JPH0728562U - Guide wire - Google Patents

Abstract

(57) [Summary] [Construction] In the guide wire 11 of the present invention, a plurality of X-ray contrast members 16 provided at predetermined intervals on the tip portion 221 of the core material 12 form a substantially smooth outer surface. The X-ray contrast member 16 is covered with a synthetic resin covering member 18, and a bulge portion 30 is provided on the tip side 16 a of the X-ray contrast member 16. [Effect] Good visibility allows safe and easy passage through narrowed areas.

Description

[Detailed description of the device]

[0001]

[Industrial applications]

 The present invention relates to a guide wire used for introducing a catheter to a target site for treatment or examination.

[0002]

[Prior art]

 Conventionally, catheters have been introduced into blood vessels for examination and treatment of heart diseases and the like. When introducing such a catheter into the target site in the body, the guide wire is inserted into the catheter, and the distal end portion of the guide wire is preceded. The tip of the guide wire reaches the target site, and then the catheter is guided to the target site.

In particular, in percutaneous transluminal coronary angioplasty (PTCA), while selecting a branch of a coronary artery under fluoroscopy, it is allowed to reach a stenosis, which is a target site, and further to pass through it, and thereafter. A dilatation catheter with a balloon at the tip is placed along the guide wire, and the balloon of the dilatation catheter is positioned at the stenosis and expanded to secure the blood flow volume for treating angina and the like. In order to advance the guide wire in the desired direction of the bifurcation of the coronary artery, it is essential that the force rotated at hand is transmitted to the distal end in order to direct the distal end of the guide wire in the desired direction. In order to perform these operations, the position of the tip of the guide wire is confirmed while irradiating X-rays, and a contrast medium is intermittently injected into the coronary arteries to visually confirm the X-ray image of the coronary arteries. Therefore, the tip of the guide wire is desired to have excellent X-ray imaging properties.

Further, in order to insert the guide wire from the femoral artery and advance the aorta, the aortic arch, and the coronary artery from the ostium of the coronary artery, the pushing force of the proximal portion is transmitted to the distal portion along with the flexibility for following the blood vessel. Things and things are needed. Furthermore, it is important that the tip of the guide wire passes through the stenosis so that the balloon of the dilation catheter is positioned at the stenosis (or occlusion) and expanded.

Examples of such guide wires include those disclosed in Japanese Patent Laid-Open No. 59-77866 and Japanese Patent Laid-Open No. 2-180277. The former guide wire is one in which the tip portion of the main wire member is tapered in diameter toward the tip, and the spring member is fixed only at that portion. In the latter guide wire, the tip of the inner core is tapered and a high X-ray contrast section is provided at the tip of the taper.

[0006]

[Problems to be solved by the device]

 However, in the guide wire disclosed in Japanese Unexamined Patent Publication No. 59-77866, the spring member at the tip is exposed, and the unevenness on the surface serves as resistance to passage through the narrowed portion. Especially when the narrowed part is smaller than the outer diameter of the tip of the guide wire and there is insertion resistance due to slight irregularities on the surface, the more flexible and easier the tip is to bend, the more the insertion resistance of the spring member allows passage. It gets harder.

Further, the guide wire disclosed in Japanese Patent Laid-Open No. 2-180277 includes an annular member having a high X-ray contrast property as a high X-ray contrast part at the extreme tip of the inner core. The outer diameter of the annular member is as small as 0.20 to 0.90 mm, and since the inside of the living body is seen through, the visibility is not as high as expected.

Further, the fixation of the annular member having high X-ray contrast to the inner core is required to have a high level of safety.

The present invention has been made in view of the above problems, and an object of the present invention is to provide a safe guide wire that has good visibility and can easily pass through a narrowed portion.

[0010]

[Means for Solving the Problems]

 Such an object is to provide a core material, a plurality of annular X-ray contrast members that are provided at a predetermined interval at the tip of the core material, and are fixed in close contact with the core material, the core material and the contrast medium. A covering member made of synthetic resin that covers the member to form a substantially smooth outer surface, and a core member at the tip side of the contrast member, and prevent movement of the contrast member toward the tip side. This is achieved by a guide wire characterized by comprising a bulge.

Furthermore, a core material, a plurality of X-ray contrast members provided at predetermined intervals at the tip of the core member, and the core member and the contrast member are covered to form a substantially smooth outer surface. And a covering member made of a synthetic resin.

Further, a core member, an annular X-ray contrast member fixedly attached to the core member, a synthetic resin covering member for covering the core member and the contrast member, and the contrast member of the core member. The guide wire is characterized in that it has a bulge portion which is provided on the distal end side and prevents the contrast member from moving toward the distal end side.

