Anti-infection pressure-adjustable hydrocephalus shunting method and system

Abstract

The invention discloses an anti-infection pressure-adjustable hydrocephalus shunting method and system, relates to the technical field of medical instruments, and aims to deeply integrate anti-infection and pressure-adjusting functions into a collaborative response closed-loop system by taking a cerebrospinal fluid endogenous biological signal as a core drive. According to the method, targeted drug release and active enhanced drainage can be synchronously triggered according to biomarkers and biochemical indexes related to infection, and the targeted drug release and the active enhanced drainage are mutually promoted, so that the treatment effect is synergistically enhanced. Moreover, when the microenvironment returns to normal, the system can automatically stop intervention, complete self-adaptive adjustment is formed, accurate, efficient and safe treatment is ensured, and therapeutic drainage can be actively executed while accurate targeted infection resistance is achieved, so that the therapeutic effect is cooperatively improved, and the autonomy and safety of the system are enhanced.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to an anti-infection adjustable pressure hydrocephalus shunt method and system. BACKGROUND

[0002] Hydrocephalus is a pathological state caused by excessive production of cerebrospinal fluid or blockage of circulation and absorption, leading to abnormal accumulation of cerebrospinal fluid in the ventricular system. Cerebrospinal fluid shunt surgery is often used for treatment. The cerebrospinal fluid shunt method usually uses a set of shunt devices to drain the intracranial accumulated cerebrospinal fluid 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, a shunt valve for controlling the drainage rate and pressure, and an abdominal end tube for draining cerebrospinal fluid to the distal end.

[0003] To improve treatment effectiveness and safety, the prior art has mainly improved in two directions. One is in the aspect of anti-infection, by coating or dipping silver ions, antibiotics and other antibacterial substances on the surface of the shunt tube, in order to inhibit bacterial adhesion and biofilm formation in the early stage of implantation. The second is in the aspect of pressure regulation, adjustable pressure shunt valves are developed, allowing doctors to non-invasively adjust the opening pressure of the valve after surgery through external magnetic fields or implanted programmable electronic devices, according to the recovery of the patient, to achieve more personalized pressure management.

[0004] Although the prior art has made some progress, there are still obvious defects. First, the anti-infection means based on coating has a limited effect, and after the drug is depleted, the shunt tube loses its protective ability and cannot cope with the risk of continuous infection faced by long-term implantation. Second, the adjustment behavior of the adjustable pressure valve depends on the intermittent evaluation and manual operation of the doctor, and lacks the ability to automatically respond to changes in the patient's physiological and pathological state in real time, and its pressure regulation logic is completely disconnected from the infection state. Simply combining antibacterial coating with adjustable pressure valve is only a simple superposition of the functions of the two technologies, and they cannot form a functional linkage and synergistic effect, and cannot fundamentally solve the vicious cycle problem of the mutual influence of infection and pressure imbalance. SUMMARY

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

[0006] To solve the above technical problems, the present application adopts the following technical scheme: the present application provides an anti-infection adjustable pressure hydrocephalus shunt method in the first aspect, comprising: S1, monitoring the concentration of a predetermined infection-related biomarker in cerebrospinal fluid to generate a real-time concentration signal, the real-time concentration signal being a signal set containing the concentrations of multiple infection-related biomarkers.

[0007] S2, triggering the intelligent drug release unit to release the preset antibacterial agent when the real-time concentration signal exceeds the preset threshold.

[0008] S3, synchronously detecting a preset biochemical index parameter in the cerebrospinal fluid to generate a biochemical state signal.

[0009] S4, based on the biochemical state signal and the intracranial pressure signal, dynamically adjusting the cerebrospinal fluid drainage rate through a double-response pressure regulating valve.

[0010] S5, generating an environmental feedback signal according to the changes in the biomarker concentration and the biochemical index of the cerebrospinal fluid after drainage.

[0011] S6, using the environmental feedback signal to control the termination of antibacterial agent release and the resetting of the pressure regulating valve.

[0012] S7, receiving the feedback waveform and analyzing the changes in the waveform characteristics to indirectly monitor the valve working mode and the local biochemical environment.

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

[0014] An intelligent drug release execution module includes a microcapsule structure coated with a responsive gel that triggers the release of antibacterial agents in response to the concentration exceeding signal.

[0015] A double-response pressure regulating module has a valve material that is sensitive to both intracranial pressure and a preset biochemical index, and reduces the opening pressure threshold based on the biochemical abnormality signal.

[0016] A closed-loop control module receives the environmental parameter change signal after drainage and coordinates the termination of drug release and valve resetting operations.

[0017] A passive monitoring interface module includes an implantable marker and an external reading and writing device to provide indirect feedback on the working state.

[0018] The double-response pressure regulating module includes: a pressure-sensitive unit composed of a spring diaphragm as a basic pressure response structure.

