A method for manufacturing a high-coaxiality guide wire

Abstract

The application relates to the technical field of medical instrument manufacturing, and particularly discloses a manufacturing method of a guide wire with high coaxiality. In order to solve the problem that the winding wire is prone to shaking during the welding process of the core wire and the winding wire, leading to the coaxiality of the core wire and the winding wire, the method comprises the following steps: S1. providing a guide wire core wire, a winding wire and an intermediate layer; the intermediate layer has an inner cavity matched with the outer diameter of the core wire and an outer surface matched with the inner diameter of the winding wire; S2. fixing the core wire in the inner cavity of the intermediate layer, and fixing the winding wire on the outer surface of the intermediate layer, so that the core wire, the intermediate layer and the winding wire are coaxial in the axial direction; S3. welding the core wire and the winding wire at the welding point in the state that the core wire, the intermediate layer and the winding wire are coaxial; S4. placing the assembly after welding in a solvent to dissolve and remove the intermediate layer; and S5. cleaning the welded assembly. The application can ensure that the core wire and the winding wire are highly coaxial during the welding process.

Description

Technical Field

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

[0002] In percutaneous coronary angioplasty and other vascular interventional procedures, the guidewire is the core tool for establishing intravascular access, and its performance directly affects the success and safety of the procedure. An ideal guidewire must possess excellent torsion control and passability: torsion control ensures that when the operator rotates the proximal end outside the vessel, the tip inside the vessel can be rotated instantly and precisely in sync, thereby enabling delicate operations such as selective access to branches and angle adjustments; passability ensures that its tip can smoothly traverse complex lesions such as calcification, angulation, or diffuse stenosis. Clinically, a "rotation-while-pushing" technique is often used, which requires a sharp and delay-free torsion control response. Essentially, this requires the core wire and the winding wire to be a continuous entity on the torque transmission path, and they must maintain a high degree of coaxiality in structure.

[0003] Modern high-performance coronary guidewires typically employ a composite design: at their core is an extremely fine metal core wire, which usually has a constant diameter proximal end to provide support during insertion, while the distal end is machined into a variable diameter structure with one or more tapered transitions, culminating in a flattened tip for enhanced shaping. The core wire is surrounded by a spring-like coil made of platinum alloy or stainless steel, coated with a lubricating layer. To accommodate coronary vessels and other devices such as balloon catheters and microcatheters, the maximum outer diameter of these guidewires is strictly limited to less than 0.014 inches, with the core wire diameter at its finest point reaching levels as small as 0.05 millimeters. The core wire and coil are fixed together at multiple points using techniques such as laser welding or brazing; the coaxial accuracy of these connections is the structural basis for determining torsional control performance.

[0004] Current standard processes typically involve placing the threaded core wire horizontally on a precision V-block or miniature jig before welding. However, both the core wire (especially the distal diameter-changing section and the flattened end) and the winding wire are extremely flexible. When placed horizontally, they are prone to bending and sagging due to their own weight and residual material stress, causing the core wire to fail to automatically center itself within the winding cavity. This results in an initial deviation in their physical axes before welding. Furthermore, and more seriously, the core wire exhibits a decreasing diameter stiffness gradient from the proximal to the distal end. In the distal region, where the diameter is smallest and the wire is most flexible, the core wire's bending resistance is weakest, drastically amplifying its positioning uncertainty. Existing jigs only provide external clamping and cannot accurately align the core wire to the geometric center of the winding before welding, nor can they resist deformation caused by thermal stress during welding. Therefore, they are completely unable to correct this coaxiality degradation problem, which inevitably occurs along the length of the guide wire due to structural stiffness differences and systematically worsens from the proximal to the distal end.

