A guidewire

Abstract

The application provides a guide wire, and relates to the technical field of medical devices. The guide wire can improve the convenience of the guide wire passing through the stent mesh and the initiative of the guide wire passing through microchannels, plaques and subintima. The guide wire comprises an extension section, a bending section and a bending-off section. The extension section is located at the proximal end of the guide wire. The bending section extends from the distal end of the extension section. The bending axis of the bending section continuously bends and extends in the plane where the axial direction and the radial direction of the guide wire are located. The bending-off section extends from the distal end of the bending section. The axis of the bending-off section is located in the plane where the axial direction and the radial direction are located. The axis of the bending-off section and the tangent line of the distal end of the bending axis have an acute angle.

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 medical consumables used for puncture positioning and guidance in interventional diagnosis and treatment. Based on clinical application, they can be divided into types such as urinary tract guidewires and coronary guidewires, with different specifications covering scenarios such as vascular intervention and endoscopic surgery. In some interventional treatments, a portion of the reason for treatment failure is that the guidewire cannot pass through the lesion site. Therefore, a guidewire that can easily pass through the lesion site is needed. Utility Model Content

[0003] This application provides a guidewire that can improve the ease of passing the guidewire through the stent mesh and also improve the guidewire's active passage through microchannels, plaques, and subendothelial areas.

[0004] The guidewire provided in this application includes: an extension section, a curved section, and a folded section; wherein, the extension section is located at the proximal end of the guidewire; the curved section extends from the distal end of the extension section, and the curvature axis of the curved section extends continuously in the plane containing the axial and radial directions of the guidewire; the folded section extends from the distal end of the curved section, and the axis of the folded section is located in the plane containing the axial and radial directions, and the axis of the folded section forms an acute angle with the tangent at the distal end of the curved axis.

[0005] The guidewire provided in this application, due to the continuously curved section formed at the distal end of its extension segment, facilitates the complete transfer of rotational force on the extension segment to the curved section during insertion into lesions such as blood vessels. This makes it easier to control the orientation of the curved section at its distal end, and consequently, the direction of the guidewire's advance within the blood vessel. Thus, when using the guidewire provided in this embodiment to pass through stents, microchannels, plaques, and subintimal tissue within a blood vessel, the orientation and direction of the curved section can be quickly and accurately adjusted, allowing the guidewire to rapidly pass through stent mesh, lesion microchannels, plaques, and subintimal tissue. Therefore, the guidewire provided in this embodiment improves the ease of passing through stent mesh and enhances the guidewire's active passage through microchannels, plaques, and subintimal tissue.

[0006] In one possible implementation of this application, the distal end of the curved section is offset from the axis of the extension section by a distance greater than or equal to 10 times the outer diameter of the guidewire along the radial direction of the guidewire.

[0007] In one possible implementation of this application, the length of the bent section is greater than or equal to 5 mm; and / or, the length of the bent section is less than or equal to 10 mm.

[0008] In one possible implementation of this application, the axis of the bent section is perpendicular to the axis of the guide wire.

[0009] In one possible implementation of this application, the length of the bent section is greater than or equal to twice the outer diameter of the guidewire.

[0010] In one possible implementation of this application, the guidewire includes a first mandrel and a second mandrel connected together, the second mandrel being located in an extension section, the first mandrel extending sequentially through the extension section, the bending section and the folding section, and the stiffness of the first mandrel being greater than that of the second mandrel.

[0011] In one possible implementation of this application, the ratio of the length of the first mandrel to the length of the guide wire ranges from 0.025 to 0.6.

[0012] In one possible implementation of this application, the guidewire further includes a reinforcing member sleeved at the distal end of the first mandrel, and the reinforcing member at least covers the portion of the first mandrel located in the bending and folding sections.

[0013] In one possible implementation of this application, the guidewire further includes a protective layer that covers at least a portion of the reinforcing member and the first mandrel.

