KR101830730B1

KR101830730B1 - The medical guide wire and a method of manufacturing

Info

Publication number: KR101830730B1
Application number: KR1020160000156A
Authority: KR
Inventors: 이장우
Original assignee: 이장우
Priority date: 2016-01-03
Filing date: 2016-01-03
Publication date: 2018-04-04
Also published as: KR20170081307A

Abstract

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical guidewire used for guiding a catheter inserted directly into a human body or through a blood vessel in examination and treatment and more specifically to a guidewire having a concave dimple And Teflon coating thickness of 4 to 20 μm or less on the basis of an ultra thin film fluoropolymer coating technology.
In order to achieve the above object, the present invention provides a medical guidewire comprising: a wire supplying step and a leveling step (1); A pretreatment / coating step (2); A vertical transfer step (3); A preheating step (4); A heat treatment step and a baking step (5); A cooling step (6); Characterized in that, in order to form a certain thickness of the fluororesin layer, the vertical transferring step (3) is vertically transferred to a height of not less than 3 meters. do.
The present invention is characterized in that a groove or a dimple formed in a fluororesin is concave so that frictional resistance can be reduced and bending of a guide wire can be smoothly carried out so that insertion and manipulation in a human body are easy, The manufacturing cost can be lowered, and homogeneous quality (coating roundness, coating thickness) can be maintained.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a medical guidewire,

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical guidewire used for guiding a catheter inserted directly into a human body or through a blood vessel in examination and treatment and more specifically to a guidewire having a concave dimple And Teflon coating thickness of 4 to 20 μm or less on the basis of an ultra thin film fluoropolymer coating technology.

The present invention relates to a guide wire for guiding a medical instrument such as a catheter to a predetermined position in a body cavity of a blood vessel or the like.

The medical guide wire is an ancillary device for guiding a catheter to a target site by inserting a guide wire into a catheter for introducing the catheter to a site in the body to be treated or inspected and guiding it to the guide wire.

When the catheter is inserted into the syringe body along the guide wire, the gap between the catheter and the guide wire has a narrow clearance, and when the catheter is inserted into the human body, A friction resistance is generated, so that the guide wire may come into close contact with the inner circumferential surface of the catheter, thereby causing troubles easily.

As a method for solving the above problem, in JP 03041966, a guide wire which is a core wire is coated with a fluororesin in order to lower the frictional resistance between the guide wire and the catheter, so that the guide wire can smoothly advance into the catheter However, the guide wire coated with a fluorine resin on the core wire surface smoothly has a problem that the frictional resistance is improved by the low frictional property of the fluorine resin, but the outer circumferential surface is flat and tightly adhered to the internal organs or the inner circumferential surface of the blood vessel Occurs.

In order to further reduce the frictional resistance between the catheter and the guide wire, JP 11 1109217 discloses a method of forming a concavoconvex shape on the outer circumferential surface of the guide wire itself, JP 11178930 discloses a method of forming a helical coil And the like. The above-described technique requires a core material to be processed, which complicates the process. Further, the core material causes a change in characteristics such as the strength and elastic modulus of the wire caused by the core material, And the frictional resistance is not greatly improved.

In addition, KR 10-1062613 discloses a method for manufacturing a medical guidewire having a convex projection with a granular material, a manufacturing cost is low, a strength is not affected, and a frictional resistance is low. However, The convex protrusions in the body block the supply of blood and damage the internal organs.

Therefore, it is necessary to improve the medical guidewire capable of reducing the frictional resistance, and a technology for reducing the manufacturing cost by the continuous production manufacturing method is needed.

1. KR 10-1062613, 'Guidewire for medical use and manufacturing method thereof', registered on August 30, 2011. 2. KR 10-0822062, 'Fluoropolymer coating system for heating wire', registered on Apr. 3. KR 10-2011-0139707, 'Medical guide wire', publication date: 29.29.2011. 4. JP 03041966, 'Guide wire', publication date: February 22, 1991. 5. JP 11019217, 'MEDICAL GUIDE WIRE', publication date: Jan. 26, 1999. 6. JP 11178930, 'MEDICAL GUIDE WIRE', publication date: June 7, 1999.

