Guidewire and method of making the same

Abstract

This application provides a guidewire and its manufacturing method. The guidewire includes a variable-diameter mandrel and a protective sleeve. The variable-diameter mandrel includes an axially connected insertion section and abutment section. The insertion section is elongated, and the abutment section is elongated under a first preset condition and coiled under a second preset condition. The abutment section includes several spaced-apart equal-diameter sections and variable-diameter sections. The protective sleeve is fitted around the outer ring of the variable-diameter mandrel along its axial direction and is fixedly connected to both ends of the variable-diameter mandrel to protect it. This guidewire can effectively reduce the risk of puncturing the sidewall at the preset contact position.

Description

Technical Field

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

[0002] Interventional surgery causes less trauma and less harm to the human body. It is a medical technology that has rapidly emerged and been promoted in recent years. It usually requires a special delivery system to deliver diagnostic and implantable devices to the lesion site, and the guidewire is a commonly used instrument in interventional surgery.

[0003] Currently, guidewires are mostly linearly extended elastic metal wires. When stretched, they are straight or slightly curved to facilitate insertion into blood vessels, and then released and unfolded within the body. Taking interventional aortic valve replacement surgery as an example, a thin guidewire is first inserted through the femoral artery or femoral vein. The tip of the guidewire enters the left ventricle after passing through the aortic valve. The tip of the guidewire is partially curled at the bottom of the left ventricle to form support. After the linearly extended guidewire enters the left ventricle, the top of the wire is an insertion section that extends roughly in a straight line downwards, and the bottom is a support section. The support section gradually curls under the action of the left ventricular sidewall and bottom, but there is still a large pressure on some areas of the ventricle, which leads to high pressure and therefore poses a risk of puncturing the ventricular wall. Summary of the Invention

[0004] This application provides a guidewire and a method for manufacturing the same, which can effectively reduce the risk of puncturing the sidewall of a predetermined location in contact with the guidewire.

[0005] To solve the above-mentioned technical problems, one technical solution adopted in this application is to provide a guide wire, which includes a variable diameter mandrel and a protective sleeve.

[0006] The variable diameter mandrel includes an axially connected insertion section and abutment section. The insertion section is elongated, and the abutment section is elongated under a first preset condition and curled under a second preset condition. The abutment section includes several spaced equal diameter sections and variable diameter sections. The protective sleeve is fitted around the outer ring of the variable diameter mandrel along the axial direction and is fixedly connected to both ends of the variable diameter mandrel to protect it.

[0007] To solve the above-mentioned technical problems, another technical solution adopted in this application is: providing a method for manufacturing a guidewire, the method comprising:

[0008] Mandrels and wires are provided;

[0009] Grinding is performed along the axial direction of the mandrel to form multiple sections of variable diameter mandrel with different radial dimensions; wherein, the variable diameter mandrel includes an axially connected insertion section and abutment section, the insertion section is elongated, the abutment section is elongated under a first preset condition and curled under a second preset condition, and the abutment section includes several spaced equal diameter sections and variable diameter sections.

[0010] The metal wire is wound to form a protective sleeve; wherein the radial dimension of the protective sleeve is larger than the radial dimension of the variable diameter mandrel;

[0011] The variable diameter mandrel is inserted into the protective sleeve along the axial direction and fixedly connected to the protective sleeve to form a guide wire.

[0012] The guidewire and its manufacturing method provided in this application involve a variable-diameter mandrel comprising an axially connected insertion section and abutment section. The insertion section is elongated to facilitate the guidewire's insertion into a preset position, such as the ventricle. Simultaneously, the abutment section is elongated under a first preset condition to facilitate its insertion into the preset position, and then coiled under a second preset condition. This coiled abutment section increases the contact area between the guidewire and the preset position after insertion, effectively reducing the risk of the guidewire puncturing the sidewall of the preset position. Furthermore, by comprising several spaced-apart equal-diameter and variable-diameter sections, the axial strength of the abutment section is ensured for insertion into the preset position, while the hardness of the abutment section is reduced, making it easier to coil under the second preset condition. Additionally, a protective sleeve is fitted around the outer ring of the variable-diameter mandrel to protect it. Attached Figure Description

[0013] Figure 1 A schematic diagram of the product structure of the guidewire provided in an embodiment of this application under first preset conditions;