Further, a core material, a plurality of annular X-ray contrast members that are fixed in close contact with the core material and are arranged in parallel at equal intervals, and a synthetic resin that covers the core material and the contrast member with substantially the same outer diameter. A covering member and a fixing member which is provided on the tip side of the contrast member of the core member and is formed by melting the core member, and which prevents the contrast member from moving toward the tip side. Is achieved by a guide wire.

Further, a NiTi core material, an annular X-ray contrast member fixedly attached to the tip of the core material, and a synthetic resin coating for covering the core material and the contrast member with substantially the same outer diameter. A member, a water-lubricating coating layer that covers the surface of the covering member, and a fixing member that is integrally formed of the same material as the core material and has a diameter larger than the inner diameter of the annular contrast member. Achieved by featuring a guide wire.

Further, a superelastic core material, a coil-shaped X-ray contrast member fixed to the tip of the core material, a synthetic resin covering member for covering the core material and the contrast member, and a covering member for the covering member. This is achieved by a guide wire comprising a water-lubricating coating layer covering the surface and a fixing member having a diameter larger than the inner diameter of the coil-shaped contrast member.

The core material preferably includes a tip portion, a transition portion, and a body portion. It is preferable that X-ray contrast members are provided at the tip portion at a predetermined interval and have a substantially uniform outer diameter. Since the tip has a substantially uniform outer diameter, it has almost the same flexibility in the axial direction. The tip is the most flexible part compared to the transition and the body. The transitional portion is a portion whose diameter decreases from the base end toward the tip end. Tapered diameter at a constant rate (which can also be called a taper portion), diameter that changes in small steps, or bending of the tip and body due to a synthetic resin covering member described later. Any structure may be used as long as it does not cause a sudden change in the physical properties of the rigidity of the tip portion and the main body portion, such as the ease of continuous or stepwise transition. By providing the transitional portion, there is no possibility of bending (kinking) without local concentration of stress. The body portion is a portion that extends toward the base end side of the transition portion and is thicker than the tip end portion. This is to transmit the torque applied at hand or the axial force (pushing force) applied at hand to insert the guide wire to the tip part to the maximum.

It is preferable that a bulging portion is provided at the tip of the core member on the tip side of the contrast member. The bulging portion prevents movement of the contrast member, and particularly prevents movement of the contrast member on the distal end side. The bulging portion is preferably fixed to the annular contrast member. As a fixing method, in addition to brazing or an adhesive, the metallic annular contrast member itself may be melted and fixed. The contrast member may be in close contact with the core material or may be spaced, but it is sufficient if the diameter of the bulging portion is such that the contrast member can be prevented from moving toward the distal end side of the guide wire. If the contrast member has an annular shape, it may have a diameter larger than its inner diameter. The shape of the bulging portion may be spherical, bullet-shaped, hemispherical, spindle-shaped, or the like. The bulging portion is formed by fixing the contrast member at the tip of the core material and then melting the core material on the tip side of the contrast member to form a predetermined shape, or by forming the bulging portion having a predetermined shape into the core material. There is a method of fixing to the tip, but since the bulging part and the core material are made of the same material and integrated, a method of melting the tip of the core material is preferable.

Although each size of the core material differs depending on the use of the guide wire, the case of a PTCA guide wire including a distal end portion, a transition portion, and a main body portion will be exemplified below. The outer diameter of the tip portion is 0.06 to 0.10 mm, the length is 10 to 50 mm, and the length of the transition portion is 50 to 600 mm. The main body has an outer diameter of 0.26 to 0.50 mm and a length of 1000 to 3000 mm.

The core material may be composed of a tip transition portion and a main body portion. In this case, since the tip transition portion is provided continuously from the main body portion, the outer diameter is tapered from the same outer diameter as the outer diameter of the main body portion having a constant outer diameter toward the tip. The X-ray contrast member is provided at the tip transition portion with a predetermined interval. In addition, the core material may have a constant outer diameter from the front end to the base end. When the bulging part is provided, it is provided on the tip side of the tip transition part.

It is preferable that a plurality of X-ray contrast members are provided from the tip of the tip of the core member. In this case, the number is not limited to a plurality, but it is desirable that two to seven are provided. The plurality of X-ray contrast members provided have a predetermined interval. The predetermined interval includes, in addition to a constant interval, an interval provided according to a predetermined standard, for example, an interval that becomes narrower or wider at a constant rate as it goes toward the tip end of the guide wire. The narrower the interval, the narrower the interval at which the X-ray contrast member is provided at the tip, and the visibility of the tip portion of the guide wire is improved. When the interval is widened at a constant rate, the flexibility of the tip portion of the core material is not hindered by the X-ray contrast member, and the flexibility of the tip portion of the guide wire increases as it goes to the tip. Moreover, since the length of the X-ray contrast member in the axial direction of the guide wire is constant, the size of the stenosis site of the blood vessel can be easily measured. By shortening the axial length toward the tip, the flexibility of the tip of the guide wire is increased, and the vessel wall is not damaged when the vessel is inserted.

