WO2025103434A1 - Deflectable guide wire - Google Patents

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 guide wire Technical Field

The invention relates to the technical field of medical devices, and in particular to an adjustable curved guide wire.

Background Art

During interventional diagnosis and treatment, the adjustable curved guidewire is an important instrument for guiding various catheters and interventional devices to the target site. The function of the adjustable curved guidewire during intravascular interventional treatment is to enter the main channel, branches and winding parts of the vascular cavity. Sometimes it is 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.

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 adjustable curved guidewire with a curved head end can be super-selected to the target vessel under the physician's delicate operation. However, the bending shape of the in vitro shaped adjustable curved guidewire with a curved head end 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 morphology of the patient's vascular pathway, resulting in difficulty in super-selection or even intervention failure.

Summary of the invention

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 prior art, an adjustable curved guide wire is provided.

The present invention solves the technical problem by the following technical solutions:

An embodiment of the present invention provides an adjustable bend guide wire, which includes: a sleeve assembly, wherein the sleeve assembly includes a first sleeve and a second sleeve that are connected to each other, the second sleeve is arranged at the distal end of the first sleeve, and the bending performance of the second sleeve is higher than the bending performance of the first sleeve; a core wire 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 close to 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 relative to the sleeve assembly along its own axial direction, and pulling the proximal end of the core wire drives the second sleeve to bend.

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.

In some embodiments of the present invention, the sleeve assembly also 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 that of the first sleeve; and/or the bending performance of the second sleeve is higher than that of the transition sleeve.

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

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.

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 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.

In some embodiments of the present invention, the adjustable curved guide wire also 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.

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

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.

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 cutout, and the first direction is perpendicular to the axis of the second sleeve.

According to the adjustable bend guide wire provided by the present invention, a second sleeve tube with higher bending performance is provided, and the proximal end of the core wire is pulled to move relative to the first sleeve tube in the direction of the proximal end, 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 tube, so that the second sleeve tube is bent and deformed, and the degree of bending deformation of the second sleeve tube is controlled by finely adjusting the moving distance of the core wire, thereby actively adjusting the bending shape of the second sleeve tube 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

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

FIG1 shows a schematic cross-sectional structure diagram of an adjustable curved guide wire according to an embodiment of the present invention;

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

FIG3 shows a schematic cross-sectional structure diagram of an adjustable curved guide wire according to an embodiment of the present invention;

FIG4 shows a schematic cross-sectional structure diagram of an adjustable curved guide wire according to an embodiment of the present invention;

FIG5 is a schematic structural diagram of a second sleeve according to an embodiment of the present invention;

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

FIG7 shows a schematic structural diagram of an adjustable curved guide wire according to an embodiment of the present invention;

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

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

FIG. 10 shows a schematic cross-sectional structure diagram of an adjustable curved guide wire according to an embodiment of the present invention.

The symbols in the accompanying drawings are as follows:
100. Adjustable curved guide wire;
10. sleeve assembly; 11. first sleeve; 111. body segment; 112. connecting segment; 12. second sleeve; 121.
Proximal support section; 122, curved section; 1221, incision; 123, head end section; 13, transition sleeve; 14, first connecting sleeve; 15, second connecting sleeve; 151, through groove; 16, first developing member; 17, second developing member; 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

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.

The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the 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. On the contrary, these embodiments are provided in order 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.

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

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, 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 teaching of the exemplary embodiment.

For ease of description, spatial 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 figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figure. For example, if the device in the figure is turned over, then the elements described as "below other elements or features" or "below other elements or features" will subsequently be oriented as "above other elements or features" or "above other elements or features". Therefore, the example term "below..." can include both upper and lower orientations. The device can be oriented otherwise (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction.

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, the first sample is placed on two supporting points at a certain distance, and the distance between the two supporting points is less than the length of the two samples. A downward load is applied to the sample above the midpoint of the two supporting 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 in the same way. When testing the second sample, the distance between the two supporting points and the distance of the pressed 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.

