Magnetic intraocular particle magnetically controlled guidance and removal device

Abstract

The application relates to the technical field of medical devices, and provides an intraocular magnetic particle magnetic control guiding and removing device, which comprises a catheter assembly, the catheter assembly comprises an outer tube and an inner tube, the outer tube is sleeved on the inner tube, the inner tube is internally provided with a substance transmission channel, the substance transmission channel is used for accommodating magnetic particles and a magnetic complex, the magnetic complex is a combination of the magnetic particles and a target lesion; a magnetic control assembly is arranged on one side of an outlet end of the catheter assembly and is used for generating a gradient magnetic field at the outlet end; an electric connection assembly is electrically connected to the magnetic control assembly and is used for supplying power to the magnetic control assembly and adjusting the gradient magnetic field; the intraocular magnetic particle magnetic control guiding and removing device has an output stage and a recovery stage, in the output stage, a power assembly drives the magnetic particles to be injected from the outlet end; in the recovery stage, the power assembly provides suction power to inject the magnetic complex from the outlet end into the substance transmission channel. The magnetic control assembly is arranged to enhance the directional migration ability of the magnetic complex recovery and improve the recovery precision.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a magnetically controlled removal device for intraocular magnetic particles. Background Technology

[0002] Vitreous opacities, clinically known as "floaters," are physical scattering structures formed by the aggregation and liquefaction of degenerated collagen fibers within the vitreous humor. These opacities project shadows onto the retina as the eye moves, severely interfering with the patient's visual quality.

[0003] Currently, the main clinical treatment for severe vitreous opacities is traditional vitrectomy (PPV). However, traditional vitrectomy has significant technical drawbacks: First, the surgery is highly invasive, requiring the removal of a large area of ​​normal vitreous tissue, which can easily alter the intraocular hydrodynamic environment, significantly increasing the risk of retinal detachment, cataracts, and intraocular pressure fluctuations. Second, because the opacities are often diffuse, tiny, and free-floating, traditional instruments struggle to completely remove these minute lesions while minimizing trauma. Furthermore, relying solely on negative pressure aspiration is highly indiscriminate, easily leading to residual lesions and potentially causing unnecessary mechanical traction on the fragile retina during the procedure.

[0004] In recent years, although some studies have proposed using functionalized magnetic beads to target and bind to turbid substances, most of the related technologies remain at the level of biomaterial development, lacking devices capable of precise drug delivery. Existing injection devices cannot achieve precise positioning and dynamic adjustment of the magnetic field intensity within the delicate space of the eyeball, resulting in uncontrollable movement paths of the magnetic beads in the body and difficulty in achieving targeted removal of lesions.

[0005] Therefore, developing an intraocular magnetic particle magnetic control guided removal device that can actively identify and capture free lesions through bio-targeting technology, and achieve localized directional drainage and minimally invasive recovery of lesions, has become a key issue that urgently needs to be addressed in the fields of minimally invasive surgery and ophthalmic treatment. Summary of the Invention

[0006] This invention aims to solve at least one of the technical problems existing in related technologies. To this end, this invention proposes an intraocular magnetic particle magnetically controlled guided removal device, which aims to actively identify and capture free lesions through bio-targeting technology, and to achieve localized directional drainage and minimally invasive retrieval of lesions. By setting a magnetic control component at the outlet end of the catheter assembly and combining it with a power component, gradient magnetic field traction, directional aggregation, and retrieval of magnetic particles and magnetic complexes are achieved.

[0007] The intraocular magnetic particle magnetocontrol guided removal device according to an embodiment of the present invention includes: A catheter assembly, comprising an outer tube and an inner tube, the outer tube being sleeved on the inner tube, the inner tube having a material transport channel for accommodating magnetic particles and a magnetic composite, the magnetic composite being a combination of magnetic particles and a target lesion; A magnetic control component is disposed on one side of the outlet end of the conduit assembly and is used to generate a gradient magnetic field at the outlet end. An electrical connection component, electrically connected to the magnetic control component, is used to supply power to the magnetic control component and adjust the magnetic field strength and / or magnetic field direction of the gradient magnetic field; A power assembly, which is connected to the material transport channel; The intraocular magnetic particle magnetoguided removal device has an output stage and a recovery stage. In the output stage, the power component drives the magnetic particles to be ejected from the outlet end. In the recovery stage, the power component provides suction power to inject the magnetic complex from the outlet end into the material transport channel.

[0008] According to one embodiment of the present invention, by setting a magnetic control component, the directional migration capability of the magnetic composite recovery is enhanced, thereby improving the recovery accuracy; the clearance efficiency of small and diffuse lesions is improved, and the residual rate is reduced; mechanical disturbance to surrounding normal tissues is reduced, thereby improving surgical safety; and the injection, aggregation, and recovery are integrated, simplifying the operation process and improving clinical applicability.

