CN118873818A - A controllable guide wire and preparation method thereof - Google Patents

Abstract

The invention provides a controllable guide wire, which comprises a first wire and a second wire, wherein the first wire and the second wire are mutually insulated and lean against each other, the distal ends of the first wire and the second wire are connected together, so that a longitudinal guide wire body and a steering end which is positioned at the distal end of the guide wire body and corresponds to the distal ends of the first wire and the second wire are formed, when the first wire and the second wire respectively serve as positive and negative electrodes to form a conductive loop, the shape memory function of the distal end of the first wire is triggered to deviate from the axial direction of the first wire, the distal end of the second wire deviates together along with the distal end of the first wire to generate elastic deformation so as to control the steering end direction of the guide wire body, and when the conductive loop formed by the first wire and the second wire is powered off, the shape memory function of the distal end of the first wire disappears and is restored under the action of the elastic restoring force of the distal end of the second wire.

Description

A controllable guide wire and preparation method thereof

Technical Field

The present invention relates to the technical field of medical devices, and in particular to a controllable guide wire and a preparation method thereof.

Background Art

Currently, in manual surgeries involving the use of catheter guidewires, the operator needs to stand near the patient to operate intracavitary medical devices such as guidewires, catheters or angioplasty catheters to enter or withdraw from the patient's body with a vascular system. The guidewire head used has a certain fixed angle. Under the monitoring of digital images, the doctor pushes the guidewire a certain distance, and rotates the guidewire at the vascular branch to adapt its curved head and enter the target branch. In this process, if necessary, it is necessary to replace the guidewire with other curved shapes according to the branch bending situation, and then push the catheter to pass through the guidewire and enter the target branch. Repeat the above process until the catheter reaches the lesion, then pull the guidewire out of the patient's body, and finally push the specific medical device along the catheter that has been formed in the patient's body and reach the lesion to complete the interventional treatment. This will lead to a longer operation time, expose medical staff to more X-ray radiation, and the surgical risk is also high, which shortens the patient's effective treatment window.

Summary of the invention

Based on this, it is necessary to provide a controllable guide wire and a preparation method thereof to address the deficiencies in the prior art.

The present invention provides a controllable guidewire, which comprises a first and a second slender guidewire, wherein the first and the second guidewire are insulated from each other and close together, and the distal ends of the first and the second guidewire are connected together to form a longitudinally long guidewire body and a turning end located at the distal end of the guidewire body and corresponding to the distal ends of the first and the second guidewires. When the first and the second guidewires are used as positive and negative electrodes to form a conductive loop, respectively, the shape memory function of the distal end of the first guidewire is triggered to deviate from the axial direction of the first guidewire, and the distal end of the second guidewire deviates with the distal end of the first guidewire and undergoes elastic deformation to control the direction of the turning end of the guidewire body. When the conductive loop formed by the first and the second guidewires is powered off, the shape memory function of the distal end of the first guidewire disappears and is restored under the action of the elastic restoring force of the distal end of the second guidewire.

Preferably, a shaping point is provided near the distal end of the first guide wire so as to allow the distal end of the first guide wire to deviate from the axial direction of the first guide wire.

Preferably, the distal end of the first wire is bent between 0° and 360° relative to the axial direction of the first wire.

Preferably, the first guide wire is shaped between the shaping point and the distal end.

Preferably, a shaping point is provided near the distal end of the second guide wire to allow the distal end of the second guide wire to deviate from the axial direction of the second guide wire, and the controllable guide wire also includes an elastic wire insulatedly provided on the second guide wire and covering the shaping point.

Preferably, the distal end of the second wire is bent between 0° and 360° relative to the axial direction of the second wire.

Preferably, the second guide wire is shaped between the shaping point and the distal end.

Preferably, the turning end on the guidewire body corresponding to the distal ends of the first and second guidewires is made of shape memory alloy and is formed by shaping.

Preferably, the guidewire body is made of shape memory alloy.