The X-ray contrast member is an annular member such as a coil (or a spring) or a pipe, and a method of plating a metal X-ray opaque material on a core or a fine particle X-ray contrast agent. Any material may be used as long as the tip of the guide wire can be easily seen when the guide wire is used under X-ray fluoroscopy, such as a resin mixed in a high ratio.

In the case of an annular X-ray contrast member, the bulging portion is provided on the tip side of the provided contrast member, but it is preferable that the contrast member and the bulging portion abut on the side surface. By abutting, the contrast member is securely fixed.

The outer diameter of the X-ray contrast member is not particularly limited as long as it satisfies the operability of the guide wire and the X-ray contrast property, but the larger the outer diameter of the contrast member, the better the X-ray contrast property. Further, the outer diameter of the projection member is equal to or smaller than the thickest portion of the outer diameter of the core member, so that torque transmission becomes easy. In the case of the core material having the three parts of the tip portion, the transition portion, and the main body portion as described above, the outer diameter of the contrast member is the same or smaller than the outer diameter of the main body portion having the largest outer diameter.

Further, depending on the configuration of the contrast member, the flexibility of the tip portion of the guide wire can be maintained as the outer diameter (and thickness) of the contrast member is smaller. Since the plurality of X-ray contrast members have the same outer diameter, the flexibility of the guide wire in the portion where the contrast member is provided is constant in the axial direction. Further, by decreasing the outer diameter of the contrast member toward the tip, the flexibility in the tip direction is increased. In addition, considering both flexibility and X-ray visibility of the tip of the guide wire, the outer diameter increases toward the tip, and contrast members with a short length are provided at regular intervals, and the comparative outer diameter is reduced. This can be achieved by sparsely enlarging large contrast members in the distal direction and densely in the proximal direction. Further, it is possible to provide a coil-shaped contrast member that relatively follows the bending of the core member on the tip side.

The covering member made of synthetic resin is intended to cover the core material and the X-ray contrast member to form a substantially smooth outer surface. The outer diameter of the guide wire covered by the covering member is almost uniform from the distal end to the proximal end, but the outer diameter of the guide wire is larger than that of other parts in order to pass through the narrowed part of the blood vessel and to insert into a fine blood vessel. By making the diameter smaller, it becomes easier to insert microvessels due to the smaller diameter, and the flexibility of the tip portion increases.

The covering member is made of synthetic resin because of its ease of coating and ease of treatment of the outer surface described later. The synthetic resin covering member is so flexible that it does not hinder the bending of the core material, and the outer surface is a smooth surface with substantially no unevenness. Further, it is also possible to mix a fine powdery X-ray contrast substance into the synthetic resin forming the synthetic resin covering member. Fine powder X-ray contrast materials include tungsten, bismuth, barium and the like. By covering a part or all of the surface of the core material with the synthetic resin covering member containing the X-ray contrast material, the whole or a part of the guide wire can be visually recognized. In particular, the visibility is further improved by applying the synthetic resin covering member containing the X-ray contrast material to the tip portion of the guide wire.

Further, the synthetic resin covering member may change the flexibility of the covering member according to the flexibility of the core material. That is, the material is changed according to the respective parts of the core material having the tip portion, the transition portion and the main body portion. As an example, the tip may be inserted into a blood vessel and may come into contact with the vessel wall, so the most flexible material should be selected, and the body should be made more rigid to reinforce the torsional and bending rigidity of the core itself. Select a material with high It is possible to select a material having intermediate rigidity for the transition portion. Further, it is possible to change two kinds of resins having different rigidity gradually or continuously so that the distribution of the resin having lower rigidity increases as it goes to the tip.

Further, the covering member made of synthetic resin may be composed of two or more layers. For example, the main body of the core material is coated with a resin having a relatively high rigidity such as polyimide to give rigidity, and the outer layer of the resin layer has many reactive groups so that a lubricating substance described later can be easily fixed. Is provided to fix a lubricating substance such as a hydrophilic material to the resin layer. Also, in order to improve the adhesiveness between the super elastic wire and the resin and improve the torque transmission, an adhesive resin such as an ionomer is used as the inner layer, and the outer layer is fixed with the above-mentioned lubricating substance having many reactive groups. It is also possible to provide a layer for. In addition, a low friction resin may be provided on the outside of the covering member. Fluorocarbon resin is a typical low friction resin.

The X-ray contrast member of the guide wire of the present invention is a high X-ray contrast material, that is, an X-ray opaque substance, and also platinum, silver, bismuth, tungsten, or an alloy of two or more of these ( Examples thereof include platinum-tungsten) and alloys with other metals (eg, gold-iridium, platinum-iridium). The surface of the contrast member 6 may be plated with another material.