[0005] This spatial inconsistency in the coaxiality of the solder joints can lead to catastrophic clinical consequences. During clinical use, when the operator rotates the proximal end of the guidewire outside the patient's body, torque is transmitted along the mandrel. Ideally, the solder joint should undergo pure torsion around the mandrel axis. If the mandrel and the guidewire at the solder joint are poorly coaxial, and the mandrel is not on the radial axis of the solder joint, the guidewire at the solder joint will wobble. If the solder joint is located in a thin or narrow blood vessel, the guidewire may be restricted from wobbling, and the torque cannot be transmitted to the guidewire tip. The guidewire tip cannot respond and rotate in time, requiring continued rotation of the proximal end to attempt to rotate it. During this process, if the blood vessel at the solder joint is narrowed, blindly rotating the proximal end will not only prevent the operator from controlling the tip's direction but may also cause the guidewire to become tangled or even break inside the body, resulting in serious surgical risks. Summary of the Invention

[0006] To improve the coaxiality of the core wire and the winding wire during the welding process, this application provides a method for manufacturing a highly coaxial guide wire.

[0007] The manufacturing method of a highly coaxial guide wire provided in this application adopts the following technical solution:

[0008] In a first aspect, this application provides a method for manufacturing a highly coaxial guide wire, comprising the following steps:

[0009] S1. Provide a guide wire preparation material, including a guide wire core wire, at least one section of winding wire, and at least one intermediate layer; process the intermediate layer to have an inner cavity that matches the outer diameter of the core wire and an outer surface that matches the inner diameter of the winding wire;

[0010] S2. The core wire is threaded and fixed into the inner cavity of the intermediate layer, and the winding wire is sleeved and fixed onto the outer surface of the intermediate layer, so that the core wire, the intermediate layer and the winding wire are relatively fixed in the axial direction and remain coaxial.

[0011] S3. With the core wire, intermediate layer and winding wire kept coaxial and fixed, the core wire and the winding wire are welded at at least one solder point;

[0012] S4. Place the welded assembly in the solvent to dissolve and remove the intermediate layer;

[0013] S5. Clean the welded assembly after removing the intermediate layer to obtain a wire guide assembly with the core wire and the winding wire height being coaxial.

[0014] Furthermore, the core wire has a constant diameter section at the near end and a variable diameter section at the far end, and the intermediate layer provides rigid support and precise positioning for at least the variable diameter section of the core wire.

[0015] Furthermore, the winding includes at least two segments, of which at least one segment is a distal developing winding; the intermediate layers are correspondingly set to at least two, and the outer diameters of the at least two intermediate layers are different from each other, so as to match windings with different inner diameters respectively.

[0016] Furthermore, the material of the distal developing winding wire can be a platinum-nickel alloy, a platinum-tungsten alloy, a platinum-iridium alloy, a palladium-rhenium alloy, etc.

[0017] Furthermore, the solvent is ethanol, and the intermediate layer material is shellac resin, rosin resin, or other resins soluble in ethanol.

[0018] Furthermore, in step S1, the intermediate layer is formed by machining the precast rod.

[0019] Furthermore, in step S1, the intermediate layer is formed by hot-melt coating of thermoplastic material onto the surface of the core wire and shaping it.

[0020] Furthermore, in step S4, dissolution is accelerated by heating and / or ultrasonic oscillation.

[0021] Secondly, this application provides a guide wire manufactured by the above method.

[0022] Thirdly, this application provides a guide wire product, including a core wire and a winding wire sleeved thereon.

[0023] The core wire includes a constant diameter section at the proximal end and a variable diameter section at the distal end;

[0024] The winding wire comprises at least two sections, wherein the distal section is a developing winding wire;

[0025] The core wire and the winding wire are welded and fixed at the connection points of each section, and the core wire and the winding wire at all weld points are kept highly coaxial.

[0026] In summary, this application includes at least one of the following beneficial technical effects:

[0027] 1. This application introduces a completely dissolvable intermediate layer as a temporary tooling, which physically forces the core wire and the winding wire to maintain precise coaxiality before and during welding. This method is particularly effective for the weakest region in the prior art, the distal diameter-changing section. By providing effective rigid support through the intermediate layer, it solves the process problem of systematic deterioration of coaxiality from the near end to the far end due to the stiffness gradient of the core wire. The resulting guide wire has its coaxiality at all weld points stably controlled at an extremely high level, achieving reliable product performance.

