Active bending neurosurgical catheter

Abstract

The application relates to an active bending neurosurgical catheter and relates to the technical field of medical devices. The operation logic of the application is unique, that is, the fixed bending point and the whole new track pushing operation logic. After the bending angle is locked, the catheter is pushed as a whole, so that the distal end of the catheter circulates around the brain tissue along a brand-new axial track after bending, and precisely reaches the deep intracranial and lateral hidden effusion cavity. The catheter body adopts a multilayer composite structure of PTFE lining, multilayer woven reinforcement and Pebax outer coating, so as to form a gradually changing rigidity structure of proximal flexibility, middle high-strength force transmission and distal softness. The head end adopts a round blunt structure and is matched with a plurality of groups of side holes and end hole composite drainage structures, is matched with a platinum-iridium developing mark belt distributed throughout the whole process, and is compatible with mainstream neuro-navigation, fluorescence and ultrasonic imaging equipment. The application is equipped with an ergonomic handle with an angle scale and a mechanical locking structure. The positioning accuracy of the application is significantly improved when the catheter is pushed, the blood clot blocking time is prolonged, and the intraoperative flushing and catheter replacement operations are reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an active bending neurosurgical drainage tube. Background Technology

[0002] In neurosurgical practice, after anterior craniotomy or burr hole surgery, effusions, hematomas, or abscesses located posterior to the brain tissue (occipital lobe, posterior temporal lobe, subdural space, multilocular ventricles, etc.) often require additional drilling or secondary surgery for effective drainage. Traditional external drainage tubes or ordinary drainage tubes are straight or passively curved, making it difficult to bypass the brain tissue to reach the target area posteriorly. This leads to the need for additional drilling or extended craniotomy, increasing the risk of brain tissue traction injury, infection, hemorrhage complications, and surgical time. Multilocular effusions require multiple adjustments or multiple drainage tubes, making the procedure complex and causing significant trauma to the patient.

[0003] Chinese Patent CN224085300U: This patent discloses a flexible neuroendoscopy, relating to the field of endoscopy technology. The flexible neuroendoscopy includes a handle, an insertion tube, a curved serpentine structure at one end of the insertion tube away from the handle, and a tip at the other end of the curved serpentine structure away from the insertion tube, with a camera mounted on the tip. The curved serpentine structure is hollow internally, and two pull wires are connected to each other on the inner sidewalls of its front end. The pull wires pass through the insertion tube and extend into the handle. The handle is equipped with a traction component for pulling the pull wires.

[0004] Chinese Patent CN116211222A: This invention relates to the field of endoscopy technology, and in particular to a guide device and an endoscope, comprising a guide member, wherein the guide member is provided with a working channel for placing the endoscope insertion part, and a controllable bending section is provided at the distal end of the guide member, wherein the stiffness of the controllable bending section in a first plane is less than the stiffness of the controllable bending section in a second plane, the first plane and the second plane are different planes passing through the axis of rotation, and a connecting structure is provided on the guide member.

[0005] While existing flexible microcatheters for vascular intervention have a steering function, they are mainly designed for intravascular operations. The bending radius, thrust transmission, tissue compatibility, and the control logic of "fixing the turning point and then advancing along a new trajectory" are not suitable for brain parenchyma / subdural effusion drainage scenarios, resulting in problems such as poor control stability and drainage smoothness. Summary of the Invention

[0006] To address the aforementioned problems, the present invention provides an actively bending neurosurgical drainage tube, comprising a control handle assembly, a dual-lumen tube body, an actively bending section, a cephalic imaging drainage assembly, and a wire drawing drive assembly.

[0007] Furthermore, the control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the fluid drainage main chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0008] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0009] The active bending section is a laser-cut nickel-titanium hypotube or a micro-jointed snake bone structure. The tube body of the active bending section is designed with an asymmetrical laser-cut pattern or a unilateral priority joint design to achieve predictable unilateral bending and fixed turning points. The active bending section is 20-30mm long, with controllable bending on only one side and a maximum bending angle of 90°-120°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the dual-lumen tube, and the front end of the active bending section is connected to the head-end imaging drainage component.