[0019] A biochemical-sensitive unit is composed of a pH-responsive shape memory alloy as a deformation driving component.

[0020] A cooperative execution unit adds the displacement of the deformation driving component to the pre-tightening force of the spring diaphragm to realize composite regulation of the opening pressure threshold.

[0021] The beneficial effects of the present invention lie in its ability to leverage endogenous cerebrospinal fluid biosignals as a core driver, deeply integrating anti-infection and pressure-regulating 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, mutually reinforcing each other and achieving a synergistic enhancement of therapeutic efficacy. Furthermore, when the microenvironment returns to normal, the system automatically terminates intervention, forming a complete adaptive regulation system that ensures precise, efficient, and safe treatment.

[0022] This invention enables early, proactive intervention for infection and pressure imbalance. The system can sense changes in the microbiochemical environment before common clinical symptoms appear and initiate therapeutic drainage mode 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 outcomes.

[0023] This invention achieves a high level of intelligence while ensuring the high reliability and long-term safety of the implant system. Its core intelligent response and control functions rely on passive smart materials and mechanical structures, avoiding the need for complex electronic components such as batteries and microprocessors to be implanted in the body. This design eliminates the risks of electronic failure, electromagnetic interference, and power failure at the source, significantly improving the long-term implant stability and biocompatibility of the shunt device and reducing the need for secondary surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0025] Figure 1 The figure is a flow chart of the steps for implementing 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 Schematic diagram of the working of the drug release unit of the present invention.

[0028] Figure 4 This is a working schematic diagram of the dual-responsive pressure regulating valve of the present invention, taking diaphragm stiffness as an example. DETAILED DESCRIPTION

[0029] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts 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, including: 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-releasing unit is triggered to release a preset antimicrobial 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, and its specific content includes: by comparing the concentration of each marker in the signal set with the preset activation threshold, and combining the mapping table of the infection type and the excess concentration of each marker in the data warehouse to identify the infection type corresponding to the real-time concentration signal, the excess concentration of each marker is specifically the value of the concentration of each marker exceeding the preset activation threshold.

[0033] A microcapsule structure that matches the infection type is activated from a variety of non-universal microcapsule structures in the smart drug dispensing unit. The microcapsule structure is coated on the inner surface of the shunt tube. The microcapsule structure encapsulates a preset antibacterial agent for a specific infection type and is sealed by a specific responsive gel that is highly sensitive to the biomarkers of the corresponding infection type.

[0034] For example, a Class A microcapsule structure is sealed with a Class A responsive gel sensitive to Gram-positive bacterial metabolites and loaded with vancomycin. Meanwhile, a Class B microcapsule structure is sealed with a Class B responsive gel sensitive to Gram-negative bacterial endotoxins and loaded with cefoperazone. When the system identifies a Gram-positive infection, only the Class A responsive gel will specifically bind to the high concentration of the target biomarker.

[0035] The microcapsule channel is opened by the swelling action of the responsive gel, and the preset antimicrobial agent is released to the infected area in a targeted manner. The triggering condition for releasing the preset antimicrobial agent is: ΔV = f(C i -T i ), when C i >T i

[0036] wherein, ΔV represents the volume change rate of the responsive gel, which is an index to measure the opening degree of the microcapsule channel. f represents the response function of the responsive gel stored in the data warehouse to the stimulus, the specific form of which is determined by the inherent properties of the gel material. C i is the real-time concentration signal of a specific infection-related biomarker i obtained by monitoring. T i is the activation threshold for distinguishing normal physiological fluctuations from pathological states for this biomarker i stored in the data warehouse. That is, once C i exceeds T i , ΔV increases significantly, and the microcapsule channel opens.

[0037] It should be noted that the specific binding of the microcapsule structure will trigger a rapid change in the physical and chemical properties of the responsive gel, i.e., swelling. The responsive gel is a high-molecular polymer network, and the cross-linking structure or hydrophilicity between its molecular chains will change due to the binding with the target biomarker, causing it to rapidly absorb the surrounding cerebrospinal fluid and significantly increase in volume. This controllable swelling physically opens or bursts the microcapsule channel, constituting a gate switch for drug release.

[0038] S3, synchronously detecting a preset biochemical index parameter in the cerebrospinal fluid to generate a biochemical state signal.

[0039] S4, based on the biochemical state signal and the intracranial pressure signal, dynamically adjusting the cerebrospinal fluid drainage rate through a double-responsive pressure regulating valve.

[0040] In specific embodiments of the present application, 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 double-responsive pressure regulating valve to a preset low gear.

[0041] By increasing the cerebrospinal fluid drainage volume, the infection site is flushed faster, and the diffusion of the antibacterial agent is promoted.

[0042] When the biochemical state signal returns to normal, the opening pressure threshold is adjusted back to the preset baseline gear.

