Magnetic guidewire control system

Abstract

The application provides a magnetic guide wire control system, which comprises a guide wire, a propelling device for propelling the guide wire, a magnetic drive source for generating a magnetic field, a moving mechanism for driving the magnetic drive source to move, a positioning signal transmitter for transmitting an electromagnetic positioning signal, and a control device, wherein the guide wire comprises a positioning part for receiving the electromagnetic positioning signal and a magnetic drive part driven by the magnetic drive source, and the positioning part and the magnetic drive part are both arranged at a distal end of the guide wire. During the implementation of a vascular intervention operation, after the position and posture of the distal end of the guide wire are acquired according to the positioning signal transmitter and the guide wire positioning part, combined with the 3D road map of the blood vessel collected by preoperative CT, three-dimensional navigation display can be performed, and the distal end of the guide wire is controlled by the magnetic drive source under the simulated endoscopic view, so that the difficulty of the operation is reduced, the efficiency of the operation is improved, and DSA imaging is not needed, and the patient does not need to bear X-Ray radiation.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, and more specifically, relates to a magnetic guide wire control system. Background Technology

[0002] Interventional vascular surgery is an important means of treating cardiovascular and cerebrovascular diseases such as coronary heart disease, stroke, and arrhythmia, with advantages such as small incisions and rapid postoperative recovery. Precise delivery of the interventional guidewire plays a crucial role in the procedure, forming the basis for the subsequent precise guidance of instruments such as microcatheters, balloons, and stents to the lesion site for treatment. In traditional interventional surgery, digital subtraction angiography (DSA) is used as an aid, with surgeons employing techniques such as pushing, pulling, rotating, and twisting to control the pre-bent guidewire along the patient's blood vessel until it reaches the vicinity of the lesion. However, in the extremely narrow and complex working environment of human blood vessels, the above-mentioned traditional guidewire delivery methods face numerous challenges. For example, in surgical scenarios involving cerebral blood vessels with extremely small diameters and complex course, the fixed distal curvature of traditional pre-bent guidewires makes it difficult to adapt to complex vascular pathways to reach the lesion site, and also carries the risk of vascular damage. The high difficulty of guidewire delivery makes the surgery highly dependent on the surgeon's skill and experience, which greatly increases the learning cost of the procedure and hinders its widespread adoption. Furthermore, during surgery, doctors need to wear heavy lead protective suits for extended periods in a radiation environment, which significantly impacts their health. To address these issues, researchers have designed various vascular interventional robots based on mechanical propulsion principles. These robots enable remote guidewire delivery, resolving the doctor's radiation exposure problem. However, these robots still deliver traditional fixed, curved guidewires, failing to address the difficulties in guidewire delivery and the high risk of vascular injury in narrow and tortuous blood vessel environments.

[0003] Magnetically controlled guidewire systems are one potential solution to address the aforementioned pain points in interventional vascular surgery. This system typically consists of a DSA imaging system, a magnetically adjustable guidewire, a magnetically controlled guidewire direction guidance system, a guidewire advancement system, and a control system. The magnetically controlled direction guidance system can actively control the distal bending direction of the magnetically adjustable guidewire according to different vascular course requirements. This effectively solves the problem of fixed distal bending degree of traditional pre-bent guidewires, greatly reducing the risk of vascular injury and the difficulty of the procedure. Using a magnetically controlled guidewire system, surgeons can easily and accurately deliver the magnetically adjustable guidewire to the location of tortuous and stenotic vascular lesions. However, current magnetically controlled guidewire systems primarily rely on DSA imaging systems for guidewire positioning. This classic guidewire positioning method has some inherent problems that remain unresolved, hindering the widespread adoption and application of this system. On the one hand, using a DSA imaging system for guidewire guidance requires frequent X-ray exposures, meaning patients still need to endure a certain dose of X-ray radiation. On the other hand, most DSA systems can only acquire 2D superimposed images in real time, and the real-time image information does not include vascular course details. In complex vascular environments, this lost information can confuse surgeons and increase the difficulty of the procedure. Angiography can provide a static vascular diagram for the surgeon's reference, but this process significantly reduces surgical efficiency and places additional physical burden on the patient. Summary of the Invention

[0004] The purpose of this invention is to provide a magnetic guidewire control system to solve the technical problems of existing magnetically controlled guidewire technology, which relies on DSA imaging for guidewire positioning, exposes the patient to radiation, and has low surgical efficiency.

[0005] To achieve the above objectives, the technical solution adopted by the present invention is as follows: a magnetic guide wire control system is provided, including a guide wire, a propulsion device for propulsing the guide wire, a magnetic drive source for generating a magnetic field, a moving mechanism for driving the magnetic drive source, a positioning signal transmitter for transmitting a positioning signal, and a control device. The guide wire includes a positioning part for receiving the positioning signal and a magnetic drive part driven by the magnetic drive source. The positioning part and the magnetic drive part are both disposed at the distal end of the guide wire. The control device is communicatively connected to the propulsion device, the moving mechanism, the positioning signal transmitter, and the positioning part.