There is no limitation on the material of the core material as long as it is a material that has appropriate flexibility with blood vessel followability, can transmit torque to the tip, and has rigidity that transmits pushing force at hand to the tip. However, stainless steel, super elastic metal, amorphous metal and the like can be mentioned. Among them, a superelastic metal wire having superelastic characteristics is preferable. The superelastic metal wire is a Ni-Ti alloy, a Cu-Zn-X alloy (X = Be, Si, Sn, Al, Ga) or a Ni-Al alloy, preferably a Ni-Ti alloy. It should be noted that a Ni-Ti alloy that does not have superelasticity properties so much as to increase the flexibility property may be used.

When the core material is a Ni—Ti alloy superelastic wire, the physical properties such as rigidity may be changed between the main body and the tip. In particular, it is preferable that the main body has physical properties with good torque transmission. In the stress-strain curve of the Ni-Ti alloy superelasticity line, the property that the torque transmission is good is that the substantially linear stress-strain line in the elastic region is the angle at the transformation start stress point where the martensite phase is stress-induced. Is changed to become a substantially straight line after that. Furthermore, if the main body is a work-hardened Ni-Ti alloy wire, the middle portion is a Ni-Ti alloy superelastic wire, and the tip is a plastically deformable Ni-Ti alloy wire, the main body has high rigidity and pushability. Is good, the main body has excellent followability of a curved blood vessel and torque transmission, and the tip can be changed to a desired tip shape to facilitate insertion. Polyurethane, polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polystyrene, fluorine resin, silicone or their respective elastomers (eg polyester elastomer) and their composite materials are suitable as materials for the synthetic resin covering member. Can be used.

It is preferable that the surface of the synthetic resin coating material has a lubricity coating layer which becomes a low friction surface by containing water when wet. When inserting a curved or meandering blood vessel, selecting a blood vessel that branches at an acute angle and inserting it, or inserting a catheter along the indwelling guide wire, the lubricous coating layer can be used. It reduces friction with the inner wall and the inner wall of the catheter, improving pushability.

Further, the hydrophilic lubricating layer is preferably a copolymer of a hydrophilic compound and a hydrophobic compound. Further, it is desirable that the block copolymer is a hydrophilic compound and a hydrophobic compound. Examples of such block copolymers of hydrophilic compound and hydrophobic compound include polyglycidyl methacrylate (PGMA) -dimethylacrylamide (DMAA), methacrylic acid chloride DMAA, methacryloyloxyethyl isocyanate-DMAA, polyglycidyl acrylate-maleic anhydride. Etc. The hydrophobic compound reacts with the coating member as the base material, and the hydrophilic compound swells with water to realize low friction.

[0034]

【Example】

 An embodiment of the guide wire of the present invention will be described with reference to the drawings. 1 is a sectional view showing a first embodiment of a guide wire according to the present invention, and FIG. 2 is a sectional view showing a second embodiment of a guide wire according to the present invention. FIG. 3 is a sectional view showing a third embodiment of the guide wire according to the present invention.

As shown in FIG. 1, a guide wire 1 according to a first embodiment of the present invention includes a core material 2 and a plurality of X-ray contrast members 6 provided at a tip end portion 21 of the core material 2 at predetermined intervals. And a core member 2 and a synthetic resin covering member 8 for covering the contrast member 6 to form a substantially smooth outer surface.

The guide wire 1 of the present invention has a total length of 180 cm and an outer diameter of 0.35 mm. The total length of the guide wire 1 can be applied in the range of 80 to 500 cm, and the outer diameter is different depending on its use, but in PTCA, it is preferably 0.5 mm or less.

The core material 2 includes a tip portion 21, a transition portion 23, and a body portion 25. The tip portion 21 has a substantially uniform outer diameter and has substantially the same flexibility, and is the portion having the highest flexibility as compared with the transition portion 23 and the main body portion 25 described later. The outer diameter of the tip portion 21 of the core material 2 is about 0. The length is 08 mm and the length is 20 mm. The transitional portion 23 is a portion whose diameter is reduced from the base end toward the distal end, and in this embodiment, the transitional portion 23 is tapered in diameter at a constant rate, and can also be referred to as a tapered portion. The length of the transition part 23 is 300 mm. By having the transition portion 23, the flexibility (flexibility) of the body portion 25 and the tip portion 21 having different outer diameters can be increased toward the tip, that is, can be made softer, and the bendability changes abruptly. The flexibility increases continuously as it goes to the tip, and it does not bend locally (kink). The main body portion 25 is a portion extending toward the base end side of the transition portion 23, and the outer diameter thereof is substantially uniform and is 0.30 mm and the length is about 1500 mm. The body portion 25 is thicker than the tip portion 21. This is because the torque applied at hand and the axial force (pushing force) applied at hand for inserting the guide wire 1 are transmitted to the distal end portion 21.

