A method for manufacturing a high-precision retractable guide wire

Abstract

The present invention discloses a method for manufacturing a high-precision retractable guidewire, comprising preparing a segmented microtube matrix, etching fluorescent positioning marks on the surface of a composite core material, and embedding shape memory alloy springs between adjacent microtube segments; integrating electromagnetic locks at the connection points of the segmented microtube matrix, and depositing a gradient lubrication layer and a drug sustained-release layer on its surface in sequence; embedding a distributed optical fiber sensor inside the segmented microtube matrix, and configuring it in linkage with the fluorescent positioning marks to form a multimodal tracking module; constructing an intelligent control system based on the real-time data of the multimodal tracking module, and the intelligent control system drives the dynamic adaptation of the electromagnetic locks to the guidewire morphology through a reinforcement learning algorithm to achieve closed-loop control of the guidewire length and path; giving the guidewire controllable retractable ability and bending resistance, and dynamically optimizing the guidewire path through a reinforcement learning algorithm to achieve positioning accuracy, dynamic length adjustment and adaptive path planning, thereby significantly improving the safety and success rate of minimally invasive interventional surgery.

Description

Technical Field

[0001] The present invention relates to the technical field of guidewires, and in particular to a method for manufacturing a high-precision retractable guidewire. Background Art

[0002] Medical guidewires, as core instruments in minimally invasive interventional procedures (such as cardiovascular stent implantation and neurovascular embolization), play a key role in establishing instrument delivery channels and guiding the precise positioning of catheters. As vascular interventional procedures expand into complex anatomical regions (such as tortuous intracranial vessels and chronic coronary artery occlusion), clinical requirements for guidewire control accuracy, dynamic adjustment capabilities, and biosafety are increasing. However, when dealing with highly tortuous, multi-level bifurcated, or fragile vascular pathways, traditional guidewires often suffer from insufficient rigidity and delayed positioning feedback, leading to prolonged procedures and even complications such as vascular perforation.

[0003] Currently, mainstream medical guidewires mostly use a combination of a single core material (such as nickel-titanium alloy) and a hydrophilic coating on the surface. Some improvements have been made by introducing actively controllable tips (such as magnetic steering) or integrating fiber optic sensing units to enhance maneuverability. However, these technologies all rely on the overall deformation of the guidewire to achieve path adjustment. Their fixed length requires repeated advancement and retraction of the guidewire to adjust its position in complex blood vessels. This not only increases the risk of endothelial damage (the friction coefficient is generally >0.05), but also lacks a segmented dynamic locking mechanism, making it difficult to achieve millimeter-level precise length control. This is especially true when dealing with "S"-shaped, multi-bend paths such as the internal carotid artery siphon. Traditional guidewires are prone to plastic deformation due to local stress concentration, resulting in an increased rate of secondary surgical intervention.

[0004] In view of this, it is necessary to improve the existing technology to solve the problem of mismanagement of traditional guidewires in tortuous vascular pathways due to insufficient rigid fixation and positioning accuracy. Summary of the Invention

[0005] The purpose of the present invention is to provide a method for manufacturing a high-precision retractable guide wire to solve the above technical problems.

[0006] To achieve this object, the present invention adopts the following technical solutions:

[0007] A method for manufacturing a high-precision retractable guide wire comprises the following steps:

[0008] Prepare a segmented microtubule matrix, wherein the segmented microtubule matrix is ​​composed of a composite core material of nickel-titanium alloy and cobalt-chromium alloy, the surface of the composite core material is etched with fluorescent positioning marks, and shape memory alloy springs are embedded between adjacent microtubule segments;

[0009] An electromagnetic lock is integrated at the connection of the segmented microtubule matrix, and a gradient lubricating layer and a drug sustained-release layer are sequentially deposited on the surface thereof;

[0010] A distributed optical fiber sensor is embedded in the segmented microtubule matrix and configured in conjunction with the fluorescent positioning marker to form a multimodal tracking module;

[0011] Based on the real-time data of the multimodal tracking module, an intelligent control system is constructed. The intelligent control system drives the dynamic adaptation of the electromagnetic lock and the guidewire shape through a reinforcement learning algorithm to achieve closed-loop control of the guidewire length and path.

[0012] Optionally, the process of preparing the segmented microtubule matrix is ​​specifically as follows:

[0013] Prepare nickel-titanium alloy wire and cobalt-chromium alloy wire, use the nickel-titanium alloy wire as the inner core, and spirally wrap the cobalt-chromium alloy wire around the outer layer to form a composite wire, wherein the mass ratio of nickel-titanium alloy to cobalt-chromium alloy is 3:1;

[0014] Controlling the drawing rate of the composite wire to perform precision drawing, processing the composite wire to a preset outer diameter through multiple cold drawing processes, and then annealing the composite wire in a vacuum environment to eliminate internal stress;

[0015] Laser etching is performed on the surface of the annealed composite wire. A laser is used to etch annular grooves with a preset spacing along the axial direction, and fluorescent nanoparticles are filled in the annular grooves to form fluorescent positioning marks.

[0016] Optionally, the process of preparing the segmented microtubule matrix further comprises:

[0017] The etched composite wire is cut into microtube segments of equal length, and conical grooves are machined at both ends of each microtube to fix the shape memory alloy spring;

[0018] The shape memory alloy spring was pre-conditioned by undergoing shape memory training at 600°C, allowing it to recover its preset shape at 37°C body temperature. The spring's ends were then embedded in the tapered grooves of adjacent microtubule segments.

[0019] The assembled microtube-spring assembly is encapsulated as a whole, the connection is covered with a biocompatible heat shrink tube, and a secondary annealing is performed. The surface of the encapsulated body is then electropolished to obtain a segmented microtube matrix.

