CN110681031A

CN110681031A - Contrast guide wire and preparation method thereof

Info

Publication number: CN110681031A
Application number: CN201911094298.6A
Authority: CN
Inventors: 窦克非; 成正辉; 易沛林; 魏磊山; 黎宇; 颜世平
Original assignee: HUNAN AIPUTE MEDICAL EQUIPMENT CO Ltd
Current assignee: HUNAN AIPUTE MEDICAL EQUIPMENT CO Ltd
Priority date: 2019-11-11
Filing date: 2019-11-11
Publication date: 2020-01-14

Abstract

The invention discloses an imaging guide wire and a preparation method thereof. The contrast guide wire provided by the application is preformed into a J-shaped bend, is not easy to enter a bifurcated vessel, and prevents the inner wall of the vessel from being damaged; the J-shaped bend can be changed into a straight shape when the spring ring sheath is extruded, so that the contrast guide wire can conveniently enter a matched instrument; the design of the spring sheath at the head end improves the tactile feedback of the operator; meanwhile, the hydrophilic coating on the surface of the contrast guide wire improves the lubricity and is easy to reach a target part of a blood vessel.

Description

Contrast guide wire and preparation method thereof

Technical Field

The invention relates to the technical field of medical instruments, in particular to a contrast guide wire and a preparation method thereof.

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.

The first type of the contrast guide wire sold on the market at present is a nickel-titanium alloy inner core and a polymer outer layer, the bending type is J-bend, and during clinical application, the guide wire is inconvenient to enter a sheath tube or a catheter due to the fact that the head end bending type is designed in a polymer and core wire integrated mode, and operation time is prolonged. The second is an inner core stainless steel, an outer layer spring and a surface layer PTFE hydrophobic coating, and the bending type is a J-bend design. In clinical application, the surface spring and the PTFE coating are designed, so that the resistance of the guide wire reaching a diseased part or conveying other matching instruments is relatively large and the guide wire is not smooth enough. In addition, the whole guide wire is covered by the spring, and gaps exist among the springs, so that thrombotic complications are easy to form.

In summary, a problem to be solved by those skilled in the art is how to provide a method for facilitating the entry of an angiographic guidewire into a sheath or a catheter and improving the smoothness of delivery of the angiographic guidewire to a lesion.

Disclosure of Invention

In view of the above, the present invention provides a contrast guidewire and a preparation method thereof, which is convenient for entering a matching instrument, is not easy to damage the inner wall of a blood vessel, and is easy to reach a target part of the blood vessel.

In order to achieve the above purpose, the invention provides the following technical scheme:

a contrast guidewire comprising a core wire having a J-bend at a distal end; a spring ring sheath is sleeved on the periphery of the J-shaped bend; the outer periphery of the core wire is provided with a polymer sheath extending from the proximal end of the core wire to the proximal end of the spring coil sheath, and the surface of the polymer sheath is provided with a hydrophilic coating.

Preferably, the polymer sheath is a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyether-ether-ketone polymer layer.

Preferably, the spring ring sheath is welded or bonded to the core wire.

Preferably, the hydrophilic coating is a polyvinylpyrrolidone coating, a polyethylene oxide coating, a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating.

Preferably, the J-shaped bend comprises a transition section, a curved section and a straight section at the far end, which are distributed along the length direction of the core wire in sequence, and the diameter of the transition section is gradually reduced from the near end to the far end.

Preferably, the straight section is of a flat structure.

Preferably, the surface of the spring coil sheath is provided with a PTFE coating, or a second hydrophilic coating, or a silicone oil coating.

A method for preparing a contrast guidewire for use with any one of the above contrast guidewires, comprising:

preparing linear core wires by machining numerical control grinding;

forming a J-shaped bend at the distal end of the core wire by using a shaping die, and carrying out heat treatment on the J-shaped bend to shape the J-shaped bend;

a spring ring sheath is formed by winding through a spring machine and is sleeved and fixed on the periphery of the J-shaped bend;

forming a polymer jacket between the proximal end of the core wire and the spring coil jacket using a rheometrically process;

and a hydrophilic coating is coated on the surface of the polymer sheath by automatic spraying or manual coating.

The contrast guide wire provided by the invention comprises a core wire, wherein the far end of the core wire is provided with a J-shaped bend, the periphery of the J-shaped bend is sleeved with a spring ring sheath, a polymer sheath is arranged between the near end of the core wire and the near end of the spring ring sheath, and the surface of the polymer sheath is provided with a hydrophilic coating.