[0028] 2. The guidewire manufactured using this method features a smooth torque transmission path and minimal resistance, enabling near-instantaneous response at the tip when the surgeon rotates the proximal end, without lag or jerking, greatly improving the precision and feel of manipulation. Simultaneously, the high coaxiality enhances the overall structural integrity and smoother transition of the guidewire tip, significantly improving its ability to pass through complex lesions such as calcification and angulation, effectively reducing the risk of guidewire locking or loss of control during surgery.

[0029] 3. This method is not only applicable to single-wire guide wires, but also adaptable to the current mainstream dual-wire (or multi-wire) structures. By designing intermediate layers with different outer diameters, the inner diameters of the proximal support wire and the distal developing wire can be precisely matched respectively, ensuring that each connection maintains independent high coaxiality in complex multi-segment welding. This solves the dilemma of traditional fixtures being unable to accurately position wires of different diameters simultaneously, providing a reliable solution for the large-scale consistent manufacturing of high-performance guide wires.

[0030] 4. The intermediate layer material and its corresponding solvent are strictly screened according to biocompatibility requirements. After welding, the intermediate layer is completely removed by dissolution and then cleaned to ensure that there are no foreign substances remaining on the final product. The entire process is a physical dissolution, avoiding the microscopic damage that may be caused by mechanical removal, ensuring the integrity of the guidewire surface, and meeting the stringent safety standards for medical devices.

[0031] 5. This method reduces reliance on ultra-high precision external fixtures and their complex debugging processes. The use of an intermediate layer makes operation more intuitive and stable, significantly reducing welding defects caused by misalignment. The simplification and stabilization of the process facilitates large-scale production, reduces overall manufacturing costs, and ensures high consistency in product performance between batches. Attached Figure Description

[0032] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0033] Figure 1 This is a flowchart illustrating an embodiment of this application;

[0034] Figure 2 This is a schematic diagram of the guide wire structure of the single-wound wire structure in the embodiments of this application;

[0035] Figure 3 This is a schematic cross-sectional view of the guide wire with a single-wound wire structure, as shown in an embodiment of this application.

[0036] Figure 4 This is a schematic diagram of the guide wire structure of the double-wound wire structure in the embodiments of this application;

[0037] Figure 5 This is a schematic cross-sectional view of the guide wire with a double-wound wire structure, as shown in an embodiment of this application.

[0038] Explanation of reference numerals in the attached diagram: 1. Core wire; 2. Winding wire; 21. Proximal winding wire; 22. Developed winding wire; 3. Intermediate layer; 31. First intermediate layer; 32. Second intermediate layer; 41. Proximal welding point; 42. Distal welding point; 43. Joint welding point. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, not all of them. Therefore, the detailed description of the embodiments of this application provided in the accompanying drawings is not intended to limit the scope of the claimed application, but merely to represent selected embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0040] It should be noted that in the field of interventional medical devices, the end of the medical device that is closer to the clinician inside the body is generally called the proximal end, and the end that is farther from the clinician is called the distal end. This principle is used to define the proximal and distal ends of any part of the interventional device. The axial direction generally refers to the length of the medical device, and the radial direction generally refers to the direction perpendicular to the axial direction.

[0041] The following combination Figures 1-5 This application will be described in further detail.

[0042] This application discloses a method for manufacturing a highly coaxial guidewire. This method ensures that the core wire 1 and the winding wire 2 of the guidewire remain highly coaxial during welding, thereby improving the guidewire's torsional control and passability. It can be passed through the stenotic lesion site via a rotational pushing operation, thus assisting the subsequent passage of balloons, stents, and other devices. The manufacturing method of the highly coaxial guidewire includes the following steps:

[0043] S1. Provide a guide wire preparation material, including a guide wire core wire 1, at least one section of winding wire 2, and at least one intermediate layer 3. The guide wire core wire 1 is preferably made of stainless steel wire or nickel-titanium wire. The guide wire core wire 1 includes a constant diameter section at the proximal end and a variable diameter section at the distal end. The constant diameter section is used to provide sufficient pushing support force. The end of the guide wire core wire 1 is usually flattened to improve the shaping ability of the end of the core wire 1.

