Magnetically Driven Traversing Tool for Arterial and Venous Occlusion

JP2024523174A5Inactive Publication Date: 2025-06-09KONINKLIJKE PHILIPS NV
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Patent Information

Application Number
JP2023574497
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2021-06-16
Filing Date
2022-06-03
Publication Date
2025-06-09
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

Existing catheter-based vascular therapy faces challenges in crossing complete or near-complete vascular occlusions, which can be time-consuming and risky, often leading to vessel rupture or requiring surgical intervention.

Method used

A guidewire insertion device incorporating an electromagnetic tip and a magnetic tip, controlled by a controller to modulate magnetic forces, facilitates efficient and safe crossing of vascular occlusions using reciprocating motion and magnetic interactions.

Benefits of technology

The device enables efficient and safe traversal of vascular occlusions, reducing the risk of vessel perforation and time required to cross the occlusions, allowing for subsequent vascular treatments.

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Abstract

The guidewire insertion device 10 includes a first guidewire 12 including an electromagnetic tip 14, a second guidewire 16 including a magnetic tip 18, and a controller 33 configured to modulate the force of the electromagnetic tip of the first guidewire to control the movement of the magnetic tip of the second guidewire.
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Description

[Technical field]

[0001] The following relates generally to the catheter, catheter guidewire, vascular treatment, and related arts. [Background technology]

[0002] In catheter-based vascular treatment, the catheter carries one or more tools at its distal end, such as angioplasty balloons, laser opening or cutting tools for thrombectomy or atherectomy, stents and associated stent deployment hardware. First, a guidewire is inserted into the blood vessel and fed until the guidewire crosses over the treatment area (e.g., clot, thrombus, aneurysm, etc.). A catheter has a guidewire lumen and is inserted into the blood vessel along the guidewire, moving the catheter tip to the treatment area. However, complete (or near complete) occlusions in the vasculature (e.g., artery or vein) are very difficult to cross. This may force the operator (e.g., physician or surgeon) to protrude from the main lumen of the blood vessel to bypass the occlusion. If the occlusion can be crossed, it generally takes a very long time for the guidewire to slowly push through the occlusion. In addition, the occlusion contains a material that is stronger than the vessel wall, which means that it is easy to cause a rupture in the vessel while attempting to cross the occlusion, which requires additional intervention to fix. Additionally, in some cases, the physician is completely unable to cross the blockage, which necessitates a surgical procedure for the blockage. Summary of the Invention [Problem to be solved by the invention]

[0003] The following discloses specific improvements that overcome these and other problems. [Means for solving the problem]

[0004] In some embodiments disclosed herein, a guidewire insertion device includes a first guidewire including an electromagnetic tip, a second guidewire including a magnetic tip, and a controller configured to modulate the force of the electromagnetic tip of the first guidewire to control movement of the magnetic tip of the second guidewire.

[0005] In some embodiments disclosed herein, a guidewire insertion device includes a guidewire including a ferromagnetic element disposed on or within a tip of the guidewire and an electromagnet disposed on or within the tip of the guidewire, and a controller configured to modulate power applied to the electromagnet to generate reciprocating motion of the tip of the guidewire driven by magnetic interaction between the electromagnet and the ferromagnetic element.

[0006] In some embodiments disclosed herein, a guidewire insertion device includes a sleeve, a plurality of electromagnets mounted on the sleeve, a guidewire having a ferromagnetic tip, and a controller configured to modulate the force of the electromagnets to control movement of the ferromagnetic tip.

[0007] One advantage resides in providing a guidewire insertion device and corresponding method of guidewire insertion that provides efficient and safe guidewire crossing of a vascular occlusion.

[0008] Another advantage resides in providing such a guidewire insertion device and corresponding guidewire insertion method, which further includes a second guidewire that magnetically engages the first guidewire to assist in maneuvering the first guidewire to cross the vascular occlusion.

[0009] Another advantage resides in providing an electromagnet at the tip of the guidewire to cross the vascular occlusion.

[0010] Another advantage resides in providing a guidewire that has an electromagnet to ensure that the guidewire does not perforate the wall of the blood vessel.