[0043] Referring to Figure 4 , specifically, the method of dynamically adjusting the cerebrospinal fluid drainage rate begins with continuous monitoring of the biochemical environment of the cerebrospinal fluid. The preset biochemical index parameters of the cerebrospinal fluid such as pH value or concentration of specific inflammatory factors are obtained in real time by integrated microsensors, and are converted into continuous biochemical state signals. When infection occurs, bacterial metabolites will cause a decrease in local pH value, or inflammation will cause an increase in the concentration of specific factors, at which time the biochemical state signal generated will deviate from the preset normal physiological range, constituting an abnormal signal.

[0044] The abnormal biochemical status signal will directly act on the dual-responsive pressure regulating valve. The core components of this valve, such as the elements that control the deformation of the diaphragm or the pre-tightening force of the spring, are made of smart materials that are sensitive to both physical pressure and biochemical signals, such as pH-responsive polymers or specific ion-sensitive shape memory alloys. Once the abnormal biochemical status signal is received, the molecular structure or crystal configuration of the smart material will undergo a pre-set reversible change, which in turn causes changes in its mechanical properties, such as elastic modulus or inherent shape. This change will change the mechanical balance inside the valve, essentially reducing the force required to resist the cerebrospinal fluid pressure and maintain the valve closed. As a result, the opening pressure threshold of the valve is automatically adjusted and lowered to a pre-set low gear. This process can be expressed as:

[0045] P _ open = P _ base - ΔP_s

[0046] where P _ open is the real-time opening pressure threshold of the valve. P _ base is the pre-set reference gear set by the doctor according to the patient's regular intracranial pressure, representing the basic pressure regulating value. ΔP_s is the pressure threshold downshift amount triggered by the biochemical status signal. ΔP_s is determined by the deviation of the biochemical status signal S_bio from its normal reference value S_norm through the characteristic conversion function g of the smart material, i.e. ΔP_s = g(S_bio - S_norm). Under normal physiological conditions, S_bio is equal to S_norm, ΔP_s is zero, and the valve operates at P_base. When infection occurs, S_bio deviates from S_norm, and ΔP_s becomes a positive value, thereby reducing P_open.

[0047] After the opening pressure threshold is lowered, even if the patient's intracranial pressure does not rise significantly, the shunt valve will be easier to open, thereby increasing the flow of cerebrospinal fluid. This enhanced drainage plays a key physical flushing role, accelerating the flushing and removal of pathogens, toxins and inflammatory debris from the infection area. More importantly, this increased cerebrospinal fluid flow synergistically enhances the distribution of the pre-set antimicrobial agent released by the intelligent drug release unit in the ventricular system, allowing it to reach the infection site faster and more uniformly, thereby forming a combined force with the chemical bactericidal effect of the drug.

[0048] When the anti-infection measures take effect and the biochemical environment of the cerebrospinal fluid begins to return to normal, the biochemical status signal also returns to the pre-set normal range. The smart material will sense this change and automatically restore its initial physical and mechanical properties. This causes the pressure threshold downshift amount ΔP_s to return to zero, and the opening pressure threshold of the valve is accurately adjusted back to the pre-set reference gear, restoring the normal drainage rate.

[0049] In specific embodiments of the present application, the adjustment process of the dual-responsive pressure regulating valve includes receiving an intracranial pressure signal to control the basic valve opening degree.

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

[0051] The opening pressure is complexly regulated by the superimposed effect of material deformation on the valve diaphragm.

[0052] Specifically, the adjustment process of the dual-responsive pressure regulating valve is a precise mechanical balance system, and the core is the fusion processing of two different signals. First, the basic pressure regulating function of the valve is realized by receiving the intracranial pressure signal. When the fluid static pressure generated by the intracranial pressure acts on the valve diaphragm, an opening force is formed. This opening force is balanced by the closing force preset by the spring or the elasticity of the diaphragm itself inside the valve. Only when the opening force indicated by the intracranial pressure signal exceeds the closing force, the valve will open, and the cerebrospinal fluid will be drained, which is the basic opening control of the valve.

[0053] On this basis, the change in the physical properties of the valve material is triggered by receiving the biochemical state signal, thereby achieving active intervention. When the abnormal biochemical state signal related to infection or inflammation is monitored, the signal will be transmitted to the intelligent material component inside the valve, such as a shape memory alloy actuator embedded in the spring system or directly linked with the valve diaphragm. After the actuator receives the abnormal biochemical state signal, the microstructure inside the material will undergo a phase change, resulting in a preset and precise material deformation on the macro level.

[0054] The displacement or force generated by this material deformation will act on the valve diaphragm through superimposition, which is equivalent to introducing an auxiliary opening force or reducing the original basic closing force. This superimposition changes the original mechanical balance, thereby achieving complex regulation of the opening pressure. The entire complex mechanical balance can be understood as: P_open=(F_base-F_aux) / A.

