Bending control wire capable of being bent in multiple directions, bending control guide wire and medical device

Abstract

The invention discloses a bending control wire capable of bending in multiple directions, a bending control guide wire and a medical device. The bending control wire comprises a bending control electric wire, a bending control lead and an insulated bending control sleeve, and the bending control sleeve is a single-cavity tube or a multi-cavity tube and is provided with one or more cavities; the bending control electric wire and the bending control lead are parallel to each other and are located in the same cavity; a loop is formed between the bending control electric wire and the bending control lead, so that the bending control electric wire is powered on or powered off; and the bending control electric wire is made of a shape memory alloy material. The bending control wire or the bending control guide wire provided by the invention has good super selectivity and deliverability, and can be adjusted into various bending shapes and angles.

Description

Technical Field

[0001] The present invention relates to a bending-controlled wire that can bend in multiple directions, and also relates to a bending-controlled guide wire including the bending-controlled wire that can bend in multiple directions, and further relates to a medical device including the bending-controlled wire that can bend in multiple directions, belonging to the technical field of medical devices. Background Art

[0002] Generally, in interventional surgery, various techniques are required to deliver a guide wire to the target position in the tortuous human body cavity, and then, with the support of the guide wire, a catheter is delivered to the target position. Therefore, an important problem to be solved is "how to reach the target position safely and quickly".

[0003] In a Chinese invention with the patent number ZL 201810217365.8, a controllable bending guide wire is disclosed. The technical solution includes a spring, an upper core wire, a lower core wire, a handle, an upper button, and a lower button. The upper core wire and the lower core wire are arranged one above the other inside the spring, and the front end of the lower core wire is connected to the front end of the spring. The handle is provided with an upper button slot and a lower button slot, and the upper button and the lower button are slidably clamped in the button slots. The rear ends of the upper core wire and the lower core wire extend into the handle and are connected to the buttons. The controllable bending guide wire provided by this invention realizes controllable bending by designing two movable core wires inside the spring. Similarly, in the prior art, the bending direction and bending radius of the guide wire are controlled by a pull rope. However, practice has proved that simply taking these technical measures is far from enough. Summary of the Invention

[0004] The primary technical problem to be solved by the present invention is to provide a bending-controlled wire that can bend in multiple directions.

[0005] Another technical problem to be solved by the present invention is to provide a bending-controlled guide wire that can bend in multiple directions.

[0006] Another technical problem to be solved by the present invention is to provide a medical device including a bending-controlled wire or a bending-controlled guide wire that can bend in multiple directions.

[0007] To achieve the above technical objectives, the present invention adopts the following technical solutions:

[0008] According to the first aspect of the embodiments of the present invention, a bending-controlled wire that can bend in multiple directions is provided, including a bending-controlled electroactive wire, a bending-controlled lead wire, and an insulating bending-controlled sleeve.

[0009] The bending-controlled sleeve is a single-lumen tube or a multi-lumen tube, having one or more lumens;

[0010] The bending-controlled electroactive wire and the bending-controlled lead wire are parallel to each other and are located in the same lumen;

[0011] A circuit is formed between the bending control electro-conductive wire and the bending control lead wire to energize or de-energize the bending control electro-conductive wire;

[0012] The bending control electro-conductive wire is made of a shape memory alloy material.

[0013] Preferably, the bending control electro-conductive wire is of a segmented structure.

[0014] Preferably, the bending control lead wire is located on the outer periphery of the bending control electro-conductive wire; or

[0015] The bending control lead wire is located at the center of the bending control electro-conductive wire.

[0016] According to a second aspect of an embodiment of the present invention, there is provided a multi-directionally bendable bending control guide wire, including a longitudinally extending first bending control wire and a second bending control wire; wherein,

[0017] The second bending control wire includes a second bending control lead wire and a second bending control electro-conductive wire that are electrically connected. A central hole is provided in the axial direction of the bending control electro-conductive wire, and one or more openings are further provided on its outer peripheral surface. The second bending control lead wire is located in the central hole, and the first bending control wire is located in the opening;

[0018] The first bending control wire includes a first bending control lead wire, a first bending control electro-conductive wire, and a bending control sleeve that are electrically connected. The bending control electro-conductive wire and the bending control lead wire are both accommodated in the bending control sleeve, and the bending control sleeve is fixed in the opening;

[0019] Both the first bending control electro-conductive wire and the second bending control electro-conductive wire are made of a shape memory alloy material and change their shapes when energized or de-energized, but their preformed shapes are different.