When the radiography guide wire provided by the application is used, the J-shaped bend can effectively prevent the blood vessel from entering the branch blood vessel, and the inner wall of the blood vessel is prevented from being damaged. Meanwhile, when the radiography guide wire enters the catheter or the sheath tube, an operator can apply axial stress to the proximal end of the spring ring sheath by fingers to adjust the bending shape of the distal end of the radiography guide wire, so that the J-shaped bend is straightened, and the radiography guide wire can enter a matched instrument more easily, so that an inserter is not needed for the radiography guide wire, and the use is convenient. In addition, the surface of the contrast guide wire is provided with the hydrophilic coating, so that the contrast guide wire has high lubricity, can easily and smoothly reach a diseased part, and can effectively avoid thrombosis.

Therefore, the contrast guide wire provided by the application has good tactile feedback, trafficability, pushing performance, flexibility, super elasticity, lubricating performance, safety, operation convenience and excellent comprehensive performance.

Drawings

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

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

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is a cross-sectional view taken along the Z-Z direction in FIG. 1;

FIG. 4 is a schematic structural view of a core wire provided by the present invention;

FIG. 5 is a cross-sectional view taken along the direction Y-Y in FIG. 4;

FIG. 6 is a cross-sectional view taken along the line X-X in FIG. 4;

fig. 7 is a flowchart of a method for preparing a contrast guidewire according to the present invention.

The reference numerals in figures 1 to 6 are:

1-core wire, 11-straight segment, 12-transition segment, 13-bending segment and 14-straight segment; 2-composite coating layer, 21-polymer sheath, 22-hydrophilic coating layer; 3-spring ring sheath, 4-radiography guide wire head end welding spot, and 5-spring ring near end welding spot.

Detailed Description

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Referring to fig. 1 to 6, fig. 1 is a schematic structural view of an angiographic guidewire according to the present invention; FIG. 2 is an enlarged view of a portion of FIG. 1; FIG. 3 is a cross-sectional view taken along the Z-Z direction in FIG. 1; FIG. 4 is a schematic structural view of a core wire provided by the present invention; FIG. 5 is a cross-sectional view taken along the direction Y-Y in FIG. 4; fig. 6 is a cross-sectional view taken along the direction X-X in fig. 4.

The application provides a contrast guide wire, which comprises a core wire 1 with a J-shaped bend at the distal end; a spring ring sheath 3 is sleeved on the periphery of the J-shaped bend; the outer circumference of the core wire 1 is provided with a polymer sheath 21 extending from the proximal end of the core wire 1 to the proximal end of the coil sheath 3, the surface of the polymer sheath 21 being provided with a hydrophilic coating 22.

Specifically, the contrast guide wire refers to a controllable preformed J-bend loach contrast guide wire for intravascular interventional diagnosis. It has a distal end, which refers to the portion of the angiographic guidewire distal to the operator, and a proximal end, which refers to the portion of the angiographic guidewire proximal to the operator.

The material from which the core wire 1 is made should have excellent durability, torsion control, tracking, etc., and provide good support and push force for the radiopaque guidewire. The surface of the core wire 1 should be smooth, clean and free of defects such as scabs, cracks, scratches and the like which are harmful to patients. The 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, of course, other materials suitable for preparing the core wire 1 can be used, and the core wire 1 is preferably made of Ni-Ti alloy in high elastic state. The core wire 1 may be produced by a method or technique such as physical grinding or chemical etching, and the physical grinding method is preferred. When the core wire 1 is made of Ni — Ti alloy, the J-bend forming can be performed by controlling the heat treatment temperature, for example, by controlling the heat treatment temperature to 400 to 750 ℃ and performing the heat treatment for a predetermined time, thereby obtaining the J-bend at the distal end and the head end softness of the core wire 1.

The core wire 1 comprises a straight section 11, a transition section 12, a bending section 13 and a straight section 14, wherein the straight section 11, the transition section 13 and the straight section 14 sequentially extend from a proximal end to a distal end along the length direction of the core wire 1, the bending section 13 is in a smooth curve shape, the straight section 11 and the transition section 12 are coaxially distributed, and the transition section 12, the bending section 13 and the straight section 14 form a J-shaped bend.

The coil sheath 3 may improve the tactile feedback capability of the contrast guidewire. The spring ring sheath 3 is formed by winding a stainless steel wire, a stainless steel wire with a PTFE pre-coating, a platinum nickel wire, a platinum tungsten wire, a medical noble metal wire and the like by a spring machine. In the process of assembling the spring coil sheath 3 and the core wire 1, the far end and the near end of the spring coil sheath 3 are respectively and coaxially connected with the far end of the core wire 1 and the core wire 1, more specifically, the far end of the spring coil sheath 3 is connected with the far end of the straight section 14, the near end of the spring coil sheath 3 can be connected with the transition section 12, and if the length of the transition section 12 is short, the near end of the spring coil sheath 3 can also be connected with the straight section 11. The spring coil sheath 3 and the core wire 1 can be fixed by any one of connection modes such as resistance welding, brazing, laser welding, ultrasonic welding, bonding and the like, and preferably, the spring coil sheath 3 and the core wire 1 are mutually connected and fixed in two welding spot areas, namely an angiography guide wire head end welding spot 4 and a spring coil near end welding spot 5, by means of brazing or laser welding.