[0014] Figure 2 A schematic diagram of the product structure of the guidewire provided in an embodiment of this application under a second preset condition;

[0015] Figure 3 A schematic diagram of the structure of the probe section provided in one embodiment of this application;

[0016] Figure 4 A schematic diagram of the probe section provided in another embodiment of this application;

[0017] Figure 5 A schematic diagram of the abutment section under a first preset condition according to an embodiment of this application;

[0018] Figure 6A schematic diagram of the abutment section under a second preset condition provided in one embodiment of this application;

[0019] Figure 7 A schematic diagram of a variable diameter mandrel under a second preset condition provided in an embodiment of this application;

[0020] Figure 8 This is a schematic flowchart illustrating a method for fabricating a guidewire according to an embodiment of this application. Detailed Implementation

[0021] 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.

[0022] 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.

[0023] 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.

[0024] The present application will now be described in detail with reference to the accompanying drawings and embodiments.

[0025] Please see Figures 1 to 2,in, Figure 1 A schematic diagram of the product structure of the guidewire provided in an embodiment of this application under first preset conditions; Figure 2 This is a schematic diagram of the product structure of the guidewire provided in an embodiment of this application under a second preset condition.

[0026] In this embodiment, a guidewire 1 is provided, which is elongated when under a first preset condition. Its specific structure can be found in [reference needed]. Figure 1 When the guidewire 1 is under the second preset condition, one end of the guidewire 1 is elongated, and the other end is coiled. For its specific structure, please refer to [link to relevant documentation]. Figure 2 The first and second preset conditions can specifically be temperature conditions.

[0027] Specifically, in one application scenario, such as when guidewire 1 is used in interventional aortic valve replacement surgery, when guidewire 1 is located in the femoral artery or femoral vein, guidewire 1 is elongated to allow it to pass through the femoral artery or femoral vein into the left ventricle. Once one end of guidewire 1 enters the left ventricle, that end is elongated while the other end is coiled. Specifically, the portion of guidewire 1 located in the femoral artery or femoral vein is elongated, while the portion within the left ventricle is coiled. This effectively increases the contact area between guidewire 1 and the left ventricular wall, thereby reducing the risk of guidewire 1 puncturing the ventricular wall. It is understood that in this application scenario, the first preset condition specifically refers to temperatures other than those within the ventricle, and the second preset condition specifically refers to the temperature within the ventricle.

[0028] Specifically, the guide wire 1 includes a variable diameter mandrel 11 and a protective sleeve 12.

[0029] The variable diameter mandrel 11 includes an axially connected insertion section 111 and abutment section 112.

[0030] For details, please see Figures 3 to 4 ,in, Figure 3 A schematic diagram of the structure of the probe section provided in one embodiment of this application; Figure 4 The diagram illustrates the structure of a probe segment according to another embodiment of this application. Specifically, in one embodiment, the probe segment 111 is a linear elongated strip, and its specific structure can be found in [reference needed]. Figure 3 In another embodiment, the insertion section 111 is a slightly curved elongated strip, the specific structure of which can be found in [reference needed]. Figure 4 .

[0031] For details, please see Figure 5 , Figure 5This is a schematic diagram of the structure of the abutting section under a first preset condition according to one embodiment of the present application. When the abutting section 112 is under the first preset condition, the abutting section 112 is specifically a straight strip. Of course, in other embodiments, when the abutting section 112 is under the first preset condition, the abutting section 112 may also be a slightly curved strip.

[0032] Further, please see Figure 6 , Figure 6 This is a schematic diagram of the structure of the abutment segment under a second preset condition according to one embodiment of the present application. When the abutment segment 112 is under the second preset condition, the abutment segment 112 is specifically in a curled state. For example, when the abutment segment 112 of the guidewire 1 is in the left ventricle, the abutment segment 112 is in a curled state, which can effectively increase the contact area between the abutment segment 112 and the left ventricular wall, thereby effectively reducing the risk of the guidewire 1 puncturing the ventricular wall. Specifically, in a specific implementation process, the abutment segment 112 can be in a three-dimensional curled state.

