CN114366994A - Guide wire and guide wire preparation method - Google Patents

Abstract

The invention provides a guide wire and a guide wire preparation method, belonging to the technical field of medical instruments, wherein the guide wire comprises a first core wire, a first sleeving component and a second sleeving component; the first core wire comprises a first connecting part and a second connecting part which are sequentially connected along the axial direction, and the first connecting part is positioned at the far end of the second connecting part; the first sleeving and connecting assembly comprises a first sleeve with a bent far end and an end head connected to the far end of the first sleeve, the first sleeve is sleeved outside the first connecting part and connected to the near end of the first connecting part, and the end head is connected to the far end of the first connecting part; the second sleeving component comprises a second sleeve, and the second sleeve is sleeved and fixedly connected to the first connecting part and is positioned inside the first sleeving component. The device aims to solve the technical problems that the guide wire in the prior art is easy to bend and poor in bending resistance.

Description

Guide wire and guide wire preparation method

Technical Field

The invention belongs to the technical field of medical instruments, and particularly relates to a guide wire and a guide wire preparation method.

Background

Coronary artery disease is a common clinical problem in the field of coronary heart disease interventional therapy, and interventional diagnosis and treatment by guide wire conveying and matching with instruments are one of the rapidly developed treatment modes at present. In the treatment of stenosis occurring in a blood vessel such as a coronary artery surrounding the heart or the treatment of a site where the blood vessel is completely occluded due to the progress of endovascular calcification (for example, chronic total occlusion: cto), it is necessary to insert a guide wire for guiding a therapeutic device such as a balloon catheter into the blood vessel prior to the insertion of the guide wire into the blood vessel. The distal portion of the guidewire is required to have high flexibility, good shape retention, and kink resistance.

At present, in order to improve the flexibility of the guide wire used in clinical practice, a layer of spring ring sheath is generally sleeved outside a core wire, and the flexibility of the guide wire is enhanced through the elasticity of the spring ring sheath; however, the overall anti-bending performance of the guide wire is poor, the problem that the guide wire is bent easily occurs in the process of inserting the guide wire into a blood vessel, the inner wall of the blood vessel is easily damaged, and the guide wire cannot reach a target part in the blood vessel.

Disclosure of Invention

The invention aims to provide a guide wire, and aims to solve the technical problems that the guide wire is easy to bend and poor in bending resistance in the prior art.

The invention is realized in such a way that a guide wire comprises:

the first core wire comprises a first connecting part and a second connecting part which are sequentially connected along the axial direction, and the first connecting part is positioned at the far end of the second connecting part;

the first sleeve connecting assembly comprises a first sleeve with a bent far end and a tip connected to the far end of the first sleeve, the first sleeve is sleeved outside the first connecting part and connected to the near end of the first connecting part, and the tip is connected to the far end of the first connecting part; and

and the second sleeving component is sleeved and fixedly connected on the first connecting part and is positioned inside the first sleeving component.

Furthermore, the first connecting part is provided with a first transition section, a first supporting section, a second transition section and a head end section which are connected in sequence along the direction from the near end to the far end; the first transition section is connected with the second connecting part; the outer diameter of the first transition section is gradually enlarged along the direction from the far end to the near end, the outer diameter of the second transition section is gradually enlarged along the direction from the far end to the near end, the first support section is axially arranged in an equal diameter mode, the diameter length of the first support section is equal to the diameter length of the far end of the first transition section and the diameter length of the near end of the second transition section, the head section is axially arranged in an equal diameter mode, and the diameter length of the head section is equal to the diameter length of the far end of the second transition section; the second sleeve joint component is at least sleeved on the second transition section, and the near end of the first sleeve is connected to the first transition section.

Furthermore, the second connecting portion is provided with a second supporting section and a third transition section which are sequentially connected in the direction from the far end to the near end, the third transition section is arranged in a gradually expanding manner in the direction from the near end to the far end, the second supporting section extends in an equal diameter mode, the diameter length of the second supporting section is equal to that of the far end of the third transition section, and the second supporting section is connected to the first connecting portion.

Further, the second supporting section and the third transition section are coated with lubricating coatings.

Further, the guidewire further includes a connection structure for connection with an external component, the connection structure being connected with the proximal end of the third transition segment.

