guide wire

CN224877139UActive Publication Date: 2026-10-23SUZHOU HENGRUI HONGYUAN MEDICAL TECH CO LTD
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Patent Information

Application Number
CN202522235545.7
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2025-10-22
Publication Date
2026-10-23
Estimated Expiration
2035-10-22

AI Technical Summary

Technical Problem

但不锈钢和镍钛作为不同种材料,材料的成分和特性有着较明显的差别,以目前的焊接技术或粘接技术难以实现两种材料的完美过渡,使得不锈钢丝和镍钛丝连接处的性能比较突兀,近端到远端的力传递效率降低,影响导丝的性能,同时在使用过程中也可能会造成不锈钢丝和镍钛丝连接处的断裂,产品可靠性低

Benefits of technology

[0014]有益效果:本申请通过设置具有不锈钢段和镍钛段的芯丝,使得导丝从近端的刚性到远端的柔性实现渐进式过渡,使导丝在推送过程中更加流畅,提升操控的稳定性和可预测性,且不锈钢段和镍钛段之间通过插接方式配合焊接,提高不锈钢段与镍钛段之间的连接稳定性。同时,芯丝外围的绕丝增强导丝的整体强度和抗扭结能力,且绕丝表面涂覆的疏水涂层能显著降低导丝表面的摩擦系数,使其在血管内或导管内推送时更加顺滑,减少导丝在推动过程中受到的阻力,从而提高推送效率。

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Abstract

The application discloses a guide wire, which comprises a core wire, a winding wire and a hydrophobic coating. The core wire comprises a stainless steel section at a proximal end and a nickel-titanium section at a distal end. The stainless steel section and the nickel-titanium section are connected by welding. One end of the stainless steel section is provided with a first plug-in structure, and one end of the nickel-titanium section is provided with a second plug-in structure. The first plug-in structure and the second plug-in structure are plug-in matched. The winding wire is wound around the periphery of the core wire. Two ends of the winding wire are flush with two ends of the core wire. The surface of the winding wire is coated with the hydrophobic coating. The core wire with the stainless steel section and the nickel-titanium section is arranged, so that the guide wire gradually transitions from rigidity at the proximal end to flexibility at the distal end. The stainless steel section and the nickel-titanium section are matched by plug-in welding, so as to improve the connection stability between the stainless steel section and the nickel-titanium section. Meanwhile, the winding wire enhances the overall strength and the anti-kinking ability of the guide wire. The hydrophobic coating on the surface of the winding wire can significantly reduce the friction coefficient of the surface of the guide wire, so as to improve the pushing efficiency.
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Description

Technical Field

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

[0002] In existing technologies, the core wire in a guidewire is composed of stainless steel wire and nickel-titanium wire connected by welding or bonding to achieve proximal support and distal flexibility. However, stainless steel and nickel-titanium are different materials with significant differences in composition and properties. Current welding or bonding techniques cannot achieve a perfect transition between the two materials, resulting in abrupt performance at the connection point. This reduces the force transmission efficiency from proximal to distal, affecting the guidewire's performance. Furthermore, breakage at the connection point may occur during use, leading to low product reliability. Utility Model Content

[0003] The main technical problem addressed by this application is to provide a guidewire that can improve the product reliability of the guidewire.

[0004] To solve the above-mentioned technical problems, this application adopts a technical solution: providing a guide wire, comprising: a core wire, including a proximal stainless steel segment and a distal nickel-titanium segment, wherein the stainless steel segment and the nickel-titanium segment are welded together, and one end of the stainless steel segment is provided with a first insertion structure, and one end of the nickel-titanium segment is provided with a second insertion structure, wherein the first insertion structure and the second insertion structure are inserted and engaged; and a winding wire, which is wound around the periphery of the core wire, wherein both ends of the winding wire are flush with both ends of the core wire, and the surface of the winding wire is coated with a hydrophobic coating.

[0005] In this embodiment, one of the first plug-in structure and the second plug-in structure includes a protrusion, and the other includes a groove for receiving the protrusion.

[0006] The protrusions are cylindrical or cross-shaped, and the shape of the grooves matches the shape of the protrusions.

[0007] The outer peripheral surface of the protrusion is provided with external threads, the groove wall is provided with internal threads, and the protrusion and the groove are threadedly connected.

[0008] In this embodiment, one of the first plug-in structure and the second plug-in structure includes a protrusion, and the other includes a coiled spring that receives the protrusion.

[0009] In particular, the diameter of the nickel-titanium segment gradually decreases at its distal end in the direction away from the stainless steel segment.

[0010] The winding wire is welded to the core wire.

