A guidewire

Abstract

The application provides a guide wire, and relates to the technical field of medical devices. The guide wire can improve the strength of the distal end of the guide wire, and is beneficial to reducing the risk of breakage of the distal end of the guide wire. The guide wire comprises a core wire, a first reinforcing member and a second reinforcing member. The core wire extends from the proximal end of the guide wire to the distal end of the guide wire. The first reinforcing member is sleeved on the distal end of the core wire. The second reinforcing member is sleeved on the first reinforcing member and at least part of the distal end of the core wire. The guide wire provided by the application is used for medical intervention surgery.

Description

Technical Field

[0001] This application relates to the field of medical device technology, and in particular to a guidewire. Background Technology

[0002] Guidewires are an indispensable component of interventional medical devices and are widely used in interventional surgeries. Clinical practice has shown that when using guidewires in areas of high resistance such as severe calcification, the distal end of the guidewire is easily clamped by plaque. This can lead to breakage of the distal end (such as the tip) of the guidewire when rotating or retracting it. Utility Model Content

[0003] This application provides a guidewire that can improve the strength of the distal end of the guidewire, thereby reducing the risk of distal end breakage.

[0004] The guidewire provided in this application includes: a core wire, a first reinforcing member, and a second reinforcing member; wherein the core wire extends from the proximal end of the guidewire to the distal end of the guidewire; the first reinforcing member is sleeved on the distal end of the core wire; and the second reinforcing member is sleeved on at least a portion of the first reinforcing member and the distal end of the core wire.

[0005] In one possible implementation of this application, the first reinforcing member is in at least one of the following shapes: spiral and woven mesh.

[0006] In one possible implementation of this application, the second reinforcing member is in the form of a woven mesh tube.

[0007] In one possible implementation of this application, the distal end of the guidewire has a bent section, and the angle between the axis of the bent section and the axis of the guidewire is an acute angle.

[0008] In one possible implementation of this application, the angle between the axis of the bent section and the axis of the guide wire is greater than or equal to 30° and less than or equal to 60°; and / or, the length of the bent section is greater than or equal to 0.5 mm and less than or equal to 3 mm.

[0009] In one possible implementation of this application, the distal end of the guidewire has a variable diameter section, the outer diameter of the distal end of the variable diameter section is smaller than the outer diameter of the proximal end of the variable diameter section, and the outer diameter of the variable diameter section changes continuously along the axial direction of the guidewire.

[0010] In one possible implementation of this application, the guidewire further includes a lubricating layer that covers the proximal end of the core wire.

[0011] In one possible implementation of this application, the guidewire further includes an outer coating that covers the surface of the guidewire and is hydrophilic.

[0012] In one possible implementation of this application, both the first reinforcing member and the second reinforcing member are welded and fixed to the core wire.

[0013] In one possible implementation of this application, the core wire is an integral structure. Attached Figure Description

[0014] Figure 1 A schematic diagram illustrating the application of guidewires in the related technologies provided in this application;

[0015] Figure 2 Schematic diagram of the guidewire provided in this application Figure 1 ;

[0016] Figure 3 Schematic diagram of the guidewire provided in this application Figure 2 ;

[0017] Figure 4 Photograph 1 of the distal portion of the guidewire provided for this application;

[0018] Figure 5 Photograph 2 of the distal portion of the guidewire provided for this application;

[0019] Figure 6 A comparison diagram of the axial fracture force at the distal end of the guidewire provided in this application.

[0020] Explanation of reference numerals in the attached figures:

[0021] 1-Guide wire; 11-Core wire; 12-First reinforcing member; 13-Second reinforcing member; 14-Lubricating layer; 15-Outer coating; 16-Bending section; 17-Diameter changing section; 18-Solder; 2-Blood vessel; 3-Plaque; Z-Axial direction. Detailed Implementation

[0022] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the specific technical solutions of this application will be further described in detail below with reference to the accompanying drawings of the embodiments of this application. The following embodiments are used to illustrate this application, but are not intended to limit the scope of this application.

[0023] In the embodiments of this application, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of indicated technical features. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the embodiments of this application, unless otherwise stated, "multiple" means two or more.