[0009] According to one embodiment of the present invention, the magnetic control component is disposed between the outer tube and the inner tube.

[0010] According to one embodiment of the present invention, the magnetic control component includes at least one array of miniature electromagnetic coils.

[0011] According to one embodiment of the present invention, the miniature electromagnetic coil array includes a first coil, a second coil, and a third coil spaced apart along the axial direction of the conduit.

[0012] According to one embodiment of the present invention, the magnetic control assembly further includes a plurality of fourth coils, the fourth coils being disposed inside the outer tube near the outlet end, and the plurality of fourth coils being arranged at circumferential intervals along the conduit assembly.

[0013] According to one embodiment of the present invention, the magnetic control assembly further includes a permanent magnet capture head, which is movably disposed in the inner tube and can extend out of the inner tube to attract the magnetic composite.

[0014] According to one embodiment of the present invention, a magnetic signal sensor is further included. The magnetic signal sensor is disposed in the tip region of the conduit and is used to detect the feedback signal of the magnetic particles or composite in real time, and to adjust the working state of the magnetic control component according to the detection result.

[0015] According to one embodiment of the present invention, the magnetic signal sensor is an AMR thin-film magnetoresistive sensor.

[0016] According to one embodiment of the present invention, the power assembly includes: A pusher assembly for propelling the magnetic particle suspension during the output phase; and / or The negative pressure suction component, which is connected to the material transport channel, is used to suction the composite during the recovery stage.

[0017] According to one embodiment of the present invention, it further includes: a spiral tube, the spiral tube being disposed between the outer tube and the inner tube, and respectively wound around the peripheral walls of the inner tube and the magnetic control assembly; The inner tube has a flushing port on its wall between the outlet end of the magnetic control assembly and the conduit assembly, and the flushing port is connected to the outlet of the spiral tube; the inlet of the spiral tube extends to the outside of the outer tube and is adapted to be connected to an external pipeline.

[0018] Compared with the prior art, the present invention has at least the following beneficial effects: It has strong targeting and recognition capabilities. By attaching targeting molecules to the surface of magnetic particles, it can actively recognize and bind to target lesions in body cavities, thereby transforming originally scattered, tiny, and free lesions into magnetic complexes that can migrate in a controlled manner.

[0019] It has strong magnetic focusing capabilities. By setting a micro electromagnetic coil array in the tip region of the conduit, a radial magnetic field can be formed on the surface and a gradient magnetic field can be formed along the axis, which can realize the directional traction, step-by-step focusing and consolidation of the magnetic complex and improve the success rate of recovery.

[0020] Less invasive. The device uses a narrow-diameter catheter and local magnetic retrieval, eliminating the need for extensive removal of normal tissue and reducing mechanical disturbance to surrounding normal structures. It is especially suitable for minimally invasive procedures on delicate tissue environments such as the intraocular region.

[0021] It has a wide range of applications. This invention is not only applicable to the removal of ophthalmic lesions such as vitreous opacities, but can also be extended to minimally invasive removal of other free lesions in body cavities by changing the target molecules and adjusting the instrument parameters.

[0022] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention or related technologies, the drawings used in the description of the embodiments or related technologies will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention and are not considered as limitations on this application. Moreover, those skilled in the art can obtain other drawings based on these drawings without creative effort.

[0024] Figure 1 This is one of the schematic structural diagrams of the magnetically controlled removal device for intraocular magnetic particles provided in the embodiments of the present invention.

[0025] Figure 2 This is the second schematic structural diagram of the magnetically controlled removal device for intraocular magnetic particles provided in this embodiment of the invention.

[0026] Figure 3 This is a schematic structural diagram of an intraocular magnetic particle magnetic guided removal device provided in another embodiment of the present invention.

[0027] Figure 4 This is a cross-sectional schematic diagram of the fourth coil and magnetic signal sensor provided in an embodiment of the present invention.

[0028] Figure label: 100. Catheter assembly; 110. Outer tube; 120. Inner tube; 121. Material transport channel; 200. Magnetization control assembly; 210. First coil; 220. Second coil; 230. Third coil; 240. Fourth coil; 400, Power assembly; 500, Magnetic signal sensor; 600, Temperature monitoring assembly; 700, Spiral tube. Detailed Implementation

[0029] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar elements or elements having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.

[0030] The specific terms used in this specification are for illustrative purposes only and are not intended to limit the illustrated embodiments. For example, expressions such as "same" and "identical" not only indicate a strictly identical state, but also indicate a state with tolerances or differences in the degree of functionality. For example, expressions indicating relative or absolute arrangement such as "in a certain direction," "along a certain direction," "side by side," "perpendicular," "centered on," "concentric," or "coaxial" not only strictly indicate such an arrangement, but also indicate a state of relative displacement by tolerances or angles or distances with the same degree of functionality.

