Deflectable guide wire

Abstract

A deflectable guide wire (100), comprising a sleeve tube assembly (10), the sleeve tube assembly (10) comprising a first sleeve tube (11) and a second sleeve tube (12) in communication, the second sleeve tube (12) being arranged at the distal end of the first sleeve tube (11), and the bendability of the second sleeve tube (12) being higher than that of the first sleeve tube (11); and a core wire (20), which is arranged in the first sleeve tube (11) and the second sleeve tube (12) in a way that allows for movement in the axial direction of the core wire, the distal end of the core wire (20) being connected to the distal end of the second sleeve tube (12) or a location near the distal end, the proximal end of the core wire (20) extending out of the first sleeve tube (11) from the proximal end of the first sleeve tube (11), and the proximal end of the core wire (20) being able to move relative to the sleeve tube assembly (10) in the axial direction of the core wire. The present deflectable guide wire (100) can be smoothly inserted into a target blood vessel.

Description

Adjustable curved guidewire Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an adjustable curved guide wire. Background Art

[0002] During interventional diagnosis and treatment, adjustable curved guidewires are important instruments for guiding various catheters and interventional devices to the target site. The function of adjustable curved guidewires in intravascular interventional treatment is to enter the main channel, branches and winding parts of the vascular cavity. Sometimes it is also necessary to break through the narrow part to reach the target site, and then guide the catheter, microcatheter or other interventional devices to the target area in the body.

[0003] For blood vessels with multiple tortuosity and many branches, a single straight adjustable curved guidewire is difficult to enter the bifurcated branch vessels. The in vitro shaped curved adjustable curved guidewire can be super-selected to the target vessel under the physician's delicate operation. However, the bending shape of the in vitro shaped curved adjustable guidewire is fixed, and the actual vascular pathways of patients vary greatly. In actual interventional operations, the shape of the in vitro shaped adjustable curved guidewire often matches the patient's vascular pathway morphology, resulting in super-selection difficulties or even intervention failure. Summary of the Invention

[0004] The technical problem to be solved by the present invention is that the head end shape of the existing adjustable curved guide wire does not match the blood vessel shape and is difficult to enter blood vessels with large tortuosity angles and many branches. In view of the defects of the existing technology, an adjustable curved guide wire is provided.

[0005] The present invention solves the technical problem by the following technical solutions:

[0006] An embodiment of the present invention provides an adjustable bend guide wire, which includes: a sleeve assembly, the sleeve assembly including a first sleeve and a second sleeve that are connected to each other, the second sleeve being arranged at the distal end of the first sleeve, and the bending performance of the second sleeve being higher than the bending performance of the first sleeve; a core wire, which is inserted into the first sleeve and the second sleeve in a manner that can be moved along its own axial direction, the distal end of the core wire is connected to the distal end or a position near the distal end of the second sleeve, and the proximal end of the core wire extends from the proximal end of the first sleeve to the outside of the first sleeve, and the proximal end of the core wire can move along its own axial direction relative to the sleeve assembly, pulling the proximal end of the core wire to drive the second sleeve to bend.

[0007] In some embodiments of the present invention, the sleeve assembly further includes a first connecting sleeve, a proximal end of the first connecting sleeve is connected to the first sleeve, and a distal end of the first connecting sleeve is connected to the second sleeve.

[0008] In some embodiments of the present invention, the sleeve assembly further includes a transition sleeve, the proximal end of the transition sleeve is connected to the distal end of the first sleeve, the distal end of the transition sleeve is connected to the proximal end of the second sleeve, the first sleeve, the transition sleeve and the second sleeve jointly define an accommodating channel, and the core wire is passed through the accommodating channel; wherein the bending performance of the transition sleeve is higher than the bending performance of the first sleeve; and / or the bending performance of the second sleeve is higher than the bending performance of the transition sleeve.

[0009] In some embodiments of the present invention, the sleeve assembly further includes a second connecting sleeve, the proximal end of the second connecting sleeve is connected to the first sleeve, the distal end of the second connecting sleeve is connected to the transition sleeve, and the core wire is movably disposed in the second connecting sleeve.

[0010] In some embodiments of the present invention, along the axial direction of the first sleeve, the distal end of the first sleeve and the proximal end of the transition sleeve are spaced apart.

[0011] In some embodiments of the present invention, from the proximal end to the distal end, the core wire includes a proximal segment, an intermediate segment and a distal segment connected in sequence, the distal end of the distal segment is connected to the distal end or a position near the distal end of the second sleeve, and the maximum diameter size of the distal segment is smaller than the maximum diameter size of the intermediate segment and the maximum diameter size of the proximal segment, respectively.

[0012] In some embodiments of the present invention, the adjustable curved guide wire further includes a third connecting sleeve, which is disposed in the sleeve assembly and sleeved outside the core wire, and the distal end of the proximal segment and the proximal end of the intermediate segment are connected through the third connecting sleeve.

[0013] In some embodiments of the present invention, the diameter of the distal segment gradually decreases from the proximal end to the distal end.

[0014] In some embodiments of the present invention, from the proximal end to the distal end, the second sleeve includes a proximal support segment, a bending segment and a head end segment connected in sequence, and the bending performance of the bending segment is higher than the bending performance of the proximal support segment and the bending performance of the head end segment.

[0015] In some embodiments of the present invention, the curved section has a first side and a second side respectively located on both sides of the axis of the second sleeve, the tube wall of the first side is provided with at least one incision, and the first direction is perpendicular to the axis of the second sleeve.

