JP2006175241A - Guide wire - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a guide wire having good visibility and safely and easily passing through a narrow part. <P>SOLUTION: In this guide wire 11, a plurality of X-ray contrast medium members 16 provided at predetermined spaces on a tip 221 of a core material 12 are covered with a synthetic resin-made covering member 18 forming a substantially smooth outer surface, and the tip 16a of each X-ray contrast medium member 16 is provided with a bulge part 30. The core material is composed of the tip part 221, a transition part 223 and a body part 225. The bulge part 30 is provided as a fixing means for the contrast medium member 16 at the foremost part of the tip part 221. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

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

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

  In particular, in percutaneous transluminal coronary angioplasty (PTCA), a branch of the coronary artery is selected under fluoroscopy, reaching the stenosis that is the target site, passing further, and then a balloon at the tip The dilatation catheter provided with is placed along the guide wire, the balloon of the dilatation catheter is positioned in the stenosis, and is expanded to ensure blood flow to treat angina or the like. In order to advance the guide wire in the desired direction of the branch portion of the coronary artery, it is important that the force rotated at hand is transmitted to the tip in order to direct the tip 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 artery to visually check the X-ray image of the coronary artery. Therefore, the tip of the guide wire is desired to have excellent X-ray contrast properties.

  Furthermore, in order to insert a guide wire from the femoral artery and advance it from the aorta, aortic arch, coronary artery mouth to the coronary artery, the pushing force of the hand part is transmitted to the tip part together with the flexibility to follow the blood vessel. Necessary. Furthermore, in order for the balloon of the dilatation catheter to be positioned at the stenosis (or occlusion) and expanded, it is important that the tip of the guide wire passes through the stenosis.

As such a guide wire, a guide wire is known in which the distal end portion of the main wire member is tapered toward the distal end and a spring member is fixed only to that portion (see Patent Document 1). Also, a guide wire is known in which the tip of the inner core is tapered and a high X-ray contrast portion is provided at the forefront (see Patent Document 2).
JP 59-77866 A JP-A-2-180277

  However, in the guide wire disclosed in Patent Document 1 described above, the spring member at the tip is exposed, and the unevenness on the surface becomes resistance to passage through the constriction. In particular, when the constriction is smaller than the outer diameter of the guide wire tip and narrow, there is insertion resistance due to slight unevenness on the surface, and the more the tip is very flexible and easier to bend, the more the passage is caused by the insertion resistance of the spring member. It becomes difficult.

  Moreover, although the guide wire shown by patent document 2 is equipped with the annular member which has high X-ray contrast property as the most advanced high X-ray contrast part of an inner core, in such an annular member, a front-end | tip outer diameter Is as small as 0.20 to 0.90 mm, and the inside of the living body is seen through, so the visibility is not so high.

  Furthermore, the fixation of the annular member having high X-ray contrast properties to the inner core continues to require a high level of safety.

  The present invention has been made in view of such 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.

Such an object is achieved by the present inventions (1) to (8) below.
(1) a core material;
A plurality of X-ray contrast members provided at predetermined intervals on the tip of the core material;
A guide wire comprising the core material and a synthetic resin covering member that covers the contrast member to form a substantially smooth outer surface.

(2) The guide according to (1), wherein the plurality of X-ray contrast members are provided so that a distance between the plurality of X-ray contrast members becomes narrower or wider at a constant rate as it goes in a distal direction of the core member. wire.

(3) The guide wire according to (1), wherein an outer diameter of the contrast member is smaller toward the tip.

(4) The guide wire according to (1), wherein an outer diameter of the contrast member increases toward the tip.

(5) The guide wire as set forth in (1), wherein the synthetic resin covering member changes in lubricity stepwise or continuously from the distal end to the proximal end.

(6) The guide wire according to (1), wherein the X-ray contrast member is fixed to the core member via an intervening material.

(7) The guide wire according to (6), wherein the interstitial material is the same or different synthetic resin as the synthetic resin covering member.

(8) a core material;
A plurality of X-ray contrast members provided at predetermined intervals on the tip of the core material;
A guide wire comprising: a part of the core material; and a synthetic resin covering member that covers the contrast member to form a substantially smooth outer surface.