[0020] Preferably, the bending control guide wire includes a plurality of mutually separated bending control segments,

[0021] In each bending control segment, there are a first bending control lead wire and a first bending control electro-conductive wire. The first bending control lead wires are respectively connected to a power source, but the first bending control electro-conductive wires are electrically connected to the first bending control lead wires within the same bending control segment, and the first bending control electro-conductive wires in different bending control segments are mutually separated.

[0022] Preferably, the first bending control electro-conductive wire and the second bending control electro-conductive wire are preformed into complementary shapes so that when energized, one is in a bent state and the other is in a straight state.

[0023] Preferably, the second bending control electro-conductive wire is pretreated to be in a soft state when the temperature is lower than the first phase change temperature point A; and in a straight state when the temperature is higher than or equal to the first phase change temperature point A.

[0024] The first bending-controlling electrofilament is pre-processed to be in a soft state when the temperature is lower than the second phase transition temperature point B; and in a bent state in a predetermined direction when the temperature is higher than or equal to the second phase transition temperature point B.

[0025] Preferably, the bending control guide wire comprises three first bending control wires,

[0026] The three first bending control wires are evenly distributed in the circumferential direction of the second bending control wire, and the first bending control electromechanical wires of the three first bending control wires are pre-processed to bend in different predetermined directions when phase change occurs.

[0027] According to a third aspect of an embodiment of the present invention, a medical device is provided, comprising the aforementioned bending control wire or bending control guide wire.

[0028] Compared with the prior art, the present invention proposes a multi-directional bending controlled guidewire and catheter based on shape memory alloy, which can be controlled and bent through electro-drive to improve the superselectivity and controllability of the guidewire. It can be used for guidewires, access catheters, measurement catheters or ablation catheters, avoiding the use of excessive instruments during surgery, and can greatly reduce surgical costs, operation time and technical requirements for the operator. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Figure 1A It is a schematic structural diagram of a spiral catheter using a bending control wire according to the first embodiment of the present invention;

[0030] Figure 1B for Figure 1A Schematic diagram of the cross-sectional structure of the bending control wire along AA;

[0031] Figure 2 This is a schematic diagram of the cross-sectional structure of the bending control wire in the second embodiment of the present invention;

[0032] Figure 3 This is a schematic diagram of the longitudinal structure of a bending control guide wire in the third embodiment of the present invention;

[0033] Figure 4 This is a schematic diagram of the cross-sectional structure of a bending control guide wire in the third embodiment of the present invention;

[0034] Figure 5 This is a schematic diagram of the three-dimensional structure of a bending control section of a bending control guide wire in the third embodiment of the present invention;

[0035] Figure 6 This is a schematic diagram of a method for controlling the bending direction of a bending guide wire in a third embodiment of the present invention;

[0036] Figure 7 This is a schematic diagram of the cross-sectional structure of a bending control guide wire in the fourth embodiment of the present invention;

[0037] Figure 8Schematic cross-sectional structure diagram of the bending control wire in the fifth embodiment of the present invention;

[0038] Figure 9 Schematic cross-sectional structure diagram of the bending control wire in the sixth embodiment of the present invention;

[0039] Figure 10 Schematic cross-sectional structure diagram of the bending control wire in the seventh embodiment of the present invention;

[0040] Figure 11 Schematic diagram of the application of the bending control wire or the bending control guide wire provided in the embodiments of the present invention in a basket ultrasonic ablation catheter. Specific embodiments

[0041] The technical content of the present invention will be described in detail with reference to the accompanying drawings and specific embodiments.