[0011] Another advantage resides in providing a guidewire with an electromagnet to provide additional force at the end of the guidewire.

[0012] Another advantage resides in providing a guidewire having an electromagnet to reduce the time required to cross an occlusion in a blood vessel.

[0013] A given embodiment may provide none, one, two, more, or all of the aforementioned advantages, and / or other advantages that will become apparent to those of ordinary skill in the art upon reading and understanding this disclosure.

[0014] The disclosure may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating preferred embodiments and are not to be construed as limiting the disclosure. [Brief description of the drawings]

[0015] [Figure 1] 1 illustrates a schematic diagram of a guidewire insertion device according to the present disclosure. [Diagram 2] 2 shows a schematic diagram of a guidewire insertion method suitably performed using the device of FIG. 1; [Diagram 3] 13A and 13B illustrate diagrammatically a guidewire insertion device according to another embodiment; [Figure 4] 13A and 13B illustrate diagrammatically a guidewire insertion device according to another embodiment; [Diagram 5] 13A and 13B illustrate diagrammatically a guidewire insertion device according to another embodiment; [Figure 6] 13A and 13B illustrate diagrammatically a guidewire insertion device according to another embodiment; [Figure 7] 13A and 13B illustrate diagrammatically a guidewire insertion device according to another embodiment; DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0016] The following disclose various approaches to incorporating an electromagnet at the tip of a guidewire to facilitate traversal of the guidewire through a complete vascular occlusion.

[0017] In some embodiments disclosed herein, two guidewires are used to approach the occlusion from both sides. One guidewire has an electromagnet at its tip, and the other guidewire has a ferromagnetic tip or a permanent magnet at its tip, or has another electromagnet. The electromagnet can be energized to attract the tip of the other guidewire towards the electromagnet. Advantageously, the electromagnet can be cycled to modulate this attractive force, which can guide the tip, thereby assisting the surgeon in pushing the tip of the other guidewire without perforating the vessel wall. If the other guidewire has a permanent magnet or a second electromagnet at its tip, the force between the two guidewire tips can be modulated between attractive and repulsive, causing the tip of the other catheter to chip away at the occlusion, similar to the action of a jackhammer. If the other guidewire has a non-magnetized ferromagnetic tip, this approach can still be used to modulate the attractive force, but in this case, repulsive forces are not achievable.

[0018] In other embodiments disclosed herein, the guidewire with electromagnet may further include an expandable cone or funnel. The guidewire includes a deployment sheath that is pulled back to release the cone or funnel. In one approach, the cone or funnel is made of a self-expanding metal, such as Nitinol, and therefore automatically expands when the deployment sheath is pulled back. In another approach, the cone or funnel includes ferromagnetic strips that are magnetized by an electromagnet and repel each other to open the funnel or cone. The purpose of the funnel or cone is to center the electromagnet in the vessel lumen, so that the electromagnet provides a center of attraction for the other guidewire tip. A symmetrical cone or funnel facilitates this centering effect. In one possible variant embodiment, when the other guidewire breaks through the occlusion, it can contact the electromagnet, so that when the deployment sheath is pushed forward, it captures the tip of the other guidewire to form a continuous wire.

[0019] In some embodiments disclosed herein, the guidewire has an array of electromagnetic coils, e.g., three coils radially spaced at 120° intervals. The surgeon can selectively manipulate the three coils (for example) to direct the movement of the other guidewire tip. In another mode of operation, when the coils are cycled in polarity, a rotational motive force can be generated to rotate the other guidewire tip, which can facilitate moving through the occlusion.

[0020] The previously described embodiments use two guidewires to approach the occlusion from opposite sides. The following also discloses an embodiment suitable for use where only a single guidewire is used.

[0021] In one such embodiment, the guidewire has a permanent magnet fixed to its tip, while the electromagnet is loosely fitted inside the guidewire. By cycling the polarity of the electromagnet, the tip can be reciprocated back and forth, again providing a jackhammer type effect to facilitate pushing the tip through the occlusion. In this embodiment, the electromagnet may be mounted on a relatively stiff inner wire surrounded by an outer sheath to which the permanent magnet is attached, so that the electromagnet remains relatively stationary. An alternative embodiment places permanent magnets on either side of the electromagnet connected by a non-magnetic shaft to provide a more balanced reciprocating motion of the assembly.