[0033] Specifically, when the abutment section 112 is under the second preset condition, the structure of the variable diameter mandrel 11 can be found in [reference needed]. Figure 7 , Figure 7 This is a schematic diagram of the structure of a variable diameter mandrel under a second preset condition, provided in an embodiment of this application.

[0034] For details, see Figure 5 The abutment section 112 includes several equal-diameter sections and variable-diameter sections spaced apart. Specifically, equal-diameter sections refer to the guide wires 1 in this section having the same radial dimension, while variable-diameter sections refer to the guide wires 1 in this section having a gradually changing radial dimension. Specifically, the radial dimension of the variable-diameter section gradually increases towards the insertion section 111, and the radial dimension at the connection position between the variable-diameter section and the equal-diameter section is the same as the radial dimension of the equal-diameter section. This arrangement not only ensures the axial strength of the abutment section 112 so that the abutment section 112 can extend into the preset position, but also reduces the hardness of the abutment section 112, making it easier for the abutment section 112 to form a curled state under the second preset condition.

[0035] Specifically, in one embodiment, based on the distribution of stress points when the abutment section 112 is in a curled state, the abutment section 112 is configured into five segments with different lengths and radial dimensions, namely, a first equal-diameter segment 1121, a second variable-diameter segment 1122, a third equal-diameter segment 1123, a fourth variable-diameter segment 1124, and a fifth equal-diameter segment 1125 connected axially in sequence; wherein, one end of the first equal-diameter segment 1121 is connected to one end of the probe section 111, and the other end of the first equal-diameter segment 1121 is connected to the second variable-diameter segment 1122, and the radial dimensions of the first equal-diameter segment 1121, the second variable-diameter segment 1122, the third equal-diameter segment 1123, the fourth variable-diameter segment 1124, and the fifth equal-diameter segment 1125 decrease sequentially, and the radial dimensions of the second variable-diameter segment 1122 and the fourth variable-diameter segment 1124 gradually increase toward the probe section 111.

[0036] In one specific implementation, the radial dimension of the probe section 111 is 0.889 mm; the radial dimension of the first equal diameter section 1121 is 0.68 mm, the radial dimension of the third equal diameter section 1123 is 0.33 mm, and the radial dimension of the fifth equal diameter section 1125 is 0.18 mm; and the axial dimension of the first equal diameter section 1121 and the second variable diameter section 1122 is 100 mm, the axial dimension of the third equal diameter section 1123 is 35 mm, the axial dimension of the fourth variable diameter section 1124 is 25 mm, and the axial dimension of the fifth equal diameter section 1125 is 20 mm.

[0037] To further prevent damage to the sidewall of the preset position after the abutment section 112 extends into the preset position, in one embodiment, the end of the abutment section 112 away from the probe section 111 is positioned near the axis around which the abutment section 112 is curled, so that the end of the abutment section 112 away from the probe section 111 is enveloped in the curled structure, thereby preventing damage to the preset position; at the same time, the end of the abutment section 112 away from the probe section 111 is set as a smooth blunt surface to further reduce the risk of puncturing the sidewall of the preset position; it should be noted that the axis around which the abutment section 112 is curled is perpendicular to the extension direction of the probe section 111.

[0038] Specifically, the variable diameter mandrel 11 can be made of stainless steel or shape memory material; the shape memory material can specifically be a nickel-titanium alloy.

[0039] The protective sleeve 12 is fitted around the outer ring of the variable diameter mandrel 11 along the axial direction of the variable diameter mandrel 11 and is fixedly connected to both ends of the variable diameter mandrel 11 to protect the variable diameter mandrel 11.

[0040] For details, see Figure 1In one embodiment, fixing blocks 113 are provided at both ends of the variable diameter mandrel 11. The radial dimension of the fixing blocks 113 is smaller than the radial dimension of the protective sleeve 12. Both ends of the protective sleeve 12 are fixedly connected to the fixing blocks 113 to be fixedly connected to the variable diameter mandrel 11. Specifically, both ends of the protective sleeve 12 can be fixed to the fixing blocks 113 by welding.

[0041] In specific implementation, the fixing block 113 can be a sphere, and the radial dimension of the sphere is smaller than the radial dimension of the protective sleeve 12, so that the protective sleeve 12 can be fitted onto the outer ring of the variable diameter mandrel 11 through the sphere to protect the variable diameter mandrel 11.

