with. This invention aims to solve these technical problems. The invention involves a shunt structure or a brain Indicates infection via a sensor module integrated into the cerebrospinal fluid flow line. By monitoring the parameters in the early stages, an infection risk can be determined based on the data obtained. It presents a decision-making unit that constitutes a level. Depending on this risk level, the default is closed. working in that location and only active when both the defined risk threshold and physician approval are met. A controlled local antimicrobial release module is activated. The system also, fail-safe features such as single dose limit, total daily release limit and manual interlock. It is equipped with mechanisms. This integrated structure combines passive biofilm-preventing surface protection with active 20 Combining local intervention with the same implant architecture to address shortcomings in the current technique. It offers an innovative solution. Patent document number US2022133410A1 describes ventriculostomy in neurosurgical operations. In shunt and craniotomy procedures, cranial tomography and / or magnetic resonance imaging are used. 25 AI-based system for determining optimal hole locations using patient photos The system is being discussed. The invention identifies the most suitable points for drilling operations on the skull. It offers a decision support system for determining this, using image processing and artificial intelligence. It assists in surgical planning through algorithms. In the present invention, surgical Unlike an external system for planning, the shunt has 30 integrated into its own structure. It has sensors and a controlled drug release mechanism, providing active protection against infection risk. An autonomous intervention capability is offered. Patent document number CN222445130U describes a device containing a hollow, soft metal channel, and this channel 35 equipped with a second shunt pipe having at least one fold in the lengthwise direction A neurosurgical shunt device is being discussed. The invention is aimed at the growth and development of pediatric patients. by allowing adaptive adjustment of the shunt tube length during the process, the body 4 the problem of the shunt becoming relatively short and requiring re-operation depending on its development It aims to solve this. In the present invention, however, rather than mechanical length adjustment of the shunt, early detection of infection risk and consequently controlled antimicrobial release An integrated system is offered, providing an active therapeutic approach as opposed to passive mechanical adaptation. Intervention capability is provided. 5 Patent document number CN211327199U describes a negative pressure device, a drainage device, and a speed control device. The invention refers to a neurosurgical drainage device containing a drainage line component. a speed adjustment mechanism located on it and a micro located in the drainage area It aims to increase drainage efficiency through a vibrating element. In the present invention, 10 Unlike simply adjusting the mechanical drainage rate, it measures cerebrospinal fluid parameters. There are sensors and a decision-making unit that determines the risk of infection based on this data, and it is passive. Beyond its drainage function, it offers active diagnostic and therapeutic capabilities. Patent document number CN216456274U describes drainage within a ring fixed to the base. two separate shunt pipes, each containing a box and connected to each other by a T-shaped pipe. The invention describes a controllable, dual-chamber neurosurgical drainage device. The device is a drainage system. It allows for the independent control of two separate shunt pipes, depending on the need. It provides... In the present invention, however, it differs from the mechanical control of multiple drainage lines. as such, an autonomous risk assessment based on infection parameters and physician 20 A controlled drug release system is integrated, operating with approval, and features passive drainage. It offers functionality far beyond mere control. Patent document number CN203724609U describes a device used in neurosurgery for the treatment of hydrocephalus. Made of elastic material, it contains two one-way valves and holds a liquid with a volume of 2.6 ml. from volume control type ventriculoperitoneal shunt tube with storage balloon It is mentioned that the invention involves applying a specific number of manual pressures daily, depending on the patient's condition. the procedure involves directing an appropriate amount of cerebrospinal fluid into the abdominal cavity. This provides a different approach than passive fluid control based on manual intervention in the present invention. It autonomously assesses risk based on sensor data and, with physician approval, 30 An integrated system that delivers controlled antimicrobial release is offered, preventing infection. An active approach is being taken towards its management. Patent document number CN211187571U describes the base, air pump number one, and shunt air. 35 containing a tube and electromagnetic valve, intended for stabilizing the patient's head during surgery. A neurosurgical detection device is being described. The invention involves the positioning of the patient's head and It includes pneumatic and mechanical elements for fixation. In the present invention, however, surgical Unlike an external fixation device for positioning, the implantable shunt itself It has the capability to monitor and intervene in