Further, the first sleeve is in a spiral spring shape; the second sleeving component comprises a second sleeve in a spiral spring shape, the near end of the second sleeve is fixedly connected with the first supporting section in a sealing mode, and the far end of the second sleeve is fixedly connected with the head end section in a sealing mode.

Further, the guide wire also comprises a second core wire which is connected with the head end section and extends in the same direction with the head end section, the proximal end of the second core wire is connected with the second transition section, and the distal end of the second core wire is connected with the head end.

Further, the second core wire comprises a plurality of helically wound wires.

Further, the outer part of the first sleeve is coated with a hydrophilic coating.

Compared with the prior art, the invention has the beneficial effects that: this seal wire adopts double-cannula's structure, and first cover joint subassembly cover is located the outside of first connecting portion, when the seal wire got into blood vessel, first sleeve pipe was located the front end, is the position of main and vascular contact, and first sleeve pipe has played the effect of guide when getting into blood vessel, and second cover joint subassembly sets up in the inside of first cover joint subassembly, plays certain supporting role to first core silk and first sleeve pipe, has improved first core silk and first sheathed tube rigidity and intensity, and then has improved the fracture resistance of seal wire.

The invention also aims to provide a guide wire preparation method, aiming at solving the technical problems of poor torque transmission performance and poor developing performance of the guide wire in the prior art.

The invention is realized in such a way that a guide wire preparation method is used for preparing the guide wire, and the guide wire preparation method comprises the following steps:

surface pretreatment of a first core wire: pre-coating a polytetrafluoroethylene coating on the surface of the wire rod of the first core wire;

preprocessing a first core wire: firstly, preparing the first core wire, and then bending the far end of the first core wire;

preparing a second core wire: firstly, preparing the second core wire formed by coiling a plurality of strands of metal wires by a wire twisting machine; bending the far end of the second core wire;

preparing a sleeve: winding by a spring machine or knitting by a knitting machine to manufacture a first sleeve and a second sleeve which are in a spiral spring shape;

assembling and fixing: connecting the second core wire with the first core wire, sleeving a second sleeve at the joint of the proximal ends of the first core wire and the second core wire, penetrating the first core wire and the second core wire into the first sleeve, sleeving the second sleeve into the first sleeve, and connecting the first sleeve with the first core wire;

surface pretreatment of a first sleeve: and coating a hydrophilic coating on the surface of the first sleeve.

Compared with the prior art, the invention has the beneficial effects that: the preparation method of the guide wire is simple to operate and easy to realize, and the prepared guide wire needs to check whether all parts are connected and fastened, whether the appearance and the size of the guide wire meet the design requirements, whether a coating is complete, whether a falling part exists and the like; the guide wire has high bending resistance, good head end molding capability and head end molding retention capability, and good comprehensive performance.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings needed to be used in the embodiments of the present invention or in the description of the prior art will be briefly described below, and it is obvious that the drawings described below are only some embodiments of the present invention, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without creative efforts.

FIG. 1 is a schematic structural diagram of a guidewire provided by an embodiment of the present invention;

FIG. 2 is a schematic view of the structure of the first core wire of FIG. 1;

FIG. 3 is a view Y-Y of FIG. 2;

FIG. 4 is a Y-Y view of the alternate embodiment of FIG. 2;

FIG. 5 is a schematic view of the structure of the second core wire of FIG. 1;

FIG. 6 is a perspective view of the second core wire of FIG. 1;

FIG. 7 is a view Z-Z of FIG. 6;

fig. 8 is an X-X view of fig. 1.

Description of reference numerals: 1. a first core wire; 101. a first connection portion; 1011. a first transition section; 1012. a first support section; 1013. a second transition section; 1014. a head end section; 102. a second connecting portion; 1021. a second support section; 1022. a third transition section; 103. a connecting structure; 2. a lubricating coating; 3. a hydrophilic coating; 301. a proximal hydrophilic coating; 302. a distal hydrophilic coating; 4. a first ferrule assembly; 5. a second nesting component; 6. a bending part; 7. a second core filament; 701. a second core wire bending part; 702. a first strand; 703. a second strand; 704. a third stranded wire; 705. a fourth strand; 706. a fifth strand; 707. a sixth strand; 708. a seventh twisted wire; 8. a sixth welding spot; 9. a fourth solder joint; 10. a fifth welding spot; 11. a third solder joint; 12. a first solder joint; 13. and (4) a terminal.

