Guide wire assembly and controllable bending guide wire

Abstract

The invention particularly relates to a guide wire assembly and a controllable bending guide wire, and the guide wire assembly is used for a vascular intervention operation and is provided with a near end and a far end. The guide wire assembly is provided with a first bent section, a supporting section and a second bent section which are sequentially arranged in the direction from the near end to the far end. A first control part is arranged in the supporting section and used for being connected with a first traction rope arranged in the guide wire assembly in a penetrating mode, and a second control part is arranged at the far end of the second bending section and used for being connected with a second traction rope arranged in the guide wire assembly and penetrating through the first control part. According to the guide wire assembly, the two bending sections with different bending directions and different bending angles can be formed at the near end and the far end so that the guide wire assembly can accurately point to and enter small branch blood vessels with different opening angles, and the problem that an existing guide wire is insufficient in trafficability in an interventional operation can be solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a guidewire assembly and a controllable bending guidewire. Background Technology

[0002] Microguidewires are key instruments in endovascular interventional procedures, used to establish delivery pathways for catheters, balloons, or stents and guide them to the target lesion area. In the field of neurointervention, microguidewires need to achieve superselective cannulation to enter tortuous and delicate intracranial vessels, and their performance directly affects the success and safety of the procedure.

[0003] Intracranial blood vessels have unique anatomical structures: their wall thickness is only one-tenth that of peripheral blood vessels of the same diameter, and they lack an external elastic layer and a complete muscle layer, making them highly fragile. Furthermore, these vessels hang from the brain surface, their branches are easily damaged by traction, and their paths are tortuous and complex, placing extremely high demands on the passage and maneuverability of microguidewires.

[0004] Currently, most clinically used microguidewires are pre-shaped at the tip or manually shaped during the procedure. The surgeon needs to adjust the guidewire tip's curvature in real time under DSA guidance. This method has significant limitations: a fixed-shape guidewire tip has poor directional accuracy during advancement, easily entering non-target branches in vascular bifurcation areas, leading to repeated manipulations. This not only prolongs the operation time and increases radiation exposure for both doctors and patients, but may also induce vasospasm or injury due to mechanical stimulation. Furthermore, the shaped tip is prone to deformation or loosening during the procedure, further affecting the accuracy of the operation.

[0005] Existing adjustable guidewires achieve distal bending through mandrel traction. These guidewires consist of a proximal cannula with high rigidity and a distal cannula with better flexibility, bending the distal end by pulling the internal mandrel. While this structure achieves tip-end adjustment, the multi-layered cannula and mandrel movement mechanism also increase overall rigidity, resulting in insufficient passage and poor flexibility when navigating extremely tortuous intracranial vessels. Furthermore, repeated bending operations increase the frictional resistance between the mandrel and cannula, leading to decreased bending response sensitivity and affecting the precision and safety of manipulation in complex vessels. Summary of the Invention

[0006] The objective of this invention is to at least address the problem of insufficient permeability of existing guidewires in interventional procedures. This objective is achieved through the following technical solution: The first aspect of the present invention provides a guidewire assembly for vascular interventional surgery, the guidewire assembly having a proximal end and a distal end, and in a direction from the proximal end toward the distal end, the guidewire assembly having a first curved section, a support section and a second curved section arranged sequentially; The support section is provided with a first control element inside, which is used to connect with a first traction rope passing through the guide wire assembly. The distal end of the second bending section has a second control element, which is used to connect with a second traction rope provided in the guide wire assembly and passing through the first control element.

[0007] The guidewire assembly of this invention, by configuring the guidewire assembly into a first curved section, a support section, and a second curved section, and by incorporating a first control element and a second control element, can cooperate with the first and second traction ropes within the guidewire assembly to form two curved sections with different bending directions and angles at the proximal and distal ends of the guidewire assembly. This results in various shapes (such as an S-shape) at the tip of the guidewire assembly, allowing for precise targeting and entry into small branch vessels with challenging opening angles. This helps address the insufficient passability of existing guidewires in interventional procedures. Simultaneously, it reduces the risk of abrasion damage to the vessel wall during implantation, making it particularly suitable for surgeries such as tumor embolization requiring precise drug delivery.

[0008] Furthermore, since the guidewire assembly achieves bending of the first and second bending segments through the traction of the first and second traction cords respectively, it improves operational flexibility when navigating multi-bend vessels such as those with an "S" shape. In practice, the proximal bending control can be used first to guide the interventional catheter through the main vessel at a large angle, and then the distal bending control can be used to selectively enter branch vessels. This segmented approach helps reduce the number of catheter adjustments, making the procedure smoother. Moreover, the support segment creates a stable support point within the vessel, effectively preventing guidewire displacement during subsequent catheter or other instrument advancement, thus improving the stability and success rate of the procedure.