[0044] The winding wire 2 is typically made of stainless steel, platinum-tungsten alloy, platinum-nickel alloy, platinum-iridium alloy, and palladium-rhenium alloy wires wound into a spring shape. Different pitches and diameters can be adjusted according to requirements. The wound wire 2 is dimensionally stable and does not spring back. The winding wire 2 can be a single section. If a single section of winding wire 2 is used as the developing winding wire 22, the preferred material is platinum-nickel alloy or platinum-tungsten alloy to improve the developability of the winding wire 2. For high-performance guide wires, at least two sections of winding wire 2 are usually required: one section as the proximal winding wire 21, typically made of stainless steel, and the other section as the distal developing winding wire 22, which in this embodiment is made of platinum-nickel alloy.

[0045] The intermediate layer 3 needs to possess a certain degree of hardness to provide stable rigid support for the core wire 1 and the winding wire 2 during welding without plastic deformation. Furthermore, the intermediate layer 3 needs to be completely soluble in a specific, biocompatible solvent, such as ethanol or a specially formulated aqueous solution. In this embodiment, ethanol is used as the solvent, and the material of the intermediate layer 3 is shellac resin, rosin resin, or other resins soluble in ethanol. The rod-shaped intermediate layer 3 material is directly machined into independent tubular components of a predetermined size, with its inner diameter matching the outer diameter of the core wire 1 at the predetermined welding position, and its outer diameter matching the inner diameter of the corresponding winding wire 2. Alternatively, for areas with complex shapes or extremely small sizes, a thermoforming method can be used. This involves heating and melting the thermoplastic intermediate layer 3 material, directly coating or injecting it onto the surface of the core wire 1, and then shaping it using a micro-mold with a precise internal cavity, thereby forming an intermediate layer 3 that precisely matches the outer contour of the core wire 1 and the inner diameter of the winding wire 2. The intermediate layer 3 is located in the constant-diameter section and the variable-diameter section of the core wire 1.

[0046] The number of intermediate layers 3 is the same as that of the winding 2. Since the size of different winding 2s will be different, the diameter of the intermediate layer 3 will be slightly different. For a single winding 2 structure, one intermediate layer 3 structure is sufficient. For a multi-winding 2 structure, the number of intermediate layer 3 structures needs to match the number of winding 2s. In this embodiment, the multi-winding 2 structure adopts a double winding 2 structure. Therefore, the intermediate layer 3 needs to be set in two sections, including a first intermediate layer 31 and a second intermediate layer 32. The first intermediate layer 31 is used to support and fix the proximal winding 21, and the second intermediate layer 32 is used to support and fix the developing winding 22.

[0047] S2. The core wire 1 is threaded and fixed inside the cavity of the intermediate layer 3, and the winding wire 2 is sleeved and fixed on the outer surface of the intermediate layer 3, so that the core wire 1, the intermediate layer 3 and the winding wire 2 are relatively fixed in the axial direction and remain coaxial.

[0048] Use the pre-processed intermediate layer 3 or the intermediate layer 3 already formed in situ on the core wire 1 as a reference. If using a prefabricated part, the specific part of the core wire 1 to be welded must be smoothly inserted into the inner cavity of the intermediate layer 3. Due to the precise match between the inner cavity size and the outer diameter of the core wire 1, the core wire 1 will be automatically corrected and stably maintained at the geometric center position of the intermediate layer 3, thereby achieving radial positioning. Then, the corresponding section of the winding wire 2 is axially fitted onto the outer surface of the intermediate layer 3. Similarly, due to the precise match between the outer diameter of the intermediate layer 3 and the inner diameter of the winding wire 2, the winding wire 2 will also be automatically centered and held tightly on the intermediate layer 3.