infections, but not during surgery. A smart system that functions actively after implantation is presented. Patent document number CN205339672U describes the base, support, controller, connecting rod, and drain. In addition to the bag, connecting tube and drainage tube, it also includes an intracranial pressure sensor and heart rate monitor. monitor, alarm, weight sensor, separator, medication bag, switch plate, flow meter and head The invention refers to an improved neurosurgical drainage device incorporating a support structure. The invention concerns intracranial... Autonomous control of drainage speed according to pressure and multi-point drainage are possible. This invention goes beyond pressure-based drainage control and focuses on infection control. sensors that measure biomarkers and generate antimicrobial release decisions based on this data. There is a decision-making unit focused on early detection of infection rather than drainage rate control, and A system for its treatment is offered. Patent document number CN201969079U describes a U-shaped pipe, with 15 grooves along its wall. shunt tubes that contain a longitudinal space and are located between the ventricle and the abdominal cavity shunt tube shaping, a neurosurgical device used for shaping and fixing shunt tubes. The invention refers to the sleeve. The invention enables the shunt tube to be held in the desired configuration and This ensures its fixation. In the present invention, however, the mechanical shaping of the shunt is achieved. Unlike a passive device, the shunt has its own structure for infection monitoring and intervention. 20 An active, intelligent system with the capability of assisting the shunt during surgery is presented. functional performance in the post-implantation period rather than its configuration that is the focus. Patent document number CN207341960U describes a base, support column, scaled multiple waste liquid 25 A neurosurgical device containing a collection tank, negative pressure unit, and sterile storage box. The invention refers to a drainage device. It involves drainage with multiple waste collection tanks. the ability to perform and the possibility of sterile storage of drainage tubes after use This provides... In the present invention, however, this is for the external equipment of the drainage system. Unlike improvements, the implantable shunt itself carries the risk of infection. 30 There is an integrated system that monitors parameters and performs controlled drug release, which is passive. An active implant technology is offered instead of drainage equipment. Patent document number CN209996853U describes the turntable, base plate, rubber head, and one-way valve. The first channel includes the liquid collection tank, pipe connection, suction pipe and liquid storage tank, 35 a neurosurgery that allows the drainage tank to be replaced without affecting normal drainage The invention refers to a surgical drainage device. It enables the seamless replacement of drainage vessels. 6 It aims to increase operational continuity by providing drainage. In the present invention, drainage is used. Unlike a mechanical improvement aimed at changing containers, it reduces the risk of infection early on. A smart implant system has been developed that offers detection and local antimicrobial intervention capabilities. Patent document number CN103800992A describes a pressureless liquid made of elastic material. A device containing a storage bubble and two one-way valves, applied manually to the brain and spinal cord. a ventriculoperitoneal shunt device that allows fluid to be redirected to the abdominal cavity The invention describes a capacity control method. It involves a specific number of manual pressure checks per day. It allows for the channeling of the desired amount of liquid. In the present invention, however, it is manual. Unlike a pressure-based passive fluid control method, automatic 10 based on sensor data. an active system that performs risk assessment and physician-approved controlled antimicrobial release It is offered as an autonomous solution for infection management, independent of manual intervention. is being brought in. Patent document number CN211986660U describes a handheld outer shell, a compression device, and 15 a multi-layered sterile cotton pad unit, sterile water storage unit, and fluid dispensing tubing The invention refers to a handheld sterilization device for neurosurgical clinics. It involves sterilizing liquid in cotton pads. It aims to increase sterilization effectiveness by ensuring homogeneous distribution on the surface. In the present invention, however, unlike an external sterilization device, the implantable shunt itself... an integrated system within its structure aimed at preventing and treating the development of infection 20 It is offered that goes beyond surface sterilization, providing real-time monitoring and controlled release. This capability is provided. Patent document number CN204951763U describes a combined drainage pipe, drainage device, and drainage system. A 25-inch tube containing a drug delivery tube, an intracranial pressure sensor, and a combined separator. The text discusses a neurosurgical drainage device. The invention involves autonomous drainage speed based on intracranial pressure. It provides control and offers the possibility of treatment through drug administration. In the present invention, however, Unlike pressure-based drainage control and a separate drug delivery channel, infection sensors that monitor biomarkers and conduct risk assessments based on this data, thus enabling controlled access. There is an integrated decision and release mechanism that carries out the release, and passive drug 30 The transition is being made from a purely application-based approach to an active and data-driven intervention model. Patent document number CN122005963A describes the equipment's main frame, washing tank, and waste liquid. container, blood drainage platform, equipment support, fluid storage container and dispensing suction tube assembly The text refers to a neurosurgical postoperative blood clot prevention and cleaning device. 