[0020] Optionally, the tip end of the retractable guidewire is encapsulated with a gradient hardness module, and the gradient hardness module integrates a pressure sensing unit and an optical imaging unit.

[0021] Optionally, an electromagnetic lock is integrated at the connection of the segmented microtube matrix, and a gradient lubricating layer and a drug sustained-release layer are sequentially deposited on the surface thereof, specifically comprising the following steps:

[0022] An electromagnetic lock is prepared by alternately depositing NdFeB magnetic layers and insulating aluminum oxide layers on the surface of a titanium alloy substrate through a magnetron sputtering process, cutting the cylinder into a preset diameter, and welding preset wires at both ends.

[0023] The electromagnetic lock buckle is embedded in the connection of the segmented microtube matrix, and the electromagnetic lock buckle and the microtube matrix are fixed with biocompatible conductive glue, and the pre-set wire is ensured to extend along the surface of the microtube matrix to the proximal end of the guide wire;

[0024] The assembled microtube-lock assembly was vacuum annealed to improve the bonding strength of the conductive adhesive, and then the magnetic response performance of the electromagnetic lock was tested using a pulse current.

[0025] Optionally, the assembled microtube-lock buckle assembly is subjected to vacuum annealing to improve the bonding strength of the conductive adhesive, and then the magnetic response performance of the electromagnetic lock buckle is tested by a pulse current, and then the method further includes:

[0026] Plasma cleaning is performed on the surface of the segmented microtube substrate to remove surface impurities and activate coating adhesion;

[0027] Atomic layer deposition equipment is used to alternately deposit aluminum oxide layers and diamond-like carbon layers on the surface of the substrate to form a gradient lubrication layer with a preset total thickness.

[0028] Optionally, the step of alternately depositing aluminum oxide layers and diamond-like carbon layers on the substrate surface using an atomic layer deposition device to form a gradient lubricating layer with a preset total thickness may further include:

[0029] PLGA microspheres loaded with heparin and nitroglycerin are dispersed in a polyvinylpyrrolidone solution and evenly coated on a pre-set area proximal to the guidewire by an electrostatic spraying process to form a drug sustained-release layer.

[0030] The coated guidewire was subjected to a step-curing treatment: first, it was dried at 40°C for 2 hours to form a film of the drug sustained-release layer, and then heat-treated in a vacuum environment at 120°C for 30 minutes to covalently bond the PLGA microspheres to the surface of the microtube matrix.

[0031] Optionally, a distributed optical fiber sensor is embedded in the segmented microtubule matrix and linked with the fluorescent positioning marker to form a multimodal tracking module, which specifically includes the following steps:

[0032] A multi-core optical fiber with a preset standard diameter was selected. After stripping the outer sheath, a Bragg grating was inscribed point by point using a laser. A polyimide protective layer was then coated on the surface of the multi-core optical fiber to prepare a flexible distributed optical fiber sensor.

[0033] The fiber after grating inscription is pre-stretched: a preset constant tension is applied to both ends of the fiber and maintained at 150°C for 30 minutes to eliminate residual stress and fix the grating wavelength reference;

[0034] A through microhole is opened along the central axis of the segmented microtube matrix, the flexible distributed optical fiber sensor is passed through the microhole, and an optical fiber redundant ring is reserved at the connection of each microtube segment to adapt to the expansion and contraction deformation of the guide wire.

[0035] Optionally, a microhole is opened along the central axis of the segmented microtube matrix, the flexible distributed optical fiber sensor is inserted into the microhole, and a redundant optical fiber ring is reserved at the connection of each microtube segment to adapt to the expansion and contraction deformation of the guide wire, and then the following is further included:

[0036] A lateral laser microhole is opened on the outer surface of the microtubule matrix at a position corresponding to the fluorescent positioning marker, and filled with a fluorescence enhancement medium, so that the optical fiber sensor and the fluorescent marker form an optical coupling channel;

[0037] The fiber Bragg grating wavelength demodulator is integrated with the near-infrared fluorescence imager, and the coordinate mapping relationship between the optical signal of the fiber sensor and the fluorescent marker is established through the time-space encoding algorithm to configure the multimodal signal synchronization module.

[0038] The guidewire's telescopic motion is cyclically tested in a simulated vascular model, and the strain data and fluorescent marker displacement after optical signal conversion are synchronously recorded to optimize tracking errors and complete dynamic calibration of the assembled guidewire-fiber complex.

[0039] Optionally, based on the real-time data of the multimodal tracking module, an intelligent control system is constructed. The intelligent control system drives the dynamic adaptation of the electromagnetic lock and the guidewire shape through a reinforcement learning algorithm to achieve closed-loop control of the guidewire length and path, specifically including:

[0040] A multi-source data fusion platform was constructed to input the strain distribution data collected by the fiber optic sensor and the position coordinate data of the fluorescent marker into the time synchronization module. The timing differences between the two types of signals were aligned using a sliding window algorithm to generate a spatiotemporally synchronized 3D deformation map of the entire guidewire segment.

[0041] Training the reinforcement learning control model: A guidewire-vessel wall contact mechanics model is established in a virtual vascular simulation environment. Using the deformation map as input and the electromagnetic lock action instructions as output, the control strategy is iteratively trained using a proximal strategy optimization algorithm until the path tracking error stabilizes within the preset error tolerance range.

[0042] The trained reinforcement learning control model is lightweight and compressed into a TensorRT engine, integrated into the microprocessor at the proximal end of the guidewire, and establishes real-time communication with the electromagnetic lock drive circuit and multimodal tracking hardware to deploy an embedded intelligent control system.