[0009] In addition, the guidewire assembly according to the present invention may also have the following additional technical features: In some embodiments of the present invention, the guide wire assembly includes a first tube body, and a plurality of slots are provided on the circumferential surface of the first tube body; From the proximal end toward the distal end, the first tube has a first region and a second region, the first region and the second region have different slot sizes, the first region forms the first curved section, and the second region forms the support section.

[0010] In some embodiments of the present invention, a first spacing is provided between two adjacent slots along the axial direction of the first tube body; The first region comprises multiple segments, and the first spacing between the multiple segments gradually decreases from the proximal end to the distal end.

[0011] In some embodiments of the present invention, a plurality of guide members are provided inside the first tube, the plurality of guide members are spaced apart along the axial direction of the first tube, and the guide members are used to separate the first traction rope and the second traction rope.

[0012] In some embodiments of the present invention, the guidewire assembly further includes a flexible component, the proximal end of which is connected to the support segment, and the distal end of which is connected to the first control element to form the second bending segment.

[0013] In some embodiments of the present invention, the flexible component includes a flexible sleeve and a flexible support disposed inside the flexible sleeve.

[0014] In some embodiments of the present invention, the flexible component further includes a developing element disposed inside the flexible sleeve and located at the distal end of the flexible support.

[0015] In some embodiments of the present invention, the first control member has a first limiting channel and a first arched channel, the first limiting channel being for passing through the second traction rope, and the first arched channel being for accommodating a portion of the first traction rope; and / or The second control component is configured as a hemispherical structure, and the interior of the second control component is provided with a second arched channel for accommodating a portion of the second traction rope.

[0016] A second aspect of the present invention provides a controllable bending guidewire, comprising a control device and a guidewire assembly as described in the present invention, wherein the control device includes a control handle, a first traction rope and a second traction rope, both of which are threaded within the guidewire assembly.

[0017] In some embodiments of the present invention, the control handle includes a handle, and a first control component and a second control component disposed on the handle, the first control component being connected to the first traction rope, the second control component being connected to the second traction rope, and the first traction rope passing through the second control component.

[0018] In some embodiments of the present invention, the first control component includes: A first bending wheel is rotatably mounted on the handle; A first transmission mechanism is connected to the first curved wheel and to the first traction rope. When the first bending wheel rotates clockwise or counterclockwise, the first traction rope is wound up and down through the first transmission mechanism to drive the first bending section to bend.

[0019] In some embodiments of the present invention, the second control component includes: A second bending wheel is rotatably mounted on the handle; The second transmission mechanism is connected to the second bending wheel and is also connected to the second traction rope. When the second bending wheel rotates clockwise or counterclockwise, the second traction rope is wound up or down through the second transmission mechanism to drive the second bending section to bend.

[0020] In some embodiments of the present invention, the first control member has a first arched channel, the first traction rope has a first knot and a second knot, the first traction rope passes through the first arched channel, and the first knot and the second knot are respectively located at both ends of the first arched channel; And / or, the second control element has a second arched channel, the second traction rope has a third knot and a fourth knot, the second traction rope passes through the second arched channel, and the third knot and the fourth knot are respectively located at both ends of the second arched channel.

[0021] In some embodiments of the present invention, the first traction rope is a metal component or a polymer structure, and / or the second traction rope is a metal component or a polymer structure; And / or, the first traction rope is a single-strand structure or a multi-strand braided structure, and / or, the second traction rope is a single-strand structure or a multi-strand braided structure. Attached Figure Description

[0022] Various other advantages and benefits will become apparent to those skilled in the art upon reading the following detailed description of preferred embodiments. The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals denote the same parts throughout the drawings. In the drawings: Figure 1 This is a schematic diagram of the structure of the controllable bending guide wire shown in an embodiment of the present invention; Figure 2 for Figure 1 A schematic diagram of the guidewire assembly in a blood vessel; Figure 3 This is a schematic diagram of another structure of the guidewire assembly shown in an embodiment of the present invention; Figure 4 This is a schematic diagram of a third structure of the guidewire assembly shown in an embodiment of the present invention; Figure 5 for Figure 1 A schematic diagram of the structure of the first tube shown in the figure; Figure 6 for Figure 1 A partial structural diagram of the distal end of the guidewire assembly shown; Figure 7 for Figure 1 A schematic diagram of the flexible component and the second traction rope shown in the figure; Figure 8 for Figure 7 A schematic diagram of the flexible component and the second traction rope shown from another perspective; Figure 9 for Figure 1 A schematic diagram of the structure of the second control component and the second traction rope shown in the figure; Figure 10 for Figure 1 A schematic diagram showing the connection between the first control element, the first traction rope, and the second traction rope. Figure 11 for Figure 1 The diagram shows the connection between the first tube, the guide, the first traction rope, and the second traction rope. Figure 12 This is a schematic diagram of another structure of the guide member shown in an embodiment of the present invention; Figure 13 for Figure 1 The diagram shows the internal structure of the control device.

