Magnetic guidewire control system

Abstract

The invention provides a magnetic guide wire control system which comprises a guide wire, a propelling device used for propelling the guide wire, a magnetic drive source used for generating a magnetic field, a moving mechanism used for driving the magnetic drive source to move, a positioning signal transmitter used for transmitting an electromagnetic positioning signal and a control device. The guide wire comprises a positioning part used for receiving the electromagnetic positioning signal and a magnetic driving part driven by the magnetic driving source, and the positioning part and the magnetic driving part are both arranged at the far end of the guide wire. In the implementation process of a vascular interventional operation, after the position posture of the far end of the guide wire is obtained according to the positioning signal emitter and the guide wire positioning part, three-dimensional migration display can be conducted in combination with a vascular 3D road map collected through preoperative CT, the magnetic driving part at the far end of the guide wire is controlled through the magnetic driving source under the simulated endoscope visual angle, the operation difficulty is reduced, the operation efficiency is improved, and the operation safety is improved. DSA imaging does not need to be used, and a patient does not need to bear X-Ray radiation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and more specifically, relates to a magnetic guide wire control system. Background Art

[0002] Vascular interventional surgery is an important means for treating cardiovascular and cerebrovascular diseases such as coronary heart disease, stroke, and arrhythmia, and has advantages such as small incisions and rapid postoperative recovery. The precise delivery of the interventional guide wire plays an extremely important role in the process of vascular interventional surgery, and is the basis for subsequently guiding instruments such as microcatheters, balloons, and stents along the guide wire to the lesion blood vessel position for treatment operations. In traditional interventional surgery, assisted by digital subtraction angiography imaging (DSA imaging for short), doctors use operation techniques such as pushing, pulling, rotating, and twisting to control the pre-bent guide wire to advance along the patient's blood vessel until it reaches near the lesion. However, in such an extremely narrow and complex working environment as the human blood vessel, the above traditional interventional guide wire delivery scheme faces many challenges. For example, in surgical scenarios where the blood vessel diameter is extremely small and the blood vessel shape is complex, such as in the cerebral blood vessels, the distal curvature of the traditional pre-bent guide wire is fixed, making it difficult to adapt to the complex blood vessel path and reach the lesion position, and there is also a risk of damaging the blood vessel. The high difficulty of guide wire delivery makes the surgery highly dependent on the doctor's operation skills and experience, which greatly increases the learning cost of the surgery and is not conducive to the popularization of the surgery. In addition, during the operation, doctors need to wear heavy lead protective clothing for a long time and work in a radiation environment, which also has a greater impact on the doctor's physical health. To solve the above problems, researchers have designed various vascular interventional robots with different configurations based on the mechanical propulsion principle. Such vascular interventional robots can help doctors achieve the remote delivery of the guide wire and solve the problem of doctor's radiation exposure. However, the guide wire delivered by such robots is still a traditional fixed-bend guide wire, and it cannot solve the problems of difficult guide wire delivery and high risk of blood vessel damage in a narrow and tortuous blood vessel environment.

[0003] The magnetic control guide wire system is one of the potential solutions to solve the pain points in the above-mentioned vascular interventional surgeries. Generally, the system consists of a DSA imaging system, a magnetically adjustable bending guide wire, a magnetic control guide wire direction guiding system, a guide wire propulsion system, and a control system. The magnetic control direction guiding system can actively control the distal bending direction of the magnetically adjustable bending guide wire according to different requirements of the blood vessel configuration, which preferably solves the problem that the distal bending degree of the traditional pre-bent guide wire is fixed, and greatly reduces the risk of blood vessel injury and the operation difficulty during the surgery. Using the magnetic control guide wire system, doctors can simply and accurately deliver the magnetically adjustable bending guide wire to the location of the tortuous and narrow blood vessel lesions. However, the current guide wire positioning in the magnetic control guide wire system mainly relies on the DSA imaging system, and there are some inherent problems in this classical guide wire positioning method that have not been solved, which affects the wide range of promotion and application of the system. On the one hand, using the DSA imaging system for guide wire guidance requires frequent X-Ray exposures, and for patients, they still need to bear a certain dose of X-Ray radiation. On the other hand, most DSAs can only collect 2D superimposed images in real time, and the image information collected in real time does not contain the blood vessel configuration. These lost information will cause confusion for doctors in a complex blood vessel environment and increase the operation difficulty for doctors. Performing angiography can obtain a static blood vessel roadmap for doctors' reference, but this process will seriously reduce the operation efficiency and also cause additional physical burden on patients. Summary of the Invention

[0004] The purpose of the embodiments of the present invention is to provide a magnetic guide wire control system to solve the technical problems in the existing magnetic control guide wire technology that the guide wire positioning depends on the DSA imaging, which has a certain radiation to the patient's body and has a relatively low operation efficiency.