[0016] According to the adjustable bend guide wire provided by the present invention, a second sleeve with higher bending performance is provided, and the proximal end of the core wire is pulled to move relative to the first sleeve toward the proximal side, and the distal end of the core wire is used to apply a pulling force toward the proximal end to the distal end of the second sleeve, so that the second sleeve is bent and deformed, and the degree of bending deformation of the second sleeve is controlled by finely adjusting the moving distance of the core wire, thereby actively adjusting the bending shape of the second sleeve according to the branch shape and tortuosity angle of the target blood vessel, so that the adjustable bend guide wire can be smoothly inserted into the target blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] The present invention will be further described below with reference to the accompanying drawings and embodiments, in which:

[0018] FIG1 shows a schematic cross-sectional structure diagram of an adjustable curved guidewire according to an embodiment of the present invention;

[0019] FIG2 shows a schematic cross-sectional structure diagram of an adjustable curved guide wire according to an embodiment of the present invention;

[0020] FIG3 shows a schematic cross-sectional structure diagram of an adjustable curved guidewire according to an embodiment of the present invention;

[0021] FIG4 shows a schematic cross-sectional structure diagram of an adjustable curved guidewire according to an embodiment of the present invention;

[0022] FIG5 shows a schematic structural diagram of a second sleeve according to an embodiment of the present invention;

[0023] FIG6 shows a schematic structural diagram of a second sleeve according to an embodiment of the present invention;

[0024] FIG7 shows a schematic structural diagram of an adjustable curved guidewire according to an embodiment of the present invention;

[0025] FIG8 is an exploded schematic diagram of parts of an adjustable curved guidewire according to an embodiment of the present invention;

[0026] FIG9 shows a schematic structural diagram of a second connecting sleeve according to an embodiment of the present invention;

[0027] FIG10 shows a schematic cross-sectional structure diagram of an adjustable curved guidewire according to an embodiment of the present invention.

[0028] The marks in the accompanying drawings represent as follows: 100, adjustable bend guide wire; 10, sleeve assembly; 11, first sleeve; 111, main body segment; 112, connecting segment; 12, second sleeve; 121, proximal support segment; 122, bending segment; 1221, incision; 123, head end segment; 13, transition sleeve; 14, first connecting sleeve; 15, second connecting sleeve; 151, through groove; 16, first developing part; 17, second developing part; 18, third connecting sleeve; 101, accommodating channel; 102, hollow portion; 20, core wire; 21, proximal segment; 22, intermediate segment; 23, distal segment; 24, cap portion; 241, curved portion; 242, flat portion. Specific embodiments

[0029] In order to have a clearer understanding of the technical features, purposes and effects of the present invention, specific embodiments of the present invention are now described in detail with reference to the accompanying drawings.

[0030] Exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0031] It should be understood that the terms used herein are for the purpose of describing specific example embodiments only and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used herein may also be meant to include plural forms. The terms "comprise", "include", "contain" and "have" are inclusive and therefore specify the presence of stated features, steps, operations, elements and / or parts, but do not exclude the presence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring them to be performed in the specific order described or illustrated, unless the order of execution is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0032] Although the terms first, second, third, etc. can be used in the text to describe multiple elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can only be used to distinguish an element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teachings of the exemplary embodiments.

[0033] For ease of description, spatially relative terms may be used herein to describe the relationship of one element or feature relative to another element or feature as shown in the figures, such as "inside," "outside," "inside," "outside," "below," "beneath," "above," and the like. Such spatially relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is flipped, an element described as "below" or "below" another element or feature would then be oriented as "above" or "above" another element or feature. Thus, the example term "below" can include both above and below orientations. The device may be otherwise oriented (rotated 90 degrees or in other orientations) and the spatially relative descriptors used herein are interpreted accordingly.

[0034] It should be noted that the terms "distal" and "proximal" are commonly used in the field of interventional medical devices. "Distal" refers to the end away from the operator during surgery, while "proximal" refers to the end closer 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 axial direction.

[0035] In an embodiment of the present invention, the comparison of the bending properties of two samples can be obtained by a three-point bending test. Specifically, a first sample is placed on two support points at a certain distance, and the distance between the two support points is less than the length of the two samples. A downward load is applied to the sample at the midpoint of the two support points, and the sample is pressed down to a certain distance. The load of the sample at this time is tested, and the second sample is tested using the same method. When testing the second sample, the distance between the two support points and the distance of the downward pressure on the sample are the same as when testing the first sample. The smaller the load, the easier it is to bend, the better the flexibility, and the higher the bending performance. For example, the first sample can be the first sleeve 11, and the second sample can be the second sleeve 12.

[0036] As shown in FIG1 , an embodiment of the present invention provides an adjustable bend guidewire 100. The adjustable bend guidewire 100 includes a sleeve assembly 10 and a core wire 20. The sleeve assembly 10 includes a first sleeve 11 and a second sleeve 12. The first sleeve 11 is located at the proximal end, and the second sleeve 12 is located at the distal end. The bending performance of the second sleeve 12 is higher than the bending performance of the first sleeve 11. The core wire 20 is inserted into the first sleeve 11 and the second sleeve 12. The distal end of the core wire 20 is connected to the distal end of the second sleeve 12. The proximal end of the core wire 20 extends from the proximal end of the first sleeve 11 to the outside of the first sleeve 11. In addition, the core wire 20 can move in the axial direction relative to the first sleeve 11. By pulling the proximal end of the core wire 20 toward the proximal side relative to the first sleeve 11, the distal end of the core wire 20 applies a pulling force toward the proximal end to the distal end of the second sleeve 12, so that the second sleeve 12 is bent and deformed. The degree of bending deformation of the second sleeve 12 is controlled by finely adjusting the moving distance of the core wire 20, thereby actively adjusting the bending shape of the second sleeve 12 according to the branch shape and tortuosity angle of the target blood vessel, so that the adjustable curved guide wire 100 can be smoothly inserted into the target blood vessel.