[0023] The markings in the attached diagram are as follows: 1000, Controllable bending guidewire; 2000, Blood vessel; 100. Guide wire assembly; 101. First bending section; 102. Support section; 103. Second bending section; 200. Control device; 10. The second tube body; 20. First tube body; 201. First region; 202. Second region; 203. Subsection; 21. Pipe body; 22. Grooving; 30. Flexible component; 31. Flexible sleeve; 32. Flexible support; 321. Protruding post; 33. Developing component; 40. First control component; 41. First arched channel; 42. First limiting channel; 50. Second control element; 51. Second arched passage; 60. Guide component; 61. Main body; 62. Second limiting channel; 71. Control handle; 72. First traction rope; 73. Second traction rope; 731. Third knot; 732. Fourth knot; 80. First control component; 81. First bending wheel; 82. First transmission mechanism; 821. First main drive; 822. First auxiliary drive; 90. Second control component; 91. Second bending wheel; 92. Second transmission mechanism; 921. Second main drive; 922. Second auxiliary drive. Detailed Implementation

[0024] Exemplary embodiments of the present disclosure will now be described in more detail with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it should be understood that the present disclosure may be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the disclosure to those skilled in the art.

[0025] It should be understood that the terminology used herein is for the purpose of describing particular exemplary embodiments only and is not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms “a,” “an,” and “described” as used herein may also mean including the plural forms. The terms “comprising,” “including,” “containing,” and “having” are inclusive and therefore indicate the presence of the stated features, steps, operations, elements, and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not construed as requiring them to be performed in a particular order described or illustrated unless the order of performance is explicitly indicated. It should also be understood that additional or alternative steps may be used.

[0026] Although terms such as first, second, third, etc., may be used in this document to describe multiple elements, components, regions, layers, and / or segments, these elements, components, regions, layers, and / or segments should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or segment from another. Unless the context clearly indicates otherwise, terms such as "first," "second," and other numerical terms used herein do not imply order or sequence. Therefore, the first element, component, region, layer, or segment discussed below may be referred to as the second element, component, region, layer, or segment without departing from the teachings of the exemplary embodiments.

[0027] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature, as shown in the figure. These relative terms include, for example, "inside," "outside," "middle," "outer," "below," "below," "above," "over," etc. Such spatial relative terms are intended to include different orientations of the device in use or operation, other than those depicted in the figure. For example, if the device in the figure is flipped, an element described as "below other elements or features" or "below other elements or features" would subsequently be oriented "above other elements or features" or "above other elements or features." Therefore, the example term "below" can include both upper and lower orientations.

[0028] It should be noted that the terms "distal" and "proximal" are used as directional terms, which are commonly used in the medical device field. "Distal" refers to the end furthest from the operator during surgery, while "proximal" refers to the end closest to the operator. Axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the medical device; radial direction refers to the direction perpendicular to the aforementioned axial direction.

[0029] like Figures 1-13 As shown, this embodiment proposes a guidewire assembly 100 for vascular interventional surgery. The guidewire assembly 100 has a proximal end and a distal end. From the proximal end to the distal end, the guidewire assembly 100 has a first curved section 101, a support section 102, and a second curved section 103 arranged sequentially. A first control member 40 is disposed inside the support section 102, and the first control member 40 is used to connect with a first traction rope 72 passing through the guidewire assembly 100. A second control member 50 is located at the distal end of the second curved section 103, and the second control member 50 is used to connect with a second traction rope 73 disposed within the guidewire assembly 100 and passing through the first control member 40.

[0030] Specifically, by configuring the guidewire assembly 100 as a first curved section 101, a support section 102, and a second curved section 103, and by providing a first control element 40 and a second control element 50, it can cooperate with the first traction rope 72 and the second traction rope 73 within the guidewire assembly 100 to form two curved sections with different bending directions and angles at the proximal and distal ends of the guidewire assembly 100. This results in various shapes (such as an S-shape) at the tip of the guidewire assembly 100, allowing for accurate targeting and entry into small branch vessels 2000 with tricky opening angles. This helps solve the problem of insufficient passability of existing guidewires in interventional procedures. Simultaneously, it reduces the risk of scratching damage to the inner wall of the vessel 2000 during implantation, making it particularly suitable for surgeries such as tumor embolization requiring precise drug delivery.

[0031] Furthermore, since the guidewire assembly 100 achieves bending of the first bending segment 101 and the second bending segment 103 respectively through the traction of the first traction rope 72 and the second traction rope 73, this improves operational flexibility when navigating multi-bend vessels 2000 such as those with an "S" shape. In actual operation, the proximal bending control can be used first to guide the interventional catheter through the main trunk of the vessel 2000 at a large angle, and then the distal bending control can be used to selectively enter the branch vessels 2000. This segmented approach helps reduce the number of adjustments to the interventional catheter, making the surgical procedure smoother. Moreover, the support segment 102 forms a stable support point within the vessel 2000, effectively preventing guidewire displacement during subsequent catheter or other instrument advancement, thus improving the stability and success rate of the surgical procedure.