[0031] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the present invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limiting the present invention.

[0032] Furthermore, features specified as "first" or "second" may explicitly or implicitly include one or more of those features. In the description of this invention, unless otherwise stated, "multiple" means two or more. In the description of the embodiments of this application, "multiple" means two or more, unless otherwise explicitly specified. In the description of the embodiments of this application, the term "and / or" is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, B1 and / or B2 can represent: B1 existing alone, B1 and B2 existing simultaneously, and B2 existing alone. Additionally, the character " / " in this document generally indicates that the preceding and following related objects have an "or" relationship.

[0033] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0034] Reference Figure 1 and Figure 2 According to an embodiment of the present invention, an intraocular magnetic particle magnetically guided ablation device includes a catheter assembly 100, a magnetic control assembly 200, an electrical connection assembly (not shown in the figure), and a power assembly 400. The catheter assembly 100 includes an outer tube 110 and an inner tube 120, with the outer tube 110 sleeved on the inner tube 120. The inner tube 120 has a material transport channel 121 inside, which is used to accommodate magnetic particles and magnetic composites. The magnetic composite is a combination of magnetic particles and a target lesion. The front end of the catheter assembly 100 forms an outlet end through which magnetic particles can be released into the target body cavity, and the magnetic composite can also enter the material transport channel 121 through the outlet end and be recovered.

[0035] The magnetic control component 200 is located on one side of the outlet end of the catheter assembly 100 and is used to generate a gradient magnetic field at the outlet end. The gradient magnetic field is used to apply directional magnetic force to magnetic particles or magnetic composites in the target body cavity, causing them to migrate and accumulate near the outlet end.

[0036] An electrical connection component is electrically connected to the magnetic control component 200 and is used to supply power to the magnetic control component 200 and adjust the magnetic field strength and / or magnetic field direction of the gradient magnetic field. In some embodiments, the electrical connection component may include conductive leads, an insulating covering structure, an external power supply, a drive circuit, and a control unit, wherein the control unit is used to regulate the current of each coil according to a preset program or feedback signal.

[0037] A power assembly 400 is connected to a material transport channel 121; it is used to provide propulsive or suction power to the material transport channel 121 at different working stages. The intraocular magnetic particle magnetoguided removal device has an output stage and a recovery stage. In the output stage, the power assembly 400 drives the magnetic particles to be ejected from the outlet end; in the recovery stage, the power assembly 400 provides suction power to draw the magnetic complex from the outlet end into the material transport channel 121 and further remove it from the body.

[0038] Through the above-described structural design, the device in this embodiment of the invention achieves integrated operation of injection, targeted capture, magnetically controlled aggregation, and retrieval. Compared with traditional methods that rely solely on mechanical cutting or blind aspiration, this invention enhances the directional migration capability of the magnetic composite retrieval by incorporating a magnetic control component 200. This improves retrieval accuracy, increases the removal efficiency of small, diffuse lesions, reduces lesion residue, and minimizes mechanical disturbance to surrounding normal tissues, thereby enhancing surgical safety and clinical applicability.

[0039] Optionally, in some embodiments, an annular lighting unit is also provided between the outer tube 110 and the inner tube 120 to provide uniform lighting for the magnetic bead aggregation area.

[0040] The intraocular magnetic particle magnetically guided removal device has an output stage and a recovery stage. In the output stage, the power component 400 drives the magnetic particles to be ejected from the outlet end; in the recovery stage, the power component 400 provides suction power to inject the magnetic complex from the outlet end into the material transport channel 121.

[0041] According to one embodiment of the present invention, the magnetic control component 200 is disposed between the outer tube 110 and the inner tube 120. That is, the conduit assembly 100 is preferably constructed as a coaxial structure, with the outer tube 110 located on the outside to form a protective structure, the inner tube 120 located on the inside to form a material transport channel 121, and the magnetic control component 200 disposed in the intermediate layer region between the two.

[0042] The above arrangement has the following advantages: on the one hand, the magnetic control component 200 can be placed as close as possible to the outlet end, which facilitates the formation of a local high gradient magnetic field near the tip and improves the traction ability of the magnetic composite; on the other hand, the magnetic control component 200 is placed between the outer tube 110 and the inner tube 120, which will not significantly occupy the fluid transmission cross-sectional area of ​​the inner tube 120, thus taking into account both injection and suction recovery functions.

[0043] In one embodiment, the magnetic control component 200 is sleeved around the side wall of the inner tube 120 and arranged along the axial direction of the conduit in the region near the outlet end. To ensure structural stability and electrical safety, an insulating layer may be provided between the magnetic control component 200 and the inner tube 120, and a heat insulation layer and / or a fixing layer may be provided between the magnetic control component 200 and the outer tube 110 to achieve functions such as coil fixing, heat conduction, electrical insulation, and prevention of liquid leakage.