[0005] To achieve the above purpose, the technical solution adopted by the present invention is: to provide a magnetic guide wire control system, including a guide wire, a propulsion device for advancing 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 emitting a positioning signal, and a control device. The guide wire includes a positioning portion for receiving the positioning signal and a magnetic drive portion driven by the magnetic drive source. Both the positioning portion and the magnetic drive portion are arranged 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 portion.

[0006] In the above solution, the magnetic guide wire control system includes a guide wire, a propulsion device, a magnetic drive source, a moving mechanism, and a positioning signal transmitter. By arranging a positioning part in the guide wire to receive the signal emitted by the positioning signal transmitter and performing inverse solution on the signal to obtain the position and attitude of the guide wire, the moving mechanism can drive the magnetic drive source to move. By arranging a magnetic drive part in the guide wire, the movement of the magnetic drive source can drive the guide wire to turn in the blood vessel, and the propulsion device can make the guide wire advance in the blood vessel. During the implementation of the vascular intervention surgery, after obtaining the position and attitude of the distal end of the guide wire according to the positioning signal transmitter and the guide wire positioning part, combined with the preoperative CT angiography 3D roadmap, three-dimensional roaming display can be performed. Under the perspective of the virtual endoscope, the magnetic drive part at the distal end of the guide wire is controlled by the magnetic drive source, reducing the surgical difficulty and improving the surgical efficiency. Moreover, without using DSA imaging, the patient does not need to bear X-Ray radiation.

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

[0008] In the above solution, the position and attitude between the magnetic drive source and the positioning signal transmitter always remain the same. The coordinate systems between the two only need to be registered once at the factory. During the vascular intervention surgery, the relative position between the coordinate systems of the two always remains unchanged. Moreover, when the magnetic drive source drives the distal end of the guide wire to turn, the magnetic drive source needs to be close to the distal end of the guide wire, thereby bringing the positioning signal transmitter close to the positioning part of the guide wire, making the positioning performance reach the best, that is, the positioning signal transmitter is always in a better working space, solving the problem of the small working range of the fixed magnetic positioning system.

[0009] Optionally, the positioning signal transmitter includes a plurality of transmitting coils, and the transmitting coils are fixed outside the magnetic drive source.

[0010] In the above solution, the positioning signal transmitter can be a magnetic field emission source, which can emit electromagnetic waves and generate a positioning magnetic field, and is realized by multiple groups of transmitting coils. The magnetic drive source is generally an integral structure, and the transmitting coils are fixed outside the magnetic drive source, which is convenient for the assembly of the positioning signal transmitter and the magnetic drive source.

[0011] Optionally, the magnetic drive source is spherical, the transmitting coils are wound along the outer periphery of the magnetic drive source, and the centers of the transmitting coils coincide with the center of the sphere of the magnetic drive source.

[0012] In the above solution, the transmitting coils are wound around the outer periphery of the magnetic drive source. When the magnetic drive source is spherical, the transmitting coils are also annular. The centers of the transmitting coils coincide with the center of the sphere of the magnetic drive source, so that the inverse solution algorithm can be simplified during positioning inverse solution.

[0013] Optionally, the magnetic drive source is spherical, the transmitting coils are disk-shaped coils distributed outside the magnetic drive source, and the central axis of the disk-shaped coils passes through the center of the sphere of the magnetic drive source.

[0014] In the above solution, the center of the transmitting coil is located outside the magnetic drive source, and the transmitting coil is in a planar spiral shape. It should be noted that the transmitting coil is not necessarily an absolute planar shape. The transmitting coil can be attached to the surface of the magnetic drive source, and the side of the transmitting coil facing the magnetic drive source is a partial spherical surface, that is, spherical. The central axis of the transmitting coil passes through the center of the sphere of the magnetic drive source, so that when performing positioning inverse solution, the inverse solution algorithm can be simplified.

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

[0016] In the above solution, an electromagnet refers to a magnet that can generate a magnetic field in the energized state and the magnetic field disappears in the de-energized state. When the magnetic drive source is an electromagnet, its magnetic field strength and direction can be adjusted, so that the magnetic drive part can be controlled more conveniently.

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

[0018] In the above solution, the direction of the distal end of the guide wire is realized by the magnetic drive source controlling the magnetic drive part. The propulsion device only needs to achieve linear propulsion, such as forward and backward, etc. Therefore, the structure of the propulsion device is relatively simple. The propulsion device can include a friction wheel propeller. The friction wheel propeller includes two friction wheels arranged at intervals. Both friction wheels can rotate, and the rotation directions of the two friction wheels are opposite and the rotation speeds are the same. The guide wire is clamped between the two friction wheels. When the two friction wheels rotate simultaneously, the guide wire can be driven forward or backward by the frictional force.