[0032] The various parts of the guide wire assembly 100 provided in this embodiment will now be described in detail with reference to the accompanying drawings: In this embodiment, the guidewire assembly 100 is elongated and flexible to facilitate movement and bending within the blood vessel 2000. Simultaneously, the outer surface of the guidewire assembly 100 is smoothly configured to facilitate movement within the blood vessel 2000 and reduce blood resistance to the guidewire.

[0033] like Figures 1 to 4 As shown, the guidewire assembly 100 has a proximal end and a distal end. From the proximal end to the distal end, the guidewire assembly 100 has a first bending section 101, a support section 102, and a second bending section 103 arranged sequentially. The guidewire assembly 100 has an internal cavity for accommodating a first traction rope 72 and a second traction rope 73. Simultaneously, a first control member 40 is disposed inside the support section 102, and a second control member 50 is located at the distal end of the second bending section 103. The first control member 40 is connected to the first traction rope 72, and the second control member 50 is connected to the second traction rope 73 passing through the first control member 40. At this time, by pulling the first traction rope 72 and the second traction rope 73, the first control member 40 and the second control member 50 can be driven, thereby achieving bending adjustment of the first bending section 101 and the second bending section 103.

[0034] It should be noted that the overall length of the guidewire assembly 100 is greater than or equal to 2100 mm, and the maximum outer diameter of the guidewire assembly 100 can be selected from specifications such as 0.014 inches, 0.024 inches or 0.035 inches to meet different clinical needs.

[0035] It is necessary to understand that, such as Figure 1 and Figure 5As shown, in this embodiment, from the proximal end to the distal end, the guidewire assembly 100 has a second tube 10, a first tube 20, and a flexible component 30 arranged sequentially. The second tube 10 helps ensure that the guidewire assembly 100 has a good length to adapt to different clinical needs. Meanwhile, the first tube 20 has a first region 201 and a second region 202. The first region 201 has good flexibility to ensure that the first region 201 can be bent to form the first curved segment 101 mentioned above. The second region 202 has good rigidity, which can be used to install the first control component 40 mentioned above to ensure the installation effect of the first tube 20 and the first control component 40. On the other hand, it can also serve as the support segment 102 mentioned above, becoming a stable mechanical fulcrum connecting the first curved segment 101 and the second curved segment 103.

[0036] like Figure 6 As shown, in this embodiment, the second control member 50 is connected and disposed at the distal end of the flexible component 30, and the second control member 50 and the flexible component 30 together constitute the aforementioned second bending segment 103. Optionally, the second control member 50 is configured as a hemispherical structure, with the spherical surface of the second control member 50 facing away from the flexible component 30, which helps to improve the convenience of implantation of the guidewire assembly 100 and reduce tissue damage during implantation. The plane of the second control member 50 is connected to the second traction wire, and under the traction of the second traction wire, the second control member 50 can drive the flexible component 30 to bend.

[0037] It should be noted that in this embodiment, the second control component 50 is manufactured using laser melting forming technology, and the second control component 50 is welded and fixed to the flexible component 30.

[0038] In this embodiment, the second control member 50 has a second arched channel 51 inside, which is used to accommodate a portion of the second traction rope 73. Specifically, from the proximal end to the distal end, the second traction rope 73 passes sequentially through the second tube 10, the first tube 20, and the flexible component 30, and then passes sequentially through the flexible component 30, the first tube 20, and the second tube 10 after passing through the second arched channel 51. At this time, in order to ensure that the two ends of the second traction rope 73 can be pulled, the second control member 50 can be driven to perform bending control, such as... Figure 9 As shown, two knots are arranged at intervals on the second traction rope 73. For ease of description, the two knots are referred to as the third knot 731 and the fourth knot 732, respectively. By pulling the two ends of the second traction rope 73, and under the action of the third knot 731 and the fourth knot 732, the second control member 50 can be driven to drive the flexible component 30 to bend.

[0039] In some embodiments, the flexible component 30 can be directly used as the second bending segment 103 described above. In this case, the second control member 50 is disposed inside the flexible component 30 and located at the distal end of the flexible component 30. Optionally, the distal end of the flexible component 30 is configured as a hemispherical structure, and the second control member 50 connected to the second traction line is disposed inside the flexible component 30.

[0040] like Figure 6 and Figure 7 As shown, the flexible component 30 includes a flexible sleeve 31 and a flexible support member 32 disposed inside the flexible sleeve 31. In this embodiment, the flexible member is a spring. Optionally, the spring is made of wound metal wire to ensure the flexibility of the distal end of the guide wire assembly 100. The metal wire can be a nickel-titanium wire with a small diameter to ensure the implantability of the flexible component 30 and its bendability. Meanwhile, the flexible support member 32 is a columnar structure that can act as a mandrel to provide support for the flexible sleeve 31, ensuring that the flexible component 30 has sufficient strength.

