A method and system for anti-infective adjustable pressure hydrocephalus shunt

Abstract

This invention discloses a method and system for adjustable pressure hydrocephalus shunt therapy to combat infection, belonging to the field of medical device technology. This invention utilizes endogenous biological signals from cerebrospinal fluid as a core driver, deeply integrating anti-infection and pressure regulation functions into a synergistic closed-loop system. This method can simultaneously trigger targeted drug release and actively enhance drainage based on infection-related biomarkers and biochemical indicators. These two processes mutually promote each other, achieving a synergistic enhancement of therapeutic effects. Furthermore, when the microenvironment returns to normal, the system can automatically terminate the intervention, forming a complete adaptive regulation that ensures precise, efficient, and safe treatment. It can achieve precise targeted anti-infection while actively performing therapeutic drainage, thereby synergistically improving treatment efficacy and enhancing system autonomy and safety.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to an anti-infective adjustable pressure hydrocephalus shunt method and system. Background Technology

[0002] Hydrocephalus is a pathological condition caused by excessive production or impaired circulation and absorption of cerebrospinal fluid (CSF), leading to its abnormal accumulation within the ventricular system. It is often treated with CSF shunt surgery. CSF shunt procedures typically utilize a shunt device to drain the accumulated CSF from the intracranial cavity to other parts of the body, such as the abdominal cavity, to reduce intracranial pressure. A standard shunt device usually includes a ventricular end tube implanted in the ventricle, shunt valves to control the drainage rate and pressure, and a peritoneal end tube to drain the CSF distally.

[0003] To improve treatment efficacy and safety, existing technologies have been improved in two main areas. First, in terms of infection control, antibacterial substances such as silver ions and antibiotics are coated or impregnated onto the surface of the shunt tube to inhibit bacterial adhesion and biofilm formation in the early stages of implantation. Second, in terms of pressure regulation, an adjustable pressure shunt valve has been developed, allowing physicians to non-invasively adjust the valve's opening pressure post-operatively using an external magnetic field or implantable programmable electronic devices based on the patient's recovery progress, thus achieving more personalized pressure management.

[0004] Despite some advancements in existing technology, significant shortcomings remain. First, the effectiveness of coating-based anti-infection measures is limited; once the medication is depleted, the shunt loses its protective capability, failing to address the ongoing infection risk associated with long-term implantation. Second, the adjustment behavior of adjustable valves relies on intermittent assessment and manual operation by physicians, lacking automatic response capabilities to real-time changes in the patient's physiological and pathological state; its pressure regulation logic is completely disconnected from the infection status. Simply combining antibacterial coatings with adjustable valves is merely a superficial superposition of the two technologies' functions; they fail to create functional synergy and fail to fundamentally resolve the vicious cycle of infection and pressure imbalance. Summary of the Invention

[0005] The purpose of this invention is to provide an anti-infective adjustable pressure hydrocephalus shunt method and system, which solves the problems existing in the background art.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution: The first aspect of the present invention provides an anti-infection adjustable pressure hydrocephalus shunt method, comprising: S1, monitoring the concentration of preset infection-related biomarkers in cerebrospinal fluid and generating a real-time concentration signal, wherein the real-time concentration signal is specifically a signal set containing the concentrations of multiple infection-related biomarkers.

[0007] S2. When the real-time concentration signal exceeds a preset threshold, the intelligent drug release unit is triggered to release a preset antibacterial agent.

[0008] S3. Simultaneously detect preset biochemical parameters in cerebrospinal fluid and generate biochemical status signals.

[0009] S4. Based on the biochemical state signal and intracranial pressure signal, the cerebrospinal fluid drainage rate is dynamically adjusted through a dual-response pressure regulating valve.

[0010] S5. Based on the changes in biomarker concentrations and biochemical indicators of cerebrospinal fluid after drainage, generate environmental feedback signals.

[0011] S6. Use the environmental feedback signal to control the cessation of antibacterial agent release and the reset of the pressure regulating valve.

[0012] S7. Receive feedback waveforms and analyze waveform characteristic changes to indirectly monitor valve operating mode and local biochemical environment.

[0013] A second aspect of the present invention provides a system for performing the anti-infection adjustable pressure hydrocephalus shunt method of the present invention, comprising: a biomarker monitoring module for real-time detection of the concentration of preset infection-related biomarkers in cerebrospinal fluid.

[0014] The intelligent drug delivery module contains microcapsule structures encapsulated with responsive gel, which trigger the release of antibacterial agents in response to signals exceeding the concentration limit.

[0015] The dual-response pressure regulation module features valve materials that are sensitive to both intracranial pressure and preset biochemical indicators, and reduces the opening pressure threshold based on abnormal biochemical signals.

[0016] The closed-loop control module receives signals of changes in environmental parameters after drainage and coordinates the termination of drug release and valve reset operations.

[0017] The passive monitoring interface module, which includes an implantable marker and an external reader / writer, provides indirect feedback on the working status.