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

[0020] In the above solution, the main body part is the main structure of the guide wire. One end of the main body part is located outside the human body, and this end is the proximal end of the guide wire. The other end of the main body part extends into the human body and is connected to the positioning part or the magnetic drive part. The positioning part and the magnetic drive part are connected to each other to jointly form the distal end of the guide wire. The positioning part is the positioning part of the guide wire and cooperates with the positioning signal transmitter for positioning. The magnetic drive part can be affected by the magnetic drive source and change its direction. The magnetic drive part at least includes magnetic substances that can be affected by the driving magnetic field. Specifically, after the magnetic drive part is magnetized, the magnetic drive part has a permanent magnetism and will be affected by the magnetic torque under the external magnetic field, so it tends to bend along the direction of the external magnetic field and change its direction.

[0021] Optionally, the positioning part includes a soft iron core and a receiving coil, and the receiving coil is arranged on the outer periphery of the soft iron core.

[0022] In the above solution, due to the presence of the rigid soft magnetic core, under the influence of the external magnetic field, the positioning part will be affected by the magnetic force and thus deflect to a certain extent, which plays a certain auxiliary role in the turning of the distal end of the guide wire.

[0023] Optionally, the magnetic driving part includes a matrix and magnetic particles uniformly dispersed in the matrix.

[0024] In the above solution, the matrix is the basic structure of the magnetic driving part. The matrix can be mixed by a polymer and has sufficient flexibility. The magnetic particles are dispersed inside the matrix. The magnetic particles can be affected by the external magnetic field acting on them, so that the whole magnetic driving part bends and turns.

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

[0026] In the above solution, both the strengthening wires and the transmission lines are arranged linearly and extend along the length direction of the main body part, so that the strengthening wires and the transmission lines are arranged side by side. The strengthening wires are used to increase the structural strength of the main body part, so that the guide wire can be deformed to a certain extent and will not be too soft to block in the blood vessel. The strengthening wires can be metal wires, such as nitinol alloy wires. The transmission lines are used to transmit signals. Specifically, one end of the transmission line is connected to the positioning part, and the other end of the transmission line extends to the proximal end of the guide wire and can be connected to the control device.

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

[0028] In the above solution, the magnetic sensor can collect the magnetic field changes in three-axis directions, so as to perform six-degree-of-freedom pose calculation. The magnetic sensor has the characteristics of a large measurement range, high precision, and high response speed, and is suitable for use in the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following will briefly introduce the drawings required for use in the embodiments or the description of the prior art. Obviously, the following drawings are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0030] Figure 1 It is a schematic structural diagram of the magnetic guide wire control system provided by the embodiment of the present invention;

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

[0032] Figure 3Schematic diagram of the second assembly structure of the magnetic drive source and the positioning signal transmitter provided by the embodiment of the present invention;

[0033] Figure 4 Schematic diagram of the structure of the distal end of the first guide wire provided by the embodiment of the present invention;

[0034] Figure 5 Schematic diagram of the structure of the main body section provided by the embodiment of the present invention;

[0035] Figure 6 Schematic diagram of the structure of the positioning section provided by the embodiment of the present invention;

[0036] Figure 7 Schematic diagram of the structure of the magnetic drive section provided by the embodiment of the present invention;

[0037] Figure 8 Schematic diagram of the structure of the distal end of the second guide wire provided by the embodiment of the present invention;

[0038] Figure 9 Schematic diagram of the structure of the distal end of the third guide wire provided by the embodiment of the present invention.

[0039] Among them, the reference numerals 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 - distal end; 41 - main body part; 411 - reinforcing wire; 412 - transmission line; 413 - outer surface 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 manners

[0041] In order to make the technical problems, technical solutions and beneficial effects to be solved by 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 only used to explain the present invention and are not used to limit the present invention.

[0042] It should be noted that when an element is referred to as "fixed to" or "disposed on" another element, it can be directly on the other element or indirectly on the other element. When an element is referred to as "connected to" another element, it can be directly connected to the other element or indirectly connected to the other element.

[0043] It should be understood that the orientation or positional relationship indicated by terms such as "length", "width", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present invention.

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

[0045] Vascular interventional surgery is currently the preferred treatment method for vascular diseases, which has the advantages of small trauma, quick recovery, and good effect. The treatment method of vascular interventional surgery is to puncture the access vessel. The access vessel is generally selected at a relatively superficial site. Common sites include the radial artery and brachial artery in the upper limb, and the femoral artery and dorsal artery of the foot in the lower limb. After successful puncture, a vascular sheath is implanted, and then a guide wire is implanted. The guide wire is guided to the lesion site. After opening the lesion site, balloon dilation is performed, and then a stent is implanted.