The tip portion 21, the transition portion 23, and the main body portion 25 of the core material 2 are an integrated body made of the same material. It is preferable that it is a one-piece product because it does not break, come off, or break. Such a core material 2 is made of a super elastic metal wire and is a Ni—Ti alloy wire. Since it is a superelastic alloy wire, it does not have a bending tendency, and even if torque is applied with a tortuous blood vessel inserted, its force is smoothly transmitted to the tip and torque transmission is excellent.

A plurality of X-ray contrast members 6 are provided on the tip portion 21 of the core material 2 at predetermined intervals. Five X-ray contrast members 6 are provided at regular intervals from the tip of the tip portion 21 of the core material 2. By providing a plurality of guide wires 1, the X-ray contrast property of the distal end portion of the guide wire 1 is enhanced, the branching of blood vessels is facilitated, and the procedure is quick and easy.

Since the contrast members 6 are provided at regular intervals, the size of the constriction or the like can be recognized through the intervals of the X-ray contrast member 6 under X-ray contrast. The contrast member 6 is composed of a coil 6a. The coil 6a is wound substantially in close contact with a length of about 1 mm, and the interval between the coils 6a is about 4 mm. By being a coil, when the guide wire 1 at the tip 21 of the core material 2 bends, the guide wire 1 at the tip 21 does not bend at the boundary between the portion with the coil and the portion without the coil, and the entire guide wire 1 at the tip 21 is smooth. You will draw a curve. Further, since the coil is a coil, the inner diameter of the coil can be changed even if the outer diameter of the distal end portion 21 is slightly varied in the manufacturing process, so that the coil can be fixed at a constant interval. As for this coil, a method in which a preformed coil is inserted from the tip of the tip portion 21 or a method in which a linear wire is wound around the core 2 and cut is considered. The coil 6a is closely wound, but may be loosely wound. Further, although the coil 6a is directly wound around the core material 2, it may be fixed to the core material 2 via an interposer. By interposing an interposer, the outer diameter of the coil 6a becomes large and the position of the coil 6a becomes easy to see under fluoroscopy. The interposer may be the same or different synthetic resin as the covering member 8. The same coil as the coil 6a, that is, the coil may be double wound.

The contrast member 6 is a gold coil 6a. Gold has a high X-ray opacity, that is, it is excellent as a material having a high image forming property.

The synthetic resin covering member 8 covers the core member 2 and the X-ray contrast member 6 so as to form a substantially smooth outer surface. The outer diameter of the guide wire 1 covered with the covering member 8 is substantially uniform from the distal end to the proximal end. The covering member 8 is made of synthetic resin because of its easy coating and easy treatment of the outer surface, which will be described later. The covering member 8 is flexible enough not to hinder the bending of the core material 2, and the outer surface is substantially uneven. There is no smooth surface. As a synthetic resin, a thermoplastic resin is preferable because of its simple production. Polyurethane is used as the covering member 8 of the guide wire 1.

Further, the synthetic resin forming the synthetic resin covering member 8 contains 45% by weight of tungsten as an X-ray contrast substance. By covering the surface of the core material 2 with the covering member 8 made of synthetic resin containing an X-ray contrast material, the whole or a part of the guide wire can be visually recognized.

A lubricating substance (not shown) is fixed to the outer surface of the synthetic resin covering member 8. If the entire outer surface of the covering member 8 is improved in slidability with the lumen in the catheter, considering the difficulty of handling due to the slipperiness of the proximal portion, the lubricating substance is fixed only in the distal end portion. May be. Further, the lubricity may be changed stepwise or continuously from the front end to the base end.

Examples of the lubricating substance include hydrophilic and water-soluble polymer substances or derivatives thereof. Further, the lubricious substance is a lubricious coating layer that becomes a low friction surface by containing water when wet. The lubricating substance is fixed to the outer surface of the synthetic resin coating member 8 by covalent bond or ionic bond. This lubricating material is, in principle, a polymer material that is chain-like and has no cross-linking, and is -OH, -CONH.₂ , -COOH, -NH₂ , -COO^- , -SO ^3 - It has a hydrophilic group such as. By fixing the lubricating substance to the synthetic resin covering member 8 which is the outer surface of the guide wire 1, the friction between the inner wall of the catheter or the blood vessel and the outer surface of the guide wire is reduced. The reduced friction improves the slidability of the guide wire. The pushing force in the axial direction of the guide wire at hand is transmitted to the distal end with little resistance even in a catheter inserted through a curved blood vessel. The rotation at hand is transmitted to the tip of the guide wire 1 at a ratio of 1: 1. Furthermore, when a lubricating substance is fixed to the distal end portion 4 of the guide wire 1, insertion into a desired branch at the branch point of a blood vessel and passage through a narrowed blood vessel are facilitated. Even if it is hydrophobic, it can be used as a covering member as long as it has lubricity like silicone.