[0041] It should be further understood that the flexible component 30 also includes a imaging element 33, which is disposed inside the flexible sleeve 31 and located at the distal end of the flexible support 32. The imaging element 33 is provided to provide clear imaging positioning during surgery. In this embodiment, a protrusion 321 is provided at the distal end of the flexible support 32, and the imaging element 33 is sleeved on the protrusion 321. Optionally, the imaging element 33 can be directly welded to the protrusion 321, or along the axial direction of the protrusion 321, the opposite ends of the imaging element 33 can be welded and fixed to the flexible support 32 and the second control element 50, respectively, to ensure the connection effect between the imaging element 33 and the flexible support 32, thereby ensuring the integrity of the flexible component 30.

[0042] In this embodiment, the developing element 33 is configured as a developing spring, the length of which can be set to 1mm-5mm. Optionally, the length of the developing spring is 3mm. The developing spring is made of a metal component wound together, and the metal component can be gold or a platinum-tungsten alloy.

[0043] It should be noted that, in addition to being configured as the aforementioned developing spring, the developing element 33 can also be configured as other structures, such as a columnar structure, with the developing element 33 welded to the far end of the flexible support 32, and the diameter of the developing element 33 being smaller than the diameter of the flexible support 32.

[0044] In some other implementations, such as Figure 3As shown, the flexible component 30 is configured as a sodium hydroxide tube structure. Optionally, the flexible component 30 is configured as a metal tube, and several through slots are formed on the circumferential surface of the metal tube. The width of the through slots is less than or equal to 0.03 mm, and the distance between two adjacent through slots is less than or equal to 1.0 mm. In this case, the flexible component 30 can be integrally formed with the first tube body 20, or welded and fixed to the first tube body 20. This application does not impose any restrictions on this.

[0045] In other implementations, such as Figure 4 As shown, the flexible component 30 is configured as a tubular or columnar structure, and the tubular or columnar structure is made of a polymer. This effectively improves the assembly efficiency of the flexible component 30, thereby improving the assembly efficiency of the guidewire assembly 100.

[0046] like Figure 5 As shown, a plurality of slots 22 are provided on the circumferential surface of the first tube 20. By adjusting the size of the slots 22, the first tube 20 can have a first region 201 and a second region 202. Furthermore, because the sizes of the slots 22 in the first region 201 and the second region 202 are different, the flexibility of the first region 201 and the second region 202 is different, thereby forming a support section 102 and a bending section 103. In this embodiment, the size of the slot 22 refers to the width of the slot 22 along the axial direction of the first tube 20 and the distance between two adjacent slots 22. Of course, the size of the slot 22 can also include the length of the slot along the circumference of the first tube 20, etc. The size of the slot 22 can be used to adjust the flexibility of the first tube 20.

[0047] Specifically, the first tube 20 includes a tube body 21 and slots 22 formed on the tube body 21 by laser engraving. There are two slots 22 along the circumference of the tube body, and the two slots 22 are spaced apart. Along the axial direction of the tube body, the slots 22 have a width, and there is a first distance between adjacent slots 22. The first region 201 serves as the first bending section 101. Compared to the second region 202, the slot width and the first distance are smaller to ensure the bending effect of the first region 201. In this embodiment, the slot width ranges from 0.01mm to 0.05mm, and the first distance ranges from 1.0mm to 2.5mm.

[0048] It is necessary to further understand that the first region 201 adopts a segmented gradient design, such as... Figure 5As shown, the first region 201 includes multiple segments 203, and the initial spacing between the segments 203 gradually decreases from the proximal end to the distal end. In this embodiment, the length of the first region 201 is 15mm to 60mm, and it can be divided into 4-8 segments 203. The length of each segment 203 ranges from 1.0mm to 3.0mm, and the groove width is 0.03mm. From the proximal end to the distal end, the initial spacing between the multiple segments 203 gradually decreases, that is, the initial spacing of each segment 203 is 0.5mm less than that of the previous segment 203. This configuration allows the stiffness of the guidewire assembly 100 to smoothly transition from the distal end to the proximal end, combining the flexibility of the distal end with the support of the proximal end. This effectively avoids the risk of kinking during the push process, ensuring that the proximal end has sufficient support for push while ensuring that the distal end is soft enough to safely pass through the fragile blood vessel 2000, resulting in more coordinated overall performance.