[0055] Where P_open represents the actual opening pressure threshold of the valve. F_base is the preset closing force of the valve determined by its mechanical structure under normal physiological conditions, which is the reference pressure regulating position set by the doctor. F_aux is the auxiliary opening force generated by material deformation triggered by the biochemical state signal, which is zero under normal conditions. A is the effective pressure area of the valve diaphragm. Through this mechanism, the abnormal biochemical state signal is converted into a specific mechanical quantity F_aux, which directly participates in the pressure regulation decision of the valve.

[0056] The method changes the valve from a simple pressure relief device into a regulator that can understand the physiological environment and make intelligent judgments. By receiving dual signals of intracranial pressure and biochemical state, the valve realizes two-dimensional control of cerebrospinal fluid drainage, which can meet the pressure management needs in the conventional state and actively implement the intervention drainage strategy in the pathological state. This composite regulation mechanism enables the system to take action at the early stage of infection before the intracranial pressure is decompensated, and through physical intervention combined with drug treatment, it shows excellent foresight and initiative. Finally, the passive design of the material deformation superimposed on the valve diaphragm ensures the high reliability and long-term stability of the system, significantly improving the accuracy and safety of hydrocephalus shunt treatment.

[0057] The present application uses cerebrospinal fluid endogenous biological signals as the core drive to deeply integrate anti-infection and pressure regulation functions into a synergistic response closed-loop system. This method can trigger targeted drug release and active drainage enhancement simultaneously according to infection-related biomarkers and biochemical indicators, which promote each other to achieve synergistic enhancement of treatment effect. Moreover, when the microenvironment returns to normal, the system can automatically terminate the intervention, forming a complete adaptive regulation to ensure the precision, efficiency and safety of treatment.

[0058] The present application realizes early active intervention of infection and pressure imbalance. The system can sense the micro-biochemical environment changes before the appearance of conventional clinical symptoms and start the therapeutic drainage mode in advance. This prospective intervention mechanism not only accelerates the clearance of pathogens and enhances drug efficacy, but also effectively prevents secondary intracranial pressure increase caused by infection, fundamentally reduces the risk of complications and improves patient prognosis.

[0059] S5、According to the changes of the biomarker concentration and the biochemical indicators of the cerebrospinal fluid after drainage, an environment feedback signal is generated.

[0060] In specific embodiments of the present application, the generation of the environment feedback signal specifically includes detecting the biomarker concentration reduction rate after drainage to generate an infection control signal.

[0061] Monitoring the duration of the biochemical indicators returning to the preset normal range to generate an environment stability signal.

[0062] Fusing the infection control signal and the environment stability signal to generate a closed-loop control instruction.

[0063] Specifically, the process of generating the environmental feedback signal is a multi-dimensional and dynamic assessment procedure, aiming to accurately determine the effectiveness of anti-infective and pressure-regulating interventions, and to provide decision-making basis for subsequent closed-loop control. This process begins with continuous detection of the concentration of key biomarkers in the cerebrospinal fluid sample after drainage. The system compares the real-time biomarker concentration data with the data before the start of treatment, and calculates the rate of its decline. When the rate of change of biomarker concentration over time, i.e. its first derivative, reaches or exceeds a pre-set negative threshold value, the system determines that the infection has been effectively controlled, and accordingly generates a clear infection control signal. This signal indicates that the pathogen load is rapidly decreasing.

[0064] At the same time, the system also continuously monitors the biochemical indicators of the cerebrospinal fluid after drainage, such as pH value. By monitoring the time required for the biochemical indicators to recover to the pre-set 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 pre-set normal physiological range, for example, pH 7.35 to 7.45, and continue for a pre-set duration, the system generates an environmental stability signal. This signal indicates that the pathological state of local acidosis caused by infection has been reversed, and the tissue microenvironment is tending towards stability.

[0065] Finally, the system fuses these two signals of different nature but complementary to each other to generate comprehensive closed-loop control instructions. The 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, and once generated, it is ready to execute the instruction to stop drug release. The generation of the environmental stability signal serves as the final condition for the pressure valve to return to the reference position. The fused closed-loop control instruction contains precise and step-by-step control information for both the drug release unit and the pressure regulating valve. The fusion logic can be abstractly represented as: C_cmd = W_inf * S_inf + W_env * S_env.

[0066] Where C_cmd represents the strength or priority of the final generated closed-loop control instruction. S_inf is the quantified infection control signal, for example, the ratio of the concentration decline rate to the threshold value. S_env is the quantified environmental stability signal, for example, the ratio of the stable duration to the pre-set duration. W_inf and W_env are the weight coefficients of the quantified infection control signal and environmental stability signal, respectively, which are pre-set by clinical experience and system design. That is, when C_cmd exceeds a pre-set execution threshold, the subsequent control action is triggered.