[0022] In yet another embodiment, suitable for use in treating peripheral limb (arm or leg) occlusions, the guidewire includes a ferromagnetic tip and an array of electromagnets is mounted on a sleeve that is fitted externally over the limb. By exciting selected electromagnets of the external surrounding array, the direction of travel of the guidewire tip can be biased.

[0023] Guidewire insertion is typically performed under image guidance (e.g., fluoroscopy) with the tip of the guidewire marked with a radiopaque marker so that the surgeon can visually observe the various movements of the tip. After the guidewire has crossed the occlusion, a catheter carrying a tool at its distal end (e.g., angioplasty balloon, laser opening or cutting tools for thrombectomy or atherectomy, stents and associated stent deployment hardware, etc.) can be delivered over the guidewire to remodel, continue to remove, stent, or otherwise treat the occlusion.

[0024] Referring to FIG. 1, an exemplary guidewire insertion device 10 is shown in schematic form. As shown in FIG. 1, the guidewire insertion device 10 is positioned adjacent to an occlusion O in a blood vessel V of a patient. The guidewire insertion device 10, more specifically, includes a first guidewire 12 having an electromagnetic tip 14 and a second guidewire 16 including a magnetic tip 18. The magnetic tip 18 of the second guidewire 16 can include an electromagnet, a permanent magnet, a ferromagnetic element, or any other suitable magnet. Specifically, the exemplary magnetic tip 16 includes a permanent magnet 18 oriented such that magnetic flux emanating from a north pole of the magnet 18 exits the tip of the second guidewire 18. The electromagnetic tip 14 of the first guidewire 12 includes at least one electromagnet 20 (i.e., formed as a solenoid with five exemplary coils (also called turns)), and more typically includes more turns, as the magnetic field of the electromagnet corresponds to the number of turns. Optionally, the electromagnet 20 may include a ferromagnetic core (not shown) to increase the strength of the magnetic field. The electromagnet 20 is oriented to generate magnetic flux lines that exit or enter the tip of the first guidewire 12. As shown in FIG. 1, the first guidewire 12 is positioned on a first (i.e., "right") side of the occlusion O, and the second guidewire 16 is positioned on a second (i.e., "left") side of the occlusion O. In the illustrative example, the second guidewire 16 has a conical tip to aid in penetrating and crossing the occlusion O. Thus, in the illustrative example, it is the catheter tip with the permanent magnet 18 (or in an alternative embodiment, with a ferromagnetic element at its tip) that is expected to cross the occlusion O by moving to the right (in the example of FIG. 1) through the occlusion O to cross the occlusion O. In other embodiments, it is contemplated that a catheter with an electromagnet is the one that is expected to cross the occlusion.

[0025] The guidewire insertion device 10 also includes a controller 22 (e.g., a processor shown diagrammatically in FIG. 1 as a box) in communication with the first guidewire 12, particularly with the electromagnet 20 of the electromagnetic tip 14. As shown in FIG. 1, the controller 22 is connected to the electromagnet 20 via a negative wire 24 and a positive wire 26. The controller 22 is configured to modulate the magnetic force generated by the electromagnet 20 of the electromagnet tip 14 to control the movement of the magnetic tip 18 of the second guidewire 16 (e.g., by supplying a current to the electromagnet 20). That is, the electromagnetic tip 14, upon exerting a magnetic force, can attract the magnetic tip 18 of the second guidewire 16 and thus control the movement of the second guidewire 16. The controller 22 is optionally configured to modulate the magnetic force of the electromagnetic tip 14 of the first guidewire 12 between an attractive force and a repulsive force to control the movement of the magnetic tip 18 of the second guidewire 16. The magnetic tip 18 can be controlled by a "back and forth motion" produced by modulating the magnetic field produced by the electromagnet 20 to break up the occlusion O with a "jackhammer type" back and forth motion. Since the second guidewire 16 has a permanent magnet 18 at its tip, the magnetic field produced by the electromagnet 20, which oscillates between "N-S" and "SN" by the zero crossings of the drive current, can induce alternating attractive and repulsive forces in the permanent magnet 18 for this purpose. If the permanent magnet 18 is replaced by a non-magnetized ferromagnetic slug, the oscillating magnetic field produced by the electromagnet 20 can induce oscillations in the attractive force applied to the slug, but cannot induce repulsive forces. Nevertheless, such oscillations in attractive force can still aid in breaking up the occlusion O.