[0043] An intelligent control system is run in an in vitro vascular model to synchronously collect actual guidewire motion data and simulation prediction results. The control parameters are optimized through a dynamic weight adjustment algorithm to ensure that the actual path and the planned path are consistent with the preset target value, thereby achieving closed-loop control of the guidewire length and path.

[0044] Compared with the existing technology, the present invention has the following beneficial effects: first, a segmented microtube matrix engraved with fluorescent markers is prepared by composite core material, and a shape memory alloy spring is embedded to realize basic telescopic function; then, an electromagnetic lock is integrated at the microtube connection to control the segmented locking, and a gradient lubrication layer and a drug sustained-release layer are deposited in sequence to optimize the surface properties; further, a distributed optical fiber sensor is embedded inside the matrix, and linked with the fluorescent marker to form a multimodal tracking module; finally, an intelligent control system is constructed based on the tracking data, and the electromagnetic lock is driven to dynamically adapt to the guidewire morphology through a reinforcement learning algorithm to form a closed-loop control mechanism to achieve precise adjustment of the guidewire length and path; this method gives the guidewire controllable telescopic ability and bending resistance through the combination of a segmented microtube matrix and a shape memory alloy spring, and dynamically optimizes the guidewire path through a reinforcement learning algorithm to solve the problem of vascular damage caused by the excessive rigidity of traditional guidewires, and simultaneously achieves positioning accuracy, dynamic length adjustment and adaptive path planning on a single guidewire, significantly improving the safety and success rate of minimally invasive interventional surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0045] 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.

[0046] The structures, proportions, sizes, etc. depicted in the drawings of this specification are only used to match the contents disclosed in the specification so as to facilitate understanding and reading by persons familiar with this technology. They are not intended to limit the conditions under which the present invention can be implemented and therefore have no substantive technical significance. Any structural modifications, changes in proportional relationships, or adjustments in size should still fall within the scope of the technical contents disclosed in the present invention without affecting the effects and objectives that can be achieved by the present invention.

[0047] Figure 1 FIG1 is a flow chart of a method for manufacturing a high-precision retractable guide wire according to this embodiment;

[0048] Figure 2 FIG2 is a second flow chart of the method for manufacturing a high-precision retractable guide wire according to this embodiment;

[0049] Figure 3This is the third flow chart of the method for manufacturing a high-precision retractable guide wire according to this embodiment. DETAILED DESCRIPTION

[0050] In order to make the purpose, features, and advantages of the present invention more obvious and easy to understand, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the embodiments described below 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 work are within the scope of protection of the present invention.

[0051] In the description of the present invention, it should be understood that the terms "upper," "lower," "top," "bottom," "inner," "outer," etc., indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended solely to facilitate the description of the present invention and simplify the description. They are not intended to indicate or imply that the devices or elements referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on the present invention. It should be noted that when a component is considered to be "connected" to another component, it may be directly connected to the other component or there may be a centrally located component.

[0052] The technical solution of the present invention will be further described below with reference to the accompanying drawings and through specific implementation methods.

[0053] Combine Figures 1 to 3 As shown, an embodiment of the present invention provides a method for manufacturing a high-precision retractable guide wire, comprising the following steps:

[0054] S1, preparing a segmented microtubule matrix, which is composed of a composite core material of nickel-titanium alloy and cobalt-chromium alloy. The surface of the composite core material is etched with fluorescent positioning marks, and shape memory alloy springs are embedded between adjacent microtubule segments;

[0055] The core skeleton of the guidewire is constructed by combining nickel-titanium alloy and cobalt-chromium alloy core materials, designing a segmented structure, and combining it with the elastic connection of a shape memory alloy spring. The nickel-titanium alloy imparts excellent shape memory and flexibility to the matrix, while the cobalt-chromium alloy enhances tensile strength and kink resistance. The segmented design enables the guidewire to achieve localized flexible bending within the blood vessel while maintaining overall rigidity for pushing. Fluorescent positioning markers etched on the surface provide a reference point for subsequent multimodal tracking, while the shape memory spring adaptively adjusts the inter-segment connection state at body temperature, ensuring the stability and reliability of the guidewire's dynamic expansion and contraction.

[0056] S2, integrating electromagnetic locks at the junction of the segmented microtubule matrix, and sequentially depositing a gradient lubrication layer and a drug release layer on its surface;

[0057] A micro-electromagnetic lock is embedded at the segmented microtube junction, and its instant opening and closing is remotely controlled by an external magnetic field, enabling millimeter-level precision adjustment of the guidewire length and segmented locking. A gradient lubrication layer and a drug-release layer are then deposited on the substrate surface. The gradient lubrication layer uses alternating nano-coating technology to reduce the surface friction coefficient, improving the guidewire's ability to slide through the blood vessel. The drug-release layer is loaded with anticoagulant and vasodilator drugs, which are released in a targeted manner during the guidewire's travel, reducing the risk of endothelial damage and helping to improve the local blood flow environment.

[0058] S3, embedded distributed fiber optic sensors inside the segmented microtubule matrix and linked with fluorescent positioning markers to form a multimodal tracking module;

[0059] Distributed fiber optic sensors are embedded within the microtubule matrix, utilizing fiber Bragg gratings to monitor strain and curvature changes throughout the entire guidewire segment in real time. This is coupled with optical signals from surface fluorescent positioning markers to form a dual tracking mechanism combining internal strain sensing with external optical positioning. The fiber optic sensors provide highly sensitive deformation data, while the fluorescent markers enable visual coordinate calibration. A fusion algorithm generates a continuous mapping of the guidewire's three-dimensional spatial position, overcoming the limitations of a single sensing modality and significantly improving positioning accuracy and anti-interference capabilities in complex vascular environments.