As such a lubricating substance, there are natural water-soluble polymer substances and synthetic water-soluble polymer substances. In the natural system, a starch system such as carboxymethyl starch, a cellulosic system such as carboxymethyl cellulose, a chitosan, etc. Examples include proteins such as polysaccharides and gelatin. Examples of the synthetic system include polyvinyl alcohol, polyalkylene glycol such as polyethylene glycol, and maleic anhydride such as methyl vinyl ether-maleic anhydride copolymer. Further, silicone can be used as the hydrophobic lubricating substance. In the guide wire 1, a maleic anhydride-based material is fixed to the covering member 8 as a hydrophilic lubricant.

On the outer surface of the synthetic resin coating member 8, an anticoagulant such as heparin or urokinase, or a silicone rubber, a block copolymer of urethane and silicone, a hydroxyethylmethacrylate-styrene copolymer or the like is used. A thrombotic material may be coated.

FIG. 2 is a sectional view showing a second embodiment of the guide wire of the present invention. The guide wire 10 shown in FIG. 2 covers a core material 12, a plurality of X-ray contrast members 16 provided at a front end portion 121 of the core member 12 at predetermined intervals, and covers the core member 12 and the X-ray contrast member 16. And a synthetic resin covering member 18 that forms a substantially smooth outer surface.

The difference from the guide wire 1 shown in FIG. 1 will be mainly described in that the contrast member 16 is a tubular member, that is, a short pipe shape. Five contrast members 16 are provided on the tip portion 21 of the core material 2 at regular intervals. The X-ray contrast member 16 has a constant interval. Since the intervals are constant, the size of the stenosis or the like can be recognized under the X-ray contrast through the intervals of the X-ray contrast member 16.

The X-ray contrast member 16 is composed of the pipe 16a as described above, and the material thereof is gold, which has a high X-ray contrast property. The pipes 16a have a length of about 1 mm, and the intervals between the pipes 16a are about 4 mm. Although the pipe 16a is directly wound around the core material 12, it may be fixed to the core material 12 via an interposer. The diameter of the pipe 16a increases due to the inclusion of the interposer so that the position of the pipe 16a can be easily seen under X-ray fluoroscopy. The interposer may be a synthetic resin that is the same as or different from the covering member 18, or may be a radiopaque coil.

FIG. 3 is a cross-sectional view showing a third embodiment of the guide wire of the present invention. The guide wire 11 shown in FIG. 3 is provided between the core material 12 and the tip portion 221 of the core material 12 at a predetermined interval, and the plurality of annular X-ray contrast members 1 fixed to the core material 12 in close contact with each other. 6, a synthetic resin covering member 18 for covering the core material 12 and the contrast member 16 to form a substantially smooth outer surface, and the core member 12 on the tip side 16a of the contrast member. It is composed of a bulging portion 30 that prevents the movement of 16 toward the tip side 16a.

Further, the guide wire 11 includes the core material 12, the annular X-ray contrast member 16 that is fixed in close contact with the tip portion 221 of the core material 12, and the synthetic resin that covers the core material 12 and the contrast member 16. The manufacturing cover member 18 and the bulging portion 30 which is provided on the tip side 16a of the contrast member 16 of the core material 12 and prevents the contrast member 16 from moving toward the tip side 16a.

The total length of the guide wire of the present invention can be applied in the range of 80 to 500 cm, and the outer diameter varies depending on its use, but it is about 1.0 to 0.5 mm for angiography and 0 for PTCA. It is preferably 0.5 mm or less. The guide wire 11 of the third embodiment has a total length of 150 cm and an outer diameter of 0.35 mm.

The core material 2 includes a tip portion 221, a transition portion 223, and a body portion 225. Further, a bulge portion 30 is provided at the tip of the tip portion 221 as a fixing means of the contrast member 16. The tip portion 221 has a substantially uniform outer diameter, has substantially the same flexibility, and is the most flexible portion as compared with the transitional portion 223 and the main body portion 225, which will be described later. The outer diameter of the tip portion 221 of the core material 2 is about 0.08 mm, and the length is 20 mm. The transitional portion 223 is a portion whose diameter is reduced from the base end toward the distal end, and in this embodiment, the transitional portion 223 is tapered at a constant rate, and can also be referred to as a tapered portion. The length of the transition part 223 is 300 mm. By including the transition portion 223, the flexibility (flexibility) of the main body 225 and the tip 221 having different outer diameters can be increased toward the tip, that is, the flexibility can be made softer and the flexibility can be changed rapidly. The flexibility increases continuously as it goes to the tip, and there is no local bending (kink). The main body portion 225 is a portion extending toward the base end side of the transition portion 223, and the outer diameter thereof is substantially uniform and is 0.30 mm and the length is about 1500 mm. The body portion 25 is thicker than the tip portion 21. This is for transmitting the torque applied at hand and the axial force (pushing force) applied at hand for inserting the guide wire 1 to the distal end portion 21.

