Adaptive antibiotic intracerebroventricular dosing and pharmacodynamic monitoring system

Abstract

This invention discloses an adaptive intraventricular antibiotic delivery and efficacy monitoring system, belonging to the field of medical device technology. The system includes an interventional fitting module, a monitoring function module, a drug delivery control module, a drug delivery execution module, and a data management module. The interventional fitting module is specifically an intraventricular drug delivery catheter with a three-chamber structure, comprehensively realizing antibiotic infusion, cerebrospinal fluid sampling, and intracranial physiological indicator collection. The monitoring function module detects drug concentration and inflammatory factors through a microfluidic chip. The drug delivery control module generates individualized dosing regimens. The drug delivery execution module includes dual-specification infusion pumps and a safety warning unit, capable of audible and visual alarms and emergency shutdown. The data management module enables data storage, visualization, and cloud sharing. All modules work collaboratively through standardized interfaces to achieve closed-loop control of the entire process of drug delivery, sampling, and monitoring, reducing treatment risks and improving the accuracy, safety, and clinical efficiency of intracranial infection treatment.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to an adaptive intraventricular antibiotic delivery and efficacy monitoring system. Background Technology

[0002] Intracranial infection is a common and serious complication after neurosurgery, with a high mortality rate. Clinically, it is necessary to administer antibiotics directly into the ventricle to cross the blood-brain barrier and ensure that antibiotics reach effective therapeutic concentrations in the cerebrospinal fluid. Currently, the Ommaya capsule is the most commonly used intraventricular drug delivery device, but it has significant limitations: it can only achieve single-drug administration and coarse sampling functions, lacks real-time monitoring capabilities, and the dosing regimen relies on experience, which can easily lead to excessively high drug concentrations causing neurotoxicity or excessively low concentrations affecting efficacy; moreover, repeated punctures increase the risk of infection, and patient tolerance is poor.

[0003] In the field of intraventricular catheterization technology, existing technologies are mostly single-lumen or double-lumen structures, which can only meet the single needs of drug administration or drainage, and cannot simultaneously achieve multi-functional integration of antibiotic infusion, cerebrospinal fluid sampling, and physiological indicator monitoring. Among existing technologies, microfluidics has been applied to the rapid detection of trace cerebrospinal fluid samples, but the drug administration, sampling, and monitoring processes are disconnected, making it impossible to adjust the dosing regimen in a timely manner according to the patient's real-time condition, thus limiting its clinical applicability. Summary of the Invention

[0004] To address the limitations of existing intraventricular drug delivery devices, such as limited functionality, lack of real-time drug efficacy monitoring and personalized drug delivery capabilities, and the difficulty of simultaneously performing antibiotic infusion, cerebrospinal fluid sampling, and intracranial physiological parameter collection using traditional single-lumen or double-lumen catheters, which leads to insufficient treatment precision and high clinical risks, this invention proposes an adaptive intraventricular antibiotic drug delivery and efficacy monitoring system and an intraventricular drug delivery catheter adapted to this system. Through modular architecture design, integrated three-lumen catheter functions, and closed-loop control logic, the system achieves full-process coordination of drug delivery, sampling, monitoring, and data management, thereby improving the safety and effectiveness of intracranial infection treatment.

[0005] To achieve the above-mentioned technical objectives, the present invention is implemented through the following technical solution: The adaptive intraventricular antibiotic administration and efficacy monitoring system includes an interventional adaptation module, a monitoring function module, a drug administration control module, a drug administration execution module, and a data management module. Each module achieves reliable connection and collaborative operation through standardized interfaces.

[0006] The interventional adapter module is specifically an intraventricular drug delivery catheter. As the core component for the system to connect with the patient's intracranial space, it coordinates the functions of antibiotic infusion, cerebrospinal fluid sampling, and intracranial physiological index collection, providing a stable interventional channel for the system.

[0007] The monitoring module is a portable microfluidic detection unit that integrates a sampling preprocessing unit, a microfluidic chip, and a data transmission unit. It can be sealed to the sampling catheter of the intraventricular drug delivery catheter to receive intracranial physiological indicators collected by the interventional adapter module. At the same time, it performs preprocessing and multi-dimensional detection on cerebrospinal fluid samples to ensure the accuracy and real-time nature of the monitoring data.

[0008] The drug delivery control module integrates a microcontroller, a data processing unit, and a touch screen. It can receive patient individual characteristic data and pathogen information entered by medical staff, as well as real-time monitoring data transmitted by the monitoring function module. Based on the built-in diagnosis and treatment logic, it generates individualized drug delivery plans and converts the plans into standard control signal outputs.