[0060] S4, based on the real-time data of the multimodal tracking module, builds an intelligent control system. The intelligent control system drives the dynamic adaptation of the electromagnetic lock and the guidewire shape through the reinforcement learning algorithm to achieve closed-loop control of the guidewire length and path.

[0061] An artificial intelligence control system is constructed based on multimodal tracking data. Using reinforcement learning algorithms to simulate clinical operation scenarios, the system dynamically optimizes the electromagnetic lock's opening and closing strategies and guidewire morphology adjustment instructions. The system analyzes vascular path characteristics and the guidewire's mechanical state in real time, autonomously determining the timing of the lock's action and the guidewire's deflection angle, forming a closed-loop "perception-decision-execution" control chain. This intelligent control mechanism enables the guidewire to adapt to tortuous anatomical structures, reducing manual intervention while ensuring accurate path planning and operational safety, ultimately achieving a synergistic improvement in guidewire delivery efficiency and success rate during minimally invasive surgery.

[0062] The working principle of the present invention is as follows: when working, a segmented microtube matrix engraved with fluorescent markers is first prepared through a composite core material, and a shape memory alloy spring is embedded to realize the basic telescopic function; then an electromagnetic lock is integrated at the microtube connection to control the segmented locking, and a gradient lubrication layer and a drug sustained-release layer are deposited in sequence to optimize the surface properties; further, a distributed optical fiber sensor is embedded inside the matrix, and linked with the fluorescent marker to form a multimodal tracking module; finally, an intelligent control system is constructed based on the tracking data, and the electromagnetic lock is driven to dynamically adapt to the guidewire morphology through a reinforcement learning algorithm to form a closed-loop control mechanism to achieve precise adjustment of the guidewire length and path; this method gives the guidewire controllable telescopic ability and bending resistance through the combination of a segmented microtube matrix and a shape memory alloy spring, and dynamically optimizes the guidewire path through a reinforcement learning algorithm to solve the problem of vascular damage caused by the excessive rigidity of traditional guidewires, and simultaneously achieves positioning accuracy, dynamic length adjustment and adaptive path planning on a single guidewire, significantly improving the safety and success rate of minimally invasive interventional surgery.

[0063] In this embodiment, it should be noted that the process of preparing the segmented microtubule matrix is ​​specifically as follows:

[0064] S11, preparing a nickel-titanium alloy wire and a cobalt-chromium alloy wire, using the nickel-titanium alloy wire as an inner core and spirally winding the cobalt-chromium alloy wire around the outer layer to form a composite wire, wherein the mass ratio of the nickel-titanium alloy to the cobalt-chromium alloy is 3:1;

[0065] The composite structure consists of a nickel-titanium alloy wire as the inner core and a spirally wound cobalt-chromium alloy wire as the outer layer. The nickel-titanium alloy provides flexibility and shape memory, while the cobalt-chromium alloy enhances tensile strength and kink resistance. The two are combined in a 3:1 mass ratio, preserving the guidewire's flexible deformation within the blood vessel while ensuring mechanical stability during delivery, laying the material foundation for subsequent precision processing.

[0066] S12, controlling the drawing rate of the composite wire to perform precision drawing, processing it to a preset outer diameter through multiple cold drawing processes, and then performing annealing treatment in a vacuum environment (temperature 450°C, time duration 2 hours) to eliminate internal stress;

[0067] The composite wire is gradually processed to the preset outer diameter through a multi-pass cold drawing process. The drawing rate is strictly controlled to prevent material hardening. It is then annealed in a vacuum environment to eliminate internal residual stress. This process not only ensures the dimensional accuracy of the microtube, but also restores the material's elastic modulus, improving the overall fatigue resistance of the guidewire.

[0068] S13, laser etching is performed on the surface of the annealed composite wire. A laser is used to etch annular grooves (depth 20 μm, width 50 μm) with a preset spacing along the axial direction, and fluorescent nanoparticles (specifically SrAl2O4:Eu2+) are filled in the annular grooves to form fluorescent positioning marks.

[0069] A high-precision laser is used to etch equally spaced annular grooves on the surface of the composite wire, which are then filled with fluorescent nanoparticles. The laser etching ensures precise and controllable mark placement, while the fluorescent filling process enhances the mark's durability and contrast, providing a high-resolution optical reference point for subsequent multimodal tracking.

[0070] S14, cutting the etched composite wire into microtube segments of equal length, and processing conical grooves (depth 100 μm, cone angle 60°) at both ends of each microtube segment to fix the shape memory alloy spring;

[0071] The etched composite wire is cut into microtube segments of equal length, and tapered grooves are machined at both ends of each microtube. This tapered groove design enhances the connection strength of the shape memory alloy spring through a mechanical interlocking structure, avoiding the stress concentration associated with traditional planar bonding and ensuring reliable inter-segment connection during guidewire extension and retraction.

[0072] S15, preconditioning a shape memory alloy spring (preferably a NiTi-Nb alloy, with a wire diameter of 0.1 mm, 5 coils, and a free length of 2 mm) by performing shape memory training at 600°C to restore the spring to its preset shape at 37°C body temperature, and then embedding both ends of the spring into the tapered grooves of adjacent microtube segments;

[0073] The shape memory alloy spring is subjected to high-temperature training, allowing it to automatically return to its preset shape at human body temperature. The preconditioned spring is then embedded in the tapered grooves of adjacent microtubule segments. This shape memory effect enables the guidewire to adaptively adjust its expansion and contraction at body temperature, enhancing its dynamic compliance within tortuous vascular pathways.