  The guide wire according to the present invention has good visibility and can easily pass through the narrowed portion. Furthermore, the size of the constriction can be measured. Further, the synthetic resin covering member that forms a substantially smooth outer surface with the bulging portion of the core material ensures the safety and ease of insertion and removal of the narrowed portion.

  Hereinafter, although the best form for implementing the guide wire which concerns on this invention is demonstrated with reference to drawings, this invention is not limited to the following forms.

  As a guide wire according to an embodiment of the present invention, a core material, a plurality of annular X-ray contrast members provided at predetermined intervals at the tip of the core material and fixed in close contact with the core material, A synthetic resin covering member that covers the core member and the contrast member to form a substantially smooth outer surface; and a distal end side of the contrast member; It consists of the bulging part which prevents the movement to.

  Furthermore, as a guide wire of another embodiment, a core material, a plurality of X-ray contrast members provided at a predetermined interval at the tip of the core material, and the core material and the contrast member are substantially covered. And a synthetic resin covering member that forms a smooth outer surface.

  A core material; an annular X-ray contrast member fixed in close contact with the core material; a synthetic resin coating member covering the core material and the contrast member; and a distal end side of the contrast member of the core material And has a bulging portion for preventing the contrast member from moving toward the distal end side.

  Furthermore, a core material, a plurality of annular X-ray contrast members arranged in parallel at equal intervals fixed in close contact with the core material, and a synthetic resin coating member that covers the core material and the contrast member with substantially the same outer diameter And a fixing member that is formed by melting the core material and prevents the contrast member from moving toward the distal end side.

  A NiTi core material; an annular X-ray contrast member fixed in close contact with the tip of the core material; a synthetic resin coating member that covers the core material and the contrast member to substantially the same outer diameter; A water-lubricating coating layer covering the surface of the coating member and a fixing member formed integrally with the core material and having a diameter larger than the inner diameter of the annular contrast member.

  Furthermore, a superelastic core material, a coiled X-ray contrast member fixed to the tip of the core material, a synthetic resin coating member that covers the core material and the contrast member, and a surface of the coating member are covered. It consists of a water-lubricating coating layer and a fixing member having a diameter larger than the inner diameter of the coiled contrast member.

  The core material is preferably composed of a tip portion, a transition portion, and a main 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 portion has a substantially uniform outer diameter, it has substantially the same flexibility in the axial direction. The tip is the most flexible part compared to the transition part and the body part. A transition part is a part which is diameter-reduced toward the front end direction from the base end. The tip and main body can be bent easily by tapering at a certain rate (which can also be referred to as a taper), one whose diameter changes gradually, or a synthetic resin coating member to be described later Any structure may be used as long as the physical properties of the rigidity of the tip and the main body are not changed suddenly, such as those that are shifted continuously or stepwise. By providing the transition part, the stress does not concentrate locally and does not bend (kink). The main body portion is a portion extending toward the proximal end side of the transition portion, and is thicker than the distal end portion. This is to transmit the torque applied by the hand and the axial force (pushing force) applied by the hand to insert the guide wire to the tip part to the maximum extent.

  It is preferable that a bulging portion is provided at the distal end side of the contrast member at the distal end portion of the core member. The bulging portion prevents the contrast member from moving, and in particular, prevents the distal end side of the contrast member from moving. The bulging portion is preferably fixed to an annular contrast member. As a fixing method, in addition to brazing or an adhesive, a metallic annular contrast member itself may be dissolved and fixed. The contrast member may be in close contact with the core material or may be spaced apart, but it is sufficient that the contrast member has a diameter at the bulging portion that can prevent the contrast member from moving toward the distal end of the guide wire. If the contrast member is annular, it may have a diameter larger than its inner diameter. The shape of the bulging portion includes a spherical shape, a shell shape, a hemispherical shape, a spindle shape, and the like. The bulging part can be prepared by fixing the contrast member at the tip of the core member and then melting the core member on the tip side of the contrast member to obtain a predetermined shape, or by forming the bulge part having a predetermined shape at the tip of the core member. However, since the bulging portion and the core material are integrated with the same material, a method of melting the core material tip is preferable.

  Each size of the core material is different depending on the use of the guide wire, but the case of the guide wire for PTCA provided with the tip portion, the transition portion, and the main body portion is exemplified as follows. 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. Since the tip transition portion in this case is provided continuously from the main body portion, the diameter is reduced in a taper shape 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 a distal end transition portion with a predetermined interval. In addition, the core member may have a constant outer diameter from the distal end to the proximal end. When the bulging portion is provided, it is provided on the distal end side of the distal end transition portion.

