CN219481249U - Automatic avoid resistance wire - Google Patents

Abstract

The utility model provides an automatic avoiding resistance guide wire. The automatic avoiding resistance guide wire comprises a rigid proximal core wire and a flexible distal core wire which are fixedly connected; the distal core wire comprises a straight section and a preformed curved section, and the proximal end of the straight section is fixedly connected with the distal end of the proximal core wire; the straight section, the proximal core wire and the curved section are all located in the same plane. The head end of the automatic avoidance resistance guide wire has excellent deformation resistance and good operability, and the automatic avoidance resistance guide wire can be prevented from entering the meshes of the bare bracket; the automatic avoidance resistance guide wire can also have the automatic avoidance resistance capability, so that the automatic avoidance resistance guide wire is prevented from entering a channel or an interlayer between the bare stent and the vascular wall; and has the advantages of simple preparation method, low cost, high stability and the like.

Description

Automatic avoid resistance wire

Technical Field

The application relates to the technical field of medical instruments, in particular to an automatic avoidance resistance guide wire.

Background

Cardiovascular and cerebrovascular diseases are healthy first killers in modern society, and the number of people dying from cardiovascular and cerebrovascular diseases every year is very high worldwide. Interventional therapy is the main means for clinically treating coronary atherosclerotic heart disease at present, and can effectively treat stenosis through balloon catheter dilating the stenosis or releasing a stent, restore normal blood circulation and ensure blood supply.

The guide wire is an indispensable matching product in interventional medical instruments, has been widely applied to medical interventional operations, and plays a role in guiding and positioning various interventional medical catheters and implantation instruments entering human organs. At present, in the process of performing an operation, a plurality of lesion sites are often arranged, when a lesion treatment of a certain site is completed and a lesion treatment of a next site is required to be performed, a guide wire often needs to pass through a bracket of a previous lesion site, and the following situations easily occur in the process: 1. when the guide wire passes through the stent, the guide wire easily passes through the meshes of the stent to enter the branches, so that the operation is delayed, and when the operation is serious, the guide wire is blocked in the stent, so that the stent or the guide wire is damaged; 2. the guide wire passes through the meshes of the bracket and then enters the bracket through the meshes of the bracket, so that the bracket is easily shifted or the subsequent treatment products, such as a balloon, the bracket and the like, cannot reach a lesion through the guide wire, and the bracket is damaged or the guide wire is broken in serious cases; 3. the guide wire easily enters the channel between the outside of the stent and the vessel wall, at the moment, the guide wire is easily restrained, and the stent is easily damaged or the guide wire is easily broken when the guide wire is retracted by adopting the saccule.

Disclosure of Invention

In view of this, the present application aims to propose an automatic avoidance resistance guide wire.

Based on the above-mentioned purpose, the present application provides an automatic dodge resistance wire, include: a rigid proximal core wire and a flexible distal core wire fixedly connected;

the distal core wire comprises a flat section and a pre-shaped bending section which are fixedly connected, and the proximal end of the flat section is fixedly connected with the distal end of the proximal core wire; the distal end of the straight section is fixedly connected with the curved section, and the straight section, the proximal core wire and the curved section are all located in the same plane.

In some of these embodiments, the curved section comprises a rounded structure with indentations, the rounded structure being connected to the straight section, the diameter of the rounded structure being larger than the mesh diameter of the bare stent to be accessed.

In some of these embodiments, the diameter of the circular structure is 1mm to 5mm and the curved length of the circular structure is 3mm to 20mm.

In some of these embodiments, the proximal end of the curved section has a predetermined angle with the straight section.

In some embodiments, the predetermined angle is 0.1 ° to 50 °.

In some of these embodiments, the proximal end of the straight section is welded to the distal end of the proximal core wire; the metal tube is fixedly bonded at the proximal end of the straight section and the distal end of the proximal core wire.

In some embodiments, the safety net is arranged on the distal core wire, the safety net is sleeved on the distal core wire, and two ends of the safety net are respectively fixed on the distal core wire; and/or

The wire winding sheath is sleeved on the distal core wire; the tip of the wire wrap sheath is used for developing.

In some of these embodiments, the safety mesh is sleeved on the distal core wire and the wire-wrapping sheath is sleeved on the safety mesh, and the distal end of the safety mesh is welded with the distal end of the curved section; and/or the unfolding length of the safety net is 20-50 mm; and/or

The wire winding sheath is a spring, the wire winding diameter is 0.001 '-0.004', and the total length of the spring is 1-30 cm.

In some of these embodiments, the safety mesh is disposed coaxially with the curved section and/or the wire wrap sheath is disposed coaxially with the safety mesh; and/or

The device further comprises a hydrophilic coating and a polymer sheath fixedly sleeved on the distal end of the straight section, wherein the hydrophilic coating is at least arranged on the surface of the proximal end of the bending section, the surface of the straight section and the surface of the wire winding sheath.