[0074] S16, the assembled microtube-spring assembly is encapsulated as a whole, the joints are covered with biocompatible heat shrink tubing, and a secondary annealing is performed (temperature 300°C, time duration 1 hour), and then the surface of the encapsulated body is electrolytically polished to obtain a segmented microtube matrix.

[0075] The electrolytic polishing conditions are a voltage of 12 V and an electrolyte of a mixture of H3PO4 and C2H5OH, so that the surface roughness Ra is ≤ 0.1 μm.

[0076] Biocompatible heat shrink tubing is used to encapsulate the microtube-spring connection. A secondary annealing step solidifies the encapsulated structure and releases assembly stress, followed by electrolytic polishing. This encapsulation process ensures the safety of the guidewire for in vivo use, while polishing reduces surface roughness, providing an ideal substrate for the uniform deposition of subsequent functional coatings.

[0077] In this embodiment, it should be noted that the tip end of the retractable guidewire is encapsulated with a gradient hardness module, and the gradient hardness module is integrated with a pressure sensing unit and an optical imaging unit.

[0078] It should be noted that the distal end (tip) of the retractable guidewire is encapsulated with a gradient hardness module. This module adopts a multi-layer composite material stacking structure. The hardness gradually increases from 50D to 80D (Shore hardness) from the tip to the proximal end, realizing the functional gradient transition of "flexible detection to rigid support". The gradient hardness module integrates a pressure sensing unit and an optical imaging unit:

[0079] Pressure sensing unit: A thin-film pressure sensor is prepared based on micro-electromechanical systems (MEMS) technology and embedded in the proximal area of ​​the module to detect the contact force between the guidewire tip and the blood vessel wall in real time to prevent vascular damage caused by excessive pressure.

[0080] The optical imaging unit integrates a 0.5mm diameter micro-endoscopic lens at the tip of the module, and is equipped with a fiber optic imaging bundle with a side-opening design to provide real-time intravascular images to assist the surgeon in identifying bifurcation angles and lesion characteristics.

[0081] The gradient hardness module is integrally formed through a 3D printing process and coated with biocompatible silicone, which protects the internal electronic components while maintaining surface lubricity. This design enables the guidewire tip to adaptively deform within tortuous blood vessels. Furthermore, through mechanical-optical dual-mode feedback, it significantly improves control safety and target positioning accuracy within complex pathways.

[0082] In this embodiment, it should be noted that step S2 specifically includes the following steps:

[0083] S21, alternately depositing NdFeB magnetic layers and insulating aluminum oxide layers on the surface of a titanium alloy substrate by a magnetron sputtering process, cutting the substrate into a cylinder with a preset diameter (preferably 200 μm), and welding pre-set wires at both ends to prepare an electromagnetic lock;

[0084] Using a magnetron sputtering process, alternating layers of NdFeB magnetic and insulating aluminum oxide are deposited on a titanium alloy substrate, creating a composite structure that combines strong magnetic response with current isolation. The NdFeB layer provides rapid magnetic control, while the aluminum oxide layer prevents current leakage. After being cut into micro-cylinders and welded with pre-wired conductors, this provides the hardware foundation for the subsequent remote control of the electromagnetic lock.

[0085] S22, embedding the electromagnetic lock buckle into the connection of the segmented microtube matrix, fixing the electromagnetic lock buckle and the microtube matrix with a biocompatible conductive glue (preferably silver epoxy resin), and ensuring that the pre-placed wire extends along the surface of the microtube matrix to the proximal end of the guide wire;

[0086] The electromagnetic lock is embedded in the joint of the segmented microtube matrix and fixed to the microtube matrix using biocompatible conductive adhesive, ensuring mechanical connection strength while maintaining electrical signal conductivity. A pre-installed wire extends along the microtube surface to the proximal end of the guidewire, forming a complete lock control chain and providing an operational interface for the subsequent precise opening and closing of the electromagnetic lock.

[0087] S23, vacuum annealing is performed on the assembled microtube-lock assembly to improve the bonding strength of the conductive adhesive, and then the magnetic response performance of the electromagnetic lock is tested by pulse current.

[0088] The assembled microtube-locking buckle assembly undergoes vacuum annealing to enhance the bonding strength between the conductive adhesive and the metal interface and eliminate assembly stress. The buckle's magnetic response is then tested using pulsed current to verify its opening and closing speed and durability, ensuring reliable operation of the electromagnetic lock in complex vascular environments.

[0089] S24, plasma cleaning (argon atmosphere, power 100 W, duration 5 min) was performed on the surface of the segmented microtube substrate to remove surface impurities and activate coating adhesion;

[0090] Plasma cleaning technology is used to deeply clean the microtube substrate surface, removing residual organic contaminants from processing and activating surface chemical activity through ion bombardment. This process significantly improves the adhesion of subsequent coatings and prevents localized peeling of the lubricant or drug layer due to surface impurities.

[0091] S25, an atomic layer deposition device is used to alternately deposit aluminum oxide layers (single layer thickness 0.1 nm, 300 cycles) and diamond-like carbon layers (DLC, single layer thickness 0.2 nm, 200 cycles) on the substrate surface to form a gradient lubrication layer with a preset total thickness.

[0092] Atomic layer deposition (ALD) is used to alternately grow aluminum oxide and diamond-like carbon nanocoatings on the substrate surface. The aluminum oxide layer provides chemical stability, while the DLC layer imparts ultra-low friction. The two are layered in a gradient to form a lubricating layer with a gradually varying friction coefficient from proximal to distal, adapting to the frictional environment requirements of different vascular segments.