Disclosed is a method for manufacturing a guidewire capable of continuous production by supplying a guidewire to a reel on the basis of an ultra-thin film Teflon coating technology having a Teflon coating thickness of 4 to 20 μm or less and winding the rewinder Is an object of the present invention.

In order to achieve the above object, the present invention provides a medical guidewire comprising: a wire supplying step and a leveling step (1); A pretreatment / coating step (2); A vertical transfer step (3); A preheating step (4); A heat treatment step and a baking step (5); A cooling step (6); And a winding step (7)

First, in order to form a certain thickness of the fluororesin layer, the vertical transfer process (3) is vertically transferred to a height of 3 meters or more.

Secondly, in order to form concave dimples, the heat treatment step and the firing step (5) are carried out in such a manner that a plurality of grooves (30, 31) recessed in the outer peripheral surface of the fluororesin (11) And the dimples (32) are cold-formed.

Third, for the formation of a homogeneous coating layer, the coating inducing member 20 located at the end of the coating process (2) comprises a housing (21) with a holder (22); A shrink tube 26 passing through the center of the housing 21 and having a diameter gradually contracted, and a coating tube 25 forming a coating layer having a predetermined diameter. I want to.

The present invention has the following effects.

First, due to the grooves or dimples formed on the outer circumferential surface of the guide wire, frictional resistance is reduced and insertion and manipulation in the human body is easy.

Secondly, the groove or the dimple is concave, so that the frictional resistance can be reduced and the warp of the guide wire can be smoothly performed, so that insertion and manipulation in the human body are easy.

Third, since the present invention can be mass-produced by a continuous reel manufacturing method, manufacturing cost can be lowered and homogeneous quality can be maintained.

Finally, the coating thickness of the fluororesin can be kept constant by the vertical transfer of the coating process part, and the roundness can be maintained around the core material.

1 is a perspective view of a preferred embodiment of the present invention;
2 is a sectional view of a guide wire.
3 is a view showing a guide wire manufacturing process.
4 is a schematic view of a guidewire manufacturing facility.
5 is a comparative photograph of a vertical transfer of the present invention with a conventional coating bath;
FIG. 6 is a photograph of a coating thickness variation according to whether or not a vertical process is included; FIG.
7 is a perspective view (A) and a sectional view (B) of the coating guide member.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings, which will be readily apparent to those skilled in the art to which the present invention pertains. The present invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein.

In order to clearly illustrate the present invention, parts not related to the description are omitted. Like reference numbers are used throughout the specification to refer to the same or like parts. In addition, the size and thickness of each component shown in the drawings are arbitrarily shown for convenience of explanation, and the present invention is not necessarily limited to those shown in the drawings. In the drawings, the thickness is enlarged to clearly show various parts and regions. In the drawings, for the sake of convenience, the thicknesses of some portions and regions are exaggerated.

The guidewire according to the present invention is used as medical equipment, for removing colon polyps, for digesting tissue tissue and for angioplasty.

It is preferable to use a material of SUS T304V as the metal core material applied to the present invention.

In order to prevent contact and reaction with the metal due to contact with the human body, a fluorocarbon resin coating is necessary on the outer side of the guide wire.

The prior art of the fluororesin coating includes a spray method in which a guide wire is cut for each product and then a fluororesin is sprayed and coated, and an extrusion molding method in which a fluororesin is coated by injection.

The spraying method has a merit that it is easy to work and has a simple process, but it has a disadvantage that it has a high production cost due to a large amount of material loss and can not keep the coating thickness constant.

The extrusion molding method is a technique of inserting a metal core material into an extrusion molding machine and then pushing out the fluorine resin layer from the mold to coat the core material. However, the extreme thin film Teflon coating process of 15.0 占 퐉 or less to be. In addition, there is a disadvantage in that the manufacturing cost is high due to the difficulty of continuous production due to the necessity of advanced manufacturing technology such as a guide wire pretreatment technique, an ultrathin film Teflon coating technique, and an ultrathin film Teflon coating heat treatment technique.