  It is preferable that a plurality of X-ray contrast members are provided from the tip of the tip of the core material. In this case, the number is not limited, but it is desirable that about 2 to 7 are provided. A plurality of X-ray contrast members provided have a predetermined interval. In addition to the predetermined interval, the predetermined interval includes an interval provided according to a predetermined reference, for example, an interval that becomes narrower or wider at a constant rate as it goes in the guide wire distal direction. When the distance is narrow, the distance at which the X-ray contrast member is provided at the tip is narrowed, and the visibility of the guide wire tip is improved. When the interval is widened at a constant rate, the flexibility of the distal end portion of the core material is not inhibited by the X-ray contrast member, and the flexibility of the distal end portion of the guide wire increases as it goes to the distal end. In addition, since the length of the X-ray contrast member in the guide wire axial direction is constant, the size of the stenosis portion of the blood vessel can be easily measured. By shortening the axial length as it goes to the distal end, the flexibility of the distal end portion of the guide wire is increased and the blood vessel wall is not damaged at the time of blood vessel insertion.

  The X-ray contrast member is a ring-shaped member such as a coil shape (or spring shape) or a pipe shape, and a method of plating a metal X-ray opaque material on the core material or a particulate X-ray contrast agent high in resin Anything can be used as long as the tip of the guide wire is easily visible when the guide wire is used under X-ray fluoroscopy, such as a mixture in a ratio.

  In the case of an annular X-ray contrast member, the bulging portion is provided on the distal end 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 fixation of the contrast member is ensured.

  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 contrast member is equal to or smaller than the thickest portion of the outer diameter of the core material, so that torque transmission is facilitated. In the case of the core material having the three parts of the tip part, the transition part, and the main body as described above, the outer diameter of the contrast member is the same or smaller than the outer diameter of the main body having the thickest outer diameter.

  Further, although depending on the configuration of the contrast member, the flexibility of the distal end 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, there is an effect that the flexibility of the guide wire in the portion where the contrast member is provided is constant in the axial direction. In addition, since the outer diameter of the contrast member is reduced as it goes to the tip, there is an effect that flexibility in the tip direction increases. In addition, taking into account both the flexibility of the guide wire tip and X-ray visibility, the outer diameter increases toward the tip, and a short contrast member is provided at regular intervals, or a contrast with a relatively large outer diameter. This can be realized by separating the members in the distal direction and closely spaced in the proximal direction. Furthermore, a coil-shaped contrast member that relatively follows the bending of the core material can be provided on the distal end side.

  The synthetic resin covering member is intended to cover the core material and the X-ray contrast member to form a substantially smooth outer surface. The guide wire covered with the covering member has a substantially uniform outer diameter from the distal end to the proximal end, but the distal end portion has an outer diameter larger than that of the other portions so as to pass through the narrowed portion of the blood vessel and to be inserted into the fine blood vessel. By thinning, the insertion of microvessels by reducing the diameter is facilitated, and the flexibility of the tip portion is increased.

  The covering member is made of a synthetic resin because of its ease of covering and the ease of processing the outer surface described later. The covering member made of synthetic resin is flexible to the extent that it does not hinder the bending of the core material, and the outer surface is a smooth surface substantially free of irregularities. Furthermore, it is also possible to mix a fine powder X-ray contrast material in the synthetic resin forming the synthetic resin coating member. Examples of the fine powder X-ray contrast material include tungsten, bismuth, and barium. By covering a part or all of the surface of the core material with the X-ray contrast material-containing synthetic resin covering member, the whole or part of the guide wire can be visually recognized. In particular, the visibility is further improved by applying the X-ray contrast material-containing synthetic resin covering member to the distal end portion of the guide wire.

  The synthetic resin covering member may change the flexibility of the covering member in accordance with the flexibility of the core material. That is, the material is changed in accordance with each portion of the core material having the tip portion, the transition portion, and the main body portion. As an example, the most flexible material is selected for the tip because it may be inserted into the blood vessel and contact the tube wall, and the body is more rigid to reinforce the torsional and bending rigidity of the core material itself. Choose a high material. An intermediate rigid material can be selected for the transition. It is also possible to change the two types of resins having different rigidity stepwise or continuously so that the distribution of the resin having low rigidity increases as it goes to the tip.