[0037] In this embodiment, the distal end of the core wire 20 can be directly connected to the distal end or a position near the distal end of the second cannula 12 by welding, gluing, etc. In other embodiments, the distal end of the core wire 20 can be indirectly connected to the distal end or a position near the distal end of the second cannula 12, for example, by connecting the distal end of the core wire 20 and the distal end or a position near the distal end of the second cannula 12 through a cap portion 24 (see FIG. 2 ).

[0038] The second cannula 12 has a higher bending performance than the first cannula 11, that is, the second cannula 12 has greater flexibility than the first cannula 11. When subjected to the tension of the core wire 20, the second cannula 12 is more likely to bend and deform to conform to the curved blood vessel morphology, thereby achieving adjustable bending of the tip of the adjustable bend guidewire 100. The first cannula 11 has higher hardness, rigidity, and bending resistance than the second cannula 12. During the process of inserting the adjustable bend guidewire 100 into the target blood vessel, the first cannula 11 can effectively transmit the pushing force to the front end of the adjustable bend guidewire 100, such as the second cannula 12.

[0039] In some embodiments, the first sleeve 11 and the second sleeve 12 are made of the same material, but the wall thickness of the second sleeve 12 is smaller than that of the first sleeve 11, so that the bending performance of the second sleeve 12 is higher than that of the first sleeve 11, that is, the second sleeve 12 has better flexibility than the first sleeve 11. The materials of the first sleeve 11 and the second sleeve 12 include, but are not limited to, stainless steel, cobalt-chromium alloy, and nickel-titanium alloy.

[0040] In order to further improve the flexibility of the second sleeve 12, the tube wall of the second sleeve 12 is provided with a plurality of hollow portions 102 (see Figure 5). For example, the hollow portion 102 is a long hole extending along the circumferential direction of the second sleeve 12. The plurality of hollow portions 102 are staggered in sequence along the axial direction of the second sleeve 12, so that the second sleeve 12 forms a hollow tubular structure.

[0041] In some embodiments, the first sleeve 11 and the second sleeve 12 are made of different materials, and the hardness and rigidity of the material of the first sleeve 11 are higher than those of the second sleeve 12 , so that the bending performance of the second sleeve 12 is higher than that of the first sleeve 11 .

[0042] It is understood that the first sleeve 11 and the second sleeve 12 can be directly connected, with the distal end of the first sleeve 11 connected to the proximal end of the second sleeve 12, for example, by laser welding, soldering, or adhesive bonding. Alternatively, the first sleeve 11 and the second sleeve 12 can be indirectly connected through other components, as long as the first sleeve 11 and the second sleeve 12 are connected.

[0043] In some embodiments, as shown in Figures 2 and 7, the sleeve assembly 10 further includes a transition sleeve 13, through which the first sleeve 11 and the second sleeve 12 are indirectly connected. Specifically, the transition sleeve 13 is disposed between the first sleeve 11 and the second sleeve 12, with the proximal end of the transition sleeve 13 connected to the distal end of the first sleeve 11, and the distal end of the transition sleeve 13 connected to the proximal end of the second sleeve 12. The first sleeve 11, the transition sleeve 13, and the second sleeve 12 collectively define an accommodating channel 101, through which the core wire 20 is passed.

[0044] The bending performance of the transition sleeve 13 is higher than that of the first sleeve 11, and / or the bending performance of the second sleeve 12 is higher than that of the transition sleeve 13. Specifically, the first sleeve 11 has greater hardness, rigidity, and bending resistance than the transition sleeve 13 and the second sleeve 12, so that when the adjustable curved guidewire 100 is pushed into the target blood vessel, the first sleeve 11 can provide sufficient pushing force to the transition sleeve 13 and the second sleeve 12. The transition sleeve 13 has greater flexibility than the first sleeve 11 to conform to the curvature of the blood vessel. At the same time, the transition sleeve 13 has greater hardness and rigidity than the second sleeve 12, allowing the transition sleeve 13 to provide both support and facilitate the transmission of pushing force to the second sleeve 12 at the tip of the adjustable curved guidewire 100. In other embodiments, the bending performance of the second sleeve 12 can also be the same as that of the transition sleeve 13.

[0045] In detail, the transition sleeve 13 is provided with a plurality of hollow portions 102, for example, the hollow portion 102 is a long hole extending along the circumferential direction of the transition sleeve 13, and the plurality of hollow portions 102 are staggered in sequence along the axial direction of the transition sleeve 13, so that the transition sleeve 13 forms a hollow tubular structure, so that the transition sleeve 13 has better flexibility relative to the first sleeve 11.

[0046] In some embodiments, as shown in Figures 5 and 6, along the first direction, the second sleeve 12 has a first side and a second side respectively located on both sides of its axis, and at least one incision 1221 is provided on the tube wall of the first side of the second sleeve 12. The incision 1221 is arranged biased toward the first side relative to the axis of the second sleeve 12, so that the tube wall material on the first side of the second sleeve 12 is less than the tube wall material on the second side. Therefore, when subjected to the pulling force of the core wire 20, the second sleeve 12 bends from the second side to the first side, so that the first side is located on the inner arc side of the second sleeve 12, and the second side is located on the outer arc side of the second sleeve 12, so as to ensure that when the core wire 20 is pulled, the head end of the adjustable curved guide wire 100 can bend and deform along a specific direction, thereby improving the certainty of the bending direction of the head end of the adjustable curved guide wire 100 and optimizing the operability of the adjustable curved guide wire 100 during intervention in the target blood vessel.

[0047] The technical solution of the present invention will be further described in detail below with reference to specific embodiments.

[0048] Example 1

[0049] As shown in FIG. 1 , in this embodiment, the adjustable bend guide wire 100 includes a first sleeve 11 , a second sleeve 12 , a core wire 20 , a first connecting sleeve 14 and a second developing member 17 .