[0006] In the above scheme, the magnetic guidewire control system includes a guidewire, a propulsion device, a magnetic drive source, a moving mechanism, and a positioning signal transmitter. A positioning section within the guidewire receives signals emitted by the positioning signal transmitter and performs inverse decoding to obtain the guidewire's position and orientation. The moving mechanism drives the magnetic drive source to move. The magnetic drive section within the guidewire allows the guidewire to be steered within the blood vessel by its movement. The propulsion device enables the guidewire to advance within the blood vessel. During vascular interventional surgery, after obtaining the position and orientation of the distal end of the guidewire from the positioning signal transmitter and the guidewire positioning section, combined with a preoperative CT 3D vascular path map, three-dimensional traversal display can be performed. Under an endoscopic-like perspective, the magnetic drive source manipulates the distal magnetic drive section of the guidewire, reducing surgical difficulty, increasing surgical efficiency, and eliminating the need for DSA imaging, thus sparing the patient from X-ray radiation.

[0007] Optionally, the magnetic drive source and the positioning signal transmitter are fixedly connected.

[0008] In the above scheme, the position and orientation of the magnetic drive source and the positioning signal transmitter remain the same at all times. The coordinate system between the two only needs to be registered once at the factory. During the vascular interventional surgery, the relative position between the two coordinate systems remains unchanged. Moreover, when the magnetic drive source drives the distal end of the guidewire to turn, the magnetic drive source needs to be close to the distal end of the guidewire, thereby bringing the positioning signal transmitter close to the positioning part of the guidewire, so that the positioning performance can be optimized. That is, the positioning signal transmitter is always in the best working space, which solves the problem of the small working range of the fixed magnetic positioning system.

[0009] Optionally, the positioning signal transmitter includes multiple transmitting coils, which are fixed to the outside of the magnetic drive source.

[0010] In the above scheme, the positioning signal transmitter can be a magnetic field emission source, capable of emitting electromagnetic waves to generate a positioning magnetic field, which is achieved through multiple sets of transmitting coils. The magnetic drive source is generally an integral structure, with the transmitting coils fixed to the outside of the magnetic drive source, facilitating the assembly of the positioning signal transmitter and the magnetic drive source.

[0011] Optionally, the magnetic drive source is spherical, and the transmitting coil is wound around the outer periphery of the magnetic drive source, with the center of the transmitting coil coinciding with the center of the sphere of the magnetic drive source.

[0012] In the above scheme, the transmitting coil is wound around the outer periphery of the magnetic drive source. When the magnetic drive source is spherical, the transmitting coil is also ring-shaped. The center of the transmitting coil coincides with the center of the sphere of the magnetic drive source, which simplifies the inverse kinematics algorithm during positioning.

[0013] Optionally, the magnetic drive source is spherical, and the transmitting coil is a disc-shaped coil distributed outside the magnetic drive source, with the central axis of the disc-shaped coil passing through the center of the sphere of the magnetic drive source.

[0014] In the above scheme, the center of the transmitting coil is located outside the magnetic drive source, and the transmitting coil is in the shape of a planar helix. It should be noted that the transmitting coil is not necessarily perfectly planar; the transmitting coil can be attached to the surface of the magnetic drive source, with the side of the transmitting coil facing the magnetic drive source being partially spherical. The central axis of the transmitting coil is set through the center of the sphere of the magnetic drive source, which simplifies the inverse kinematics algorithm during positioning.

[0015] Optionally, the magnetic drive source is a permanent magnet or an electromagnet.

[0016] In the above scheme, an electromagnet refers to a magnet that can generate a magnetic field when energized and whose magnetic field disappears when de-energized. When the magnetic drive source is an electromagnet, its magnetic field strength and direction can be adjusted, thereby making it easier to control the magnetic drive unit.

[0017] Optionally, the propulsion device can output linear motion to advance the guide wire.

[0018] In the above scheme, the direction of the distal end of the guide wire is controlled by the magnetic drive source to achieve the magnetic drive unit. The propulsion device only needs to achieve linear propulsion, such as forward or backward movement. Therefore, the structure of the propulsion device is relatively simple. The propulsion device may include a friction wheel propeller, which includes two spaced friction wheels. Both friction wheels can rotate, and the two friction wheels rotate in opposite directions and at the same speed. The guide wire is clamped between the two friction wheels. When the two friction wheels rotate simultaneously, the friction force can drive the guide wire to move forward or backward.

[0019] Optionally, the guidewire includes a main body, a positioning part, and a magnetic drive part, wherein the main body, the positioning part, and the magnetic drive part are connected in sequence, or the main body, the magnetic drive part, and the positioning part are connected in sequence.

[0020] In the above scheme, the main body is the core structure of the guidewire. One end of the main body is located outside the human body, forming the proximal end of the guidewire. The other end of the main body extends into the human body and connects to either the positioning section or the magnetic drive section. The positioning section and the magnetic drive section are interconnected, together forming the distal end of the guidewire. The positioning section is the positioning part of the guidewire, cooperating with the positioning signal transmitter for positioning. The magnetic drive section can be oriented by a magnetic drive source, changing its direction. The magnetic drive section includes at least a magnetic material that can be acted upon by a driving magnetic field. Specifically, after being magnetized, the magnetic drive section possesses permanent magnetism. Under an applied magnetic field, it experiences a torque from the magnetic field, thus tending to bend and change direction along the direction of the external magnetic field.

[0021] Optionally, the positioning part includes a soft magnetic core and a receiving coil, the receiving coil being disposed on the outer periphery of the soft magnetic core.

[0022] In the above scheme, due to the presence of the rigid soft magnetic core, the positioning part will be subjected to magnetic force under the influence of the external magnetic field, thus causing a certain deflection, which plays a certain auxiliary role in the turning of the distal end of the guide wire.