Detailed Description

Reference will now be made in detail to embodiments of the present invention, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to the same or similar elements or elements having the same or similar function throughout. The embodiments described below with reference to the drawings are illustrative and intended to be illustrative of the invention and are not to be construed as limiting the invention.

In the description of the present invention, it is to be understood that the terms "length", "width", "upper", "lower", "upward", "vertical", "horizontal", "bottom", "inner", "outer", "inner", "outer", etc., indicate orientations or positional relationships based on those shown in the drawings, and are only for convenience of description and simplicity of description, but do not indicate or imply that the device or element being referred to must have a particular orientation, be constructed and operated in a particular orientation, and thus, are not to be construed as limiting the present invention.

Furthermore, the terms "first", "second", etc. are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of the present invention, "a plurality" means two or more unless specifically defined otherwise.

In the present invention, unless otherwise expressly stated or limited, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can, for example, be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention is described in further detail below with reference to the accompanying drawings and embodiments.

Referring to fig. 1, a guide wire according to an embodiment of the present invention includes a first core wire 1, a first sleeving member 4, and a second sleeving member 5; the first core wire 1 comprises a first connecting part 101 and a second connecting part 102 which are sequentially connected along the axial direction, wherein the first connecting part 101 is positioned at the far end of the second connecting part 102; the first sleeving connection assembly 4 comprises a first sleeve with a bent far end and an end head 13 connected to the far end of the first sleeve, the far end of the first sleeve is provided with a bent part 6, the bent part 6 is bent, the first sleeve is sleeved outside the first connection part 101 and connected to the near end of the first connection part 101, and the end head 13 is connected to the far end of the first connection part 101; the second sleeving component 5 comprises a second sleeve which is sleeved and fixedly connected to the first connecting portion 101 and located inside the first sleeving component 4, specifically, the second sleeve is located inside the first sleeve, and a preset distance is arranged between the far end of the second sleeving component 5 and the far end of the first sleeving component 4. It should be noted that, the front end may also be called as the far end, and for convenience of description, the following are defined: when the guidewire is inserted into a blood vessel, the end distal to the operator is defined as the distal or leading end and the end proximal to the operator is defined as the proximal or trailing end.

Specifically, the material of the first core wire 1 should have excellent properties of torque transmission, tracking, support, superelasticity, durability, and fatigue, and provide good support and pushing force for the guide wire. The surface of the first core wire 1 should be smooth and clean without defects such as scabs, cracks, burrs and scratches that could potentially risk the patient. The first core wire 1 is made of any one or more of Ni-Ti alloy, stainless steel, cobalt-based alloy, Fe-Mn alloy, Cu-Zn alloy, and Fe-Ni alloy, but other materials having suitable properties may be used to manufacture the first core wire 1. The first core wire 1 is preferably made of a high-strength, high-elasticity stainless steel wire.

The beneficial effect of this embodiment lies in: compared with the prior art, the guide wire adopts a double-sleeve structure, the first sleeving component 4 is sleeved outside the first connecting part 101, when the guide wire enters a blood vessel, the first sleeve is positioned at the front end and is a part mainly contacted with the blood vessel, the first sleeve plays a guiding role when entering the blood vessel, the second sleeving component 5 is arranged inside the first sleeving component 4 and plays a certain supporting role for the first core wire 1 and the first sleeve, the rigidity and the strength of the first core wire 1 and the first sleeve are improved, and the folding resistance of the guide wire is further improved; in addition, the first core wire 1, the first sleeving component 4 and the second sleeving component 5 jointly form a composite developing section of the guide wire head end, so that the guide wire head end has a stronger developing effect under X-rays.

In addition, the bending part 6 is bent or is an A-shaped elbow, or the bending part 6 is a J-shaped elbow, the bending part 6 and the straight part of the first sheathing component 4 are integrally formed, and the bending part 6 is formed and shaped through die bending. The bending part 6 is arranged, so that when the guide wire is inserted into a blood vessel, the front end of the guide wire cannot be pressed against the blood vessel wall when encountering a tortuous blood vessel, and the inner wall of the blood vessel can be prevented from being damaged or the blood vessel can be prevented from being perforated.