[0009] The drug delivery module receives control signals and precisely executes drug delivery operations. It includes two types of infusion pumps: adult and pediatric. Both types of infusion pumps are equipped with a unified medical-grade electrical control interface and tubing connection interface, which can be flexibly adapted to different users and stably connected to the intraventricular drug delivery catheter. Its internally integrated safety warning unit can promptly trigger audible and visual alarms and automatically pause drug delivery in response to risks such as excessive drug concentration or abnormal intracranial pressure, ensuring treatment safety.

[0010] The data management module integrates a local storage unit, a real-time visualization unit, and a cloud data platform. The local storage unit can automatically record basic patient information, medication records, monitoring data, early warning information, and operation logs. The real-time visualization unit intuitively presents changes in various indicators, details of the medication regimen, and the operating status of the equipment through a high-definition touch screen. The cloud data platform will desensitize patient privacy data, support multi-center data sharing, and provide data support for clinical research and treatment optimization.

[0011] The system's standardized interfaces include medical-grade Luer-locking tubing interfaces, medical-grade waterproof aviation plug electrical interfaces, and medical-grade encrypted data interfaces, ensuring compatibility, sealing, and data transmission security between modules.

[0012] A ventricular drug delivery catheter includes a catheter body, wherein the catheter body includes an inner lumen, a middle lumen, and an outer lumen, the three lumens being coaxially arranged and independently. The inner cavity serves as an antibiotic injection channel. Multiple inclined side holes are equidistantly arranged along the circumference at the proximal end of the cavity, which allows the antibiotic to diffuse evenly into the cerebrospinal fluid during infusion, avoiding excessive local drug concentration that could cause neurotoxicity. A one-way valve is provided on the posterior side of the side holes to prevent backflow during infusion. The distal end of the inner cavity is connected to an infusion catheter, and the end of the infusion catheter is equipped with a quick-connect check valve, which can be sealed to the drug delivery unit. The posterior part of the cavity, away from the brain, is solid and symmetrically equipped with a sampling conduit to serve as a cerebrospinal fluid sampling channel. The anterior part of the cavity is a hollow annular channel with an annular filter membrane. The filter membrane can filter impurities in the cerebrospinal fluid, avoid contaminating the sampling channel, and maintain the accuracy of the cerebrospinal fluid test results. Miniature pressure sensors and temperature sensors are symmetrically distributed circumferentially inside the external cavity, which can monitor changes in intracranial pressure and temperature in real time. The distal end of the external cavity is sealed and connected to a multi-dimensional monitoring module via a signal wire, which can stably transmit the monitored data.

[0013] Furthermore, a butterfly-shaped fixing plate is fixedly connected to the distal end of the catheter body. The butterfly-shaped fixing plate has several anti-slip grooves on the surface corresponding to the brain. By using the butterfly-shaped fixing plate in conjunction with medical sutures, the catheter body can be fixed to the patient's scalp to prevent the catheter from falling out during drug administration.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. A modular system enables collaborative management of drug administration, sampling, and monitoring data throughout the entire process, accurately matching individual patient characteristics and disease dynamics, allowing for timely adjustments to dosing regimens and improving the treatment efficacy for intracranial infections. Standardized interfaces ensure secure and stable connections between modules and smooth, confidential data transmission, enhancing operational convenience and collaborative efficiency. Closed-loop control logic integrates multi-source data to generate individualized dosing regimens, reducing the risk of overdose or underdose. Monitoring modules rapidly and accurately detect multi-dimensional indicators, providing real-time and reliable data support for regimen adjustments. The data management module enables encrypted storage, real-time visualization, and multi-center sharing of diagnostic and treatment data, ensuring data security and traceability, supporting clinical research and treatment optimization. A safety warning unit monitors abnormal situations in real time and automatically suspends dosing, improving treatment safety.