As shown in FIG1 , an embodiment of the present invention provides an adjustable curved guide wire 100, which 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. The core wire 20 can move in the axial direction relative to the first sleeve 11. The proximal end of the core wire 20 is pulled toward the proximal side to move relative to the first sleeve 11, and the distal end of the core wire 20 is used to apply 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.

In this embodiment, the distal end of the core wire 20 can be directly connected to the distal end or a position close to the distal end of the second sleeve 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 close to the distal end of the second sleeve 12, for example, by connecting the distal end of the core wire 20 to the distal end or a position close to the distal end of the second sleeve 12 through a cap portion 24 (see FIG. 2 ).

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, and when subjected to the pulling force of the core wire 20, it is easier for the second sleeve 12 to bend and deform to conform to the curved blood vessel morphology and realize the adjustable bend of the head end of the adjustable bend guide wire 100. The first sleeve 11 has higher hardness, rigidity and bending resistance than the second sleeve 12. During the process of the adjustable bend guide wire 100 intervening in the target blood vessel, the first sleeve 11 can effectively transmit the pushing force to the front end of the adjustable bend guide wire 100, such as the second sleeve 12.

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 less than the wall thickness 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.

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 FIG. 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 arranged alternately in sequence along the axial direction of the second sleeve 12, so that the second sleeve 12 forms a hollow tubular cavity structure.

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 .

It is understandable that the first sleeve 11 and the second sleeve 12 can be directly connected, and the distal end of the first sleeve 11 is connected to the proximal end of the second sleeve 12, for example, the first sleeve 11 and the second sleeve 12 are connected as a whole 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.

In some embodiments, as shown in Fig. 2 and Fig. 7, the sleeve assembly 10 further includes a transition sleeve 13, and the first sleeve 11 and the second sleeve 12 are indirectly connected through the transition sleeve 13. Specifically, the transition sleeve 13 is disposed between the first sleeve 11 and the second sleeve 12, 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, and 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.

Among them, 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 better hardness, rigidity and bending resistance than the transition sleeve 13 and the second sleeve 12, so that in the process of pushing the adjustable curved guide wire 100 to 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 better flexibility than the first sleeve 11, so as to conform to the curved shape of the blood vessel. At the same time, the transition sleeve 13 has better hardness and rigidity than the second sleeve 12, so that the transition sleeve 13 takes into account the support, so as to facilitate the transmission of the pushing force to the second sleeve 12 at the head end of the adjustable curved guide wire 100. In other embodiments, the bending performance of the second sleeve 12 can also be the same as the bending performance of the transition sleeve 13.

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. 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 cavity structure, so that the transition sleeve 13 has better flexibility relative to the first sleeve 11.

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 arranged on the tube wall of the first side of the second sleeve 12, and the incision 1221 is arranged biased towards 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.

The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments.

Embodiment 1

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 .

The first sleeve 11 may be a steel pipe, and has good support. 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 the diameter of the body segment 111, so that the distal end of the first sleeve 11 is set in a stepped shape. The second sleeve 12 is connected to the distal end of the connecting segment 112, and 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.

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 curved guide wire 100 is bent and deformed, due to the difference in the bending properties of the first sleeve 11 and the second sleeve 12, it is easy to generate stress concentration at the connection between the first sleeve 11 and the second sleeve 12, so that the connection between the first sleeve 11 and the second sleeve 12 is sharply bent and deformed, which is easy 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, so that the deformation is evenly distributed, 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 curved guide wire 100. In other embodiments, the proximal end of the first connecting sleeve 14 can also be arranged in the first sleeve 11, and the distal end of the first connecting sleeve 14 can be arranged in the second sleeve 12.

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 FIG. 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 arranged alternately in sequence along the axial direction of the second sleeve 12, so that the second sleeve 12 forms a hollow tubular cavity structure.

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 inserted into 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, the 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 bend.

Further, the distal end of the core wire 20 is provided with a cap portion 24, which is in a hemispherical shape and has a curved portion 241 and a flat portion 242. The cap portion 24 is located at 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, the flat portion 242 abuts against the distal end of the second sleeve 12, and 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 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 can move 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.

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 of the target blood vessel, and improve the probability of successful surgery.