[0024] Furthermore, in the embodiments of this application, directional terms such as "upper," "lower," "left," and "right" are defined relative to the positions in which the components are schematically placed in the accompanying drawings. It should be understood that these directional terms are relative concepts, used for relative description and clarification, and can change accordingly depending on the position of the components in the accompanying drawings.

[0025] In the embodiments of this application, unless otherwise explicitly specified and limited, the term "connection" should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral part; it can be a direct connection or an indirect connection through an intermediate medium.

[0026] In embodiments of this application, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes that element.

[0027] In the embodiments of this application, the terms "exemplary" or "for example" are used to indicate that something is an example, illustration, or description. Any embodiment or design that is described as "exemplary" or "for example" in the embodiments of this application should not be construed as being more preferred or advantageous than other embodiments or design. Specifically, the use of the terms "exemplary" or "for example" is intended to present the relevant concepts in a specific manner.

[0028] Interventional therapy is currently the main clinical treatment for coronary atherosclerotic heart disease. By dilating the narrowed area through balloon catheters or by releasing stents, it can effectively treat the stenotic lesions, restore normal blood flow, and ensure blood supply.

[0029] Chronic total occlusion (CTO), a type of coronary artery disease, is often referred to as the "last bastion to be conquered" in percutaneous coronary intervention (PCI). In 95% of CTO PCI failures, the guidewire cannot pass through the lesion; therefore, the guidewire plays a crucial role in the management of CTO lesions.

[0030] Reference Figure 1 , Figure 1This is a schematic diagram illustrating the application of the guidewire in the related technology provided in this application. When using guidewire 1 in high-resistance lesions such as those with severe calcification, the tip of guidewire 1 is often clamped by plaque 3. Excessive rotation or retraction of guidewire 1 can cause the tip of guidewire 1 to break.

[0031] This application provides a guidewire 1, as shown in the embodiment. Figure 2 and Figure 3 , Figure 2 This is a schematic diagram of the guidewire provided in this application. Figure 3 Schematic diagram of the guidewire provided in this application Figure 2 .

[0032] The guide wire 1 provided in this application embodiment includes: a core wire 11, a first reinforcing member 12 and a second reinforcing member 13; wherein, the core wire 11 extends from the proximal end of the guide wire 1 to the distal end of the guide wire 1; the first reinforcing member 12 is sleeved on the distal end of the core wire 11; and the second reinforcing member 13 is sleeved on at least a portion of the first reinforcing member 12 and the distal end of the core wire 11.

[0033] In this embodiment, the guide wire 1 can be configured to include a core wire 11 and a reinforcing member. The core wire 11 can extend through the entire guide wire 1, and the reinforcing member can be located at the distal end of the guide wire 1. For example, the core wire 11 can be made of a material with good support, high rigidity, and suitable for use as the guide wire 1, such as 304 stainless steel, 316 stainless steel, cobalt-based alloy, iron-manganese alloy, copper-zinc alloy, nickel-titanium alloy, iron-nickel alloy, etc. This embodiment does not limit the specific material of the core wire 11. The length of the core wire 11 can be set according to the specific application scenario, such as setting the length of the core wire 11 to 100cm to 400cm.

[0034] It should be noted that in this application, "distal" and "proximal" refer to the extension direction of the guidewire 1 along its Z-axis. The distal end is the end of the guidewire 1 furthest from the operator, meaning it is the end that first enters or is closest to the body. The proximal end is the end of the guidewire 1 closest to the operator, meaning it is the end that last enters or is furthest from the body. For example, as... Figure 2 As shown, the far end is Figure 2 The upper end, proximal end is Figure 2 Lower middle section.

[0035] In this embodiment, multiple reinforcing members can be provided at the distal end of the core wire 11. The reinforcing members can be made of metal, plastic, composite materials, etc. For example, the distal end of the core wire 11 can be processed into a conical, streamlined, parabolic, or spindle shape by grinding, chemical etching, etc., so that the outer diameter of the distal part of the core wire 11 is smaller than the outer diameter of the proximal part of the core wire 11.