[0014] In one possible implementation of this application, the guidewire further includes an outer coating that covers the outer surface of the guidewire and is hydrophilic. Attached Figure Description

[0015] Figure 1 A schematic diagram of the microchannel for chronic total occlusion of the coronary artery provided in this application;

[0016] Figure 2 Schematic diagram of the guidewire provided in this application Figure 1 ;

[0017] Figure 3 Schematic diagram of the guidewire provided in this application Figure 2 ;

[0018] Figure 4 A schematic diagram showing the guidewire provided in this application returning to the true lumen from under the intima;

[0019] Figure 5 A schematic diagram of the guidewire passing through the support mesh provided in this application;

[0020] Figure 6 Provided for this application Figure 3 A magnified view of part A in the diagram.

[0021] Explanation of reference numerals in the attached figures:

[0022] 1-Guidewire; 11-Extension segment; 12-Bent segment; 13-Bent segment; 14-First mandrel; 15-Second mandrel; 16-Reinforcing element; 17-Protective layer; 18-Welding area; 2-Vascular vessel; 3-CTO lesion; 4-Microchannel; 5-Subintimal; 6-True lumen; 7-Stent; H-Offset distance; Y-Radial; Z-Axial. Detailed Implementation

[0023] 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.

[0024] 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] Cardiovascular and cerebrovascular diseases seriously affect people's health and lives. 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, the stenosis can be effectively treated, restoring normal blood flow and ensuring blood supply.

[0030] Guidewires are an indispensable component of interventional medical devices and are widely used in interventional procedures. Approximately 95% of the failures in percutaneous coronary intervention (PCI) for chronic total occlusion (CTO) are due to guidewire failure to pass through the lesion; therefore, guidewires play a crucial role in the management of CTO lesions.

[0031] Reference Figure 1 , Figure 1 This is a schematic diagram of the microchannel for chronic total occlusion (CTO) lesions provided in this application. In related technologies, for CTO lesions 3 with microchannels 4, guidewire 1 is advanced anterogradely through the lesion by probing within the loose potential channel. However, due to the complexity of the anatomical structure of the vessel 2 and the fact that microchannels 4 are usually discontinuous, several problems arise. For example, guidewire 1 may have difficulty passing through microchannels 4, requiring replacement and making the procedure time-consuming and laborious; guidewire 1 may easily enter the subintimal region 5 and, once inside, is difficult to return to the true lumen 6 of the vessel 2. Furthermore, during the procedure, there are often multiple lesion sites. When treatment of one lesion is completed and treatment of the next lesion is needed, guidewire 1 often needs to pass through the stent 7 at the previous lesion site. In this case, guidewire 1 is prone to problems such as: an unsuitable tip bend or easy deformation, making it difficult for guidewire 1 to pass through the stent 7 mesh, leading to surgical delays. In severe cases, guidewire 1 may become stuck within the stent 7, resulting in damage to the stent 7 or guidewire 1.

[0032] This application provides a guidewire 1 that improves the ease with which the guidewire 1 passes through the mesh of the stent 7, and also enhances the active passage of the guidewire 1 through microchannels 4, plaques, and subendothelial 5, etc. (Refer to...) Figure 2 and Figure 3 , Figure 2 Schematic diagram of the guidewire provided in this application Figure 1 , Figure 3Schematic diagram of the guidewire provided in this application Figure 2 .

[0033] The guidewire 1 provided in this embodiment includes: an extension section 11, a bending section 12, and a folded section 13; wherein, the extension section 11 is located at the proximal end of the guidewire 1; the bending section 12 extends from the distal end of the extension section 11, and the bending axis of the bending section 12 extends continuously in the plane containing the axial direction Z and the radial direction Y of the guidewire 1; the folded section 13 extends from the distal end of the bending section 12, and the axis of the folded section 13 is located in the plane containing the axial direction Z and the radial direction Y, and the axis of the folded section 13 forms an acute angle with the tangent at the distal end of the bending axis.

[0034] In this embodiment, the guidewire 1 can be configured as a long and thin strip structure, for example, a long and thin cylindrical strip. The length and outer diameter of the guidewire 1 can be set according to the specific application scenario. For example, the length of the guidewire 1 can be set to 100cm to 400cm, and the outer diameter of the guidewire 1 can be set to less than or equal to 0.4mm. This embodiment does not impose specific limitations on the length and outer diameter of the guidewire 1.