[0015] 2. The three-lumen coaxial independent structure ensures that the collection of intracranial physiological indicators during antibiotic infusion and cerebrospinal fluid sampling does not interfere with each other, avoiding cross-contamination. The inclined side hole design of the inner lumen ensures uniform diffusion of antibiotics during infusion. The combination of a one-way valve and a quick-connect check valve prevents cerebrospinal fluid backflow and drug reflux. The medical sterile ring filter membrane in the middle lumen, paired with the sampling catheter, effectively traps impurities and pathogen fragments in the cerebrospinal fluid, improving the accuracy of test results. The solid rear section structure enhances the stability of the sampling catheter installation, preventing displacement during sampling and affecting the sampling effect. The symmetrically arranged miniature pressure and temperature sensors in the outer lumen accurately collect intracranial pressure and temperature data, avoiding direct contact with cerebrospinal fluid and causing adverse reactions. The distal end of the outer lumen is sealed to prevent cerebrospinal fluid leakage and external contamination. The anti-slip grooves and circular suture holes of the butterfly-shaped fixation plate effectively prevent catheter displacement or dislodgement, improving the stability and safety of long-term indwelling. Attached Figure Description

[0016] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments are briefly introduced below.

[0017] Figure 1 This is a system framework diagram of Embodiment 1 of the present invention; Figure 2 This is a system application flowchart of Embodiment 1 of the present invention; Figure 3 This is a schematic diagram of the overall structure of the intraventricular drug delivery catheter according to Embodiment 1 of the present invention; Figure 4 This is a rear view of the intraventricular drug delivery catheter of Embodiment 1 of the present invention; Figure 5 This is a cross-sectional view of the intracerebral drug delivery catheter of Embodiment 1 of the present invention.

[0018] The structural names represented by the labels in the attached diagram are as follows: 1-Catheter body, 101-Inner lumen, 102-Middle lumen, 103-Outer lumen, 2-Side hole, 3-Infusion catheter, 301-Quick-connect check valve, 302-One-way valve, 4-Filter membrane, 5-Sampling catheter, 6-Pressure sensor, 7-Temperature sensor, 8-Signal wire, 9-Butterfly-shaped fixing plate, 901-Anti-slip groove. Specific Implementation The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments.

[0020] Example 1 See Figures 1 to 5 As shown, this embodiment provides a specific implementation of an adaptive intraventricular antibiotic delivery and efficacy monitoring system, including an interventional adapter module, a monitoring function module, a drug delivery control module, a drug delivery execution module, and a data management module. Each module achieves reliable connection and collaborative operation through a standardized interface. The interventional adapter module is an intraventricular drug delivery catheter. The catheter body 1 is made of medical-grade silicone, which has excellent biocompatibility and flexibility. It is sterilized with ethylene oxide and has a coaxially arranged and independent inner lumen 101, middle lumen 102, and outer lumen 103 inside.

[0021] The inner cavity 101 serves as an antibiotic injection channel. The proximal end of the inner cavity is provided with inclined side holes 2 at equal intervals along the circumference, which allows the antibiotic to diffuse evenly into the cerebrospinal fluid during infusion, avoiding excessive local concentration that could cause neurotoxicity. A medical one-way valve 302 is built into the rear side of the side hole 2 to prevent cerebrospinal fluid backflow. The distal end of the inner cavity 101 is fixedly connected to the infusion catheter 3. A medical quick-connect check connector 301 is installed at the tail end of the infusion catheter 3 for sealed connection with the drug delivery module.

[0022] The middle cavity 102 is a cerebrospinal fluid sampling channel. The rear section is a solid structure with a sampling catheter 5 embedded in the center to enhance installation stability. The front section is a hollow annular cavity with a medical sterile annular filter membrane 4 fixedly installed inside. The edge of the filter membrane 4 is sealed to the inner wall of the cavity, which can trap impurities and pathogen fragments in the cerebrospinal fluid.

[0023] Miniature pressure sensors 6 and miniature temperature sensors 7 are symmetrically fixed circumferentially inside the external cavity 103. They are connected to the signal interface of the external cavity 103 via signal wires 8, enabling real-time acquisition of intracranial pressure and temperature data. The distal end of the external cavity 103 is sealed by laser welding to prevent cerebrospinal fluid leakage and external contamination. The distal end of the catheter body 1 has an integrally formed butterfly-shaped fixation plate 9. The fixation plate is made of medical polypropylene material, and the surface facing the brain has evenly distributed anti-slip grooves 901. The edge has circular suture holes, which are used to fix the catheter to the patient's scalp with PGA absorbable sutures to prevent catheter displacement or dislodgement.