[0010] The wire drawing drive assembly includes 1-2 stainless steel or nickel-titanium wire drawing drive cables. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After releasing the lock, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0011] The head-end imaging drainage assembly includes a connector, a steel tube, a miniature camera, and an optical lens. The steel tube is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel tube, and the optical lens is assembled at the front end of the steel tube. The head end has a rounded and blunt structure, with a main drainage opening at the end. 4-8 side drainage holes are evenly distributed on the tube wall within a range of 3-5cm posterior to the head end. Platinum-iridium imaging markers are set at the head end, the start and end positions of the active bending section, and every 5-10cm intervals in the main body of the double-lumen tube.

[0012] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0013] Furthermore, the active bending section adopts a micro multi-joint snake bone structure. The snake bone is miniaturized using the micro snake bone processing technology of an endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0014] Furthermore, the active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumferential direction. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0015] Furthermore, the inner diameter of the main fluid drainage chamber of the dual-lumen tube is 1.8-2.2 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0016] Furthermore, the outer wall of the inner steel wire pull rod of the handle is provided with continuous sawtooth meshing teeth, and the mechanical locking button has built-in elastic locking teeth. The locking teeth mesh with the sawtooth teeth to lock the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0017] Furthermore, the front end of the active bending section is sealed to the steel pipe with an interference fit via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is annularly wrapped around the outer wall of the connecting ring, both ends of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0018] Furthermore, the side drainage holes on the blunt outer wall of the head end are elliptical through holes, and the side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens, and the main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0019] Furthermore, the platinum-iridium contrast marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0020] Furthermore, the overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0021] Furthermore, the preparation method of the hydrophilic modified PTFE liner is as follows:

[0022] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 3–6 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 15–30 minutes; the modification solution consists of 0.3–0.9 wt% trehalose, 0.2–0.6 wt% oligodextrose, 0.1–0.3 wt% dextran, 0.1–0.3 wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0023] A2: Drain excess modified liquid from the surface of the lining, place it in a sealed environment at 50-60℃, and irradiate it continuously with a medical surgical UV lamp for 1.5-4 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 20-30℃ to obtain a hydrophilic modified PTFE lining layer.

[0024] Reaction mechanism:

[0025] The dual effects of ultraviolet irradiation: ① It excites the photoinitiator to generate a large number of free radicals, and at the same time activates the carbon free radicals and hydroxyl oxygen free radicals of polyhydroxy sugars in the pre-irradiated PTFE; ② The two types of free radicals undergo covalent cross-linking reaction, and the polyhydroxy sugars are chemically grafted and fixed to the inner wall of the PTFE liner to build a three-dimensional hydrophilic cross-linking network, thus eliminating the problem of simple physical coating peeling.

[0026] Trehalose, oligodextrose, and dextran are rich in polyhydroxy active sites. Under ultraviolet light, they can generate oxygen free radicals, which can covalently cross-link with carbon free radicals generated by PTFE irradiation, greatly improving the binding force of the hydrophilic layer. During continuous drainage and flushing during surgery, they are not easy to fall off.

[0027] Add a PTFE pre-irradiation activation process: construct free radical sites on the PTFE surface in advance to solve the defect of PTFE's inertness and difficulty in grafting, and achieve chemical bonding rather than simple coating;

[0028] Introducing a medical ultraviolet light initiation system: directionally mediating free radical cross-linking reaction, resulting in a dense and uniform cross-linking network that significantly enhances the lining's anti-coagulation and anti-protein adsorption capabilities, making it suitable for long-term drainage of intracranial effusion / hematoma in neurosurgery.

[0029] Technical effects:

[0030] The present invention provides an actively flexible neurosurgical drainage tube, which has the following significant advantages compared with the prior art:

[0031] 1. The catheter is equipped with a dedicated fixed bending pivot and a mechanical locking structure, which ensures strong stability of the bending shape during the push process and greatly improves the accuracy of intracranial target area positioning. There is no need to repeatedly adjust the catheter posture during the operation.