[0023] Optionally, the magnetic drive unit includes a matrix and magnetic particles uniformly dispersed within the matrix.

[0024] In the above scheme, the matrix is ​​the basic structure of the magnetic drive unit. The matrix can be made of a mixture of high molecular polymers and has sufficient flexibility. Magnetic particles are dispersed inside the matrix. The magnetic particles can be subjected to the force of an external magnetic field, causing the entire magnetic drive unit to bend and rotate.

[0025] Optionally, the main body includes transmission lines arranged side by side and reinforcing wires for increasing the strength of the main body, the transmission lines being electrically connected to the receiving coil.

[0026] In the above scheme, both the reinforcing wire and the transmission line are linear and extend along the length of the main body, so that they are arranged side by side. The reinforcing wire is used to increase the structural strength of the main body, allowing the guidewire to deform to a certain extent without becoming too soft and causing blockage in the blood vessel. The reinforcing wire can be a metal wire, such as a nickel-titanium alloy wire. The transmission line is used to transmit signals. Specifically, one end of the transmission line is connected to the positioning part, and the other end extends to the proximal end of the guidewire, where it can be connected to the control device.

[0027] Optionally, the positioning unit includes a magnetic sensor.

[0028] In the above scheme, the magnetic sensor can collect changes in the magnetic field along three axes, thereby performing six-degree-of-freedom pose calculations. The magnetic sensor features a large range, high precision, and high response speed, making it suitable for use in this invention. Attached Figure Description

[0029] To more clearly illustrate the technical solutions in the embodiments of the present invention, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0030] Figure 1 This is a schematic diagram of the magnetic guide wire control system provided in an embodiment of the present invention;

[0031] Figure 2 A schematic diagram of a first assembly structure of a magnetic drive source and a positioning signal transmitter provided in an embodiment of the present invention;

[0032] Figure 3A schematic diagram of a second assembly structure for a magnetic drive source and a positioning signal transmitter provided in an embodiment of the present invention;

[0033] Figure 4 A schematic diagram of the distal end of the first type of guidewire provided in an embodiment of the present invention;

[0034] Figure 5 This is a schematic diagram of the main body segment provided in an embodiment of the present invention;

[0035] Figure 6 This is a schematic diagram of the positioning segment provided in an embodiment of the present invention;

[0036] Figure 7 This is a schematic diagram of the structure of the magnetic drive section provided in an embodiment of the present invention;

[0037] Figure 8 A schematic diagram of the distal end of the second type of guidewire provided in an embodiment of the present invention;

[0038] Figure 9 This is a schematic diagram of the distal end of the third type of guidewire provided in an embodiment of the present invention.

[0039] The following are the labeling elements in the figure:

[0040] 1-Moving mechanism; 2-Magnetic drive source; 201-Driving magnetic field; 21-Driving housing; 3-Positioning signal transmitter; 301-Positioning magnetic field; 4-Guide wire; 401-Distant end; 41-Main body; 411-Reinforcing wire; 412-Transmission line; 413-Outer layer; 42-Positioning part; 421-Receiving coil; 422-Soft magnetic core; 423-Wrapping layer; 43-Magnetic drive part; 431-Magnetic particles; 432-Matrix; 5-Propulsion device. Detailed Implementation

[0041] To make the technical problems to be solved, the technical solutions, and the beneficial effects of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present invention and are not intended to limit the present invention.

[0042] It should be noted that when a component is referred to as being "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as being "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0043] It should be understood that the terms "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and simplifying the description, and do not 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 limitations on the present invention.

[0044] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, unless otherwise explicitly specified.

[0045] Interventional vascular surgery is currently the preferred treatment for vascular diseases, offering advantages such as minimal invasiveness, rapid recovery, and high efficacy. The procedure involves puncturing a blood vessel at a superficial site, commonly the radial and brachial arteries in the upper limbs, and the femoral and dorsalis pedis arteries in the lower limbs. After successful puncture, a vascular sheath is inserted, followed by a guidewire. The guidewire is then guided to the lesion site, and after opening the lesion, balloon dilation is performed, followed by stent implantation.

[0046] In traditional interventional surgery, digital subtraction angiography (DSA) is used as an aid. Surgeons employ techniques such as pushing, pulling, rotating, and twisting to control a pre-bent guidewire along the patient's blood vessel until it reaches the vicinity of the lesion. However, in the extremely narrow and complex working environment of human blood vessels, this traditional guidewire delivery method faces numerous challenges. For example, in surgical scenarios involving blood vessels with extremely small diameters and complex course, such as those in the brain, the fixed degree of curvature at the distal end of the traditional pre-bent guidewire makes it difficult to adapt to complex vascular pathways to reach the lesion, and also carries the risk of vascular damage. The high difficulty of guidewire delivery makes the surgery highly dependent on the surgeon's skill and experience, which significantly increases the learning cost of the procedure and hinders its widespread adoption. Furthermore, during the procedure, surgeons need to wear heavy lead protective suits for extended periods in a radiation environment, which also has a significant impact on their health.