From the above, it can be seen that the automatic avoidance resistance guide wire provided by the application is fixedly connected with the flexible distal core wire by adopting the rigid proximal core wire, and the distal end of the distal core wire is provided with the pre-shaped bending section, and the bending section, the straight section of the distal core wire and the proximal core wire are all positioned in the same plane, so that the head end of the automatic avoidance resistance guide wire has excellent deformation resistance, and meanwhile, has better operability, and can avoid the automatic avoidance resistance guide wire from entering the meshes of the bare stent; the automatic avoidance resistance guide wire can also have the automatic avoidance resistance capability, so that the automatic avoidance resistance guide wire is prevented from entering a channel or an interlayer between the bare stent and the vascular wall; and has the advantages of simple preparation method, low cost, high stability and the like.

Drawings

In order to more clearly illustrate the technical solutions of the present application or related art, the drawings that are required to be used in the description of the embodiments or related art will be briefly described below, and it is apparent that the drawings in the following description are only embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort to those of ordinary skill in the art.

FIG. 1 is a schematic view of a current guidewire entering a bare stent mesh;

FIG. 2 is a schematic view of an automatic avoidance resistance guidewire provided in an embodiment of the present application;

FIG. 3 is a schematic view of another automatic avoidance resistance guidewire provided in an embodiment of the present application;

FIG. 4 is a schematic cross-sectional view at A-A in FIG. 2 or FIG. 3;

FIG. 5 is a schematic view of a guidewire within a bare stent according to an embodiment of the present application;

FIG. 6 is a schematic flow chart of a method for preparing an automatic avoidance resistance guide wire according to an embodiment of the present application;

fig. 7 is a schematic structural diagram of an assembled automatic avoidance resistance guide wire according to an embodiment of the present disclosure;

fig. 8 is a schematic diagram of another assembled structure of the automatic avoidance resistance guide wire according to the embodiment of the present application.

Detailed Description

For the purposes of making the objects, technical solutions and advantages of the present application more apparent, the present application will be further described in detail below with reference to the accompanying drawings.

It should be noted that unless otherwise defined, technical or scientific terms used in the embodiments of the present application should be given the ordinary meaning as understood by one of ordinary skill in the art to which the present application belongs. The terms "first," "second," and the like, as used in embodiments of the present application, do not denote any order, quantity, or importance, but rather are used to distinguish one element from another. The word "comprising" or "comprises", and the like, means that elements or items preceding the word are included in the element or item listed after the word and equivalents thereof, but does not exclude other elements or items. The terms "connected" or "connected," and the like, are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", etc. are used merely to indicate relative positional relationships, which may also be changed when the absolute position of the object to be described is changed.

Stents generally include covered stents and bare stents. The stent is generally used for treating aortic dissection or aortic aneurysm diseases, and blood is isolated from flowing into the dissection or aortic aneurysm during treatment, so that the dissection or aortic aneurysm can be prevented from further expanding to cause massive hemorrhage. The stents used for treating cardiovascular and cerebrovascular diseases are mostly bare stents, and because the vascular diseases are mostly vascular stenosis or vascular calcification, and the like, the stents mainly play a role in supporting and maintaining the patency of vascular lumen during treatment.

At present, the head end of a guide wire is mostly straight and linear, as shown in fig. 1, in the implementation process of an operation related to a bare stent, a plurality of pathological change positions are often arranged, when the pathological change treatment of a certain position is completed and the pathological change treatment of the next position is required, the guide wire always needs to pass through the bare stent at the previous pathological change position, and the head end of the guide wire is easy to be blocked into the meshes of the bare stent due to the very small diameter of the guide wire, so that the operation is delayed and the bare stent or the guide wire is damaged; or the guide wire passes through the meshes of the bare stent and then enters the bare stent through the meshes of the bare stent, so that the bare stent is shifted or the subsequent treatment products cannot reach the lesion, and the bare stent is damaged or the guide wire is broken; or the guide wire passes through the meshes of the bare stent and enters the channel or interlayer between the bare stent and the vascular wall, and the like, so that the guide wire is restrained, and the bare stent is damaged or the guide wire is broken when the guide wire is withdrawn.

Based on this, the embodiment of the application provides an automatic dodge resistance wire and preparation method thereof, through the circular that has the breach in the head end pre-shaping of automatic dodge resistance wire, the diameter of circle is greater than naked support mesh, circular structure position is in the coplanar with non-circular structure position to the operation process is automatic dodge resistance wire when walking in naked support, can avoid passing naked support mesh and get into unnecessary branch, simultaneously because the ability of automatic dodging resistance, can avoid automatic dodging resistance wire to get into passageway and intermediate layer in the naked support outer blood vessel, and then shorten operation time, improve the operation success rate.

The definition of "proximal" and "distal" in this application is: "proximal" generally refers to the end of the medical device that is closest to the operator during normal operation, and "distal" generally refers to the end of the medical device that first enters the patient during normal operation. The core wire generally guides the core portion of the wire, typically made of metal wire.