The polymer sheath 21 is arranged in the surface of the core wire 1 in the area not coated with the coil sheath 3, i.e. the polymer sheath 21 extends from the proximal end of the core wire 1 to the proximal end of the coil sheath 3, the polymer sheath 21 and the hydrophilic coating 22 forming the composite coating 2. In actual processing, the polymer sheath 21 may be a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyetheretherketone polymer layer.

The hydrophilic coating 22 is a polyvinylpyrrolidone coating, or a polyethylene oxide coating, or a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating. The hydrophilic coating 22 makes the surface of the contrast guide wire smoother, and water molecules absorbed by the hydrophilic coating form a gel surface on the surface of the contrast guide wire, so that the passing resistance of the contrast guide wire is reduced, the contrast guide wire has good lubricity and tracking performance, the passing resistance of the contrast guide wire in blood vessels is reduced, the contrast guide wire is easy to push, and the passing capacity of the contrast guide wire is improved.

The core wire 1 of the contrast guide wire provided by the application is preformed to be J-shaped, the surface of the contrast guide wire is coated with a hydrophilic coating 22, and the outer far end is coated by a spring ring sheath 3. When the contrast guide wire enters the catheter or the sheath, the finger extrudes the spring ring sheath 3 towards the far end, so that the J-shaped bend becomes a straight shape, and the contrast guide wire can conveniently enter a matched instrument. The contrast guide wire keeps the J-shaped bend unchanged in the blood vessel, is difficult to enter the bifurcated blood vessel and prevents the inner wall of the blood vessel from being damaged. In addition, the surface of the contrast guide wire is provided with the hydrophilic coating 22, so that the contrast guide wire has high lubricity and is easy to reach a blood vessel target part.

Optionally, in practical application, the specific size of the contrast guidewire needs to be selected according to practical requirements, and the following specifications are preferably adopted in this embodiment: the preforming of the distal end of the contrast guide wire is a J-shaped bend, the diameter D of the J-shaped bend is 2-8 mm, the diameter D of the contrast guide wire is 0.010-0.038 ", and the total length of the contrast guide wire is 50-450 cm. In the spring ring sheath 3, the wire diameter of the spring is 0.0015-0.01 ", the outer diameter of the spring is 0.01-0.038", and the length of the spring is 1-300 cm.

Further, in order to optimize the use effect of the core wire 1, in an embodiment of a specific structure of the transition section 12 provided by the present application, the diameter of the transition section 12 is gradually reduced from the proximal end to the distal end, so that the distal end of the contrast guidewire has good flexibility and can more easily pass through a blood vessel branch. The transition section 12 may be any one of conical, parabolic, and streamlined in shape.

In an embodiment of a specific structure of the straight section 14 provided by the present application, the straight section 14 and the transition section 12 are substantially parallel, the cross section of the straight section 14 may be circular, and preferably, the straight section 14 is a flat structure. More specifically, the core wire 1 with the straight section 14 in a right circular shape is subjected to flat processing, and the flat structure can adjust the flexibility and the elastic rate of the head end of the contrast guide wire and simultaneously improve the welding strength of the tip end.

Optionally, in order to optimize the use effect of the contrast guidewire, the present application provides an embodiment in which the surface of the spring coil sheath 3 is provided with a PTFE coating, or a second hydrophilic coating, or a silicone oil coating. Specifically, the coating provided on the spring coil sheath 3 extends from the proximal end of the spring coil sheath 3 to the distal end of the spring coil sheath 3, thereby further reducing the push resistance of the contrast guidewire. When the spring coil sheath 3 is provided with the second hydrophilic coating at the time of actual processing, it is preferable that the second hydrophilic coating provided to the spring coil sheath 3 be identical to the hydrophilic coating 22 provided to the polymer sheath 21, thereby reducing the difficulty of processing.