[0018] The dual-response pressure regulating module includes a pressure-sensitive unit, which is composed of a spring diaphragm forming the basic pressure response structure.

[0019] The biochemically sensitive unit is a deformation-driven component made of pH-responsive shape memory alloy.

[0020] The collaborative execution unit superimposes the displacement of the deformation driving component onto the preload of the spring diaphragm to achieve composite control of the opening pressure threshold.

[0021] The beneficial effects of this invention are as follows: By utilizing endogenous biological signals in cerebrospinal fluid as the core driver, this invention deeply integrates anti-infection and pressure regulation functions into a synergistic closed-loop system. This method can simultaneously trigger targeted drug release and actively enhance drainage based on infection-related biomarkers and biochemical indicators; the two mutually promote each other, achieving a synergistic enhancement of therapeutic effects. Furthermore, when the microenvironment returns to normal, the system can automatically terminate the intervention, forming a complete adaptive regulation that ensures precise, efficient, and safe treatment.

[0022] This invention enables early proactive intervention in infection and stress imbalance. The system can detect changes in the microscopic biochemical environment before the onset of routine clinical symptoms and initiate therapeutic drainage in advance. This proactive intervention mechanism not only accelerates pathogen clearance and enhances drug efficacy, but also effectively prevents secondary intracranial hypertension caused by infection, fundamentally reducing the risk of complications and improving patient prognosis.

[0023] This invention achieves a high degree of intelligence while ensuring high reliability and long-term safety of the implantation system. Its core intelligent response and control functions rely on passive intelligent materials and mechanical structures, avoiding the need for complex electronic components such as batteries and microprocessors implanted in the body. This design eliminates risks such as electronic malfunctions, electromagnetic interference, and power depletion at the source, significantly improving the long-term implantation stability and biocompatibility of the shunt device and reducing the need for secondary surgeries. Attached Figure Description

[0024] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0025] Figure 1 This is a schematic diagram of the implementation steps of the method of the present invention.

[0026] Figure 2 This is a schematic diagram of the system structure connection of the present invention.

[0027] Figure 3 This is a schematic diagram of the drug delivery unit of the present invention.

[0028] Figure 4 This is a schematic diagram of the operation of the dual-response pressure regulating valve of the present invention, taking diaphragm stiffness as an example. Detailed Implementation

[0029] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0030] Reference Figure 1 As shown, the present invention provides an anti-infection adjustable pressure hydrocephalus shunt method, comprising: S1, monitoring the concentration of preset infection-related biomarkers in cerebrospinal fluid and generating a real-time concentration signal, wherein the real-time concentration signal is specifically a signal set containing the concentrations of multiple infection-related biomarkers.

[0031] S2. When the real-time concentration signal exceeds a preset threshold, the intelligent drug release unit is triggered to release a preset antibacterial agent.

[0032] Reference Figure 3 As shown, in a specific embodiment of the present invention, the triggering intelligent drug release unit releases a preset antibacterial agent, which specifically includes: comparing the concentration of each marker in the signal set with a preset activation threshold, and combining the mapping table of infection types and the excess amount of each marker concentration in the data warehouse to identify the infection type corresponding to the real-time concentration signal, wherein the excess amount of each marker concentration is specifically the value of each marker concentration exceeding the preset activation threshold.

[0033] Activation of an infection-type-matched microcapsule structure from a variety of non-universal microcapsule structures in the intelligent drug delivery unit. The microcapsule structure is coated on the inner surface of the shunt tube and encapsulates a pre-set antimicrobial agent for a specific infection type. It is sealed by a specific responsive gel that is highly sensitive to the corresponding infection type biomarkers.

[0034] For example, type A microcapsule structures are sealed with a type A responsive gel sensitive to Gram-positive bacterial metabolites and loaded with vancomycin. Type B microcapsule structures, on the other hand, are sealed with a type B responsive gel sensitive to Gram-negative bacterial endotoxins and loaded with cefoperazone. When the system detects a Gram-positive bacterial infection, only the type A responsive gel specifically binds to high concentrations of the target biomarker.

[0035] The swelling effect of the responsive gel opens microcapsule channels, allowing for the targeted release of a pre-set antibacterial agent to the infected area. The triggering condition for releasing the pre-set antibacterial agent is as follows: ,when

[0036] in, The volume change rate, representing the responsive gel, is an indicator of the degree of microcapsule channel opening. The response function of the responsive gel stored in the data warehouse to stimuli is represented by the specific form of the gel material. It is the real-time concentration signal of a specific infection-related biomarker i obtained through monitoring. This is the activation threshold for distinguishing normal physiological fluctuations from pathological states for the biomarker i stored in the data warehouse. That is, once... Exceed ΔV increased significantly, and the microcapsule channels opened.

[0037] It should be noted that the specific binding of the microcapsule structure triggers a rapid change in the physicochemical properties of the responsive gel, namely, swelling. The responsive gel is a network of polymer molecules whose inter-chain cross-linking structure or hydrophilicity changes upon binding to the target biomarker, leading to rapid absorption of surrounding cerebrospinal fluid and a significant increase in volume. This controllable swelling physically opens or ruptures the microcapsule channels, acting as a gating switch for drug release.