[0050] The first sleeve 11 can be a steel pipe and has good support. It includes a body segment 111 and a connecting segment 112 connected to the distal end of the body segment 111. The diameter of the connecting segment 112 is smaller than that of the body segment 111, resulting in a stepped distal end of the first sleeve 11. The second sleeve 12 is connected to the distal end of the connecting segment 112. The wall thickness of the second sleeve 12 is the same as that of the connecting segment 112, and the outer diameter of the second sleeve 12 is the same as that of the connecting segment 112.

[0051] The proximal end of the first connecting sleeve 14 is sleeved outside the first sleeve 11, and the distal end of the first connecting sleeve 14 is sleeved outside the second sleeve 12. The first sleeve 11, the first connecting sleeve 14 and the second sleeve 12 are welded into an integrated structure through a welding process. It should be noted that when the adjustable bend guide wire 100 is bent and deformed, due to the difference in bending properties between the first sleeve 11 and the second sleeve 12, stress concentration is easily generated at the connection between the first sleeve 11 and the second sleeve 12, causing the connection between the first sleeve 11 and the second sleeve 12 to bend and deform sharply, which is likely to cause the connection between the first sleeve 11 and the second sleeve 12 to break. Therefore, by arranging the first connecting sleeve 14 between the first sleeve 11 and the second sleeve 12, the strength of the connection structure between the first sleeve 11 and the second sleeve 12 is improved. Furthermore, the length of the first connecting sleeve 14 extends in the axial direction, and the first connecting sleeve 14 can lengthen the weak area that is easily deformed, thereby evenly distributing the deformation and avoiding excessive deformation at a certain point (i.e., the connection point between the distal end of the first sleeve 11 and the proximal end of the second sleeve 12), thereby reducing the probability of bending and breaking of the adjustable bend guidewire 100. In other embodiments, the proximal end of the first connecting sleeve 14 can also be disposed within the first sleeve 11, and the distal end of the first connecting sleeve 14 can be disposed within the second sleeve 12.

[0052] In this embodiment, in order to further improve the flexibility of the second sleeve 12, the tube wall of the second sleeve 12 is provided with a plurality of hollow portions 102 (see Figure 5). For example, the hollow portion 102 is a long hole extending along the circumferential direction of the second sleeve 12. The plurality of hollow portions 102 are staggered in sequence along the axial direction of the second sleeve 12, so that the second sleeve 12 forms a hollow tubular structure.

[0053] In this embodiment, the core wire 20 includes a connected proximal segment 21 and a distal segment 23, the proximal segment 21 is located on the proximal side relative to the distal segment 23, the distal end of the distal segment 23 is connected to the distal end of the second sleeve 12, the distal segment 23 is arranged inside the second sleeve 12, the proximal segment 21 is passed through the first sleeve 11, and the proximal end of the proximal segment 21 extends from the proximal end of the first sleeve 11 to the outside of the first sleeve 11, wherein, from the proximal end to the distal end, the diameter of the distal segment 23 gradually decreases, and the maximum diameter of the distal segment 23 is smaller than the maximum diameter of the proximal segment 21, so as to effectively improve the support of the proximal segment 21 of the adjustable bend guide wire 100 and the flexibility of the distal segment 23. In the process of moving the core wire 20, support is provided by the proximal segment 21, and the flexibility of the distal segment 23 is used to make the distal end of the adjustable bend guide wire 100 easier to adjust.

[0054] Furthermore, a cap portion 24 is provided at the distal end of the core wire 20. The cap portion 24 is hemispherical in shape and has a curved portion 241 and a flat portion 242. The cap portion 24 is located on one side of the distal end of the second sleeve 12 and is connected to the second sleeve 12. Specifically, the curved portion 241 is disposed toward the distal end, and the flat portion 242 abuts against the distal end of the second sleeve 12. Furthermore, the distal end of the distal segment 23, the distal end of the second sleeve 12, and the flat portion 242 are connected by dispensing glue or soldering.

[0055] In the axial direction, the cap portion 24 covers at least part of the distal end surface of the second sleeve 12. When the adjustable curved guide wire 100 is pushed forward in the blood vessel, the cap portion 24 directly contacts the blood vessel wall as the head end of the adjustable curved guide wire 100, and uses the smooth curved surface of the curved portion 241 to provide a guiding effect and reduce the friction between the head end of the adjustable curved guide wire 100 and the blood vessel wall, so that the adjustable curved guide wire 100 moves more smoothly in the blood vessel.

[0056] It should be noted that the shape of the curved surface portion 241 includes but is not limited to a spherical surface, a conical surface, and an umbrella-shaped curved surface.

[0057] Furthermore, the second developing member 17 is wound around the outside of the second sleeve 12 to facilitate the development and visibility of the adjustable curved guide wire 100 in the body, so that the operator can clearly observe the bending direction and bending angle of the second sleeve 12 of the adjustable curved guide wire 100, provide visual guidance for super-selection of the target blood vessel, and improve the probability of successful surgery.

[0058] The second developing member 17 includes, but is not limited to, a filament-like, tubular, or rod-like shape. In this embodiment, the second developing member 17 is in the shape of a spring. The second developing member 17 is sleeved outside the second sleeve 12. The proximal end of the second developing member 17 abuts against the distal end of the first connecting sleeve 14, and the distal end of the second developing member 17 abuts against the cap portion 24.

[0059] In other embodiments, the second developing member 17 may not be provided separately, and the second sleeve 12 itself only needs to have developing properties. For example, the second sleeve 12 may be made of a metal material with developing properties.

[0060] Example 2

[0061] In this embodiment, as shown in FIG. 2 and FIG. 7 , the adjustable bend guide wire 100 includes a first sleeve 11 , a transition sleeve 13 , a second sleeve 12 , a core wire 20 , a third connecting sleeve 18 and a second developing member 17 .