[0032] 2. The large-diameter main drainage lumen combined with the composite opening drainage structure at the tip can significantly reduce the probability of blood clot adhesion and blockage, reduce the number of intraoperative flushing and catheter replacement procedures, and simplify the surgical process.

[0033] 3. The inner lining adopts a covalently bonded hydrophilic modified PTFE structure, the hydrophilic layer is firmly bonded and not easy to fall off, with excellent anti-clogging performance, maintaining smooth flow under long-term drainage conditions and reducing the risk of pipe blockage. Attached Figure Description

[0034] Figure 1 This is an axial sectional view of the guide tube;

[0035] Figure 2 This is a partial axial half-section view of the diversion tube;

[0036] Figure 3 The mirror part of the guide tube;

[0037] Figure 4 This is an enlarged view of the inserted section.

[0038] Among them, the appendix Figure 1 In the middle: 1 is the rear Luer, 2 is the wire pull rod, 3 is the handle, 4 is the double-lumen tube, 5 is the wire pull ring, and 6 is the head end.

[0039] Among them, the appendix Figure 2 In the middle: 1 is the curved section, and 2 is the straight section.

[0040] Among them, the appendix Figure 3 In the middle: 1 is the mirror handle, and 2 is the insertion part.

[0041] Among them, the appendix Figure 4 In the middle: 1 is the insertion tube, 2 is the connector, 3 is the steel pipe, 4 is the head end, 5 is the head end, and 6 is the lens. Detailed Implementation

[0042] To further illustrate the technical means and effects of the present invention in achieving its intended purpose, the following detailed description of the specific implementation methods, structures, features, and effects of the present invention, in conjunction with the accompanying drawings and preferred embodiments, is provided below.

[0043] Testing equipment: Angle tester, intracranial tissue simulation silicone model, flow test device.

[0044] 1. Bending angle offset test: Bend to 90° and lock, apply a 5N pushing force along the axial direction of the conduit, and record the bending angle offset.

[0045] 2. Anti-clogging performance test: Simulate intracranial blood clot mixture (plasma + fibrin clot), drain under constant negative pressure for 10 minutes, and record the anti-clogging time of blood clot drainage.

[0046] Example 1

[0047] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0048] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0049] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0050] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 20mm long, with controllable bending on only one side and a maximum bending angle of 90°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0051] The wire drawing drive assembly includes a nickel-titanium wire drawing drive wire cable. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After the lock is released, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0052] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Four side drainage holes are evenly distributed on the pipe wall within 3 cm posterior to the head end. Platinum-iridium imaging markers are set at 5 cm intervals at the head end, the start and end positions of the active bending section, and the main body of the double-lumen tube.

[0053] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0054] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0055] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0056] The dual-lumen tube fluid drainage main cavity has an inner diameter of 1.8 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0057] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0058] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0059] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0060] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0061] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0062] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0063] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 3 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 15 minutes; the modification solution consists of 0.3wt% trehalose, 0.2wt% oligodextrose, 0.1wt% dextran, 0.1wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0064] A2: Drain excess modified liquid from the inner lining surface, place it in a 50℃ sealed environment, and continuously irradiate it with a medical surgical UV lamp for 1.5 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 20℃ to obtain a hydrophilic modified PTFE inner lining layer.

[0065] Example 2

[0066] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0067] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0068] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0069] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 25mm long, with controllable bending on only one side and a maximum bending angle of 100°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0070] The wire drawing drive assembly includes a nickel-titanium wire drawing drive wire cable. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After the lock is released, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0071] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Six side drainage holes are evenly distributed on the pipe wall within a 4cm range backward from the head end. Platinum-iridium imaging markers are set at the head end, the start and end positions of the active bending section, and every 6cm interval of the dual-lumen tube body.