[0036] For example, a first reinforcing member 12 can be provided at the distal end of the core wire 11. The first reinforcing member 12 can be configured as a cylindrical shape that matches the distal end of the core wire 11. The first reinforcing member 12 can be sleeved on the distal end of the core wire 11, and the first reinforcing member 12 can be tightly attached to the circumferential surface of the distal end of the core wire 11. Along the axial direction Z of the guide wire 1, the end face of the distal end of the first reinforcing member 12 can coincide with the end face of the distal end of the core wire 11. For example, the first reinforcing member 12 and the core wire 11 can be fixedly connected by means of bonding, snap-fitting, welding, etc.

[0037] In another example, a second reinforcing member 13 can be provided on the first reinforcing member 12. The second reinforcing member 13 can be a cylindrical shape that matches the distal portions of the first reinforcing member 12 and the core wire 11 that are not covered by the first reinforcing member 12. The second reinforcing member 13 can be sleeved on the distal portions of the first reinforcing member 12 and the core wire 11. Along the radial direction of the guide wire 1, there can be a gap between the second reinforcing member 13 and the first reinforcing member 12, and there can also be a gap between the second reinforcing member 13 and the core wire 11. Along the axial direction Z of the guide wire 1, the length of the second reinforcing member 13 can be greater than the length of the first reinforcing member 12. For example, both ends of the second reinforcing member 13 can be fixedly connected to the core wire 11 by means of bonding, snap-fitting, welding, etc.

[0038] The guidewire 1 provided in this embodiment has a core wire 11 extending from the proximal end to the distal end, which allows for the transmission of a larger torque, thus improving the torsional control performance of the guidewire 1. Furthermore, a first reinforcing member 12 is provided at the distal end of the core wire 11, enhancing the distal end's resistance to deformation and improving its maneuverability. Simultaneously, a second reinforcing member 13 is provided at the distal ends of both the first reinforcing member 12 and the core wire 11, increasing the tensile strength of the distal end of the guidewire 1 and reducing the risk of breakage due to the distal end being clamped by plaques 3 or similar objects. Therefore, the guidewire 1 provided in this embodiment enhances the strength of the distal end, reducing the risk of distal end breakage and thus improving surgical efficiency and success rate.

[0039] In some possible embodiments of this application, such as Figure 1 and Figure 2 As shown, the first reinforcing member 12 has at least one of the following shapes: spiral and woven mesh.

[0040] In this embodiment, the first reinforcing member 12 can be spiral-shaped. For example, the first reinforcing member 12 can be made of thin metal wire, which is spirally wound around the distal end of the core wire 11 so that the first reinforcing member 12 is approximately in the shape of a helical spring. The thin metal wire can be fixedly connected to the core wire 11 by welding or other methods. Alternatively, the first reinforcing member 12 can be made of a woven mesh. For example, the first reinforcing member 12 can be made of 4, 6, 8, or 16 strands of thin metal wire. Multiple thin metal wires can be woven into a mesh that matches the distal end of the core wire 11 using a braiding machine. The woven mesh first reinforcing member 12 is then fitted onto the distal end of the core wire 11, and both ends of the mesh first reinforcing member 12 are fixedly connected to the core wire 11 by welding, bonding, or other methods.

[0041] For example, the first reinforcing member 12 can be made of a metal material that is opaque to X-rays or has low X-ray penetration capability, thereby improving the visibility of the guide wire 1 under X-rays. Along the axial direction Z of the guide wire 1, the length of the first reinforcing member 12 can be set from 1 cm to 5 cm, such as 1 cm, 2 cm, 3 cm, 4 cm, or 5 cm. The length of the first reinforcing member 12 can be selected according to the specific application scenario of the guide wire 1; this embodiment does not limit the specific length of the first reinforcing member 12.

[0042] In the above embodiments, since the first reinforcing member 12 is spiral or woven mesh, it can not only make the distal end of the guidewire 1 have good toughness, but also improve the strength of the distal end of the guidewire 1, thereby making the guidewire 1 have good maneuverability.

[0043] In some possible embodiments of this application, reference is made to Figure 4 and Figure 5 , Figure 4 Photograph 1 of the distal portion of the guidewire provided in this application. Figure 5 Photograph 2 of the distal portion of the guidewire provided in this application. The second reinforcing member 13 is in the form of a woven mesh tube.