[0042] The technical concept in the embodiments of the present invention is as follows: Utilizing the austenite-martensite phase transformation inverse characteristics of shape memory alloy (SMA), multiple bending control segments are arranged at different positions of the control wire. By controlling the bending of the bending control segments at different positions, the overall control wire is bent in a specified direction. More preferably, for a control guide wire with multiple bending control wires arranged in parallel, different bending degrees can also be achieved for different bending control segments of different bending control wires, enabling the entire control guide wire to bend in any direction within the 360° range of the radial plane, so that the overall control guide wire forms a twist or bend in three-dimensional space to conform to tortuous human body cavities such as blood vessels. Here, the materials of the shape memory alloy include, but are not limited to, nickel-titanium alloy, copper-based alloy, iron-based alloy, etc.

[0043] The bending control wire or the bending control wire provided in the embodiments of the present invention is arranged in a medical device (such as an ablation catheter). By virtue of the bending control segments of the bending control wire being located in different sections of the medical device, the bending direction and curvature of each bending control segment are controlled by a control handle, thereby changing the bending or twisting degree of the longitudinal component in the medical device. The bending control wire of the present invention can be either a wire independent of the catheter (such as an ablation catheter) (the bending control wire can slide relative to other parts of the catheter as a wire), or fixed inside the catheter and integrated with other parts of the catheter (the bending control wire is integrated with the catheter and cannot slide relative to each other).

[0044] The first embodiment

[0045] The bending control wire 10 provided in the first embodiment of the present invention, as shown in Figure 1A and Figure 1BAs shown in the figure, it is used inside the spiral catheter 200. The bending control wire 10 includes a bending control electroactive wire 11, a bending control lead 12, and an insulating bending control sleeve 14. The outer periphery of the bending control sleeve 14 is covered with a hydrophilic coating to facilitate delivery. The bending control sleeve 14 is a single-lumen tube or a multi-lumen tube, having one or more channels. When the bending control sleeve 14 is a single-lumen tube, the bending control electroactive wire 11 and the bending control lead 12 are located in this channel; when the bending control sleeve 14 is a multi-lumen tube, the bending control electroactive wire 11 and the bending control lead 12 are located in the same channel. Hereinafter, the case where the bending control sleeve 14 is a single-lumen tube is taken as an example for illustration, but this does not limit the present invention.

[0046] Both the bending control electroactive wire 11 and the bending control lead 12 are longitudinally long in shape and are arranged in parallel in the inner cavity of the bending control sleeve 14. One end of the bending control electroactive wire 11 is used to connect to the handle, and the other end is electrically connected to the bending control lead 12. One end of the bending control lead 12 is used to connect to the handle, and the other end is electrically connected to the bending control electroactive wire 11. Therefore, a circuit can be formed among the bending control electroactive wire 11, the bending control lead 12, and the handle, so that the bending control electroactive wire 11 can be energized or de-energized under the control of, for example, the handle.

[0047] The bending control electroactive wire 11 is made of SMA material and has a second phase change temperature point B, which is pre-treated into a preset shape: ① When the temperature of the bending control electroactive wire is less than B, the bending control electroactive wire maintains plasticity and soft characteristics, for example, in a straight shape; ② When the temperature of the bending control electroactive wire reaches or exceeds B, the bending control electroactive wire hardens and bends into a preset shape (such as a C shape). In this embodiment, the value of the second phase change temperature point B is determined by the characteristics of the SMA material, and is exemplified by 45 - 55 °C (slightly higher than the normal human body temperature, but not too high to avoid causing discomfort).

[0048] The bending control lead 12 is a wire with an insulated outer surface located inside the bending control sleeve 14. In this embodiment, the bending control lead 12 is an enameled wire or other wire. Inside the bending control sleeve 14, the bending control lead 12 forms a circuit with the bending control electroactive wire 11 (this circuit is connected to the power supply or control circuit in the handle), so the bending control wire is controlled by the handle, deforms when energized, or remains soft when not energized.

[0049] The bending control electroactive wire 11, under the control of the handle, can act as a resistor and generate heat when energized, and then bend in a preset manner when reaching the second phase change temperature point B. Specifically, in normal temperature and body temperature environments (for example, normal temperature is 15 - 45 °C, and body temperature is 37 °C), the bending control electroactive wire 11 remains soft for convenient delivery. When bending is required, the control handle can heat the bending control electroactive wire 11 to the second phase change temperature point B (higher than normal temperature and body temperature), so that the bending control wire 10 bends in a preset direction.