[0046] In traditional interventional surgery, assisted by digital subtraction angiography imaging (referred to as DSA imaging), doctors use operation techniques such as pushing, pulling, rotating, and twisting to control the pre-bent guide wire to advance along the patient's blood vessel until it reaches near the lesion. However, in an extremely narrow and complex working environment such as the human blood vessel, the above traditional interventional guide wire delivery scheme faces many challenges. For example, in surgical scenarios where the blood vessel diameter is extremely small and the blood vessel trajectory is complex, such as in the cerebral blood vessel, the distal bending degree of the traditional pre-bent guide wire is fixed, making it difficult to adapt to the complex blood vessel path to reach the lesion position and there is also a risk of damaging the blood vessel. The relatively high guide wire delivery difficulty makes the surgery highly dependent on the doctor's operation skills and experience, which greatly increases the learning cost of the surgery and is not conducive to the popularization of the surgery. In addition, during the operation, doctors need to wear heavy lead protective clothing for a long time to work in a radiation environment, which also has a greater impact on the doctor's physical health.

[0047] The magnetic control guidewire system can actively control the distal bending direction of the magnetically adjustable guidewire according to different requirements of blood vessel trajectories, which better solves the problem of the fixed distal bending degree of traditional pre-bent guidewires and greatly reduces the risk of blood vessel injury and the operation difficulty during the surgery. However, the current guidewire positioning in the magnetic control guidewire system mainly relies on the DSA imaging system. There are still some inherent problems in this classic guidewire positioning method that have not been solved, which affects the wide promotion and application of this system. On the one hand, using the DSA imaging system for guidewire guidance requires frequent X-Ray exposures. For patients, they still need to bear a certain dose of X-Ray radiation. On the other hand, most DSAs can only collect 2D superimposed images in real time, and the real-time collected image information does not contain the blood vessel trajectory. These lost information will cause confusion for doctors in a complex blood vessel environment and increase the operation difficulty for doctors. Performing angiography can obtain a static blood vessel roadmap for doctors' reference, but this process will seriously reduce the surgical efficiency and cause additional physical burden on patients. To solve the above technical problems, the present invention proposes a new magnetic guidewire control system.

[0048] The magnetic guidewire control system provided by the embodiments of the present invention will be described below.

[0049] Please refer to Figure 1 and Figure 4 , the magnetic guidewire control system includes a guidewire 4, a propulsion device 5, a magnetic drive source 2, a moving mechanism 1, a positioning signal transmitter 3, and a control device.

[0050] The guidewire 4 is a filamentous structure that enters the human blood vessel through percutaneous puncture and can reach the lesion position under the control of driving force. The guidewire 4 is used to reach the target through tortuous, calcified, stenotic, and collateral circulation in application scenarios such as coronary arteries, peripheral blood vessels, and neurovascular vessels; and is used to establish a channel to further deliver treatment devices such as balloons and stents. Among them, the end of the guidewire 4 extending into the human body is called the distal end 401 of the guidewire 4, and the end of the guidewire 4 located outside the human body is called the proximal end of the guidewire 4.

[0051] The guidewire 4 includes a positioning part 42 and a magnetic drive part 43, and both the positioning part 42 and the magnetic drive part 43 are arranged at the distal end 401 of the guidewire 4. The positioning part 42 is used to receive the positioning signal emitted by the positioning signal transmitter 3 and is used to obtain the position and attitude 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 advancing direction of the guidewire 4 in the blood vessel.

[0052] The magnetic drive source 2 is made of magnetic material and can generate a magnetic field in the working space, which can be called a 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 posture change. Specifically, the orientation of the distal end 401 of the guide wire 4 can be changed, and then the direction of the distal end 401 of the guide wire 4 can be changed according to the direction of the blood vessel.

[0053] The moving mechanism 1 is used to drive the change of the position of the magnetic drive source 2, so that the magnetic drive source 2 can generate a driving magnetic field 201 of a 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, and keeps 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 the positioning signal, and the positioning part 42 of the guide wire 4 is used to receive the transmitted positioning signal. After the positioning part 42 of the guide wire 4 receives the positioning signal, the positioning signal can be calculated by the control device to obtain the position and posture of the positioning part 42.

[0055] The propulsion device 5 is used to propel the guide wire 4 forward, and the contact position between the propulsion device 5 and the guide wire 4 is located at the proximal end of the guide wire 4. The magnetic drive source 2 changes the direction of the magnetic drive portion 43 through its driving magnetic field 201, and the propulsion device 5 gradually pushes the guide wire 4 into the target blood vessel when the advancing direction of the guide wire 4 is correct.