[0093] S26, dispersing PLGA microspheres loaded with heparin and nitroglycerin in a polyvinylpyrrolidone solution and evenly coating them on a pre-set area proximal to the guidewire by an electrostatic spraying process to form a drug sustained-release layer;

[0094] PLGA microspheres loaded with heparin (anticoagulant) and nitroglycerin (vasodilator) are dispersed in a binder solution and applied to a pre-set area at the distal end of the guidewire via an electrostatic spraying process. This process achieves localized, high-concentration drug delivery, ensuring drug release only in the target vascular segment, minimizing systemic side effects.

[0095] It should be noted that PLGA microspheres are biodegradable microparticles made of poly(lactic-co-glycolic acid) copolymers, which can be loaded with drugs (such as heparin and nitroglycerin). By regulating the PLGA molecular ratio and microsphere size, sustained release of drugs within blood vessels can be achieved, prolonging the duration of local drug effects while avoiding the side effects of systemic administration. They are ideal carriers for localized targeted therapies using medical devices.

[0096] S27, the coated guidewire is subjected to a step curing treatment: first drying at 40°C for 2 hours to form a drug sustained-release layer, and then heat treating at 120°C in a vacuum environment for 30 minutes to covalently bond the PLGA microspheres to the surface of the microtube matrix.

[0097] The coated composite guidewire undergoes a step-by-step curing process: first, low-temperature drying forms a continuous film layer, followed by vacuum heat treatment to strengthen the interfacial bond between the PLGA microspheres and the substrate. While maintaining drug activity, this step-by-step curing enhances the coating's mechanical durability, enabling it to withstand repeated bending of the guidewire and friction with the vessel wall.

[0098] In this embodiment, it should be noted that step S3 specifically includes the following steps:

[0099] S31, select a multi-core optical fiber with a preset standard diameter, strip the outer sheath, use a laser to write Bragg gratings point by point, and coat the surface of the multi-core optical fiber with a polyimide protective layer to prepare a flexible distributed optical fiber sensor;

[0100] A multi-core optical fiber is used as the sensing medium. After stripping the outer sheath, a Bragg grating is laser-engraved point by point to form highly sensitive strain sensing nodes. A polyimide protective layer is then applied to the optical fiber surface to enhance its bending and corrosion resistance, ensuring stability during dynamic expansion and contraction of the guidewire.

[0101] S32, pre-stretching the optical fiber after the grating is inscribed: applying a preset constant tension to both ends of the optical fiber and maintaining it at 150°C for 30 minutes to eliminate residual stress and fix the grating wavelength reference;

[0102] Applying constant tension to the fiber optic cable inscribed with the grating and subjecting it to high temperature eliminates residual stress and stabilizes the grating wavelength reference. This step improves the measurement consistency of the fiber optic sensor and prevents signal drift caused by ambient temperature or mechanical deformation during subsequent use.

[0103] S33, a through microhole is opened along the central axis of the segmented microtube matrix, the flexible distributed optical fiber sensor is inserted into the microhole, and a redundant optical fiber ring is reserved at the connection of each microtube to adapt to the expansion and contraction deformation of the guide wire.

[0104] The fiber optic sensor is inserted along the central axis of the microtubule matrix, with redundant loops reserved at each connection. The redundant loops absorb the axial stress generated by the guidewire's expansion and contraction through elastic deformation, preventing the fiber from breaking due to excessive stretching while maintaining the continuity of the sensing signal.

[0105] S34, opening a lateral laser microhole on the outer surface of the microtubule matrix at a position corresponding to the fluorescent positioning marker, filling it with a fluorescence enhancement medium, so that the optical fiber sensor and the fluorescent marker form an optical coupling channel;

[0106] Lateral microholes are created on the microtubule surface at locations corresponding to fluorescent markers and filled with a fluorescence-enhancing medium, enabling coupling between the fiber optic sensor and the light signal from the external fluorescent marker. This design enables the coordinated verification of fiber optic strain data and fluorescent visual positioning, enhancing the reliability of multimodal tracking.

[0107] S35, integrating the fiber Bragg grating wavelength demodulator with the near-infrared fluorescence imager, and establishing a coordinate mapping relationship between the optical signal of the fiber sensor and the fluorescent marker through a time-space encoding algorithm to configure a multimodal signal synchronization module;

[0108] The fiber optic demodulator is integrated with a fluorescence imager, and a coding algorithm is used to establish a mapping relationship between optical signals and spatial coordinates. Time-space synchronization technology addresses the timing differences between different sensing modalities and generates a high-precision three-dimensional guidewire morphology map.

[0109] S36, cyclically test the extension and contraction motion of the guidewire in a simulated vascular model, synchronously record the strain data and fluorescent marker displacement after optical signal conversion, optimize the tracking error, and complete the dynamic calibration of the assembled guidewire-fiber complex.

[0110] Guidewire motion is tested in a simulated vascular environment, with simultaneous acquisition of optical fiber strain data and fluorescence displacement information. Tracking errors are then compared and analyzed to optimize algorithm parameters. After calibration, the system achieves submillimeter positioning accuracy, meeting the clinical requirements for navigating complex vascular pathways.

[0111] In this embodiment, it should be noted that step S4 specifically includes the following steps:

[0112] S41: Build a multi-source data fusion platform to input the strain distribution data collected by the fiber optic sensor and the pose coordinate data of the fluorescent marker into the time synchronization module. Use the sliding window algorithm to align the timing differences of the two types of signals to generate a spatiotemporally synchronized 3D deformation map of the entire guidewire segment.

[0113] A multi-source data fusion platform was constructed to time-align the strain distribution data collected by the fiber optic sensor across the entire guidewire segment with the optical pose coordinate data of the fluorescent marker. To address the discrepancy between the high-frequency sampling of the fiber optic signal and the low-frequency frame rate of the fluorescent image, a sliding window algorithm was used to dynamically match the timestamps of the two data types, eliminating millisecond-level delay errors. The fused data was then used to reconstruct a continuous deformation map of the entire guidewire segment using a three-dimensional spatial interpolation algorithm. This accurately characterizes the real-time bending, torsion, and extension of the guidewire within the blood vessel, providing high-precision input for subsequent intelligent control.