As shown in fig. 2, an embodiment of the present application provides an automatic avoidance resistance guide wire, including: a rigid proximal core wire 1 and a flexible distal core wire 2. The distal end core wire 2 is located at the distal end of the automatic avoidance resistance guide wire and extends to the head end of the automatic avoidance resistance guide wire, the proximal end core wire 1 is located at the proximal end of the automatic avoidance resistance guide wire, and the distal end of the proximal end core wire 1 is fixedly connected with the proximal end of the distal end guide wire.

The distal core wire 2 comprises a flat section and a preformed unclosed curved section 7 which are fixedly connected, wherein the proximal end of the flat section is fixedly connected with the distal end of the proximal core wire 1; the distal end of the straight section is connected with the curved section 7, and the straight section, the proximal core wire 1 and the curved section 7 are all located in the same plane.

According to the automatic avoidance resistance guide wire, the rigid proximal core wire 1 is fixedly connected with the flexible distal core wire 2, the pre-shaped bending section 7 is arranged at the distal end of the distal core wire 2, and the bending section 7, the straight section of the distal core wire 2 and the proximal core wire 1 are all located in the same plane, so that the head end of the automatic avoidance resistance guide wire has excellent deformation resistance, has good operability, and can avoid the automatic avoidance resistance guide wire from entering the meshes of the bare support 93; the automatic avoidance resistance guide wire can also have the automatic avoidance resistance capability, so that the automatic avoidance resistance guide wire is prevented from entering a channel or an interlayer between the bare stent 93 and the wall of the blood vessel 94; and has the advantages of simple preparation method, low cost, high stability and the like.

In some embodiments, the cross-sectional shape of the tip of the proximal core wire 1 may be tapered, parabolic, streamlined, or any other configuration, and the cross-sectional shape of the tip of the distal core wire 2 may be tapered, parabolic, streamlined, or any other configuration, to provide good compliance and pushability for the self-retracting resistive guide wire.

In some embodiments, the proximal core wire 1 may be made of any material that is well resistant to deformation and suitable for use as a self-retracting resistive guidewire, including, but not limited to, nickel-titanium alloys, fe-Ni alloys, ti-Ni-X alloys, and the like. The distal core wire 2 may be made of any material that is well supported, strong in stiffness and suitable for use as a self-retracting resistive guidewire, including but not limited to 304 stainless steel, 316 stainless steel, cobalt-based alloys, fe-Mn alloys, cu-Zn alloys, and the like.

In some embodiments, as shown in fig. 2, the curved section 7 comprises only a circular structure with a notch, which is connected to the straight section. The diameter of the circular structure is larger than the mesh diameter of the bare stent 93 to be accessed. The diameter of the circular structure is determined according to the diameter of the blood vessel 94 and the mesh size of the bare stent 93, and is larger than the mesh diameter of the bare stent 93 to be entered and smaller than the diameter of the blood vessel 94.

In some embodiments, the diameter of the circular structure is preferably 1mm to 5mm, and the curved length of the circular structure is 3mm to 20mm. That is, the circular structure has a length of 3mm to 20mm after being straightened. Like this, the shape of bending section 7 and the shape looks adaptation of the mesh of the naked support 93 that waits to get into, and the diameter of bending section 7 is greater than the diameter of the mesh of this naked support 93 that waits to get into, can avoid the automatic resistance wire that dodges to get into the mesh of naked support 93, simultaneously because the automatic resistance wire head end of dodging is circular structure, the resistance wire head end of dodging automatically in the propelling movement process can dodge the resistance automatically, avoid getting into the passageway or the intermediate layer between naked support 93 and vessel 94 wall, make the automatic resistance wire that dodges keep in naked support 93 or true intracavity walking.

In some embodiments, as shown in fig. 3 and 7, the proximal end of the curved section is at a predetermined angle to the straight section. Specifically, the bending section 7 further includes a bending structure 8, that is, the bending section includes a circular structure and a bending structure, and the bending structure is located between the circular structure and the straight section, that is, the proximal end of the bending structure and the straight section have the preset included angle. In particular, the distal end of the bending structure 8 is connected to the proximal end of the rounded structure with indentations, and the proximal end of the bending structure 8 is connected to the distal end of the straight section. It can be understood that the head end of the automatic avoidance resistance guide wire is of a circular structure, and meanwhile, the near end of the circular structure is also provided with a bend A. The bending structure 8 can be used for direction selection, i.e. for selecting a branch vessel 94 to be accessed. By providing the bending structure 8, the automatic avoidance resistance guide wire can be adapted to clinically different lesion requirements, such as entering a branch vessel 94 at different angles, etc.

It will be appreciated that since the curved section 7 is in the same plane as the straight section and the proximal core wire 1 and the bending structure 8 is part of the curved section 7, the bending structure 8 is in the same plane as the rounded structure with indentations, the straight section, the proximal core wire 1 and the curved section 7.