[0050] In the foregoing solution, the bending control wire 10 has bending control electro-active wires 11 and bending control leads 12 throughout its entire length (i.e., both are continuous), so that the bending degree of the entire length range of the bending control wire 10 can be controlled. As an alternative solution, the bending control electro-active wires 11 in the bending control wire 10 are segmented and not continuous, and only the bending control leads 12 are continuous. Such an alternative solution only controls the bending of a part of the bending control wire 10.

[0051] Specifically, within the two segmented sections indicated by the Figure 1A dashed boxes shown, there are bending control electro-active wires 11 and bending control leads 12 respectively; at other positions (between the segments, i.e., between the dashed boxes), there are no bending control electro-active wires 11, and only bending control leads 12. Therefore, the continuous bending control leads 12 are used to supply power to the bending control electro-active wires 11 of each segment. Relative to the power source or control circuit in the handle, the bending control electro-active wires 11 of each segment are connected in parallel or in series, preferably in parallel. In such a case, by selectively energizing the bending control electro-active wires 11 of different segments, the bending control wire 10 can be bent locally. For example, at the first time, only the bending control electro-active wire 11 shown in the upper dashed box in Figure 1A is energized, and the other one is not; at the second time, only the bending control electro-active wire 11 shown in the lower dashed box in Figure 1A is energized, and the other one is not.

[0052] Using such a locally bent bending control wire to control the medical device can cause different parts of the longitudinal part of the medical device to bend and some other parts not to bend. For example, at the aforementioned first time and second time, Figure 1A the spiral catheter presents different three-dimensional bending shapes to fit blood vessels of different shapes.

[0053] In this embodiment, by disposing the bending control wire 10 (using the bending control wire 10 as a guide wire) inside the medical device, such as a catheter, the bending of the whole or part of the catheter can be controlled by using the bending control electro-active wire 11. Compared with the technical solution of using SMA material for the entire distal end of the catheter (a catheter can only have one preformed bending shape), this embodiment can use different inserted or internally fixed bending control wires 10 (the bending shapes of each bending control wire 10 are different), so that the same catheter can also have different bending shapes. Therefore, the versatility of the catheter is improved.

[0054] It should be noted here that the cross-sectional shape of the first bending control electro-active wire 11 and the second bending control electro-active wire 21 perpendicular to the length direction is not limited to a circular shape, and can also be an elliptical shape, an irregular shape, etc., as long as it meets the conventional requirements of the guide wire shape design.

[0055] Second Embodiment

[0056] Different from the above embodiments, the bending control wire 20 provided in the embodiment of the present invention is different in structure from that of the first embodiment. The first embodiment is an eccentric structure, while this embodiment is a centrosymmetric structure.

[0057] As Figure 2 shown, the bending control wire 20 includes a bending electroactive wire 21 and a bending lead 22. Among them, both the bending electroactive wire 21 and the bending lead 22 are longitudinally elongated, and the bending electroactive wire 21 has a central hole 211 to accommodate the bending lead 22, so that the two are coaxially arranged. One end of the bending electroactive wire 21 and the bending lead 22 is used to connect to the handle, and the other ends are electrically connected to each other to form a circuit. Therefore, under the control of the handle, the bending electroactive wire 21 can be powered on or off. The outer periphery of the bending electroactive wire 21 is covered with a hydrophilic coating, replacing the bending sleeve in the first embodiment, for the convenience of delivery.

[0058] Similar to the first embodiment, the bending electroactive wire 21 is made of SMA material. However, the phase change temperature point of the bending electroactive wire 21 is A, and the pretreatment is as follows: ① When the temperature of the bending electroactive wire is lower than the first phase change temperature point A, the bending electroactive wire 21 maintains plasticity and soft characteristics; ② When the temperature of the central electroactive wire is greater than or equal to the first phase change temperature point A, the bending electroactive wire 21 hardens. In this embodiment, the value of the first phase change temperature point A is in an interval, taking 50 - 60 °C as an example. The value interval of the first phase change temperature point A can be greater than the value interval of the second phase change temperature point B, that is, the lowest temperature of the first phase change temperature point A is higher than the highest temperature of the second phase change temperature point B, or the value interval of B can be greater than the interval of A. However, when the bending electroactive wires of the first embodiment and the second embodiment are simultaneously powered on, they have different states (soft or hardened) at a specific temperature, and the central values of the value intervals of the first phase change temperature points A and B need to be different (for example, one is 50 - 60 degrees; the other is 45 - 55 degrees).