The second developing member 17 includes, but is not limited to, a filament, a tube, a rod, etc. In this embodiment, the second developing member 17 is in a spring shape, and the second developing member 17 is sleeved outside the second sleeve 12, and 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.

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.

Embodiment 2

In this embodiment, as shown in FIG. 2 and FIG. 7 , the adjustable curved 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 .

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, 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, 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.

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 the diameter of the body segment 111, so that the distal end of the first sleeve 11 is set in a step shape. The transition sleeve 13 is sleeved outside the connecting segment 112, the proximal end of the transition sleeve 13 is against the distal end of the body segment 111, and 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 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 than 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 and has no protrusions as a whole, which is conducive to the adjustable curved guide wire 100 to move more smoothly in the blood vessel.

The proximal end of the second sleeve 12 is sleeved in the transition sleeve 13, and the transition sleeve 13 and the second sleeve 12 are connected and fixed by welding or bonding. Among them, 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, and improves the support of the adjustable curved guide wire 100 near the distal end. It can be understood that the diameter of the second sleeve 12 is smaller than the diameter 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 to ensure that when the core wire 20 is pulled, it is easier to bend the second sleeve 12.

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 which are 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.

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

Among them, the maximum diameter of the middle segment 22 is larger than the maximum diameter of the proximal segment 21, which can improve the support of the corresponding area of the middle segment 22 and the transition sleeve 13 of the core wire 20 in the adjustable curved guidewire 100, so as to provide a greater driving force to the head end (i.e., the second sleeve 12 and the distal segment 23) of the adjustable curved guidewire 100. Based on the present embodiment, the wall thickness of the body 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 middle segment 22 to be larger than the maximum diameter of the proximal segment 21 can increase the support force of the middle segment 22. In some embodiments, the proximal segment 21, the middle segment 22 and the distal segment 23 are made of the same material, and the proximal segment 21, the middle segment 22 and the distal segment 23 are integrally processed and formed using a core wire 20.

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.

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 to each other by laser welding, soldering or gluing.

When the proximal segment 21 and the middle segment 22 are not integrally formed parts, in order to improve the stability of the connection between the proximal segment 21 and the middle segment 22, the adjustable curved guide wire 100 further includes a third connecting sleeve 18, which is arranged in the accommodating channel 101 and sleeved outside the core wire 20. The third connecting sleeve 18 is connected to the proximal segment 21 and the middle segment 22 of the core wire 20 by laser welding, soldering or adhesive. 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 head end of the adjustable curved guide wire from being excessively bent to damage the blood vessel.

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 alternately arranged in sequence along the axial direction, so that the second sleeve 12 and the transition sleeve 13 both form a hollow tubular cavity structure, so that the transition sleeve 13 and the second sleeve 12 have better flexibility than the first sleeve 11.

Further, the distal end of the core wire 20 is provided with a cap portion 24, which is in a hemispherical 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 arranged toward the distal end, the flat portion 242 is against the distal end of the second sleeve 12, and 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 part 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, and uses 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.

Furthermore, the second developing member 17 is wound around the outside of the second sleeve 12, which is convenient for 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 filamentary, tubular, rod-shaped and other shapes. 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, and 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.

Embodiment 3

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 described in detail here.

In this embodiment, as shown in FIGS. 3 , 8 and 10 , the adjustable curved 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 .

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.

In some embodiments, as shown in FIG3 , since steel pipes of the same diameter are difficult to be butted together by welding, in order to connect and fix the first sleeve 11 and the transition sleeve 13 together by welding, a second connecting sleeve 15 is embedded in the first sleeve 11 and the transition sleeve 13, the proximal end of the second connecting sleeve 15 is inserted into the first sleeve 11 and connected to the first sleeve 11 by welding, and the distal end of the second connecting sleeve 15 is inserted into the transition sleeve 13 and connected to the transition sleeve 13 by welding, so that the first sleeve 11 and the transition sleeve 13 are connected and fixed 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 sleeve 11 and connected to the first sleeve 11, and the distal end of the second connecting sleeve 15 is sleeved outside the transition sleeve 13 and connected to the transition sleeve 13.