The bulging portion 30, the tip portion 221, the transition portion 223, and the main body portion 225 of the core material 2 are an integral body of the same material. It is preferable that it is a one-piece product because it does not break and does not come off or break. Such a core material 2 is made of a super elastic metal wire and is a Ni—Ti alloy wire. Since it is a superelastic alloy wire, it does not have a bending tendency, and even if torque is applied with a tortuous blood vessel inserted, its force is smoothly transmitted to the tip and torque transmission is excellent. A plurality of X-ray contrast members 16 are provided at a predetermined interval on the tip portion 221 of the core material 12. Five X-ray contrast members 16 are provided at regular intervals from the tip of the tip portion 221 of the core material 2. By providing a plurality of X-rays, the X-ray contrast property of the distal end portion of the guide wire 11 is enhanced, the branching of blood vessels is facilitated, and the procedure is quick and easy.

Since the contrast members 16 are provided at regular intervals, the size of the stenosis or the like can be recognized through the intervals between the X-ray contrast members 16 under X-ray contrast. The X-ray contrast member 16 has an annular shape and is composed of a pipe 16a, and is a material having a high X-ray contrast property. The pipes 16a have a length of about 1 mm, and the intervals between the pipes 16a are about 4 mm. Although the pipe 16a is fixed in close contact with the core material 12, it may be fixed to the core material 12 via an interposer. Since the pipe 16 having a large outer diameter can be used by interposing the interposer, the position of the pipe 16a can be easily seen under fluoroscopy. The interposer may be a synthetic resin which is the same as or different from that of the covering member 18, and may be an X-ray opaque coil. The contrast member 16 is a platinum pipe 16a. Platinum has high X-ray opacity, that is, it is excellent as having high contrast.

A bulging portion 30 is provided following the tip portion 221 of the core material 12 on the tip side 16 a of the contrast member 16 at the tip. The bulging portion 30 is formed into a spherical shape by inserting the contrast member 16 into the tip portion 221 of the core member 12 and then melting the portion protruding from the contrast member 16 with heat. The diameter of the bulging portion 30 is larger than the inner diameter of the contrast member 16 and equal to or smaller than the outer diameter. The contrast member 16 and the core member 12 are fixed by an adhesive. It is preferable to apply an adhesive to the portion 30a where the tip side 16a of the contrast member 16 and the bulging portion 30 are in contact with each other because the adhesive area is increased.

The synthetic resin covering member 18 covers the core member 12 and the X-ray contrast member 16 so as to form a substantially smooth outer surface. The outer diameter of the guide wire 11 covered with the covering member 18 is substantially uniform from the distal end to the proximal end. The covering member 18 is made of synthetic resin because of its ease of covering and ease of treatment of the outer surface to be described later, and is flexible enough not to hinder the bending of the core material 12, and the outer surface is substantially uneven. It has no smooth surface. As the synthetic resin, a thermoplastic resin is preferable because of its easy production. A modified polyolefin (trade name: Bondine) is used as the covering member 18 of the guide wire 11. The raw material of the coating member 18 is melted and extruded together with the core material 12 to closely coat the core material 12.

Further, the synthetic resin forming the synthetic resin covering member 18 contains about 45% by weight of tungsten as an X-ray contrast material. By covering the surface of the core material 12 with the covering member 18 made of a synthetic resin containing an X-ray contrast material, the whole or a part of the guide wire can be visually recognized.

A lubricating substance (not shown) is fixed to the outer surface of the synthetic resin covering member 18. If the entire outer surface of the covering member 18 is improved in slidability with the lumen in the catheter, considering the difficulty of handling due to the slipperiness of the proximal portion, only the tip portion has the lubricating substance fixed. Is also good. Further, the lubricity may be changed stepwise or continuously from the tip end to the base end.

The lubricating substance is a block copolymer of polyglycidyl methacrylate (PGMA) -dimethylacrylamide (DMAA), which is a block copolymer of a hydrophilic compound and a hydrophobic compound. The hydrophilic compound increases lubricity, and the hydrophobic compound reacts with the substrate to immobilize the hydrophilic compound. If a block copolymer of a hydrophilic compound and a hydrophobic compound is used, thrombus is unlikely to adhere. Further, the outer surface of the synthetic resin coating member 18 is coated with heparin as an anticoagulant.