[0042] In the specific implementation process, the surface of the protective sleeve 12 away from the variable diameter mandrel 11 is also coated with a lubricating layer to reduce the friction between the guide wire 1 and the conveying pipe, so that the guide wire 1 can be separated from the conveying pipe after entering the preset position.

[0043] Specifically, the protective sleeve 12 can be a spring coil. In the specific implementation process, the lubricating layer can be directly coated on the outer wall of the spring so that the surface of the spring coil formed by the spring away from the variable diameter mandrel 11 is coated with the lubricating layer.

[0044] Specifically, during the use of guidewire 1, a straightener can be added to the proximal end of guidewire 1 so that guidewire 1 is elongated before being inserted into the preset position, making it easier for guidewire 1 to be inserted into the preset position; at the same time, when guidewire 1 is not in use, guidewire 1 can be placed in a coil for storage.

[0045] The guidewire 1 provided in this embodiment features a variable-diameter mandrel 11, which includes an axially connected insertion section 111 and an abutment section 112. The insertion section 111 is elongated to facilitate the guidewire 1's insertion into a preset position, such as the ventricle. Simultaneously, the abutment section 112 is elongated under a first preset condition to allow it to extend into the preset position, and under a second preset condition, it is coiled to allow the guidewire 1's abutment section 112 to remain coiled after insertion into the preset position, such as the ventricle. The abutment section 112 increases the contact area between the guide wire 1 and the preset position, thereby effectively reducing the risk of the guide wire 1 puncturing the side wall of the preset position. In addition, by setting the abutment section 112 to include several spaced equal diameter sections and variable diameter sections, not only can the axial strength of the abutment section 112 be guaranteed so that the abutment section 112 can extend into the preset position, but the hardness of the abutment section 112 can also be reduced, making the abutment section 112 easier to form a curled state under the second preset condition. Furthermore, by sleeved with a protective sleeve 12 on the outer ring of the variable diameter mandrel 11, the variable diameter mandrel 11 can be protected.

[0046] Specifically, the guidewire 1 described above is manufactured using the guidewire fabrication method described in the following embodiments; for details, please refer to [link to specific documentation]. Figure 8 , Figure 8 This is a schematic flowchart illustrating a method for fabricating a guidewire according to an embodiment of this application.

[0047] In this embodiment, a method for fabricating a guidewire is provided, which specifically includes:

[0048] Step S11: Provide the mandrel and wire.

[0049] Specifically, the materials of the aforementioned mandrel and metal wire can be stainless steel.

[0050] Step S12: Grind along the axial direction of the mandrel to form multiple sections of variable diameter mandrel with different radial dimensions.

[0051] Specifically, according to the set parameters, the mandrel is ground along the axial direction using a machine tool to sequentially form the fifth equal diameter section 1125, the fourth variable diameter section 1124, the third equal diameter section 1123, the second variable diameter section 1122, the first equal diameter section 1121, and the insertion section 111 of the variable diameter mandrel 11. The first equal diameter section 1121, the second variable diameter section 1122, the third equal diameter section 1123, the fourth variable diameter section 1124, and the fifth equal diameter section 1125 are sequentially axially connected to form the abutment section 112 of the variable diameter mandrel 11. The insertion section 111 and the abutment section 112 are axially connected to form the variable diameter mandrel 11. Specifically, under the first preset condition, the variable diameter mandrel 11 is elongated; under the second preset condition, the insertion section 111 is elongated, and the abutment section 112 is curled.

[0052] Understandably, the insertion segment 111 can be elongated; the abutment segment 112 can be elongated under the first preset condition and coiled under the second preset condition, so that after the abutment segment 112 extends into the preset position, such as after it extends into the ventricle, the contact area between the guidewire 1 and the preset position is increased by the coiled abutment segment 112, thereby effectively reducing the risk of the guidewire 1 puncturing the side wall of the preset position.

[0053] Specifically, one end of the first equal diameter section 1121 is connected to one end of the probe section 111, and the other end of the first equal diameter section 1121 is connected to the second variable diameter section 1122. The radial dimensions of the first equal diameter section 1121, the second variable diameter section 1122, the third equal diameter section 1123, the fourth variable diameter section 1124, and the fifth equal diameter section 1125 decrease sequentially. The radial dimensions of the second variable diameter section 1122 and the fourth variable diameter section 1124 gradually increase toward the probe section 111. The radial dimension at the connection point between the second variable diameter section 1122 and the first equal diameter section 1121 is the same as the radial dimension of the first equal diameter section 1121. The radial dimension at the connection point between the fourth variable diameter section 1124 and the third equal diameter section 1123 is the same as the radial dimension of the third equal diameter section 1123.