  Further, the synthetic resin covering member may be formed of two or more layers. For example, the core of the core is coated with a relatively rigid resin such as polyimide in order to give rigidity, and the outer layer is a resin layer having many reactive groups that can easily fix a lubricating material described later. And a lubricating substance such as a hydrophilic material is fixed to the resin layer. Also, in order to improve the torque transmission by improving the adhesion between the superelastic wire and the resin, an adhesive resin such as 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 these layers. Further, a low friction resin may be provided outside the covering member. A typical example of the low-friction resin is a fluorine resin.

  The X-ray contrast member of the guide wire of the present invention is a high X-ray contrast property, that is, a radiopaque material, and in addition, platinum, silver, bismuth, tungsten, or an alloy of two or more of these (for example, platinum -Tungsten) or alloys with other metals (for example, gold-iridium, platinum-iridium). Another material may be plated on the surface of the contrast member 6.

  The core material is not limited as long as it is a material having moderate flexibility with blood vessel followability, rigidity capable of transmitting torque to the tip, and transmitting the pushing force at hand to the tip, but stainless steel. , Super elastic metal, amorphous metal and the like. Among them, a superelastic metal wire exhibiting superelastic properties is preferable. The superelastic metal wire is a Ni-Ti alloy, a Cu-Zn-X alloy (X = Be, Si, Sn, Al, Ga), a Ni-Al alloy, and preferably a Ni-Ti alloy. In addition, in order to increase the property of flexibility, it may be a Ni-Ti alloy that does not have so much superelastic characteristics.

  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 a physical property with good torque transmission. The physical property with good torque transmission is the stress-strain curve of the Ni-Ti alloy superelastic line, where 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 a substantially straight line after that. Furthermore, if the main body part is a work-hardened Ni-Ti alloy wire, the middle part is a Ni-Ti alloy superelastic wire, and the tip part is a plastically deformable Ni-Ti alloy wire, the main body part is highly rigid and pushable. The body portion is excellent in followability of curved blood vessels and torque transmission properties, and the tip portion is changed to a desired tip shape to facilitate insertion. As a material of the synthetic resin covering member, polyurethane, polyethylene, polyvinyl chloride, polyester, polypropylene, polyamide, polystyrene, fluorine resin, silicone or each elastomer (for example, polyester elastomer) and composite materials thereof are preferably used. it can.

  It is preferable that the surface of the synthetic resin coating material has a lubricity coating layer which is hydrated when wet and becomes a low friction surface. When inserting a curved or meandering blood vessel, when selecting and inserting a blood vessel that branches at an acute angle, or when inserting a catheter along an indwelling guide wire, the lubricity coating layer is applied to the inner wall of the blood vessel. It reduces friction with the inner wall of the catheter and improves pushability.

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

  A guide wire according to an embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a sectional view showing a first embodiment of the guide wire of the present invention, and FIG. 2 is a sectional view showing a second embodiment of the guide wire of the present invention. FIG. 3 is a cross-sectional view showing a third embodiment of the guide wire of 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, a plurality of X-ray contrast members 6 provided at a predetermined interval on a distal end portion 21 of the core material 2, It consists of a synthetic resin covering member 8 that covers the core member 2 and 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 is preferably 0.5 mm or less in PTCA.

  The core material 2 includes a tip portion 21, a transition portion 23, and a main body portion 25. The distal end 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 21 of the core material 2 is about 0.08 mm, and the length is 20 mm. The transition portion 23 is a portion that is reduced in diameter from the proximal end toward the distal end, and in the present embodiment, is reduced in diameter to a taper shape 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 part 23, the bending ease (flexibility) of the main body part 25 and the distal end part 21 having different outer diameters can be increased as it goes to the distal end, that is, it can be softened, and the bending ease changes rapidly. The flexibility increases continuously as it goes to the tip, and it does not kink locally. The main body portion 25 is a portion extending toward the proximal end side of the transition portion 23, and has an outer diameter substantially uniform, 0.30 mm, and a length of about 1500 mm. The main body 25 is thicker than the tip 21. This is to transmit the torque applied by hand and the axial force (pushing force) applied by hand to insert the guide wire 1 to the tip 21.