[0047] The magnetically controlled guidewire system can actively control the distal bending direction of the magnetically adjustable guidewire according to different vascular course requirements. This effectively solves the problem of fixed distal bending degree of traditional pre-bent guidewires, greatly reducing the risk of vascular injury and the difficulty of the operation. However, the guidewire positioning in current magnetically controlled guidewire systems mainly relies on DSA imaging systems. This classic guidewire positioning method has some inherent problems that have not yet been solved, affecting the widespread promotion and application of the system. On the one hand, guidewire guidance using DSA imaging systems requires frequent X-ray exposure, which still exposes patients to a certain dose of X-ray radiation. On the other hand, most DSA systems can only acquire 2D superimposed images in real time, and the real-time image information does not contain vascular course information. In complex vascular environments, this lost information can cause confusion for doctors and increase the difficulty of the operation. Angiography can obtain a static vascular path map as a reference for doctors, but this process can seriously reduce the efficiency of the operation and also place an additional physical burden on the patient. To solve the above technical problems, this invention proposes a new magnetic guidewire control system.

[0048] The magnetic guide wire control system provided in the embodiments of the present invention will now be described.

[0049] Please see Figure 1 and Figure 4 The magnetic guide wire control system includes a guide wire 4, a propulsion device 5, a magnetic drive source 2, a moving mechanism 1, a positioning signal transmitter 3, and a control device.

[0050] Guidewire 4 is a filamentous structure that enters the blood vessel percutaneously and can reach the lesion site under controlled driving force. Guidewire 4 is used in coronary arteries, peripheral blood vessels, and neurovascular applications to reach the target through tortuous, calcified, stenotic, and collateral circulation pathways; it is also used to establish channels for delivering therapeutic devices such as balloons and stents. The end of guidewire 4 that extends into the human body is called the distal end 401 of guidewire 4, and the end of guidewire 4 that is located outside the human body is called the proximal end of guidewire 4.

[0051] The guidewire 4 includes a positioning part 42 and a magnetic drive part 43, both of which are disposed at the distal end 401 of the guidewire 4. The positioning part 42 is used to receive positioning signals emitted by the positioning signal transmitter 3 to obtain the position and orientation of the distal end 401 of the guidewire 4. The magnetic drive part 43 can be driven by a magnetic field, thereby changing the orientation of the magnetic drive part 43, that is, changing the direction of the guidewire 4 as it advances within the blood vessel.

[0052] The magnetic drive source 2 is made of magnetic material. The magnetic drive source 2 can generate a magnetic field in the working space. This magnetic field can be called the driving magnetic field 201. The magnetic drive part 43, which is also in the working space, will be affected by the driving magnetic field 201 and produce a change in posture. Specifically, it can change the orientation of the distal end 401 of the guidewire 4, and thus change the direction of the distal end 401 of the guidewire 4 according to the direction of the blood vessel.

[0053] The moving mechanism 1 is used to drive the magnetic drive source 2 to change its pose, so that the magnetic drive source 2 can generate a driving magnetic field 201 of target size and direction at the position of the distal end 401 of the guide wire. The moving mechanism 1 enables the magnetic drive source 2 to change with the position of the distal end 401 of the guide wire 4, keeping the distal end 401 of the guide wire 4 always within the coverage area of ​​the driving magnetic field 201.

[0054] The positioning signal transmitter 3 is used to transmit positioning signals, and the positioning part 42 of the guide wire 4 is used to receive the transmitted positioning signals. After receiving the positioning signals, the positioning part 42 of the guide wire 4 can be calculated by the control device and the like to obtain the position and attitude of the positioning part 42.

[0055] The propulsion device 5 is used to advance the guidewire 4 forward, and the contact position between the propulsion device 5 and the guidewire 4 is located at the proximal end of the guidewire 4. The magnetic drive source 2 changes the direction of the magnetic drive section 43 through its driving magnetic field 201. When the guidewire 4 is in the correct direction of advancement, the propulsion device 5 gradually pushes the guidewire 4 into the target blood vessel.

[0056] The control device is communicatively connected to the propulsion device 5, the moving mechanism 1, the positioning signal transmitter 3, and the guide wire positioning part 42. The control device has the ability to receive, transmit, store, and calculate data. The control device may include a host computer and a slave computer. The control device may be a motherboard or similar structure installed in a computer. The control device is electrically connected at least to the propulsion device 5, the moving mechanism 1, the positioning signal transmitter 3, and the positioning part 42. When the magnetic drive source 2 is an electromagnet, the control device is also electrically connected to the magnetic drive source 2.

[0057] During the vascular interventional procedure, the distal end 401 of the guidewire 4 is first inserted into the blood vessel. The guidewire 4 needs to be gradually advanced along the direction of the blood vessel. The positioning signal transmitter 3 emits a positioning signal, which is received by the positioning part 42 inside the blood vessel. The positioning part 42 is then determined based on the positioning signal. According to the position and orientation of the positioning part 42 and the preoperative CT 3D vascular path map, the magnetic drive part 43 can be manipulated by the magnetic drive source 2 under a simulated endoscopic view, ensuring that the direction of the distal end 401 of the guidewire 4 remains consistent with the direction of the blood vessel, greatly reducing the difficulty of the procedure.

