Interventional guidewire

Abstract

The invention relates to an interventional guide wire. More than two grooves are formed in the radial side wall of a near-end pushing shaft of the interventional guide wire. Compared with an existing intervention guide wire, the groove is additionally formed in the radial side wall of the near-end pushing shaft. The outer wall of the shaft is evacuated and provided with multiple holes, a certain deformation receding space is formed, the shaft can adapt to translocation generated by deformation, the control difficulty caused by mutual limiting is reduced, and an intervention guide wire can be guided into and pass through a target area in a more flexible and changeable form. The flexibility of the pushing rod at the near end of the interventional guide wire is improved, so that the controllability, supporting performance and interventional passing performance of the interventional guide wire are improved, the operation difficulty is reduced, and the operation efficiency is improved.

Description

Technical Field

[0001] The present application relates to the technical field of interventional guidewires, and in particular to an interventional guidewire. Background Art

[0002] Interventional therapy is a new, high-tech, minimally invasive treatment technique characterized by minimal trauma, a wide range of indications, definite efficacy, and rapid postoperative recovery. It is a key development trend in future medicine. Within interventional therapy, vascular interventional therapy represents a niche area with the highest technical requirements and entry barriers.

[0003] Vascular interventional technology refers to minimally invasive procedures that use medical consumables such as puncture needles, guidewires, and catheters to introduce specific medical consumables into the affected area through vascular pathways under the guidance of medical imaging equipment. Cardiovascular disease is caused by heart and vascular diseases, including coronary heart disease and congenital heart disease.

[0004] Interventional guidewires are an important part of cardiovascular interventional treatment. They are used to guide other devices into blood vessels and establish access pathways that facilitate the insertion of intravascular devices. When the correct guidewire is used, it can improve the results and increase the success rate of the operation, as well as shorten the operation time.

[0005] Traditional interventional guidewires are pushed using a proximal cylindrical push rod. Although they can guide and assist the operation of instruments such as catheters, they have poor flexibility, which hinders the controllability of the interventional guidewire. When encountering complex lesions, the interventional guidewire is difficult to pass smoothly, delaying the operation time and affecting the treatment effect.

[0006] Therefore, how to improve the proximal flexibility of the interventional guidewire has become an urgent problem to be solved by those skilled in the art. Summary of the Invention

[0007] In order to improve the proximal flexibility of an interventional guidewire, the present application provides an interventional guidewire.

[0008] The present application provides an interventional guidewire, wherein the radial side wall of the proximal pushing shaft of the interventional guidewire is provided with two or more grooves.

[0009] In a possible implementation, the preset depth of the groove is 1 / 10 to 1 / 2 of the diameter of the proximal pushing shaft.

[0010] In a possible implementation, the opening directions of the two or more grooves are perpendicular to the axial direction of the proximal pushing shaft.

[0011] In one possible implementation, the interventional guidewire is provided with two or more groups of second flexibility enhancing portions, the second flexibility enhancing portions include two or more grooves located on the radial side walls of the interventional guidewire, the two or more grooves of the second flexibility enhancing portions are distributed circumferentially along the axis of the proximal push shaft, and the two or more groups of the second flexibility enhancing portions are adjacently distributed along the axial direction of the proximal push shaft.

[0012] In a possible implementation, the interventional guidewire includes a proximal push shaft, a core wire, a support sleeve, a coil spring, and a distal head;

[0013] Along the proximal end to the distal end of the interventional guide wire, the proximal push shaft, the support sleeve, the coil spring and the distal head are connected in sequence, the two ends of the axial opening of the support sleeve are respectively connected to one axial end of the proximal push shaft and one axial end of the coil spring, the other axial end of the coil spring facing away from the support sleeve is connected to the distal head, the core wire is installed in the support sleeve, one end of the core wire is connected to the proximal push shaft at the opening of one axial end of the support sleeve, and the other end of the core wire protrudes out of the support sleeve through the opening of the other axial end of the support sleeve and enters the interior of the coil spring, and is arranged close to the distal head.

[0014] In a possible implementation, the core wire is truncated cone-shaped, the proximal push shaft, the core wire, and the winding spring are coaxially arranged, and the diameter of the core wire decreases from the proximal end to the distal end of the interventional guide wire.

[0015] In a possible implementation, the difference between the inner diameter of the support tube and the outer diameter of the core wire is 0.02 to 0.5 mm.

[0016] In a possible implementation, the outer wall of the interventional guidewire is coated with a protective coating.