[0054] In a specific implementation process, the parameters set can be as follows: the radial dimension of the probe section 111 is 0.889 mm; the radial dimension of the first equal diameter section 1121 is 0.68 mm; the radial dimension of the third equal diameter section 1123 is 0.33 mm; and the radial dimension of the fifth equal diameter section 1125 is 0.18 mm.

[0055] In order to reduce the sharpness of the variable diameter mandrel 11 and further reduce the risk of puncturing the sidewall of the preset position, in one embodiment, the end of the abutment section 112 away from the probe section 111 is ground to make the position a smooth, blunt surface.

[0056] After the variable diameter mandrel 11 is formed, two fixing blocks 113 are fixedly connected to both ends of the variable diameter mandrel 11. The radial dimension of the fixing blocks 113 is slightly larger than the radial dimension of the protruding section 111. Specifically, the two fixing blocks 113 can be fixed to both ends of the variable diameter mandrel 11 by welding. The fixing blocks 113 can be spheres to facilitate the subsequent insertion of the variable diameter mandrel 11 into the protective sleeve 12 and reduce the insertion resistance.

[0057] Step S13: Wind the metal wire to form a protective sleeve.

[0058] Specifically, the metal wire is wound into a ring structure, and the radial dimension of the ring structure is greater than the radial dimension of the variable diameter mandrel 11 and the fixing block 113, so as to form a protective sleeve 12 with a radial dimension greater than the radial dimension of the variable diameter mandrel 11 and the fixing block 113; specifically, the winding density of the metal wire during the winding process, that is, the gap distance between the rings, can be set according to the actual situation, and this embodiment does not limit it.

[0059] In one specific implementation, in order to reduce the friction between the protective sleeve 12 and other equipment, a lubricating layer is pre-coated on the surface of the metal wire before winding it, so that the outer surface of the formed protective sleeve 12 is coated with a lubricating layer. Of course, in other embodiments, a lubricating layer may be coated only on the outer side of the protective sleeve 12 after winding it to reduce the friction between the protective sleeve 12 and other equipment, thereby reducing production costs.

[0060] Step S14: Insert the variable diameter mandrel into the protective sleeve along the axial direction of the protective sleeve and fix it to the protective sleeve to form a guide wire.

[0061] Specifically, after inserting the variable diameter mandrel 11 into the protective sleeve 12 along the axial direction of the protective sleeve 12, the two ends of the protective sleeve 12 are fixed to the two ends of the variable diameter mandrel 11 respectively; specifically, the fixing can be done by welding.

[0062] In a specific embodiment, the two ends of the protective sleeve 12 can be welded to the fixing blocks 113 at both ends of the variable diameter mandrel 11 to achieve a fixed connection between the protective sleeve 12 and the variable diameter mandrel 11.

[0063] The method for manufacturing a guide wire provided in this embodiment involves providing a mandrel and a metal wire, then grinding along the axial direction of the mandrel to form multiple sections of variable-diameter mandrel 11 with different radial dimensions; then winding the metal wire to form a protective sleeve 12, and inserting the variable-diameter mandrel 11 along the axial direction of the protective sleeve 12 into the protective sleeve 12 and fixing it to the protective sleeve 12 to form a guide wire 1; wherein, since the insertion section 111 of the formed variable-diameter mandrel 11 is elongated, and the abutment section 112 can be elongated under a first preset condition, the guide wire 1 can be easily inserted into a preset position; at the same time, since the formed abutment section 112 includes several The equal-diameter and variable-diameter sections in the dry septum not only ensure the axial strength of the abutment section 112 so that it can extend into the preset position, but also reduce the hardness of the abutment section 112, making it easier for it to form a coiled state under the second preset condition. This allows the contact area between the guidewire 1 and the preset position to be increased by the coiled abutment section 112 after it extends into the preset position, such as after it extends into the ventricle, thereby effectively reducing the risk of the guidewire 1 puncturing the side wall of the preset position. In addition, the variable-diameter mandrel 11 can be protected by the protective sleeve 12 fitted around its outer ring.