In some embodiments, as shown in fig. 3, the preset included angle α between the proximal end of the curved section (i.e. the proximal end of the bending structure 8) and the flat section (i.e. the outer included angle) is 0.1-50 °, and the unfolded length of the bending structure 8 is 3-20 mm. It will be appreciated that the proximal end of the bent structure 8 is at an angle of 0.1 to 50 deg. to the extension of the distal end of the straight section. The length of the bent structure 8 after being straightened is 3mm-20mm.

The distal end of the proximal core wire 1 is fixedly connected with the proximal end of the distal core wire 2. Specifically, the proximal end of the straight section in the distal core wire 2 is fixedly connected to the distal end of the proximal core wire 1. In some embodiments, the connection between the proximal core wire 1 and the distal core wire 2 may be one or more of resistance welding, soldering, ultrasonic welding, laser welding, adhesive bonding, and snap fitting. Preferably, as shown in fig. 4, the proximal core wire 1 and the distal core wire 2 are fixedly connected by means of resistance welding, i.e. the proximal end of the straight section in the distal core wire 2 is connected to the distal end of said proximal core wire 1 by resistance welding, with a weld 9. Resistance welding may promote torque transfer between the proximal core wire 1 and the distal core wire 2.

Further, the device further comprises a metal tube 91 sleeved on the proximal end of the straight section and the distal end of the proximal core wire 1, and the metal tube 91 is fixedly bonded on the proximal end of the straight section and the distal end of the proximal core wire 1. That is, the proximal core wire 1 and the distal core wire 2 are connected together by means of resistance welding and bonding. It will be appreciated that the proximal end of the straight section is bonded to the distal end of the proximal core wire 1 by a metal tube 91 by an adhesive 92. The bonding mode can avoid that the near-end core wire 1 and the far-end core wire 2 are not coaxial or bent after resistance welding and the stress concentration at the welding part 9 easily causes the fracture problem when the automatic avoidance resistance guide wire is bent, thereby improving the torsion control property of the automatic avoidance resistance guide wire, and the high-strength near-end core wire 1 can provide good supporting force and pushing force for the automatic avoidance resistance guide wire, and the far-end core wire 2 with strong deformation resistance can provide good deformation resistance and flexibility for the automatic avoidance resistance guide wire, so that the automatic avoidance resistance guide wire has excellent control property.

In some embodiments, metal tube 91 may be made of any deformation resistant material, including but not limited to nickel-titanium alloys, fe-Ni alloys, ti-Ni-X alloys, or the like. The adhesive 92 may be made of any material that is well-connected, including but not limited to one or more of AB glue, shellac, solder.

In some embodiments, as shown in fig. 7 and 8, (where fig. 8 may be understood as a cross-section of the area at the wire wrap 6 in fig. 7 to more clearly show the wire wrap 6 and the safety net 5) further comprises a safety net 5 sleeved between the distal core wire 2 and the wire wrap 6, i.e. the structure from inside to outside in radial direction is core wire, safety net and wire wrap, it may be understood that the safety net is sleeved on the distal core wire 2 and the wire wrap is sleeved on the safety net. Wherein the safety mesh may be provided only over the whole curved section 7, or may be provided at the whole curved section and at a part of the straight section, or may be provided over the whole distal core wire. In some embodiments, the safety net 5 is sleeved on the bending section 7 and fixedly connected with the bending section 7. The safety net 5 is understood to be a wire mesh-like structure, a mesh-like structure woven by interlacing wires with each other by a dedicated braiding machine. Specifically, the safety net 5 can be fixedly connected to any position of the head end (namely the bending section 7) of the automatic avoidance resistance guide wire according to actual requirements. Through setting up safety net 5 cover and establish at the automatic resistance wire head end of dodging (also bending section 7), can make the automatic resistance wire of dodging possess higher breaking force when having soft head end, can avoid the fracture of automatic resistance wire head end (also bending section 7) better. It should be understood that in fig. 2 and 3, the safety net 5 is shown in cross-section.

In some embodiments, the distal end of the safety mesh 5 is welded, e.g. welded in parallel, to the distal end of the curved section 7. Preferably, the safety net 5 may be made of 6-20 wires 3. And the safety net 5 with different mesh densities (PPIs) or different wire sizes can be manufactured according to the different hardness requirements of the end of the automatic avoiding resistance guide wire. Preferably, the safety net 5 has a length ranging from 20 to 50mm. It will be appreciated that the deployed length (i.e. the straightened length) of the security mesh 5 may be in the range 20 to 50mm.

Further, the safety net 5 is arranged coaxially with the curved section 7. That is, the safety net 5 is sleeved on the bending section 7 and is coaxially nested with the bending section 7. In this way, the connection stability of the safety net 5 and the bending section 7 can be better improved, and the flexibility of the end of the automatic avoidance resistance guide wire and the like can be further improved.