[0017] The proximal push shaft, also called the proximal push rod, as the name suggests, is a component that provides pushing force at the proximal end of the interventional guidewire. Its main function is to transfer the force applied by the operator to the proximal end of the interventional guidewire to the distal end. It is made of solid metal wire with good supporting strength and flexible deformation ability.

[0018] Because of the specificity of the human vascular anatomical structure, the performance of vascular interventional guidewires must meet the actual clinical requirements. These performance standards include but are not limited to support, flexibility, button control, touch feedback and development. Among them, flexibility is a very important evaluation indicator. It should be noted that in the technical field of interventional treatment, flexibility does not simply refer to the flexibility parameters of uniform metal materials such as the solid wire of the push shaft and the core wire metal wire used to prepare the interventional guidewire, but refers to the ability of the interventional guidewire itself to change, deform and bend with the degree of curvature of the blood vessel. In practice, it is found that although the proximal push shaft is a proximal component, its flexibility, that is, its deformation and bending ability, especially the deformation and bending ability at the distal end of this component, will affect the passing effect of the interventional guidewire during the treatment process and interfere with the treatment effect. The existing proximal push shaft adopts a cylindrical shaft without grooves. Under the bending force formed by the vascular structure and the operator's operation, the core wire bends and deforms with the blood vessel. At this point, the cylindrical shaft bends, folding in half axially. The bend expands and contracts radially on both sides. Material accumulates on both ends of the bend on the side that is squeezed and contracted, creating a repulsive force (interaction force) opposite to the bending force (pulling closer together). This results in a sluggish deformation of the proximal push shaft, making it unable to bend in time, lacking sensitivity, and unsuitable for high-precision surgeries. Furthermore, the degree of bending (e.g., the maximum bending angle) is also limited by the squeezing at both ends of the bend.

[0019] In this application, by setting a groove on the radial side wall of the proximal push shaft, if bending is required during the intervention process, the groove is rotated so that its open end faces and is located on the inner side of the bend (the compressed side with one side extended and the other compressed). There is a certain gap as a buffer space for the mutual compression at both ends of the bending point. Even if the bending angle is too large, it is necessary to continue bending after the buffer bending. The metal materials on both sides of the groove open end also contact and squeeze each other, and the degree of bending is far beyond that of a purely cylindrical shaft-type push rod. In other words:

[0020] Compared with existing interventional guidewires, this application adds grooves on the radial sidewalls of the proximal push shaft, making the outer wall of the shaft porous and having a certain amount of deformation space, which can adapt to the displacement caused by deformation, reduce the difficulty of manipulation caused by mutual limitation, and enable the interventional guidewire to be introduced through the target area in a more flexible and changeable form. It has the effect of improving the flexibility of the push rod at the proximal end of the interventional guidewire, thereby improving the controllability, support and intervention passability of the interventional guidewire, reducing the difficulty of surgery and improving surgical efficiency. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 A schematic structural diagram of an interventional guidewire according to an embodiment of the present application is shown;

[0022] Figure 2 A schematic structural diagram showing a proximal push shaft according to an embodiment of the present application;

[0023] Figure 3 A schematic diagram showing the structure of the proximal push shaft when the interventional guidewire according to an embodiment of the present application is not bent, wherein the dotted line represents the axis of the entire interventional guidewire;

[0024] Figure 4 Show Figure 3 A schematic diagram of the structure of the proximal push shaft when the interventional guidewire of the embodiment is bent, wherein the dotted line is the axis of the entire interventional guidewire;

[0025] Figure 5 Show Figure 3 Bend to Figure 4 The magnified comparison of the proximal push shaft in the state, the arrow on the upper side is Figure 3 The structure diagram of the proximal push shaft in the state, the lower side of the arrow is Figure 4 of;

[0026] Figure 6 Show Figure 1 A schematic structural diagram of one of the circular tubes in the embodiment;

[0027] Figure 7 Show Figure 1 A schematic structural diagram of one of the circular tubes in the embodiment;

[0028] Figure 8 A schematic structural diagram of a support tube according to an embodiment of the present application is shown;

[0029] Figure 9 A schematic structural diagram of the core wire according to an embodiment of the present application is shown;

[0030] Figure 10 A schematic diagram showing the relative installation positions of the support tube and the core wire according to an embodiment of the present application is shown.

[0031] Proximal pushing shaft 100 , groove 110 , support sleeve 200 , core wire 300 , winding spring 400 , distal head 500 . DETAILED DESCRIPTION

[0032] Various exemplary embodiments, features, and aspects of the present application will be described in detail below with reference to the accompanying drawings. The same reference numerals in the accompanying drawings represent elements with the same or similar functions. Although various aspects of the embodiments are shown in the accompanying drawings, the drawings are not necessarily drawn to scale unless otherwise indicated.