[0011] The welding positions between the winding wire and the core wire include at least the welding point at the near end and the welding point at the far end.

[0012] The winding wire has a single-layer or multi-layer structure.

[0013] The material of the winding wire includes stainless steel, and the material of the hydrophobic coating includes polytetrafluoroethylene.

[0014] Beneficial Effects: This application, by incorporating a core wire with stainless steel and nickel-titanium segments, achieves a gradual transition from proximal rigidity to distal flexibility in the guidewire. This results in smoother guidewire advancement, improved stability and predictability of maneuvering. Furthermore, the stainless steel and nickel-titanium segments are welded together via a plug-in connection, enhancing the connection stability between them. Simultaneously, the outer wrapping around the core wire strengthens the overall guidewire and improves its resistance to kinking. The hydrophobic coating on the wrapping surface significantly reduces the coefficient of friction, making advancement within blood vessels or catheters smoother and reducing resistance during advancement, thereby improving advancement efficiency. Attached Figure Description

[0015] To more clearly illustrate the technical solutions in the embodiments of this application, the accompanying drawings used in the description of the embodiments 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. Wherein: Figure 1 This is a schematic diagram of the guidewire provided in one embodiment of this application; Figure 2 This is a schematic diagram of the core wire structure provided in one embodiment of this application; Figure 3 This is a schematic diagram of the core wire structure provided in another embodiment of this application; Figure 4 This is a schematic diagram of the core wire structure provided in another embodiment of this application; Figure 5 This is a schematic diagram of the core wire structure provided in another embodiment of this application; Figure 6 This is a schematic diagram of the core wire structure provided in another embodiment of this application. Detailed Implementation

[0016] 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, and not all of the embodiments. Based on the embodiments of this application, all other embodiments obtained by those of ordinary skill in the art without creative effort are within the scope of protection of this application.

[0017] The terms "first," "second," and "third" in this application are 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," "second," or "third" may explicitly or implicitly include at least one of that feature. In the description of this application, "multiple" means at least two, such as two, three, etc., unless otherwise explicitly specified. All directional indications (such as up, down, left, right, front, back, etc.) in the embodiments of this application are only used to explain the relative positional relationships and movements between components in a specific orientation (as shown in the figures). If the specific orientation changes, the directional indications also change accordingly. Furthermore, the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or device that includes a series of steps or units is not limited to the listed steps or units, but may optionally include steps or units not listed, or may optionally include other steps or units inherent to these processes, methods, products, or devices.

[0018] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0019] In this article, "distal" and "proximal" are used as directional terms, which are commonly used in the field of interventional medical devices. "Distal" refers to the end furthest from the operator during the procedure, while "proximal" refers to the end closest to the operator. "Axial" refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; "radial" refers to the direction perpendicular to the aforementioned "axial".

[0020] Please see Figure 1 This application provides a guide wire 100, which is used in the field of minimally invasive intervention to serve as a guide and for rapid positioning in various interventional procedures during interventional treatment.

[0021] The guide wire 100 includes a core wire 10 and a winding wire 20 wrapped around the core wire 10. The core wire 10 is the core support part of the guide wire 100, which determines the overall mechanical properties of the guide wire 100, such as rigidity, flexibility, torsion resistance and pushing ability. The winding wire 20 enables the core wire 10 to move forward smoothly during the insertion process.

[0022] Specifically, the core wire 10 includes a stainless steel segment 11 at the proximal end 101 and a nickel-titanium segment 12 at the distal end 102, with the stainless steel segment 11 and the nickel-titanium segment 12 interconnected.

[0023] The proximal end 101 of the guidewire 100 is usually the end closest to the operator. Stainless steel has high rigidity and torsional strength. Therefore, using stainless steel to prepare the proximal end 101 of the core wire 10 makes it easier for the operator to apply pushing force and rotation control outside the body, ensuring efficient force transmission and enabling the guidewire 100 to accurately respond to the operator's instructions.

[0024] The distal end 102 of the guidewire 100 is the end furthest from the operator. Nickel-titanium has superelasticity and shape memory effect, and can quickly return to its original shape after bending or being compressed. Therefore, the distal end 102 of the core wire 10 is made of nickel-titanium material, which makes the distal end 102 of the guidewire 100 soft and elastic, and can conform to the course of the blood vessel, thereby reducing the damage of the guidewire 100 to the blood vessel wall, reducing the risk of complications such as perforation or dissection during intervention, and improving the safety of the guidewire 100.

[0025] The winding filament 20 is wound around the outer periphery of the core filament 10. The two ends of the winding filament 20 are flush with the two ends of the core filament 10, and the surface of the winding filament 20 is coated with a hydrophobic coating (not shown).