[0026] In some embodiments, one or more radiopaque markers 28 may be attached to the first guidewire 12 and / or the second guidewire 16. Advantageously, this may allow the first guidewire 12 and the second guidewire 16 (particularly the electromagnetic tip 14 and the magnetic tip 18) to be visible under fluoroscopic imaging, thereby allowing a user (e.g., a physician, surgeon, or another operator) to visualize the electromagnetic tip 14 and the magnetic tip 18 relative to the occlusion O.

[0027] Continuing with reference to Figure 1, Figure 2 illustrates an exemplary embodiment of a vascular treatment method 30, shown generally as a flow chart. In act 32, a first guidewire 12 is on a first side of an occlusion O in a target tissue (i.e., blood vessel V). In act 34, a second guidewire 16 is positioned on an opposite, second side of the occlusion O. Acts 32, 34 can be reversed in time or performed simultaneously.

[0028] In operation 36, with the tips of the two catheters 12, 16 on either side of the occlusion O, optionally as viewed under fluoroscopic imaging, the controller 22 is operated to modulate the force of the electromagnetic tip 14 of the first guidewire 12 to control the movement of the magnetic tip 18 of the second guidewire 16. In one example, the controller 22 can be operated to selectively retract the magnetic tip 18 of the second guidewire 16 towards the electromagnetic tip 14 of the first guidewire 12. In another example, the controller 22 can be operated to cycle the force of the electromagnetic tip 14 between repulsive and attractive forces to drive a reciprocating motion (i.e., a jackhammer motion) of the magnetic tip 18 of the second guidewire 16.

[0029] In operation 37, it is detected that the occlusion has been crossed, for example as observed in fluoroscopic imaging and / or as a sudden decrease in resistance to further insertion of the guidewire 16 is recognized. In another embodiment, the crossing may be detected via a sensor (not shown) on the tip of one of the guidewires 12, 16. For example, upon crossing of the occlusion O, if the electromagnet 20 is set to attract the magnet 18 of the other guidewire 16, the two catheter tips may come into direct contact, so that a contact sensor on one or the other of the catheter tips can detect the contact. In another approach, a magnetic sensor on one or the other of the catheter tips can be used to detect the proximity of the magnet 18 of the second guidewire 16 to the electromagnetic tip 14 of the first guidewire 12. Once the crossing is detected, operation 37 further includes completing the insertion of the guidewire 16. For example, it is often desirable to insert the guidewire a certain distance (e.g., a centimeter or a few centimeters) beyond the treatment site (which is likely to be the occlusion O). In some instances, the physician creates two access points in the blood vessel V, one for the first guidewire 12 and one for the second guidewire 16. After crossing the occlusion O, one of the guidewires 12, 16 is removed from one of the access points and the other guidewire 12, 16 exits through the blood vessel V at the same access site. This gives the physician maximum support for any desired type of catheter to load onto the guidewires 12, 16 for treatment.

[0030] Once guidewire insertion is complete, the vascular treatment can then be performed in operation 38 by inserting a catheter having a tool (e.g., angioplasty balloon, laser opening or cutting tool, stent and associated stent deployment hardware, etc.) along the guidewire and using the tool to perform the vascular treatment.