[0044] In this embodiment, the second reinforcing member 13 can be a woven mesh structure. For example, the second reinforcing member 13 can be made of materials such as platinum-tungsten wire, platinum-nickel wire, platinum-iridium wire, gold wire, or stainless steel wire. Multiple wires can be interwoven into a mesh tube shape that matches the distal portions of the first reinforcing member 12 and the core wire 11 using a braiding machine. The mesh tube-shaped second reinforcing member 13 can be fitted onto the distal ends of the first reinforcing member 12 and the core wire 11. For example, the distal end of the second reinforcing member 13 can be welded to the distal end of the core wire 11 to form an approximately hemispherical solder 18 at the distal end of the guide wire 1. The proximal end of the second reinforcing member 13 can also be welded to the core wire 11 to form an annular solder 18 at the proximal end of the core wire 11 and on the surface of the guide wire 1.

[0045] For example, along the axial direction Z of the guidewire 1, the length of the second reinforcing member 13 can be set from 1cm to 30cm, such as 1cm, 3cm, 5cm, 8cm, 10cm, 15cm, 18cm, 20cm, 25cm, or 30cm. The length of the second reinforcing member 13 can be selected according to the specific application scenario of the guidewire 1. This application embodiment does not limit the specific length of the second reinforcing member 13.

[0046] In the above embodiments, since the second reinforcing member 13 is in the shape of a woven mesh, the second reinforcing member 13 can have good fracture resistance, thereby improving the fracture resistance of the distal end of the guide wire 1 and reducing the risk of fracture at the distal end of the guide wire 1 during use.

[0047] In some possible embodiments of this application, such as Figure 3 , Figure 4 and Figure 5 As shown, the distal end of the guidewire 1 has a bent section 16, and the angle between the axis of the bent section 16 and the axis Z of the guidewire 1 is an acute angle.

[0048] In this embodiment, a bent section 16 can be provided at the distal end of the guidewire 1 to give the distal end of the guidewire 1 a bent structure. For example, a portion of the first reinforcing member 12 can be bent at the distal end of the guidewire 1 to form the bent section 16. The bent section 16 can be set at an acute angle to the axial direction Z of the guidewire 1 so that the bent section 16 is inclined relative to the axial direction Z of the guidewire 1, but the inclination angle does not exceed 90°.

[0049] For example, the angle between the axis of the bent segment 16 and the axial direction Z of the guidewire 1 can be set to a range greater than or equal to 30° and less than or equal to 60°. The tilt angle of the bent segment 16 relative to the axial direction Z of the guidewire 1 can be set according to the specific application scenario of the guidewire 1. For example, when the interventional vessel 2 is relatively thick, the tilt angle of the bent segment 16 relative to the axial direction Z of the guidewire 1 can be larger, while when the interventional vessel 2 is relatively thin, the tilt angle of the bent segment 16 relative to the axial direction Z of the guidewire 1 can be smaller. The angle between the axis of the bent segment 16 and the axial direction Z of the guidewire 1 can be set to 30°, 35°, 40°, 45°, 50°, 55°, 58°, or 60°, etc. This embodiment of the application does not limit the specific value of the angle between the axis of the bent segment 16 and the axial direction Z of the guidewire 1.

[0050] In another example, the length of the bend 16 can be set to be greater than or equal to 0.5 mm and less than or equal to 3 mm. The length of the bend 16 can be set according to the specific application scenario of the guidewire 1. For example, if the interventional vessel 2 is relatively thick, the length of the bend 16 can be longer, while if the interventional vessel 2 is relatively thin, the length of the bend 16 can be shorter. The length of the bend 16 can be set to 0.5 mm, 0.8 mm, 1 mm, 1.3 mm, 1.5 mm, 1.8 mm, 2 mm, 2.5 mm, or 3 mm, etc.

[0051] In the above embodiment, since a bent section 16 is provided at the distal end of the guidewire 1, and the axis of the bent section 16 has an acute angle with the axial direction Z of the guidewire 1, the orientation of the bent section 16 can be changed by rotating the guidewire 1 during the process of inserting the guidewire 1 into the blood vessel 2, thereby facilitating the adjustment of the direction of the guidewire 1 in the blood vessel 2.

[0052] In some possible embodiments of this application, such as Figure 3 , Figure 4 and Figure 5 As shown, the distal end of the guidewire 1 has a variable diameter section 17. The outer diameter of the distal end of the variable diameter section 17 is smaller than the outer diameter of the proximal end of the variable diameter section 17, and the outer diameter of the variable diameter section 17 changes continuously along the axial direction Z of the guidewire 1.