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.

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

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 curvature of the blood vessel.

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

As shown in FIG. 8 and FIG. 9 , 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 .

Embodiment 4

The differences between the fourth embodiment and the third and second embodiments will be described below, and the same or similar aspects between the fourth embodiment and the third and second embodiments will not be described in detail here.

In this embodiment, as shown in FIG. 4 , the adjustable curved 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 .

The distal end of the first sleeve 11 and the proximal end of the transition sleeve 13 are not directly against each other, but the distal end of the first sleeve 11 and the proximal end of the transition sleeve 13 are arranged at intervals. The length of the second connecting sleeve 15 in this embodiment is longer than that of the second connecting sleeve 15 in the third embodiment, 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 bending degree of the connection between the first sleeve 11 and the transition sleeve 13 can be observed through the first developing member 16. When the bending angle at the connection between the first sleeve 11 and the transition sleeve 13 is large, the intervention operation can be terminated in time to prevent the bending angle at the connection between the first sleeve 11 and the transition sleeve 13 from exceeding the limit value and causing the adjustable curved guide wire 100 to break, thereby reducing the risk of surgery.

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 as a whole without protrusions, which is conducive to smoother movement of the adjustable curved guide wire 100 in the blood vessel.

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 and deform sharply, which is likely to cause the connection between the first sleeve 11 and the transition sleeve 13 to break. By lengthening the length of 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, so that the deformation is evenly distributed, avoiding excessive deformation of 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 breaking of the adjustable curved guidewire 100.

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 may 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.

Embodiment 5

The differences between the fifth embodiment and the first embodiment, the second embodiment, the third embodiment and the fourth embodiment will be described below, and the same or similar aspects between the fifth embodiment and the first embodiment, the second embodiment, the third embodiment and the fourth embodiment will not be described in detail here.

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 bending segment 122 and a head end segment 123 connected in sequence, and the bending performance of the bending segment 122 is higher than the bending performance of the proximal support segment 121 and the head end segment 123.

In this embodiment, the proximal support segment 121 has better support than the curved segment 122, so that the proximal support segment 121 has certain support and flexibility, and can maintain a certain degree of softness to facilitate conforming to the deformation of the blood vessel shape without damaging the blood vessel. At the same time, when the curved segment 122 bends, the proximal support segment 121 can maintain a small degree of bending. The curved segment 122 is more likely to bend relatively due to its better flexibility.

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 .

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.

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 sleeve 12, and at least one incision 1221 is arranged on the tube wall of the first side of the second sleeve 12, and the incision 1221 is arranged biased towards 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 in 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.

It can be understood 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.

In some 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.

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

The above is only a preferred specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (10)

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. The adjustable bend guidewire according to claim 1 is characterized in that the sleeve assembly also includes a first connecting sleeve, the proximal end of the first connecting sleeve is connected to the first sleeve, and the distal end of the first connecting sleeve is connected to the second sleeve. The adjustable curved guidewire according to claim 1 is characterized in that the sleeve assembly further comprises 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 accommodation channel, and the core wire is inserted into the accommodation 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. The adjustable bend guidewire according to claim 3 is 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. The adjustable bend guidewire according to claim 4 is characterized in that, 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. The adjustable bend guidewire according to claim 1 is 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. The adjustable bend guidewire according to claim 6 is characterized in that the adjustable bend guidewire also includes a third connecting sleeve, the third connecting sleeve is arranged in the sleeve assembly and is 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. The adjustable curved guidewire according to claim 6 is characterized in that the diameter of the distal segment gradually decreases from the proximal end to the distal end. The adjustable bendable guidewire according to any one of claims 1 to 8 is characterized in that, in the direction from the proximal end to the distal end, the second sleeve comprises a proximal support segment, a curved segment and a head end segment connected in sequence, and the bending performance of the curved segment is higher than the bending performance of the proximal support segment and the bending performance of the head end segment. The adjustable curved guidewire according to claim 9 is characterized in that, along the 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 incision, and the first direction is perpendicular to the axis of the second sleeve.