[0067] By evaluating the pathogen clearance rate and the microenvironment recovery status respectively, the system can comprehensively and accurately grasp the treatment process from two key dimensions, avoiding premature or late termination of intervention caused by single indicator judgment. The closed-loop control instruction generated by integrating infection control signal and environmental stability signal ensures that the withdrawal time of the drug release and pressure regulation systems is optimal and coordinated, ensuring that the infection is completely eradicated and the unnecessary intervention time is minimized. This not only improves the safety and effectiveness of treatment, but also embodies the high autonomy and intelligence of the system, truly forming a complete feedback loop from intervention to evaluation to adjustment.

[0068] In specific embodiments of the present application, the execution of the closed-loop control instruction includes triggering the responsive gel to shrink to close the microcapsule channel when the infection control signal reaches the preset standard.

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

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

[0071] Specifically, the execution of the closed-loop control instruction is a phased and coordinated process, aiming to smoothly transition the system from active intervention to regular monitoring.

[0072] First, when the system receives the closed-loop control instruction generated by the environmental feedback signal and the intensity reaches the preset standard, the instruction will act on the intelligent drug release unit first. Specifically, when the infection control signal part of the instruction confirms that the biomarker concentration has decreased significantly, it means that the concentration of the target molecule that activates the responsive gel has decreased, and the driving force of the swelling effect caused by the combination with the target molecule has weakened. The molecular chain of the responsive gel undergoes a conformational change, gradually returning from the swollen state to the dense contracted state. The contraction process of the gel will physically close or re-block the previously opened microcapsule channel, effectively stopping the further release of the preset antibacterial agent.

[0073] Next, or in parallel under certain preset logic, the environmental stability signal part of the closed-loop control instruction begins to act on the dual-responsive pressure regulating valve. When the signal confirms that the biochemical indicators such as the pH value of the cerebrospinal fluid have remained stable within the normal range, the biochemical stimulus acting on the valve intelligent material component is declared released. Taking shape memory alloy as an example, the return of the temperature or chemical environment to the condition that triggers its initial shape memory shape means that the alloy actuator will automatically undergo a reverse phase change, thereby accurately releasing its previously generated deformation state, and the generated auxiliary opening force F_aux also disappears.

[0074] Finally, as the smart material component restores its original shape and physical properties, the superimposed force on the valve membrane is completely removed. At this time, the mechanical balance of the control valve opening and closing is completely returned to the opening force generated by the intracranial pressure signal and the elastic closing force of the valve membrane itself. The valve membrane realizes accurate reset under the action of its own elasticity, so that the opening pressure threshold of the valve automatically and smoothly restores to the preset baseline drainage pressure set by the doctor initially. At this time, the anti-infection and active pressure regulation intervention of the whole system completes a complete self-limiting closed loop, and the system returns to the conventional basic monitoring and pressure regulation mode only in response to intracranial pressure.

[0075] The technical effect of the method is to realize the autonomous and safe exit of the system intervention measure, and constitutes the last link of the intelligent closed loop. By closing the drug release channel through the contraction of the responsive gel, it is ensured that the drug stops exposure immediately after completing the task, avoiding unnecessary drug use and potential side effects. At the same time, through the deformation state release of the double-responsive material and the elastic reset of the valve membrane, it is ensured that the pressure regulating system can accurately and reliably return to the basic working mode, effectively preventing the risk of continuing excessive drainage after infection control. The whole process does not require external intervention, which embodies the high autonomy of the system and the accurate response ability to the changes of the physiological environment, ensures that the treatment process is not only efficient but also self-limiting, and greatly improves the safety of long-term implantation treatment and the life quality of patients.

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

[0077] S7, receiving the feedback waveform and analyzing the change of the waveform characteristics to indirectly monitor the valve working mode and the local biochemical environment.

[0078] In a specific embodiment of the application, the specific content of S7 is: subcutaneously implanting a passive marker, which produces a characteristic response to a magnetic field or sound wave.

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

[0080] The change of the waveform characteristics is analyzed to indirectly monitor the valve working mode and the local biochemical environment.

[0081] Specifically, the method provides a means of non-invasive monitoring of the internal state of the implant. First, during the manufacturing stage of the system, one or more passive markers are integrated into the key subcutaneous components of the shunt system, such as the wall of the reservoir or the housing of the pressure regulating valve. The passive markers are special materials that do not contain power sources by themselves, but can produce predictable and characteristic responses to external specific energy fields. For example, it can be an LC circuit with a specific resonant frequency, or an acoustic material with strong reflection or scattering characteristics for specific frequency ultrasonic waves.

[0082] When in vitro monitoring is needed, the doctor or technician will use the matching in vitro device. The device is a handheld probe that can emit electromagnetic fields or acoustic waves of specific frequencies. The operator will place the device close to the patient's skin surface, aiming at the location of the subcutaneously implanted passive marker, and start the energy emission. The emitted energy field will penetrate the skin tissue and couple or interact with the implanted passive marker.