35 The invention relates to the removal of blood from a surgical wound using a negative pressure component and a distribution suction tube assembly. It aims to remove accumulated waste quickly and efficiently. In the present invention, however, 7 Unlike an external device for postoperative blood drainage, an implantable shunt It has the capability for continuous monitoring and controlled intervention against the risk of infection, and is passive. Beyond evacuation, an active infection prevention system is provided. Patent document number CN119075038A describes the outer shell, connecting pipe, protective casing, and filter 5. components, flow tube, pipe clip, fitting, ball joint and negative pressure adsorption a neurosurgical operation involving a component that allows for precise control of drainage rate and amount The invention refers to a drainage control device. It prevents excessive or insufficient drainage. It aims to minimize intracranial pressure fluctuations. In the present invention, drainage... Unlike mechanical control of speed and quantity, risk based on infection parameters 10 There is an integrated system that performs the evaluation and carries out the antimicrobial release. and has an active function in infection management beyond drainage control. It is presented. Patent document CN102772239A describes a lumboperitoneal shunt consisting of two parts. having a shaft, containing a straight section and a curved section, conforming to the anatomy of the human body. The invention refers to a subcutaneous tunnel needle designed in this way. The invention involves a shunt tube connecting the lower back to the waist. Minimizing surgical trauma by directing the flow of blood from the affected area to the abdominal area. The aim is to achieve this. In the present invention, a surgical instrument to assist in shunt implantation is used. In contrast, the implantable shunt has its own infection monitoring and intervention capability. 20 An integrated system is offered, focusing on the functional aspect of the implant rather than the surgical technique. The focus is on its features. Patent document number CN204468837U describes a suction tube passing through a washing pipe. a neurosurgical lavage and suction 25 containing and creating a lavage space between these two tubes The device in question is described. The invention involves washing and suction with valves located on a control lever. It enables the monitoring of surgical procedures. In the present invention, however, procedures used during surgery are monitored. Unlike an external flushing and suction device, an implantable shunt can cause infection. A smart system is presented that monitors parameters and delivers controlled antimicrobial release. Post-implantation active infection management rather than passive cleaning during surgery 30 is provided. Patent document number RU2353303C1 describes ventriculoperitoneal abnormalities in patients with obstructive hydrocephalus. Ventriculostomy and temporary shunt for the treatment of drainage-dependent conditions after shunt placement. The surgical method involving occlusion is described. The invention relates to a shunt-related 35 Endoscopic perforation and shunt placement to reduce complications. The procedure involves removing the shunt depending on the patient's condition. In the present invention, however, the shunt... 8 Unlike a surgical method for removal, the shunt is left in place and an integrated system capable of providing controlled local antimicrobial release against infection risk It is presented with the aim of enabling the shunt to actively contribute to infection management. Patent document number CN219700018U describes a shunt catheter, protective balloon, and interface, comprising 5 By inflating the protective balloon, it adapts to the vascular morphology and allows blood flow to continue. The invention refers to an intravascular vessel protection and bypass device that enables such protection. It aims to prevent vascular injuries during neurosurgical procedures. In the present invention... However, unlike a passive bypass device used for vascular protection during surgery, An integrated system that detects infection risk early and responds with antimicrobial release. An implant system is offered, providing an active and data-driven protection mechanism. Patent document number CN1583189A describes the washing-suction head, distribution chamber, and suction pipe. single unit including washing tube, handle, pressure plate, valve core, sealing ring and spring. 15 allows the washing and suction processes to be carried out independently by the person. The text refers to a multifunctional surgical lavage-suction transducer that recognizes and utilizes existing technology. In contrast to an external washing-suction device used during surgery, this invention uses an implant. The shunt can be continuously monitored and controlled for intervention against the risk of infection. An integrated system is offered for active infection management in the post-surgical period. is provided. 