[0031] FIG. 3 illustrates another embodiment of the device 10. The embodiment of FIG. 3 includes most of the components of the embodiment of FIG. 1. In particular, the second guidewire 16 is unchanged in the embodiment of FIG. 3 and is therefore not illustrated. The first guidewire 12 of the embodiment of FIG. 3 again includes an electromagnet 20 and a controller 22 connected to the electromagnet 20 by wires 24, 26. As shown in FIG. 3, the first guidewire 12 includes an expandable member 40 (e.g., having a cone shape, funnel, etc.) disposed around the electromagnetic tip 14. The expandable member 40 is configured to align the electromagnetic tip 14 with the center of the blood vessel V. This provides a centering location for the electromagnet 20, thereby centering the magnetic tip 18 of the second guidewire 16 (the second guidewire 16 is not shown in FIG. 3 for clarity and brevity) so that it is drawn toward the centered electromagnet 20. The expandable member 40 can be a self-expanding member. For example, the expandable member 40 can have Nitinol to self-expand. The deployment sheath 42 is configured to surround the first guidewire 12 and retain the expandable member 40 and subsequently release it when the first guidewire 12 is positioned adjacent the occlusion O. In another approach to providing self-expansion of the expandable member 40, the expandable member 40 includes a plurality of ferromagnetic elements 44 (three of which are shown in FIG. 3 ) that are magnetized by the electromagnetic tip 14 of the first guidewire 12 to cause the ferromagnetic elements 44 to repel each other to expand the expandable member 40. The expandable member 40 has a magnetic field that tapers as the expandable member approaches the electromagnet 20, thus providing effective centering for the magnetic tip 18 of the other guidewire 16 as it is drawn toward the electromagnet 20. In another contemplated variation (not shown), the expandable member 40 may be replaced by an inflatable balloon (not shown) similar to an angioplasty balloon, but inflated to just a low enough pressure to center the electromagnet 20 within the blood vessel V.

[0032] FIG. 4 illustrates an alternative embodiment of the guidewire 20, i.e., a modified guidewire 52 disposed on one side of an occlusion O in a blood vessel V opposite another guidewire 16 (not shown in FIG. 4). As shown in FIG. 4, the guidewire 52 includes multiple electromagnets 54 (e.g., three electromagnets 54 shown in FIG. 4) disposed radially around the tip 56 of the guidewire 52. Each electromagnet 54 is connected to the controller 22 via a corresponding negative pole wire 24 and positive pole wire 26. Each electromagnet 54 is independently operable by the controller 22. This design allows the attraction of the magnet 18 of the other guidewire 16 to be steered by selectively energizing or de-energizing the various electromagnets 54. For example, if the tip of the other guidewire 16 is pointing to the left, the electromagnet located to the left is turned off and the electromagnet located to the right is turned on, attracting the magnet 18 and thus the tip of the guidewire 16 to the right and re-centering it. In another example, if the tip of the other guidewire 16 is pointing to the left, the electromagnet located on the left is turned on to repel the top of the guidewire 16 and the electromagnet located on the right is turned off (or vice versa).

[0033] The exemplary guidewire insertion device of Figures 1, 3, and 4 utilizes two guidewires 12, 16 (or two guidewires 52, 16 in the example of Figure 4) to magnetically assist traversal of the guidewire 16 through the occlusion O. In the next embodiment, described with reference to Figures 5, 6, and 7, the guidewire insertion device includes only a single guidewire.

[0034] 5, the guidewire tip 54 includes a ferromagnetic element 58 and an electromagnet 60. For example, the ferromagnetic element 58 is a permanent (i.e., steady-state) magnet, although a non-magnetized ferromagnetic slug is alternatively contemplated. The ferromagnetic element 58 is fixed to a sheath 62, and the electromagnet 60 is disposed inside the sheath 62, but is not fixed to the sheath 62 (it will be understood that the opposite configuration can be implemented, in which the ferromagnetic element 58 is not fixed to the sheath 62, and the electromagnet 60 is fixed to the sheath 62). Also, a spring 64 is connected to the end of the sheath 62. The spring 64 allows for movement of the ferromagnetic element 58 relative to the remainder of the guidewire.

[0035] The controller 22 (not shown in FIG. 5 ) is configured to modulate the power applied to the electromagnet 60 to generate a reciprocating motion of the guidewire tip 54 driven by the magnetic interaction between the electromagnet 60 and the ferromagnetic element 58. The controller 22 supplies current to the electromagnet 60 to draw the ferromagnetic element 58 inward (i.e., away from the occlusion O) and compress the spring 64. Turning off the current releases the attractive force of the ferromagnetic element 58, and the spring 64 then pushes the ferromagnetic element 58 outward (i.e., toward the occlusion O). Thus, pulsing current through the electromagnet 60 causes the guidewire tip 54 to move back and forth at a frequency equal to the frequency of the pulsing current. This oscillating motion can be used to “chip through” the occlusion O. Note that in this embodiment, there is only one guidewire.