[0024] The monitoring module is a portable microfluidic detection unit, integrating a sampling preprocessing unit, a microfluidic chip, and a data transmission unit. It is sealed to the sampling catheter 5 via a medical-grade Luer-locking tubing interface. The microfluidic chip is made of PDMS material and can simultaneously detect the concentrations of common antibiotics such as ceftriaxone and vancomycin, as well as the levels of inflammatory factors such as IL-6 and TNF-α. The data transmission unit uses a medical-grade wireless transmission module, supporting real-time push of detection data to the drug delivery control module. The drug delivery control module integrates an STM32 medical-grade microcontroller, a data processing unit, and a medical touchscreen. It connects to other modules via a medical waterproof aviation connector and can receive patient information, pathogen information, and monitoring data entered by medical personnel. Based on the built-in clinical diagnosis and treatment algorithm, it generates personalized dosing plans and outputs control signals.

[0025] The drug delivery module includes medical-grade high-precision micro-infusion pumps for adults and children, both equipped with standardized medical-grade electrical control interfaces and tubing connection interfaces. It is compatible with the quick-connect check valve 301 of the infusion catheter 3 via a Luer-locked tubing interface. The internally integrated safety warning unit consists of a data comparison module, an audible and visual alarm module, and an emergency stop control module. The data comparison module compares intracranial pressure, antibiotic concentration, equipment operating parameters, and preset safety thresholds in real time. When intracranial pressure exceeds 25 mmHg, antibiotic concentration exceeds the treatment window by ±30%, catheter blockage causes abnormal infusion pressure, or power supply voltage is too low, the audible and visual alarm module immediately activates a flashing red LED warning light and an 85dB buzzer alarm. Simultaneously, the emergency stop control module sends a signal to pause drug delivery, and the touchscreen displays the warning type and abnormal data.

[0026] The data management module integrates a local Flash storage unit, a real-time visualization unit, and Alibaba Cloud's dedicated medical cloud data platform. The local storage unit automatically records basic patient information, drug dosage, infusion rate, monitoring data, early warning records, and operation logs according to timestamps. The real-time visualization unit intuitively presents the dynamic changes of various indicators in the form of curves and numerical values ​​through a touch screen. The cloud data platform uses AES-256 encryption technology to receive local data. After desensitization processing to remove privacy information such as patient names and ID numbers, a traceable medical data archive is formed. Each module ensures data transmission security through medical-grade encrypted data interfaces.

[0027] The specific procedure for using this invention is as follows: First, a minimally invasive puncture is performed using a medical guide needle. Under image guidance, the intraventricular drug delivery catheter is implanted into the patient's ventricle. The catheter body 1 is securely fixed to the scalp using the suture holes of the butterfly fixation piece 9 and PGA absorbable sutures. The modules are connected via standardized interfaces: the sampling catheter 5 is sealed to the monitoring module, the infusion catheter 3 is connected to the drug delivery module, the signal interface is connected to the monitoring module via a shielded signal cable, and all modules are electrically connected via a medical aviation connector. Medical staff input the patient's age, weight, pathogen type, and target antibiotic concentration range via a touchscreen. After the system is started, the power module supplies power to all modules, and the local storage unit synchronously records the initial parameters. According to the initial settings, the control module drives a high-precision medical micro-infusion pump to evenly infuse the antibiotics in the drug storage tank into the ventricle through the side hole 2 of the inner cavity 101. Simultaneously, the pressure and temperature sensor 7 in the external cavity 103 collects intracranial physiological data in real time, while the sampling catheter 5 in the middle cavity 102 continuously collects cerebrospinal fluid samples. After filtration through the filter membrane 4, the samples are delivered to the monitoring module, where a microfluidic chip detects antibiotic concentration and inflammatory factor levels. The data is synchronized to the drug delivery control module and the cloud data platform via an encrypted interface. The control module analyzes the real-time data. If the antibiotic concentration is below the effective threshold, it instructs the infusion pump to increase the flow rate. If the concentration exceeds the safe range or intracranial pressure is abnormal, the safety warning unit immediately activates an audible and visual alarm and suspends drug delivery. During treatment, the local storage module continuously records all data, and the touchscreen displays the monitoring curve in real time. The cloud data platform supports collaborative viewing by multi-center medical teams. Medical staff can adjust the drug delivery plan based on dynamic data until the monitoring data shows that the intracranial infection is under control. At this point, a treatment termination command is issued via the touchscreen, the system stops drug delivery, generates a complete treatment report, and then the catheter and all modules are removed, completing the treatment process.

[0028] For those skilled in the art, various modifications and variations can be made to the above embodiments without departing from the principles of the present invention, and all such modifications and variations should fall within the protection scope of the present invention.