[0059] Similar to the first embodiment, the bending lead 22 is an insulating lead. The distal end of the bending lead 22 is connected to the distal end of the bending electroactive wire 21, and the proximal ends of the bending electroactive wire 21 and the bending lead 22 are connected to the handle.

[0060] Therefore, the bending lead 22, the bending electroactive wire 21, and the handle form an electric current loop. When powered on, the bending electroactive wire 21 generates heat as a resistor. Under normal temperature and body temperature environments (taking 15 - 45 °C as an example, where the human body temperature is 37 °C), the bending electroactive wire 21 remains in a soft state for convenient delivery; when heated to the interval of the temperature point A, the rigidity of the bending electroactive wire 21 increases (the stiffness is greater than the stiffness of the central wire 20 in the soft state), so as to control the bending degree of the whole bending control wire.

[0061] In the above description, the bending control electro-conductive wire 21 is a continuous whole section to simultaneously change the entire bending shape and degree of bending of the bending control wire 20; it can also be multiple discontinuous series-connected segments. By energizing different segments at different times, the local bending shape and degree of bending of the bending control wire 20 can be respectively controlled.

[0062] Third Embodiment

[0063] Different from the above embodiments, the bending control guide wire 110 provided in the embodiment of the present invention includes single or multiple bending control segments 100. Each bending control segment 100 includes a first bending control wire 10' and a second bending control wire 20', as Figures 3 to 5 shown. Among them, the number of the first bending control wires 10' in each bending control segment 100 is one or more. In this embodiment, the bending control guide wire provided only includes two bending control segments 100, and each bending control segment 100 includes three bending control wires 10' as an example.

[0064] In each bending control segment, it includes a first bending control lead and a first bending control electro-conductive wire, and the first bending control leads are respectively connected to a power source, but the first bending control electro-conductive wires are electrically connected to the first bending control leads within the same bending control segment, and the first bending control electro-conductive wires in different bending control segments are separated from each other and not connected.

[0065] In the bending control guide wire 110 of this embodiment, the second bending control wire 20' has a longitudinal structure, and the three bending control wires 10' located on the outer periphery of the second bending control wire 20' are segmented structures. In other words, at local positions of the longitudinal second bending control wire 20', three short bending control wires 10' are arranged radially. In this way, by combining the control of the first bending control wire 10' and / or the second bending control wire 20', the bending direction of the bending control guide wire can be accurately controlled in all directions. A detailed description will be given below.

[0066] The structure of the first bending control wire 10' is similar to that of the first embodiment. The first bending control wire 10' includes a first bending control electro-conductive wire 11' and a first bending control lead 12'. The distal ends of the first bending control electro-conductive wire 11' and the first bending control lead 12' are connected to each other, and the proximal ends are connected to the handle to form a loop. In this embodiment, the length of the first bending control electro-conductive wire 11' is significantly shorter than the length of the second bending control electro-conductive wire 21', for example, 1 / 3 to 1 / 5 of the length of the second bending control electro-conductive wire 21'. If the first bending control wire 10' in each bending control segment 100 is too short, it will cause the second bending control wire 20' to not bend with it; if the first bending control wire 10' is too long, it will cause it to not bend with the second bending control wire 20'. Therefore, the length relationship between the two is designed such that they can change each other's bending degree.

[0067] The second bending control wire 20' includes a second electro-bending wire 21' and a second bending control lead 22'. Its structure is substantially the same as that of the second embodiment (the distal ends are interconnected, and the proximal ends are connected to the handle to form a loop). Only the differences will be described here. The second electro-bending wire 21' houses the second bending control lead 22' inside, and a plurality of openings 201 are also provided on its outer peripheral surface ( Figure 4 ), so as to fix a first bending control wire 10' at each opening 201.