[0072] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0073] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0074] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0075] The dual-lumen tube fluid drainage main cavity has an inner diameter of 1.9 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0076] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0077] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0078] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0079] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0080] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0081] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0082] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 4 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 20 minutes; the modification solution consists of 0.5wt% trehalose, 0.3wt% oligodextrose, 0.2wt% dextran, 0.2wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0083] A2: Drain excess modified liquid from the inner lining surface, place it in a 55℃ sealed environment, and continuously irradiate it with a medical surgical ultraviolet lamp for 2.5 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 25℃ to obtain a hydrophilic modified PTFE inner lining layer.

[0084] Example 3

[0085] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0086] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0087] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0088] The active bending section is a laser-cut nickel-titanium hypotube or a micro-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 25mm long, and can be bent controllably on only one side with a maximum bending angle of 110°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0089] The wire drawing drive assembly includes two nickel-titanium wire drawing drive wire cables. One end of each wire cable is fixed to a wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever, in conjunction with the wire rod, pulls the wire cable to make the active bending section bend unilaterally around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After releasing the lock, the elasticity of the tube body, combined with the micro-opposing pulling force of the wire drawing, realizes the automatic reset of the bending section.

[0090] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Six side drainage holes are evenly distributed on the pipe wall within a 4cm range backward from the head end. Platinum-iridium imaging markers are set at the head end, the start and end positions of the active bending section, and every 8cm interval of the dual-lumen tube body.

[0091] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0092] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0093] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0094] The dual-lumen tube fluid drainage main cavity has an inner diameter of 2.1 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0095] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0096] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0097] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0098] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0099] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0100] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0101] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 5 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 25 minutes; the modification solution consists of 0.7wt% trehalose, 0.5wt% oligodextrose, 0.2wt% dextran, 0.2wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0102] A2: Drain excess modified liquid from the inner lining surface, place it in a 55℃ sealed environment, and continuously irradiate it with a medical surgical ultraviolet lamp for 3.5 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 25℃ to obtain a hydrophilic modified PTFE inner lining layer.

[0103] Example 4

[0104] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0105] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0106] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0107] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-joint snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 30mm long, with controllable bending on only one side and a maximum bending angle of 120°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0108] The wire drawing drive assembly includes two nickel-titanium wire drawing drive wire cables. One end of each wire cable is fixed to a wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever, in conjunction with the wire rod, pulls the wire cable to make the active bending section bend unilaterally around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After releasing the lock, the elasticity of the tube body, combined with the micro-opposing pulling force of the wire drawing, realizes the automatic reset of the bending section.

[0109] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Eight side drainage holes are evenly distributed on the pipe wall within 5cm posterior to the head end. Platinum-iridium imaging markers are set at the head end, the start and end positions of the active bending section, and every 10cm interval of the dual-lumen tube body.

[0110] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0111] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0112] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0113] The dual-lumen tube fluid drainage main cavity has an inner diameter of 2.2 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0114] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0115] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0116] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0117] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0118] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0119] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0120] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 6 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 30 minutes; the modification solution consists of 0.9wt% trehalose, 0.6wt% oligodextrose, 0.3wt% dextran, 0.3wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0121] A2: Drain excess modified liquid from the lining surface, place in a 60℃ sealed environment, and irradiate continuously for 4 hours using a medical surgical UV lamp; after curing, remove and wash thoroughly with sterile pure water, and dry with 30℃ sterile cold air to obtain a hydrophilic modified PTFE lining layer.

[0122] Comparative Example 1

[0123] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0124] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0125] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0126] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 20mm long, with controllable bending on only one side and a maximum bending angle of 90°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0127] The wire drawing drive assembly includes a nickel-titanium wire drawing drive wire cable. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After the lock is released, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0128] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Four side drainage holes are evenly distributed on the pipe wall within 3 cm posterior to the head end. Platinum-iridium imaging markers are set at 5 cm intervals at the head end, the start and end positions of the active bending section, and the main body of the double-lumen tube.