[0053] In this embodiment, a variable diameter section 17 can be provided at the distal end of the guidewire 1. For example, the variable diameter section 17 can be configured as an approximately conical structure, so that the outer diameter of the distal end of the variable diameter section 17 is smaller than the outer diameter of the proximal end of the variable diameter section 17. The variable diameter section 17 can also be configured as an approximately spindle-shaped structure, a parabola-shaped structure, a streamlined structure, etc. The surface of the variable diameter section 17 is a continuous and smooth surface, meaning that the variable diameter section 17 does not exhibit an approximately step-like abrupt change in outer diameter.

[0054] For example, the length of the variable diameter section 17 can be set from 1cm to 10cm. For instance, the length of the variable diameter section 17 can be set to 1mm, 2mm, 3mm, 5mm, 8mm, or 10mm, etc. Figure 3 As shown, the length of the variable diameter section 17 can be greater than the length of the bent section 16, that is, a bent section 16 is formed at the far end of the variable diameter section 17. Figure 4 As shown, the length of the variable diameter section 17 can also be less than the length of the bent section 16, that is, a variable diameter section 17 can be machined at the far end of the bent section 16.

[0055] In the above embodiments, since a variable diameter section 17 is provided at the distal end of the guidewire 1, the resistance of the distal end of the guidewire 1 in inserting into the embolization or other lesions can be reduced by the variable diameter section 17, which is conducive to the rapid insertion of the distal end of the guidewire 1 into the occluded and severely calcified lesion sites, thereby shortening the operation time.

[0056] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, the guide wire 1 also includes a lubricating layer 14, which covers the proximal end of the core wire 11.

[0057] In this embodiment, a lubricating layer 14 can be provided at the proximal end of the guide wire 1. The lubricating layer 14 can be one or more of polytetrafluoroethylene, polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone. The lubricating layer 14 can be provided as a thin film, covering the surface of the portion of the core wire 11 where the second reinforcing member 13 is not provided. For example, the lubricating layer 14 can be fixed to the surface of the core wire 11 by a hot-melt process.

[0058] In the above embodiment, since a lubricating layer 14 is provided at the proximal end of the core wire 11, the proximal end of the core wire 11 can have a smooth and flat surface, which is beneficial to improve the lubricity of the surface of the core wire 11, thereby reducing the resistance of other instruments to pass through the guide wire 1 and facilitating the delivery of instruments through the guide wire 1.

[0059] In some possible embodiments of this application, the guidewire 1 further includes an outer coating 15, which covers the surface of the guidewire 1 and is hydrophilic.

[0060] In this embodiment, an outer coating 15 can be provided on the surface of the guide wire 1. The outer coating 15 can be made of a hydrophilic material, for example, one or more of polyvinylpyrrolidone, polyethylene oxide, chloroacrylate, or polymethyl vinyl ether-maleic anhydride. The outer coating 15 can be applied to the outer surfaces of the core wire 11, the second reinforcing member 13, and the lubricating layer 14 by spraying or smearing.

[0061] In the above embodiments, since the surface of the guidewire 1 has a hydrophilic outer coating 15, it is beneficial to improve the lubricity of the guidewire 1, thereby reducing the passage resistance of the guidewire 1 in the blood vessel 2 and reducing the difficulty of pushing the guidewire 1.

[0062] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, the core wire 11 is an integral structure.

[0063] In this embodiment, the core wire 11 can be configured as an integral structure. For example, the core wire 11 can be made of 304 stainless steel, 316 stainless steel, cobalt-based alloy, iron-manganese alloy, copper-zinc alloy, nickel-titanium alloy, iron-nickel alloy, etc. The core wire 11 can be first prepared into a cylindrical slender strip, and then the distal end of the core wire 11 can be processed into a structure with a finer outer diameter, such as an approximately conical, spindle-shaped, or streamlined shape, through grinding, chemical etching, etc., so as to facilitate the installation of the first reinforcing member 12 and the second reinforcing member 13, thereby making the core wire 11 an integral structure.