[0038] S3. Simultaneously detect preset biochemical parameters in cerebrospinal fluid and generate biochemical status signals.

[0039] S4. Based on the biochemical state signal and intracranial pressure signal, the cerebrospinal fluid drainage rate is dynamically adjusted through a dual-response pressure regulating valve.

[0040] In a specific embodiment of the present invention, the dynamic adjustment of the cerebrospinal fluid drainage rate specifically includes: when the biochemical state signal is abnormal, adjusting the opening pressure threshold of the dual-response pressure regulating valve to a preset low level.

[0041] Increasing cerebrospinal fluid drainage accelerates the flushing of infected foci and promotes the spread of antibacterial agents.

[0042] When the biochemical status signal returns to normal, the pressure threshold will be reset to the preset baseline level.

[0043] Reference Figure 4 As shown, specifically, the method for dynamically adjusting the cerebrospinal fluid drainage rate begins with continuous monitoring of the cerebrospinal fluid biochemical environment. Pre-defined biochemical parameters of the cerebrospinal fluid, such as pH value or the concentration of specific inflammatory factors, are acquired in real time using integrated micro-sensors and converted into continuous biochemical state signals. When an infection occurs, bacterial metabolites cause a decrease in local pH value, or an inflammatory response leads to an increase in the concentration of specific factors. The resulting biochemical state signal deviates from the preset normal physiological range, constituting an abnormal signal.

[0044] The abnormal biochemical state signal directly affects the dual-response pressure regulating valve. The valve's core components, such as elements controlling diaphragm deformation or spring preload, are made of smart materials sensitive to both physical pressure and biochemical signals, such as pH-responsive polymers or shape memory alloys sensitive to specific ions. Upon receiving the abnormal biochemical state signal, the molecular structure or crystal configuration of this smart material undergoes a pre-defined reversible change, leading to changes in its mechanical properties, such as elastic modulus or intrinsic shape. This change alters the valve's internal mechanical balance, essentially reducing the force required to resist cerebrospinal fluid pressure and maintain valve closure. As a result, the valve's opening pressure threshold is automatically adjusted and lowered to a pre-defined low level. This process can be described as follows:

[0045]

[0046] in, This is the real-time opening pressure threshold for the valve. This is a preset baseline setting for doctors based on the patient's routine intracranial pressure, representing the baseline pressure adjustment value. This is the amount of pressure threshold reduction triggered by biochemical state signals. It is determined by the deviation between the biochemical state signal S_bio and its normal reference value S_norm, through the characteristic conversion function g of the smart material. Under normal physiological conditions, S_bio equals S_norm. When S_bio is zero, the valve operates according to P_base. When an infection occurs, S_bio deviates from S_norm. This makes it a positive value, thus reducing P_open.

[0047] With a lowered opening pressure threshold, the shunt valve opens more easily even if the patient's intracranial pressure does not increase significantly, thereby increasing cerebrospinal fluid drainage. This enhanced drainage plays a crucial physical flushing role, accelerating the removal of pathogens, toxins, and inflammatory debris from the infected area. More importantly, this increased cerebrospinal fluid flow synergistically enhances the distribution of the pre-set antibacterial agent released by the intelligent drug delivery unit within the ventricular system, allowing it to reach the infection site more quickly and evenly, thus working in conjunction with the chemical bactericidal effect of the drug.

[0048] Once anti-infection measures take effect, the biochemical environment of the cerebrospinal fluid begins to return to normal, and the biochemical state signals also return to the preset normal range. Smart materials sense this change and automatically restore their initial physical and mechanical properties. This leads to a reduction in the pressure threshold. Once reset to zero, the valve's opening pressure threshold is precisely adjusted back to the preset reference level, and the drainage rate returns to normal.

[0049] In a specific embodiment of the present invention, the adjustment process of the dual-response pressure regulating valve includes: receiving an intracranial pressure signal to control the opening degree of the basic valve.

[0050] The biochemical state signal triggers a change in the physical properties of the valve material.

[0051] By superimposing material deformation on the valve diaphragm, a composite regulation of the opening pressure is achieved.

[0052] Specifically, the regulation process of a dual-response pressure regulating valve is a precise mechanical balance system, the core of which lies in the fusion processing of two signals of different natures. First, the valve's basic pressure regulating function is achieved by receiving intracranial pressure signals. When the hydrostatic pressure generated by intracranial pressure acts on the valve diaphragm, it creates an opening force. This opening force counteracts the closing force preset inside the valve, generated by the spring or the elasticity of the diaphragm itself. Only when the opening force indicated by the intracranial pressure signal exceeds the closing force will the valve open to allow cerebrospinal fluid drainage; this is the valve's basic opening control.