[0049] If there are multiple welding points on the core wire 1 and corresponding to multiple winding wire segments 2, this operation needs to be repeated, using their respective matching intermediate layers 3 for fixation. During this process, the core wire 1, all intermediate layers 3, and all winding wire segments 2 are assembled into a temporary, integrated composite structure. After assembly, a non-contact micrometer or laser displacement sensor can be used to perform preliminary testing on the assembly to confirm that the radial runout of the outer ring of the winding wire 2 is extremely small, thus verifying the coaxial effect.

[0050] S3. With the core wire 1, intermediate layer 3 and winding wire 2 in a fixed state of being coaxial, the core wire 1 and winding wire 2 are welded at at least one solder point.

[0051] Welding fixtures are used to clamp the assembly to prevent it from moving as a whole, thus eliminating its function of precision alignment. The locations and number of welds required are determined according to the product design. For example, for a single-winding wire 2 structure, two welding points are typically provided: a near-end welding point 41 and a far-end welding point 42. The near-end welding point 41 is used to weld between the near end of the developing winding wire 22 and the near end of the core wire 1, and the far-end welding point 42 is used to weld between the far end of the developing winding wire 22 and the far end of the core wire 1.

[0052] For the double-wound wire 2 structure, welding may be performed at multiple locations, such as the start and end ends of the proximal winding wire 21, the junction of the two winding wires 2, and the end of the distal winding wire 2. Taking laser welding as an example, the focus of the laser beam is precisely adjusted to the contact interface between the winding wire 2 and the core wire 1. In this embodiment, the double-wound wire 2 structure is provided with three welding points, including a proximal welding point 41, a junction welding point 43, and a distal welding point 42. The proximal welding point 41 is used to weld at the proximal end of the proximal winding wire 21 and the proximal end of the core wire 1. The distal welding point 42 is used to weld at the distal end of the developing winding wire 22 and the distal end of the core wire 1. The junction welding point 43 is used to weld at the junction of the proximal winding wire 21 and the developing winding wire 22, and is used to weld the distal end of the proximal winding wire 21, the proximal end of the developing winding wire 22, and the core wire 1 located thereto together.

[0053] Because the rigid support of the intermediate layer 3 effectively suppresses deformation caused by thermal stress, and there is no relative displacement between components, the welding process is very stable. By optimizing parameters such as laser power, pulse width, and frequency, a strong metallurgical weld can be formed within a minimal heat-affected zone, achieving a reliable connection between the core wire 1 and the winding wire 2, while perfectly freezing the highly coaxial state at the moment of welding.

[0054] S4. Place the welded components in a solvent to dissolve and remove the intermediate layer 3.

[0055] After welding, the temporary intermediate layer 3 needs to be removed. Based on the solubility characteristics of the intermediate layer 3 material, a suitable solvent and dissolution conditions should be selected. For example, if the intermediate layer 3 is shellac resin or rosin resin, ethanol with a concentration of 75% or higher can be selected as the solvent.

[0056] The assembly with solder joints is immersed in a sufficient amount of the solvent. To accelerate the dissolution process, physical methods are usually employed: first, heating the solvent system to increase molecular motion speed and solubility; second, applying ultrasonic oscillation to utilize cavitation effects to impact and peel off the intermediate layer 3, and promote the exchange of fresh solvent with residues. The dissolution process needs to continue for a sufficient time until microscopic observation confirms that all intermediate layer 3 material has completely dissolved, and no solid residues adhere to the surface of the core wire 1 or remain in the gaps of the winding wire 2.

[0057] S5. Clean the welding assembly after removing the intermediate layer 3 to obtain a wire guide assembly in which the core wire 1 and the winding wire 2 are coaxial in height.

[0058] After dissolution, the surface and interior of the component may retain the dissolved intermediate layer 3 material or solvent. Remove the component from the solution and transfer it to ethanol for immersion and ultrasonic cleaning. This process can be repeated 2-3 times to fully displace and remove any residue. Subsequently, rinse with deionized water as needed to remove any solvent residue. Finally, perform drying treatment, such as drying in a clean inert gas stream or low-temperature vacuum drying.

[0059] This application also provides a guide wire manufactured using the above method.