[0049] In this embodiment, the second region 202 serves as a bending fulcrum. Compared to the first region 201, the first spacing is larger. Optionally, the groove width ranges from 0.03mm to 0.08mm, and the first spacing ranges from 1.0mm to 2.5mm. This configuration allows the second region 202 to have higher rigidity, making it a stable mechanical fulcrum connecting the first bending segment 101 and the second bending segment 103. In this case, the second region 202 is the axial spacing between the first bending segment 101 and the second bending segment 103. Along the axial direction of the first tube body 20, the range of the second region 202 is 5mm-30mm, so that the guidewire assembly 100 can form complex bending shapes such as "S" shapes to adapt to complex blood vessel bifurcation 2000.

[0050] Still Figure 1 As shown, a first control element 40 is provided inside the second region 202. The first control element 40 has a first limiting channel 42 and a first arched channel 41. The first limiting channel 42 is used to pass through the second traction rope 73, and the first arched channel 41 is used to accommodate a portion of the first traction rope 72. The first limiting channel 42 ensures that the second traction rope 73 remains parallel and spaced apart inside the flexible component 30, thereby ensuring the limiting effect of the third knot 731 and the fourth knot 732 when the second traction rope 73 is pulled. On the other hand, it can reduce the impact of the second traction rope 73 on the first traction rope 72.

[0051] In this embodiment, the first control member 40 is located at the distal end of the second region 202. The first traction rope 72 passes sequentially through the second tube 10 and the first region 201, and then through the first arched channel 41 before passing sequentially through the first region 201 and the second tube 10. The first control member 40 houses a portion of the first traction rope 72. Optionally, the first traction rope 72 has a first knot and a second knot. The first traction rope 72 passes through the first arched channel 41, and the first knot and the second knot are located at opposite ends of the first arched channel 41. Pulling on both ends of the first traction rope 72, in conjunction with the first knot and the second knot, can cause the second region 202 to bend.

[0052] like Figure 1 and Figure 10 As shown, a plurality of guide members 60 are provided inside the first tube body 20. These guide members 60 are spaced apart along the axial direction of the first tube body 20 and serve to separate the first traction rope 72 and the second traction rope 73. Specifically, the guide members 60 allow for precise management of the paths of the first traction rope 72 and the second traction rope 73, preventing interference between them and avoiding the generation of non-axial forces. In this embodiment, a plurality of guide members 60 are spaced apart within the cavity of the first tube body 20. Optionally, one guide member 60 is provided every other section 203.

[0053] In this embodiment, such as Figure 11 As shown, the guide member 60 includes a main body 61 and a second limiting channel 62 disposed on the main body 61. Optionally, the guide member 60 is configured with a cross structure. In this case, the four notches of the guide member 60 are the second limiting channels 62. The guide member 60 can be fixed inside the first tube 20 by welding, and the guide member 60 and the inner wall of the first tube 20 can cooperate to form four second limiting channels 62. In this case, a first traction rope 72 and a second traction rope 73 are disposed in each pair of opposite second limiting channels 62, thereby achieving effective separation of the first traction rope 72 and the second traction rope 73. This ensures that the first traction rope 72 and the second traction rope 73 have clear paths during movement, preventing them from tangling or rubbing violently against the tube wall. This helps to improve the efficiency of force transmission, makes the operation feel clearer, and also reduces the possibility of traction rope wear, extending the service life of the guide wire.

[0054] In some other implementations, such as Figure 11As shown, the guide member 60 can also be configured as a cylindrical structure with four through holes, namely four second limiting channels 62, arranged around the axis of the guide member 60. A first traction rope 72 and a second traction rope 73 are disposed in each pair of opposite through holes. Furthermore, the guide member 60 is welded and fixed inside the first tube 20. In this case, the guide member 60 can effectively separate the first traction rope 72 and the second traction rope 73. Of course, besides providing four through holes on the cylinder, other structures that separate the four areas can be provided to achieve the effect of not interfering with the traction ropes, either alone or in conjunction with the inner wall of the first tube 20.

[0055] It should be further understood that, in this embodiment, the length of the first curved section 101 is 15mm-60mm, the length of the support section 102 is 5mm-50mm, and the length of the second curved section 103 is 3mm-30mm. This configuration helps ensure that the guidewire assembly 100 has sufficient implantation depth, thereby improving the implantation effect of the guidewire assembly 100. Moreover, by limiting the lengths of the first curved section 101, the support section 102, and the second curved section 103, it is possible to effectively ensure that the guidewire assembly 100 can form various shapes (such as S-shape), thereby more accurately pointing to and entering those small branch vessels 2000 with tricky opening angles, which helps to reduce the risk of scratching damage to the inner wall of the vessel 2000, and is especially suitable for surgeries such as tumor embolization that require precise drug delivery.

[0056] This embodiment also relates to a controllable bending guide wire 1000, which includes a control device 200 and the above-mentioned guide wire assembly 100. The control device 200 includes a control handle 71, a first traction rope 72 and a second traction rope 73, both of which are threaded inside the guide wire assembly 100.