[0026] The guidewire 20 is typically a spiral metal wire wound around the periphery of the core wire 10. The guidewire 20 has a tightly wound structure, meaning that each turn of the guidewire 20 is tightly fitted together. By setting the guidewire 20 around the core wire 10, the guidewire 100 can advance smoothly in tortuous blood vessels while reducing direct contact between the core wire 10 and the blood vessel, thus lowering the risk of injury.

[0027] The alignment of the two ends of the winding 20 with the two ends of the core wire 10 helps maintain the overall contour consistency of the guide wire 100 and reduces the risk of step effects or jamming during the push process. The hydrophobic coating applied to the winding 20 can significantly reduce the coefficient of friction on the surface of the guide wire 100, which helps to reduce the adhesion of blood, tissue fluid, etc. on the surface of the guide wire 100, making the guide wire 100 easier to advance and rotate in complex paths, thereby improving sliding performance.

[0028] In the aforementioned guidewire 100, by incorporating a core wire 10 with a stainless steel section 11 and a nickel-titanium section 12, the guidewire 100 achieves a gradual transition from rigidity at the proximal end 101 to flexibility at the distal end 102. This makes the guidewire 100 smoother during deployment, improving the stability and predictability of manipulation. Simultaneously, the surrounding wire 20 enhances the overall strength and anti-kink capability of the guidewire 100, and the hydrophobic coating on the surface of the surrounding wire 20 significantly reduces the coefficient of friction on the guidewire 100 surface, making it smoother during deployment within blood vessels or catheters, reducing resistance encountered during the advancement process, and thus improving deployment efficiency.

[0029] Please refer to the following: Figure 1 and Figure 2 In one embodiment, the stainless steel segment 11 and the nickel-titanium segment 12 are welded together. By welding the stainless steel segment 11 and the nickel-titanium segment 12, the functional requirements of the guide wire 100—rigid at the proximal end 101 and flexible at the distal end 102—can be met while ensuring that the core wire 10 has high strength, small size and high surface quality.

[0030] In one embodiment, the welding method between the stainless steel segment 11 and the nickel-titanium segment 12 includes any one of laser welding, soldering, or hot-melt welding. Laser welding utilizes a high-energy laser beam focused on the connection area between the stainless steel segment 11 and the nickel-titanium segment 12, causing localized melting and fusion of the metals. Laser welding features concentrated heat input and a small heat-affected zone, reducing the risk of performance degradation at the distal end 102 of the nickel-titanium segment 12. Soldering uses tin-based solder (such as tin-lead or tin-silver-copper) to melt at a lower temperature, filling the connection gap and forming a metallurgical bond. Hot-melt welding typically refers to resistance welding, friction welding, or arc welding to weld the stainless steel segment 11 and the nickel-titanium segment 12 together. It is understood that the specific welding method between the stainless steel segment 11 and the nickel-titanium segment 12 in this application is determined according to requirements and is not limited herein.

[0031] Please refer to it again. Figure 1 In one embodiment, the winding wire 20 is welded to the core wire 10. The winding wire 20 and the core wire 10 are fixed by welding to form an integrated guide wire 100, thereby improving the structural stability of the guide wire 100.

[0032] In one embodiment, the welding positions between the winding filament 20 and the core filament 10 include at least a proximal welding point 101 and a distal welding point 102. The proximal welding point 101 refers to welding the starting end of the winding filament 20 to the proximal end 101 of the core filament 10, reducing the risk of the winding filament 20 shifting backward during the pushing process. The distal welding point 102 refers to welding the end of the winding filament 20 to the distal end 102 of the core filament 10, reducing the risk of the winding filament 20 unraveling within the blood vessel and causing tissue injury.

[0033] In one embodiment, the welding position between the winding wire 20 and the core wire 10 further includes intermediate spot welding, that is, spot welding is performed in the middle area between the winding wire 20 and the core wire 10, thereby enhancing the overall structural stability of the guide wire 100. It is understood that the number of intermediate spot welds is set according to the specific requirements and is not limited here.

[0034] In one embodiment, the welding method between the winding wire 20 and the core wire 10 includes plasma ball welding or solder welding. Plasma ball welding utilizes a micro-plasma arc or high-frequency arc to instantaneously heat the end of the metal wire (e.g., the starting / ending end of the winding wire 20), melting it and forming a smooth spherical structure, i.e., a molten ball, under surface tension. This molten ball simultaneously fuses with the proximal end 101 / distal end 102 of the core wire 10, achieving both mechanical anchoring and metallurgical bonding. Solder welding uses a low-melting-point solder (such as tin-lead or tin-silver-copper alloy) which, after heating and melting, fills the connection interface (between the winding wire 20 and the core wire 10), forming a connection upon cooling. It is understood that the specific welding method between the winding wire 20 and the core wire 10 in this application is determined according to requirements and is not limited herein.