[0064] In the above embodiments, since the core wire 11 is an integral structure, the torque transmission performance of the guide wire 1 can be improved, thereby enhancing the torque controllability of the guide wire 1. Furthermore, the high-strength core wire 11 can provide good support and pushing force for the guide wire 1, which is beneficial to improving the maneuverability of the guide wire 1.

[0065] The manufacturing method of the guide wire 1 provided in this application embodiment will be described below with reference to the guide wire 1 provided in any of the above embodiments.

[0066] First, the core wire 11, lubricating layer 14, first reinforcing member 12, and second reinforcing member 13 are fabricated:

[0067] The core wire 11 can be processed by grinding, grinding its distal end into a conical, parabolic, streamlined, or other structure. This provides the guide wire 1 with good flexibility and pushing performance, and allows the distal end of the guide wire 1 to have different hardness. The core wire 11 can be made of one or more materials suitable for making the guide wire 1. For example, the core wire 11 can be made of 304 stainless steel, 316 stainless steel, cobalt-based alloys, iron-manganese alloys, copper-zinc alloys, nickel-titanium alloys, iron-nickel alloys, etc. When the core wire 11 is composed of multiple materials, the connection method of the multiple materials can be one or more of resistance welding, brazing, ultrasonic welding, laser welding, bonding, and snap-fit. For example, if the core wire 11 is composed of 304 stainless steel, making the core wire 11 a one-piece stainless steel structure can improve the torque transmission performance of the guide wire 1.

[0068] The first reinforcing member 12 can be made of any one of 304 stainless steel, nickel-titanium alloy, platinum-tungsten alloy, or platinum-nickel alloy. It can be formed into a spiral shape by winding a metal wire using a spring machine. The first reinforcing member 12 can be used as a imaging element, enhancing the visibility of the guide wire 1 under X-rays.

[0069] The second reinforcing member 13 can be made of one or two of the following: platinum-tungsten alloy, platinum-nickel alloy, platinum-iridium alloy, gold, and stainless steel. The second reinforcing member 13 can be woven using a braiding machine, and the braiding method can be one or more of various patterns such as 1-over-1, 1-over-2, 2-over-1, and 2-over-2. The number of metal braided wires can be 4, 6, 8, or 16 strands. For example, the second reinforcing member 13 can use metal braided wires with a diameter ranging from 0.02 mm to 0.15 mm. The braided wires and the braiding mandrel can be loaded into the braiding machine, and one end of the metal braided wire can be fixed to the braiding mandrel. Then, the relevant parameters of the braiding machine, such as PPI and length, can be set. The second reinforcing member 13 can be woven using the braiding machine, and its length along the axial Z of the guide wire 1 can be from 1 cm to 30 cm.

[0070] Then, the distal end of guidewire 1 is shaped:

[0071] A 1mm long, 45° bend 16 is pre-shaped at the distal end of the guidewire 1. The shape of the bend 16 at the distal end of the guidewire 1 can be achieved through a shaping process, which can be heat treatment shaping and / or cold shaping. For example, heat treatment shaping can be used to form bends at the distal ends of the core wire 11, the first reinforcing member 12, and the second reinforcing member 13. The heat treatment temperature can be from 200°C to 600°C, and the heat treatment time can be from 1 minute to 30 minutes.

[0072] Next, assemble the core wire 11, the first reinforcing member 12, and the second reinforcing member 13:

[0073] The first reinforcing member 12 is sleeved on the distal end of the core wire 11 and is coaxial with the core wire 11. It can be fixedly connected to the core wire 11 by one or more of the following methods: resistance welding, brazing, ultrasonic welding, laser welding, bonding, and snap-fit. For example, brazing can be used to fix the first reinforcing member 12 to the core wire 11 at a welding temperature of 200℃ to 500℃. The second reinforcing member 13 is sleeved on the first reinforcing member 12 and the core wire 11 and is coaxial with them. It can be fixedly connected to the first reinforcing member 12 and the core wire 11 by one or more of the following methods: resistance welding, brazing, ultrasonic welding, laser welding, bonding, and snap-fit. For example, brazing can be used to fix the second reinforcing member 13, the first reinforcing member 12, and the core wire 11 at a welding temperature of 200℃ to 500℃.

[0074] Finally, a lubricating layer 14 is coated on the surface of the core wire 11, and an outer coating layer 15 is coated on the surface of the guide wire 1.