In the embodiment, the bent part 6 is arranged at the end part of the first sleeving component 4, the bent part 6 is beneficial to the guide wire to enter a sheath tube, a guide catheter, a microcatheter, a balloon dilatation catheter and other matching instruments, the guide wire is not easy to enter a branch blood vessel in the operation process, the target part can be smoothly reached, and meanwhile, the head end of the guide wire can be effectively prevented from damaging the inner wall of the blood vessel.

Further, as a preferred embodiment of the present embodiment, as shown in fig. 2, the first connecting portion 101 has a first transition section 1011, a first supporting section 1012, a second transition section 1013 and a head end section 1014 connected in sequence in the proximal-to-distal direction; the first transition section 1011 is connected with the second connecting part 102; the outer diameter of the first transition section 1011 is gradually enlarged from the far end to the near end, the outer diameter of the second transition section 1013 is gradually enlarged from the far end to the near end, the first support section 1012 is axially arranged in an equal diameter, and the diameter length of the first support section 1012 is equal to the diameter length of the far end of the first transition section 1011 and the diameter length of the near end of the second transition section 1013, the head end section 1014 is axially arranged in an equal diameter, and the diameter length of the head end section is equal to the diameter length of the far end of the second transition section 1013; the second sleeve joint component 5 is at least sleeved on the second transition section 1013, and the proximal end of the first sleeve is connected to the first transition section 1011.

In this embodiment, the head end section 1014 is defined as a distal end, the first transition section 1011 is defined as a proximal end, and the diameter of the proximal end of the first core wire 1 is larger than that of the distal end, so that the distal end of the first core wire 1 has good flexibility and support performance, and can more easily pass through tortuous blood vessels, the outer contour shapes of the first transition section 1011 and the second transition section 1013 can be any one of a cone shape, a parabola shape or a streamline shape, as shown in fig. 3 and 4, the cross section of the head end section 1014 is round or flat by press working, which is beneficial to optimizing the mechanical properties of the head end of the first core wire 1, and further can obtain suitable guide wire head end flexibility.

In addition, the surface of the metal wire processed into the first core wire 1 is pre-coated with a PTFE (polytetrafluoroethylene) coating, that is, the outer surfaces of the first transition section 1011, the first support section 1012, the second transition section 1013 and the head end section 1014 are pre-coated with PTFE coatings, which is beneficial to improving the passing performance of the guide wire in the blood vessel; the first core wire 1 can be manufactured by using methods or technologies such as physical grinding, electrolytic polishing, chemical etching and the like to manufacture a linear first core wire 1, preferably by using the physical grinding method, and then the distal end of the first core wire 1 is subjected to pressure processing to manufacture a complete metal core.

In this embodiment, the diameter of first connecting portion 101 sets up from the near-end to distal end tapering, and the middle part still sets up the support section of constant diameter and supports, when increasing the core silk pliability, can keep certain rigidity, has better anti bending property, is favorable to the distal end of first core silk 1 to get into the blood vessel better.

Further, as a preferred embodiment of this embodiment, as shown in fig. 2, the second connecting portion 102 has a second supporting section 1021 and a third transition section 1022 connected in sequence along a direction from the distal end to the proximal end, the third transition section 1022 is disposed gradually expanding along the direction from the proximal end to the distal end, the second supporting section 1021 extends in an equal diameter, and has a diameter length equal to that of the distal end of the third transition section 1022, and the second supporting section 1021 is connected to the first connecting portion 101.

Specifically, the cross section of the second support section 1021 is circular, the diameter of the second support section 1021 is equal to the diameter of the divergent ends of the third transition section 1022 and the first transition section 1011, the second support section 1021 and the third transition section 1022 have a good supporting effect and a good pushing effect on the first connection part at the far end, and the stability of the guide wire in the use process is ensured; in addition, the lubricating coating 2 is coated on the outer parts of the second supporting section 1021 and the third transition section 1022, specifically, the lubricating coating 2 adopts a PTFE (polytetrafluoroethylene) coating, which is beneficial to improving the trafficability of the guide wire in the blood vessel and the lumen of the related matched instrument.