[0057] Specifically, by using the guidewire assembly 100 in conjunction with a control device 200 having a control handle 71, a first traction rope 72, and a second traction rope 73, the guidewire assembly 100 can form a stable support point within the blood vessel 2000 by controlling the first bending segment 101 after the distal end of the guidewire assembly 100 reaches the target position. This support point effectively prevents guidewire displacement during subsequent catheter or other instrument advancement, improving the stability and success rate of the surgical procedure. Simultaneously, by controlling the second bending segment 103, the distal end of the guidewire assembly 100 can selectively enter the branch blood vessel 2000. This segmented approach reduces the number of repeated adjustments, making the surgical process smoother.

[0058] Simultaneously, by positioning the two curved segments at the proximal and distal ends of the guidewire assembly 100 at different angles, it can be directed and inserted into small branch vessels 2000 with tricky opening angles. This helps reduce the risk of abrasion damage to the inner wall of the vessel 2000, making it particularly suitable for procedures such as tumor embolization that require precise drug delivery.

[0059] It should be understood that the control handle 71 includes a handle, and a first control component 80 and a second control component 90 disposed on the handle. The first control component 80 is connected to the first traction rope 72, and the second control component 90 is connected to the second traction rope 73 passing through the second control component 90. By providing the first control component 80 and the second control component 90 on the handle, the first traction rope 72 and the second traction rope 73 can be controlled separately, which helps improve the accuracy and convenience of control, and enhances the performance of the controllable bending guide wire 1000.

[0060] like Figure 13 As shown, the first control component 80 includes a first bending wheel 81 and a first transmission mechanism 82. The first bending wheel 81 is rotatably mounted on the handle, and the first transmission mechanism 82 is connected to and driven by the first bending wheel 81, and is also connected to the first traction rope 72. When the first bending wheel 81 rotates clockwise or counterclockwise, the first transmission mechanism 82 retracts or expands the first traction rope 72 to drive the first bending segment 101 to bend. Specifically, the handle has a mounting groove, the first bending wheel 81 is rotatably mounted on the handle, and the axis of the first bending wheel 81 is on the same straight line as the axis of the handle. In this case, the first bending wheel 81 can rotate clockwise or counterclockwise.

[0061] In this embodiment, the first transmission mechanism 82 includes a first main transmission 821 and a first auxiliary transmission 822. Optionally, the first main transmission 821 is connected to the first bending wheel 81 and is configured as a helical gear. The first main transmission 821 and the first bending wheel 81 are concentrically arranged. Meanwhile, the first auxiliary transmission 822 is configured as two transmission components. The two transmission components are arranged radially spaced along the first bending wheel 81 and mesh with the first main transmission 821. The transmission components include a helical gear meshing with the first main transmission 821 and a connecting rod fixed to the handle. The axis of the connecting rod and the axis of the helical gear are on the same straight line. One end of the connecting rod is wound with a first traction rope 72 or a second traction rope 73. When the first bending wheel 81 rotates, it will drive the first main transmission 821 to rotate, thereby driving the first auxiliary transmission 822 to rotate, thereby pulling the first traction rope 72 or the second traction rope 73, thereby realizing the bending control of the second bending segment 103 and the second bending segment 103.

[0062] Still Figure 13As shown, the second control component 90 includes a second bending wheel 91 and a second transmission mechanism 92. The second bending wheel 91 is rotatably mounted on the handle, and the second transmission mechanism 92 is connected to the second bending wheel 91 and is also connected to the second traction rope 73. When the second bending wheel 91 rotates clockwise or counterclockwise, the second transmission mechanism 92 releases or retracts the second traction rope 73 to drive the second bending segment 103 to bend. That is, the structure of the second control component 90 is the same as that of the first control component 80, and the control method is the same. In other words, the second control component 90 includes a second main transmission 921 and a second auxiliary transmission 922, which will not be described in detail in this application.

[0063] It should be noted that the structure of the first control component 80 and the second control component 90 on the handle is not limited to the meshing structure of the worm and helical gear described above. It can also be replaced by a chain drive with a reversing mechanism or a planetary gear mechanism to improve transmission efficiency and structural compatibility. This application does not impose any restrictions on this.

[0064] In this embodiment, both the first traction rope 72 and the second traction rope 73 are single. The first control member 40 has a first arched channel 41, and the first traction rope 72 has a first knot and a second knot. The first traction rope 72 passes through the first arched channel 41, with the first knot and the second knot located at opposite ends of the first arched channel 41. Simultaneously, the second control member 50 has a second arched channel 51, and the second traction rope 73 has a third knot 731 and a fourth knot 732. The second traction rope 73 passes through the second arched channel 51, with the third knot 731 and the fourth knot 732 located at opposite ends of the second arched channel 51. By utilizing the knots, the first traction rope 72 can drive the first control member 40, and the second traction rope 73 can drive the second control member 50. This design is simple, provides precise control, and helps reduce the assembly efficiency of the controllable bending guide wire 1000.