[0036] Referring to Figure 6, another embodiment of the guidewire tip 54 is shown. As shown in Figure 6, the ferromagnetic element 58 includes a first permanent magnet 66 and a second permanent magnet 68, and the electromagnet 60 is disposed between the first permanent magnet 66 and the second permanent magnet 68. The two permanent magnets 66, 68 are disposed to have the same magnetic pole facing the electromagnet 60. In the illustrative example, the north pole of each magnet 66, 68 faces the electromagnet 20, however, alternatively, the south pole of each magnet can be disposed to face the electromagnet 20. The wires 24, 26 are embedded in the wall of the sheath 62 (thereby fixing the position of the electromagnet 60 relative to the sheath 62), while the electromagnet 60, the first magnet 66, and the second magnet 68 are "free floating" within the sheath 62, but are constrained by physical interference with the electromagnet 60. A non-magnetic shaft 70 is also disposed inside the sheath 62 and connects the two magnets 66, 68, and the windings of the electromagnet 20 are disposed around but not touching the shaft 70. The first permanent magnet 66 is disposed at a first end of the non-magnetic shaft 70 (e.g., the side adjacent the occlusion O as shown in FIG. 4) and the second permanent magnet 68 is disposed at an opposite second end (e.g., within the sheath 62). The electromagnet 60 is disposed between the first permanent magnet 66 and the second permanent magnet 68. In operation, the electromagnet 60 generates a N|S orientation under the control of the controller 22 (not shown in FIG. 6), so that the first magnet 66 is repelled from the opposing N pole of the electromagnet 20, while the second magnet 68 is simultaneously attracted to the opposing S pole of the electromagnet 20. This urges the assembly including the magnets 66, 68 connected by the shaft 70 forward, i.e., toward the occlusion. When the controller 22 reverses the polarity of the electromagnet 60 to S|N polarity, the first magnet 66 is attracted to the opposing S pole of the electromagnet 20 and the second magnet 68 is simultaneously repelled from the opposing N pole of the electromagnet 20. This urges the assembly including the magnets 66, 68 connected by the shaft 70 backwards, i.e., away from the occlusion.By cycling the electromagnet 60 between the N|S and S|N orientations using the controller 22, the assembly including the magnets 66, 68 connected by the shaft 70 is reciprocated back and forth, providing a "jack-hammer" action that aids in crossing the occlusion.

[0037] FIG. 7 illustrates another guidewire insertion device 80. As shown in FIG. 7, the device 80 includes a guidewire 82 that is inserted into a blood vessel of a patient's limb (an exemplary leg) 84, and an external sleeve or cuff 86 configured to attach to and surround the outside of the patient's limb 84 (e.g., an arm or exemplary leg). The tip of the guidewire 82 includes a ferromagnetic slug 88, and the sleeve or cuff 86 is disposed on the outside of the limb 84 around the tip of the guidewire 82. A plurality of electromagnets 90 are attached to the sleeve 86. A controller 92 independently operates the electromagnets 90 to apply a magnetic force to the magnetic slug 88. As shown in section AA of FIG. 7, by energizing selected electromagnets 90 of the surrounding array, the direction of movement of the ferromagnetic slug 88, and thus the tip of the guidewire 82, can be biased toward the energized electromagnet. Back and forth vibration of magnetic slug 88 (and thus the tip of guidewire 82) can also be induced, optionally, by switching a powered electromagnet back and forth. In some examples, depending on the number of electromagnets 90 attached to sleeve 86, the tip of guidewire 82 can be moved in any direction in three-dimensional (3D) space.

[0038] The present disclosure has been described with reference to the preferred embodiment. Modifications and alterations may occur to others upon reading and understanding the preceding detailed description. It is intended that the exemplary embodiments be construed as including all such modifications and alterations insofar as they come within the scope of the appended claims or the equivalents thereof.