[0058] The magnetic guidewire control system in the above embodiment includes a guidewire 4, a propulsion device 5, a magnetic drive source 2, a moving mechanism 1, and a positioning signal transmitter 3. A positioning part 42 is provided within the guidewire 4 to receive signals emitted by the positioning signal transmitter 3, and the position and orientation of the guidewire 4 are obtained by inverse decoding of the signals. The moving mechanism 1 can drive the magnetic drive source 2 to move. A magnetic drive part 43 is provided within the guidewire 4, allowing the movement of the magnetic drive source 2 to rotate the guidewire 4 within the blood vessel. The propulsion device 5 enables the guidewire 4 to advance within the blood vessel. During the vascular interventional surgery, after obtaining the position and orientation of the distal end 401 of the guidewire 4 based on the positioning signal transmitter 3 and the positioning part 42, combined with the preoperative CT vascular 3D path map, three-dimensional traversal display can be performed. Under an endoscopic-like perspective, the magnetic drive source 2 controls the rotation of the magnetic drive part 43 at the end of the guidewire 4, reducing surgical difficulty, increasing surgical efficiency, and eliminating the need for DSA imaging, thus sparing the patient from X-ray radiation.

[0059] When performing vascular interventional surgery using the magnetic guidewire control system provided by this invention, the positioning signal emitted by the positioning signal transmitter 3 is received by the positioning unit 42 and transmitted to the control device. The control device calculates the position and orientation of the positioning unit 42 using positioning algorithms such as six degrees of freedom and five degrees of freedom, and combines it with the preoperative CT vascular 3D path map to obtain the subsequent turning of the guidewire 4 and the required forward displacement of the guidewire 4. The turning signal and displacement signal are sent to the moving mechanism 1 and the propulsion device 5 respectively. The moving mechanism 1 moves the magnetic drive source 2 to the corresponding position to turn the distal end 401 of the guidewire 4, and the propulsion device 5 propels the guidewire 4 forward by a predetermined displacement.

[0060] In some embodiments of the present invention, the control device includes a storage and processing module for receiving and processing signals, and a remote control module. The remote control module is communicatively connected to the storage and processing module, and can transmit execution signals to the storage and processing module. The storage and processing module then sends signals to the moving mechanism 1, the propulsion device 5, the magnetic drive source 2, etc., to enable them to perform relevant operations. The remote control module allows doctors to remotely operate and control the moving mechanism 1, the propulsion device 5, and the magnetic drive source 2, thereby realizing the movement of the guidewire 4. The remote control module includes signal input devices such as a handle, keyboard, and mouse.

[0061] In the magnetic guide wire control system provided by the present invention, the direction change of the distal end 401 of the guide wire 4 is achieved by the magnetic drive source 2 controlling the magnetic drive unit 43. The propulsion device 5 only needs to achieve linear propulsion, such as forward or backward movement. Therefore, the structure of the propulsion device 5 is relatively simple.

[0062] In some embodiments, the propulsion device 5 includes a friction wheel propeller, which includes two friction wheels spaced apart. Both friction wheels can rotate, and the two friction wheels rotate in opposite directions and at the same speed. The guide wire 4 is clamped between the two friction wheels. When the two friction wheels rotate simultaneously, the guide wire 4 can be driven forward or backward by friction.

[0063] In some embodiments of the present invention, please refer to Figure 2 and Figure 3 The magnetic drive source 2 and the positioning signal transmitter 3 are fixedly connected, and can move synchronously under the action of the moving mechanism 1. Because the magnetic drive source 2 and the positioning signal transmitter 3 are fixedly connected, their positions and orientations remain the same. Their coordinate systems only need to be registered once at the factory, and their relative positions remain unchanged during the vascular interventional procedure. Furthermore, when the magnetic drive source 2 drives the distal end 401 of the guidewire 4 to turn, the magnetic drive source 2 needs to approach the distal end 401 of the guidewire 4, thereby bringing the positioning signal transmitter 3 closer to the positioning part 42 of the guidewire 4, maximizing positioning performance. This ensures that the positioning signal transmitter 3 is always within an optimal working space, solving the problem of a small working range in fixed magnetic positioning systems. In fixed magnetic positioning systems, the position of the positioning signal transmitter 3 is relatively fixed and cannot move with the guidewire 4, resulting in a fixed and relatively small working range.

[0064] In some embodiments, the magnetic drive source 2 and the positioning signal transmitter 3 are fixed to each other by adhesive bonding. Alternatively, the magnetic drive source 2 and the positioning signal transmitter 3 are fixed to each other by compression. Alternatively, the magnetic drive source 2 and the positioning signal transmitter 3 are connected and fixed to each other by a threaded connection or the like.

[0065] In some embodiments, the positioning signal transmitter 3 includes multiple transmitting coils, which are fixed to the outside of the magnetic drive source 2. The positioning signal transmitter 3 can be a magnetic field emission source, capable of emitting electromagnetic waves and generating a positioning magnetic field 301, which is achieved through multiple sets of transmitting coils. The magnetic drive source 2 is generally an integral structure, with the transmitting coils fixed to the outside of the magnetic drive source 2, facilitating the assembly of the positioning signal transmitter and the magnetic drive source 2.

[0066] In some embodiments, the number of transmitting coils is three, five, eight, etc., and the number is not limited here. The axial direction and position of each transmitting coil are different. During positioning, each group of transmitting coils can conduct pulsed square wave current in a time-division manner, or continuously conduct sinusoidal current of different frequencies. The positioning unit 42 performs inverse kinematics based on the received signal to perform six-degree-of-freedom or five-degree-of-freedom positioning. The movements of each degree of freedom (three orthogonal directions of movement and three orthogonal directions of rotation) of the positioning unit 42 can be detected and tracked, which can be used to determine the position and attitude of the robot actuators and sensors. In this invention, precise positioning and navigation of the distal end 401 of the guidewire 4 is achieved through measurement and modeling. Five-degree-of-freedom positioning is largely the same as six-degree-of-freedom positioning and will not be described further here.