[0053] Based on this, proactive intervention is achieved by receiving biochemical state signals to trigger changes in the physical properties of valve materials. When abnormal biochemical state signals related to infection or inflammation are detected, the signal is transmitted to intelligent material components within the valve, such as an embedded spring system or a shape memory alloy actuator directly linked to the valve diaphragm. Upon receiving the abnormal biochemical state signal, the actuator undergoes a phase transition in its internal microstructure, resulting in a pre-defined and precise material deformation on a macroscopic scale.

[0054] The displacement or force generated by this material deformation will act superimposed on the valve diaphragm, equivalent to introducing an auxiliary opening force or reducing the original basic closing force. This superimposed effect changes the original mechanical balance, thereby achieving a composite regulation of the opening pressure. The mechanical balance of the entire composite regulation can be understood as follows: .

[0055] Here, P_open represents the actual opening pressure threshold of the valve. F_base is the preset closing force of the valve under normal physiological conditions, determined by its mechanical structure; specifically, it is the baseline pressure adjustment level set by the doctor. F_aux is the auxiliary opening force triggered by biochemical signals and generated through material deformation; its value is zero under normal conditions. A is the effective pressure-bearing area of ​​the valve diaphragm. Through this mechanism, abnormal biochemical signals are converted into a specific mechanical quantity F_aux, which directly participates in the valve's pressure regulation decision.

[0056] This method transforms the valve from a simple pressure relief device into a regulator capable of understanding the physiological environment and making intelligent judgments. By receiving dual signals from intracranial pressure and biochemical status, the valve achieves two-dimensional control of cerebrospinal fluid drainage, meeting both pressure management needs under normal conditions and proactively executing interventional drainage strategies under pathological conditions. This composite regulatory mechanism enables the system to take action in the early stages of infection, before intracranial pressure decompensation, combining physical intervention with drug therapy, demonstrating remarkable foresight and proactivity. Finally, the passive design of this material deformation superimposed on the valve diaphragm ensures the system's high reliability and long-term stability, significantly improving the accuracy and safety of hydrocephalus shunt therapy.

[0057] This invention utilizes endogenous biological signals in cerebrospinal fluid as a core driver to deeply integrate anti-infection and pressure regulation functions into a synergistic closed-loop system. This method can simultaneously trigger targeted drug release and actively enhance drainage based on infection-related biomarkers and biochemical indicators; these two processes mutually promote each other, achieving a synergistic enhancement of therapeutic effects. Furthermore, when the microenvironment returns to normal, the system automatically terminates the intervention, forming a complete adaptive regulation that ensures precise, efficient, and safe treatment.

[0058] This invention enables early proactive intervention in infection and stress imbalance. The system can detect changes in the microscopic biochemical environment before the onset of routine clinical symptoms and initiate therapeutic drainage in advance. This proactive intervention mechanism not only accelerates pathogen clearance and enhances drug efficacy, but also effectively prevents secondary intracranial hypertension caused by infection, fundamentally reducing the risk of complications and improving patient prognosis.

[0059] S5. Based on the changes in biomarker concentrations and biochemical indicators of cerebrospinal fluid after drainage, generate environmental feedback signals.

[0060] In a specific embodiment of the present invention, the generation of the environmental feedback signal specifically includes: detecting the rate of decrease in biomarker concentration after drainage and generating an infection control signal.

[0061] The system monitors the time it takes for biochemical indicators to return to the preset normal range, generating an environmental stability signal.

[0062] The infection control signal and the environmental stability signal are combined to generate a closed-loop control command.

[0063] Specifically, the process of generating environmental feedback signals is a multi-dimensional, dynamic evaluation process designed to accurately assess the effectiveness of anti-infection and blood pressure regulation interventions and provide a basis for subsequent closed-loop control decisions. This process begins with the continuous monitoring of key biomarker concentrations in post-drainage cerebrospinal fluid samples. The system compares the real-time biomarker concentration data with data prior to treatment and calculates the rate of decline. When the rate of change of biomarker concentration over time, i.e., its first derivative, reaches or exceeds a preset negative threshold, the system determines that the infection has been effectively controlled and generates a clear infection control signal. This signal indicates that the pathogen load is rapidly decreasing.

[0064] Simultaneously, the system continuously monitors the biochemical indicators of the cerebrospinal fluid after drainage, such as pH value. By monitoring the time required for these biochemical indicators to return to the preset normal range, the system can assess the overall improvement of the local microenvironment. When key indicators such as pH value enter and stabilize within the preset normal physiological range, such as pH 7.35 to 7.45, and remain there for the preset duration, the system generates an environmental stabilization signal. This signal indicates that the pathological state such as local acidosis caused by infection has been reversed, and the tissue microenvironment is stabilizing.

[0065] Ultimately, the system fuses these two complementary signals, which are different in nature, to generate a comprehensive closed-loop control command. This fusion process is not a simple logical AND operation, but a weighted decision model. For example, the system may prioritize the achievement of the infection control signal; once generated, it prepares to execute the command to stop drug release. The generation of the environmental stability signal serves as the final condition for confirming that the valve pressure has returned to the baseline level. The fused closed-loop control command contains precise, step-by-step control information for both the drug release unit and the pressure regulating valve subsystems. The fusion logic can be abstractly represented as follows: .