Preferably, the first wire and the second wire are temperature-controlled wires.

Preferably, the elastic wire is insulated and extends to a distal end of the second conductive wire.

Preferably, the elastic wire is insulated and extends to the proximal end of the second conductive wire.

Preferably, the elastic thread has superelasticity.

Preferably, the proximal end of the first conductive wire and the proximal end of the second conductive wire respectively form wiring terminals for connecting to a power source.

The present invention also provides a method for preparing a controllable guidewire, which comprises: 1) providing a first and a second slender wire connected together, and making the first and the second wires insulated from each other and close together, so as to form a longitudinal guidewire body and a turning end located at the distal end of the guidewire body; 2) shaping the distal end of the corresponding connection on the first wire, so that when the first and the second wires are used as positive and negative electrodes to form a conductive loop respectively, the shape memory function of the distal end of the first wire is triggered to deviate from the axial direction of the first wire, and the distal end of the second wire deviates with the distal end of the first wire and undergoes elastic deformation to control the direction of the turning end of the guidewire body, and when the conductive loop formed by the first and the second wires is powered off, the shape memory function of the distal end of the first wire disappears and is restored under the action of the elastic restoring force of the distal end of the second wire.

Preferably, the first conductive wire and the second conductive wire are formed by bending the same conductive wire.

Preferably, the distal end of the first conductive wire and the distal end of the second conductive wire are welded together.

Preferably, the first conductive wire and the second conductive wire are braided together.

Preferably, the first conductive wire is shaped to form a shaping point near the distal end.

Preferably, shaping processing is performed between the shaping point and the distal end of the first guide wire.

Preferably, the first conductive wire is made of shape memory alloy.

Preferably, the second conductive wire is shaped to form a shaping point near the distal end, and the shaping point of the second conductive wire is insulated and covered with an elastic wire.

Preferably, shaping processing is performed between the shaping point and the distal end of the second guide wire.

Preferably, the second conductive wire is made of shape memory alloy.

Preferably, the shaping process is to perform plastic deformation on the shape memory alloy at a high temperature so that the shape memory alloy is in a complete austenite phase.

Preferably, glue is coated on the surfaces of the first conductive wire and the second conductive wire respectively and then cured to form an insulating layer.

Preferably, the first conductive wire and the second conductive wire that are close together are coated with glue and cured to form the guide wire body.

Preferably, glue is coated on the surface of the elastic thread and cured to form an insulating layer.

Preferably, the elastic thread is fixed to the second conductive wire by coating glue and curing the glue.

Preferably, the glue is UV glue and forms an insulating layer after being cured by ultraviolet rays.

The first and second wires of the controllable guide wire of the present invention are insulated from each other and close together. When the first and second wires are energized to form a conductive loop, the shape memory function of the distal end of the first wire is triggered to control the bending direction of the steering end to adapt to surgical needs. There is no need to replace the guide wire during the operation, which greatly saves surgical time and alleviates patient pain.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG1 is a schematic diagram of a controllable guide wire according to a first embodiment of the present invention, wherein the steering end is deflected by about 30° toward the pre-shaping direction.

FIG2 is a schematic diagram of a controllable guide wire according to the first embodiment of the present invention, wherein the steering end is deflected by about 60° toward the pre-shaping direction.

FIG3 is a schematic diagram of a controllable guide wire according to the first embodiment of the present invention, wherein the steering end is deflected by about 90° toward the pre-shaping direction.

FIG. 4 is a cross-sectional view of a controllable guide wire according to the first embodiment of the present invention.

FIG5 is a schematic diagram of a controllable guide wire according to a second embodiment of the present invention.

FIG. 6 is a schematic diagram of a guidewire body obtained by the method for preparing a controllable guidewire according to the first embodiment of the present invention.

FIG. 7 is a schematic diagram of the guide wire body in FIG. 6 after being shaped.

FIG8 is a schematic diagram of the guidewire body in FIG7 after the reshaping is restored.