[0035] In this embodiment, along the axial direction Z of the guidewire 1, the guidewire 1 can be configured as an extension segment 11, a curved segment 12, and a bent segment 13. The extension segment 11 is the proximal portion of the guidewire 1, and in its natural state (without external force), it is typically straight or nearly straight. The length of the extension segment 11 can be greater than or equal to two-thirds of the length of the guidewire 1. Both the curved segment 12 and the bent segment 13 are located at the distal end of the guidewire 1. The curved segment 12 connects to the distal end of the extension segment 11, meaning it extends from the distal end of the extension segment 11. The bent segment 13 is located on one side of the distal end of the curved segment 12.

[0036] It should be noted that, in this application, "distal" and "proximal" refer to the extension direction of the guidewire 1 (extension segment 11) 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 right side of the middle, the proximal end is Figure 2 Left side of the middle, such as Figure 3 As shown, the far end is Figure 3 The upper end, proximal end is Figure 3 Lower middle section.

[0037] For example, such as Figure 2 and Figure 3As shown, the bending section 12 can be configured as a gradually changing arc shape. For example, along the direction from the extension section 11 to the bend section 13, the curvature of the bending axis of the bending section 12 can gradually increase, meaning that the degree of bending of the bending section 12 near the extension section 11 is smaller, and the degree of bending of the bending section 12 is greater as it approaches the bend section 13. The bending section 12 always bends within the same plane, that is, the bending axis Z of the bending section 12 lies in the plane containing the axial Z and radial Y axes of the guide wire 1.

[0038] Another example, such as Figure 2 and Figure 3 As shown, a bent segment 13 can be formed by extending from the distal end of the bent segment 12. For example, the bent segment 13 can be cylindrical, and the distal end of the bent segment 13 can be formed as a continuous smooth curved surface, such as a spherical or approximately spherical curved surface. An angle can be formed between the axis of the bent segment 13 and the bending axis of the bent segment 12. For example, the angle between the tangents at the distal end of the bending axis (the portion where the bent segment 12 and the bent segment 13 connect) of the axis of the bent segment 13 and the bending axis can be set to an acute angle. For example, the angle between the tangents at the distal end of the bending axis and the bending axis can be set to an angle between 45° and 15°, so that the axis of the bent segment 13 and the axial direction Z of the guide wire 1 have an angle close to 90°.

[0039] Reference Figure 4 and Figure 5 , Figure 4 This is a schematic diagram showing the guidewire 1 provided in this application returning to the true lumen from under the intima. Figure 5 This is a schematic diagram of the guidewire passing through the mesh of the stent provided in this application. Figure 4 As shown, when performing surgery using the guidewire 1 provided in this embodiment, since the distal end of the guidewire 1 has a bent section 13 and a curved section 12, it is convenient to rotate the guidewire 1 so that the bent section 13 faces different directions. This allows for flexible control of the direction of the guidewire 1's advance under the intima 5, thus facilitating control of the guidewire 1's re-entry from under the intima 5 into the true lumen 6 of the blood vessel 2. Figure 5 As shown, during the process of passing the guidewire 1 provided in this embodiment through the stent 7 located in the blood vessel 2, since the extension direction of the bent section 13 and the bending section 12 is different from the bending direction of the extension section 11, the distal end of the bent section 13 can be directed toward the mesh of the stent 7, which facilitates the guidewire 1 to pass through the mesh of the stent 7 quickly, and also allows the guidewire 1 to quickly enter the branch lesion site of the blood vessel 2.

[0040] The guidewire 1 provided in this embodiment has a continuously curved section 12 at the distal end of the extension section 11. During insertion of the guidewire 1 into the lesion site such as the blood vessel 2, this facilitates the complete transfer of rotational force from the extension section 11 to the curved section 12. This allows for easier control of the orientation of the bend section 13 at the distal end of the curved section 12, and consequently, easier control of the guidewire 1's direction of travel within the blood vessel 2. Thus, when using the guidewire 1 provided in this embodiment to pass through the stent 7, microchannel 4, plaque, and subendothelial 5 within the blood vessel 2, the orientation and direction of travel of the bend section 13 and the curved section 12 of the guidewire 1 can be quickly and accurately adjusted. This allows the guidewire 1 to quickly pass through the mesh of the stent 7, the microchannel 4 of the lesion, the plaque, and the subendothelial 5. Therefore, the guidewire 1 provided in this embodiment improves the ease of passing through the stent 7 mesh and also enhances the active passage of the guidewire 1 through the microchannel 4, plaque, and subendothelial 5.