[0066] in, This represents the strength or priority of the final generated closed-loop control command. This is a quantified infection control signal, such as the ratio of the rate of decrease in concentration to a threshold. This refers to the quantized environmental stability signal, for example, the ratio of the stability duration to the preset duration. and These are the weighting coefficients for the quantified infection control signal and environmental stability signal, respectively, pre-set by clinical experience and system design. That is, when... When the execution threshold is exceeded, subsequent control actions are triggered.

[0067] By separately assessing pathogen clearance rate and microenvironment recovery status, the system can comprehensively and accurately grasp the treatment progress from two key dimensions, avoiding premature or delayed intervention termination that might be caused by judging based on a single indicator. The system integrates infection control signals and environmental stability signals to generate closed-loop control commands, ensuring that the withdrawal timing of the drug release and pressure regulation systems is coordinated and optimal. This guarantees complete eradication of the infection while minimizing unnecessary intervention time. This not only improves the safety and effectiveness of treatment but also demonstrates the system's high degree of autonomy and intelligence, truly forming a complete feedback loop from intervention to assessment to adjustment.

[0068] In a specific embodiment of the present invention, the execution of the closed-loop control command includes: triggering responsive gel contraction to close the microcapsule channels when the infection control signal reaches a preset standard.

[0069] When the environmental stability signal continues for a preset duration, the deformation state of the dual-response material is released.

[0070] The reference drainage pressure is restored by the elastic reset of the valve diaphragm.

[0071] Specifically, the execution of closed-loop control commands is a phased, coordinated process designed to smoothly transition the system from an active intervention state back to a routine monitoring state.

[0072] First, when the system receives a closed-loop control command generated from environmental feedback signals and whose intensity meets a preset standard, the command preferentially acts on the intelligent drug delivery unit. Specifically, when the infection control signal portion of the command confirms a significant decrease in biomarker concentration, it means that the concentration of the target molecule activating the responsive gel has decreased, and the driving force of the swelling effect previously caused by binding to the target molecule has weakened. This triggers a conformational change in the molecular chains of the responsive gel, gradually restoring it from a swollen state to a dense, contracted state. The gel's contraction process physically closes or re-blocks previously opened microcapsule channels, effectively halting further release of the preset antibacterial agent.

[0073] Subsequently, or in parallel under certain preset logic, the environmental stabilization signal portion of the closed-loop control command begins to act on the dual-response pressure regulating valve. Once this signal confirms that biochemical indicators such as the pH value of the cerebrospinal fluid have remained consistently stable within the normal range, the biochemical stimulation previously acting on the valve's intelligent material components is released. Taking shape memory alloys as an example, the restoration of a normal environment means that the temperature or chemical environment in which they are located has returned to the conditions that triggered their initial shape memory. Therefore, the alloy actuator automatically undergoes a reverse phase transition, thereby precisely releasing its previously generated deformation state, and the auxiliary opening force F_aux generated by it also disappears.

[0074] Finally, as the smart material component returns to its initial shape and physical properties, its superimposed force on the valve diaphragm is completely removed. At this point, the mechanical balance controlling the valve's opening and closing is entirely determined by the opening force generated solely by the intracranial pressure signal and the valve diaphragm's own elastic closing force. The valve diaphragm achieves precise repositioning under its own elasticity, allowing the valve's opening pressure threshold to automatically and smoothly return to the doctor's initially set preset baseline drainage pressure. Thus, the entire system's anti-infection and active pressure regulation intervention completes a full self-limiting closed loop, and the system returns to its conventional basic monitoring and pressure regulation mode, responding only to intracranial pressure.

[0075] The technical effect of this method is that it enables the autonomous and safe withdrawal of system interventions, forming the final link in an intelligent closed loop. By closing the drug release channel through the contraction of the responsive gel, drug exposure is ensured to cease immediately after the task is completed, avoiding unnecessary drug use and potential side effects. Simultaneously, the release of the deformation state of the dual-responsive material and the elastic reset of the valve diaphragm ensure that the pressure regulating system can accurately and reliably return to its basic operating mode, effectively preventing the risk of continued excessive drainage after infection control. The entire process requires no external intervention, demonstrating the system's high degree of autonomy and precise response to changes in the physiological environment. This ensures that the treatment process is both highly efficient and self-limiting, greatly improving the safety of long-term implantation therapy and the patient's quality of life.

[0076] S6. Use the environmental feedback signal to control the cessation of antibacterial agent release and the reset of the pressure regulating valve.

[0077] S7. Receive feedback waveforms and analyze waveform characteristic changes to indirectly monitor valve operating mode and local biochemical environment.

[0078] In a specific embodiment of the present invention, the specific content of S7 is: implanting a passive marker under the skin, wherein the passive marker produces a characteristic response to a magnetic field or sound wave.

[0079] The passive marker is excited by an external device and a feedback waveform is received.

[0080] Analyze waveform characteristics to indirectly monitor valve operating modes and local biochemical environment.