Further, as a preferred embodiment of this embodiment, as shown in fig. 2, the guide wire further includes a connecting structure 103 for connecting with an external component, and the connecting structure 103 is connected with a proximal end of the third transition section 1022, i.e., fixedly connected with an end of the third transition section 1022 far from the second support section 1021.

Specifically, connection structure 103 is the cylinder, and the one end of cylinder is fixed in the tip of third changeover portion 1022, and the surface of cylinder is equipped with structures such as screw thread for be connected with external component, and firm in connection is reliable, and the suitability is stronger.

Further, as a preferred embodiment of this embodiment, as shown in fig. 1, the first sleeve is in a shape of a coil spring, one end of the first sleeve is fixedly connected to the end of the first transition section 1011 near the second support section 1021 (i.e. the proximal end of the first transition section 1011) in a sealing manner, and the other end of the first sleeve is fixedly connected to the end of the head end section 1014 far from the second transition section 1013 (i.e. the distal end of the head end section 1014) in a sealing manner; the second sleeve joint component 5 comprises a second sleeve in the shape of a spiral spring, the proximal end of the second sleeve is fixedly connected with the first supporting section 1012 in a sealing way, and the distal end of the second sleeve is fixedly connected with the head end section 1014 in a sealing way.

Specifically, the first sleeve is formed by winding a single-strand wire or a plurality of strands of wires through a spring machine or is woven through a weaving machine, and a single-strand wire spring ring is preferably adopted as the first sleeve; the second sleeve is formed by winding single strand or multiple strands of wires by a spring machine or knitting by a knitting machine, and the second sleeve is preferably a 6-strand spring ring; the multi-strand wire can be made of the same material or a plurality of different materials, and the cross section of the wire is circular, or rectangular, or irregularly shaped. The metal wire for manufacturing the first sleeve and the second sleeve can be stainless steel wire, stainless steel wire with a PTFE coating, platinum nickel wire, platinum tungsten wire, gold wire or medical precious metal alloy wire, and the like, wherein any one or more materials are formed by winding through a spring machine or weaving through a weaving machine. Preferably, the second sleeve is made of stainless steel wires; preferably, the straight cylindrical part of the first sleeve is made of stainless steel wire, the bending part 6 of the first sleeve is made of platinum tungsten wire or platinum nickel wire, and the straight cylindrical part and the bending part 6 can be fixedly connected through any one of the connection modes of brazing, laser welding, resistance welding, ultrasonic welding, crimping, bonding and the like.

In the embodiment, the straight cylindrical part of the first sleeve is processed by spraying, and the surface roughness of the straight cylindrical part is far higher than that of the bent part 6, so that the near end and the far end of the first sleeve can obtain different hydrophilic coating thicknesses, and the tactile feedback capacity of the guide wire can be improved; the hydrophilic coating 3 is coated on the outer portion of the first sleeve, the hydrophilic coating 3 comprises a near-end hydrophilic coating 301 and a far-end hydrophilic coating 302, the thickness of the near-end hydrophilic coating 301 is larger than that of the far-end hydrophilic coating 302, namely the thickness of one end, close to the second connecting portion 102, of the first sleeve is larger than that of one end, far away from the second connecting portion 102, of the first sleeve, and the thickness difference is about 1-20 microns; the hydrophilic coating 3 can improve the lubricity of the far end surface of the guide wire, and the mechanism is that the hydrophilic coating 3 absorbs water molecules to form a gel-like film on the surface of the first sleeve, and the film can reduce the passing resistance of the first sleeve in a blood vessel and related matched instruments, so that the first sleeve has good lubricity and tracking performance, the guide wire is easy to push, the passing capacity of the guide wire is effectively improved, the guide wire can easily reach a target part in the blood vessel, and the formation of thrombus in the blood vessel can be effectively avoided.

Alternatively, the exterior of the first sleeve can be coated with a PTFE coating, a hydrophilic coating 3 or a silicone oil coating, wherein the coating can be one of the coatings or a combination of the coatings.