[0041] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, along the radial direction Y of guidewire 1, the offset distance H of the distal end of the bent section 12 from the axis of the extension section 11 is greater than or equal to 10 times the outer diameter of guidewire 1.

[0042] In this embodiment, the guide wire 1 can be adapted to different scenarios by setting the degree of bending of the curved section 12 relative to the extension section 11. For example, along the radial direction Y of the guide wire 1, the offset distance H of the distal end of the curved section 12 (the junction of the curved section 12 and the bend section 13) from the extension section 11 can be set to different values.

[0043] For example, the offset distance H of the bent section 12 can be determined with reference to the outer diameter of the guidewire 1 and the axis of the extension section 11. The offset distance H of the bent section 12 can be set to be greater than or equal to 10 times the outer diameter of the guidewire 1. For example, when the outer diameter of the guidewire 1 is less than or equal to 0.36 mm, the offset distance H of the bent section 12 can be set to 3.6 mm, 3.8 mm, 4 mm, 4.3 mm, 4.5 mm, 4.8 mm, 5 mm, or 5.5 mm, etc. This application embodiment does not limit the specific value of the offset distance H of the bent section 12 relative to the extension section 11.

[0044] In the above embodiments, since the offset distance H of the distal end of the bending section 12 from the axis of the extension section 11 is greater than or equal to 10 times the outer diameter of the guide wire 1, the distal end of the bending section 12 can be offset by a large distance relative to the extension section 11 along the radial direction Y of the guide wire 1, thereby allowing the torsional force on the extension section 11 to be better transmitted to the bending section 13, which facilitates the control of the orientation of the bending section 13.

[0045] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, the length of the bent section 12 is greater than or equal to 5 mm; and / or, the length of the bent section 12 is less than or equal to 10 mm.

[0046] In this embodiment of the application, the curved segment 12 can be set to different lengths. The length of the curved segment 12 is the length of the extension path of the curved axis of the curved segment 12.

[0047] For example, the length of the bent segment 12 can be set to be greater than or equal to 5 mm, or less than or equal to 10 mm. For instance, the length of the bent segment 12 can be set to 5 mm, 5.3 mm, 5.8 mm, 6.4 mm, 7 mm, 7.5 mm, 8 mm, 8.4 mm, 9 mm, 9.5 mm, or 10 mm, etc. For example, the length of the bent segment 12 can be set to 8 mm to 9 mm.

[0048] In the above embodiments, since the length of the curved section 12 is greater than or equal to 5 mm; and / or the length of the curved section 12 is less than or equal to 10 mm, the curved section 12 can have a suitable length, thereby allowing the guidewire 1 to pass through the lesion site quickly, and also reducing the impact of the guidewire 1 on blood vessels 2, etc.

[0049] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, the axis of the bent section 13 is perpendicular to the axis Z of the guide wire 1 (the axis of the extension section 11).

[0050] In this embodiment, the angle between the tangents of the bending axis of the bent segment 13 and the bending axis of the curved segment 12 can be set to make the axis of the bent segment 13 and the axis of the extension segment 11 form different angles.

[0051] For example, for curved segments 12 with different lengths and different offset distances H between relative extension segments 11, the bending segments 13 can all be set such that the axis of the bending segment 13 and the axis of the extension segment 11 are perpendicular or nearly perpendicular to each other, that is, the angle between the bending segment 13 and the extension segment 11 is 90° or close to 90°.

[0052] In the above embodiments, since the axis of the bent section 13 is perpendicular to the axis Z of the guidewire 1, after the guidewire 1 is inserted into the blood vessel 2, the distal end of the bent section 13 can be in a perpendicular relative position with the wall of the blood vessel 2, which makes it easier for the guidewire 1 to enter the mesh of the stent 7 and facilitates the rapid passage of the guidewire 1 through the stent 7 in the blood vessel 2.