[0129] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0130] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0131] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0132] The dual-lumen tube fluid drainage main lumen has an inner diameter of 1.8 mm, and the tube body consists of a PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0133] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0134] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0135] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0136] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0137] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0138] Comparative Example 2

[0139] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0140] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0141] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0142] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 20mm long, with controllable bending on only one side and a maximum bending angle of 90°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0143] The wire drawing drive assembly includes a nickel-titanium wire drawing drive wire cable. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After the lock is released, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0144] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Four side drainage holes are evenly distributed on the pipe wall within 3 cm posterior to the head end. Platinum-iridium imaging markers are set at 5 cm intervals at the head end, the start and end positions of the active bending section, and the main body of the double-lumen tube.

[0145] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0146] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0147] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0148] The dual-lumen tube fluid drainage main cavity has an inner diameter of 1.8 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0149] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0150] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0151] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0152] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0153] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0154] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0155] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 3 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 15 minutes; the modification solution consists of 0.2wt% oligodextrose, 0.1wt% dextran, 0.1wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0156] A2: Drain excess modified liquid from the inner lining surface, place it in a 50℃ sealed environment, and continuously irradiate it with a medical surgical UV lamp for 1.5 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 20℃ to obtain a hydrophilic modified PTFE inner lining layer.

[0157] Comparative Example 3

[0158] An active bending neurosurgical drainage tube, characterized in that it includes a control handle assembly, a dual-lumen tube body, an active bending section, a cephalic imaging drainage assembly, and a steel wire drawing drive assembly;

[0159] The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly.

[0160] The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided reinforcing layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end.

[0161] The active bending section is a laser-cut nickel-titanium hypotube or a micro multi-jointed snake bone structure. The tube body of the active bending section is set with an asymmetrical laser-cut pattern to achieve predictable unilateral bending and fixed turning points. The active bending section is 20mm long, with controllable bending on only one side and a maximum bending angle of 90°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the double-lumen tube, and the front end of the active bending section is connected to the head end imaging drainage component.

[0162] The wire drawing drive assembly includes a nickel-titanium wire drawing drive wire cable. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After the lock is released, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section.

[0163] The head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is assembled at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. Four side drainage holes are evenly distributed on the pipe wall within 3 cm posterior to the head end. Platinum-iridium imaging markers are set at 5 cm intervals at the head end, the start and end positions of the active bending section, and the main body of the double-lumen tube.

[0164] The operation logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

[0165] The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

[0166] The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

[0167] The dual-lumen tube fluid drainage main cavity has an inner diameter of 1.8 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

[0168] The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

[0169] The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

[0170] The side drainage holes on the blunt outer wall of the head end are elliptical through holes. The side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main cavity of the fluid drainage inside the double-lumen tube.

[0171] The platinum-iridium imaging marker band is clearly visible under CT, MRI, and ultrasound imaging, and the entire drainage tube is compatible with Stealth, Brainlab neuronavigation systems, and intraoperative fluorescence imaging equipment.

[0172] The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

[0173] The method for preparing the hydrophilic modified PTFE liner is as follows:

[0174] A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 3 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 15 minutes; the modification solution consists of 0.3wt% trehalose, 0.1wt% dextran, 0.1wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection;

[0175] A2: Drain excess modified liquid from the inner lining surface, place it in a 50℃ sealed environment, and continuously irradiate it with a medical surgical UV lamp for 1.5 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 20℃ to obtain a hydrophilic modified PTFE inner lining layer.

[0176] Table 1. Detection results of bending angle offset and blood coagulation drainage anti-blockage time in the specific implementation plan.

[0177] Bending angle offset Duration of blood coagulation drainage to prevent blockage Example 1 2.0° 10-minute blockage Example 2 1.8° 12min blockage Example 3 1.5° 14min blockage Example 4 1.3° 15min blockage Comparative Example 1 28° 3.2min blockage Comparative Example 2 8° 6.3min blockage Comparative Example 3 6° 7.8min blockage

[0178] Table 1 Summary of data on bending angle offset and duration of blood coagulation drainage anti-blockage test results