Further, as a preferred embodiment of this embodiment, as shown in fig. 1, 5 and 8, the guide wire further includes a second core wire 7 connected to the head end section 1014 and extending in the same direction as the head end section 1014, a proximal end of the second core wire 7 is connected to the second transition section 1013, and a distal end thereof is connected to the tip 13, a distal end of the second core wire 7 is provided with a second core wire bending portion 701, and a bending shape of the second core wire bending portion 701 is matched with the bending portion 6; specifically, the second core wire 7 is fixed to a side portion of the head end section 1014, the second core wire 7 is located inside the first sleeve, the second core wire 7 is at least partially located inside the second sleeve, a distal end of the second core wire 7 is fixedly connected with a distal end of the first sleeve and a distal end of the head end section 1014 in a sealing manner, so as to form the head 13, the fixedly connected sealing manner may be any one of soldering, laser welding, resistance welding, ultrasonic welding, crimping, bonding, and the like, and the second core wire 7 is fixedly connected with the core wire of the head end section 1014 in a side-by-side manner.

Specifically, the second core wire 7 includes a plurality of strands of metal wires spirally wound, the second core wire 7 is prepared by a twisting machine using a twisted wire, and the twisted wire constituting the second core wire 7 should have excellent properties of torque transmissibility, tracking property, supporting property, superelasticity, durability, fatigue property, and the like, and provide a good shaping ability and a shaping holding ability to the tip end of the guide wire, so that the tip end of the guide wire is not wound in a blood vessel. The surface of the skein constituting the second core wire 7 should be smooth and clean, without the defects of scabs, cracks, burrs, scratches and the like which have potential risks to patients, the skein constituting the second core wire 7 is made of any one or more of alloy wires such as Ni-Ti alloy wire, stainless steel wire, cobalt-based alloy wire, Fe-Mn alloy wire, Cu-Zn alloy wire, Fe-Ni alloy wire, platinum-nickel alloy wire, platinum-tungsten alloy wire, gold wire and medical noble metal wire, of course, other materials with appropriate performance can be used to prepare the second core wire 7; preferably, the second core wire 7 is made of a stainless steel wire having high elasticity. As shown in fig. 5 and 6, the distal end (end far from the second sleeve) of the second core wire 7 is sleeved in the inner cavity of the mold by using a cold set bending mold, so that the distal end head (end head 13) of the second core wire 7 forms an a-shaped bend, and the mold with the a-shaped bend and the distal end head of the second core wire 7 are subjected to a suitable heat treatment process, for example, the heat treatment temperature is controlled to be 600 ℃ to 1200 ℃, heat preservation is performed for a specified time, a suitable cooling mode is selected, so that the a-shaped bend is heat-set, and the distal end of the second core wire 7 obtains a suitable head end softness; or the cold bending technology is utilized to carry out cold bending on the head end of the far end of the second core wire 7 so as to obtain an A-shaped elbow; or the distal end of the second core wire 7 and the head end of the first core wire 1 are shaped into an A-shaped elbow by the same method.

In the present embodiment, referring to fig. 8, the second core wire 7 is designed to be connected and fixed in parallel with the head end section 1014 of the first core wire 1, so as to improve the shaping capability, the shaping holding capability and the head end safety of the guide wire head end; the second sleeve is sleeved and fixed on the peripheries of the first core wire 1 and the second core wire 7, and the end heads 13 of the first core wire 1 and the second core wire 7 are exposed out of the far end of the second sleeve for a certain distance; the first sleeve is sleeved and fixed outside the guide wire, and the second core wire 7 and the first core wire 1 can be connected and fixed in any one of the connection modes such as soldering, laser welding, resistance welding, ultrasonic welding, crimping or bonding. As shown in fig. 1, preferably, the sixth welding point 8, the fourth welding point 9, the fifth welding point 10, the first welding point 12, and the second welding point (end head 13) are connected and fixed by soldering or laser welding, and the end head 13 is formed by welding and defined as the second welding point; preferably, the third welding points 11 are connected and fixed by soldering or crimping. The second core wire 7, the first sleeve and the second sleeve form a composite cone structure in the guide wire head end together, and the structure can improve the connection strength, the molding capacity, the molding retention capacity, the support performance, the folding resistance and the torque transmission performance of the guide wire head end; the second core wire 7, the first sleeve and the second sleeve jointly form a guide wire head end composite developing section, so that the head end of the guide wire has a strong developing effect under X-rays.