FIG. 9 is a schematic diagram showing a guide wire body in FIG. 8 after an elastic wire is arranged on the guide wire body.

FIG10 is a cross-sectional view of a controllable guidewire prepared by the method for preparing a controllable guidewire according to the second embodiment of the present invention.

11 is a cross-sectional view of a controllable guidewire prepared by the method for preparing a controllable guidewire according to the third embodiment of the present invention.

FIG12 is a cross-sectional view of a controllable guidewire produced by the method for producing a controllable guidewire according to the fourth embodiment of the present invention.

13 is a cross-sectional view of a controllable guidewire produced by the method for producing a controllable guidewire according to the fifth embodiment of the present invention.

DETAILED DESCRIPTION

In order to make the purpose, technical solution and advantages of the invention more clearly understood, the invention is further described in detail below in conjunction with the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the invention and are not intended to limit the invention.

In the description of the present invention, the term "proximal end" refers to the end close to the operator, and the term "distal end" refers to the end far from the operator; the term "delivery", "push", "pull" or "advance" refers to the process of moving from a place far from the operator to a place near the operator, and the term "withdrawal" or "backward" refers to the process of moving from a place close to the operator to a place far from the operator, and the terms "horizontal", "vertical", "up", "down", "left", "right", "inside", "outside", "between", "between" and the like indicate the orientation or position relationship based on the orientation or position relationship shown in the drawings, which is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. Unless otherwise clearly specified and limited, the terms "connect", "connected", "fixed" and "installed" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, an electrical connection or a magnetic connection; it can be a direct connection, or an indirect connection through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. For those skilled in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

In addition, the terms "first", "second", etc. are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Thus, a feature defined as "first", "second", etc. may explicitly or implicitly include one or more of the feature. In the description of the present invention, "multiple" means one/time or more than one/time.

Please refer to Figures 1-4, which are controllable guidewires disclosed in the first embodiment of the present invention. For the clear display of the controllable guidewire of the present invention, although some parts are omitted in the figures, they are still important.

The controllable guidewire includes an elongated first wire 10, a second wire 20 and an elastic wire 30. The first wire 10 and the second wire 20 are insulated from each other and close together to form a longitudinally long guidewire body 40. The first wire 10 and the second wire 20 are connected together at the distal end portion corresponding to the distal end of the guidewire body 40, and the proximal end portion corresponding to the proximal end of the guidewire body 40 forms a terminal 11, 21 (such as a length of about 2cm) for connecting the positive and negative electrodes of the power supply. Usually, insulating layers 12, 22 are formed on the surfaces of the first wire 10 and the second wire 20, respectively, and the insulating layers 12, 22 are made of a coating material with biocompatibility, heat insulation, heat resistance, and plasticity, preferably a coating material that can be cured without heating. In this embodiment, a layer of UV glue with good biocompatibility is coated on the surface of the first wire 10 and the second wire 20, while the terminal 11, 21 is not coated, and then a high-power ultraviolet lamp is used to cure the UV glue. The first conductive wire 10 and the second conductive wire 20 are twisted and braided together to be tightly combined, and then UV glue is coated thereon and cured with a high-power ultraviolet lamp to obtain the guide wire body 40.

As shown in the figure, the first wire 10 and the second wire 20 are made of the same shape memory alloy wire. For example, a single nickel-titanium wire of a certain length, diameter, and phase transition temperature (transformation temperature of the martensite phase and the austenite phase) is obtained, and a layer of UV glue that meets biocompatibility is coated on its surface and cured (UV glue is not coated on the ends of the nickel-titanium wire), and then folded in the middle to form two long sections, which are respectively used as the first wire 10 and the second wire 20, and the UV glue layer forms an insulating layer 12, 22, and the ends of the nickel-titanium wire are used as the wiring terminals 11, 21. The first wire 10 and the second wire 20 are twisted and braided together, and UV glue is coated on them, and then a high-power ultraviolet lamp is used for curing to allow the first wire 10 and the second wire 20 to be tightly fixed together, thereby obtaining a guide wire body 40, and the proximal end of the guide wire body 40 is the wiring terminal 11, 21, and the distal end of the guide wire body 40 is the turning end 42. In other embodiments, the first wire 10 and the second wire 20 may be respectively made of two shape memory alloy wires, and one end of them may be connected together by welding or the like.