20 Patent document number RU2189181C1 describes the treatment of arteriovenous malformations. a procedure involving the creation of an arteriovenous shunt between afferent arteries and draining veins The treatment method is being discussed. The invention reduces hemodynamic complications by preventing bleeding. It aims to minimize the risk. In the present invention, 25 vascular malformations Unlike a method for treating hydrocephalus, a shunt is used in the treatment of hydrocephalus. An integrated implant system that offers active monitoring and intervention capabilities against infection risk. It has been improved and exhibits a different indication and functional approach. Patent document number CN214912338U describes a hollow tube structure with a drainage hole at the top. a venous sinus found and secured with a hemostatic sponge during neurosurgical procedure. from an intraoperative venous sinus bypass device used for drainage and protection It is mentioned that the invention involves establishing an intravascular bypass before surgery to drain venous sinus blood. It aims to ensure the continuity of the flow. In the present invention, however, it is used during surgery. Unlike a passive venous bypass device, an implantable shunt has a higher risk of infection. an integrated system that monitors parameters and delivers controlled antimicrobial release It is being offered, and active infection management capabilities are being introduced. 9 Patent document number RU2016121971A describes the use of Kocher and Dendi devices in pediatric neurosurgery. for ventriculo-peritoneal shunt pump and / or ventriculo-subgaleal shunt pocket at points The invention refers to a craniocorrector device involving incisions. The invention is relevant in the postoperative period. and subsequently allows for the correction of the cranial arch. In the present invention, the skull 5 Unlike an external device used for shaping, the shunt itself can cause infection. An integrated implant system with monitoring and intervention capabilities is offered, surgically. Active infection management is provided in the post-infection period. Patent document number CN211024340U describes drainage bags, plastic plates, rings, drainage pipes, and 10 other items. A neurosurgical procedure involving a drainage head, first and second shunt tubes, and a compression device. The invention refers to a drainage device. The invention involves a compression mechanism mounted on shunt pipes. It allows for the rapid removal of blockages by sliding the material. In the present invention, however, Unlike an external intervention tool for mechanical obstruction removal, infection An integrated system that prevents biofilm formation through early detection of risk and controlled antimicrobial release. An implant system is offered, focusing on intervention before the blockage rather than after the blockage. A proactive approach is being adopted. Patent document number CN201988035U describes a suction head on a flexible tube and this from a simple neurosurgical drainage device with a distribution tube on the head to 20 It is mentioned. In the present invention, however, unlike a simple mechanical drainage structure, the implant Sensors monitoring infection parameters of the shunt, decision unit and controlled release An integrated system is offered that includes modules ranging from passive drainage to active infection management. Transition is enabled. Patent document number RU2005103217A describes intercostal and lumbar spinal cord injuries. an experimental surgical procedure to create bilateral interneural shunts between nerves The method is being discussed. In the present invention, nerve treatment for spinal cord injuries is being considered. Unlike reconstruction, infection of a shunt used in the treatment of hydrocephalus An implant system has been developed that offers active monitoring and intervention capabilities against the risk, 30 A completely different indication and technological approach is being demonstrated. Patent document number RU2721455C1 describes a ventriculo- for the treatment of progressive hydrocephalus. including subarachnoid drainage, ventricular drainage and the use of a pump with a perforated base, If necessary, the pump can be connected to a peritoneal shunt to drain cerebrospinal fluid into the abdominal cavity. 35 The text describes a method that enables guidance. In the present invention, however, the surgical method... And unlike shunt connection procedures, sensors are integrated into the existing shunt structure, active and autonomous response to infection risk through decision-making unit and controlled drug release mechanism. An implant system has been developed that offers intervention capabilities, going beyond passive drainage function. Functionality is provided. Patent document number CN201958979U describes neurosurgical procedures for hydrocephalus patients. used, consisting of an outer tube and a tube core, low cost, high safety and reusable A usable shunt placement device is being discussed. In the present invention, however, the shunt is surgically placed. Unlike a device that assists in placement, an implantable shunt has its own structure. A smart system is offered that has infection monitoring and controlled drug release capabilities, The focus is on the functional characteristics of the implant itself, rather than the placement device. 