In practical application, the specific size of the guide wire needs to be designed according to practical requirements, and the following size specifications are preferably adopted in the embodiment: the distal end of the head end section 1014 of the guide wire is pre-shaped to form a bent part 6, or is hot-shaped and cold-shaped to form an A-shaped elbow, the transverse length of the A-shaped elbow is 0.5-5.5 mm, the diameter D of the first core wire 1 is 0.010-0.038 ", and the total length of the first core wire 1 is 50-450 cm; the diameter of the second core wire 7 is 0.001 'to 0.04', and the diameter of a twisted wire (also called a twisted wire) for preparing the second core wire 7 is 0.0003 'to 0.013'; in the second sleeve, the wire diameter of the spring ring (the raw material for manufacturing the second sleeve) is 0.001-0.004 ", the outer diameter of the spring ring is 0.006-0.038", and the length of the spring is 1-100 mm; in the first sleeve, the wire diameter of the spring ring is 0.0015-0.01 ', the outer diameter of the spring ring is 0.01-0.038', and the length of the spring is 1-450 cm; the thickness of the coating on the outer portions of the second supporting section 1021 and the third transition section 1022 is 0.004-0.02 mm, and the thickness of the hydrophilic coating 3 coated on the outer portion of the first sleeve is 0.004-0.01 mm. Referring to fig. 6 and 7, the first stranded wire 702, the second stranded wire 703 and the third stranded wire 704 are made of stainless steel wires, the fourth stranded wire 705, the fifth stranded wire 706, the sixth stranded wire 707 and the seventh stranded wire 708 are made of platinum tungsten wires or platinum nickel wires, and the second core wire 7 formed by stranding the wire stranding machine can enhance the development performance of the guide wire tip.

In another aspect, the present invention provides a method for preparing a guide wire, which is used for preparing the guide wire of any one of the above aspects, and comprises the following steps:

surface pretreatment of a first core wire: pre-coating a PTFE (polytetrafluoroethylene) coating on the surface of the wire rod of the first core wire 1 by one of automatic spraying and dip coating;

preprocessing a first core wire: firstly, preparing a first core wire 1 by machining numerical control grinding and combining a physical grinding or electropolishing or chemical etching technology, then carrying out pressure processing on the far end of the first core wire 1, and then bending the far end of the first core wire 1 to prepare a bending part 6;

preparing a second core wire: firstly, preparing the second core wire 7 formed by coiling a plurality of strands of metal wires by a wire twisting machine; then bending the far end of the second core wire 7; specifically, the distal end of the second core wire 7 is sleeved in the inner cavity of the mold by using a cold-set bending mold, so that the distal end of the second core wire 7 forms a bent part 6 (namely an A-shaped elbow), and the mold with the A-shaped elbow and the distal end of the second core wire 7 are subjected to a proper heat treatment process to heat-set the A-shaped elbow; or the distal end of the second core wire 7 is subjected to cold bending by utilizing a cold bending technology to obtain an A-shaped elbow; or the distal end of the second core wire 7 and the head end of the first core wire 1 are shaped into an A-shaped elbow by the same method;

preparing a sleeve: winding by a spring machine or knitting by a knitting machine to manufacture a first sleeve and a second sleeve which are in a spiral spring shape;

assembling and fixing: connecting the second core wire 7 with the first core wire 1 in a welding or bonding mode, sleeving a second sleeve at the joint of the proximal ends of the first core wire 1 and the second core wire 7, penetrating the first core wire 1 and the second core wire 7 into the first sleeve, sleeving the second sleeve into the first sleeve, and connecting the first sleeve with the first core wire 1;

surface pretreatment of a first sleeve: the hydrophilic coating 3 is coated on the surface of the first sleeve by one of automatic spraying, dip coating or manual coating.

The preparation method of the guide wire is simple to operate and easy to realize, and the prepared guide wire needs to check whether all parts are connected and fastened, whether the appearance and the size of the guide wire meet the design requirements, whether a coating is complete, whether a falling part exists and the like; the guide wire has high head end molding capacity, head end molding retention capacity and proper head end softness, and simultaneously has good tactile feedback, controllability, trafficability, lubricity and safety, and good comprehensive performance.