The guide wire body 40 is made of a shape memory alloy, that is, the first wire 10 and the second wire 20 are made of a shape memory alloy. As described above, in this embodiment, the first wire 10 and the second wire 20 are temperature-controlled nickel-titanium wires, which can be plastically deformed at high temperatures to make the temperature-controlled nickel-titanium wires in a complete austenite phase. After annealing and cooling, the temperature-controlled nickel-titanium wires after deformation are connected to a power source, that is, the terminals 11 and 21 of the first wire 10 and the second wire 20 are connected to positive and negative voltages respectively. According to the Joule effect, as time goes by, the temperature of the plastic part of the first wire 10 and the second wire 20 continues to rise to the phase transition temperature from the martensite phase to the austenite phase, then the shape memory function of the plastic part is triggered and the plastic deformation is restored, that is, the guide wire body 40 adopts an electric current heating method to allow the turning end 42 to automatically deform to the plastic state.

As shown in the figure, the turning end 42 is made of shape memory nickel-titanium alloy and is formed by shaping. Specifically, a shaping point 44 is set between the guide wire body 40 and the turning end 42, such as about 2 cm away from the far end. Place a round stick with a smaller diameter at the shaping point 44, and bend the turning end 42 90° away from the axial direction of the guide wire body 40. Let the temperature of the hot air gun rise to hundreds of degrees (such as 350°-600°) and stabilize at this temperature, and then place the shaping point 44 at the outlet of the hot air gun for heating, so that the shaping point 44 can be shaped, and the turning end 42 is basically linear. In fact, the shaping point 44 can be set at any position according to actual needs; during shaping, the axial direction of the turning end 42 relative to the guide wire body 40 can be changed between 0-360°; the shaping point 44 can also be shaped by other physical heating methods such as induction heating or current resistance heating. In fact, the shaping point 44 between the guide wire body 40 and the turning end 42 can be regarded as the first wire 10 and the second wire 20 are respectively provided with shaping points near the distal end, so that the distal end of the first wire 10 and the distal end of the second wire 20 are respectively deviated from the axial direction of the first wire 10 and the second wire 20, that is, the distal end of the first wire 10 and the distal end of the second wire 20 are respectively bent between 0°-360° relative to the axial direction of the first wire 10 and the second wire 20. In other embodiments, the entire turning end 42 can be shaped, such as using a mold with an arc groove, placing the turning end 42 in the arc groove and heating and shaping it into an arc-shaped or curved turning end 42 (this can also be regarded as an infinite number of shaping points 44 connected to form an arc-shaped or curved turning end 42).

After the shaping point 44 is cooled, the turning end 42 is restored to the axial direction of the guide wire body 40, that is, the distal end of the first wire 10 and the distal end of the second wire 20 are restored to the axial direction of the first wire 10 and the second wire 20, respectively, and the guide wire body 40 and the turning end 42 are basically straight. The elastic wire 30 is insulated and arranged on the guide wire body 40. As shown in the figure, a super elastic nickel titanium wire (whose diameter can be the same as or different from the diameter of the first wire 10 and the second wire 20) with a length equivalent to that of the first wire 10 and the second wire 20 is obtained as the elastic wire 30, which is wound and woven on the guide wire body 40, that is, the two ends of the elastic wire 30 correspond to the proximal end and the distal end of the guide wire body 40, respectively. Similarly, a biocompatible UV glue is coated and a high-power ultraviolet lamp is used to cure to form an insulating layer 32, so that the super elastic nickel titanium wire and the temperature-controlled nickel titanium wire are integrated, that is, the elastic wire 30 is tightly fixed on the guide wire body 40, and the first wire 10, the second wire 20 and the elastic wire 30 constitute an integral controllable guide wire. Generally, the controllable guide wire is longer from the proximal end to the distal end, and can vary within the range of 2000mm-3000mm. In other embodiments, the elastic wire 30 can be insulated and fixed on the part of the guide wire body 40, i.e., extending from the turning end 42 to the part of the guide wire body 40 but not further extending to the guide wire body 40 proximal end, or can only be incorporated on the part of the turning end 42 (when the whole turning end 42 is all processed by shaping).