In some embodiments, a wire wrap sheath 6 is also included over the distal core wire. The wire-wrapping sheath 6 may be provided only over the whole curved section 7, or may be provided at the whole curved section and at a part of the straight section, or may be provided over the whole distal core wire. The length of the wire-wrapping sheath 6 may be adapted to the length of the safety net, and the proximal end of the wire-wrapping sheath 6 may be fixedly connected to the distal end of the straight section. The wire winding sheath 6 is mainly used for developing, and can realize the visibility of the automatic avoiding resistance guide wire under X-ray. The wire-wrapping sheath 6 can be understood as a spiral structure of wires, which is wound side by a dedicated spring machine.

Further, the wire-wrapping sheath 6 may also be disposed on the bending structure 8 to better enable the visibility of the automatic avoidance of the drag guidewire tip under X-rays.

Preferably, the wire winding sheath 6 may be a developing spring, and the developing spring may be any one of a platinum tungsten spring, a platinum nickel spring, a platinum iridium spring, a gold spring and a stainless steel spring or formed by connecting any two of the two springs. The development spring has good development performance, and can enhance the visibility of the automatic avoidance resistance guide wire under X-rays.

In some embodiments, the wire windings are each wound by a spring machine. Preferably, the wire winding diameter is 0.001 'to 0.004', the pitch is 0.01 to 0.05mm, and the total length of the spring is 1 cm to 30cm.

In some embodiments, the wire-wrap sheath 6 is disposed coaxially with the safety mesh 5. In this way, the circular structure with the notches, the safety net 5, is arranged coaxially with the wire-wrapping sheath 6. It will be appreciated that when the bending section 7 further comprises a bending structure 8, both the notched circular structure and the bending structure 8 are arranged coaxially with the safety net 5 and the wire-wrapping sheath 6. Due to the coaxial arrangement of the curved section 7, the safety net 5 and the wire winding sheath 6, the proximal core wire 1 and the distal core wire 2 and the safety net 5 and the wire winding sheath 6 are coaxially arranged, so that the safety net 5 and the wire winding sheath 6 have good stability.

In some embodiments, a polymer sheath 3 may also be included that fits over the distal end of the straight section. The polymer sheath 3 may be made of polymer, and has excellent lubricity, and the function of the polymer sheath is mainly to provide excellent lubricity, so that the resistance guidewire can automatically avoid passing through the tortuous blood vessel 94.

In some embodiments, a hydrophilic coating 4 may be further included to improve the lubricity of the automatic avoidance resistance guidewire, so that the automatic avoidance resistance guidewire has good lubricity, thereby reducing the passing resistance of the automatic avoidance resistance guidewire in the blood vessel 94, and enabling the automatic avoidance resistance guidewire to be pushed easily. The hydrophilic coating 4 may be provided at least on the surface of the bending structure 8, on the surface of the straight section and on the surface of the wire-wrapping sheath 6. Preferably, the hydrophilic coating 4 may be provided on the surface of all areas of the proximal core wire 1 and the distal core wire 2 to provide the self-avoiding resistive guide wire with good lubricity.

In some embodiments, the hydrophilic coating 4 is one of a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating, or a polymethylvinyl ether-maleic anhydride coating. Hydrophilic coating 4 may be applied to the surface of all areas of proximal core wire 1 and distal core wire 2.

In some embodiments, the proximal end of the proximal core wire 1 may have a larger dimension than the distal end for better grip during handling. Preferably, the proximal end of the proximal core wire 1 may be provided with cleats or the like to increase friction or the like for better grip.

As shown in fig. 5, the automatic avoidance resistance guide wire provided in the embodiment of the present application can avoid entering the mesh of the bare stent 93, and is soft and does not hurt the blood vessel 94; the automatic avoidance resistance guide wire has the automatic avoidance resistance capability, and can be prevented from entering the channel between the outside of the bare stent 93 and the wall of the blood vessel 94 or entering the interlayer; the head end of the circular structure of the automatic avoidance resistance guide wire is positioned on the same plane with the non-circular structure part, so that the operability of the automatic avoidance resistance guide wire is improved; the distal core wire 2 (namely the distal guide wire) is made of a material with strong deformation resistance and good flexibility, so that the automatic avoidance resistance guide wire has excellent bending holding capacity; the proximal core wire 1 (i.e. proximal guide wire) is made of a material with good support and strong rigidity, so that the automatic avoidance resistance guide wire has good support and pushing performance. The distal end guide wire and the proximal end guide wire are connected together through welding and bonding, the welding mode can enable the automatic avoidance resistance guide wire to be coaxial after being connected, torque transmission of the automatic avoidance resistance guide wire is improved, the bonding can avoid breakage of the automatic avoidance resistance guide wire caused by stress concentration at a welding position 9 when the automatic avoidance resistance guide wire is bent, and meanwhile, the bonding can also correct the guide wire which is not coaxial or bent at the rear part of the welding, so that the distal end guide wire and the proximal end guide wire are coaxial, and torsion control performance and safety of the automatic avoidance resistance guide wire are improved.