The foregoing is considered as illustrative only of the preferred embodiments of the invention, and is presented merely for purposes of illustration and description of the principles of the invention and is not intended to limit the scope of the invention in any way. Any modifications, equivalents and improvements made within the spirit and principles of the invention and other embodiments of the invention without the creative effort of those skilled in the art are included in the protection scope of the invention based on the explanation here.

Claims (10)

1. A guidewire, comprising:

the first core wire comprises a first connecting part and a second connecting part which are sequentially connected along the axial direction, and the first connecting part is positioned at the far end of the second connecting part;

the first sleeve connecting assembly comprises a first sleeve with a bent far end and a tip connected to the far end of the first sleeve, the first sleeve is sleeved outside the first connecting part and connected to the near end of the first connecting part, and the tip is connected to the far end of the first connecting part; and

and the second sleeving component is sleeved and fixedly connected on the first connecting part and is positioned inside the first sleeving component.

2. The guide wire of claim 1, wherein the first connection portion has a first transition section, a first support section, a second transition section and a head end section connected in sequence in a proximal-to-distal direction; the first transition section is connected with the second connecting part; the outer diameter of the first transition section is gradually enlarged along the direction from the far end to the near end, the outer diameter of the second transition section is gradually enlarged along the direction from the far end to the near end, the first support section is axially arranged in an equal diameter mode, the diameter length of the first support section is equal to the diameter length of the far end of the first transition section and the diameter length of the near end of the second transition section, the head section is axially arranged in an equal diameter mode, and the diameter length of the head section is equal to the diameter length of the far end of the second transition section; the second sleeve joint component is at least sleeved on the second transition section, and the near end of the first sleeve is connected to the first transition section.

3. The guide wire of claim 2, wherein the second connecting portion has a second support section and a third transition section connected in series in a distal-to-proximal direction, the third transition section being disposed in a proximal-to-distal direction, the second support section extending in a constant diameter and having a diameter length equal to a diameter length of a distal end of the third transition section, the second support section being connected to the first connecting portion.

4. The guidewire of claim 3, wherein the second support section and the third transition section are externally coated with a lubricious coating.

5. The guidewire of claim 3, further comprising a connection structure for connecting to an external component, the connection structure being connected to a proximal end of the third transition segment.

6. The guidewire of claim 3, wherein the first sleeve is in the form of a coil spring; the second sleeving component comprises a second sleeve in a spiral spring shape, the near end of the second sleeve is fixedly connected with the first supporting section in a sealing mode, and the far end of the second sleeve is fixedly connected with the head end section in a sealing mode.

7. The guidewire of claim 3, further comprising a second core wire connected to and co-extensive with the tip section, the second core wire having a proximal end connected to the second transition section and a distal end connected to the tip.

8. The guidewire of claim 7, wherein the second core wire comprises a plurality of helically wound wires.

9. The guidewire of claim 1, wherein the first sleeve is coated on an exterior thereof with a hydrophilic coating.

10. A method of preparing a guidewire for use in preparing a guidewire as defined in any one of claims 1-9, the method comprising the steps of:

surface pretreatment of a first core wire: pre-coating a polytetrafluoroethylene coating on the surface of the wire rod of the first core wire;

preprocessing a first core wire: firstly, preparing the first core wire, and then bending the far end of the first core wire;

preparing a second core wire: firstly, preparing the second core wire formed by coiling a plurality of strands of metal wires by a wire twisting machine; bending the far end of the second core wire;

preparing a sleeve: winding by a spring machine or knitting by a knitting machine to manufacture a first sleeve and a second sleeve which are in a spiral spring shape;

assembling and fixing: connecting the second core wire with the first core wire, sleeving a second sleeve at the joint of the proximal ends of the first core wire and the second core wire, penetrating the first core wire and the second core wire into the first sleeve, sleeving the second sleeve into the first sleeve, and connecting the first sleeve with the first core wire;

surface pretreatment of a first sleeve: and coating a hydrophilic coating on the surface of the first sleeve.

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