When using a controllable guidewire for surgery, the terminals 11 and 21 of the first wire 10 and the second wire 20 are connected to the positive and negative electrodes of the power supply respectively, and the turning end 42 of the guidewire body 40 is placed in a blood vessel, a natural channel or an organ lumen and the guidewire is delivered. When the turning end 42 reaches the natural channel, organ lumen, vascular branch or tortuous blood vessel that needs to be turned, the first wire 10 and the second wire 20 are energized to form a conductive loop. Due to the presence of resistance, heat is generated, and the temperature of the guidewire body 40 continues to rise. When the temperature of the shaping point 44 reaches the phase transition temperature of the martensite phase to the austenite phase, the turning end 42 gradually deviates from the axial direction of the guidewire body 40 until it is aligned with the natural channel, organ lumen, vascular branch or tortuous blood vessel that needs to be turned, and at the same time, the elastic wire 30 follows the turning end 42 to undergo elastic deformation, thereby delivering the turning end 42 into the corresponding natural channel, organ lumen, vascular branch or tortuous blood vessel.

The specific degree to which the steering end 42 deviates from the axial direction of the guidewire body 40 is not only related to the thickness of the guidewire, but also to parameters such as the current and voltage, and the power-on time. The following is an explanation using different power-on times as an example: 1) When the power is on for about 1-2S, the steering end 42 deflects about 30° toward the pre-shaping direction, as shown in FIG1; 2) When the power is on for about 2-3S (cumulative), the steering end 42 deflects about 60° toward the pre-shaping direction, as shown in FIG2; 3) When the power is on for about 3-5S (cumulative), the steering end 42 deflects about 90° toward the pre-shaping direction (i.e., the preset maximum deflection angle), as shown in FIG3.

At this time, turn off the power supply, the conductive circuit formed by the first wire 10 and the second wire 20 is powered off, and the steering end 42 stops deflecting. Subsequently, the temperature of the guide wire body 40 continues to decrease, and when the temperature of the shaping point 44 reaches the phase transition temperature of the austenite phase to the martensite phase, its shape memory function disappears. At this time, under the elastic recovery force of the elastic wire 30, the steering end 42 follows the elastic wire 30 to recover to the axial direction of the guide wire body 40, allowing the steering end 42 to continue to advance along the corresponding natural channel, organ lumen, vascular branch or tortuous blood vessel. As shown in Figure 7, when the current is disconnected, the temperature-controlled nickel-titanium wire has no deflection force to drive the superelastic nickel-titanium wire to deflect, but as the temperature of the temperature-controlled nickel-titanium wire decreases, the deflection force continues to decrease, and the superelastic nickel-titanium wire, due to its own superelastic recovery stress, causes the temperature-controlled nickel-titanium wire to follow the superelastic nickel-titanium wire and gradually recover along the original deflection path, and returns to a linear state after about 3-6S (accumulated). According to the actual needs of interventional surgery, it can be repeatedly powered on and off for multiple times. The distal end can repeatedly deflect and cycle within 0-360°. It is not disposable and can enable the distal end to successfully enter large-angle blood vessels or tortuous lesions, greatly improving the success rate of the operation. There is no need for doctors to repeatedly take out conventional guide wires for distal shaping, which greatly reduces operation time and patient pain.