10 Patent document number CN110433235A describes hardened subdural effusion and various types of hydrocephalus. For the treatment of its forms, with olfactory, kidney tonic, carminative, expectorant and stasis remover. The text describes a traditional Chinese medicine compound with spleen-revitalizing effects. The present invention... However, unlike a pharmacological treatment combination, it is a sensor-based 15 against the risk of infection. An integrated implant system is offered that provides monitoring and controlled local antimicrobial release, A local and data-driven intervention approach is being introduced, replacing systemic drug administration. Patent document number CN210612295U describes neurosurgical cervical and orthopedic lumbar surgeries. Liquid guide distribution pipes used in operations requiring a prone position, such as those mentioned above. 20 The text refers to a male perineal protection pad containing [specific material]. In the present invention, however, the patient... Unlike an external protective pad for positioning, an implantable shunt An integrated system has been developed that offers active monitoring and intervention capabilities against infection risks. This focuses on implant functionality rather than patient comfort. Patent document CN202185063U describes automatic pressure monitoring for intraventricular shunt tubes. The invention refers to a control valve, PS Medical valve for liquid storage bag. A freely moving titanium alloy ball, a remote speed limiter for liquid storage. six barriers were added to the side near the bag, and a flow that could be visualized under X-ray. It includes a direction indicator. The valve base is made of rigid polypropylene plastic and is suitable for scalps up to 30°. It can be sutured to the muscle or fascia layer. The invention is based on the patient's upright or supine position. By automatically adjusting the pressure inside the fluid storage bag, it protects the brain and spinal cord in the ventricle. to prevent the fluid from draining too quickly and excessive shunting after ventriculo-peritoneal shunting. It reduces complications. In the present invention, mechanical pressure regulation is applied. Unlike a valve improvement, sensors and controlled 35 that monitor infection biomarkers. An integrated system containing an antimicrobial release mechanism is offered, with passive pressure. A transition is being made from control to active infection management. 11 Patent document number CN202538121U describes a neurosurgical medical device that uses X-ray and computer imaging. an inner nucleus with 36 lateral orifices in the head, visible in tomography images. After the needle is removed, it forms an "I" shaped support and is 1 cm long on the tube body. 5 new ventricular obstruction prevention shunt tubes with intermittent black scale markings It is mentioned that the invention provides more precise drilling depth and eliminates shunt pipe blockage. It prevents mechanical blockage in the shunt pipe. In the present invention, however, the structural design prevents mechanical blockage in the shunt pipe. Unlike improvements, it involves early detection of infection risk and controlled antimicrobial release. An active system is offered that prevents biofilm formation and related blockages, while a passive system is also available. Beyond structural improvements, a data-driven and dynamic intervention capability is introduced. 10 In patent document number CN102753218A, the subcutaneous base portion is described as fitting into a complementary indentation in the bone. an implant that can be placed and fixed directly to the bone, a percutaneous part, and one or more Percutaneous drug delivery including a shunt unit for fluid delivery to multiple neurosurgical catheters. The device in question is described. The invention involves an implantable base and percutaneous access to target 15 It provides liquid medicine distribution to the region. In the present invention, however, the medicine is delivered from an external source. Unlike a percutaneous device for delivery, a shunt itself can cause infection. an integrated system that monitors its parameters and performs controlled release autonomously It is presented in a completely closed form within the implant, unlike external drug application. A loop is being created. 20 Studies have shown that the majority of existing shunting systems only serve a passive drainage function. the mechanical system that sees and directs cerebrospinal fluid from the ventricular region to the body cavities There are implant devices, and these systems can detect the development of infection at an early stage. It appears that it does not include any sensor-based monitoring mechanism. The shunt 25 in the current technology in these systems, pH, lactate, glucose, protein, or specific inflammatory substances in the cerebrospinal fluid biochemical parameters indicating infection, such as cytokines, in real time or There is no integrated system that allows for periodic measurements, therefore the risk of infection, fever, until advanced clinical signs such as meningeal irritation or device obstruction appear It is not noticeable. On the other hand, 30 antibiotic-impregnated tablets are used to reduce the risk of infection. or existing surface modifications such as catheters coated with antimicrobial agents These approaches provide passive protection with a fixed effect that wears off over time, preventing biofilm formation. It becomes ineffective when it starts and provides a dynamic response depending on the measured parameters. It cannot produce it. In addition, systemic or local antibiotic administrations can damage the blood-brain barrier. Due to the inability to reach a sufficient therapeutic concentration in the cerebrospinal fluid, high 35 disadvantages include dosage requirements and the inability to maintain sustainable drug concentrations. It carries a decision that assesses the level of infection risk in existing shunt systems. 