[0033] It should be understood that the terms "length", "width", "height", "up", "down", "front", "back", "left", "right", "top", "bottom", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, and are only for the convenience of describing the present application or simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0034] In addition, numerous specific details are provided in the detailed description below to better illustrate the present application. Those skilled in the art will appreciate that the present application can be practiced without certain specific details. In some instances, methods, means, components, and circuits well known to those skilled in the art are not described in detail in order to highlight the main purpose of the present application.

[0035] The present application provides an interventional guidewire having two or more grooves 110 formed on the radial sidewall of the proximal push shaft 100 of the interventional guidewire. The proximal push shaft 100 is preferably a solid wire. The grooves 110 are machined on the radial outer wall of the solid wire. The present application does not specify the method for machining the grooves 110; the grooves 110 may be integrally formed, machined, laser engraved, or otherwise machined.

[0036] The proximal push shaft, also called the proximal push rod, as the name suggests, is a component that provides pushing force at the proximal end of the interventional guidewire. Its main function is to transfer the force applied by the operator to the proximal end of the interventional guidewire to the distal end. It is made of solid metal wire with good supporting strength and flexible deformation ability.

[0037] Because of the specificity of the human vascular anatomical structure, the performance of vascular interventional guidewires must meet the actual clinical requirements. These performance standards include but are not limited to support, flexibility, twist control, touch feedback and development. Among them, flexibility is a very important evaluation indicator. It should be noted that in the technical field of interventional treatment, flexibility does not simply refer to the flexibility parameters of uniform metal materials such as the solid wire of the push shaft and the core wire metal wire used to prepare the interventional guidewire, but refers to the ability of the interventional guidewire itself to change, deform and bend with the degree of curvature of the blood vessel. In practice, it is found that although the proximal push shaft is a proximal component, its flexibility, that is, its deformation and bending ability, especially the deformation and bending ability at the distal end of this component, will affect the passing effect of the interventional guidewire during the treatment process and interfere with the treatment effect. The existing proximal push shaft adopts a cylindrical shaft without grooves. Under the bending force formed by the vascular structure and the operator's operation, the core wire bends and deforms with the blood vessel. At this point, the cylindrical shaft bends, folding in half axially. The bend expands and contracts radially on both sides. Material accumulates on both ends of the bend on the side that is squeezed and contracted, creating a repulsive force (interaction force) opposite to the bending force (pulling closer together). This results in a sluggish deformation of the proximal push shaft, making it unable to bend in time, lacking sensitivity, and unsuitable for high-precision surgeries. Furthermore, the degree of bending (e.g., the maximum bending angle) is also limited by the squeezing at both ends of the bend.

[0038] In the present application, a groove is provided on the radial side wall of the proximal pushing shaft. If bending is required during the intervention process, the groove is rotated so that its open end faces and is located on the inner side of the bend (the compressed side with one side extended and the other side compressed, such as Figure 4 The lower right corner of the dotted line shown), the mutual extrusion at both ends of the bending point ( Figure 4 The grooves on the lower right side of the dotted line have a certain gap (the gap between the two opposing walls) that acts as a buffer. Even if the bending angle is too large, further bending is required after the buffer bend. The metal materials on both sides of the groove opening also contact and squeeze each other, and the degree of bending is far greater than that of a purely cylindrical push rod. In other words:

[0039] Compared with existing interventional guidewires, the present application adds a groove 110 on the radial side wall of the proximal push shaft 100. This makes the outer wall of the shaft evacuated and porous, with a certain amount of deformation space, which can adapt to the displacement caused by deformation, reduce the difficulty of manipulation caused by mutual limitation, and enable the interventional guidewire to be introduced through the target area in a more flexible and changeable form. It has the effect of improving the flexibility of the push rod at the proximal end of the interventional guidewire, thereby improving the controllability, support and intervention passability of the interventional guidewire, reducing the difficulty of surgery and improving surgical efficiency.

[0040] In a possible implementation, the preset depth of the groove 110 is 1 / 10 to 1 / 2 of the diameter of the proximal pushing shaft 100 .

[0041] In a possible implementation, the opening directions of the two or more grooves 110 are perpendicular to the axial direction of the proximal pushing shaft 100 .