For the controllable guidewire of the first embodiment, a shaping point 44 is set between the guidewire body 40 and the turning end 42, that is, for both the first wire 10 and the second wire 20, the shaping point can also be set only on the portion of the first wire 10 corresponding to the distal end of the guidewire body 40 or the portion of the second wire 20 corresponding to the distal end of the guidewire body 40. The following is an example of the shaping point being set at the distal end portion close to the first wire 10: when the first wire 10 and the second wire 20 are energized to form a conductive loop, only the distal end of the first wire 10 has a shape memory function, and the temperature of its shaping point rises and undergoes phase change conversion, then the distal end of the first wire 10 gradually deviates from its axial direction, and the distal end of the second wire 20 deviates with the distal end of the first wire 10 and undergoes elastic deformation, causing the turning end 42 of the guidewire body 40 to deform. After the current on the first wire 10 and the second wire 20 is cut off, the shaping point gradually cools down, and the shaping point is transformed from the austenite phase to the martensite phase, that is, the shape memory function of the distal end of the first wire 10 disappears, and under the elastic restoring force of the distal end of the second wire 20, the distal end of the first wire 10 follows the distal end of the second wire 20 to recover to its axial direction, so that the turning end 42 and the guide wire body 40 are restored to a linear state, thereby manufacturing a controllable guide wire of the second embodiment, as shown in Figure 5. It can be seen that the controllable guide wire of the second embodiment only includes the first wire 10 and the second wire 20, and does not need to be provided with an elastic wire 30, so the process is simpler and the cost is lower.

The present invention also provides a method for preparing a controllable guidewire. As shown in Figures 4, 6-9, the first embodiment of the method for preparing a controllable guidewire of the present invention comprises the following steps: 1) forming insulating layers 12 and 22 on the surfaces of the first wire 10 and the second wire 20. The first wire 10 and the second wire 20 connected together can be formed by folding the same wire in the middle, or the distal ends of the first wire 10 and the second wire 20 can be connected together by welding or the like to form a conductive loop. The first wire 10 and the second wire 20 are insulated and placed close together (such as being wound and braided together), UV glue is then applied thereon, and then a high-power ultraviolet lamp is used for curing to allow the first wire 10 and the second wire 20 to be tightly fixed together, thereby obtaining a guidewire body 40 and a turning end 42 located at the distal end of the guidewire body 40, as shown in Figure 6. The specific process is described above.

2) A shaping point 44 is formed between the guide wire body 40 and the turning end 42. This is achieved by respectively setting shaping points near the distal ends of the first guide wire 10 and the second guide wire 20. For example, the first guide wire 10 and the second guide wire 20 are made of shape memory alloy guide wires, specifically temperature-controlled nickel-titanium wires, and the temperature-controlled nickel-titanium wires are plastically deformed at high temperatures to make the temperature-controlled nickel-titanium wires in a completely austenite phase, so that the distal ends of the first guide wire 10 and the distal ends of the second guide wire 20 deviate from the axial direction of the first guide wire 10 and the second guide wire 20, respectively, as shown in 7, and after annealing and cooling, they are restored to the axial direction of the first guide wire 10 and the second guide wire 20 (in practice, tools are needed to be bent to the axial direction), as shown in 8. The specific process is described above.

3) The elastic wire 30 is insulated and arranged on the guide wire body 40. The elastic wire 30 can be wound and woven on the guide wire body 40, and the two ends of the elastic wire 30 correspond to the proximal end and the distal end of the guide wire body 40 respectively. As before, a biocompatible UV glue is coated and a high-power ultraviolet lamp is used to cure to form an insulating layer 32, that is, the elastic wire 30 is tightly fixed on the guide wire body 40, thereby forming an integral controllable guide wire, as shown in FIG9. In other embodiments, an insulating layer can also be first formed on the elastic wire 30 in the above manner, and then fixed to the guide wire body 40 through another insulating layer, as shown in FIG10.