[0035] In one embodiment, the material of the winding 20 includes stainless steel, which has high strength, good ductility, and is easy to perform precision spiral winding. In other embodiments, the material of the winding 20 can also be a combination of stainless steel and nickel-titanium, depending on the requirements, and is not limited here.

[0036] Please continue reading. Figure 1 In one embodiment, the winding 20 is a single-layer structure, which enables the transfer of mechanical properties between the proximal end 101 and the distal end 102 of the guide wire 100, reducing torque loss. In other embodiments, without changing the practicality of the guide wire 100, the winding 20 can be set as a double-layer or multi-layer structure. The material of the multi-layer structure can be the same, for example, all of them can be stainless steel, or the materials of the multi-layer structure can be different, depending on the requirements, and no restrictions are imposed here.

[0037] In one embodiment, the hydrophobic coating material includes polytetrafluoroethylene (PTFE) to reduce friction during the insertion of the guide wire 100. In other embodiments, the hydrophobic coating material also includes fluorinated polyethylene or other synthetic fluoropolymers, depending on the requirements and not limited herein.

[0038] Please refer to it again. Figure 1 and Figure 2In one embodiment, the diameter of the distal end 102 of the nickel-titanium segment 12 gradually decreases in the direction away from the stainless steel segment 11, that is, the distal end 102 of the nickel-titanium segment 12 decreases continuously or in a stepwise manner, forming a conical structure. The smaller the diameter of the distal end 102 of the nickel-titanium segment 12, the lower its stiffness, making the distal end 102 of the nickel-titanium segment 12 more flexible and able to safely pass through tortuous, narrow, or fragile blood vessels, thus improving the safety of the guidewire 100.

[0039] Please refer to the following: Figure 1 and Figure 3 In one embodiment, one end of the stainless steel segment 11 is provided with a first insertion structure 30, and one end of the nickel-titanium segment 12 is provided with a second insertion structure 40. The first insertion structure 30 and the second insertion structure 40 are inserted and fitted together. Based on the welding of the stainless steel segment 11 and the nickel-titanium segment 12, the addition of the first insertion structure 30 and the second insertion structure 40 provides a more complete connection, further improving the connection strength between the stainless steel segment 11 and the nickel-titanium segment 12. This enhances the tensile and torsional strength of the guide wire 100, providing high elasticity and toughness under significant deformation, and reducing the likelihood of breakage.

[0040] In one embodiment, the connection method of the first plug-in structure 30 and the second plug-in structure 40 includes any one of interference fit, snap fit or threaded connection, which is set according to the requirements and is not limited here.

[0041] Please continue reading. Figure 1 and Figure 3 In one embodiment, one of the first insertion structure 30 and the second insertion structure 40 includes a protrusion 50, and the other includes a groove 60 for receiving the protrusion 50. For example, when the protrusion 50 is provided as the first insertion structure 30 on the stainless steel section 11, the groove 60 is provided as the second insertion structure 40 on the nickel-titanium section 12; conversely, when the protrusion 50 is provided as the second insertion structure 40 on the nickel-titanium section 12, the groove 60 is provided as the first insertion structure 30 on the stainless steel section 11. The cooperation between the protrusion 50 and the groove 60 ensures that the stainless steel section 11 and the nickel-titanium section 12 are aligned axially during connection, reducing the risk of eccentricity or misalignment during connection and improving the overall straightness and maneuverability of the guide wire 100.

[0042] Please refer to the following: Figure 1 , Figure 3 and Figure 4In one embodiment, the protrusion 50 has a cylindrical or cross-shaped structure, and the shape of the groove 60 matches the shape of the protrusion 50. That is, for a cylindrical protrusion, the groove 60 is a corresponding cylindrical hole, and the groove 60 and the cylindrical protrusion 50 can be heat-welded together; for a cross-shaped protrusion, the inside of the groove 60 is a corresponding cross-shaped keyway to accommodate the cross-shaped fins on the cross-shaped protrusion, and the groove 60 and the cross-shaped protrusion can be heat-welded together, thereby enhancing the circumferential locking capability of the first insertion structure 30 and the second insertion structure 40 and reducing the risk of relative rotation of the first insertion structure 30 and the second insertion structure 40.

[0043] In other embodiments, the protrusion 50 may also be conical, rectangular or other irregular shapes, depending on the requirements, and is not limited here.