[0075] A lubricating layer 14 is coated on the surface of the proximal end of the core wire 11. The lubricating layer 14 can be made of polytetrafluoroethylene (PTFE), and the coating method can be spraying or dipping. The lubricating layer 14 is cured and formed in a certain way to prevent it from falling off. The PTFE coating has a certain degree of lubricity, which can reduce the resistance of other instruments on the guide wire 1 and facilitate the delivery of instruments.

[0076] An outer coating 15 is applied to the surface of guidewire 1. The outer coating 15 can be one or more of polyvinylpyrrolidone, polyethylene oxide, hyaluronic acid acrylate, or polymethyl vinyl ether-maleic anhydride. The coating can be applied by spraying or smearing, and the outer coating 15 is cured and formed using a specific method to prevent it from peeling off. After the outer coating 15 is applied, its appearance on the guidewire 1 can be observed for any abnormalities. The outer coating 15 provides good lubricity to the guidewire 1, thereby reducing the resistance to passage of the guidewire 1 within the blood vessel 2, making the guidewire 1 easier to advance.

[0077] Reference Figure 6 , Figure 6 This is a comparison diagram of the axial fracture force at the distal end of the guidewire provided in this application. Compared to guidewires in related technologies, the guidewire 1 provided in this embodiment significantly improves the resistance to fracture at the distal end of the guidewire 1 by providing a braided second reinforcement 13. Figure 6 As shown, the axial Z-fracture force of the distal end of the guidewire 1 provided in this embodiment is 3.25 times that of the distal end of the guidewire in the related art. Therefore, the guidewire 1 provided in this embodiment can reduce the risk of the distal end of the guidewire 1 being clamped by the plaque 3, leading to the breakage of the guidewire 1. Furthermore, by heat treatment and / or laser heat treatment and / or cold treatment, a bent section 16 is formed at the distal end of the guidewire 1, which facilitates control of the guidewire 1's forward direction, thereby facilitating the manipulation of the guidewire 1 through the occluded lesion site. Moreover, by providing a spiral-shaped first reinforcing member 12 inside the distal end of the guidewire 1, the guidewire 1's resistance to deformation can be improved, which is beneficial to further enhancing the maneuverability of the guidewire 1. At the same time, by designing the distal end of the guidewire 1 with different hardnesses, the guidewire 1 can pass through lesion sites with different degrees of calcification by utilizing its own distal end hardness and good maneuverability and tracking ability.

[0078] The above embodiments are merely illustrative of the technical solutions of this application and are not intended to limit it. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this application, and all should be covered within the scope of the specification of this application. In particular, as long as there is no structural conflict, the various technical features mentioned in the embodiments can be combined in any way.

Claims

1. A guidewire, characterized in that, include: A core wire extending from the proximal end of the guidewire to the distal end of the guidewire; A first reinforcing member is sleeved on the distal end of the core wire; A second reinforcing member is sleeved on at least a portion of the distal end of the first reinforcing member and the core wire.

2. The guidewire according to claim 1, characterized in that, The first reinforcing member has at least one of the following shapes: spiral and woven mesh.

3. The guidewire according to claim 1, characterized in that, The second reinforcing member is in the form of a woven mesh tube.

4. The guidewire according to claim 1, characterized in that, The distal end of the guidewire has a bent section, and the angle between the axis of the bent section and the axis of the guidewire is an acute angle.

5. The guidewire according to claim 4, characterized in that, The angle between the axis of the bent section and the axis of the guide wire is greater than or equal to 30° and less than or equal to 60°. And / or, the length of the bent segment is greater than or equal to 0.5 mm and less than or equal to 3 mm.

6. The guidewire according to claim 1, characterized in that, The guidewire has a variable diameter section at its distal end, the outer diameter of which is smaller than ...

7. The guidewire according to claim 1, characterized in that, The guidewire also includes a lubricating layer that covers the proximal end of the core wire.

8. The guidewire according to claim 1, characterized in that, The guidewire also includes an outer coating that covers the surface of the guidewire and is hydrophilic.

9. The guidewire according to claim 1, characterized in that, Both the first reinforcing member and the second reinforcing member are welded and fixed to the core wire.

10. The guidewire according to claim 1, characterized in that, The core wire is a single-piece structure.

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