Claims

1. An adaptive intraventricular antibiotic administration and efficacy monitoring system, characterized in that: The system includes independently packaged interventional adapter module, monitoring function module, drug delivery control module, drug delivery execution module, and data management module, all connected via standardized interfaces. The interventional adapter module is an intraventricular drug delivery catheter used for antibiotic infusion, cerebrospinal fluid sampling, and intracranial physiological parameter acquisition. The monitoring function module is a portable microfluidic detection unit integrating a sampling preprocessing unit, a microfluidic chip, and a data transmission unit. The drug delivery control module integrates a microcontroller, a data processing unit, and a touchscreen to receive individual patient characteristic data, pathogen information, and monitoring data, generate individualized drug delivery plans, and output control signals. The drug administration module is used to receive control signals to perform drug administration operations and integrates a safety early warning unit; the data management module integrates a local storage unit, a real-time visualization unit, and a cloud data platform.

2. The adaptive intraventricular antibiotic delivery and efficacy monitoring system according to claim 1, characterized in that: The monitoring module integrates a microfluidic detection unit, which can be sealed and connected to the sampling catheter (5) of the intraventricular drug delivery catheter; the monitoring module can receive intracranial physiological indicators collected by the interventional adapter module.

3. The adaptive intraventricular antibiotic delivery and efficacy monitoring system according to claim 1, characterized in that: The drug delivery module includes an adult-sized infusion pump and a pediatric-sized infusion pump. Both types of infusion pumps are equipped with a unified medical-grade electrical control interface and tubing connection interface, which can be connected to the intraventricular drug delivery catheter and perform infusion under the control of the drug delivery control module. The internally integrated safety warning unit can trigger audible and visual alarms and automatically suspend drug delivery in response to risks such as excessive drug concentration or abnormal intracranial pressure.

4. The adaptive intraventricular antibiotic delivery and efficacy monitoring system according to claim 1, characterized in that: The standardized interfaces include a medical-grade Luer-locking conduit interface, a medical-grade waterproof aviation plug electrical interface, and a medical-grade encrypted data interface.

5. The adaptive intraventricular antibiotic delivery and efficacy monitoring system according to claim 1, characterized in that: The local storage unit automatically records basic patient information, medication records, monitoring data, early warning information, and operation logs; the real-time visualization unit intuitively presents changes in various indicators, details of the medication regimen, and the operating status of the equipment through a high-definition touch screen; the cloud data platform can anonymize patient privacy data and supports multi-center data sharing.

6. A ventricular drug delivery catheter, characterized in that: The catheter body (1) includes an inner cavity (101), a middle cavity (102), and an outer cavity (103) arranged coaxially, with the three cavities being independent of each other. The inner cavity (101) is an antibiotic injection channel, with inclined side holes (2) equidistantly arranged along the circumference at the proximal end. A one-way valve (302) is built into the posterior side of the side hole (2), and an infusion catheter (3) is fixedly connected to the distal end. The middle cavity (102) is a cerebrospinal fluid sampling channel. The posterior section of the middle cavity (102) is a solid structure, with a sampling catheter (5) embedded at the axial center of the solid section. The anterior section is a hollow annular cavity, with an annular filter membrane (4) fixedly installed inside the cavity. A miniature pressure sensor (6) and a miniature temperature sensor (7) are symmetrically fixed along the circumference inside the outer cavity (103). The distal end of the outer cavity (103) is sealed and has a signal interface for connecting to the sensors. A butterfly-shaped fixing piece (9) is integrally formed at the distal end of the catheter body (1).

7. The intraventricular drug delivery catheter according to claim 6, characterized in that: The infusion catheter (3) is fixedly equipped with a quick-connect check connector (301) at its tail end, and the quick-connect check connector (301) is adapted to the pipeline connection interface of the drug delivery module.

8. The intraventricular drug delivery catheter according to claim 6, characterized in that: The miniature pressure sensor (6) and the miniature temperature sensor (7) are connected to the signal interface of the outer cavity (103) through shielded signal lines, the outer side of which is covered with a medical-grade insulating layer.

9. The intraventricular drug delivery catheter according to claim 6, characterized in that: The butterfly-shaped fixation piece (9) has evenly distributed anti-slip grooves (901) on the surface facing the brain, and a circular suture hole is opened on the edge of the fixation piece.

10. The intraventricular drug delivery catheter according to claim 6, characterized in that: The annular filter membrane (4) is a medical sterile filter membrane (4), and the edge of the filter membrane (4) is sealed and fitted to the inner wall of the hollow annular cavity of the central cavity (102).

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