[0044] In some embodiments, the outer tube 110 may be made of a non-magnetic material to reduce interference with the magnetic field distribution formed by the magnetic control component 200. The material of the outer tube 110 may be a non-magnetic metal, a flexible polymer, a titanium alloy, and / or an alloy with shape memory properties.

[0045] The outer tube 110 can have a diameter of 1~2cm to accommodate human gripping.

[0046] According to one embodiment of the present invention, the miniature electromagnetic coil array includes a first coil 210, a second coil 220 and a third coil 230 spaced apart along the axial direction of the conduit.

[0047] Furthermore, in some embodiments, the magnetic field strength of the first coil 210 is greater than that of the second coil 220, and the magnetic field strength of the second coil 220 is greater than that of the third coil 230. That is, the coil closer to the exit end generates a stronger magnetic field to form the strongest tip attraction center; the coil farther from the exit end generates a relatively weaker but longer-covering auxiliary traction magnetic field. This allows the dispersed magnetic complex at the far end to gradually migrate towards the exit end, and eventually gather and lock near the exit end, ultimately being recovered into the material transport channel.

[0048] Specifically, in some embodiments, the first coil 210 can serve as the main attraction source. When the system inputs a high current to the first coil 210, a magnetic field peak is formed near the outlet end, which can lock the magnetic complex near the catheter orifice near the retrieval inlet. The second coil 220 can serve as an auxiliary pulling unit, used to work with the first coil 210 to form a gradient magnetic field with a longer working distance, thereby guiding the magnetic complex farther from the catheter orifice to migrate forward. The third coil 230 can serve as a holding unit, used to provide a relatively stable weak magnetic field after the magnetic complex has entered the catheter orifice or the proximal region of the catheter, in order to reduce the risk of slippage or detachment due to body fluid disturbance, posture change, or complex backslipping.

[0049] Thus, by working in concert with multiple coils, this invention achieves a division of labor and coordination among three functions: distal traction, proximal convergence, and tube end retention, enabling the device to achieve better magnetic control within the limited size of the duct tip area.

[0050] In some embodiments, the electrical connection assembly is used to control the current intensity and / or current ratio of each coil to adjust the magnitude and direction of the attraction of the local gradient magnetic field to the magnetic particles or composite.

[0051] In some implementations, the conventional operating current of the magnetic control component 200 is 2.0A to 3.0A, the short-time pulse current is 4.0A to 6.0A, the power-on time is 0.2 to 0.6s, and the power-off time for heat dissipation is 1 to 2s.

[0052] The control unit can independently or jointly power the first coil 210, the second coil 220, and the third coil 230 based on the surgical stage, the aggregation state of the magnetic particles, the magnetic feedback signal, and the temperature. For example, when the magnetic composite is far from the catheter outlet, the activation ratio of the second coil 220 and / or the third coil 230 can be increased to form a longer guiding magnetic field; when the magnetic composite is close to the outlet, the activation ratio of the first coil 210 can be increased to make the composite quickly gather near the catheter opening; during the retrieval and aspiration process, the coordinated operation of the first coil 210 and the third coil 230 can be maintained to prevent the composite from retracting during the aspiration flow.

[0053] In some implementations, the control unit can employ a combination of preset operating modes and real-time feedback adjustment modes. In the preset operating mode, several operating programs can be pre-stored based on the target cavity type, lesion nature, catheter model, and magnetic particle type; in the real-time feedback adjustment mode, the current output parameters can be dynamically adjusted based on sensor detection results.

[0054] In some alternative embodiments, the magnetic control assembly 200 may also include a permanent magnet assembly with an adjustable spatial position, which provides an auxiliary magnetic field. For example, under certain operating conditions, a basic magnetic bias can be provided by a permanent magnet, while a finely tuned magnetic field can be provided by a miniature electromagnetic coil to balance energy consumption and control accuracy; or, in the case of a power outage of the electromagnetic coil, a temporary holding magnetic field can be provided by a permanent magnet to reduce the risk of complex dissipation.

[0055] According to one embodiment of the present invention, such as Figure 4 As shown, the magnetic control assembly 200 also includes a plurality of fourth coils 240, which are located inside the outer tube 110 near the outlet end. The plurality of fourth coils 240 are arranged at intervals along the circumference of the conduit assembly 100.

[0056] In this embodiment, multiple fourth coils 240 are arranged circumferentially at one end near the outlet between the outer tube 110 and the inner tube 120. The multiple fourth coils 240 can cooperate with the first coil 210, the second coil 220 and the third coil 230 to jointly construct a three-dimensional magnetic field gradient near the outlet, so as to better drive the magnetic particles and magnetic composites, release the magnetic particles and recycle the magnetic composites.