[0083] Under the excitation of the energy field, the passive marker will produce a feedback waveform. For example, the LC circuit marker will produce a weak electromagnetic radiation signal at its resonant frequency, while the acoustic marker will reflect or scatter part of the incident acoustic wave. The in vitro device also has receiving function, which captures the weak feedback waveform transmitted back from the body. This feedback waveform carries key information about the passive marker and its microenvironment state.

[0084] Finally, the signal processing unit built into the in vitro device will analyze 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 the early warning drainage mode, the deformation of the intelligent material inside the valve may slightly change the physical size or electromagnetic properties of the marker connected to it, causing a measurable shift in its resonant frequency. Similarly, changes in the local biochemical environment, such as changes in pH, can also affect the dielectric constant or acoustic impedance of the marker material itself, thereby changing the decay characteristics of the feedback waveform. By comparing the changes in the analyzed waveform characteristics with the pre-calibrated database, the working mode of the valve and the local biochemical environment can be non-invasively and indirectly evaluated.

[0085] In specific embodiments of the invention, the analyzed waveform characteristic changes specifically include: identifying the frequency offset of the waveform to determine whether the valve is in the low gear early warning drainage mode.

[0086] Detecting the decay rate of the waveform to evaluate the degree of local pH recovery.

[0087] Optimizing the closed-loop control parameters in combination with the early warning drainage mode state and the pH recovery degree.

[0088] Specifically, the process of analyzing the waveform feature changes to obtain the implant state information is a fine data processing on the feedback waveform received by the extracorporeal device.

[0089] First, the system performs a spectral analysis on the received feedback waveform to identify the frequency shift. When the dual-responsive pressure regulating valve enters the early warning drainage mode due to receiving an abnormal biochemical state signal, the deformation of the internal smart material will slightly change the physical structure or electromagnetic properties of the passive marker coupled thereto. This change will cause a slight but measurable drift in the resonant frequency of the marker. By comparing the currently measured resonant frequency with the baseline resonant frequency previously calibrated by the device in the normal state, the frequency shift is calculated. When the frequency shift exceeds the preset discrimination threshold, the system determines that the valve is currently in the low gear early warning drainage mode. The relationship between the slope shift Δf and the state S can be expressed as

[0090] Δf = f_current - f_base = k * g(S)

[0091] Where Δf is the frequency shift, f_current is the currently measured frequency, and f_base is the baseline frequency. k is the coupling coefficient stored in the data warehouse, which depends on the design of the marker and the connection method with the smart material. g(S) is a function representing the relationship between the deformation of the smart material and its driving signal S, i.e., the biochemical state signal.

[0092] In the above g(S) is a function representing the relationship between the deformation of the smart material and its driving signal S, which can be specifically understood as a quantitative characterization of how the change in S causes the change in the deformation of the smart material, and the specific form is determined by the inherent characteristics of the smart material. The core features include: the correspondence between input and output, the independent variable of g(S) is S, and the dependent variable is the deformation, for example, if the response of the smart material to S is linear, then g(S) is a linear function, if there is a threshold effect, then g(S) is a piecewise function, and it has reversibility, which is set by the experimenters at the beginning of the design, and will not be described here.

[0093] Secondly, the system detects the decay rate of the waveform to evaluate the recovery degree of the local pH. The pH value of the cerebrospinal fluid affects its electrical conductivity or acoustic properties. When the infection is controlled and the local pH value recovers from acidity to the normal physiological range, the electromagnetic or acoustic properties of the medium around the marker will also change. Directly affecting the energy decay rate of the feedback waveform. By measuring the rate at which the amplitude of the feedback waveform decreases over time, i.e., its time constant τ, and comparing it with the decay rates calibrated at different pH values in the database, the recovery degree of the current local pH is indirectly inferred.

[0094] Finally, the system fuses the parsed information, i.e. the pre-warning drainage mode state and the pH recovery degree, to optimize the built-in closed-loop control parameters.

[0095] For example, if the system monitors that the valve is still in the pre-warning drainage mode, but at the same time the pH recovery degree has approached normal, it may mean that the pathological stimulus is about to disappear. At this time, it is recommended that the clinician or through internal algorithms, appropriately adjust the trigger threshold of the subsequent closed-loop control instructions to make them more sensitive, so that the valve can be reset faster after the environment is completely restored. This combined analysis enables the system to also make certain predictions about future trends, thereby dynamically optimizing the internal adaptive control logic.

[0096] The technical effects produced by the method significantly improve the information dimension and clinical value of non-invasive monitoring. By deeply analyzing the multi-dimensional features of the waveform, quantitative information about the internal different subsystems of the system, such as the pressure regulating state and the microenvironment state, is provided. By identifying the frequency offset and detecting the decay rate, the doctor can more comprehensively and accurately grasp the treatment progress. More importantly, combining these information to optimize the closed-loop control parameters enables the entire system to have a higher level of intelligence, which can fine-tune its internal autonomous control strategy according to external monitoring feedback, thereby achieving more personalized and forward-looking treatment management, further improving the safety and effectiveness of treatment.