[0067] In some embodiments, the positioning signal transmitter 3 is directly fixed to the outer wall of the magnetic drive source 2.

[0068] In some embodiments, the magnetic drive source 2 is externally enclosed by a drive housing 21, which may be a non-metallic shell. The positioning signal transmitter 3 is fixed to the non-metallic shell. The non-metallic shell does not shield the electromagnetic waves emitted by the magnetic drive source 2, which is suitable for this embodiment. Specifically, the positioning signal transmitter 3 may be fixed to the outer or inner wall of the non-metallic shell.

[0069] In some embodiments of the present invention, please refer to Figure 2 The magnetic drive source 2 is spherical. A transmitting coil is wound around the outer periphery of the magnetic drive source 2, with its center coinciding with the center of the sphere. When the magnetic drive source 2 is spherical, the transmitting coil is also annular. Having the center of the transmitting coil coincide with the center of the sphere facilitates modeling and simplifies the inverse kinematics algorithm during localization. In other embodiments, the transmitting coil may also be square or other shapes. In other embodiments, the magnetic drive source 2 may also be cubic, flat, or other structures; the specific shape of the magnetic drive source 2 is not limited here. In other embodiments, the center of the transmitting coil may not coincide with the center of the sphere.

[0070] There are multiple transmitting coils, and each transmitting coil is located in a different position. For example, when there are three transmitting coils, the three transmitting coils are arranged orthogonally in pairs on the outer periphery of the magnetic drive source 2.

[0071] In some embodiments of the present invention, please refer to Figure 3The magnetic drive source 2 is spherical, and the transmitting coil is a disc-shaped coil distributed outside the magnetic drive source 2, with its central axis passing through the center of the sphere. In this embodiment, the center of the transmitting coil is located outside the magnetic drive source 2, and the disc shape facilitates its fixation to the outside of the magnetic drive source 2. It should be noted that the transmitting coil is not necessarily perfectly planar; it can be attached to the surface of the magnetic drive source 2, with the side of the transmitting coil facing the magnetic drive source 2 being partially spherical. The central axis of the transmitting coil passing through the center of the sphere facilitates modeling, thus simplifying the inverse kinematics algorithm during positioning.

[0072] There are multiple transmitting coils, which are evenly arranged on the outer periphery of the magnetic drive source 2.

[0073] In some embodiments of the present invention, the magnetic drive source 2 is a permanent magnet. A permanent magnet is a magnet that can retain a high remanence for a long time in an open-circuit state, and a permanent magnet can generate a constant magnetic field.

[0074] In some embodiments of the present invention, the magnetic drive source 2 is an electromagnet. An electromagnet is a magnet that generates a magnetic field when energized and whose magnetic field disappears when de-energized. When the magnetic drive source 2 is an electromagnet, its magnetic field strength and direction can be adjusted, thereby making it easier to control the magnetic drive unit 43.

[0075] In some embodiments of the present invention, the moving mechanism 1 is used to move the magnetic drive source 2. The moving mechanism 1 may include a multi-axis robotic arm or other multi-degree-of-freedom mobile device, enabling the magnetic drive source 2 to change its position and orientation. The multi-axis robotic arm may include multiple rotary joints and linear joints to realize the movement of the magnetic drive source 2 in the x-axis, y-axis, and z-axis directions, as well as its rotation in the x-axis, y-axis, and z-axis directions.

[0076] In some embodiments of the present invention, the magnetic drive source 2 can generate a strong driving magnetic field 201, such as 20 to 100 mT, in the working space, which acts on the magnetic drive part 43 of the guide wire 4, thereby adjusting the direction of the distal end 401 of the guide wire 4.

[0077] In some embodiments of the present invention, please refer to Figure 4 The guide wire 4 includes a main body 41, a positioning part 42 and a magnetic drive part 43. The length directions of the main body 41, the positioning part 42 and the magnetic drive part 43 are all arranged along the length direction of the guide wire 4.

[0078] The main body 41 is the main structure of the guidewire 4. One end of the main body 41 is located outside the human body and is the proximal end of the guidewire 4. The other end of the main body 41 extends into the human body and is connected to the positioning part 42 or the magnetic drive part 43. The positioning part 42 and the magnetic drive part 43 are connected to each other and together constitute the distal end 401 of the guidewire 4.

[0079] The positioning part 42 is the positioning part of the guide wire 4, and it works in conjunction with the positioning signal transmitter 3 to perform positioning.

[0080] The magnetic drive section 43 can be induced to change direction by the magnetic drive source 2. The magnetic drive section 43 includes at least a magnetic material that can be induced to change direction by the driving magnetic field 201. Specifically, after being magnetized, the magnetic drive section 43 acquires permanent magnetism and will be subjected to the torque of the magnetic field under an applied magnetic field, thus tending to bend and change direction along the direction of the external magnetic field.

[0081] In some embodiments, the main body 41, the positioning part 42, and the magnetic drive part 43 are connected in sequence. The magnetic drive part 43 is located at the foremost end of the guide wire 4 and is directly connected to the positioning part 42, which can improve the steering capability of the guide wire 4. However, this does not provide a direct method for locating the actual position and orientation of the magnetic drive part 43. Nevertheless, the length of the magnetic drive part 43 is usually short, not exceeding 10 mm, and it tends to move in the direction of the applied magnetic field. Therefore, its position and orientation can be estimated based on the orientation of the positioning part 42 and the magnetic field of the magnetic drive source 2 near the magnetic drive part 43.