[0062] The first sleeve 11 is a steel pipe, and the first sleeve 11 has good support. Along the axial direction, the transition sleeve 13 is arranged between the first sleeve 11 and the second sleeve 12, and the proximal end of the transition sleeve 13 is connected to the distal end of the first sleeve 11, and the distal end of the transition sleeve 13 is connected to the proximal end of the second sleeve 12. The first sleeve 11, the transition sleeve 13 and the second sleeve 12 jointly define an accommodating channel 101, and the core wire 20 is passed through the accommodating channel 101, and the distal end of the core wire 20 is connected to the distal end of the second sleeve 12, and the proximal end of the core wire 20 extends from the proximal end of the first sleeve 11 to the outside of the accommodating channel 101.

[0063] Specifically, the first sleeve 11 includes a body segment 111 and a connecting segment 112 connected to the distal end of the body segment 111. The diameter of the connecting segment 112 is smaller than that of the body segment 111, resulting in a stepped distal end of the first sleeve 11. The transition sleeve 13 is sleeved over the connecting segment 112, with the proximal end of the transition sleeve 13 abutting against the distal end of the body segment 111. The transition sleeve 13 and the first sleeve 11 are connected and fixed by welding or bonding. The wall thickness of the main segment 111 of the first sleeve 11 is greater than the wall thickness of the transition sleeve 13, so as to improve the support of the proximal end of the adjustable curved guide wire 100. The wall thickness of the transition sleeve 13 is less than the wall thickness of the main segment 111, so that the transition sleeve 13 has higher bending performance relative to the first sleeve 11. The outer diameter of the transition sleeve 13 is the same as the outer diameter of the connecting segment 112, so that the outer peripheral surface of the adjustable curved guide wire 100 is smooth as a whole without protrusions, which is conducive to the adjustable curved guide wire 100 moving more smoothly in the blood vessel.

[0064] The proximal end of the second sleeve 12 is sleeved within the transition sleeve 13, and the transition sleeve 13 and the second sleeve 12 are connected and fixed by welding or bonding. The diameter of the transition sleeve 13 is larger than the diameter of the second sleeve 12, so that the transition sleeve 13 has better hardness, rigidity, and bending resistance relative to the second sleeve 12, thereby improving the support of the adjustable bend guidewire 100 near the distal end. It is understandable that the diameter of the second sleeve 12 is smaller than the diameters of the transition sleeve 13 and the first sleeve 11, so that the bending performance of the second sleeve 12 is higher than that of the transition sleeve 13 and the first sleeve 11, and the second sleeve 12 has better flexibility, thereby ensuring that the second sleeve 12 is easier to bend when the core wire 20 is pulled.

[0065] Furthermore, from the proximal end to the distal end, the core wire 20 includes a proximal segment 21, an intermediate segment 22 and a distal segment 23 connected in sequence, the distal segment 23 is correspondingly arranged in the second sleeve 12, the intermediate segment 22 is correspondingly arranged in the transition sleeve 13, the proximal segment 21 is passed through the first sleeve 11, and the proximal end of the proximal segment 21 extends from the proximal end of the first sleeve 11 to the outside of the accommodating channel 101.

[0066] In some embodiments, the proximal segment 21 and the distal segment 23 are both in the shape of a constant diameter round rod, the intermediate segment 22 is in the shape of a round rod, and at least part of the intermediate segment 22 is configured as a variable diameter round rod. In detail, the intermediate segment 22 is located between the proximal segment 21 and the distal segment 23, the proximal end of the intermediate segment 22 is connected to the distal end of the proximal segment 21, and the distal end of the intermediate segment 22 is connected to the proximal end of the distal segment 23, wherein the diameter of the distal segment 23 is smaller than the diameter of the proximal segment 21, the maximum diameter of the intermediate segment 22 is larger than the diameter of the proximal segment 21, and the diameter of the proximal side of the intermediate segment 22 gradually increases from the proximal end to the distal end, so that the intermediate segment 22 and the proximal segment 21 are connected. The outer peripheral surface of the connection is smoothly transitioned, and the diameter of the distal side of the intermediate segment 22 gradually decreases from the proximal end to the distal end, so that the outer peripheral surface of the connection between the intermediate segment 22 and the proximal segment 21 is smoothly transitioned. When the core wire 20 is bent, the deformation of the connection between the intermediate segment 22 and the proximal segment 21 and the connection between the intermediate segment 22 and the distal segment 23 is evenly distributed, avoiding the problem of stress concentration at the connection and causing excessive deformation, thereby reducing the probability of the core wire 20 bending and breaking.

[0067] Among them, making the maximum diameter of the intermediate segment 22 larger than the maximum diameter of the proximal segment 21 can improve the support of the corresponding area of ​​the intermediate segment 22 of the core wire 20 and the transition sleeve 13 in the adjustable curved guidewire 100, so as to provide a greater driving force to the head end of the adjustable curved guidewire 100 (i.e., the second sleeve 12 and the distal segment 23). Based on this embodiment, the wall thickness of the main segment 111 of the first sleeve 11 is greater than the wall thickness of the transition sleeve 13, and the outer diameter of the transition sleeve 13 is the same as the outer diameter of the connecting segment 112. Further setting the maximum diameter of the intermediate segment 22 to be larger than the maximum diameter of the proximal segment 21 can increase the supporting force of the intermediate segment 22. In some embodiments, the proximal segment 21, the intermediate segment 22 and the distal segment 23 are made of the same material, and the proximal segment 21, the intermediate segment 22 and the distal segment 23 are integrally processed and formed using a core wire 20.