[0044] Please refer to the following: Figure 1 and Figure 5 In one embodiment, the outer peripheral surface of the protrusion 50 is provided with external threads, and the groove wall of the groove 60 is provided with internal threads, and the protrusion 50 and the groove 60 are threadedly connected. By screwing the externally threaded protrusion 50 into the internally threaded groove 60, a helical mechanical lock is formed between the first insertion structure 30 and the second insertion structure 40, providing good axial fixation and torque transmission capability for the core wire 10.

[0045] It is understandable that after the external thread protrusion 50 is screwed into the internal thread groove 60, the groove 60 and the protrusion 50 can be heat-welded together to further improve the structural strength of the core wire 10.

[0046] Please refer to the following: Figure 1 and Figure 6 In one embodiment, one of the first insertion structure 30 and the second insertion structure 40 includes a protrusion 50, and the other includes a coiled spring 70 that receives the protrusion 50. The coiled spring 70 is a hollow tubular structure formed by tightly wound metal wire. When the coiled spring 70 serves as the second insertion structure 40, its inner diameter is slightly smaller than the outer diameter of the protrusion 50. When the protrusion 50 is inserted into the coiled spring 70, the coiled spring 70 elastically expands, wrapping around and clamping the protrusion 50, thus achieving an interference fit connection between the first insertion structure 30 and the second insertion structure 40. Simultaneously, the coiled spring 70 is elastic, providing continuous clamping force while absorbing some impact loads, thereby improving the connection stability between the first insertion structure 30 and the second insertion structure 40.

[0047] It is understandable that after the protrusion 50 is inserted into the coiled spring 70, the protrusion 50 and the coiled spring 70 can be soldered together to further improve the structural strength of the core wire 10.

[0048] In the aforementioned guidewire 100, the core wire 10, comprising a stainless steel segment 11 and a nickel-titanium segment 12, allows for a gradual transition from the rigidity of the proximal end 101 to the flexibility of the distal end 102. This makes the guidewire 100 smoother during deployment, improving the stability and predictability of manipulation. Furthermore, the stainless steel segment 11 and the nickel-titanium segment 12 are welded together via a plug-in connection, enhancing the connection stability between them. Simultaneously, the surrounding wire 20 of the core wire 10 strengthens the overall strength and anti-kink capability of the guidewire 100. The hydrophobic coating on the surface of the wire 20 significantly reduces the coefficient of friction on the guidewire 100 surface, making it smoother during deployment within blood vessels or catheters, reducing resistance during advancement, and thus improving deployment efficiency.

[0049] The above are merely embodiments of this application and do not limit the scope of this patent application. Any equivalent structural or procedural changes made using the content of this application's specification and drawings, or direct or indirect applications in other related technical fields, are similarly included within the scope of patent protection of this application.

Claims

1. A guidewire, characterized in that, include: The core wire includes a stainless steel segment at the near end and a nickel-titanium segment at the far end. The stainless steel segment and the nickel-titanium segment are welded together. One end of the stainless steel segment is provided with a first insertion structure, and one end of the nickel-titanium segment is provided with a second insertion structure. The first insertion structure and the second insertion structure are inserted and engaged. The winding wire is wrapped around the periphery of the core wire, with both ends of the winding wire being flush with both ends of the core wire, and the surface of the winding wire is coated with a hydrophobic coating.

2. The guidewire according to claim 1, characterized in that, One of the first plug-in structure and the second plug-in structure includes a protrusion, and the other includes a groove for receiving the protrusion.

3. The guidewire according to claim 2, characterized in that, The protrusion has a cylindrical or cross-shaped structure, and the shape of the groove matches the shape of the protrusion.

4. The guidewire according to claim 2, characterized in that, The outer peripheral surface of the protrusion is provided with external threads, the groove wall is provided with internal threads, and the protrusion and the groove are threadedly connected.

5. The guidewire according to claim 1, characterized in that, One of the first plug-in structure and the second plug-in structure includes a protrusion, and the other includes a coiled spring that receives the protrusion.

6. The guidewire according to claim 1, characterized in that, The diameter of the nickel-titanium segment gradually decreases at its distal end in the direction away from the stainless steel segment.

7. The guidewire according to claim 1, characterized in that, The winding wire is welded to the core wire.

8. The guidewire according to claim 7, characterized in that, The welding positions between the winding wire and the core wire include at least the welding point at the near end and the welding point at the far end.

9. The guidewire according to claim 1, characterized in that, The winding wire has a single-layer or multi-layer structure.

10. The guidewire according to claim 1, characterized in that, The material of the winding includes stainless steel, and the material of the hydrophobic coating includes polytetrafluoroethylene.