[0060] The radial deviation between the axis of the core wire 1 and the axis of the winding wire 2 at the welding point of the guide wire is measured, including the following steps.

[0061] 1. Experimental sample preparation and grouping

[0062] In this application, group B (labeled as group B): following the complete process described in the aforementioned manufacturing method embodiments, and with strict control over the parameters of each step, 10 guidewire core component samples were prepared, numbered B-01 to B-10. All samples used the same shellac resin interlayer and ethanol solvent.

[0063] Comparative control group (labeled Group A): The current mainstream precision V-block clamp horizontal welding process was used as a control. Key controls: The same core wire blank, winding material and welding equipment as Group B were used (only the intermediate layer fixing step was removed), and 10 samples were prepared by the same senior technician in the same clean room, numbered A-01 to A-10, to minimize differences in materials, equipment and human factors and ensure the scientific validity of the comparison.

[0064] 2. Testing equipment, methods and testing conditions

[0065] Inspection equipment: Nikon LV150N coordinate measuring machine system, equipped with a 20x long working distance objective lens, a 0.5μm resolution grating ruler and NIS-Elements D automatic image analysis software.

[0066] Testing method: Each sample was horizontally fixed on an air-floating vibration isolation platform. The radial deviation between the axis and the winding axis was measured at each weld point (near-end weld point A, joint weld point B, and far-end weld point C).

[0067] Deviation calculation: Calculate the average radial deviation between the axis and the winding axis at each welding point for groups A and B respectively, and use the average value as the obtained data.

[0068] Environmental conditions: constant temperature (22±0.5)℃ and relative humidity (50±5)% in the laboratory. All samples were equilibrated in the laboratory for 24 hours before testing.

[0069] 3. Original experimental measurement data

[0070] The table below records the measurement results of 20 samples (a total of 60 solder joints), in millimeters (mm).

[0071] Table 1: Measurement results of radial coaxial deviation of weld points for each sample in the comparative example group (Group A)

[0072] Sample number Near-end welding point A Handover welding point B Remote welding point C A-01 0.0192 0.0501 0.0883 A-02 0.0205 0.0518 0.0927 A-03 0.0188 0.0493 0.0859 A-04 0.0221 0.0546 0.0951 A-05 0.0197 0.0522 0.0904 A-06 0.0213 0.0487 0.0876 A-07 0.0208 0.0531 0.0938 A-08 0.0195 0.0509 0.0892 A-09 0.0216 0.0553 0.0960 A-10 0.0189 0.0478 0.0865

[0073] Table 2: Measurement results of radial coaxial deviation of weld points for each sample in Group B of this application

[0074] Sample number Near-end welding point A Handover welding point B Remote welding point C B-01 0.0085 0.0098 0.0179 B-02 0.0091 0.0105 0.0186 B-03 0.0082 0.0093 0.0172 B-04 0.0098 0.0112 0.0195 B-05 0.0089 0.0101 0.0180 B-06 0.0095 0.0108 0.0189 B-07 0.0086 0.0096 0.0175 B-08 0.0093 0.0106 0.0184 B-09 0.0084 0.0095 0.0174 B-10 0.0090 0.0103 0.0182

[0075] 4. Statistical Analysis and Results

[0076] Statistical analysis was performed on the above data, and the average value of each group at each solder joint position was calculated. The results are shown in the table below.

[0077] Table 3: Comparison of the average radial coaxial deviation of the two groups of samples (unit: mm)

[0078] Groups and parameters Near-end welding point A Handover welding point B Remote welding point C Comparative control group (Group A) 0.0204 0.05138 0.09055 This application is in Group B. 0.00893 0.0107 0.01816

[0079] The guide wires manufactured in this application (Group B) have the following characteristics: at the near-end welding point 41, the radial average deviation between the axis of the core wire 1 and the axis of the winding wire 2 is approximately 0.01 mm; at the far-end welding point 42, the radial deviation between the axis of the core wire 1 and the axis of the winding wire 2 is approximately 0.02 mm; and at the junction welding point 43B, the radial deviation between the axis of the core wire 1 and the axis of the winding wire 2 is between the above two.