[0068] In some embodiments, the proximal segment 21, the middle segment 22 and the distal segment 23 are made of the same material, the middle segment 22 and the distal segment 23 are integrally formed using a core wire 20, and the proximal segment 21 and the middle segment 22 are connected by laser welding, soldering or gluing.

[0069] In some embodiments, the middle segment 22 and the distal segment 23 are made of the same material and are integrally formed using a core wire 20. The proximal segment 21 and the middle segment 22 are made of different materials and are connected by laser welding, soldering, or gluing.

[0070] When the proximal segment 21 and the intermediate segment 22 are not integrally formed parts, in order to improve the stability of the connection between the proximal segment 21 and the intermediate segment 22, the adjustable curved guidewire 100 further includes a third connecting sleeve 18, which is disposed in the accommodating channel 101 and sleeved on the outside of the core wire 20. The third connecting sleeve 18 is connected to the proximal segment 21 and the intermediate segment 22 of the core wire 20 by laser welding, soldering or gluing. In this embodiment, during the movement of the core wire 20 toward the proximal end, the third connecting sleeve 18 can also abut against the distal end of the connecting segment 112 to control the movement distance of the core wire 20 and prevent the tip of the adjustable curved guidewire from excessively bending and damaging the blood vessel.

[0071] In this embodiment, the tube wall of the transition sleeve 13 and the tube wall of the second sleeve 12 are respectively provided with a plurality of hollow portions 102. For example, the hollow portion 102 is a long hole extending in the circumferential direction of the second sleeve 12. The plurality of hollow portions 102 are staggered in sequence along the axial direction, so that the second sleeve 12 and the transition sleeve 13 both form a hollow tubular structure, so that the transition sleeve 13 and the second sleeve 12 have better flexibility than the first sleeve 11.

[0072] Furthermore, the distal end of the core wire 20 is provided with a cap portion 24, which is hemispherical and has a curved portion 241 and a flat portion 242. The cap portion 24 is located on one side of the distal end of the second sleeve 12 and is connected to the second sleeve 12. Specifically, the curved portion 241 is arranged toward the distal end, and the flat portion 242 abuts against the distal end of the second sleeve 12. Moreover, the distal end of the distal segment 23, the distal end of the second sleeve 12, and the flat portion 242 are connected by dispensing or soldering. In the axial direction, the cap portion 24 covers at least a portion of the second sleeve 12. When the adjustable curved guide wire 100 is advanced in the blood vessel, the cap portion 24 directly contacts the blood vessel wall as the head end of the adjustable curved guide wire 100, utilizes the smooth curved surface of the curved portion 241 to provide a guiding effect, and reduces the friction between the head end of the adjustable curved guide wire 100 and the blood vessel wall, so that the adjustable curved guide wire 100 moves more smoothly in the blood vessel. It should be noted that the shape of the curved surface portion 241 includes but is not limited to a spherical surface, a conical surface, and an umbrella-shaped curved surface.

[0073] Furthermore, the second developing member 17 is wound around the outside of the second sleeve 12 to facilitate the development and visibility of the adjustable curved guide wire 100 in the body, so that the operator can clearly observe the bending direction and bending angle of the second sleeve 12 of the adjustable curved guide wire 100, provide visual guidance for superselection to the target blood vessel, and improve the probability of successful surgery. The second developing member 17 includes but is not limited to shapes such as filaments, tubes, and rods. In this embodiment, the second developing member 17 is in the shape of a spring, and the second developing member 17 is sleeved outside the second sleeve 12. The proximal end of the second developing member 17 is against the distal end of the transition sleeve 13, and the distal end of the second developing member 17 is against the cap portion 24. The distal segment 23 of the core wire 20, the cap portion 24, the second sleeve 12, and the second developing member 17 are fixed together by bonding or welding.

[0074] Example 3

[0075] The differences between the third embodiment and the second embodiment will be described below, and the same or similar aspects between the third embodiment and the second embodiment will not be repeated here.

[0076] In this embodiment, as shown in FIG3 , FIG8 and FIG10 , the adjustable bend guide wire 100 includes a first sleeve 11 , a transition sleeve 13 , a second sleeve 12 , a core wire 20 , a second connecting sleeve 15 and a second developing member 17 .

[0077] In this embodiment, no step-like structure is provided at the distal end of the first sleeve 11, the inner diameter of the first sleeve 11 is equal to the inner diameter of the transition sleeve 13, and the outer diameter of the first sleeve 11 is equal to the outer diameter of the transition sleeve 13, and the distal end of the first sleeve 11 abuts against the proximal end of the transition sleeve 13.

[0078] In some embodiments, as shown in FIG3 , since steel pipes of the same diameter are difficult to butt together by welding, in order to connect and fix the first casing 11 and the transition casing 13 together by welding, a second connecting sleeve 15 is embedded in the interior of the first casing 11 and the interior of the transition casing 13. The proximal end of the second connecting sleeve 15 is inserted into the first casing 11 and connected to the first casing 11 by welding, and the distal end of the second connecting sleeve 15 is inserted into the transition casing 13 and connected to the transition casing 13 by welding, thereby connecting and fixing the first casing 11 and the transition casing 13 by welding using the second connecting sleeve 15. In other embodiments, the proximal end of the second connecting sleeve 15 is sleeved outside the first casing 11 and connected to the first casing 11, and the distal end of the second connecting sleeve 15 is sleeved outside the transition casing 13 and connected to the transition casing 13.

[0079] In this embodiment, as shown in Figure 3, from the proximal end to the distal end, the core wire 20 includes a proximal segment 21, an intermediate segment 22 and a distal segment 23 connected in sequence, the distal segment 23 is correspondingly arranged in the second sleeve 12, the intermediate segment 22 is correspondingly arranged in the transition sleeve 13, the proximal segment 21 is passed through the first sleeve 11, and the proximal end of the proximal segment 21 extends from the proximal end of the first sleeve 11 to the outside of the accommodating channel 101.