[0068] Three first bending control wires (located in the same bending section 100) are circumferentially arranged at the distal end of the second bending control wire 20', namely the first bending control wire A 101, the first bending control wire B 102, and the first bending control wire C 103, and are arranged parallel to the second bending control wire 20' in a radially symmetric manner. In other words, the three first bending control wires are evenly distributed in the circumferential direction of the second bending control wire 20'. All or part of each first bending control wire is embedded in the corresponding opening 201.

[0069] Both the first electro-bending wire 11' and the second electro-bending wire 21' are made of shape memory alloy materials, and their shapes change when powered on or off, but their preformed shapes are different. When the first electro-bending wire 11' and the second electro-bending wire 21' are not powered on, they both remain in a soft state. When it is necessary to change the bending direction of the bending control wire 110, one or more of the first electro-bending wires 11' in the bending section 100 are powered on. For example, when the first electro-bending wire 113 of the first bending control wire C 103 is applied with current and heated to the second phase change temperature point B, the material hardens and bends outward by 180° in the preformed direction (see the arrow ① shown in Figure 6 ), and at the same time drives the still soft (not yet powered on) second bending control wire 20' and the first bending control wire A 101 and the first bending control wire B 102 to bend outward by 180° together.

[0070] When it is necessary to adjust the angle again, for example, to offset outward by another 240° (see the arrow ② shown in Figure 6 ), the first bending control wire A 101 is powered on to heat it to the second phase change temperature point B, and the material of the first electro-bending wire 111 of the first bending control wire A 101 hardens and bends outward by 300° in the preformed direction (see the arrow ③ shown in Figure 6 ). Affected by the fact that the first electro-bending wire 113 has already bent, the bending control wire bends and deforms outward by 240° (see the arrow ② shown in Figure 6 ).

[0071] It should be noted that by controlling the current intensity and energization time (i.e., heating temperature and duration) of the first bending control electrothermal wire, the curvature of the first bending control electrothermal wire can be controlled, but the bending direction cannot be changed. The control of the bending direction of the first bending control electrothermal wire is determined by the SMA material characteristics and is achieved through preforming technology.

[0072] After power-off, the first bending control electrothermal wire 11' cools down below the second phase transition temperature point B, and the first bending control electrothermal wire returns to a soft state, but it cannot fully return to a straight state at this time. At this time, a current is applied to the second bending control electrothermal wire 21' of the second bending control wire 20', and it is heated to the first phase transition temperature point A, and the material hardens and is converted into a preformed state - a straight state.

[0073] When the second bending control electrothermal wire 21' returns to a straight form, it will drive the first bending control wire 101, the second bending control wire 102, and the third bending control wire 103 to return to a straight state. With such a design, it is avoided that because the temperature drop of the first bending control electrothermal wire 11' is a slow process and requires a long time, the waiting time during the operation is increased. By applying current to heat the second bending control electrothermal wire 21', the second bending control wire 20' is switched to a straight state with high stiffness, so as to forcibly change the entire bending control wire 110 into a straight state quickly.

[0074] It can be seen that in this embodiment, the preforms of the first bending control wire 10' and the second bending control wire 20' are complementary shapes, so that when energized, one is in a bent state and the other is in a straight state. For example, when the first bending control wire 10' is energized, it becomes a bent shape, and when the second bending control wire 20' is energized, it becomes a straight shape, so that the first bending control wire 10' can be quickly changed or restored to a straight shape.

[0075] Moreover, because multiple first bending control wires 10' are independently controlled, they can be energized and heated at different times, so that the bending control wire has different bending shapes or angles at different times. For example, in the foregoing Figure 6 example, the bending control wire changes from the angle shown by arrow ① to the angle shown by arrow ②.

[0076] Within the same bending control section 100, the phase change stress of the second bending control wire 20' is greater than the recovery stress of the first bending control wire 10', so as to achieve the reliability of directly switching the first bending control wire 10' from a bent state (the state after phase change) to a straight state. Therefore, the controllability and reliability of the delivery of the bending control wire can be improved, and the operation time can also be saved.