[0097] Reference Figure 2 The second aspect of the present application provides a system for performing the anti-infective pressure-adjustable hydrocephalus shunt method described in the present application, comprising: a biomarker monitoring module for real-time detection of the concentration of a pre-set infection-related biomarker in cerebrospinal fluid.

[0098] An intelligent drug release execution module contains a microcapsule structure coated with a responsive gel that triggers the release of an antibacterial agent in response to a concentration exceeding signal.

[0099] A dual-response pressure regulating module has a valve material that is sensitive to both intracranial pressure and pre-set biochemical indicators, and reduces the opening pressure threshold based on biochemical abnormality signals.

[0100] A closed-loop control module receives environmental parameter change signals after drainage and coordinates the termination of drug release and valve reset operations.

[0101] A passive monitoring interface module includes an implantable marker and an external reading and writing device to provide indirect feedback on the working state.

[0102] In a specific embodiment of the present application, the dual-response pressure regulating module includes: a pressure-sensitive unit consisting of a spring diaphragm as the basic pressure response structure.

[0103] A biochemical-sensitive unit consists of a pH-responsive shape memory alloy as a deformation driving component.

[0104] The cooperative execution unit superimposes the displacement amount of the morphing driving component to the pre-tightening force of the spring diaphragm, to realize the composite control of the opening pressure threshold.

[0105] The present application ensures high reliability and long-term safety of the implanted system while realizing high intelligence. The core intelligent response and control function relies on passive intelligent materials and mechanical structures, avoiding the implantation of complex electronic components such as batteries and microprocessors in the body. This design eliminates the risks of electronic failure, electromagnetic interference and power depletion from the source, significantly improves the long-term implant stability and biocompatibility of the shunt device, and reduces the need for secondary surgery.

[0106] It should be further supplemented that the various thresholds in the present application are always set around the core goal of distinguishing between cerebrospinal fluid normal physiological state and infection pathological state. Specifically, on the one hand, taking the biomarker concentration of cerebrospinal fluid of healthy people in a large number of clinical data, such as the content of gram-positive metabolic products, the normal fluctuation range of biochemical indicators such as pH value 7.35-7.45, as the basis, the critical value of pathological state is determined, such as the activation threshold of biomarker concentration when infected, the determination threshold of abnormal biochemical indicators. On the other hand, combined with the response characteristics of intelligent materials, such as the minimum concentration stimulus of responsive gel swelling, the minimum biochemical signal intensity of shape memory alloy deformation, and the treatment safety window such as the lower limit of pressure threshold to avoid excessive drainage, and the upper limit of concentration threshold to ensure the effective release of antibacterial agents, the specific values are determined through experimental calibration and clinical verification. This multi-dimensional setting method based on physiological rules, material characteristics and clinical needs not only ensures that the threshold can accurately identify the micro changes in the early stage of infection, but also avoids false triggering or insufficient treatment, so it has a solid scientific basis and practical operability.

[0107] The above is merely an example and description of the present application, and those skilled in the art can make various modifications or supplements to the described specific embodiments or use similar ways to replace them, as long as they do not deviate from the concept of the present application or exceed the scope defined by the present application.

Claims

1. An anti-infective and pressure-adjustable hydrocephalus shunt method, characterized in that: include: S1. Monitoring the concentration of a preset infection-related biomarker in the cerebrospinal fluid to generate a real-time concentration signal, wherein the real-time concentration signal is specifically a signal set including the concentrations of multiple infection-related biomarkers; S2. When the real-time concentration signal exceeds a preset threshold, the intelligent drug-releasing unit is triggered to release a preset antimicrobial agent; S3, synchronously detecting preset biochemical index parameters in the cerebrospinal fluid and generating a biochemical status signal; S4. Dynamically adjusting the cerebrospinal fluid drainage rate through a dual-responsive pressure regulating valve based on the biochemical status signal and the intracranial pressure signal; S5. Generate environmental feedback signals based on changes in biomarker concentrations and biochemical indicators in the cerebrospinal fluid after drainage; S6. Using the environmental feedback signal to control the suspension of the release of the antimicrobial agent and the resetting of the pressure regulating valve.

2. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 1, characterized in that: The triggering of the intelligent drug release unit to release the preset antimicrobial agent specifically includes: Identifying the infection type corresponding to the real-time concentration signal by comparing the concentration of each marker in the signal set with a preset activation threshold; Activating a microcapsule structure that matches the infection type from a variety of non-universal microcapsule structures in the smart drug dispensing unit. The microcapsule structure is coated on the inner surface of the shunt tube. The microcapsule structure encapsulates a preset antibacterial agent for the specific infection type and is sealed by a specific responsive gel that is highly sensitive to biomarkers of the corresponding infection type. The microcapsule channel is opened by the swelling action of the responsive gel, and the preset antimicrobial agent is released to the infected area in a targeted manner. The triggering condition for releasing the preset antimicrobial agent is: ΔV = f(C i -T i ), when C i >T i Wherein, ΔV represents the volume change rate of the responsive gel, which is an indicator to measure the degree of opening of the microcapsule channel; f represents the response function of the responsive gel to the stimulus stored in the data bin, and its specific form is determined by the inherent properties of the gel material; C i is the real-time concentration signal of a specific infection-related biomarker i obtained by monitoring; T i It 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 and pressure-adjustable hydrocephalus shunt method according to claim 1, characterized in that: The dynamic regulation of cerebrospinal fluid drainage rate specifically includes: When the biochemical state signal is abnormal, the opening pressure threshold of the dual-responsive pressure regulating valve is adjusted to a preset low gear; Accelerates flushing of infection sites by increasing cerebrospinal fluid drainage and promotes the diffusion of antimicrobial agents; When the biochemical status signal returns to normal, the opening pressure threshold will be adjusted back to the preset reference level.

4. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 3, characterized in that: The adjustment process of the dual-responsive pressure regulating valve includes: Receive intracranial pressure signal to control the opening of basic valve; Receiving biochemical status signals to trigger changes in the physical properties of valve materials; The compound adjustment of the opening pressure is achieved by superimposing the material deformation on the valve diaphragm. The mechanical balance of the compound adjustment can be understood as: P_open = (F_base - F_aux) / A; Here, P_open represents the actual valve opening pressure threshold; F_base is the preset closing force determined by the valve's mechanical structure under normal physiological conditions, specifically the baseline pressure adjustment setting set by the physician; F_aux is the auxiliary opening force generated by material deformation, triggered by biochemical state signals, and is zero under normal conditions; and 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 contributes to the valve's pressure regulation decision.

5. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 1, characterized in that: The generating of the environmental feedback signal specifically includes: Detect the rate of decline of biomarker concentration after drainage to generate infection control signals; Monitor the time it takes for biochemical indicators to return to the preset normal range and generate an environmental stability signal; The infection control signal and the environmental stability signal are integrated to generate a closed-loop control instruction. The integration logic can be expressed as: C_cmd=W_inf*S_inf+W_env*S_env; Among them, C_cmd represents the strength or priority of the final closed-loop control instruction; S_inf is the quantified infection control signal; S_env is the quantified environmental stability signal; W_inf and W_env are the weight coefficients of the quantified infection control signal and environmental stability signal, respectively, which are pre-set by clinical experience and system design.

6. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 5, characterized in that: The execution of the closed-loop control instruction includes: When the infection control signal reaches a preset standard, the responsive gel is triggered to contract to close the microcapsule channel; When the environmental stability signal continues for a preset time, the deformation state of the dual-responsive material is released; The base drainage pressure is restored by the elastic return of the valve diaphragm.

7. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 1, characterized in that: The method further includes: S7, receiving the feedback waveform and analyzing the waveform feature changes to indirectly monitor the valve working mode and the local biochemical environment, the specific contents of which are: implanting a passive marker subcutaneously, the passive marker producing a characteristic response to a magnetic field or sound waves; Exciting the passive marker via an external device and receiving a feedback waveform; Analyze changes in waveform characteristics to indirectly monitor valve operating mode and local biochemical environment.

8. The anti-infective and pressure-adjustable hydrocephalus shunt method according to claim 7, characterized in that: The analysis of waveform feature changes specifically includes: Identify the waveform frequency offset to determine whether the valve is in the low-speed warning diversion mode; The waveform decay rate was detected to assess the degree of local pH recovery; The closed-loop control parameters were optimized based on the early warning drainage mode status and pH recovery degree.

9. A system for executing the anti-infective and adjustable pressure hydrocephalus shunt method according to any one of claims 1 to 9, characterized in that: include: A biomarker monitoring module is used to detect the concentration of preset infection-related biomarkers in cerebrospinal fluid in real time; An intelligent drug release execution module, comprising a microcapsule structure coated with a responsive gel, triggers the release of the antimicrobial agent in response to a concentration exceeding the standard signal; Dual-response pressure regulating module, with valve materials that are sensitive to both intracranial pressure and preset biochemical indicators, lowering the opening pressure threshold based on biochemical abnormality signals; The closed-loop control module receives signals of environmental parameter changes after drainage and coordinates the suspension of drug release and valve reset operations; The passive monitoring interface module, which includes an implantable marker and an in vitro reading and writing device, provides indirect feedback on the working status.

10. The system according to claim 9, characterized in that The dual-response voltage regulation module includes: The pressure sensitive unit consists of a spring diaphragm forming a basic pressure response structure; The biochemical sensitive unit is composed of a pH-responsive shape memory alloy as a deformation driving component; The collaborative execution unit adds the displacement of the deformation driving component to the preload force of the spring diaphragm to achieve compound regulation of the opening pressure threshold.

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