12 The absence of a logic that initiates a local and controlled antimicrobial release when a risk arises. The absence of an integrated intervention module and the need for physician approval, dose limit, and error-safe release. The fact that it is not managed within a security architecture framework stands out as a fundamental shortcoming in the current technology. This invention aims to solve these technical problems, and to address them in terms of shunt structure or... via at least one biosensor module integrated into the cerebrospinal fluid flow line 5 early monitoring of parameters indicating infection, based on the data obtained It presents a decision unit that establishes an infection risk level. Depending on this risk level, It operates in the default closed state and only with a defined risk threshold and physician approval. controlled localization via a microvalve-controlled reservoir structure that is activated when the supply is provided. It delivers antimicrobial release; it also has a single dose limit, a total daily release limit, and 10 It is equipped with fail-safe safety mechanisms such as manual locking. In addition, The biofilm-inhibiting or biofilm-reducing surface structure located on the shunt surface provides passive protection, The integrated structure, consisting of a sensor-decision unit and a controlled release module, enables active intervention. This is a technical solution that combines passive and active protection within the same implant architecture. It reveals and, unlike existing passive shunt systems, the infection is only noticeable 15 The aim is not to suppress it, but to technically suppress it at an early stage. 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. A BRIEF DESCRIPTION OF THE INVENTION The present invention has been developed to eliminate the technical shortcomings mentioned above. It relates to a smart shunt system that provides sensor-based controlled drug release. The main purpose of the invention is to enable conventional shunt systems to operate based on passive drainage functionality. This principle stems from the fact that infection development only occurs after advanced clinical symptoms appear. The goal is to offer a fundamental solution to the underlying technical problem that prevents it from being noticed later. This In this way, cerebrospinal fluid is transmitted through the biosensor module integrated into the shunt structure. Parameters indicating infection, such as pH, lactate, and inflammation markers, are true. monitoring on a time-limited or periodic basis and determining the infection risk level based on this data. This ensures that it can be created in the early stages. 30 Another aim of the invention is to improve existing antimicrobial coated catheters and surfaces. In contrast to the passive protection feature of modifications, which is fixed in effect and depletes over time, data... The aim is to offer a dynamic intervention mechanism based on and addressing the identified risks. This ensures that only the identified risks are addressed. Controlled local therapy comes into play when the threshold is exceeded and physician approval is obtained. 13 early suppression of infection development and biofilm formation through antimicrobial release modulus The aim is to prevent its formation. Another aim of the invention is to enable controlled drug release in a safe and predictable manner. The goal is to create a fail-safe security architecture that enables this. Single dose limit, Thanks to mechanisms such as daily total emission limits and manual interlocking, false positives are minimized to 5. In scenarios or situations where physician approval is not available, the system is in a secure, closed state. This makes it possible to contain and prevent the uncontrolled release of drugs. Another aim of the invention is to combine passive biofilm-preventing surface protection with active local intervention simultaneously. The goal is to provide a dual-action protection mechanism by integrating it within the implant architecture. This integrated system... Thanks to this approach, the sensor-10 has a passive effect on reducing microorganism adhesion through its surface structure. The decision-making unit works in conjunction with the active intervention of controlled antimicrobial release and the infection. A system offering both preventive and curative measures is available. Another aim of the invention is to address device infection encountered in existing shunt systems. removal, need for repeat surgery, need for intensive care, and long hospital stays, etc. The aim is to contribute to reducing serious clinical and economic problems. Early diagnosis and controlled 15 Thanks to local intervention, systemic spread of infection and loss of device function are prevented. prevention, improvement of patient quality of life and reduction of healthcare costs is the goal. Another purpose of the invention is to provide the physician with a warning that gives feedback on the level of infection risk. and to support the clinical decision-making process by providing a notification system. When the risk level increases 20 Thanks to the notifications generated, the physician can make timely and informed decisions regarding patient management. This