[0064] 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 variable diameter mandrel includes an axially connected insertion section and abutment section. The insertion section is elongated, and the abutment section is elongated under a first preset condition and curled under a second preset condition. The abutment section includes several spaced-apart equal diameter sections and variable diameter sections. A protective sleeve is fitted around the outer ring of the variable diameter mandrel along the axial direction of the variable diameter mandrel and is fixedly connected to both ends of the variable diameter mandrel to protect the variable diameter mandrel. Wherein, the radial dimension of the variable diameter section gradually increases in the direction of the probe section, and the radial dimension of the connection position between the variable diameter section and the constant diameter section is the same as the radial dimension of the constant diameter section; The first preset condition and the second preset condition are temperature conditions.

2. The guidewire according to claim 1, characterized in that, The abutment section includes a first equal-diameter section, a second variable-diameter section, a third equal-diameter section, a fourth variable-diameter section, and a fifth equal-diameter section connected in sequence; Wherein, one end of the first constant diameter section is connected to one end of the probe section, the other end of the first constant diameter section is connected to the second variable diameter section, and the radial dimensions of the first constant diameter section, the second variable diameter section, the third constant diameter section, the fourth variable diameter section and the fifth constant diameter section decrease sequentially.

3. The guidewire according to claim 2, characterized in that, The radial dimension of the probe section is constant.

4. The guidewire according to claim 3, characterized in that, The radial dimension of the probe section is 0.889 mm; the radial dimension of the first equal-diameter section is 0.68 mm, the radial dimension of the third equal-diameter section is 0.33 mm, and the radial dimension of the fifth equal-diameter section is 0.18 mm. The axial dimensions of the first constant diameter section and the second variable diameter section are 100 mm, the axial dimension of the third constant diameter section is 35 mm, the axial dimension of the fourth variable diameter section is 25 mm, and the axial dimension of the fifth constant diameter section is 20 mm.

5. The guidewire according to any one of claims 1-4, characterized in that, The abutting section is in a three-dimensional curled state under the second preset condition, and the end of the abutting section away from the probing section is adjacent to the axis around which the abutting section is curled; wherein, the axis is perpendicular to the extension direction of the probing section.

6. The guidewire according to any one of claims 1-4, characterized in that, The end of the abutment section away from the probe section has a smooth, blunt surface.

7. The guidewire according to any one of claims 1-4, characterized in that, The variable diameter mandrel is also provided with fixing blocks at both ends, and the radial dimension of the fixing blocks is smaller than the radial dimension of the protective sleeve; The two ends of the protective sleeve are fixedly connected to the fixing block to be fixedly connected to the variable diameter mandrel.

8. The guidewire according to any one of claims 1-4, characterized in that, The protective sleeve has a lubricating layer coated on the side of its surface away from the variable diameter mandrel to reduce the friction between the guide wire and the delivery pipe.

9. The guidewire according to any one of claims 1-4, characterized in that, The variable diameter mandrel is made of stainless steel or a shape memory material, and the shape memory material is a nickel-titanium alloy. The protective sleeve is a spring coil.

10. A method for manufacturing a guidewire, characterized in that, include: Mandrels and wires are provided; Grinding is performed along the axial direction of the mandrel to form multiple sections of variable diameter mandrel with different radial dimensions; wherein, the variable diameter mandrel includes an axially connected insertion section and abutment section, the insertion section is elongated, the abutment section is elongated under a first preset condition and curled under a second preset condition, and the abutment section includes several spaced equal diameter sections and variable diameter sections. The metal wire is wound to form a protective sleeve; wherein the radial dimension of the protective sleeve is larger than the radial dimension of the variable diameter mandrel; The variable diameter mandrel is inserted into the protective sleeve along the axial direction of the protective sleeve and fixedly connected to the protective sleeve to form the guide wire; Wherein, the radial dimension of the variable diameter section gradually increases in the direction of the probe section, and the radial dimension of the connection position between the variable diameter section and the constant diameter section is the same as the radial dimension of the constant diameter section; The first preset condition and the second preset condition are temperature conditions.

Images