[0062]

[Action]

 The operation of the guide wire of the present invention will be described using PTCA. First, the guiding catheter is advanced through the aorta to the ostium of the coronary artery, and in order to confirm the target site of the coronary artery with the stenosis, a contrast medium is discharged from the tip of the guiding catheter to perform coronary angiography. Next, the guide wire of the present invention is inserted into the guide wire lumen of the dilatation catheter having the balloon for dilating the stenosis at the front end, and the dilatation catheter with the guide wire inserted is guided. Insert into the catheter. When the tip of the guiding catheter is reached, stop the insertion of the dilatation catheter and push it into the coronary artery while appropriately shaping only the guide wire. In the guide wire of the present invention, a plurality of X-ray contrast members are provided at the tip of the core member at predetermined intervals, so that the tip end of the guide wire can be easily confirmed under X-ray contrast. Also, because it has a synthetic resin covering member that forms a substantially smooth outer surface, the angle rotated when twisting by hand to change the direction of the tip of the guide wire as described above. The ability to turn the tip as it is (torque transmission) is further improved. In the present embodiment, since the outer surface of the synthetic resin coating member is lubricated by the hydrophilic coating, the torque transmission property is excellent, and the choice in the branching of the blood vessel can be performed freely.

The guide wire reaches the narrowed portion and further passes through it. At this time, the covering member and the hydrophilic coating described above allow passage even when the narrowed portion is very narrow. In addition, it becomes possible to measure the length and thickness of the stenosis using a plurality of X-ray contrast members in a state where the X-ray contrast members are passed, and the balloon size for dilation can be selected.

Next, push the dilatation catheter forward along the guide wire, confirm that the balloon of the dilatation catheter is in the center of the stenosis, and inject the contrast agent into the balloon and pressurize it to dilate it. Expand the stenosis. The guidewire of the present invention has a substantially smooth outer surface after the dilatation is completed or when the dilatation catheter is withdrawn to replace it with another dilatation catheter and the guidewire is also retracted from the target site. Since it has a synthetic resin covering member that forms a wire, the spring stretches by catching the narrowed portion like a guide wire with an exposed spring, and in the worst case, the guide wire cannot be pulled out. The situation cannot occur and can be removed without unnecessary consideration.

In addition to the PTCA, the guide wire of the present invention can be used for angiography of the brain, abdomen, etc. and insertion of a catheter for treatment.

[0066]

[Effect of device]

The present invention provides a core material, a plurality of annular X-ray contrast members which are provided at a predetermined interval at the tip of the core material, and which are closely fixed to the core material, the core material and the contrast member. It has a synthetic resin covering member that covers the outer surface to form a substantially smooth outer surface, and the core member on the front end side of the contrast member to prevent movement of the contrast member toward the front end side. The guide wire is characterized in that it is formed of a swelling portion, and thus has good visibility and can easily pass through the narrowed portion. Further, it becomes possible to measure the size of the narrowed portion. Further, the synthetic resin covering member to form a bulged portion and substantially smooth outer surface of the core material ensures safety and ease of insertion and removal of the stenosis. The uniform outer diameter of the synthetic resin covering member, that is, the outer diameter of the guide wire improves the safety and easiness thereof.

When the core material is a superelastic alloy, torque can be easily transmitted and the tip of the guide wire can be smoothly rotated.

Further, a core material, an annular X-ray contrast member that is fixed in close contact with the core material, a synthetic resin coating member that covers the core material and the contrast member, and the contrast member of the core material. The guide wire has a bulging part that is provided on the distal end side of the contrast member and prevents the contrast member from moving toward the distal end side, so it has good visibility and can easily pass through the narrowed part. it can. Furthermore, it is possible to measure the size of the narrowed portion. In addition, the synthetic resin covering member forming the substantially smooth outer surface guarantees the safety and ease of inserting and removing the narrowed portion. The uniform outer diameter of the synthetic resin covering member, that is, the outer diameter of the guide wire improves the safety and easiness thereof.

When a plurality of X-ray contrast members are provided at regular intervals, it is possible to easily perform measurement while viewing the X-ray image. Also, if the core material is a super elastic wire, it does not tend to bend, and the tip can be rotated as it is when the guide wire is twisted and rotated to change the direction of the tip.

[Brief description of drawings]

FIG. 1 is a sectional view showing a first embodiment of a guide wire according to the present invention.

FIG. 2 is a sectional view showing a second embodiment of the guide wire of the present invention.

FIG. 3 is a sectional view showing a third embodiment of the guide wire of the present invention.

[Explanation of symbols]

 Guide wire 1, 10, 100 Core material 2, 12 Tip portion 21, 121, 221 X-ray contrast member 6 16 Synthetic resin covering member 8 18 Swelling portion 30

Claims (1)

[Scope of utility model registration request] 1. A core material, and a plurality of annular Xs provided at a predetermined interval at the tip of the core material and fixed in close contact with the core material.
A line contrast member, a covering member made of synthetic resin for covering the core member and the contrast member to form a substantially smooth outer surface, and a tip end side of the contrast member of the core member. A guide wire comprising a bulging portion that prevents the member from moving toward the distal end side.