[0077] Optionally, the bending control guide wire 110 provided in the embodiment of the present invention replaces the guide wire in the prior art. A developing marker ball is provided at the distal end of the bending control guide wire 110 so as to be clearly developed under a radiographic image. As is well known, due to the limitation of the SMA material, the bending angle of the entire catheter made of the SMA material in the prior art is limited, and it can only be actively bent and enter a slightly tortuous lumen. In this embodiment, a plurality of independently controlled bending control wires 10 are used and are distributed at different positions at the distal end of the catheter (as Figure 3 shown, axially offset from each other and radially offset from each other), and different bending control wires 10 can be controlled according to the tortuosity of the lumen to adapt to lumens with different bending degrees. For example, in combination with Figure 3 and Figure 6 , by changing the angle of one of the first bending control wires 10' in the same bending control section respectively for different bending control sections 100, different bending control sections 100 can be bent towards different angles, and the entire bending control guide wire presents a twisted shape in three-dimensional space. Based on such a design, not only for tortuous, but also for grade I (classification of kinking by Metz in 1961), and even grade II kinked lumens, the present embodiment can also achieve active bending and entry.

[0078] Fourth Embodiment

[0079] Different from the third embodiment, the bending control guide wire provided in the embodiment of the present invention includes a second bending control wire 20 and two first bending control wires 10, as Figure 7 shown. The two first bending control wires 10 are symmetrically arranged in the circumferential direction of the second bending control wire 20, and the two are axially parallel.

[0080] Fifth Embodiment

[0081] Different from the third embodiment, the bending control guide wire provided in the embodiment of the present invention includes a second bending control wire 20 and a first bending control wire 10, as Figure 8 shown.

[0082] In this embodiment, the first bending control wire 10 and the second bending control wire 20 are axially parallel.

[0083] Sixth Embodiment

[0084] Different from the above embodiments, the bending control guide wire provided in the embodiment of the present invention includes a second bending control wire 20 and a first bending control wire 10'', as Figure 9 shown.

[0085] In this embodiment, the first bending control wire 10'' is wound around the outer periphery of the second bending control wire 20 in a spiral shape.

[0086] Seventh Embodiment

[0087] Different from the above sixth embodiment, the bending control wire provided by the embodiment of the present invention includes a second bending control wire 20 and two first bending control wires 10", as Figure 10 shown. The two first bending control wires 10" are parallel to each other and are wound around the outer periphery of the central wire 20 with the second bending control wire 20 as the reference, forming a double helix.

[0088] Eighth Embodiment

[0089] A medical device includes the bending control wire or the bending control guide wire provided by any one of the above embodiments. The bending control wire or the bending control guide wire is disposed in one or more longitudinal members of the medical device to change the bending angle or direction of the distal end of the longitudinal member. For example, by controlling the on / off state and the energization duration of each bending control electro-wire 11 and / or the bending control electro-wire 21, the bending direction and the curvature of the catheter can be controlled.

[0090] As Figure 11 shown, taking the basket ultrasonic ablation device as an example, the medical device 300 includes a catheter 301. The bending control guide wire includes a plurality of bending control segments 100. Each bending control segment 100 is respectively disposed in the distal end guide wire head segment 302, the distal end guide wire middle segment 303, the basket segment 304, the basket tail segment 305, and the catheter segment 306 of the catheter 301 to drive and control the bending position, direction, and curvature of the catheter 301. Among them, the bending control segments 100 disposed in the distal end guide wire head segment 302 and the distal end guide wire middle segment 303 can change the bending direction and the arc of the corresponding segment, thereby controlling the delivery direction of the guide wire. Since the basket segment 304 is provided with a basket balloon, the bending strength is large and the required bending moment is greater. The bending control segment 100 disposed in the basket segment 304 can actively bend the basket segment 304 and reduce the bending difficulty. It should be noted that the bending control guide wire provided by the embodiment of the present invention is also applicable to medical devices that require bending control, such as radiofrequency ablation catheters, microwave ablation catheters, guiding catheters, balloon catheters, etc. As the control wire for controlling the bending of these medical devices, it will not be elaborated one by one.