[0056] The control device is communicatively connected with the propulsion device 5, the mobile mechanism 1, the positioning signal transmitter 3, and the guide wire positioning part 42. The control device has the ability to receive data, send data, store and calculate data. The control device may include a host computer and a slave computer. The control device may be a structure such as a motherboard installed in a computer. The control device is at least electrically connected to the propulsion device 5, the mobile mechanism 1 and 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 surgery, the distal end 401 of the guide wire 4 is first extended into the blood vessel, and the guide wire 4 needs to be gradually pushed forward along the direction of the blood vessel. The positioning signal transmitter 3 transmits a positioning signal, and the positioning part 42 inside the blood vessel receives the positioning signal, and the position and posture of the positioning part 42 are obtained by inverse analysis based on the positioning signal. According to the position and posture of the positioning part 42 and the preoperative CT vascular 3D road map, the magnetic drive part 43 can be controlled by the magnetic drive source 2 under the simulated endoscope perspective, so that the direction of the distal end 401 of the guide wire 4 is always consistent with the direction of the blood vessel, and the difficulty of the operation is greatly reduced.

[0058] The magnetic guide wire control system in the above embodiments includes a guide wire 4, a propulsion device 5, a magnetic drive source 2, a moving mechanism 1, and a positioning signal transmitter 3. By arranging a positioning part 42 in the guide wire 4 to receive the signal emitted by the positioning signal transmitter 3 and inversely solve the signal to obtain the position and attitude of the guide wire 4, the moving mechanism 1 can drive the magnetic drive source 2 to move. By arranging a magnetic drive part 43 in the guide wire 4, the movement of the magnetic drive source 2 can drive the guide wire 4 to turn in the blood vessel, and the propulsion device 5 can make the guide wire 4 advance in the blood vessel. During the implementation of the vascular intervention surgery, after obtaining the position and attitude of the distal end 401 of the guide wire 4 according to the positioning signal transmitter 3 and the positioning part 42 and combining with the preoperative CT angiography 3D roadmap, three-dimensional roaming display can be performed. Under the perspective of the virtual endoscope, the magnetic drive part 43 at the end of the guide wire 4 is turned and controlled by the magnetic drive source 2, reducing the surgical difficulty and improving the surgical efficiency. Moreover, there is no need to use DSA imaging, and the patient does not need to bear X-Ray radiation.

[0059] When performing a vascular intervention surgery using the magnetic guide wire control system provided by the present invention, the positioning signal emitted by the positioning signal transmitter 3 is received by the positioning part 42 and transmitted to the control device. The control device calculates the position and attitude of the positioning part 42 through positioning algorithms such as six degrees of freedom and five degrees of freedom, and combines with the preoperative CT angiography 3D roadmap to obtain the subsequent turning of the guide wire 4 and the displacement required for the guide wire 4 to advance. Then, the turning signal and the displacement signal are respectively sent to the moving mechanism 1 and the propulsion device 5. The moving mechanism 1 moves the magnetic drive source 2 to the corresponding position to turn the distal end 401 of the guide wire 4, and the propulsion device 5 advances the guide wire 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 also includes a remote control module. The remote control module is communicatively connected to the storage and processing module and can transmit an execution signal 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 make them perform related operations. The setting of the remote control module enables the doctor to remotely operate and control the moving mechanism 1, the propulsion device 5, the magnetic drive source 2, etc., thereby realizing the movement of the guide wire 4. The remote control module includes signal input devices such as a handle, a keyboard, and a mouse.

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

[0062] In some embodiments, the propulsion device 5 includes a friction wheel thruster, which includes two friction wheels arranged at intervals. Both of the two friction wheels can rotate, and the rotation directions of the two friction wheels are opposite and the rotation speeds are the same. 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 to move forward or backward by the frictional force.

[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 the magnetic drive source 2 and the positioning signal transmitter 3 can move synchronously under the action of the moving mechanism 1. Since the magnetic drive source 2 and the positioning signal transmitter 3 are fixedly connected, the position and attitude between the magnetic drive source 2 and the positioning signal transmitter 3 always remain the same. The coordinate systems between the two only need to be registered once at the factory. During the vascular intervention surgery, the relative position between the coordinate systems of the two always remains unchanged. Moreover, when the magnetic drive source 2 drives the distal end 401 of the guide wire 4 to turn, the magnetic drive source 2 needs to be close to the distal end 401 of the guide wire 4, thereby driving the positioning signal transmitter 3 close to the positioning portion 42 of the guide wire 4, so that the positioning performance is optimized, that is, the positioning signal transmitter 3 is always in a better working space, solving the problem of the small working range of the fixed magnetic positioning system. In the fixed magnetic positioning system, the position of the positioning signal transmitter 3 is relatively fixed and cannot move with the movement of the guide wire 4, resulting in a fixed working range and a 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 bonding. Alternatively, the magnetic drive source 2 and the positioning signal transmitter 3 are fixed to each other by pressing. Alternatively, the magnetic drive source 2 and the positioning signal transmitter 3 are fixedly connected to each other by fixing members such as threaded members.