[0057] In some embodiments, the outer tube 110 is constructed with a hemispherical dome structure near the outlet end. The end of the hemispherical dome structure is connected to the outlet end. The outlet end is the end tube of the inner tube 120 (which can be used with a 25G scleral puncture cannula). The inner diameter of the outlet end is 0.51~0.62mm and the length is 4~6mm to meet the needs of entering the body cavity through small incisions, while taking into account flexibility, strength and operational stability. The fourth coil 240 is disposed between the hemispherical dome structure and the outlet end.

[0058] According to one embodiment of the present invention, the magnetic control assembly 200 includes at least one array of miniature electromagnetic coils disposed within a range of 0 mm to 6 mm from the outlet end. Preferably, the array of miniature electromagnetic coils is distributed along the axial direction of the catheter in a localized region near the outlet end to form a localized gradient magnetic field near the catheter tip, rather than forming a large-scale magnetic field over the entire length of the catheter.

[0059] Specifically, the first coil 210 is located 0mm to 1mm from the outlet end; the second coil 220 is located 2mm to 4mm from the outlet end; and the third coil 230 is located 5mm to 6mm from the outlet end.

[0060] The first coil 210 has 50 to 100 turns, the second coil 220 has 20 to 40 turns, and the third coil 230 has 10 to 20 turns. By matching and setting the number of turns, length, spacing, and power supply parameters of the coils at different positions, a progressive and stepped magnetic field distribution can be formed in the axial direction of the conduit tip.

[0061] Optionally, in some embodiments, the magnetic control assembly 200 further includes a permanent magnet capture head, which is movably disposed in the inner tube 120 and can extend out of the inner tube 120 to attract the magnetic composite.

[0062] In this embodiment, a retractable permanent magnet capture head is designed at the end of the inner tube 120. The permanent magnet capture head can extend out of the inner tube 120 during the recovery of the magnetic composite to actively attract the magnetic composite, so as to cooperate with the magnetic field generated by the magnetic coil to recover the magnetic composite more quickly.

[0063] Specifically, the permanent magnet capture head can adopt a lentil-shaped structure.

[0064] According to one embodiment of the present invention, a magnetic signal sensor 500 is also included. The magnetic signal sensor 500 is disposed in the tip region of the conduit and is used to detect the feedback signal of the magnetic particles or composite in real time, and adjust the working state of the magnetic control component 200 according to the detection result.

[0065] According to one embodiment of the present invention, the magnetic signal sensor 500 is an AMR thin-film magnetoresistive sensor. AMR sensors have advantages such as small size, high sensitivity, and suitability for miniaturized integration, enabling indirect sensing of changes in the position, concentration, or aggregation degree of magnetic particles or magnetic complexes within a limited space at the tip of a conduit.

[0066] Specifically, after the output phase, the magnetic particles enter the target body cavity and gradually combine with the lesion to form a magnetic complex. Subsequently, the control system activates the magnetic control component 200, and the AMR sensor monitors the changes in magnetic feedback intensity near the tip in real time. When the sensor detects a weak magnetic feedback signal, it indicates that the magnetic complex is far from the catheter tip. At this time, the control system can increase the drive ratio of the distal coil to enhance the long-distance guidance effect. When the sensor detects that the magnetic feedback is gradually increasing, it indicates that the magnetic complex is gradually approaching the catheter outlet. At this time, the control system can enhance the adsorption effect of the first coil 210, causing the complex to be concentrated and locked near the retrieval inlet. When the detected magnetic feedback reaches a set threshold, the control system can switch to retrieval mode and activate the power component 400 to draw the complex into the catheter.

[0067] With the above configuration, the device of the present invention can form a closed-loop control system of magnetic feedback-magnetic field output-recovery execution, which has better real-time performance, controllability and repeatability compared with the open-loop operation method that relies solely on the operator's experience and judgment.

[0068] According to one embodiment of the present invention, the power assembly 400 includes a pusher assembly for propelling a magnetic particle suspension during the output phase.

[0069] In some implementations, such as Figure 1 As shown, the pusher assembly can be a manual pusher structure. The surgeon can quantitatively release the magnetic particle suspension in the inner tube 120 and assist in the aspiration of residual liquid by pushing and pulling the pusher. The manual pusher structure has advantages such as low cost, direct response, and intuitive operation, making it suitable for clinical use in minimally invasive surgical scenarios.

[0070] Alternatively, in other embodiments, such as Figure 3 As shown, the power assembly 400 includes a negative pressure suction assembly connected to the material transport channel 121, used to suction the magnetic composite during the recovery phase.

[0071] In this embodiment, the conduit assembly 100 is provided with a negative pressure suction port. By connecting the negative pressure suction assembly and the negative pressure suction port, the negative pressure suction assembly can suction the magnetic composite material through the material transfer channel 121 during the recovery stage, so as to recover the magnetic composite material more quickly.