[0091] The bending control wire or the bending control guide wire provided by the embodiment of the present invention has good super-selectivity and deliverability, and can be adjusted into various bending shapes and angles as required. Therefore, the operator can easily deliver the bending control guide wire to the target position in the tortuous human body cavity by controlling the bending direction and the curvature of the bending control guide wire.

[0092] It should be noted that the above-mentioned multiple embodiments are only examples, and the technical solutions of each embodiment can be combined, and all are within the protection scope of the present invention.

[0093] In addition, the terms "first" and "second" are for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the quantity of the indicated technical features. Thus, 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.

[0094] The above provides a detailed description of a shape memory alloy-based multi-directionally bendable bending control wire and catheter provided by the present invention. For those of ordinary skill in the art, any obvious changes made without departing from the essence of the present invention will constitute an infringement of the patent right of the present invention and will bear corresponding legal responsibilities.

Claims

1. A bending-controlled wire with multi-directional bending, characterized in that It includes a bending control electrothermal wire, a bending control lead wire, and an insulating bending control sleeve. The bending control sleeve is a single-chamber tube or a multi-chamber tube, having one or more channels. The bending control electrothermal wire and the bending control lead wire are parallel to each other and located in the same channel. A circuit is formed among the bending control electrothermal wire, the bending control lead wire, and the handle, so that the bending control electrothermal wire is powered on or off. The bending control electrothermal wire is made of a shape memory alloy material.

2. The multi-directionally bendable bending control wire according to claim 1, wherein the bending control electrothermal wire is of a segmented structure.

3. The multi-directionally bendable bending control wire according to claim 1 or 2, wherein the bending control lead wire is located on the outer periphery of the bending control electrothermal wire; or the bending control lead wire is located at the center of the bending control electrothermal wire.

4. A bending control guide wire with multi-directional bending, characterized in that It includes a longitudinally long first bending control wire and a second bending control wire; wherein, the second bending control wire includes a second bending control lead wire and a second bending control electrothermal wire which are electrically connected. A central hole is provided in the axial direction of the second bending control electrothermal wire, and one or more openings are further provided on its outer peripheral surface. The second bending control lead wire is located in the central hole, and the first bending control wire is located in the opening; the first bending control wire includes a first bending control lead wire, a first bending control electrothermal wire, and a bending control sleeve which are electrically connected. The first bending control electrothermal wire and the first bending control lead wire are both accommodated in the bending control sleeve, and the bending control sleeve is fixed in the opening; the first bending control wire and the second bending control wire are parallel axially; or, the first bending control wire is wound around the outer periphery of the first bending control electrothermal wire; Both the first bending control electrothermal wire and the second bending control electrothermal wire are made of a shape memory alloy material, and change their shapes when powered on or off, but their preformed shapes are different.

5. The multi-directionally bendable bending control wire according to claim 4, wherein: It includes a plurality of mutually separated bending control segments. In each bending control segment, it includes a first bending control lead wire and a first bending control electrothermal wire. The first bending control lead wires are respectively connected to a power source, but the first bending control electrothermal wire is electrically connected to the first bending control lead wire within the same bending control segment, and the first bending control electrothermal wires in different bending control segments are mutually separated.

6. The multi-directionally bendable bending control guide wire according to claim 5, wherein: the first bending control electrothermal wire and the second bending control electrothermal wire are preformed into complementary shapes, so that when powered on, one is in a bent state and the other is in a straight state.

7. The multi-directionally bendable bending control guide wire according to claim 6, wherein: the second bending control electrothermal wire is pretreated to be in a soft state when below the first phase change temperature point; and in a straight state when higher than or equal to the first phase change temperature point; the first bending control electrothermal wire is pretreated to be in a soft state when below the second phase change temperature point; and in a bent state in a predetermined direction when higher than or equal to the second phase change temperature point.

8. The multi-directionally bendable wire for controlling bending according to any one of claims 4 to 7, characterized in that It includes three first bending control wires. The three first bending control wires are evenly distributed in the circumferential direction of the second bending control wire, and the first bending control electrothermal wires of the three first bending control wires are pretreated to bend in different predetermined directions when a phase change occurs.

9. A medical device, characterized in that It includes the bending control wire according to any one of claims 1 to 3 or the multi-directionally bendable bending control guide wire according to any one of claims 4 to 8.

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