[0065] In some embodiments, the positioning signal transmitter 3 includes a plurality of transmitting coils, and the transmitting coils are fixed outside the magnetic drive source 2. The positioning signal transmitter 3 can be a magnetic field emission source, capable of emitting electromagnetic waves to generate a positioning magnetic field 301, which is realized by multiple groups of transmitting coils. The magnetic drive source 2 is generally an integral structure, and the transmitting coils are fixed outside the magnetic drive source 2, which is convenient for the assembly of the positioning signal transmitter and the magnetic drive source 2.

[0066] In some embodiments, the number of transmitting coils is three groups, five groups, eight groups, etc., and the number is not limited here. The axial directions of the respective transmitting coils are different, and the set positions are different. During positioning, each group of transmitting coils can be turned on with a pulsed square wave current in a time-sharing manner, or a sine wave current of different frequencies can be continuously turned on. The positioning unit 42 performs inverse solution based on the received signal, and thus six-degree-of-freedom or five-degree-of-freedom positioning can be performed. Among them, the movements of each degree of freedom (movements in three orthogonal directions and rotational movements in three orthogonal directions) of the positioning unit 42 can all be detected and tracked, and can be used to determine the position and attitude of the robot actuator and sensor. In the present invention, precise positioning and navigation of the distal end 401 of the guide wire 4 are achieved through measurement and modeling. Five-degree-of-freedom positioning is substantially the same as six-degree-of-freedom positioning, and will not be elaborated here.

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

[0068] In some embodiments, the outside of the magnetic drive source 2 is wrapped with a drive housing 21. The drive housing 21 can be a non-metallic housing. The positioning signal transmitter 3 is fixed on the non-metallic housing. The non-metallic housing will not shield the electromagnetic wave emitted by the magnetic drive source 2, which is suitable for this embodiment. Specifically, the positioning signal transmitter 3 can be fixed on the outer wall or the inner wall of the non-metallic housing.

[0069] In some embodiments of the present invention, please refer to Figure 2 , the magnetic drive source 2 is spherical. The transmitting coils are wound around the outer periphery of the magnetic drive source 2, and the centers of the transmitting coils coincide with the center of the sphere of the magnetic drive source 2. When the transmitting coils are wound around the outer periphery of the magnetic drive source 2 and the magnetic drive source 2 is spherical, the transmitting coils are also in a circular ring shape. When the centers of the transmitting coils coincide with the center of the sphere of the magnetic drive source 2, it is convenient for modeling, and when performing positioning inverse solution, the inverse solution algorithm can be simplified. In other embodiments, the transmitting coils can also be in other shapes such as square. In other embodiments, the magnetic drive source 2 can also be in structures such as a cube shape or a flat shape, and the specific shape of the magnetic drive source 2 is not limited here. In other embodiments, the centers of the transmitting coils can not coincide with the center of the sphere of the magnetic drive source 2.

[0070] The number of transmitting coils is multiple, and the positions of the respective transmitting coils are different. For example, when the number of transmitting coils is three, the three transmitting coils are arranged orthogonally to each other on the outer periphery of the magnetic drive source 2.

[0071] In some embodiments of the present invention, please refer to Figure 3, the magnetic drive source 2 is spherical, the transmitting coil is a disc-shaped coil distributed outside the magnetic drive source 2, and the central axis of the transmitting coil passes through the center of the sphere of the magnetic drive source 2. In this embodiment, the center of the transmitting coil is located outside the magnetic drive source 2, and the transmitting coil is disc-shaped, which is convenient to fix it outside the magnetic drive source 2. It should be noted that the transmitting coil is not necessarily an absolute planar shape. The transmitting coil can be attached to the surface of the magnetic drive source 2, and the side of the transmitting coil facing the magnetic drive source 2 is a partial spherical surface, that is, spherical. The central axis of the transmitting coil passes through the center of the sphere of the magnetic drive source 2, which can facilitate modeling, so that when performing positioning inverse solution, the inverse solution algorithm can be simplified.

[0072] The number of transmitting coils is multiple, and the multiple transmitting coils are uniformly 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 refers to a magnet that can retain a relatively high residual magnetism 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 refers to a magnet that can generate a magnetic field in the energized state and the magnetic field disappears in the de-energized state. When the magnetic drive source 2 is an electromagnet, its magnetic field strength and magnetic field direction can be adjusted, so that the magnetic drive part 43 can be controlled more conveniently.