The present invention relates to a method for continuously coating a wire wound around a reel in a reel continuous manufacturing method without cutting the wire, and is suitable for a procedure in which the thickness of a Teflon (PTFE) coating is 4.0 to 20.0 탆 or less And can be manufactured.

Fig. 1 is a perspective view of a preferred embodiment of the present invention, and Fig. 2 is a sectional view of a guide wire.

The present invention is characterized in that a plurality of concave grooves (30, 31) to dimples (32) are formed on the outer circumferential surface of the fluororesin layer to reduce frictional resistance of the guide wire.

The concave grooves (30, 31) to the dimples (32) can reduce the frictional resistance with the human body or can easily bend and provide convenience in the treatment and operation.

The present invention provides a medical guide wire comprising: a core (10) made of metal; And a plurality of grooves (30, 31) to dimples (32) concaved in the outer circumferential surface of the fluororesin (11), wherein the grooves (30, 31) to the dimples (32) are formed at regular intervals from horizontal to spiral.

1 (A) is a cross-sectional view showing the embodiment of FIG. 2A in which the horizontal grooves 30 are formed on the outer circumferential surface of the fluororesin. FIG. 1 (B) 2B, and FIG. 1C is an embodiment in which dimples 32 are formed on the outer circumferential surface of the fluororesin, and the cross section is as shown in FIG. 2C.

As shown in FIG. 1, the present invention is characterized in that grooves (30, 31) to dimples (32) are formed on the outer circumferential surface of the fluororesin (11) at regular intervals from horizontal to spiral.

After the heat treatment step, the protrusions are provided in gears or rollers passing through the guide wire in a semi-dried state of the fluororesin, so that the grooves 30, 31 to the dimples 32 are formed on the outer circumferential surface of the fluororesin at regular intervals .

In addition, irregular dimples 32 can be formed by blasting particles having a small diameter on a guide wire coated with a fluororesin.

Therefore, the present invention is characterized in that the grooves (30, 31) to dimples (32) formed at the above-mentioned intervals are irregularly formed.

The fluororesin may be selected from the group consisting of polytetrafluoroethylene (PTFE), tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA), polychlorotrifluoroethylene (PCTFE), polyvinylidene fluoride (PVDF) (PET), tetrafluoroethylene-hexafluoropropylene copolymer (FEP), and tetrafluoroethylene-ethylene copolymer (PETFE). Of these, at least one selected from polytetrafluoroethylene (PTFE) and tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA) is preferable. It has a relatively high melting point and is safe for the human body.

It is preferable that the thickness of the fluorine resin coating layer is within 4.0 to 20 占 퐉. This thickness is not influenced by the medical operation of the wire.

Further, it is preferable that the average depth of the dimples is 0.1 탆 or more and 10 탆 or less. In this range, the frictional resistance is reduced and the guide wire is more easily bent.

It is preferable that the surface of the fluororesin layer includes a flat portion and a plurality of dimples. This configuration has the effect of reducing the frictional resistance.

Fig. 3 is a view showing a guide wire manufacturing process, and Fig. 4 is a schematic view of a guide wire manufacturing facility.

The present invention is characterized in that, in the production of a guide wire, a fluororesin is not coated by a spray method or an extrusion molding method, and is continuously produced by a reel.

The present invention relates to a manufacturing method for winding a guide wire coated with a fluororesin on a reel through a sintering process in which a reel wound with a metal core is continuously fed to form a fluororesin coating and a dimple (32).