[0072] Alternatively, the power unit 400 may also employ pneumatic actuators, hydraulic transmissions, or other precision mechanical propulsion mechanisms to achieve a more stable drug delivery and recovery process.

[0073] In some embodiments, such as Figure 1 As shown, the intraocular magnetic particle magnetic control guided removal device also includes a spiral tube 700, which is located between the outer tube 110 and the inner tube 120, and is respectively wound around the peripheral wall of the inner tube 120 and the peripheral wall of the magnetic control component 200.

[0074] The inner tube 120 has a flushing port on its wall between the outlet end of the magnetic control assembly 200 and the conduit assembly 100, and the flushing port is connected to the outlet of the spiral tube 700; the inlet of the spiral tube 700 extends to the outside of the outer tube 110 and is suitable for connection with external pipelines.

[0075] In this embodiment, a spiral tube 700 is provided between the outer tube 110 and the inner tube 120, and the middle part of the spiral tube 700 is wrapped around the peripheral wall of the inner tube 120 and the peripheral wall of the magnetic control component 200. The inlet of the spiral tube 700 is connected to the external pipeline, and the outlet of the spiral tube 700 is connected to the flushing port on the wall of the inner tube 120 at the front end of the magnetic control component 200, so that the external washing liquid can be introduced into the inner tube 120 at the front end of the magnetic control component 200 along the spiral tube 700. This design can simultaneously achieve heat dissipation of the magnetic control component 200 and prevent the recovered magnetic composite from accumulating in the corresponding cavity of the magnetic control component 200 and causing blockage.

[0076] Specifically, a flexible fluoroplastic (such as PTFE) or polyimide thin soft water tube (i.e., spiral tube 700) with an outer diameter of 0.05mm-0.15mm can be introduced from the side wall of the outer tube 110 and enter the interlayer space between the outer tube 110 and the inner tube 120. This water tube is not laid in a straight line along the axis, but is closely attached to the outer wall of the skeleton of the first coil 210, the second coil 220 and the third coil 230, and extends forward axially in a multi-turn, high-density spiral winding manner; the water tube passes over the third coil 230 and the second coil 220 in sequence, and finally cuts precisely into and positions itself at the very front end of the first coil 210 (i.e., near the outlet end of the conduit assembly 100). A micro nozzle is opened on the tube wall at the front end of the first coil 210 and communicates with it to form a flushing port, and the outlet arrangement is configured so that the sprayed liquid does not pass through the inner cavity of each coil to avoid interfering with the magnetic field distribution.

[0077] During the recovery of the magnetic composite, when the first coil 210, the second coil 220 and the third coil 230 are energized to attract and lock the magnetic composite in the inner tube 120 cavity at the front end of the first coil 210, a washing solution (BSS ophthalmic balanced salt solution can be used) can be quantitatively injected into the rinsing port through the spiral tube 700 by an external infusion pump.

[0078] The washing liquid is sprayed laterally at a specific flow rate (e.g., 0.1 mL / min - 0.5 mL / min), generating a localized shear flow. Because the water flow has a backward velocity component and does not pass through the coil cavity, it can instantaneously strip the magnetic composite from the strong magnetic retention zone before a high-density aggregation occurs in the inner tube 120 cavity at the front end of the first coil 210 due to strong magnetic force, and smoothly push it backward into the multifunctional material storage chamber along the flow channel. This design greatly highlights the active capture capability of the magnetocontrol component at the microscale, successfully utilizing weak fluid kinetic energy to achieve efficient material transport.

[0079] Meanwhile, the washing liquid flowing along the spiral tube 700 can also carry away the heat generated by the first coil 210, the second coil 220 and the third coil 230 through convection heat exchange, so as to reduce the temperature of the first coil 210, the second coil 220 and the third coil 230 and the outer wall of the outer tube 110.

[0080] In some embodiments, the magnetic control assembly 200 further includes a permanent magnet assembly with an adjustable spatial position, the permanent magnet assembly being used to provide an auxiliary magnetic field.

[0081] Since the miniature electromagnetic coil may generate Joule heat when it is powered on, in order to ensure safety in use, especially in sensitive tissue environments such as the intraocular eye, in some embodiments, the intraocular magnetic particle magnetic control guided removal device also includes a temperature monitoring component 600. The temperature monitoring component 600 is disposed at the outlet end and is used to monitor the temperature at the outlet end.

[0082] In some embodiments, when the temperature monitoring component 600 detects that the tip temperature exceeds 39.5°C, the control system shuts off the current output of the magnetic control component 200 and switches the device to mechanical recovery mode. Mechanical recovery mode can be understood as stopping electromagnetic traction and relying solely on the already completed localized accumulation state and push rod action to continue recovery, thereby reducing the risk of thermal damage.