Referring to fig. 7, fig. 7 is a flowchart of a method for preparing a contrast guidewire according to the present invention. The application also provides a preparation method for manufacturing any one of the contrast guide wires, which comprises the following steps:

and step S1, preparing the linear core wire 1 by machining and numerical control grinding. Specifically, the core wire 1 with the transition section 12, the bending section 13 and the flat section 14 is prepared by machining numerical control grinding. If the transition section 12 is of a conical structure, the transition section 12 needs to be subjected to numerical control grinding to gradually reduce the diameter thereof. If the flat straight section 14 is of a flat structure, the flat straight section 14 is processed by a flattening process, that is, the head end of the core wire 1 is flattened by the head end with the flat structure, so as to prepare a whole core wire 1.

And step S2, forming the distal end of the core wire 1 into a J-shaped bend by using a shaping mould, and carrying out heat treatment on the J-shaped bend to shape the J-shaped bend. That is, the distal end of the core wire 1 is shaped into a J-shaped bend by a suitable heat treatment process in combination with a shaping mold.

And step S3, winding the spring ring sheath 3 by using a spring machine, and sleeving and fixing the spring ring sheath 3 on the periphery of the J-shaped bend. Specifically, a stainless steel round wire is wound by a spring machine to form a spring ring sheath 3, then the spring ring sheath 3 is sleeved on the far end of the core wire 1, the spring ring sheath 3 and the core wire 1 are coaxially distributed, and then two ends of the spring ring sheath 3 are fixedly connected with the core wire 1 in a welding or bonding mode.

Step S4, a polymer sheath 21 is formed between the proximal end of the core wire 1 and the spring coil sheath 3 using a rheo-logical process.

Step S5, the hydrophilic coating 22 is coated on the surface of the polymer sheath 21 by automatic spraying or manual coating.

The preparation method of the contrast guide wire is simple to operate and easy to realize, and the size of the J-shaped bend of the contrast guide wire can be adjusted according to clinical requirements without influencing the overall design of the contrast guide wire. The prepared contrast guide wire should be checked whether all parts are connected tightly, whether the size meets the design requirements, whether the coating is complete, whether a falling part exists, and the like.

The embodiments in the present description are described in a progressive manner, each embodiment focuses on differences from other embodiments, and the same and similar parts among the embodiments are referred to each other.

The contrast guide wire and the preparation method thereof provided by the invention are described in detail above. The principles and embodiments of the present invention are explained herein using specific examples, which are presented only to assist in understanding the method and its core concepts. It should be noted that, for those skilled in the art, it is possible to make various improvements and modifications to the present invention without departing from the principle of the present invention, and those improvements and modifications also fall within the scope of the claims of the present invention.

Claims

1. A contrast guidewire, comprising a core wire (1) having a J-bend at its distal end; a spring ring sheath (3) is sleeved on the periphery of the J-shaped bend; the periphery of the core wire (1) is provided with a polymer sheath (21) extending from the proximal end of the core wire (1) to the proximal end of the spring coil sheath (3), and the surface of the polymer sheath (21) is provided with a hydrophilic coating (22).

2. The contrast guidewire of claim 1, wherein the polymer sheath (21) is a polyurethane polymer layer, a nylon polymer layer, a polylactic acid polymer layer, or a polyetheretherketone polymer layer.

3. The contrast guidewire according to claim 1, characterized in that the spring coil sheath (3) is welded or adhesively fixed to the core wire (1).

4. The contrast guidewire of claim 1, wherein the hydrophilic coating (22) is a polyvinylpyrrolidone coating, or a polyethylene oxide coating, or a transparent acid ester acrylic coating, or a polymethyl vinyl ether maleic anhydride coating.

5. The contrast guidewire according to claim 1, wherein the J-shaped bend comprises a transition section (12), a bent section (13) and a straight section (14) at the far end which are distributed along the length direction of the core wire (1), and the diameter of the transition section (12) is gradually reduced from the near end to the far end.

6. The visualization guidewire of claim 5, wherein the straight section (14) is of a flattened configuration.

7. The contrast guidewire according to any one of claims 1 to 6, characterized in that the surface of the spring coil sheath (3) is provided with a PTFE coating, or a second hydrophilic coating, or a silicone oil coating.

8. A method for preparing a contrast guidewire for use in making a contrast guidewire according to any one of claims 1 to 7, comprising:

preparing a linear type core wire (1) by machining numerical control grinding;

forming a J-shaped bend at the distal end of the core wire (1) by using a shaping die, and carrying out heat treatment on the J-shaped bend to shape the J-shaped bend;

a spring ring sheath (3) is formed by winding through a spring machine, and the spring ring sheath (3) is sleeved and fixed on the periphery of the J-shaped bend;

forming a polymer jacket (21) between the proximal end of the core wire (1) and the spring coil jacket (3) using a rheometrically process;

and a hydrophilic coating (22) is coated on the surface of the polymer sheath (21) by automatic spraying or manual coating.