enables the device to be picked up and to make manual interventions when necessary. Another aim of the invention is to explore different sensor types, biomarker combinations, and antimicrobial agents. The aim is to offer a flexible platform that can be modularly adapted to reservoir structures. This flexibility Thanks to this, the system can be personalized according to different clinical needs and patient profiles, and 25 It is designed to be open to future technological developments. Another aim of the invention is to expand into the medical device sector, particularly in neurosurgical implant technologies. in the field, by offering an innovative alternative to existing treatment protocols, clinical applications The aim is to contribute to its development. In this way, we will shift from passive to active approaches in infection management. and leading technological advancements that enable the transition to data-driven systems 30 is the goal. 14 All the purposes mentioned above and those that will emerge from the detailed explanation below. The present invention aims to achieve early reduction of the risk of infection in cerebrospinal fluid drainage. with an integrated smart implant system that provides detection and controlled local antimicrobial release It is related to the system in question; the flow of cerebrospinal fluid from the ventricular region to the distal region. A shunt body that enables its transport, and within the aforementioned shunt body are located brain 5 A Cerebrospinal Fluid Flow Line, which directs the flow of cerebrospinal fluid, is the aforementioned shunt. Located on the body or on the aforementioned Cerebrospinal Fluid Flow Line and markers of infection such as pH, lactate, cytokines and inflammation in the cerebrospinal fluid. At least one Sensor Module measuring the indicated parameters, from the aforementioned Sensor Module A Decision Unit that processes the collected data and establishes an infection risk level, is referred to as Decision 10. Depending on the risk level determined by the unit and with the approval of a physician, controlled local treatment may be necessary. A Controlled Drug Release Module that delivers antimicrobial release, the aforementioned Controlled Drug An antimicrobial unit located within the release module that stores antimicrobial agents. The Agent Reservoir is located within the aforementioned Controlled Drug Release Module and is the default... By operating in a closed position, only when the aforementioned risk level and physician approval are provided together, 15 A microvalve controlled release mechanism is activated in the aforementioned controlled drug release module. related to single dose limit, total daily release limit, manual interlocking and fail-safe. An Approval Mechanism that provides control is located on the surface of the aforementioned Shunt Body and A biofilm inhibitor surface structure that prevents or delays biofilm formation, as mentioned Notification to the physician or user when the risk level determined by the Decision Unit increases. 20 a Feedback Unit that comprises the aforementioned Sensor Module, the aforementioned Decision Unit, For the operation of the aforementioned Controlled Drug Release Module and the aforementioned Feedback Unit It includes a Power Supply Unit that provides the necessary energy. 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. 25 BRIEF DESCRIPTION OF THE FIGURES Figure 1: Schematic view of an intelligent shunt system providing sensor-based controlled drug release. REFERENCE NUMBERS 30 1. Shunt Body 2. Cerebrospinal Fluid Flow Line 3. Sensor Module 4. Decision-Making Unit 5. Controlled Drug Release Module 35 6. Antimicrobial Agent Reservoir 7. Microvalve Controlled Release Mechanism 8. Approval Mechanism 9. Biofilm-Inhibiting Surface Structure 10. Feedback Unit 11. Power Supply Unit 5 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, A smart shunt system providing sensor-based controlled drug release is described. 10 Figure 1 is a schematic view of an intelligent shunt system that provides sensor-based controlled drug delivery. Accordingly, the system: • A shunt that allows cerebrospinal fluid to move from the ventricular region to the distal region. Body (1), 15 • Located within the aforementioned Shunt Body (1) and directing the flow of cerebrospinal fluid a Cerebrospinal Fluid Flow Line (2), • On the aforementioned Shunt Body (1) or the aforementioned Cerebrospinal Fluid Flow Line (2) It is located on and regulates pH, lactate, cytokines, and inflammation in the cerebrospinal fluid. At least one Sensor Module (3) measuring parameters indicating infection such as markers, 20 • By processing the data received from the mentioned Sensor Module (3), it creates an infection risk level. a Decision Unit (4), • Depending on the risk level determined by the aforementioned Decision Unit (4) and with physician approval. A Controlled Drug Release Module (5) that delivers controlled local antimicrobial release. • The Controlled Drug Release Module (5) mentioned contains antimicrobial agents 25 An Antimicrobial Agent Reservoir (6) • Located within the Controlled Drug Release Module (5) mentioned and default closed Working in that location is only permitted when the aforementioned risk level is met along with physician approval. A Microvalve Controlled Release Mechanism (7), • In relation to the mentioned Controlled Drug Release Module (5), the single dose limit is 30 total daily release. A Confirmation Mechanism (8) that provides limit, manual locking and fail-safe control, 16 • Located