[0083] In some embodiments, a heat-conducting layer is provided on the outside of the magnetic control assembly 200. The heat-conducting layer is used to conduct the working heat of the coil to the outer sleeve for dissipation. Further, the heat-conducting layer is an aluminum nitride ceramic coating with a thickness of 0.005 mm to 0.05 mm, preferably about 0.01 mm.

[0084] In some preferred embodiments, the heat from the coil can be rapidly conducted to the outer tube 110 via the heat-conducting layer. Especially when the outer tube 110 is made of titanium alloy or other non-magnetic materials with good thermal conductivity, the heat can be further carried away by the flowing fluid within the body cavity. In intraocular applications, the circulating perfusion fluid can also be used to locally dissipate heat from the catheter tip, thereby further controlling the temperature rise.

[0085] In some embodiments, the outer sheath is a 25G conduit made of non-magnetic metal, flexible polymer, titanium alloy and / or alloy with shape memory properties.

[0086] In some embodiments, the magnetic particle includes: a magnetic core; a biocompatible coating covering the outer surface of the magnetic core; and a targeting molecule attached to the surface of the biocompatible coating, wherein the targeting molecule is capable of specifically binding to free lesions in the target body cavity, thereby enabling the lesion to form a magnetically responsive complex that can be pulled by an external magnetic field.

[0087] Through the above design, lesions that are originally difficult to be directly grasped by machinery and are dispersed and floating in body fluids can be endowed with magnetic responsiveness, thereby facilitating subsequent directional migration and centralized recovery through local gradient magnetic fields.

[0088] In some embodiments, the magnetic core comprises one or more of magnetite, sesquioxide, ferrite, metallic alloy magnetic materials, or composite materials thereof. Preferably, the magnetic core has superparamagnetism or high magnetic responsiveness so as to respond quickly under the action of an external magnetic field and not easily aggregate after the external magnetic field is removed.

[0089] In some embodiments, the average particle size of the magnetic core is 50 nm to 500 nm, preferably 100 nm to 200 nm. Using particles within this size range is beneficial for balancing dispersion stability in body fluids, lesion binding ability, magnetic response capability, and subsequent recovery efficiency.

[0090] In some embodiments, the magnetic core is spherical, rod-shaped, disc-shaped, or other geometric configurations suitable for movement in a body fluid environment.

[0091] In some embodiments, the biocompatible coating includes a silica layer, a polymeric biocompatible layer, or a composite layer thereof.

[0092] In some embodiments, the target molecules are covalently coupled to the surface of the biocompatible coating.

[0093] In some embodiments, the target molecule is one or more of an antibody, antibody fragment, peptide, aptamer, receptor ligand, protein, or small molecule recognition group. The specific target molecule can be matched according to the type of lesion to achieve specific recognition and binding to different pathological free substances.

[0094] In some embodiments, the magnetic particles are modified magnetic beads for the removal of vitreous opacities, and the targeting molecules are specific binding peptides targeting denatured collagen, preferably type II collagen.

[0095] Specifically, Fe3O4 nanoparticles can be used as the magnetic core. The Fe3O4 nanoparticles preferably possess superparamagnetism, and their average particle size is preferably controlled within the range of 100 nm to 200 nm. Subsequently, a biocompatible silica coating is formed on the surface of the magnetic core through chemical coating. After the silica coating is formed, further surface activation treatment can be performed to introduce active groups suitable for coupling reactions, such as amino, carboxyl, epoxy, aldehyde, or other reactive functional groups. Then, a binding peptide with specific recognition ability for denatured type II collagen is covalently coupled to the coating surface, thereby obtaining functionalized modified magnetic beads.

[0096] In some embodiments, the modified magnetic beads described above can be prepared as a sterile suspension. The suspension medium can be selected as a physiologically acceptable medium according to the requirements of intraocular injection, and its osmotic pressure, pH value and dispersion stability can be adjusted to make it suitable for intravitreal use.

[0097] In clinical application, the modified magnetic bead suspension is first injected into the vitreous cavity of the patient using the magnetically controlled injection and recovery device of this invention. After injection, the magnetic beads diffuse within the vitreous cavity and come into contact with suspended vitreous opacities. Because the surface of the magnetic beads contains targeting molecules for denatured collagen, the beads can specifically bind to the denatured collagen fibers in the opacities, thereby forming a magnetic bead-opacity complex. This complex exhibits magnetic responsiveness and can undergo directional migration under the influence of a local gradient magnetic field.

[0098] After lesion capture is completed, the magnetic control component 200 is activated. By inputting a preset current into the first coil 210, second coil 220, and third coil 230 in the catheter tip region, a local gradient magnetic field is generated in the needle tip region. The magnetic bead-turbidity complex distributed in the vitreous cavity gradually moves towards the device tip under the attraction of the magnetic field. The distal complex is preferentially pulled by the coils at more distant positions, while the proximal complex is gradually locked near the catheter orifice by the main attraction coil, eventually forming a relatively concentrated aggregation area at the catheter exit end.