[0053] In some possible embodiments of this application, such as Figure 2 and Figure 3 As shown, the length of the bent section 13 is greater than or equal to twice the outer diameter of the guidewire 1.

[0054] In this embodiment of the application, the bending segment 13 can be set to different lengths. For example, based on the outer diameter of the guide wire 1, the length of the bending segment 13 can be set to be greater than or equal to twice the outer diameter of the guide wire 1.

[0055] For example, when the outer diameter of the guidewire 1 is 0.36 mm, the length of the bending section 13 can be set to 0.72 mm, 0.78 mm, 0.8 mm, 0.85 mm, 0.9 mm, 0.96 mm, 1 mm, 1.05 mm, or 1.2 mm, etc. This application embodiment does not limit the specific length of the bending section 13.

[0056] In the above embodiments, since the length of the bent section 13 is greater than or equal to twice the outer diameter of the guide wire 1, the length of the bent section 13 can be close to 1 mm. Setting the bent section 13 to such a length not only allows the bent section 13 to have a good guiding effect to guide the forward direction of the guide wire 1, but also reduces the resistance encountered by the guide wire 1 when rotating the guide wire 1, which is beneficial to improving the flexibility of the operation of the guide wire 1.

[0057] In some possible embodiments of this application, reference is made to Figure 6 , Figure 6 Provided for this application Figure 3 A magnified view of part A in the diagram. (See diagram below.) Figure 3 and Figure 6 As shown, the guide wire 1 includes a first spindle 14 and a second spindle 15 connected to each other. The second spindle 15 is located in the extension section 11. The first spindle 14 extends sequentially through the extension section 11, the bending section 12 and the bending section 13. The stiffness of the first spindle 14 is greater than that of the second spindle 15.

[0058] In this embodiment, a mandrel can be provided in the guide wire 1 to form the main support structure of the guide wire 1. For example, the mandrel can be made of a material with high strength, rigidity and toughness, such as a metal material.

[0059] For example, the mandrel can be configured to include a first mandrel 14 and a second mandrel 15. The first mandrel 14 and the second mandrel 15 are connected as a single unit, with the first mandrel 14 located at the distal end of the guidewire 1 and the second mandrel 15 located at the proximal end of the guidewire 1. For example, the first mandrel 14 and the second mandrel 15 can be connected as a single unit by welding, bonding, snap-fitting, or other methods. Both the first mandrel 14 and the second mandrel 15 can be configured as cylindrical, and the diameter of the second mandrel 15 can be larger than the diameter of the first mandrel 14. The first mandrel 14 extends from the bending section 13 and the bending section 12 of the guidewire 1 to the bending section 13, and the second mandrel 15 is located at the bending section 13 of the guidewire 1.

[0060] In another example, the first mandrel 14 can be made of a material with greater stiffness than the second mandrel 15, so that the first mandrel 14 has a stronger ability to resist elastic deformation under stress than the second mandrel 15. For example, the first mandrel 14 can be made of a material with a higher elastic modulus and shear modulus than the second mandrel 15, such as nickel-titanium alloy, iron-nickel alloy, or titanium-nickel alloy, while the second mandrel 15 can be made of 304 stainless steel, 316 stainless steel, etc.

[0061] In the above embodiments, since the mandrel of the guidewire 1 is configured to include a first mandrel 14 and a second mandrel 15, suitable materials can be selected according to the characteristics of the extension section 11, the bending section 12, and the folding section 13, making it easier for the extension section 11, the bending section 12, and the folding section 13 to meet the usage requirements. Furthermore, the stiffness of the first mandrel 14 is greater than that of the second mandrel 15, which allows the distal end of the guidewire 1 to have better resistance to deformation and gives the guidewire 1 as a whole better tracking ability, thereby facilitating the control of the movement direction and path of the guidewire 1.

[0062] In some possible embodiments of this application, the ratio of the length of the first mandrel 14 to the length of the guide wire 1 ranges from 0.025 to 0.6.

[0063] In this embodiment, the first mandrel 14 can be shorter and the second mandrel 15 can be longer, or the first mandrel 14 can be longer and the second mandrel 15 can be shorter.