[0114] S42, training a reinforcement learning control model: establishing a guidewire-vessel wall contact mechanics model in a virtual vascular simulation environment, using a deformation map as input and electromagnetic lock action instructions as output, and iteratively training the control strategy using a proximal strategy optimization algorithm until the path tracking error stabilizes within a preset error tolerance range;

[0115] A guidewire-vessel wall contact mechanics model was established within a virtual vascular simulation environment. Based on coupled fluid and solid mechanics simulations, the guidewire's motion resistance and deformation response under varying vascular curvatures and bifurcation angles were simulated. Using the deformation map as input features and the electromagnetic lock opening and closing instructions as output actions, a proximal strategy optimization algorithm was employed for reinforcement learning training. Through millions of iterations, the model learned to autonomously determine the lock action timing and guidewire pushing strategy within complex paths, ultimately converging the path tracking error to within ±0.3mm, achieving the clinical operational accuracy threshold.

[0116] S43 compresses the trained reinforcement learning control model into a lightweight TensorRT engine, integrates it into the microprocessor at the proximal end of the guidewire, and establishes real-time communication with the electromagnetic lock drive circuit and multimodal tracking hardware to deploy an embedded intelligent control system;

[0117] The trained reinforcement learning model is lightweight and compressed using the TensorRT engine, removing redundant compute nodes and quantizing floating-point precision, reducing the model size to 15% of its original size. The compressed model is then deployed to an embedded microprocessor (preferably an ARM Cortex-M7) at the proximal end of the guidewire, establishing a low-latency communication link with the electromagnetic latch driver circuit and fiber demodulation module. This embedded system enables millisecond-level real-time analysis of guidewire morphology and issuance of control commands, ensuring immediate responsiveness during intraoperative procedures.

[0118] It should be noted that the TensorRT engine is a high-performance deep learning inference optimizer that can convert the training model into a lightweight computing engine, significantly improving the inference speed and reducing computing resource usage. It is suitable for real-time intelligent computing needs of embedded devices.

[0119] S44 runs an intelligent control system in an in vitro vascular model, synchronously collects actual guidewire motion data and simulation prediction results, and optimizes control parameters through a dynamic weight adjustment algorithm to ensure that the actual path and the planned path are consistent with the preset target value, thereby achieving closed-loop control of the guidewire length and path.

[0120] An intelligent control system was run within an in vitro vascular model, simultaneously capturing the actual guidewire trajectory and the simulated predicted path, and comparing and analyzing the deviations between the two. A dynamic weight adjustment algorithm was used to optimize parameters in the control model, such as path smoothness and buckle life, to balance control accuracy and hardware durability. After multiple rounds of iterative optimization, the alignment between the actual and planned paths improved, demonstrating the system's ability to adapt to vascular anatomical variations, ultimately completing the technical verification of guidewire closed-loop control.

[0121] As described above, the above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the above embodiments, those skilled in the art should understand that the technical solutions described in the above embodiments can still be modified, or some of the technical features thereof can be replaced by equivalents. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A method for manufacturing a high-precision retractable guide wire, characterized in that: The following steps are involved: Prepare a segmented microtubule matrix, wherein the segmented microtubule matrix is ​​composed of a composite core material of nickel-titanium alloy and cobalt-chromium alloy, the surface of the composite core material is etched with fluorescent positioning marks, and shape memory alloy springs are embedded between adjacent microtubule segments; An electromagnetic lock buckle is integrated at the connection of the segmented microtube matrix, and a gradient lubricating layer and a drug-release layer are sequentially deposited on its surface; specifically, the following steps are included: a neodymium iron boron magnetic layer and an insulating aluminum oxide layer are alternately deposited on the surface of a titanium alloy substrate by a magnetron sputtering process, the cylinder is cut into a preset diameter, and pre-set wires are welded at both ends to prepare an electromagnetic lock buckle; the electromagnetic lock buckle is embedded in the connection of the segmented microtube matrix, and the electromagnetic lock buckle and the microtube matrix are fixed with a biocompatible conductive glue, and it is ensured that the pre-set wire extends along the surface of the microtube matrix to the proximal end of the guide wire; the assembled microtube-lock buckle assembly is vacuum annealed to improve the bonding strength of the conductive glue, and then the magnetic response performance of the electromagnetic lock buckle is tested by a pulse current; A distributed optical fiber sensor is embedded in the segmented microtubule matrix and configured in conjunction with the fluorescent positioning marker to form a multimodal tracking module; Based on the real-time data of the multimodal tracking module, an intelligent control system is constructed. The intelligent control system drives the dynamic adaptation of the electromagnetic lock and the guidewire shape through a reinforcement learning algorithm to achieve closed-loop control of the guidewire length and path. Specifically, it includes: A multi-source data fusion platform was constructed to input the strain distribution data collected by the fiber optic sensor and the position coordinate data of the fluorescent marker into the time synchronization module. The timing differences between the two types of signals were aligned using a sliding window algorithm to generate a spatiotemporally synchronized 3D deformation map of the entire guidewire segment. Training the reinforcement learning control model: A guidewire-vessel wall contact mechanics model is established in a virtual vascular simulation environment. Using the deformation map as input and the electromagnetic lock action instructions as output, the control strategy is iteratively trained using a proximal strategy optimization algorithm until the path tracking error stabilizes within the preset error tolerance range. The trained reinforcement learning control model is lightweight and compressed into a TensorRT engine, integrated into the microprocessor at the proximal end of the guidewire, and establishes real-time communication with the electromagnetic lock drive circuit and multimodal tracking hardware to deploy an embedded intelligent control system. An intelligent control system is run in an in vitro vascular model to synchronously collect actual guidewire motion data and simulation prediction results. The control parameters are optimized through a dynamic weight adjustment algorithm to ensure that the actual path and the planned path are consistent with the preset target value, thereby achieving closed-loop control of the guidewire length and path.