The embodiment of the application also provides a preparation method of the automatic avoidance resistance guide wire, which comprises the steps of shaping the head end of the automatic avoidance resistance guide wire into a circular structure through heat treatment and/or laser heat shaping and/or cold shaping, so that the automatic avoidance resistance guide wire is prevented from entering the meshes of the bare support 93, the pushing process has the capacity of automatically avoiding resistance, the circular structure part and the non-circular structure part are positioned on the same plane, and the automatic avoidance resistance guide wire has stronger operability.

As shown in fig. 6, the method for preparing the automatic avoidance resistance guide wire may include:

s10, respectively manufacturing a rigid proximal core wire 1 and a flexible distal core wire 2, and fixedly connecting the distal end of the proximal core wire 1 with the proximal end of the distal core wire 2 to obtain a straight core wire of the automatic avoidance resistance guide wire.

In some embodiments, the proximal core wire 1 and the distal core wire 2 may be manufactured by grinding processes, respectively. The cross-sectional shape of the tip of the proximal core wire 1 may be tapered, parabolic, streamlined or any other configuration, and the cross-sectional shape of the tip of the distal core wire 2 may be tapered, parabolic, streamlined or any other configuration, to provide good compliance and pushability for the self-retracting resistive guide wire.

In some embodiments, the proximal core wire 1 may be made of any material that is well resistant to deformation and suitable for use as a self-retracting resistive guidewire, including, but not limited to, nickel-titanium alloys, fe-Ni alloys, ti-Ni-X alloys, and the like. The distal core wire 2 may be made of any material that is well supported, strong in stiffness and suitable for use as a self-retracting resistive guidewire, including but not limited to 304 stainless steel, 316 stainless steel, cobalt-based alloys, fe-Mn alloys, cu-Zn alloys, and the like.

In some embodiments, the distal core wire 2 tip is located distal to and extends to the distal end of the automatic avoidance resistance wire, the proximal core wire 1 is located proximal to the automatic avoidance resistance wire, and the distal end of the proximal core wire 1 is fixedly connected to the proximal end of the distal wire. In some embodiments, the connection between the proximal core wire 1 and the distal core wire 2 may be one or more of resistance welding, soldering, ultrasonic welding, laser welding, adhesive bonding, and snap fitting. Preferably, as shown in fig. 4, the proximal core wire 1 and the distal core wire 2 are fixedly connected by means of resistance welding, i.e. the proximal end of the straight section in the distal core wire 2 is connected to the distal end of said proximal core wire 1 by resistance welding, with a weld 9. Resistance welding may promote torque transfer between the proximal core wire 1 and the distal core wire 2.

Preferably, the proximal core wire 1 and the distal core wire 2 are also connected together by means of bonding, i.e. the proximal core wire 1 and the distal core wire 2 are connected together by means of resistance welding and bonding. Specifically, as shown in fig. 4, the proximal core wire 1 and the distal core wire 2 are directly connected together by resistance welding, and then the proximal core wire 1, the distal core wire 2 and the metal tube 91 are bonded together by a metal tube 91 under the action of an adhesive 92. Through resistance welding and bonding mode, can promote the moment of torsion transmission of automatic resistance wire of dodging, can avoid after the resistance welding near-end core wire 1 and far-end core wire 2 different axle or crooked and automatic dodge the resistance wire when crooked and lead to the fracture problem at 9 stress concentrations of welded part easily to promote the torsion accuse nature of automatic resistance wire of dodging, and high strength near-end core wire 1 can provide good holding power and push away power for automatic resistance wire dodging, and the strong far-end core wire 2 of deformability can provide good deformability and compliance for automatic resistance wire dodging, makes automatic resistance wire dodging possess excellent operability.

In some embodiments, metal tube 91 may be made of any deformation resistant material, including but not limited to nickel-titanium alloys, fe-Ni alloys, or Ti-Ni-X alloys; the adhesive 92 may be made of any material that is well-connected, including but not limited to one or more of AB glue, shellac, solder.

Preferably, the length of the proximal core wire 1 and the distal core wire 2 after being connected may be 100 to 400cm. At this time, the proximal core wire 1 and the distal core wire 2 are both straight strips, and the connected proximal core wire 1 and distal core wire 2 are both straight strips.

In some embodiments, the step S10 may further include: a safety net 5 and a wire-wrapping sheath 6 are made. The safety net 5 is understood to be a net-like structure formed by interlacing wires with each other by a dedicated braiding machine. The safety net 5 is used for being sleeved at the head end of the automatic avoidance resistance guide wire, namely the far end of the far-end core wire 2, so that the automatic avoidance resistance guide wire has a soft head end and has higher breaking force, and the breaking of the head end of the automatic avoidance resistance guide wire can be better avoided.