  The distal end portion 21, the transition portion 23, and the main body portion 25 of the core material 2 are an integral part of the same material. It is preferable that it is an integral object because it is not broken, detached or damaged. Such a core material 2 is composed of a superelastic metal wire and is a Ni-Ti alloy wire. Because it is a superelastic alloy wire, it does not bend and does not wrinkle, and even if torque is applied while passing through a meandering blood vessel, the force is transmitted smoothly to the tip and rich in torque transmission.

  A plurality of X-ray contrast members 6 are provided at a predetermined interval at the distal end portion 21 of the core material 2. Five X-ray contrast members 6 are provided at regular intervals from the tip of the tip 21 of the core member 2. By providing a plurality, the X-ray contrast property of the distal end portion of the guide wire 1 is enhanced, and it is easy to select a blood vessel branch, thereby facilitating the operation quickly and easily.

  By providing the contrast member 6 at a constant interval, there is an effect that the size of a stenosis or the like can be recognized through the interval of the X-ray contrast member 6 under X-ray contrast. The contrast member 6 is constituted by a coil 6a. The coils 6a are wound with substantially 1 mm in length, and the intervals between the coils 6a are about 4 mm. By being a coil, when the guide wire 1 of the tip portion 21 of the core material 2 is bent, the guide wire 1 of the tip portion 21 does not bend at the boundary between the portion where the coil is present and the portion where the coil is not present, and a smooth curve is drawn. It will be. Further, since the coil is used, the inner diameter of the coil can be changed even if there is a slight variation in the outer diameter of the tip portion 21 during the manufacturing process, so that the coil can be fixed at a constant interval. For this coil, a method in which a coil formed in advance is inserted from the tip of the tip portion 21 and a method in which a linear wire is wound around the core 2 and cut are conceivable. The coil 6a is wound tightly, but may be loosely wound. Moreover, although the coil 6a is wound directly around the core material 2, it may be fixed to the core material 2 via an interposition. By interposing the interposition, the outer diameter of the coil 6a is increased, and the position of the coil 6a can be easily seen under X-ray fluoroscopy. As the interposition, the same or different synthetic resin as that of the covering member 8 may be used, or the same coil as the coil 6a, that is, the coil may be wound twice.

  The contrast member 6 is a gold coil 6a. Gold is excellent in that it has high radiopacity, that is, exhibits high contrast.

  The synthetic resin covering member 8 is covered so as to cover the core material 2 and the X-ray contrast member 6 to form a substantially smooth outer surface. The guide wire 1 covered with the covering member 8 has a substantially uniform outer diameter from the distal end to the proximal end. The covering member 8 is made of a synthetic resin because of its ease of covering and the ease of processing the outer surface, which will be described later. The covering member 8 is flexible to the extent that the bending of the core material 2 is not hindered, and the outer surface is substantially uneven. Has no smooth surface. As the synthetic resin, a thermoplastic resin is preferable because of its simplicity of 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 material. By covering the surface of the core material 2 with the X-ray contrast material-containing synthetic resin coating member 8, the entire guide wire or a part thereof 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 slidable with the lumen in the catheter, the lubrication substance is fixed only at the distal end portion in consideration of difficulty in handling due to the slidability of the hand portion. good. Further, the lubricity may be changed stepwise or continuously from the tip to the base end.

  Lubricating substances include hydrophilic and water-soluble polymer substances or derivatives thereof. Further, the lubricating substance is a lubricating coating layer that is hydrated when wet and forms a low friction surface. The lubricating substance is fixed to the outer surface of the synthetic resin covering member 8 by covalent bonding or ionic bonding. This lubricating material is in principle a polymer material that is chain-like and has no crosslinking, and has hydrophilic groups such as —OH, —CONH 2, —COOH, —NH 2, —COO—, and —SO 3 —. 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 blood vessel and the outer surface of the guide wire is reduced. By reducing the friction, the slidability of the guide wire is improved. 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. Further, rotation at hand is transmitted to the tip of the guide wire 1 at a ratio of 1: 1. Further, when a lubricating substance is fixed to the distal end portion 4 of the guide wire 1, insertion into a desired branch at the blood vessel branch point and passage through the blood vessel stenosis portion are facilitated. Even if it is hydrophobic, it can be used as a covering member if it has lubricity like silicone.