2. The method for manufacturing a high-precision retractable guide wire according to claim 1, wherein: The process of preparing the segmented microtubule matrix is ​​specifically as follows: Prepare nickel-titanium alloy wire and cobalt-chromium alloy wire, use the nickel-titanium alloy wire as the inner core, and spirally wrap the cobalt-chromium alloy wire around the outer layer to form a composite wire, wherein the mass ratio of nickel-titanium alloy to cobalt-chromium alloy is 3:1; Controlling the drawing rate of the composite wire to perform precision drawing, processing the composite wire to a preset outer diameter through multiple cold drawing processes, and then annealing the composite wire in a vacuum environment to eliminate internal stress; Laser etching is performed on the surface of the annealed composite wire. A laser is used to etch annular grooves with a preset spacing along the axial direction, and fluorescent nanoparticles are filled in the annular grooves to form fluorescent positioning marks.

3. The method for manufacturing a high-precision retractable guide wire according to claim 2, wherein: The process of preparing the segmented microtubule matrix also includes: The etched composite wire is cut into microtube segments of equal length, and conical grooves are machined at both ends of each microtube to fix the shape memory alloy spring; The shape memory alloy spring was pre-conditioned by undergoing shape memory training at 600°C, allowing it to recover its preset shape at 37°C body temperature. The spring's ends were then embedded in the tapered grooves of adjacent microtubule segments. The assembled microtube-spring assembly is encapsulated as a whole, the connection is covered with a biocompatible heat shrink tube, and a secondary annealing is performed. The surface of the encapsulated body is then electropolished to obtain a segmented microtube matrix.

4. The method for manufacturing a high-precision retractable guide wire according to claim 1, wherein: The tip end of the retractable guide wire is encapsulated with a gradient hardness module, and the gradient hardness module is integrated with a pressure sensing unit and an optical imaging unit.

5. The method for manufacturing a high-precision retractable guide wire according to claim 1, wherein: The assembled microtube-lock buckle assembly is vacuum annealed to improve the bonding strength of the conductive adhesive, and then the magnetic response performance of the electromagnetic lock buckle is tested by pulse current, and then the following steps are further included: Plasma cleaning is performed on the surface of the segmented microtube substrate to remove surface impurities and activate coating adhesion; Atomic layer deposition equipment is used to alternately deposit aluminum oxide layers and diamond-like carbon layers on the surface of the substrate to form a gradient lubrication layer with a preset total thickness.

6. The method for manufacturing a high-precision retractable guide wire according to claim 5, characterized in that: The method further comprises: alternately depositing aluminum oxide layers and diamond-like carbon layers on the substrate surface using an atomic layer deposition device to form a gradient lubricating layer with a preset total thickness; and then further comprising: PLGA microspheres loaded with heparin and nitroglycerin are dispersed in a polyvinylpyrrolidone solution and evenly coated on a pre-set area proximal to the guidewire by an electrostatic spraying process to form a drug sustained-release layer. The coated guidewire was subjected to a step-curing treatment: first, it was dried at 40°C for 2 hours to form a film of the drug sustained-release layer, and then heat-treated in a vacuum environment at 120°C for 30 minutes to covalently bond the PLGA microspheres to the surface of the microtube matrix.

7. The method for manufacturing a high-precision retractable guide wire according to claim 1, wherein: A distributed optical fiber sensor is embedded in the segmented microtubule matrix and linked with the fluorescent positioning marker to form a multimodal tracking module, which specifically includes the following steps: A multi-core optical fiber with a preset standard diameter was selected. After stripping the outer sheath, a Bragg grating was inscribed point by point using a laser. A polyimide protective layer was then coated on the surface of the multi-core optical fiber to prepare a flexible distributed optical fiber sensor. The fiber after grating inscription is pre-stretched: a preset constant tension is applied to both ends of the fiber and maintained at 150°C for 30 minutes to eliminate residual stress and fix the grating wavelength reference; A through microhole is opened along the central axis of the segmented microtube matrix, the flexible distributed optical fiber sensor is passed through the microhole, and an optical fiber redundant ring is reserved at the connection of each microtube segment to adapt to the expansion and contraction deformation of the guide wire.

8. The method for manufacturing a high-precision retractable guide wire according to claim 7, characterized in that: The method further comprises: providing a microhole along the central axis of the segmented microtube matrix, inserting the flexible distributed optical fiber sensor into the microhole, and reserving a redundant optical fiber ring at the connection of each microtube segment to adapt to the expansion and contraction deformation of the guide wire. A lateral laser microhole is opened on the outer surface of the microtubule matrix at a position corresponding to the fluorescent positioning marker, and filled with a fluorescence enhancement medium, so that the optical fiber sensor and the fluorescent marker form an optical coupling channel; The fiber Bragg grating wavelength demodulator is integrated with the near-infrared fluorescence imager, and the coordinate mapping relationship between the optical signal of the fiber sensor and the fluorescent marker is established through the time-space encoding algorithm to configure the multimodal signal synchronization module. The guidewire's telescopic motion is cyclically tested in a simulated vascular model, and the strain data and fluorescent marker displacement after optical signal conversion are synchronously recorded to optimize tracking errors and complete dynamic calibration of the assembled guidewire-fiber complex.

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