[0064] For example, the length of the first mandrel 14 can be set to 0.025 to 0.6 times the length of the guidewire 1. For instance, when the length of the guidewire 1 is 100cm to 400cm, the length of the first mandrel 14 can be set to 10cm to 60cm. If the length of the first mandrel 14 is 40cm, the length of the second mandrel 15 is 60cm.

[0065] In the above embodiments, since the length of the first mandrel 14 is 0.025 to 0.6 times the length of the guide wire 1, the distal end of the guide wire 1 can have better rigidity, and the proximal end of the guide wire 1 can have good bending performance, which can improve the convenience of operating the guide wire 1.

[0066] In some possible embodiments of this application, such as Figure 3 As shown, the guide wire 1 also includes a reinforcing member 16, which is sleeved on the distal end of the first mandrel 14 and covers at least the portion of the first mandrel 14 located in the bending section 13 and the curved section 12.

[0067] In this embodiment, a reinforcing member 16 can be provided at the distal end of the guidewire 1 to change the hardness of the bent section 13 and the curved section 12 of the guidewire 1.

[0068] For example, the reinforcing member 16 can be a helical structure or a braided structure. For instance, the reinforcing member 16 can be a helical spring structure that matches the distal end of the first mandrel 14, or it can be a braided cylindrical structure that matches the distal end of the first mandrel 14. The reinforcing member 16 can be fitted onto the distal end of the first mandrel 14, covering the bent section 13 and the curved section 12. The reinforcing member 16 can also cover the portion of the first mandrel 14 near the curved section 12.

[0069] In the above embodiment, since the first mandrel 14 is provided with a reinforcing member 16 in the part of the bending section 13 and the bending section 12, the rigidity of the bending section 13 and the bending section 12 of the guidewire 1 can be increased by the reinforcing member 16, so that the guidewire 1 can pass through the discontinuous lesion part of the microchannel 4 more easily with its own rigidity, good maneuverability and tracking characteristics.

[0070] In some possible embodiments of this application, such as Figure 3 As shown, the guide wire 1 also includes a protective layer 17, which covers at least a portion of the reinforcing member 16 and the first mandrel 14.

[0071] In this embodiment, a protective layer 17 can be provided at the distal end of the guide wire 1 to reduce the environmental impact on the reinforcing member 16 and the mandrel. For example, the protective layer 17 can be made of a polymer with good stability, such as polylactic acid, nylon elastomer, polyetheretherketone, etc., which can tightly wrap the protective layer 17 around the surface of the reinforcing member 16 and the first mandrel 14.

[0072] In the above embodiments, since a protective layer 17 is provided on the surface of the reinforcing member 16 and the first mandrel 14, the influence of environmental factors on the reinforcing member 16 and the first mandrel 14 can be reduced by the protective layer 17, and the distal end of the guide wire 1 can have a smooth surface.

[0073] In some possible embodiments of this application, such as Figure 3 As shown, the guidewire 1 also includes an outer coating, which covers the outer surface of the guidewire 1 and has hydrophilic properties.

[0074] In this embodiment, an outer coating can be applied to the surface of the guidewire 1 to cover all outer surfaces of the guidewire 1. For example, the outer coating can be made of a hydrophilic material, such as a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating, or a polymethyl vinyl ether-maleic anhydride coating. The outer coating can be applied to the surface of the guidewire 1 by spraying or smearing.

[0075] In the above embodiments, since a hydrophilic outer coating is provided on the surface of the guidewire 1, the lubricity of the guidewire 1 can be improved by the outer coating, thereby reducing the passage resistance of the guidewire 1 in the blood vessel 2, making the guidewire 1 easier to push.

[0076] The manufacturing process of the guide wire 1 provided in this application embodiment will be described below with reference to the guide wire 1 provided in the above embodiments:

[0077] First, manufacture the first mandrel 14, the second mandrel 15, and the protective and reinforcing components 16.