[0042] In one possible implementation, the interventional guidewire is provided with two or more groups of second flexibility enhancing portions, the second flexibility enhancing portions including two or more grooves 110 located on the radial side walls of the interventional guidewire, the two or more grooves 110 of the second flexibility enhancing portions are distributed circumferentially along the axis of the proximal push shaft 100, and the two or more groups of second flexibility enhancing portions are distributed adjacent to each other along the axial direction of the proximal push shaft 100.

[0043] In one possible implementation, the grooves 110 are distributed in a spiral shape on the radial outer wall of the proximal push shaft 100. Two or more grooves 110 are coaxially disposed with the proximal push shaft 100, and the two or more grooves 110 are adjacently distributed along the axial direction of the spiral and have a predetermined spacing along the axial direction of the spiral. The grooves 110 may be arranged in a single spiral, a double spiral, or multiple spirals.

[0044] In one possible implementation, the interventional guidewire is provided with at least one first flexible portion, which includes two or more grooves 110 located on the radial side wall of the interventional guidewire, and the two or more grooves 110 of the first flexible portion are distributed sequentially along the same spiral line.

[0045] In one possible implementation, the interventional guidewire is provided with two or more sets of first flexible portions, the spiral lines of the two or more sets of first flexible portions are coaxial with the proximal push shaft 100, and the spiral lines of the two or more sets of first flexible portions have a preset spacing along their axial direction.

[0046] In a possible implementation, the width of the groove 110 is 0.02-0.5 mm.

[0047] In one possible implementation, the interventional guidewire includes a proximal push shaft 100, a core wire 300, a support sleeve 200, a coil spring 400, and a distal head 500. The proximal push shaft 100, the support sleeve 200, the coil spring 400, and the distal head 500 are fixedly connected in sequence from the proximal end to the distal end of the interventional guidewire. This application does not limit the fixed connection method, as long as the connection stability is guaranteed. The combined component can be directly prepared into an integral molded part by welding, bonding, or machining. The two ends of the axial opening of the support sleeve 200 are respectively connected to one axial end of the proximal push shaft 100 and one axial end of the coil spring 400. The other axial end of the coil spring 400 facing away from the support sleeve 200 is connected to the distal head 500. The core wire 300 is installed in the support sleeve 200. One end of the core wire 300 is connected to the proximal push shaft 100 at the axial opening of one end of the support sleeve 200. The other end of the core wire 300 protrudes out of the support sleeve 200 through the axial opening of the other end of the support sleeve 200 and enters the interior of the coil spring 400, and is arranged close to the distal head 500.

[0048] In one possible implementation, the support sleeve 200 includes two or more circular (cylindrical) tubes (thin metal tubes) of different diameters. Along the proximal end to the distal end of the interventional guidewire, the two or more circular tubes are distributed in sequence and the diameters decrease, and the two or more circular tubes are connected end to end, that is, the two adjacent circular tubes are connected to communicate. One end of a circular tube near the proximal end of the interventional guidewire that is away from the other circular tubes is connected to the axial end of the proximal push shaft 100, and one end of a circular tube near the distal end of the interventional guidewire that is away from the other circular tubes is connected to the axial end of the coil spring 400. The diameter ratio of the two adjacent circular tubes is 1.02 to 1.5:1, preferably 1.3:1. This application does not specifically limit the connection method of the two adjacent circular tubes, and welding or bonding can be used. When the connection method is welding. The length of its welding area along the axis of the circular tube is 0.05 to 1.0 mm. When the connection method is bonding or mechanical structure connection, the length of the bonding area along the axis of the circular tube is 0.2 to 3 mm. Two adjacent circular tubes are connected by a truncated cone-shaped pipe. The axial ends of the truncated cone-shaped pipe are open. The diameter of the opening at one axial end of the truncated cone-shaped pipe matches the diameter of one of the circular tubes and is relatively connected. The diameter of the opening at the other axial end matches the diameter of the other circular tube and is relatively connected.

[0049] In the interventional guidewire provided in the present application, a solid wire is prepared with a proximal push shaft 100 having a circular outer wall with multiple depressions and a metal round tube segmented docking design, which can enhance the force transmission effect (from the proximal end to the distal end) and improve the controllability and support of the interventional guidewire.

[0050] In one possible implementation, the distal head 500 is hemispherical, with one flat end of the hemispherical shape connected to the axial end of the coil spring 400 facing away from the support tube, and the spherical radius at the vertex of the curved surface coincides with the axis of the coil spring 400. The coil spring 400 is wound from a highly developable metal wire and has a spring-like shape. The axial length of the coil spring 400 is 1 to 50 mm. The metal wire can be made of at least one of gold, tungsten, platinum-tungsten alloy, tantalum metal, platinum-iridium alloy, platinum, or the like (or a combination of one or more of these). The wire diameter is 0.05 to 0.5 mm.