[0080] Among them, the distal segment 23 is in the shape of a constant diameter round rod, at least part of the proximal segment 21 and at least part of the intermediate segment 22 are in the shape of a variable diameter round rod. Specifically, the intermediate segment 22 is located between the proximal segment 21 and the distal segment 23, the proximal end of the intermediate segment 22 is connected to the distal end of the proximal segment 21, and the distal end of the intermediate segment 22 is connected to the proximal end of the distal segment 23.

[0081] In some embodiments, the diameter of the distal segment 23 is smaller than the minimum diameter of the proximal segment 21 and the minimum diameter of the middle segment 22, so that the distal segment 23 has the highest bending performance relative to the proximal segment 21 and the middle segment 22, and the maximum diameter of the proximal segment 21 is larger than the maximum diameter of the middle segment 22, so that the proximal segment 21 has the highest support relative to the middle segment 22 and the distal segment 23, while the middle segment 22 takes into account both support and flexibility, so that the middle segment 22 can provide sufficient pushing force to the distal segment 23 while maintaining better flexibility to better conform to the curved shape of the blood vessel.

[0082] It should be noted that the outer diameter of the proximal segment 21 corresponding to the second connecting sleeve 15 becomes smaller in order to avoid the second connecting sleeve 15, so that the core wire 20 can move in the axial direction relative to the second connecting sleeve 15, thereby realizing the bending function of the head end of the adjustable guide wire 100.

[0083] As shown in FIG8 and FIG9 , a through groove 151 is provided in the wall of the second connecting sleeve 15 , so that the proximal segment 21 of the core wire 20 is partially placed into the second connecting sleeve 15 through the through groove 151 .

[0084] Example 4

[0085] The following describes the differences between the fourth embodiment and the third and second embodiments. The same or similar aspects of the fourth embodiment to the third and second embodiments will not be described in detail.

[0086] In this embodiment, as shown in FIG. 4 , the adjustable bend guide wire 100 includes a first sleeve 11 , a transition sleeve 13 , a second sleeve 12 , a core wire 20 , a second connecting sleeve 15 , a first developing member 16 and a second developing member 17 .

[0087] The distal end of the first sleeve 11 and the proximal end of the transition sleeve 13 do not directly abut against each other. Instead, the distal end of the first sleeve 11 and the proximal end of the transition sleeve 13 are spaced apart. The length of the second connecting sleeve 15 in this embodiment is longer than that of the second connecting sleeve 15 in Example 3, and the length of the second connecting sleeve 15 ranges from 2 mm to 100 mm. A first developing member 16 is disposed outside the second connecting sleeve 15, and the first developing member 16 is located between the first sleeve 11 and the transition sleeve 13. The first developing member 16 can be used to observe the degree of bending at the connection between the first sleeve 11 and the transition sleeve 13. When the bending angle at the connection between the first sleeve 11 and the transition sleeve 13 is large, the interventional procedure can be terminated in a timely manner to prevent the bending angle at the connection between the first sleeve 11 and the transition sleeve 13 from exceeding the limit value, thereby preventing the adjustable curved guidewire 100 from breaking, thereby reducing surgical risks.

[0088] In some embodiments, the outer diameters of the first sleeve 11, the first developing member 16, the transition sleeve 13 and the second developing member 17 are equal, so that the outer peripheral surface of the adjustable curved guide wire 100 is smooth and has no protrusions, which is conducive to smoother movement of the adjustable curved guide wire 100 in the blood vessel.

[0089] It should be noted that due to the difference in bending properties between the first sleeve 11 and the transition sleeve 13, stress concentration is likely to occur at the connection between the first sleeve 11 and the transition sleeve 13, causing the connection between the first sleeve 11 and the transition sleeve 13 to bend sharply and deform, which can easily lead to fracture at the connection between the first sleeve 11 and the transition sleeve 13. By lengthening the second connecting sleeve 15, the second connecting sleeve 15 can lengthen the weak area between the connection between the first sleeve 11 and the transition sleeve 13 that is prone to deformation, thereby evenly distributing the deformation and avoiding excessive deformation at the connection between the distal end of the first sleeve 11 and the proximal end of the transition sleeve 13, thereby reducing the probability of bending and fracture of the adjustable bend guidewire 100.

[0090] In other embodiments, the first developing member 16 and / or the second developing member 17 may not be provided separately, and the second connecting sleeve 15 and the second sleeve 12 themselves only need to have developing properties. For example, the second connecting sleeve 15 and the second sleeve 12 may be made of a metal material with developing properties.

[0091] Example 5

[0092] The following describes the differences between the fifth embodiment and the first, second, third and fourth embodiments. The same or similar aspects of the fifth embodiment to the first, second, third and fourth embodiments will not be repeated here.

[0093] In this embodiment, as shown in Figure 5, from the proximal end to the distal end, the second sleeve 12 includes a proximal support segment 121, a curved segment 122 and a head end segment 123 connected in sequence, and the bending performance of the curved segment 122 is higher than the bending performance of the proximal support segment 121 and the head end segment 123.

[0094] In this embodiment, the proximal support segment 121 provides greater support than the curved segment 122, giving the proximal support segment 121 a certain degree of support and flexibility. This allows the proximal support segment 121 to maintain a certain degree of flexibility, facilitating conformity to vascular deformation without damaging the vessel. Furthermore, when the curved segment 122 bends, the proximal support segment 121 can maintain a relatively small degree of bending. Due to its greater flexibility, the curved segment 122 is more susceptible to relative bending.

[0095] In some embodiments, the proximal support segment 121 , the curved segment 122 and the head segment 123 are made of different materials, and the flexibility of the material of the curved segment 122 is better than the flexibility of the material of the proximal support segment 121 and the head segment 123 .