  Examples of such lubricating substances include natural water-soluble polymer substances and synthetic water-soluble polymer substances. In the natural system, starches such as carboxymethyl starch, celluloses such as carboxymethyl cellulose, polysaccharides such as chitosan, gelatin And the like. Synthetic systems include polyalkylene glycols such as polyvinyl alcohol and polyethylene glycol, and maleic anhydrides such as methyl vinyl ether-maleic anhydride copolymer. The hydrophobic lubricating substance can be silicone. In the guide wire 1, a maleic anhydride-based material is fixed to the covering member 8 as a hydrophilic lubricating substance.

  The outer surface of the synthetic resin covering member 8 is coated with an antithrombotic material such as an anticoagulant such as heparin or urokinase or a silicone rubber, a urethane / silicone block copolymer, or a hydroxyethyl methacrylate-styrene copolymer. May be.

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

  If it demonstrates centering on difference with the guide wire 1 of FIG. 1, it is that the contrast member 16 is a tubular member, ie, a short pipe shape. Five contrast members 16 are provided at the distal end portion 21 of the core member 2 at regular intervals. The X-ray contrast member 16 has a constant interval. Due to the fixed interval, there is an effect that the size of the stenosis or the like can be recognized through the interval of the X-ray contrast member 16 under X-ray contrast.

  The X-ray contrast member 16 is constituted by the pipe 16a as described above, and is made of gold having a high X-ray contrast property. The pipe 16a has a length of about 1 mm, and the interval between the pipes 16a is about 4 mm. The pipe 16a is directly wound around the core material 12, but may be fixed to the core material 12 via an interposition. By passing the interposition, the outer diameter of the pipe 16a is increased, and the position of the pipe 16a is easily seen under X-ray fluoroscopy. The intervening material may be the same or different synthetic resin as 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 with a core material 12 and a plurality of annular X-ray contrast members 16 that are provided at predetermined intervals on the distal end portion 221 of the core material 12 and fixed in close contact with the core material 12. A covering member 18 made of a synthetic resin that covers the core member 12 and the contrast member 16 to form a substantially smooth outer surface; and a distal end side 16a of the contrast member of the core member 12; It is comprised from the bulging part 30 which prevents the movement to the front end side 16a.

  Further, the guide wire 11 includes a core material 12, an annular X-ray contrast member 16 fixed in close contact with the tip 221 of the core material 12, and a synthetic resin coating member 18 that covers the core material 12 and the contrast member 16. And a bulging portion 30 that is provided on the distal end side 16a of the contrast member 16 of the core member 12 and prevents the contrast member 16 from moving to the distal end 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 is different depending on its use, but is about 1.0 to 0.5 mm for angiography and 0.5 mm or less for PTCA. preferable. 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 front end part 221, a transition part 223, and a main body part 225. Further, a bulging portion 30 is provided at the forefront of the distal end portion 221 as a fixing means for the contrast member 16. The distal end portion 221 has a substantially uniform outer diameter, has substantially the same flexibility, and is the portion having the highest flexibility as compared with a transition portion 223 and a main body portion 225 described later. The outer diameter of the tip 221 of the core material 2 is about 0.08 mm, and the length is 20 mm. The transition portion 223 is a portion that is reduced in diameter from the proximal end toward the distal end, and is reduced in diameter in a tapered shape at a constant rate in the present embodiment, and can also be referred to as a tapered portion. The length of the transition part 223 is 300 mm. By having the transition portion 223, the ease of bending (flexibility) of the main body portion 225 and the distal end portion 221 having different outer diameters can be increased toward the distal end, that is, can be softened, and the easiness of bending changes rapidly. The flexibility increases continuously as it goes to the tip, and it does not kink locally. The main body portion 225 is a portion extending toward the proximal end side of the transition portion 223, and has an outer diameter substantially uniform, 0.30 mm, and a length of about 1500 mm. The main body 25 is thicker than the tip 21. This is to transmit the torque applied by hand and the axial force (pushing force) applied by hand to insert the guide wire 1 to the tip 21.