Preferably, the safety net 53 may be made of 6-20 wires. And the safety net 5 with different mesh densities (PPIs) or different wire sizes can be manufactured according to the different hardness requirements of the end of the automatic avoiding resistance guide wire. Preferably, the safety net 5 has a length ranging from 20 to 50mm. It will be appreciated that the deployed length (i.e. the straightened length) of the security mesh 5 may be in the range 20 to 50mm.

Wherein the wire wrap 6 is adapted to be disposed at the distal end of the self-retracting resistive guidewire distal core wire 2, such as the distal end of the distal core wire 2. The arrangement of the wire winding sheath 6 is mainly used for developing, and the visibility of the automatic avoiding resistance guide wire under X-rays is realized. The wire-wrapping sheath 6 can be understood as a spiral structure of wires, which is wound side by a dedicated spring machine.

Preferably, the wire winding sheath 6 may be a developing spring, and the developing spring may be any one of a platinum tungsten spring, a platinum nickel spring, a platinum iridium spring, a gold spring and a stainless steel spring or formed by connecting any two of the two springs. The development spring has good development performance, and can enhance the visibility of the automatic avoidance resistance guide wire under X-rays.

In some embodiments, the wire windings are each wound by a spring machine. Preferably, the wire winding diameter is 0.001 'to 0.004', the pitch is 0.01 to 0.05mm, and the total length of the spring is 1 cm to 30cm.

S20, shaping the distal end of the distal core wire 2 into a bending section 7, wherein the bending section 7, the straight section of the distal core wire 2 and the proximal core wire 1 are positioned in the same plane. That is, the curved section 7 is a pre-shaped curved section 7.

In some embodiments, the shaping may be accomplished by a shaping process, which may be heat treatment shaping and/or cold shaping. For example, heat treatment for shaping may be used, and the specific process may be heat treatment at 200-600 deg.c for 1-30 min.

In some embodiments, the curved section 7 may be a circular structure with indentations having a diameter greater than the mesh diameter of the bare stent 93 to be accessed. The diameter of the circular structure is determined according to the diameter of the blood vessel 94 and the mesh size of the bare stent 93, and is larger than the mesh diameter of the bare stent 93 to be entered and smaller than the diameter of the blood vessel 94.

In some embodiments, the diameter of the circular structure is preferably 1mm to 5mm, and the expanded length of the circular structure is 3mm to 20mm.

In other embodiments, as shown in fig. 3, the curved section 7 further comprises a curved structure 8, the distal end of the curved structure 8 being connected to the proximal end of the notched circular structure, the proximal end of the curved structure 8 being connected to the distal end of the straight section. It can be understood that the head end of the automatic avoidance resistance guide wire is of a circular structure, and meanwhile, the near end of the circular structure is also provided with a bend A. The bending structure 8 can be used for direction selection, i.e. for selecting a branch vessel 94 to be accessed. By providing the bending structure 8, the automatic avoidance resistance guide wire can be adapted to clinically different lesion requirements, such as entering a branch vessel 94 at different angles, etc.

In some embodiments, the outer included angle alpha between the bending structure 8 and the straight section is 0.1-50 degrees, and the unfolding length of the bending structure 8 is 3-20 mm.

In some embodiments, the method may further comprise:

after step S20, the safety net 5 is sleeved on the bending section 7, the wire winding sheath 6 is sleeved on the bending section 7, and the bending section 7, the safety net 5 and the wire winding sheath 6 are fixedly connected. In this way, the curved section 7, the safety net 5 and the wire-wrapping sheath 6 are coaxially arranged, so that the safety net 5 has good stability with said wire-wrapping sheath 6.

This step is understood to be the sequence of sleeving the safety net 5 over the connected proximal and distal core wires 1, 2, and then wrapping the wire sheath 6, and then connecting the three together.

In some embodiments, the connection may be one or more of resistance welding, brazing, ultrasonic welding, laser welding, adhesive bonding, snap fitting. For example, a braze joint may be used, and the welding temperature may be 200-500 ℃. The welding temperature is obtained through screening. The brazing temperature cannot be too high, which may damage the proximal core wire 1 and the distal core wire 2, resulting in an affected connection stability of the proximal core wire 1 and the distal core wire 2. The brazing temperature cannot be too low, and the combination of the proximal core wire 1 and the distal core wire 2 is affected by the brazing temperature, so that the automatic avoidance resistance guide wire with good connection stability cannot be obtained.

In some embodiments, the method may further comprise: a polymer sheath 3 is fixedly sleeved on the distal end of the straight section. The material of the polymer sheath 3 can be one or more of polyurethane, polylactic acid, nylon elastomer and polyether-ether-ketone. In particular, the sheath 3 may be secured to the distal core wire 2 by a hot melt process.