[0081] Specifically, the method provides a non-invasive means of monitoring the internal state of an implant. First, during the system manufacturing phase, one or more passive markers are integrated into key subcutaneous components of the shunt system, such as the wall of a reservoir or the housing of a pressure regulating valve. The passive marker is a special material that does not contain a power source itself but produces a predictable and characteristic response to a specific external energy field. For example, it could be an LC circuit with a specific resonant frequency, i.e., an inductor-capacitor circuit, or an acoustic material with strong reflection or scattering properties for ultrasound waves of a specific frequency.

[0082] When in vitro monitoring is required, doctors or technicians use a specialized external device. This device is a handheld probe that emits electromagnetic fields or sound waves of a specific frequency. The operator holds the device close to the patient's skin surface, aligns it with the location of the subcutaneous passive marker, and initiates energy emission. The emitted energy field penetrates the skin tissue and couples or interacts with the implanted passive marker.

[0083] Under the excitation of an energy field, passive markers generate a feedback waveform. For example, an LC circuit marker will produce a weak electromagnetic radiation signal at its resonant frequency, while an acoustic marker will reflect or scatter a portion of the incident sound waves. An external device also has a receiving function, capturing the weak feedback waveform transmitted from within the body. This feedback waveform carries crucial information about the passive marker and the state of its microenvironment.

[0084] Finally, the signal processing unit built into the external device analyzes the received feedback waveform. By analyzing specific parameters of the waveform, such as frequency, amplitude, phase, or decay time, the internal state of the implant can be indirectly inferred. For example, if the valve enters a pre-warning drainage mode, the deformation of its internal smart material may slightly alter the physical dimensions or electromagnetic properties of the attached marker, resulting in a measurable drift in its resonant frequency. Similarly, changes in the local biochemical environment, such as pH changes, may affect the dielectric constant or acoustic impedance of the marker material itself, thereby altering the decay characteristics of the feedback waveform. By comparing the analyzed waveform characteristics with a pre-calibrated database, a non-invasive, indirect assessment of the valve's operating mode and the local biochemical environment can be achieved.

[0085] In a specific embodiment of the present invention, the analysis of waveform feature changes specifically includes: identifying waveform frequency offset to determine whether the valve is in a low-gear warning diversion mode.

[0086] The waveform decay rate was detected to assess the degree of local pH recovery.

[0087] Optimize closed-loop control parameters by combining the status of the early warning and diversion mode and the degree of pH recovery.

[0088] Specifically, the process of analyzing waveform feature changes to obtain implant status information involves refined data processing of the feedback waveforms received by the external device.

[0089] First, the system performs spectral analysis on the received feedback waveform to identify the frequency offset. When the dual-response pressure regulating valve enters the warning drainage mode due to receiving an abnormal biochemical state signal, the deformation of its internal smart material slightly alters the physical structure or electromagnetic properties of the coupled passive marker. This change causes a small but measurable drift in the marker's resonant frequency. The frequency offset is calculated by comparing the currently measured resonant frequency with a pre-calibrated reference resonant frequency of the device under normal conditions. When the frequency offset exceeds a preset threshold, the system determines that the valve is currently in a low-level warning drainage mode. (Slope offset) The relationship with state S can be expressed as:

[0090]

[0091] in, It is the frequency offset. This is the currently measured frequency. is the reference frequency. k is the coupling coefficient stored in the data warehouse, which depends on the design of the markers and how they are connected to the smart materials. It is a function representing the relationship between the deformation of a smart material and its driving signal S, i.e., the biochemical state signal.

[0092] The above This represents the deformation of a smart material and its driving signal S. Specifically, it can be understood as a quantitative characterization of how changes in S cause changes in the deformation of the smart material. The specific form is determined by the inherent characteristics of the smart material, and its core features include the correspondence between input and output. The independent variable is S, and the dependent variable is a deformable variable. For example, if the response of a smart material to S is linear, then... If the smart material exhibits a threshold effect, then... It is a piecewise function and is invertible. The specific settings were determined by the experimenters at the beginning of the design and will not be elaborated here.

[0093] Secondly, the system detects the decay rate of the waveform to assess the degree of local pH recovery. The pH of cerebrospinal fluid affects its conductivity and acoustic properties. As the infection is controlled and the local pH returns from acidic to the normal physiological range, the electromagnetic or acoustic properties of the medium surrounding the marker also change, directly affecting the energy decay rate of the feedback waveform. This is achieved by measuring the rate at which the amplitude of the feedback waveform decreases over time, i.e., its time constant. The pH recovery rate of the local environment is indirectly inferred by comparing it with the decay rate calibrated at different pH values ​​in the database.

[0094] Finally, the system integrates the parsed information, namely the status of the early warning drainage mode and the degree of pH recovery, to optimize the built-in closed-loop control parameters.