[0179] The bending angle offset and blood coagulation drainage anti-blockage time of embodiments (1-4) of this invention are superior to those of comparative examples (1-3), indicating that the trehalose, oligodextrose, and dextran of this invention synergistically exert hydrophilic anti-adhesion effects. Combined with the photoinitiator and PTFE pre-irradiation crosslinking process, a stable hydrophilic layer is formed on the inner lining wall, reducing blood coagulation and protein deposition blockage at the source. At the same time, the complete gradient stiffness tube body and the fixed pivot mechanical locking structure work together to ensure that the bending angle is stable and does not deviate during the pushing process. Under the synergistic effect of each component, the bending positioning stability and long-term anti-blockage performance of the drainage tube are significantly optimized simultaneously, making the clinical intraoperative operation more difficult and the drainage continuity better.

[0180] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the scope of the present invention shall still fall within the scope of the present invention.

Claims

1. An actively flexible neurosurgical drainage tube, characterized in that: It includes a control handle assembly, a dual-lumen tube body, an active bending section, a head-end imaging drainage assembly, and a steel wire drawing drive assembly.

2. The actively flexible neurosurgical drainage tube according to claim 1, characterized in that: The control handle assembly includes a handle body, a rear Luer connector, and a wire pull rod locking mechanism. The rear Luer connector is located at the tail of the handle and communicates with the main fluid drainage chamber of the dual-chamber tube. The wire pull rod is slidably assembled inside the handle, and the front end of the wire pull rod is connected to a wire pulling drive assembly. The dual-lumen tube body is divided into a rigid straight section and an active bending section at the front end along the axial direction. The fluid drainage main cavity and the wire drawing auxiliary secondary cavity are coaxially arranged inside the dual-lumen tube. The fluid drainage main cavity is lined with a PTFE layer, and the tube body is covered with a Pebax outer sheath. A multi-layer braided winding reinforcement layer is set in the middle of the tube body to achieve a gradual change in stiffness. The rigid straight section at the near end of the dual-lumen tube has flexible and fitting characteristics, the middle section transmits thrust torque, and the hardness gradually decreases towards the active bending section at the far end. The active bending section is a laser-cut nickel-titanium hypotube or a micro-jointed snake bone structure. The tube body of the active bending section is designed with an asymmetrical laser-cut pattern or a unilateral priority joint design to achieve predictable unilateral bending and fixed turning points. The active bending section is 20-30mm long, with controllable bending on only one side and a maximum bending angle of 90°-120°. The tail end of the active bending section is seamlessly bonded to the rigid straight section of the dual-lumen tube, and the front end of the active bending section is connected to the head-end imaging drainage component. The described wire drawing drive assembly includes 1-2 stainless steel or nickel-titanium wire drawing drive cables. One end of the wire cable is fixed to the wire loop at the front end of the active bending section, and the other end passes through the auxiliary cavity of the double-lumen tube and is fixedly connected to the wire rod inside the handle. The handle is equipped with an angle scale knob / lever and a mechanical locking button. The knob / lever is linked to the wire rod to pull the wire cable, causing the active bending section to bend on one side around the fixed turning pivot area. The mechanical locking button can lock the displacement of the wire rod to maintain the bending angle. After releasing the lock, the elasticity of the tube body and the micro-opposing pulling force of the wire drawing realize the automatic reset of the bending section. The described head-end imaging drainage assembly includes a connector, a steel pipe, a miniature camera, and an optical lens. The steel pipe is sealed and fixed to the front end of the active bending section by the connector. The miniature camera is housed inside the steel pipe, and the optical lens is mounted at the front end of the steel pipe. The head end has a rounded and blunt structure, with a main drainage opening at the end. 4-8 side drainage holes are evenly distributed on the pipe wall within a range of 3-5cm posterior to the head end. Platinum-iridium imaging markers are set at intervals of 5-10cm at the head end, the start and end positions of the active bending section, and the main body of the double-lumen tube. The operating logic of the drainage tube is as follows: the steel wire is pulled by the handle to bend the active bending section to the target angle and lock it mechanically, keeping the fixed turning pivot area unchanged, and the whole body of the double lumen tube is pushed forward. The distal end of the catheter travels along the new axial trajectory after bending, bypassing the brain tissue to reach the deep fluid cavity to complete the single-hole multi-directional precise drainage.

3. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The active bending section adopts a miniature multi-joint snake bone structure. The snake bone is miniaturized using the micro-snake bone processing technology of the endoscope. The snake bone joint is set with a limiting boss on only one side to form a unique fixed turning pivot area. The steel wire cable pulls the front end of the snake bone on only one side to achieve unidirectional bending.

4. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The active bending section is a laser-cut nickel-titanium hypotube. The hypotube wall has asymmetrically distributed spiral cutting grooves, and the depth of the cutting grooves is set differently along the circumference. Only one side of the tube wall has bending deformation allowance, naturally forming a fixed bending pivot area, and the rebound stress is evenly distributed after bending.

5. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The fluid drainage main cavity of the dual-lumen tube has an inner diameter of 1.8-2.2 mm, and the tube body consists of a hydrophilic modified PTFE inner lining, a metal braided reinforcement layer, and a Pebax outer layer from the inside out.

6. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The handle has a continuous serrated meshing tooth on the outer wall of the internal steel wire pull rod, and a mechanical locking button with built-in elastic teeth. The meshing of the teeth with the serrated teeth locks the position of the steel wire pull rod. The outer wall of the handle is printed with bending angle scales, and the lever links the steel wire pull rod to slide linearly along the scale range to control the bending angle.

7. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The front end of the active bending section is connected to the steel pipe by an interference seal via a connecting ring. A miniature camera is coaxially encapsulated inside the steel pipe, with the front end of the camera facing the optical lens. Medical sealant is filled between the outer wall of the steel pipe and the connecting ring to achieve waterproof isolation. Platinum-iridium imaging marker tape is wrapped around the outer wall of the connecting ring, the beginning and end of the active bending section, and the outer wall of the rigid straight section of the double-lumen tube.

8. The actively flexible neurosurgical drainage tube according to claim 2, characterized in that: The side drainage holes on the blunt outer wall of the head end are elliptical through holes, and the side drainage holes are arranged in a staggered manner along the circumference of the tube wall. The main drainage opening is opened on the tube end face next to the optical lens. The main drainage opening and the side drainage holes are connected to the main lumen of the fluid drainage inside the double-lumen tube. The platinum-iridium imaging marker band is clearly visible under CT, MRI and ultrasound imaging. The entire drainage tube is compatible with Stealth, Brainlab neuronavigation system and intraoperative fluorescence imaging equipment.

9. The actively curved neurosurgical drainage tube according to claim 2, characterized in that: The overall assembly and connection sequence of the guide tube is as follows: handle rear Luer connector, handle steel wire pull rod, double-lumen tube rigid straight section, active bending section, connecting ring, steel pipe, miniature camera, and optical lens; the steel wire cable is fully housed in the double-lumen tube wire pulling auxiliary cavity, with only the front end fixed to the front steel wire pull ring of the active bending section, and no exposed metal structure comes into contact with human tissue.

10. The actively flexible neurosurgical drainage tube according to claim 4, characterized in that: The method for preparing the hydrophilic modified PTFE liner is as follows: A1: After cleaning and drying the PTFE liner tube, pre-irradiate it with a medical surgical UV lamp for 3–6 minutes; filter the modification solution through a 0.22μm sterile filter membrane; completely immerse the pre-irradiated PTFE liner in the modification solution and soak it in the light-protected solution for 15–30 minutes; the modification solution consists of 0.3–0.9 wt% trehalose, 0.2–0.6 wt% oligodextrose, 0.1–0.3 wt% dextran, 0.1–0.3 wt% medical photoinitiator HEMAP, and the remainder is sterile water for injection; A2: Drain excess modified liquid from the surface of the lining, place it in a sealed environment at 50-60℃, and irradiate it continuously with a medical surgical UV lamp for 1.5-4 hours; after curing, remove it, wash it thoroughly with sterile pure water, and dry it with sterile cold air at 20-30℃ to obtain a hydrophilic modified PTFE lining layer.

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