[0096] In some embodiments, the proximal support segment 121, the curved segment 122 and the head end segment 123 are made of the same material, the cross-sectional area of ​​the curved segment 122 is smaller than the cross-sectional area of ​​the proximal support segment 121, and the cross-sectional area of ​​the curved segment 122 is smaller than the cross-sectional area of ​​the head end segment 123, so that the curved segment 122 has better flexibility relative to the proximal support segment 121 and the head end segment 123.

[0097] In some embodiments, the curved section 122 has a first side and a second side respectively located on both sides of the axis of the second cannula 12, and at least one incision 1221 is provided on the tube wall of the first side of the second cannula 12. The incision 1221 is arranged biased toward the first side relative to the axis of the second cannula 12, so that the tube wall material on the first side of the second cannula 12 is less than the tube wall material on the second side. Therefore, when subjected to the pulling force of the core wire 20, the second cannula 12 bends from the second side to the first side, so that the first side is located on the inner arc side of the second cannula 12, and the second side is located on the outer arc side of the second cannula 12, so as to ensure that when the core wire 20 is pulled, the head end of the adjustable curved guide wire 100 can bend and deform along a specific direction, thereby improving the certainty of the bending direction of the head end of the adjustable curved guide wire 100 and optimizing the operability of the adjustable curved guide wire 100 during intervention in the target blood vessel.

[0098] It is understandable that in some exemplary embodiments, as shown in FIG. 5 , the curved section 122 is provided with a cutout 1221 , and the length of the cutout 1221 extends along the axial direction.

[0099] In other exemplary embodiments, as shown in FIG. 6 , the curved section 122 is provided with a plurality of cutouts 1221 , and the plurality of cutouts 1221 are sequentially arranged along the axial direction.

[0100] It should be emphasized that the technical solution of this embodiment can be combined with any one of Examples 1, 2, 3 and 4, and the technical solution of this embodiment can be combined with any one of Examples 1, 2, 3 and 4, and is also covered by the protection scope of the present invention.

[0101] The foregoing description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any modifications or substitutions that can be readily conceived by a person skilled in the art within the technical scope disclosed in the present invention are intended to be encompassed within the scope of protection of the present invention. Therefore, the scope of protection of the present invention shall be subject to the scope of protection of the claims.

Claims

1. An adjustable curved guide wire, characterized in that: The adjustable curved guide wire comprises: A sleeve assembly, the sleeve assembly comprising a first sleeve and a second sleeve that are connected, the second sleeve is arranged at the distal end of the first sleeve, and the bending performance of the second sleeve is higher than that of the first sleeve; The core wire is inserted into the first sleeve and the second sleeve in a manner that it can move along its own axial direction. The distal end of the core wire is connected to the distal end or a position close to the distal end of the second sleeve. The proximal end of the core wire extends from the proximal end of the first sleeve to the outside of the first sleeve. The proximal end of the core wire can move along its own axial direction relative to the sleeve assembly, and the proximal end of the core wire is pulled to drive the second sleeve to bend.

2. The adjustable curved guide wire according to claim 1, characterized in that: The sleeve assembly further includes a first connecting sleeve, a proximal end of the first connecting sleeve is connected to the first sleeve, and a distal end of the first connecting sleeve is connected to the second sleeve.

3. The adjustable curved guide wire according to claim 1, characterized in that: The sleeve assembly further includes a transition sleeve, the proximal end of the transition sleeve is connected to the distal end of the first sleeve, the distal end of the transition sleeve is connected to the proximal end of the second sleeve, the first sleeve, the transition sleeve and the second sleeve jointly define an accommodating channel, and the core wire is inserted into the accommodating channel; Wherein, the bending performance of the transition sleeve is higher than that of the first sleeve; and / or, the bending performance of the second sleeve is higher than that of the transition sleeve.

4. The adjustable curved guide wire according to claim 3, characterized in that: The sleeve assembly also includes a second connecting sleeve, the proximal end of the second connecting sleeve is connected to the first sleeve, the distal end of the second connecting sleeve is connected to the transition sleeve, and the core wire is movably inserted into the second connecting sleeve.

5. The adjustable curved guide wire according to claim 4, characterized in that: Along the axial direction of the first sleeve, the distal end of the first sleeve is spaced apart from the proximal end of the transition sleeve.

6. The adjustable curved guide wire according to claim 1, characterized in that: From the proximal end to the distal end, the core wire includes a proximal segment, an intermediate segment and a distal segment connected in sequence, the distal end of the distal segment is connected to the distal end or a position close to the distal end of the second sleeve, and the maximum diameter size of the distal segment is smaller than the maximum diameter size of the intermediate segment and the maximum diameter size of the proximal segment, respectively.

7. The adjustable curved guide wire according to claim 6, characterized in that: The adjustable curved guide wire also includes a third connecting sleeve, which is arranged in the sleeve assembly and sleeved outside the core wire. The distal end of the proximal segment and the proximal end of the intermediate segment are connected through the third connecting sleeve.

8. The adjustable curved guide wire according to claim 6, characterized in that: From the proximal end to the distal end, the diameter of the distal segment gradually decreases.

9. The adjustable curved guidewire according to any one of claims 1 to 8, characterized in that: In the direction from the proximal end to the distal end, the second sleeve includes a proximal support segment, a bending segment and a head end segment which are connected in sequence, and the bending performance of the bending segment is higher than the bending performance of the proximal support segment and the bending performance of the head end segment.

10. The adjustable curved guide wire according to claim 9, characterized in that: Along a first direction, the curved section has a first side and a second side respectively located on both sides of the axis of the second sleeve, the tube wall of the first side is provided with at least one cutout, and the first direction is perpendicular to the axis of the second sleeve.

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