[0095] For example, if the system detects that the valve is still in the warning drainage mode, but the pH level has almost returned to normal, this may mean that the pathological stimulus is about to disappear. In this case, it is recommended that clinicians, or through internal algorithms, appropriately adjust the trigger threshold of subsequent closed-loop control commands to make them more sensitive so that the valve can be reset more quickly after the environment has fully recovered. This combined analysis allows the system to also make certain predictions about future trends, thereby dynamically optimizing the internal adaptive control logic.

[0096] This method significantly enhances the information dimensionality and clinical value of non-invasive monitoring. Through in-depth analysis of multi-dimensional waveform characteristics, it provides quantitative information about different subsystems within the system, such as voltage regulation and microenvironment status. By identifying frequency offsets and detecting attenuation rates, physicians can gain a more comprehensive and accurate understanding of the treatment process. More importantly, combining this information to optimize closed-loop control parameters imbues the entire system with a higher level of intelligence. It can fine-tune its internal autonomous control strategies based on external monitoring feedback, thereby achieving more personalized and proactive treatment management and further improving the safety and effectiveness of treatment.

[0097] Reference Figure 2 As shown, a second aspect of the present invention provides a system for performing the anti-infection adjustable pressure hydrocephalus shunt method of the present invention, comprising: a biomarker monitoring module for real-time detection of the concentration of preset infection-related biomarkers in cerebrospinal fluid.

[0098] The intelligent drug delivery module contains microcapsule structures encapsulated with responsive gel, which trigger the release of antibacterial agents in response to signals exceeding the concentration limit.

[0099] The dual-response pressure regulation module features valve materials that are sensitive to both intracranial pressure and preset biochemical indicators, and reduces the opening pressure threshold based on abnormal biochemical signals.

[0100] The closed-loop control module receives signals of changes in environmental parameters after drainage and coordinates the termination of drug release and valve reset operations.

[0101] The passive monitoring interface module, which includes an implantable marker and an external reader / writer, provides indirect feedback on the working status.

[0102] In a specific embodiment of the present invention, the dual-response pressure regulating module includes: a pressure-sensitive unit, which is composed of a spring diaphragm forming a basic pressure response structure.

[0103] The biochemically sensitive unit is a deformation-driven component made of pH-responsive shape memory alloy.

[0104] The collaborative execution unit superimposes the displacement of the deformation driving component onto the preload of the spring diaphragm to achieve composite control of the opening pressure threshold.

[0105] This invention achieves a high degree of intelligence while ensuring high reliability and long-term safety of the implantation system. Its core intelligent response and control functions rely on passive intelligent materials and mechanical structures, avoiding the need for complex electronic components such as batteries and microprocessors implanted in the body. This design eliminates risks such as electronic malfunctions, electromagnetic interference, and power depletion at the source, significantly improving the long-term implantation stability and biocompatibility of the shunt device and reducing the need for secondary surgeries.

[0106] It should also be added that the various thresholds described in this invention are always set around the core objective of distinguishing between the normal physiological state and the pathological state of cerebrospinal fluid infection. Specifically: on the one hand, based on the normal fluctuation range of biomarker concentrations in the cerebrospinal fluid of healthy individuals, such as the content of Gram-positive metabolites and biochemical indicators such as pH 7.35-7.45, from a large amount of clinical data, critical values ​​for pathological states are determined, such as the activation threshold of biomarker concentration during infection and the judgment threshold for abnormal biochemical indicators. On the other hand, combined with the response characteristics of smart materials, such as the minimum concentration stimulation for responsive gel swelling, the minimum biochemical signal intensity for shape memory alloy deformation, and the treatment safety window, such as the lower limit of the pressure threshold to avoid excessive drainage and the upper limit of the concentration threshold to ensure effective release of antibacterial agents, specific values ​​are determined through experimental calibration and clinical verification. This multi-dimensional setting method based on physiological laws, material characteristics, and clinical needs ensures that the thresholds can accurately identify microscopic changes in the early stage of infection while avoiding false triggering or insufficient treatment, thus possessing solid scientific basis and practical operability.

[0107] The above content is merely an example and illustration of the concept of the present invention. Those skilled in the art can make various modifications or additions to the specific embodiments described, or use similar methods to replace them, as long as they do not deviate from the concept of the invention or exceed the scope defined by the present invention, and all such modifications and additions should fall within the protection scope of the present invention.