[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 moving devices, so that the magnetic drive source 2 can change its position and attitude. 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 three directions of the x-axis, y-axis, and z-axis, as well as the rotation in the three directions of the x-axis, y-axis, and z-axis.

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

[0077] In some embodiments of the present invention, please refer to Figure 4 , the guide wire 4 includes a main body part 41, a positioning part 42 and a magnetic drive part 43, and the length directions of the main body part 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 part 41 is the main structure of the guide wire 4. One end of the main body part 41 is located outside the human body, and this end is the proximal end of the guide wire 4. The other end of the main body part 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 to jointly form the distal end 401 of the guide wire 4.

[0079] The positioning part 42 is the positioning portion of the guide wire 4, which cooperates with the positioning signal transmitter 3 for positioning.

[0080] The magnetic drive part 43 can be affected by the magnetic drive source 2 and change its direction. The magnetic drive part 43 at least includes magnetic substances that can be affected by the driving magnetic field 201. Specifically, after the magnetic drive part 43 is magnetized, it has a permanent magnetism. Under an external magnetic field, it will be affected by the torque of the magnetic field, and thus tend to bend and change its direction along the direction of the external magnetic field.

[0081] In some embodiments, the main body part 41, the positioning part 42, and the magnetic drive part 43 are connected in sequence. The magnetic drive part 43 is located at the front end of the guide wire 4 and is directly connected to the positioning part 42, which can improve the steering ability of the guide wire 4. However, in this way, there is no direct method to position the actual pose of the magnetic drive part 43. However, the length of the magnetic drive part 43 is usually short, not exceeding 10 mm, and it tends to move along the direction of the external magnetic field. Therefore, its position and attitude can be estimated based on the pose 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 part 41, the magnetic drive part 43, and the positioning part 42 are connected in sequence. The positioning part 42 is located at the front end of the guide wire 4. The positioning part 42 is both the positioning area and the steering area of the guide wire 4, and can directly position the front end of the guide wire 4. However, the positioning part 42 generally has a relatively high stiffness, and its steering 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 iron core 422. The receiving coil 421 is used to receive the positioning signal emitted by the transmitting coil, and the receiving coil 421 is arranged on the outer periphery of the soft iron core 422. Due to the presence of the rigid soft iron core 422, under the influence of an external magnetic field, the positioning part 42 will be affected by the magnetic force and thus deflect to a certain extent, playing a certain auxiliary role in steering the distal end 401 of the guide wire 4.

[0084] In some embodiments of the present invention, the positioning part 42 includes a receiving coil 421 and a soft iron core 422, which can collect the change in magnetic flux (magnetic field change) in a single-axis direction, so as to perform five-degree-of-freedom pose calculation (lacking the angle information of 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 micro-sized (side length less than 1 mm, even less than 0.5 mm) magnetic sensors is continuously improving. Many of these magnetic sensors have the characteristics of a large measurement range, high precision, and high response speed, and are suitable for use in the present invention.

[0086] The magnetic sensor has the following advantages:

[0087] First, the magnetic sensor is a three-axis sensor. Compared with a single-axis receiving coil, such a magnetic sensor can sense magnetic fields in three orthogonal directions in a limited space, thereby reducing the requirement for the number of transmitting coils. Only three sets of transmitting coils are needed (instead of eight sets of transmitting coils).

[0088] Second, it has a higher integration level. Current commercial magnetic sensors can directly output digital signals, thus reducing the complexity of backend 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, and the interference with the steering of the magnetic drive unit 43 is smaller (the diameter of the sensor formed by the existing receiving coil is <0.5 mm, but the length is usually ≥10 mm; while the width of the magnetic sensor is about 1 mm, and including the circuit board, the length is <5 mm).

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

[0091] In some embodiments of the present invention, refer to Figure 6 , the outer periphery of the positioning part 42 is wrapped with a wrapping layer 423. The wrapping layer 423 is wrapped around the receiving coil 421 or the magnetic sensor. One is to protect the internal structure of the positioning part 42, and the other is to connect with the outer layers of the main body part 41 and the magnetic drive unit 43 through the wrapping layer 423. Specifically, when processing the guide wire 4, a high-temperature melting welding method can be used to achieve stable connection of the main body part 41, the positioning part 42, and the magnetic drive unit 43.

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

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

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

[0095] In some embodiments, the substrate 432 can be made of at least one of PDMS, Ecoflex, and TPU. In this embodiment, the substrate 432 has a certain flexibility, which can make the bending and turning of the magnetic drive part 43 easier. At the same time, it is also less likely to damage blood vessels.