Claims

1. A first guide wire including an electromagnetic tip, A second guide wire including a magnetic tip, A controller configured to modulate the force of the electromagnetic tip of the first guide wire to control the movement of the magnetic tip of the second guide wire, A guide wire insertion device having the above.

2. The controller according to claim 1, wherein the controller is configured to modulate the force of the electromagnetic tip of the first guide wire between an attractive force and a repulsive force to control the movement of the magnetic tip of the second guide wire.

3. The guide wire insertion device according to claim 1, wherein the magnetic tip of the second guide wire has one of an electromagnet, a permanent magnet, or a ferromagnetic element.

4. The guide wire insertion device according to claim 1, wherein the electromagnetic tip of the first guide wire includes at least three electromagnets radially spaced around the central axis of the first guide wire.

5. The guide wire insertion device according to claim 4, wherein the controller is configured to independently modulate the force applied by each respective electromagnet to manipulate the movement of the magnetic tip of the second guide wire.

6. The guide wire insertion device according to claim 1, wherein the first guide wire further includes an expandable member disposed around the electromagnetic tip and configured to align the electromagnetic tip with the magnetic tip of the second guide wire.

7. The expandable member is a self-expanding member, and the guide wire insertion device according to claim 6, wherein the first guide wire further includes a deployment sheath configured to release the self-expanding member.

8. The guide wire insertion device according to claim 6, wherein the expandable member has nitinol.

9. The expandable member includes a plurality of ferromagnetic elements, and the plurality of ferromagnetic elements are magnetized by the electromagnetic tip of the first guide wire to repel each other to expand the expandable member. The guide wire insertion device according to claim 6.

10. The guide wire insertion device according to claim 1, further including one or more radiopaque markers attached to the first guide wire and the second guide wire.

11. In a guide wire insertion method performed using the guide wire insertion device according to any one of claims 1 to 10, placing the first guide wire on a first side of an occlusion within a target tissue; placing the second guide wire on a second side opposite the occlusion; operating the controller to modulate the force of the electromagnetic tip of the first guide wire so as to control the movement of the magnetic tip of the second guide wire; A guide wire insertion method comprising:

12. The operating step is operating the controller to selectively draw the magnetic tip of the second guide wire toward the electromagnetic tip of the first guide wire; The guide wire insertion method according to claim 12, comprising:

13. The operating step is operating the controller to circulate the force of the electromagnetic tip of the first guide wire between a repulsive force and an attractive force to drive a reciprocating movement of the magnetic tip of the second guide wire, The guide wire insertion method according to claim 12, comprising:

14. A guide wire including a ferromagnetic element disposed on or in the tip of the guide wire and an electromagnet disposed on or in the tip of the guide wire, and a controller configured to modulate the power applied to the electromagnet to generate a reciprocating movement of the tip of the guide wire driven by a magnetic interaction between the electromagnet and the ferromagnetic element; A guide wire insertion device having:

15. At least the tip of the guide wire includes a sheath, One of the ferromagnetic element or the electromagnet is fixed to the sheath, The other of the ferromagnetic element or the electromagnet is not fixed to the sheath, The guide wire insertion device according to claim 14.

16. The guide wire insertion device according to claim 15, wherein the ferromagnetic element is a permanent magnet.

17. The guide wire insertion device according to claim 14, wherein at least the tip of the guide wire is hollow.

18. a non-magnetic shaft disposed inside the hollow tip of the guide wire; further comprising The ferromagnetic element includes a first permanent magnet and a second permanent magnet disposed at both ends of the non-magnetic shaft inside the hollow tip of the guide wire. The guide wire insertion device according to claim 17.

19. The electromagnet is disposed between the first and second permanent magnets, and at least one of the first and second permanent magnets is fixed to the guide wire. The guide wire insertion device according to claim 18.

20. A sleeve, A plurality of electromagnets attached to the sleeve, A guide wire having a ferromagnetic tip, A controller configured to modulate the force of the electromagnet to control the movement of the ferromagnetic tip, A guide wire insertion device having the same.