[0082] In some embodiments, the main body 41, the magnetic drive 43, and the positioning part 42 are connected in sequence. The positioning part 42 is located at the foremost end of the guide wire 4. The positioning part 42 is both the positioning area and the turning area of ​​the guide wire 4. It can directly position the foremost end of the guide wire 4. However, the positioning part 42 generally has high rigidity, and its turning ability may be weakened.

[0083] In some embodiments of the present invention, please refer to Figure 6 The positioning part 42 includes a receiving coil 421 and a soft magnetic core 422. The receiving coil 421 is used to receive the positioning signal emitted by the transmitting coil and is disposed on the outer periphery of the soft magnetic core 422. Due to the presence of the rigid soft magnetic core 422, the positioning part 42 will be subjected to magnetic force under the influence of an external magnetic field, thus undergoing a certain deflection, which plays a certain auxiliary role in the turning of the distal end 401 of the guide wire 4.

[0084] In some embodiments of the present invention, the positioning unit 42 includes a receiving coil 421 and a soft magnetic core 422, which can collect the change in magnetic flux (magnetic field change) in a single-axis direction, thereby performing a five-degree-of-freedom pose calculation (lacking angle information about rotation around the axis).

[0085] In some embodiments of the present invention, the positioning part 42 includes a magnetic sensor. With the development of MEMS (Micro-Electro-Mechanical System) technology, the performance of miniature (side length less than 1 mm, or even less than 0.5 mm) magnetic sensors is constantly improving. Many of these magnetic sensors have the characteristics of large range, high precision, and high response speed, and are suitable for use in the present invention.

[0086] Magnetic sensors have the following advantages:

[0087] First, the magnetic sensor is a triaxial sensor. Compared to a single-axis receiving coil, this magnetic sensor can sense magnetic fields in three orthogonal directions in a limited space, thereby reducing the number of transmitting coils required, requiring only three sets of transmitting coils (not eight sets).

[0088] Secondly, it has a higher degree of integration. Current commercial magnetic sensors can directly output digital signals, thereby reducing the complexity of back-end signal processing. The guide wire 4 can be directly connected to the propulsion device 5 and then transmitted to the control device.

[0089] Third, the magnetic sensor is shorter and does not require a soft magnetic core 422 for signal enhancement. Therefore, the length of the distal end 401 of the guide wire 4 is shorter, resulting in less steering interference to the magnetic drive unit 43 (existing receiving coils form sensors with a diameter of <0.5mm, but a length of ≥10mm; while the magnetic sensor is about 1mm wide and, including the circuit board, is <5mm long).

[0090] In some embodiments, please refer to Figure 8 and Figure 9 The positioning section 42 includes a Hall sensor, which meets the requirements of the present invention for measuring range (~100mT) and accuracy (~1μT). The size of the Hall sensor is on the order of 1mm, which is larger than the existing guide wire 4 (~0.5mm diameter). Therefore, if such a sensor is used, the positioning section will inevitably become thicker. However, the Hall sensor is relatively short, which causes less interference to the steering of the magnetic drive section 43.

[0091] In some embodiments of the present invention, please refer to Figure 6 The positioning part 42 is surrounded by a covering layer 423, which covers the receiving coil 421 or the magnetic sensor. This serves two purposes: first, it protects the internal structure of the positioning part 42; second, it allows for connection with the outer layers of the main body 41 and the magnetic drive part 43. Specifically, during the fabrication of the guide wire 4, a stable connection between the main body 41, the positioning part 42, and the magnetic drive part 43 can be achieved using high-temperature fusion welding.

[0092] In some embodiments, the encapsulation layer 423 is a polymer layer, which may be made of at least one of PDMS, Ecoflex, and TPU.

[0093] In some embodiments of the present invention, please refer to Figure 7 The magnetic drive unit 43 includes a substrate 432 and magnetic particles 431 uniformly dispersed inside the substrate 432.

[0094] The substrate 432 is the basic structure of the magnetic drive unit 43. The substrate 432 can be made of a mixture of high molecular polymers and has sufficient flexibility.

[0095] In some embodiments, the substrate 432 may be made of at least one of PDMS, Ecoflex, and TPU. In this embodiment, the substrate 432 has a certain degree of flexibility, which makes it easier to bend and turn the magnetic drive part 43, and at the same time, it is less likely to damage blood vessels.

[0096] Magnetic particles 431 are disposed inside the substrate 432. The magnetic particles 431 can be subjected to the force of an external magnetic field, causing the magnetic drive part 43 to bend and turn as a whole.

[0097] In some embodiments, the magnetic particles 431 comprise NdFeB magnetic powder. After the magnetic particles 431 are magnetized, the magnetic drive section 43 acquires permanent magnetism and will be subjected to the torque of the magnetic field under an applied magnetic field, thus tending to bend along the direction of the external magnetic field.

[0098] In some embodiments of the present invention, please refer to Figure 5 The main body 41 includes a transmission line 412 arranged side by side and a reinforcing wire 411 for increasing the strength of the main body 41. The transmission line 412 is electrically connected to the positioning part 42, thereby providing the guide wire 4 with a certain structural strength and transmission channel.