[0080] The guide wires made in the comparative group (Group A) showed that the average radial deviation between the axis of the core wire 1 and the axis of the winding wire 2 was about 0.02 mm at the near-end welding point 41, and about 0.09 mm at the far-end welding point 42; and about 0.05 mm at the junction welding point 43B.

[0081] This application not only improves the coaxial accuracy of the near-end welding point 41 to approximately 0.01 mm, but more importantly, it significantly reduces the deviation of the far-end welding point 42 to approximately 0.02 mm, bringing the far-end welding point 42 to the same high-precision level as the near-end welding point. The deviation of the far-end welding point 42 is reduced by approximately 78% compared to the prior art, solving the problem of coaxiality deteriorating as the core wire 1 becomes thinner. This application achieves a high level of consistency in the coaxiality of the welding points throughout the entire length of the guide wire.

[0082] This application also provides a guide wire, including a core wire 1 and a winding wire 2 sleeved thereon. The core wire 1 includes a constant diameter section at the proximal end and a variable diameter section at the distal end. The winding wire 2 includes at least two sections, wherein the distal section is a developing winding wire 22. The core wire 1 and the winding wire 2 are welded and fixed at the joints of each section, and the core wire 1 and the winding wire 2 are highly coaxial at all weld points.

[0083] The above description is merely a preferred embodiment of this application and is not intended to limit this application. Various modifications and variations can be made to this application by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of this application should be included within the protection scope of this application.

Claims

1. A method of manufacturing a high-coaxiality guide wire, characterized by, Includes the following steps: S1. Provide a guide wire preparation material, including a guide wire core wire (1), at least one section of winding wire (2) and at least one intermediate layer (3); the intermediate layer (3) is processed to have an inner cavity that matches the outer diameter of the core wire (1) and an outer surface that matches the inner diameter of the winding wire (2); S2. The core wire (1) is threaded through and fixed into the inner cavity of the intermediate layer (3), and the winding wire (2) is sleeved and fixed onto the outer surface of the intermediate layer (3), so that the core wire (1), the intermediate layer (3) and the winding wire (2) are relatively fixed in the axial direction and remain coaxial. S3. While the core wire (1), intermediate layer (3) and winding wire (2) are kept coaxial and fixed, the core wire (1) and the winding wire (2) are welded at at least one welding point. S4. Place the welded components in a solvent to dissolve and remove the intermediate layer (3); S5. Clean the welding assembly after removing the intermediate layer (3) to obtain a wire guide assembly with the core wire (1) and the winding wire (2) being coaxial in height; The core wire (1) has a constant diameter section at the near end and a variable diameter section at the far end, and the intermediate layer (3) provides rigid support and precise positioning for at least the variable diameter section of the core wire (1). The winding (2) includes at least two segments, of which at least one segment is a distal developing winding (22); the intermediate layer (3) is configured to be at least two, and the outer diameters of the at least two intermediate layers (3) are different from each other, so as to match the windings (2) with different inner diameters respectively.

2. The method of manufacturing a high-coaxiality guide wire according to claim 1, wherein The material of the distal developing winding wire (22) is a platinum-nickel alloy, a platinum-tungsten alloy, a platinum-iridium alloy, or a palladium-rhenium alloy.

3. The method of claim 1, wherein the high-coaxiality guide wire is manufactured by the steps of: The solvent is ethanol, and the intermediate layer (3) material is shellac resin, rosin resin or other resins soluble in ethanol.

4. The method of claim 1, wherein the high-coaxiality guide wire is manufactured by the steps of: In step S1, the intermediate layer (3) is formed by machining prefabricated rods.

5. The method of claim 1, wherein In step S1, the intermediate layer (3) is formed by hot-melt coating of thermoplastic material onto the surface of the core wire (1) and shaping it.

6. The method of claim 1, wherein the high-coaxiality guide wire is manufactured by the steps of: In step S4, dissolution is accelerated by heating and / or ultrasonic oscillation.

7. A guidewire comprising: It is manufactured by the method according to any one of claims 1 to 6.

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