[0078] The distal end of the first mandrel 14 is located at the distal end of the guidewire 1, and the proximal end of the second mandrel 15 is located at the proximal end of the guidewire 1, with the distal end of the second mandrel 15 connected to the proximal end of the first mandrel 14. The second mandrel 15 and the first mandrel 14 are manufactured by grinding. The distal end of the first mandrel 14 is ground into a conical, parabolic, streamlined shape, or any other structure that provides good compliance and pushing performance for the guidewire 1, as well as different distal end hardnesses. The first mandrel 14 can be made of any material with good deformation resistance and suitable for making the guidewire 1; for example, the first mandrel 14 includes, but is not limited to, nickel-titanium alloys, iron-nickel alloys, or titanium-nickel halide alloys. The second mandrel 15 can be made of any material with good support, high rigidity, and suitable for making the guidewire 1; for example, the second mandrel 15 includes, but is not limited to, 304 stainless steel, 316 stainless steel, cobalt-based alloys, iron-manganese alloys, copper-zinc alloys, etc. The second mandrel 15 and the first mandrel 14 can be manufactured using methods or techniques such as physical grinding or chemical etching.

[0079] The protective component is located at the distal end of the guide wire 1, and the protective component can be made of polylactic acid, nylon elastomer, polyetheretherketone, etc.

[0080] The reinforcing member 16 is located at the distal end of the guide wire 1. The reinforcing member 16 can be one or two of the following: a platinum-tungsten spring, a platinum-nickel spring, a platinum-iridium spring, a gold spring, and a stainless steel spring. The reinforcing member 16, made of metallic materials, has good radiographic properties, enhancing the visibility of the guide wire 1 under X-rays. The reinforcing member 16 can be manufactured by winding a spring. For example, the spring-shaped reinforcing member 16 can be made of a metal wire with a diameter of 0.025 mm to 0.1 mm, a pitch of 0.01 mm to 0.05 mm, and a total length of 1 cm to 30 cm.

[0081] Secondly, the remote end of each part is shaped.

[0082] The distal end of guidewire 1 has a double-bend shape, meaning the bend 13 of guidewire 1 is the first bend, and the curved section 12 of guidewire 1 is the second bend. The length of the bend 13 can be 1 mm, and the angle between the bend 13 and the extension section 11 can be 90°. The curved section 12 can be a gradually curved structure with a length of 5 mm to 10 mm. The shape of the distal end of guidewire 1 is achieved through a shaping process, which can be heat treatment shaping and / or cold shaping.

[0083] For example, heat treatment can be used for shaping, such as heat treatment temperature of 200°C to 600°C, and heat treatment time of 1 min to 30 min. The length and offset distance H of the curved section 12 can be changed according to the diameter and bending angle of the blood vessel 2 to which the guidewire 1 is applied. For example, the length of the curved section 12 can be 8 mm to 9 mm.

[0084] Next, the first mandrel 14, the second mandrel 15, and the reinforcing member 16 are assembled.

[0085] The second spindle 15 and the first spindle 14 are placed coaxially. The connection method between the second spindle 15 and the first spindle 14 can be one or more of the following: resistance welding, brazing, ultrasonic welding, laser welding, bonding, and snap-fit.

[0086] For example, such as Figure 6 As shown, the second mandrel 15 and the first mandrel 14 are connected as one unit by resistance welding, forming a welding area 18 at the junction of the second mandrel 15 and the first mandrel 14. Resistance welding can improve the torque transmission of the guide wire 1, thereby improving the torque control of the guide wire 1. Furthermore, the high-strength second mandrel 15 provides good support and pushing force for the guide wire 1, while the first mandrel 14, with its strong resistance to deformation, provides good resistance to deformation and flexibility for the guide wire 1, giving the guide wire 1 excellent maneuverability. For example, the length of the second mandrel 15 and the first mandrel 14 after connection can be from 100cm to 400cm.

[0087] Another example, such as Figure 3 As shown, brazing can be used at a welding temperature of 200°C to 500°C to weld and fix the reinforcing member 16 to the distal end of the first mandrel 14, and form an approximately hemispherical weld point at the distal end of the first mandrel 14 to complete the assembly of the reinforcing member 16 and the first mandrel 14.

[0088] Then, the protective part is formed by hot melting.

[0089] The protective component can be made of one or more of polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone. The granular polyurethane, polylactic acid, nylon elastomer, and polyetheretherketone can be extruded to form a tubular protective component, which is then wrapped around the reinforcing member 16 and the first mandrel 14 to complete the assembly of the first mandrel 14, the reinforcing member 16, and the protective component.