In some embodiments, the method may further comprise: a hydrophilic coating 4 is applied at least to the surface of the bending structure 8, to the surface of the straight sections and to the surface of the wire-wrapping sheath 6. The hydrophilic coating 4 may be one of a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acrylate coating, or a polymethylvinyl ether-maleic anhydride coating. The coating mode can adopt a spraying method or a smearing method, and the coating is solidified and formed by a certain method, so that the coating is not easy to fall off. After the hydrophilic coating 4 is coated, whether the appearance of the surface coating of the automatic avoidance resistance guide wire is abnormal or not is observed. The hydrophilic coating 4 can enable the automatic avoidance resistance guide wire to have very good lubricity, so that the passing resistance of the automatic avoidance resistance guide wire in the blood vessel 94 is reduced, and the automatic avoidance resistance guide wire is easy to push.

Preferably, the hydrophilic coating 4 is applied to all surfaces of the self-avoiding resistive guidewire. In this way, the entire surface of the self-retracting resistive guidewire may be provided with a hydrophilic coating 4.

The preparation method is simple and easy to realize, and the diameter of the circular structure part can be changed according to the requirement without affecting the integral design of the automatic avoidance resistance guide wire. The prepared automatic avoidance resistance guide wire can prevent the head end of the automatic avoidance resistance guide wire from entering meshes of the bare support 93, so that the automatic avoidance resistance guide wire enters unnecessary branches, the automatic avoidance resistance guide wire has the automatic avoidance resistance capability, the automatic avoidance resistance guide wire can be prevented from entering a channel between the outside of the bare support 93 and the wall of the blood vessel 94 or entering an interlayer, and the head end of the circular structure of the automatic avoidance resistance guide wire is positioned on the same plane with the non-circular structure part, so that the automatic avoidance resistance guide wire has stronger operability; meanwhile, the round structure part of the automatic avoiding resistance guide wire is smooth and soft in transition and free of wound. In addition, the preparation method has lower cost.

Those of ordinary skill in the art will appreciate that: the discussion of any of the embodiments above is merely exemplary and is not intended to suggest that the scope of the disclosure, including the claims, is limited to these examples; the technical features of the above embodiments or in the different embodiments may also be combined under the idea of the present disclosure, the steps may be implemented in any order, and there are many other variations of the different aspects of the embodiments of the present disclosure as described above, which are not provided in details for the sake of brevity.

While the present disclosure has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations of those embodiments will be apparent to those skilled in the art in light of the foregoing description.

The disclosed embodiments are intended to embrace all such alternatives, modifications and variances which fall within the broad scope of the appended claims. Accordingly, any omissions, modifications, equivalents, improvements, and the like, which are within the spirit and principles of the embodiments of the disclosure, are intended to be included within the scope of the disclosure.

Claims (10)

1. An automatic avoidance resistance guidewire, comprising: a rigid proximal core wire and a flexible distal core wire fixedly connected;

the distal core wire comprises a straight section and a preformed curved section which are connected, and the proximal end of the straight section is fixedly connected with the distal end of the proximal core wire; and the straight section, the proximal core wire and the curved section are all located in the same plane.

2. The self-retracting resistance guidewire of claim 1, wherein the curved segment comprises a rounded structure with a notch, the rounded structure being connected to the straight segment, the diameter of the rounded structure being greater than the mesh diameter of the bare stent to be accessed.

3. The automatic avoidance resistance guide wire of claim 2 wherein the diameter of the circular structure is 1mm to 5mm and the curved length of the circular structure is 3mm to 20mm.

4. The automatic avoidance resistance guidewire of claim 1 wherein the proximal end of the curved section is at a predetermined angle to the straight section.

5. The automatic avoidance resistance guidewire of claim 4 wherein the predetermined included angle is 0.1-50 °.

6. The automatic avoidance resistance guidewire of claim 1 wherein the proximal end of the straight section is welded to the distal end of the proximal core wire; the metal tube is sleeved at the proximal end of the straight section and the distal end of the proximal core wire, and the metal tube is fixedly bonded at the proximal end of the straight section and the distal end of the proximal core wire; and/or

The flexible bending section comprises a bending section, a bending section and a hydrophilic coating, wherein the bending section is provided with a bending section, and the bending section is provided with a bending section and a bending section.

7. The automatic avoidance resistance guidewire of claim 1 or 4 further comprising a safety mesh disposed over the distal core wire, the safety mesh being disposed over the distal core wire and both ends of the safety mesh being secured to the distal core wire, respectively; and/or

The wire winding sheath is sleeved on the distal core wire; the tip of the wire wrap sheath is used for developing.

8. The automatic avoidance drag guidewire of claim 7, comprising the safety mesh and the wire wrap sheath, the safety mesh being over the distal core wire, the wire wrap sheath being over the safety mesh, the distal end of the safety mesh being welded to the distal end of the curved section; and/or the total length of the safety net is 20-50 mm; and/or

The wire winding sheath is a spring, the wire winding diameter is 0.001-0.010 ", and the total length of the spring is 1-30 cm.

9. The automatic avoidance resistance guidewire of claim 8 wherein the safety mesh is disposed coaxially with the distal core wire.

10. The automatic avoidance resistance guidewire of claim 8 wherein the wire wrap sheath is disposed coaxially with the safety mesh.