[0096] The magnetic particles 431 are arranged inside the substrate 432. The magnetic particles 431 can be affected by the external magnetic field force acting on them, causing the entire magnetic drive part 43 to bend and turn.

[0097] In some embodiments, the magnetic particles 431 include NdFeB magnetic powder. After the magnetic particles 431 are magnetized, the magnetic drive part 43 has a permanent magnetism and will be affected by the magnetic torque under an external magnetic field, so it tends 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 part 41 includes a transmission line 412 arranged side by side and a reinforcing wire 411 for increasing the strength of the main body part 41. The transmission line 412 is electrically connected to the positioning part 42, so that the main body part 41 provides a certain structural strength and transmission channel for the guide wire 4.

[0099] Both the reinforcing wire 411 and the transmission line 412 are arranged linearly and extend along the length direction of the main body part 41, so that the reinforcing wire 411 and the transmission line 412 are arranged side by side. The reinforcing wire 411 is used to increase the structural strength of the main body part 41, so that the guide wire 4 can be deformed to a certain extent and will not be too soft to block in the blood vessel. The reinforcing wire 411 can be a metal wire, such as a nitinol 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 guide wire 4 and can be connected to the control device.

[0100] In some embodiments, the main body part 41 is provided with an outer surface layer 413, and both the reinforcing wire 411 and the transmission line 412 are arranged inside the outer surface layer 413. The outer surface layer 413 can 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 part 43, the wrapping layer 423 of the positioning part 42, and the outer surface layer 413 of the main body part 41 can all be polymer layers, which facilitates the mutual connection of the magnetic drive part 43, the positioning part 42, and the main body part 41. Specifically, the substrate 432 of the magnetic drive part 43, the wrapping layer 423 of the positioning part 42, and the outer surface layer 413 of the main body part 41 can be connected to each other by means of hot melt welding.

[0102] In some embodiments of the present invention, the outer surfaces of the magnetic driving part 43, the positioning part 42 and the main body part 41 all have a hydrophilic coating to ensure the super-slippery performance of the entire outer surface of the guide wire 4, making it easier for the guide wire 4 to be introduced deep into the blood vessel.

[0103] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A magnetic guide wire control system, characterized in that: Comprising 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 movement of the magnetic drive source (2), a positioning signal transmitter (3) for transmitting a positioning signal, and a control device, the guide wire (4) comprising a positioning portion (42) for receiving the positioning signal and a magnetic drive portion (43) driven by the magnetic drive source (2), the positioning portion (42) and the magnetic drive portion (43) both being provided at the distal end of the guide wire (4), and the control device being communicatively connected to the propulsion device (5), the moving mechanism (1), the positioning signal transmitter (3), and the positioning portion (42).

2. The magnetic guide wire control system according to claim 1, characterized in that: The magnetic drive source (2) and the positioning signal transmitter (3) are fixedly connected.

3. The magnetic guide wire control system according to claim 2, characterized in that: The positioning signal transmitter (3) comprises a plurality of transmitting coils, and the transmitting coils are fixed to the outside of the magnetic drive source (2).

4. The magnetic guide wire control system according to claim 3, characterized in that: The magnetic drive source (2) is spherical, the transmitting coils are wound along the outer circumference of the magnetic drive source (2), and the center of the transmitting coils coincides with the center of the sphere of the magnetic drive source (2); or, The magnetic drive source (2) is spherical, the transmitting coils are disc-shaped coils distributed outside the magnetic drive source (2), and the central axis of the disc-shaped coils passes through the center of the sphere of the magnetic drive source (2).

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

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

7. The magnetic guide wire control system according to claim 1, characterized in that: The guide wire (4) comprises a main body portion (41), the positioning portion (42), and the magnetic drive portion (43), the main body portion (41), the positioning portion (42), and the magnetic drive portion (43) being connected in sequence, or the main body portion (41), the magnetic drive portion (43), and the positioning portion (42) being connected in sequence.

8. The magnetic guide wire control system according to claim 7, characterized in that: The positioning portion (42) comprises a soft magnetic core (422) and a receiving coil (421), and the receiving coil (421) is provided on the outer circumference of the soft magnetic core (422).

9. The magnetic guide wire control system according to claim 7, characterized in that: The magnetic drive portion (43) comprises a substrate (432) and magnetic particles (431) uniformly dispersed in the substrate (432).

10. The magnetic guide wire control system according to claim 7, characterized in that: The main body portion (41) comprises transmission lines (412) arranged side by side and strengthening wires (411) for increasing the strength of the main body portion (41), and the transmission lines (412) are electrically connected to the positioning portion (42).

11. The magnetic guide wire control system according to claim 7, characterized in that: The positioning portion (42) comprises a magnetic sensor.

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