[0065] It is important to further understand that the first traction rope 72 and the second traction rope 73 have the same structure. The following description uses the first traction rope 72 as an example. The first traction rope 72 is configured as a metal component or a polymer structure, and it can be a single-strand structure or a multi-strand braided structure. Optionally, the diameter of the first traction rope 72 is not greater than 0.05 mm, preferably in the range of 0.02 mm–0.04 mm.

[0066] It should be noted that, in addition to the above-mentioned structure, the first traction rope 72 can also be set as a conventional rope structure. This application does not limit this. Moreover, the first traction rope 72 and the second traction rope 73 have the same structure. That is to say, the second traction rope 73 is a metal part or a polymer structure, and the structure is a single strand structure or a multi-strand braided structure.

[0067] The above description is merely a preferred embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A guidewire assembly for vascular interventional surgery, the guidewire assembly having a proximal end and a distal end, characterized in that, From the proximal end toward the distal end, the guidewire assembly has a first curved section, a support section and a second curved section arranged sequentially. The support section is provided with a first control element inside, which is used to connect with a first traction rope passing through the guide wire assembly. The distal end of the second bending section has a second control element, which is used to connect with a second traction rope provided in the guide wire assembly and passing through the first control element.

2. The guidewire assembly according to claim 1, characterized in that, The guide wire assembly includes a first tube body, and a plurality of slots are provided on the circumferential surface of the first tube body. From the proximal end toward the distal end, the first tube has a first region and a second region, the first region and the second region have different slot sizes, the first region forms the first curved section, and the second region forms the support section.

3. The guidewire assembly according to claim 2, characterized in that, Along the axial direction of the first tube, there is a first spacing between two adjacent slots; The first region comprises multiple segments, and the first spacing between the multiple segments gradually decreases from the proximal end to the distal end.

4. The guidewire assembly according to claim 2, characterized in that, The first tube is provided with a plurality of guide members, which are spaced apart along the axial direction of the first tube and are used to separate the first traction rope and the second traction rope.

5. The guidewire assembly according to claim 1, characterized in that, The guidewire assembly further includes a flexible component, the proximal end of which is connected to the support segment, and the distal end of which is connected to the first control element to form the second bending segment.

6. The guidewire assembly according to claim 5, characterized in that, The flexible component includes a flexible sleeve and a flexible support member disposed inside the flexible sleeve.

7. The guidewire assembly according to claim 6, characterized in that, The flexible component also includes a developing element, which is disposed inside the flexible sleeve and located at the distal end of the flexible support.

8. The guidewire assembly according to claim 1, characterized in that, The first control element has a first limiting channel and a first arched channel, the first limiting channel being for passing through the second traction rope, and the first arched channel being for accommodating a portion of the first traction rope; and / or, The second control component is configured as a hemispherical structure, and the interior of the second control component is provided with a second arched channel for accommodating a portion of the second traction rope.

9. A controllable bending guidewire, characterized in that, The device includes a control device and a guide wire assembly as described in any one of claims 1-8, wherein the control device includes a control handle, a first traction rope, and a second traction rope, both of which are threaded within the guide wire assembly.

10. The controllable bending guidewire according to claim 9, characterized in that, The control handle includes a handle, and a first control component and a second control component disposed on the handle. The first control component is connected to the first traction rope, the second control component is connected to the second traction rope, and the first traction rope passes through the second control component.

11. The controllable bending guidewire according to claim 10, characterized in that, The first control component includes: A first bending wheel is rotatably mounted on the handle; A first transmission mechanism is connected to the first curved wheel and to the first traction rope. When the first bending wheel rotates clockwise or counterclockwise, the first traction rope is wound up and down through the first transmission mechanism to drive the first bending section to bend.

12. The controllable bending guidewire according to claim 10, characterized in that, The second control component includes: A second bending wheel is rotatably mounted on the handle; The second transmission mechanism is connected to the second bending wheel and is also connected to the second traction rope. When the second bending wheel rotates clockwise or counterclockwise, the second traction rope is wound up or down through the second transmission mechanism to drive the second bending section to bend.

13. The controllable bending guidewire according to claim 10, characterized in that, The first control element has a first arched channel, the first traction rope has a first knot and a second knot, the first traction rope passes through the first arched channel, and the first knot and the second knot are respectively located at both ends of the first arched channel; And / or, the second control element has a second arched channel, the second traction rope has a third knot and a fourth knot, the second traction rope passes through the second arched channel, and the third knot and the fourth knot are respectively located at both ends of the second arched channel.

14. The controllable bending guidewire according to claim 9, characterized in that, The first traction rope is a metal component or a polymer structure, and / or the second traction rope is a metal component or a polymer structure; And / or, the first traction rope is a single-strand structure or a multi-strand braided structure, and / or, the second traction rope is a single-strand structure or a multi-strand braided structure.

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