Accordingly, the present invention provides a medical guidewire comprising: a wire feeding process and a leveling process (1) for feeding a wire of a metal core wound around a reel and spreading it in a straight line; A pretreatment step for smoothly coating the metal core material while removing foreign substances from the surface of the metal core material after the wire supplying step and the leveling step (1); a coating step (2) for coating the outer surface of the metal core material with fluorine resin; After the coating step (2), a vertically moving vertical transfer step (3); A preheating step (4) for preheating the heat treatment process after the vertical transfer process (3); After the preheating step (4), a heat treatment step of forming a plurality of grooves (30, 31) to dimples (32) concaved in the outer circumferential surface of the fluorine resin layer after the drying of the fluorine resin and the coating layer are formed, ; A cooling step (6) for cooling after the heat treatment step and the baking step (5); And a wire winding step (7) of winding the completed guide wire around the reel after the cooling step (6), wherein in order to form a certain thickness of the fluororesin layer, the coating step (3) And then vertically transported to a distance of 3 meters or more.

The pretreatment process has a function of removing pickling treatment and other foreign substances and inducing the fluorine resin to be easily attached.

When the coating process 3 is horizontally transferred, the fluororesin layer 11 is formed on the core material 10 and the core material 10 is coated on the core material 10, So that a constant thickness can not be formed.

Therefore, in order to maintain the roundness while maintaining the coating thickness of the fluororesin 10 at a constant level, it is preferable to transport the fluororesin vertically, and the feeding speed of the transfer and the time of the fluorination determine the coating thickness of the fluororesin. That is, the coating thickness of the fluororesin becomes thick when the feeding speed and the time of the melting are prolonged.

Preferably, the vertical transfer step (3) includes a height adjusting means, and the height adjusting means should be adjustable within a vertical transfer height of 3 to 6 meters.

FIG. 5 is a comparative photograph of a normal coating bath and a vertical transfer of the present invention, and FIG. 6 is a photograph of a coating thickness variation according to whether a vertical process is included or not.

The main object of the present invention is to form a coating layer of a fluororesin on a steel wire and form a concave groove or concave dimple. Therefore, when it is desired to form concave grooves or dimples in the coating layer, it is very important to secure a homogeneous thickness first in the coating layer.

Normally, in order to coat the wire material, the coating solution is formed on the outer circumferential surface while tilting to a height of less than 1 meter in the bath containing the coating solution.

However, in the present invention, as a result of attempting to form a homogeneous thickness of the coating and roundness formation, it is characterized in that it is vertically transferred over 3 meters after passing through the coating bath. As a result of the applicant's various tests and trials, it has been confirmed that the vertical transfer of more than 3 meters is advantageous in forming the roundness of the coating, that is, the uniform thickness of the coating.

FIG. 6 is a photograph of the coating thickness variation according to whether or not the vertical process (3) is included.

As shown in Fig. 6, it is a photograph which can compare how the roundness of the coating thickness is affected by the height of the vertically conveying at a distance of 3 meters or more after the coated molten steel of the present invention.

In the manufacturing process of the present invention, the section including the vertical transporting process (3) at a vertical height of 3 meters or more and the section cut with the guide wire when the vertical transporting process is not included is cut.

In the above photograph, the left side shows vertical transfer after the coating process, and the thickness of the fluororesin layer on the outer circumferential surface of the core material is close to the roundness, but the variation of the coating thickness on the right side is very significant.

The preheating step (4) is a preheating step for drying the fluororesin, and the heat treatment step (5) causes the fluororesin (11) to adhere well to the core material (10).

In the firing step (5), it is preferable to form the horizontal groove (30), the spiral groove (31) and the dimple (32) in a state where the fluororesin is dried at 70% (30, 31) to the dimples (32) are plastic molded into protrusions formed in rollers or gears passing through guide wires coated with fluororesin.

Conventionally, when a projection is to be formed on the wire coating layer, a technique of press molding with a die roller preheated to a glass transition temperature or higher is used. However, a die roller having a heater usually has a good moldability when pressed, but a portion which is in close contact with the die roller is not easily detached and a surface roughness becomes poor around the edge.