[0099] Once the complex has assembled, the corresponding coil remains energized to stably lock the complex's position. Simultaneously, the power component 400, connected to the material transport channel 121, is activated to draw the complex into the catheter through the outlet end and further retrieve it outside the body. If necessary, the operator can simultaneously use the push rod assembly for subtle pushing and pulling to improve fluid response within the catheter and the smoothness of complex retrieval.

[0100] This method can transform the originally scattered, floating vitreous opacities that are difficult to remove completely by traditional methods into a target complex that can be controlled to aggregate and can be recovered as a whole, thereby achieving minimally invasive removal of floaters-related lesions.

[0101] It should be noted that this invention is not limited to the removal of vitreous opacities in ophthalmology. The device of this invention can also be applied to the removal of free lesions in other open or closed body cavities.

[0102] For example, in some embodiments, by changing the targeting molecule, magnetic particles can be used to identify free thrombus components in the cardiovascular system, causing thrombus fragments to form magnetically migratable complexes; in other embodiments, they can be used to enrich and remove free tumor cells, tissue debris, or intraoperative residues in the peritoneal environment; they can also be used to clear inflammatory debris, cartilage fragments, or other suspended pathological materials in the joint cavity.

[0103] For different application scenarios, the size of the outer tube 110, the catheter material, the coil parameters, the particle size of the magnetic particles, the type of target molecules, and the control program can all be adjusted accordingly. However, as long as the basic principle is still to impart magnetic responsiveness to the lesion through magnetic particles and to achieve aggregation and recovery through the local gradient magnetic field at the tip of the catheter, it can all fall within the scope of the technical concept of this invention.

[0104] Finally, it should be noted that the above embodiments are only for illustrating the present invention and not for limiting the present invention. Although the present invention has been described in detail with reference to the embodiments, those skilled in the art should understand that various combinations, modifications, or equivalent substitutions of the technical solutions of the present invention do not depart from the spirit and scope of the technical solutions of the present invention and should be covered within the scope of the claims of the present invention.

Claims

1. A magnetically controlled removal device for intraocular magnetic particles, characterized in that, include: A catheter assembly, comprising an outer tube and an inner tube, the outer tube being sleeved on the inner tube, the inner tube having a material transport channel for accommodating magnetic particles and a magnetic composite, the magnetic composite being a combination of magnetic particles and a target lesion; A magnetic control component is disposed on one side of the outlet end of the conduit assembly and is used to generate a gradient magnetic field at the outlet end. An electrical connection component, electrically connected to the magnetic control component, is used to supply power to the magnetic control component and adjust the gradient magnetic field; A power assembly, which is connected to the material transport channel; The intraocular magnetic particle magnetically guided removal device has an output stage and a recovery stage. In the output stage, the power component drives the magnetic particles to be ejected from the outlet end. During the recovery phase, the power assembly provides suction power to inject the magnetic composite from the outlet end into the material transport channel; The magnetic control component is disposed between the outer tube and the inner tube; The magnetic control component includes at least one array of miniature electromagnetic coils; The miniature electromagnetic coil array includes a first coil, a second coil, and a third coil spaced apart along the axial direction of the conduit; the magnetic control assembly also includes a plurality of fourth coils, which are located inside the outer tube near the outlet end, and the plurality of fourth coils are arranged circumferentially along the conduit assembly. A spiral tube is disposed between the outer tube and the inner tube, and is respectively wound around the peripheral walls of the inner tube and the magnetic control assembly; A flushing port is provided in the tube wall between the outlet end of the magnetic control assembly and the conduit assembly, and the flushing port is connected to the outlet of the spiral tube; the inlet of the spiral tube extends to the outside of the outer tube and is adapted to be connected to an external pipeline.

2. The intraocular magnetic particle magnetically guided removal device according to claim 1, characterized in that, The magnetic control assembly also includes a permanent magnet capture head, which is movably disposed in the inner tube and can extend out of the inner tube to attract the magnetic composite.

3. The magnetically controlled removal device for intraocular magnetic particles according to any one of claims 1 to 2, characterized in that, It also includes a magnetic signal sensor, which is disposed in the tip region of the conduit assembly to detect feedback signals from magnetic particles or composites in real time and adjust the working state of the magnetic control assembly according to the detection results.

4. The intraocular magnetic particle magnetically guided removal device according to claim 3, characterized in that, The magnetic signal sensor is an AMR thin-film magnetoresistive sensor.

5. The magnetically controlled removal device for intraocular magnetic particles according to any one of claims 1 to 4, characterized in that, The power assembly includes: A pusher assembly for propelling the magnetic particle suspension during the output phase; and / or A negative pressure suction assembly connected to the material transport channel is used to suction the magnetic composite during the recycling phase.

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