[0099] Both the reinforcing wire 411 and the transmission line 412 are linear and extend along the length of the main body 41, so that they are arranged side by side. The reinforcing wire 411 is used to increase the structural strength of the main body 41, so that the guidewire 4 can deform to a certain extent without being too soft and blocking the blood vessel. The reinforcing wire 411 can be a metal wire, such as a nickel-titanium alloy wire. The transmission line 412 is used to transmit signals. Specifically, one end of the transmission line 412 is connected to the positioning part 42, and the other end of the transmission line 412 extends to the proximal end of the guidewire 4 and can be connected to the control device.

[0100] In some embodiments, the main body 41 is provided with an outer surface layer 413, and the reinforcing filaments 411 and the transmission lines 412 are both disposed inside the outer surface layer 413. The outer surface layer 413 may be made of at least one of PDMS, Ecoflex, and TPU.

[0101] In some embodiments of the present invention, the substrate 432 of the magnetic drive portion 43, the wrapping layer 423 of the positioning portion 42, and the outer surface layer 413 of the main body portion 41 can all be polymer layers, thereby facilitating the interconnection of the magnetic drive portion 43, the positioning portion 42, and the main body portion 41. Specifically, the substrate 432 of the magnetic drive portion 43, the wrapping layer 423 of the positioning portion 42, and the outer surface layer 413 of the main body portion 41 can be interconnected by high-temperature fusion welding.

[0102] In some embodiments of the present invention, the outer surfaces of the magnetic drive part 43, the positioning part 42 and the main body part 41 are all coated with a hydrophilic coating to ensure the super-slippery performance of the entire outer surface of the guidewire 4, making it easier to insert the guidewire 4 into the depth of the blood vessel.

[0103] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A magnetic guide wire control system, characterized in that: The system includes a guide wire (4), a propulsion device (5) for advancing the guide wire (4), a magnetic drive source (2) for generating a magnetic field, a moving mechanism (1) for driving the magnetic drive source (2), a positioning signal transmitter (3) for transmitting a positioning signal, and a control device. The guide wire (4) includes a positioning part (42) for receiving the positioning signal and a magnetic drive part (43) driven by the magnetic drive source (2). The positioning part (42) and the magnetic drive part (43) are both located at the distal end of the guide wire (4). The control device is connected to the propulsion device (5) and the magnetic drive source (2). The moving mechanism (1), the positioning signal transmitter (3), and the positioning part (42) are all communicatively connected; the positioning signal transmitter (3) transmits a positioning signal, the positioning part (42) inside the blood vessel receives the positioning signal, and the position and orientation of the positioning part (42) are obtained by inverse decomposition based on the positioning signal; based on the position and orientation of the positioning part (42) and the preoperative CT vascular 3D path map, the magnetic drive source (2) controls the magnetic drive part (43) so that the direction of the distal end (401) of the guidewire (4) is always consistent with the direction of the blood vessel; The magnetic drive source (2) and the positioning signal transmitter (3) are fixedly connected. The positioning signal transmitter (3) includes multiple transmitting coils. Each group of transmitting coils conducts pulse square wave current in a time-division manner, or continuously conducts sinusoidal current of different frequencies. The positioning unit (42) performs inverse decoding based on the received signal to perform six-degree-of-freedom or five-degree-of-freedom positioning.

2. The magnetic guide wire control system as described in claim 1, characterized in that: The transmitting coil is fixed to the outside of the magnetic drive source (2).

3. The magnetic guide wire control system as described in claim 2, characterized in that: The magnetic drive source (2) is spherical, and the transmitting coil is wound around the outer periphery of the magnetic drive source (2), with the center of the transmitting coil coinciding with the center of the sphere of the magnetic drive source (2); or, The magnetic drive source (2) is spherical, and the transmitting coil is a disc-shaped coil distributed outside the magnetic drive source (2), with the central axis of the disc-shaped coil passing through the center of the sphere of the magnetic drive source (2).

4. The magnetic guide wire control system as described in claim 1, characterized in that: The magnetic drive source (2) is a permanent magnet or an electromagnet.

5. The magnetic guide wire control system as described in claim 1, characterized in that: The propulsion device (5) is capable of outputting linear motion to propel the guide wire (4).

6. The magnetic guide wire control system as described in claim 1, characterized in that: The guide wire (4) includes a main body (41), a positioning part (42), and a magnetic drive part (43). The main body (41), the positioning part (42), and the magnetic drive part (43) are connected in sequence, or the main body (41), the magnetic drive part (43), and the positioning part (42) are connected in sequence.

7. The magnetic guide wire control system as described in claim 6, characterized in that: The positioning part (42) includes a soft magnetic core (422) and a receiving coil (421), the receiving coil (421) being disposed on the outer periphery of the soft magnetic core (422).

8. The magnetic guide wire control system as described in claim 6, characterized in that: The magnetic drive unit (43) includes a substrate (432) and magnetic particles (431) uniformly dispersed within the substrate (432).

9. The magnetic guide wire control system as described in claim 6, characterized in that: The main body (41) includes a transmission line (412) arranged side by side and a reinforcing wire (411) for increasing the strength of the main body (41). The transmission line (412) is electrically connected to the positioning part (42).

10. The magnetic guide wire control system as described in claim 6, characterized in that: The positioning unit (42) includes a magnetic sensor.

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