  The bulging part 30, the tip part 221, the transition part 223, and the main body part 225 of the core material 2 are an integral part of the same material. It is preferable that it is an integral object because it is not broken, detached or damaged. Such a core material 2 is composed of a superelastic metal wire and is a Ni-Ti alloy wire. Because it is a superelastic alloy wire, it does not bend and does not wrinkle, and even if torque is applied while passing through a meandering blood vessel, the force is transmitted smoothly to the tip and rich in torque transmission. A plurality of X-ray contrast members 16 are provided at a predetermined interval at the distal end portion 221 of the core material 12. Five X-ray contrast members 16 are provided at regular intervals from the front end of the tip 221 of the core member 2. By providing a plurality, the X-ray contrast property of the distal end portion of the guide wire 11 is enhanced, and it is easy to select a blood vessel branch, thereby facilitating a quick and easy procedure.

  By providing the contrast member 16 at a constant interval, there is an effect that the size of a stenosis or the like can be recognized through the interval of the X-ray contrast member 16 under X-ray contrast. The X-ray contrast member 16 has an annular shape and is constituted by a pipe 16a. The material is a material having a high X-ray contrast property. The pipe 16a has a length of about 1 mm, and the interval between the pipes 16a is about 4 mm. The pipe 16a is also fixed in close contact with the core material 12, but may be fixed to the core material 12 via an interposition. The pipe 16 having a large outer diameter can be used by interposing the interposition, and the position of the pipe 16a can be easily seen under X-ray fluoroscopy. The intervening material may be the same or different synthetic resin as the covering member 18 or may be a radiopaque coil. The contrast member 16 is a platinum pipe 16a. Platinum has a high radiopacity, that is, is excellent as a material exhibiting high contrast.

  On the distal end side 16 a of the most distal contrast member 16, a bulging portion 30 is provided following the distal end portion 221 of the core member 12. The bulging portion 30 is formed into a spherical shape by allowing the contrast member 16 to pass through the distal end 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 is equal to or smaller than the outer diameter. The contrast member 16 and the core material 12 are fixed with an adhesive. It is preferable that the adhesive area is increased by applying an adhesive to a portion 30a where the distal end side 16a of the contrast member 16 and the bulging portion 30 are in contact with each other.

  The synthetic resin covering member 18 is covered so as to cover the core member 12 and the X-ray contrast member 16 to form a substantially smooth outer surface. The guide wire 11 covered by the covering member 18 has a substantially uniform outer diameter from the distal end to the proximal end. The covering member 18 is made of a synthetic resin because of its ease of covering and ease of processing of the outer surface, which will be described later. The covering member 18 is flexible to the extent that the bending of the core material 12 is not hindered, and the outer surface is substantially uneven. Has no smooth surface. As the synthetic resin, a thermoplastic resin is preferable because of its simplicity of production. As the covering member 18 of the guide wire 11, a modified polyolefin (trade name: Bondine) is used. The raw material of the covering member 18 is melted and extruded together with the core material 12 so as to adhere and cover 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 X-ray contrast material-containing synthetic resin coating member 18, the entire guide wire or a part thereof can be visually recognized.

  A lubricious 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 slidable with the lumen in the catheter, the lubrication substance is fixed only at the distal end portion in consideration of difficulty in handling due to the slipperiness of the hand portion. good. Further, the lubricity may be changed stepwise or continuously from the tip 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 lubricity is increased by the hydrophilic compound, and the hydrophobic compound reacts with the substrate to fix the hydrophilic compound. A block copolymer of a hydrophilic compound and a hydrophobic compound makes it difficult for thrombus to adhere to the block copolymer. Further, the outer surface of the synthetic resin coating member 18 is coated with heparin as an anticoagulant.

  Next, the operation of the guide wire according to the present invention will be described using PTCA. First, the guiding catheter is advanced through the aorta to the coronary ostium, and in order to confirm the target site of the coronary artery having a stenosis, coronary angiography is performed by discharging a contrast medium from the tip of the guiding catheter. Next, the guide wire of the present invention is inserted through a guide wire lumen of the dilatation catheter provided with a balloon for dilating the stenosis at the tip, and the dilatation catheter into which the guide wire is inserted is used as a guiding catheter. Insert it. When reaching the distal end of the guiding catheter, the insertion of the dilatation catheter is stopped and only the guide wire is pushed into the coronary artery while appropriately imaging. Since the guide wire of the present invention is provided with a plurality of X-ray contrast members at predetermined intervals at the distal end portion of the core material, it is easy to confirm the distal end of the guide wire under X contrast. In addition, since it has a synthetic resin covering member that forms a substantially smooth outer surface, as described above, the angle rotated when turning by hand to change the direction of the tip of the guide wire. The performance of turning the tip as it is (torque transmission) is further improved. In this embodiment, the outer surface of the synthetic resin coating member is further provided with lubricity by a hydrophilic coating, so that torque transmission is excellent, and selection in the blood vessel branch is as desired.