[0051] In one possible implementation, the core wire 300 passes through the inner lumens of the support tube and the coil spring 400, and the proximal end of the core wire 300 is respectively connected to the distal end of the proximal push shaft 100 and the proximal end of the support tube. The distal end of the core wire 300 is connected to the distal end of the coil spring 400. The core wire 300 does not directly contact the coil spring 400 nor is it directly fixed to the coil spring 400. The elasticity of the spring structure of the coil spring 400 is used to form a buffer space between the core wire 300 and the distal head 500. During the interventional guidewire insertion process, the distal head 500 moves away from / closer to the distal end of the core wire 300, and the core wire 300 is used to provide stable support for the coil spring 400 axis, preventing deformation and sagging, and enhancing the tracking performance of the interventional guidewire. The core wire 300 and the proximal push shaft 100, the support sleeve 200, and the coil spring 400 are connected by welding or bonding. The diameter of the core wire 300 is larger at the proximal end and smaller at the distal end, with the diameter changing in a uniform or segmented manner. The gradually tapering metal tube better matches the inner core wire 300 and can significantly improve the support performance of the distal end of the interventional guidewire.

[0052] In one possible implementation, the core wire 300 is truncated cone-shaped, with the proximal push shaft 100, core wire 300, and coil spring 400 coaxially arranged. The diameter of the core wire 300 decreases from the proximal end to the distal end of the interventional guidewire, reducing the size of the guidewire and improving its passability, thereby reducing surgical difficulty and improving surgical efficiency. Furthermore, the difference between the inner diameter of the support tube and the outer diameter of the core wire 300 is 0.02 to 0.5 mm. By adjusting this difference, the guidewire's support and compliance performance can be adjusted.

[0053] In a possible implementation, the outer wall of the interventional guidewire is coated with a protective coating, such as a PTFE coating, a parylene coating, or a hydrophilic coating, wherein the thickness of the protective coating is 0.005 to 0.2 mm.

[0054] The embodiments of the present application have been described above. The above description is illustrative and not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. An interventional guidewire, characterized in that: The radial side wall of the proximal pushing shaft of the interventional guide wire is provided with more than two grooves.

2. The interventional guidewire according to claim 1, characterized in that: The preset depth of the groove is 1 / 10 to 1 / 2 of the diameter of the proximal pushing shaft.

3. The interventional guidewire according to claim 1, characterized in that: The opening directions of the two or more grooves are perpendicular to the axial direction of the proximal pushing shaft.

4. The interventional guidewire according to claim 1, characterized in that: The interventional guidewire is provided with more than two groups of second flexibility enhancing portions, the second flexibility enhancing portions include more than two grooves located on the radial side wall of the interventional guidewire, the more than two grooves of the second flexibility enhancing portions are distributed circumferentially along the axis of the proximal push shaft, and the more than two groups of the second flexibility enhancing portions are adjacently distributed along the axial direction of the proximal push shaft.

5. The interventional guidewire according to claim 1, characterized in that: The interventional guidewire comprises a proximal push shaft, a core wire, a support sleeve, a winding spring and a distal head; Along the proximal end to the distal end of the interventional guide wire, the proximal push shaft, the support sleeve, the coil spring and the distal head are connected in sequence, the two ends of the axial opening of the support sleeve are respectively connected to one axial end of the proximal push shaft and one axial end of the coil spring, the other axial end of the coil spring facing away from the support sleeve is connected to the distal head, the core wire is installed in the support sleeve, one end of the core wire is connected to the proximal push shaft at the opening of one axial end of the support sleeve, and the other end of the core wire protrudes out of the support sleeve through the opening of the other axial end of the support sleeve and enters the interior of the coil spring, and is arranged close to the distal head.

6. The interventional guidewire according to claim 5, characterized in that: The core wire is in a truncated cone shape, the proximal push shaft, the core wire and the winding spring are coaxially arranged, and the diameter of the core wire decreases from the proximal end to the distal end of the interventional guide wire.

7. The interventional guidewire according to claim 5, characterized in that: The difference between the inner diameter of the support tube and the outer diameter of the core wire is 0.02-0.5 mm.

8. The interventional guidewire according to claim 1, characterized in that: The outer wall of the interventional guide wire is coated with a protective coating.

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