In some cases, a technique has been disclosed in which dimples are formed by using viscosity and gravity of a coating material in a drying fixation after deep dimples are formed in a coating process. However, the depth of grooves or dimples to be formed in the medical guide wire It is a unit of several to several tens of micrometers, but the grooves formed in the wire core do not keep the fine grooves on the surface after the coating process. This is because it is common to form a smooth surface by depositing fine grooves by the viscosity and flow of the coating material. Therefore, when applied to the mass production process, there is a disadvantage that product realization is deteriorated.

The present invention is a method in which the fluororesin layer is rolled and dried at about 70%, and the roller is pressed. If the fluororesin layer is dried by 70%, the surface of the fluororesin layer is dried but the inside is not completely dried. Therefore, it is easy to form grooves or dimples on the coating surface, It is characterized by being smooth.

7 is a perspective view (A) and a sectional view (B) of the coating guide member 10. Fig.

7, the coating inducing member 20 is a member to be installed at the end of the coating step (2). When the wire comes out from the bath of the molten metal, the coating agent passes through the coating inducing member 20, And has a function of inducing the wire to be adsorbed well on the coating.

The coating inducing member (20) comprises: a housing (21) having a holder (22); A shrink tube 26 passing through the center of the housing 21 and gradually contracting in diameter, and a coating tube 25 forming a coating layer having a predetermined diameter.

The shrinking tube 26 has a shape in which the diameter is gradually contracted and has a function of guiding the coating liquid to be attracted to the wire well while guiding the wire to be positioned at the center while the coating liquid rises. Therefore, it has a function of guiding the coating liquid to form a circle around the wire.

Also, the shrinking tube 26 prevents the coating solution from being excessively adsorbed on the wire, and induces the excessive adsorbed coating solution to flow down to form a uniform coating layer.

The coating tube 25 is a section having a constant diameter, which stabilizes the wire coating layer and forms a uniform coating layer.

Due to the vertical transfer process (3) at a height of 3 meters or more and the coating guide member (20), a medical guidewire having a uniform coating thickness and a constant coating thickness can be manufactured.

Further, the present invention is advantageous in that the manufacturing cost is lower than that of the conventional spraying method and the continuous production can be stably performed.

1: wire feeding and leveling process, 2: preprocessing / coating process,
3: vertical transfer process, 4: preheating process,
5: heat treatment process and firing process, 6: cooling process,
7: wire winding process,
10: core material, 11: fluororesin,
20: coating inducing member, 21: housing, 22: holder,
25: coating tube, 26: shrink tube
30: horizontal groove, 31: oblique groove, 32: dimple.

Claims

In manufacturing the medical guide wire,
A wire feeding process and a leveling process (1) for feeding a wire of a metal core wound around a reel and spreading in a straight line;
A pretreatment step of smoothly coating the metal core material while removing foreign substances from the surface of the metal core material after the wire supplying step and the leveling step (1), a coating step (2) of coating the outer surface of the metal core material with fluorine resin,
After the coating step (2), a vertically moving vertical transfer step (3);
A preheating step (4) for preheating the heat treatment process after the vertical transfer process (3);
After the preheating step (4), a heat treatment step of forming a plurality of grooves (30, 31) to dimples (32) concaved in the outer circumferential surface of the fluorine resin layer after the drying of the fluorine resin and the coating layer are formed, ;
A cooling step (6) for cooling after the heat treatment step and the baking step (5);
And a wire winding step (7) of winding the completed guide wire around the reel after the cooling step (6)
In order to form a certain thickness of the fluororesin layer,
Wherein the vertical transfer step (3) is vertically transferred to a height of 3 meters or more.

The method according to claim 1,
The heat treatment step and the baking step (5)
Wherein the plurality of grooves (30, 31) to dimples (32) concaved in the outer circumferential surface of the fluororesin (11) are subjected to cold plastic forming in a state that the coated fluororesin is dried at 70%.

The method according to claim 1,
The coating guide member 20 located at the end of the coating process (2)
A housing (21) having a holder (22);
A shrinking tube (26) passing through the center of the housing (21) and contracting in diameter, and a coating tube (25) forming a coating layer with a predetermined diameter.