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

  Next, push the dilatation catheter along the guide wire, confirm that the balloon of the dilatation catheter is at the center of the stenosis, and inject and pressurize the contrast medium into the balloon to expand the stenosis. Expand. After the dilatation is completed, or when the dilatation catheter is removed for replacement with another size dilation catheter and the guidewire is also retracted from the target site, the guidewire of the present invention has a substantially smooth outer surface. Because it has a synthetic resin coating member that forms a spring, the spring stretches by pulling the constricted part with a spring like a guide wire with an exposed spring, and in the worst case the guide wire cannot be pulled out Can not be removed and can be removed without unnecessary consideration.

  In addition to PTCA, the guide wire of the present invention can be used for angiographic and therapeutic catheter insertion in the brain and abdomen.

  The present invention provides a core material, a plurality of annular X-ray contrast members which are provided at predetermined intervals on the tip of the core material and are fixed in close contact with the core material, and the core material and the contrast member. A synthetic resin coating member that covers and forms a substantially smooth outer surface, and a bulge that has the core material on the distal end side of the contrast member and prevents the contrast member from moving to the distal end side Since the guide wire is characterized by comprising a portion, the visibility is good and the constricted portion can be easily passed. Furthermore, the size of the constriction can be measured. Further, the synthetic resin covering member that forms a substantially smooth outer surface with the bulging portion of the core material ensures the safety and ease of insertion and removal of the narrowed portion. When the outer diameter of the synthetic resin covering member, that is, the outer diameter of the guide wire is uniform, its safety and ease are improved.

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

  A core material; an annular X-ray contrast member fixed in close contact with the core material; a synthetic resin coating member covering the core material and the contrast member; and a distal end side of the contrast member of the core material The guide wire is characterized by comprising a bulging portion that prevents the contrast member from moving toward the distal end side, so that it has good visibility and can easily pass through the narrowed portion. Furthermore, the size of the constriction can be measured. In addition, the synthetic resin covering member that forms a substantially smooth outer surface ensures the safety and ease of insertion and removal of the narrowed portion. When the outer diameter of the synthetic resin covering member, that is, the outer diameter of the guide wire is uniform, its safety and ease are improved.

  When a plurality of X-ray contrast members are provided at regular intervals, measurement can be easily performed while viewing an X-ray image. In addition, if the core material is a superelastic wire, it is difficult to bend, and the tip can be rotated as it is when it is turned by hand to change the direction of the tip of the guide wire.

FIG. 1 is a cross-sectional view showing a first embodiment of the guide wire of the present invention. FIG. 2 is a cross-sectional view showing a second embodiment of the guide wire of the present invention. FIG. 3 is a cross-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 part 21, 121, 221
X-ray contrast member 6 16
Synthetic resin covering member 8 18
Bulge 30

Claims (8)

A core material,
A plurality of X-ray contrast members provided at predetermined intervals on the tip of the core material;
A guide wire comprising the core material and a synthetic resin covering member that covers the contrast member to form a substantially smooth outer surface. 2. The guide wire according to claim 1, wherein the plurality of X-ray contrast members are provided so that a distance between the plurality of X-ray contrast members becomes narrower or wider at a constant rate as it goes in a distal direction of the core member. The guide wire according to claim 1, wherein an outer diameter of the contrast member is smaller toward a distal end. The guide wire according to claim 1, wherein an outer diameter of the contrast member increases toward a distal end. 2. The guide wire according to claim 1, wherein the synthetic resin covering member has a lubricity that changes stepwise or continuously from a distal end to a proximal end. The guide wire according to claim 1, wherein the X-ray contrast member is fixed to the core member via an interposition. The guide wire according to claim 6, wherein the interstitial material is the same or different synthetic resin as the synthetic resin covering member. A core material,
A plurality of X-ray contrast members provided at predetermined intervals on the tip of the core material;
A guide wire comprising: a part of the core material; and a synthetic resin covering member that covers the contrast member to form a substantially smooth outer surface.

Images