Claims

1. An anti-infective adjustable pressure hydrocephalus shunt system, characterized in that, include: A biomarker monitoring module is used to monitor the concentration of preset infection-related biomarkers in cerebrospinal fluid and generate a real-time concentration signal. Specifically, the real-time concentration signal is a set of signals containing the concentrations of multiple infection-related biomarkers. The intelligent drug release execution module includes a microcapsule structure coated with a responsive gel, which is used to trigger the intelligent drug release unit to release a preset antibacterial agent when the real-time concentration signal exceeds a preset threshold; Miniature sensors are used to simultaneously detect preset biochemical parameters in cerebrospinal fluid and generate biochemical state signals. The dual-response pressure regulating module has a valve material that is sensitive to both intracranial pressure and preset biochemical indicators. It is used to dynamically adjust the cerebrospinal fluid drainage rate based on the biochemical state signal and the intracranial pressure signal through the dual-response pressure regulating valve. The dual-response voltage regulation module includes: The pressure-sensitive unit consists of a spring diaphragm forming the basic pressure response structure. The biochemically sensitive unit is a deformation-driven component made of a pH-responsive shape memory alloy. The collaborative execution unit superimposes the displacement of the deformation driving component onto the preload of the spring diaphragm to achieve composite control of the opening pressure threshold. The closed-loop control module is used to control the cessation of antibacterial agent release and the reset of the pressure regulating valve using environmental feedback signals; The environmental feedback signal is generated based on changes in the concentration of biomarkers and changes in biochemical indicators of the cerebrospinal fluid after drainage. The passive monitoring interface module, which includes an implantable marker and an external reader / writer, provides indirect feedback on the working status. It is used to receive feedback waveforms and analyze changes in waveform characteristics to indirectly monitor the valve's working mode and local biochemical environment.

2. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 1, characterized in that, The triggering intelligent drug release unit releases a preset antibacterial agent, the specific contents of which include: By comparing the concentration of each marker in the signal set with a preset activation threshold, the infection type corresponding to the real-time concentration signal is identified; Activate a microcapsule structure matching the infection type from a variety of non-universal microcapsule structures in the intelligent drug delivery unit. The microcapsule structure is covered on the inner surface of the shunt tube and encapsulates a pre-set antimicrobial agent for a specific infection type. It is sealed by a specific responsive gel that is highly sensitive to the corresponding infection type biomarkers. The swelling effect of the responsive gel opens microcapsule channels, allowing for the targeted release of a pre-set antibacterial agent to the infected area. The triggering condition for releasing the pre-set antibacterial agent is as follows: ,when in, The volume change rate, representing the responsive gel, is an indicator of the degree of microcapsule channel opening. The response function of the responsive gel stored in the data warehouse to stimuli is represented by the specific form of the gel material. It is the real-time concentration signal of a specific infection-related biomarker i obtained through monitoring; This is the activation threshold for distinguishing normal physiological fluctuations from pathological states for the biomarker i stored in the data warehouse.

3. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 1, characterized in that, The specific content of the dynamic adjustment of cerebrospinal fluid drainage rate includes: When the biochemical state signal is abnormal, adjust the opening pressure threshold of the dual-response pressure regulating valve to the preset low level; Increasing cerebrospinal fluid drainage accelerates the flushing of the infection site and promotes the spread of antibacterial agents. When the biochemical status signal returns to normal, the pressure threshold will be reset to the preset baseline level.

4. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 3, characterized in that, The regulating process of the dual-response pressure regulating valve includes: Receives intracranial pressure signals to control the opening of basic valves; Receive biochemical state signals to trigger changes in the physical properties of valve materials; By superimposing material deformation on the valve diaphragm, a composite regulation of the opening pressure is achieved. The mechanical balance of this composite regulation can be understood as follows: ; Wherein, P_open represents the actual opening pressure threshold of the valve; F_base is the preset closing force of the valve under normal physiological conditions, determined by its mechanical structure; F_aux is the auxiliary opening force generated by material deformation triggered by biochemical state signals, and its value is zero under normal conditions; A is the effective pressure-bearing area of ​​the valve diaphragm. Through this mechanism, abnormal biochemical state signals are converted into a specific mechanical quantity F_aux, which directly participates in the valve's pressure regulation decision.

5. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 1, characterized in that, The environmental feedback signal specifically includes the following content: Detect the rate of decrease in biomarker concentrations after drainage to generate infection control signals; The system monitors the time it takes for biochemical indicators to return to the preset normal range, generating an environmental stabilization signal. The infection control signal and the environmental stability signal are fused to generate a closed-loop control command. The fusion logic is expressed as follows: ; in, This represents the strength or priority of the final generated closed-loop control command; This is a quantified infection control signal; This is the quantized environmental stability signal; and The weighting coefficients for the quantified infection control signal and environmental stability signal are pre-set based on clinical experience and system design.

6. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 5, characterized in that, The execution of the closed-loop control command includes: When the infection control signal reaches a preset standard, it triggers responsive gel contraction to close the microcapsule channels; When the environmental stability signal continues for a preset duration, the deformation state of the dual-response material is released; The reference drainage pressure is restored by the elastic reset of the valve diaphragm.

7. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 1, characterized in that, The passive monitoring interface module contains the following features: A passive marker is implanted subcutaneously, which produces a characteristic response to a magnetic field or sound wave; The passive marker is excited by an external device and a feedback waveform is received. Analyze waveform characteristics to indirectly monitor valve operating modes and local biochemical environment.

8. The anti-infective adjustable pressure hydrocephalus shunt system according to claim 7, characterized in that, The specific content of the analyzed waveform feature changes includes: Identify waveform frequency offset to determine whether the valve is in a low-gear warning diversion mode; The waveform decay rate was detected to assess the degree of local pH recovery. Optimize closed-loop control parameters by combining the status of the early warning and diversion mode and the degree of pH recovery.

Images