In addition, the insulating layer between the first conductive wire 10, the second conductive wire 20 and the elastic wire 30 can also be formed in the following manner: as shown in FIG. 11, insulating layers 12, 22, and 32 are respectively formed on the surfaces of the first conductive wire 10, the second conductive wire 20 and the elastic wire 30, and then they are put together (such as twisted and braided together) and coated with glue and cured to obtain an integral controllable guide wire; as shown in FIG. 12, insulating layers 12 and 22 are respectively formed on the surfaces of the first conductive wire 10 and the second conductive wire 20 and put together, and then the elastic wire 30 (without The insulating layer) is also placed together, that is, glue is applied and cured once to form an insulating layer 32, so as to obtain an integral controllable guide wire; as shown in FIG13, an insulating layer 22 is first formed on the surface of the second conductor 20 (which may also be the first conductor 10), the first conductor 10 (without insulating layer) is placed against the second conductor 20 with the insulating layer 22, glue is applied and cured to form an insulating layer 12, the elastic wire 30 (without insulating layer) is placed against the non-insulating layer 12 of the first conductor 10, glue is applied and cured to form an insulating layer 32, so as to obtain an integral controllable guide wire.

The distal end of the controllable guide wire can also be configured to have better tactile feedback performance, that is, when encountering resistance, it can be transmitted to the proximal end in time; the pushing force applied to the proximal end of the controllable guide wire is transmitted to the distal end without causing obvious blockage at the proximal end, so that the controllable guide wire has better transmission ability.

Finally, it should be noted that, if there is no conflict, the embodiments of the present invention and the various features in the embodiments can be combined with each other, all within the protection scope of the present invention.

The above-mentioned embodiments only express limited implementation methods of the invention, and the description thereof is relatively specific and detailed, but it cannot be understood as limiting the scope of the invention patent. It should be pointed out that for ordinary technicians in this field, several modifications and improvements or deteriorations can be made without departing from the inventive concept, which all belong to the protection scope of the invention. Therefore, the protection scope of the invention patent shall be based on the claims.

Claims (30)