on the surface of the aforementioned Shunt Body (1) and preventing biofilm formation or A Biofilm Inhibitory Surface Structure that delays (9), • When the risk level created by the aforementioned Decision Unit (4) increases, contact the physician or a Feedback Unit (10) that generates a notification to the user and • The mentioned Sensor Module (3), the mentioned Decision Unit (4), the mentioned Controlled Drug Release 5 Providing the energy required for the operation of the Module (5) and the aforementioned Feedback Unit (10). a Power Supply Unit (11) It includes. The invention, an intelligent shunt system, reduces the risk of infection during cerebrospinal fluid drainage in the early 10 days. It was developed for the purpose of detection and controlled local antimicrobial intervention, and its working principle is... sensor-based data collection, risk assessment, and physician-approved controlled drug release. The system is based on the Cerebrospinal Fluid Flow Line (2) located within the Shunt Body (1). It is initiated by the transport of cerebrospinal fluid from the ventricular region to the distal region and During this flow, 15 on the Shunt Trunk (1) or on the Cerebrospinal Fluid Flow Line (2) The positioned Sensor Module (3) measures pH, lactate, cytokine and in the cerebrospinal fluid. Parameters indicating infection, such as inflammation markers, in real-time or Measures periodically. Measurement data obtained by Sensor Module (3) Decision Unit (4) is transmitted to this unit and the threshold exceedance, rate of change and / or multi-parameter in the data in question Based on the scoring result, it establishes the infection risk level. Low risk, 20 by the Decision Unit (4). Risk levels are classified as risks requiring monitoring and risks requiring intervention; intervention when the required risk level is reached and by the physician through the Approval Mechanism (8) When the necessary approval is given, the Controlled Drug Release Module (5) becomes active. Controlled Drug The Microvalve Controlled Release Mechanism (7) located within the Release Module (5) is defaulted to By switching from the closed position to the open position, 25 stored in the Antimicrobial Agent Reservoir (6) It initiates the local release of antimicrobial agents. During this release, the Approval Mechanism (8), by providing single dose limit, total daily release limit, manual interlocking and fail-safe control. ensuring the system is kept in a secure, closed position and preventing uncontrolled drug release. At the same time, the Biofilm Preventive Surface Structure (9) located on the surface of the Shunt Body (1), While providing passive protection by reducing the adhesion of microorganisms to the device surface, Decision Unit 30 When the risk level created by (4) increases, the Feedback Unit (10) informs the physician or It supports the clinical decision-making process by generating notifications for the user. All these sensors in the system... during data collection, risk assessment, decision-making, drug release and notification processes Sensor Module (3), Decision Unit (4), Controlled Drug Release Module (5) and Feedback Unit (10) operates with the energy provided by the Power Supply Unit (11) and thus the infection 35 17 early detection combined with controlled local antimicrobial release An integrated smart intervention process is completed. 10 20

Claims

18 REQUESTS 1. It is an intelligent shunt system that provides sensor-based controlled drug release, and its features include: • Enables the transport of cerebrospinal fluid from the ventricular to the distal region. a Shunt Body (1), • Located within the mentioned Shunt Body (1) and regulating the flow of cerebrospinal fluid 5 a Cerebrospinal Fluid Flow Line directing (2), • On the aforementioned Shunt Body (1) or the aforementioned Cerebrospinal Fluid Flow Line (2) located on and pH, lactate, cytokine and in cerebrospinal fluid at least parameters that indicate infection, such as inflammation markers a Sensor Module (3), 10 • By processing the data received from the mentioned Sensor Module (3), infection risk level a Decision Unit (4), • Depending on the risk level determined by the aforementioned Decision Unit (4) and the physician A Controlled Drug Release (CDDR) system that delivers controlled local antimicrobial release with approval. Module (5), 15 • Located within the mentioned Controlled Drug Release Module (5) and containing antimicrobial An Antimicrobial Agent Reservoir (6) that stores agents. • Located within the Controlled Drug Release Module (5) mentioned and default closed working in that location only when the aforementioned risk level is met with physician approval. A Microvalve Controlled Release Mechanism (7), 20 • In relation to the mentioned Controlled Drug Release Module (5), the single dose limit is the total daily dose. An approval mechanism providing release limit, manual interlocking and fail-safe control. (8), • Located on the surface of the aforementioned Shunt Body (1) and preventing biofilm formation or A Biofilm Inhibitory Surface Structure that Delays (9), 25 • When the risk level created by the aforementioned Decision Unit (4) increases, contact the physician or a Feedback Unit (10) that generates a notification to the user and 19 • The mentioned Sensor Module (3), the mentioned Decision Unit (4), the mentioned Controlled Drug The Oscillation Module (5) and the aforementioned Feedback Unit (10) are required for operation. a Power Supply Unit (11) that provides energy It is characterized by its inclusion. 10 20 30 35

Images