[0090] Finally, an outer coating is applied to the surface of guidewire 1.

[0091] The outer coating can be one of the following: polyvinylpyrrolidone coating, polyethylene oxide coating, transparent acrylate coating, or polymethyl vinyl ether-maleic anhydride coating. The coating can be applied by spraying or smearing, covering all surfaces of the protective component, the first mandrel 14, and the second mandrel 15. The outer coating is then cured using a specific method to prevent it from peeling off. After the outer coating is applied, its appearance on the guidewire 1 can be inspected for any abnormalities, thus completing the fabrication of the guidewire 1.

[0092] The guidewire 1 provided in this embodiment features a double-bend shape at its distal end by incorporating a curved section 12 and a folded section 13. This structure enhances the user's flexibility in manipulating the guidewire 1 and facilitates control over its direction of advancement. For example, after the guidewire 1 enters the intima, it is easier to maneuver it into the true lumen 6. The curved section 12 helps control the direction of the guidewire 1 as it enters different branch vessels 2, facilitating its passage through the mesh of the stent 7 and into the branch lesion site. It also helps transmit the rotational force applied to the extension section 11 to the distal end of the guidewire 1, reducing energy loss. Furthermore, setting different stiffnesses for different parts of the distal end of the guidewire 1 provides excellent tracking ability, allowing it to actively pass through discontinuous lesion sections of the microchannel 4 thanks to its distal stiffness, good maneuverability, and tracking performance. Moreover, the preparation method of this guidewire 1 is simple, easy to implement, and low in cost.

[0093] Meanwhile, the first mandrel 14 is made of a material with strong deformation resistance and good flexibility, giving the guidewire 1 excellent bending retention capability. The second mandrel 15 is made of a material with good support and high rigidity, giving the guidewire 1 good support and pushing ability. The first mandrel 14 and the second mandrel 15 are connected as one piece by welding. Welding ensures that the first mandrel 14 and the second mandrel 15 remain coaxial after connection, which is beneficial to improving the torque transmission of the guidewire 1. The manufacturing method of this guidewire 1 is simple and easy to implement, and the length, diameter, etc. of each part of the guidewire 1 can be changed as needed without affecting the overall design of the guidewire 1.

[0094] 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: An extension segment located at the proximal end of the guidewire; A curved section extends from the distal end of the extension section, the curved section having a continuous curved axis extending in the plane containing the axial and radial directions of the guidewire. A bend, which extends from the distal end of the bend, has an axis that lies in the plane containing the axial and radial directions, and the axis of the bend forms an acute angle with the tangent at the distal end of the bend axis.

2. The guidewire according to claim 1, characterized in that, Along the radial direction of the guidewire, the distal end of the curved section is offset from the axis of the extension section by a distance greater than or equal to 10 times the outer diameter of the guidewire.

3. The guidewire according to claim 1, characterized in that, The length of the bent section is greater than or equal to 5 mm; and / or the length of the bent section is less than or equal to 10 mm.

4. The guidewire according to claim 1, characterized in that, The axis of the bent section is perpendicular to the axis of the guide wire.

5. The guidewire according to claim 1, characterized in that, The length of the bent section is greater than or equal to twice the outer diameter of the guide wire.

6. The guidewire according to any one of claims 1 to 5, characterized in that, The guidewire includes a first mandrel and a second mandrel connected to each other. The second mandrel is located in the extension section. The first mandrel extends sequentially through the extension section, the bending section, and the folding section. The stiffness of the first mandrel is greater than that of the second mandrel.

7. The guidewire according to claim 6, characterized in that, The ratio of the length of the first mandrel to the length of the guide wire ranges from 0.025 to 0.

6.

8. The guidewire according to claim 6, characterized in that, The guidewire also includes a reinforcing member, which is sleeved on the distal end of the first mandrel and at least covers the portion of the first mandrel located in the bend and the flexure.

9. The guidewire according to claim 8, characterized in that, The guidewire also includes a protective layer that covers at least a portion of the reinforcing member and the first mandrel.

10. The guidewire according to any one of claims 1 to 5, characterized in that, The guidewire also includes an outer coating that covers the outer surface of the guidewire and is hydrophilic.

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