1. A controllable guidewire, characterized in that the controllable guidewire comprises a first and a second slender wire, the first and the second wire are insulated from each other and close together, the distal ends of the first and the second wire are connected together to form a longitudinally long guidewire body and a turning end located at the distal end of the guidewire body and corresponding to the distal ends of the first and the second wire, when the first and the second wire are used as positive and negative electrodes to form a conductive loop, the shape memory function of the distal end of the first wire is triggered and deviates from the axial direction of the first wire, and the distal end of the second wire deviates with the distal end of the first wire and undergoes elastic deformation to control the direction of the turning end of the guidewire body, when the conductive loop formed by the first and the second wire is powered off, the shape memory function of the distal end of the first wire disappears and is restored under the action of the elastic restoring force of the distal end of the second wire. 2. A controllable guide wire as described in claim 1, characterized in that: a shaping point is set near the distal end of the first wire to allow the distal end of the first wire to deviate from the axial direction of the first wire. 3. A controllable guide wire as described in claim 2, characterized in that the distal end of the first wire is bent between 0-360° relative to the axial direction of the first wire. 4. A controllable guide wire as described in claim 2, characterized in that: the first wire is shaped between the shaping point and the distal end. 5. A controllable guide wire as described in claim 2, characterized in that: a shaping point is set near the distal end of the second conductor to allow the distal end of the second conductor to deviate from the axial direction of the second conductor, and the controllable guide wire also includes an elastic wire that is insulated and arranged on the second conductor and covers the shaping point. 6. A controllable guide wire as described in claim 5, characterized in that the distal end of the second wire is bent between 0°-360° relative to the axial direction of the second wire. 7. A controllable guide wire as described in claim 5, characterized in that the second guide wire is shaped between the shaping point and the distal end. 8. A controllable guidewire as described in any one of claims 2-7, characterized in that the turning end of the guidewire body corresponding to the distal end of the first wire and the second wire is made of shape memory alloy and is formed by shaping. 9. A controllable guidewire as described in claim 8, characterized in that the guidewire body is made of shape memory alloy. 10. A controllable guidewire as claimed in claim 9, characterized in that the first wire and the second wire are temperature-controlled wires. 11. A controllable guide wire as described in claim 5, characterized in that the elastic wire extends in an insulated manner to the distal end of the second guide wire. 12. A controllable guide wire as described in claim 5, characterized in that the elastic wire extends in an insulated manner to the proximal end of the second guide wire. 13. A controllable guide wire as claimed in claim 5, characterized in that the elastic wire has superelasticity. 14. A controllable guidewire as described in claim 1, characterized in that the proximal end of the first conductive wire and the proximal end of the second conductive wire respectively form wiring terminals for connecting to a power source. 15. A method for preparing a controllable guidewire, characterized in that the preparation method comprises: 1) providing a first and second slender wire connected together, and making the first and second wires insulated from each other and close together, so as to form a longitudinal guidewire body and a turning end located at the distal end of the guidewire body; 2) shaping the distal end of the corresponding connection on the first wire, so that when the first and second wires are used as positive and negative electrodes to form a conductive loop respectively, the shape memory function of the distal end of the first wire is triggered to deviate from the axial direction of the first wire, and the distal end of the second wire deviates with the distal end of the first wire and undergoes elastic deformation to control the direction of the turning end of the guidewire body, and when the conductive loop formed by the first and second wires is powered off, the shape memory function of the distal end of the first wire disappears and is restored under the action of the elastic restoring force of the distal end of the second wire. 16. A method for preparing a controllable guide wire as claimed in claim 15, characterized in that the first guide wire and the second guide wire are formed by bending the same guide wire. 17. A method for preparing a controllable guide wire as described in claim 15, characterized in that the distal end of the first conductive wire and the distal end of the second conductive wire are welded together. 18. A method for preparing a controllable guide wire as claimed in claim 15, characterized in that the first conductive wire and the second conductive wire are braided together. 19. A method for preparing a controllable guide wire as described in claim 15, characterized in that: the first guide wire is shaped to form a shaping point near the distal end. 20. A method for preparing a controllable guide wire as described in claim 19, characterized in that: shaping treatment is performed between the shaping point and the distal end of the first guide wire. 21. A method for preparing a controllable guide wire as claimed in claim 19 or 20, characterized in that: the first conductive wire is made of a shape memory alloy. 22. A method for preparing a controllable guide wire as described in claim 19, characterized in that: the second conductive wire is shaped to form a shaping point near the distal end, and the shaping point of the second conductive wire is insulated and covered with an elastic wire. 23. A method for preparing a controllable guide wire as described in claim 22, characterized in that: shaping treatment is performed between the shaping point and the distal end of the second guide wire. 24. A method for preparing a controllable guide wire as claimed in claim 24 or 25, characterized in that the second guide wire is made of a shape memory alloy. 25. A method for preparing a controllable guide wire as described in claim 1, 19, 20, 22 or 23, characterized in that: the shaping treatment is to plastically deform the shape memory alloy at a high temperature so that the shape memory alloy is in a completely austenite phase. 26. A method for preparing a controllable guide wire as claimed in claim 15, characterized in that: glue is coated on the surface of the first conductive wire and the second conductive wire respectively and then cured to form an insulating layer. 27. A method for preparing a controllable guidewire as claimed in claim 26, characterized in that: the first conductive wire and the second conductive wire placed close together are coated with glue and then cured to form the guidewire body. 28. A method for preparing a controllable guide wire as claimed in claim 22, characterized in that: glue is coated on the surface of the elastic wire and then cured to form an insulating layer. 29. A method for preparing a controllable guide wire as claimed in claim 22 or 28, characterized in that the elastic wire is fixed to the second guide wire by coating glue and curing it. 30. A method for preparing a controllable guide wire as described in claim 26, 27 or 28, characterized in that the glue is UV glue and forms an insulating layer after being cured by ultraviolet rays.