JP2012213667A - Guide wire - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a guide wire which is excellent in sliding property, and has a high safety.SOLUTION: The guide wire 1 includes: a wire body 2 which is constituted of a core wire 3 having flexibility or pliability; a raised section forming layer 4 having a color which is different from that of the core wire 3; and a coating layer 5 having transparency at a degree by which the raised section forming layer 4 is visible. For the guide wire 1, a raised section forming region 40 which is the region where the raised section forming layer 4 is formed is set. On the outer periphery of the core wire 3 in the raised section forming region 40, the raised section forming layer 4 is partially installed. The coating layer 5 coats the raised section forming layer 4 and the core wire 3 at least in the raised section forming region 40. The raised section forming layer 4 is constituted of a material containing a resin and a pigment, and the coating layer 5 is constituted of a material containing a resin. On the external surface of the coating layer 5, areas where the raised section forming layer 4 is installed are raised to areas where the raised section forming layer 4 is not installed.

Description

  The present invention relates to a guide wire, and more particularly, to a guide wire (a guide wire for a transendoscope) that is inserted into a living body via an endoscope.

  When a catheter is inserted into a biological lumen such as a digestive tract or a blood vessel, a guide wire is used to guide the catheter to a target site in the biological lumen. This guide wire is used by being inserted into a catheter.

  In addition, observation and treatment of a living body lumen using an endoscope is also performed, and a guide is also provided for guiding a catheter inserted into the endoscope or the lumen of the endoscope to a target site such as a living body lumen. Wire is used.

  Some guidewires have irregularities formed on the outer surface of the guidewire for various purposes.

  For example, it has been proposed that the guide wire has a curved portion, and an unevenness is formed on the outer surface of the curved portion to increase the flexibility of the curved portion (see, for example, Patent Document 1). In this guide wire, a coil is wound around the outer surface of a curved portion at a predetermined interval, the coil is heated, and a part of the outermost layer is removed to form irregularities.

  However, with this method, only spiral or annular irregularities corresponding to the coil winding pattern can be formed.

  Moreover, since the unevenness is formed by removing a part of the outermost layer of the guide wire, it is difficult to smooth the outer surface of the guide wire, and there is a disadvantage that the slidability is poor.

JP 2006-150066 A

  An object of the present invention is to provide a guide wire that is excellent in slidability and high in safety.

Such an object is achieved by the present inventions (1) to (7) below.
(1) a wire body having a core wire;
An underlayer provided on at least a part of the outer periphery of the wire body;
A raised portion forming layer partially provided on the underlayer;
At least in the region where the raised portion forming layer is formed, the raised portion forming layer and a covering layer covering the wire body,
A guide wire characterized in that, on the outer surface of the guide wire, a portion where the raised portion forming layer is provided is raised relative to a portion where the raised portion forming layer is not provided.

  (2) The guide wire according to the above (1), wherein the constituent material of the raised portion forming layer and the constituent material of the base layer include mutually compatible resins.

(3) The raised portion forming layer has a color different from that of the base layer,
The covering layer has transparency to the extent that the raised portion forming layer is visible,
The guide wire according to (1) or (2), wherein the raised portion forming layer is configured to function as a visual marker.

  (4) The guide wire according to any one of (1) to (3), wherein the coating layer is in close contact with the base layer at a portion where the protruding portion forming layer is not provided.

  (5) In the region where the raised portion forming layer is formed, the above-described (1) to (4) are formed with minute irregularities on the surface immediately below the covering layer where the raised portion forming layer is not formed. The guide wire according to any one of the above.

  (6) The guide wire according to any one of (1) to (5), wherein the raised portion forming layer is formed in a spiral shape, an annular shape, or a lattice shape.

  (7) The guide wire according to any one of the above (1) to (6), wherein the constituent material of the raised portion forming layer and the constituent material of the covering layer include mutually compatible resins.

The guide wire of the present invention comprises an outer layer that covers the covering layer,
It is preferable that the constituent material of the outer layer and the constituent material of the coating layer contain compatible resins.

The guide wire of the present invention comprises an outer layer that covers the covering layer and has a transparency that allows the raised portion forming layer to be visually recognized.
It is preferable that the constituent material of the outer layer and the constituent material of the coating layer contain compatible resins.

In the guide wire of the present invention, at least in the region where the raised portion forming layer is formed, the outer periphery of the wire body is covered, and an underlayer having a color different from that of the raised portion forming layer is provided.
It is preferable that the raised portion forming layer is partially provided on the base layer.

  In the guide wire of the present invention, it is preferable that the constituent material of the base layer and the constituent material of the raised portion forming layer contain mutually compatible resins.

In the guide wire of the present invention, the raised portion forming layer is made of a material containing a first resin, a second resin different from the first resin, and a pigment,
The coating layer is preferably made of a material containing the second resin.

  In the guide wire of the present invention, in the region where the raised portion forming layer is formed, the area of the outer surface of the raised portion forming layer is the area of the surface immediately below the covering layer where the raised portion forming layer is not formed. Larger is preferred.

The guide wire of the present invention comprises an outer layer that covers the covering layer and has a transparency that allows the raised portion forming layer to be visually recognized.
The raised portion forming layer is made of a material containing a first resin and a pigment,
The coating layer is made of a material including a resin compatible with the first resin and a second resin different from the compatible resin,
The outer layer is preferably made of a material containing the second resin.

In the guide wire of the present invention, at least in the region where the raised portion forming layer is formed, the outer periphery of the wire body is covered, and an underlayer having a color different from that of the raised portion forming layer is provided.
The underlayer is made of a material containing the first resin and a pigment having a different color from the pigment of the raised portion forming layer,
It is preferable that the raised portion forming layer is partially provided on the base layer.

In the guide wire of the present invention, the second resin is preferably a fluororesin.
In the guide wire of the present invention, the first resin is preferably a resin having a melting point of 200 ° C. or higher.

In the guide wire of the present invention, the first resin is preferably a thermosetting resin.
In the guide wire of the present invention, the raised portion forming layer is formed by removing a part of the raised portion forming layer provided on the entire surface immediately below the covering layer in the raised portion forming layer forming region. Is preferred.

  In the guide wire of the present invention, the total value of the thickness of the raised portion forming layer and the thickness of the covering layer is preferably 50 μm or less.

  In the guide wire of the present invention, it is preferable that the raised portion of the outer surface of the guide wire is rounded.

In the guide wire of the present invention, the raised portions and the recessed portions are alternately formed along the longitudinal direction of the wire body.
It is preferable that an interval between the protruding portions adjacent to each other in the longitudinal direction of the wire body is 0.5 to 10 mm, and a height of the protruding portion is 1 to 30 μm.

  According to the present invention, since the outer surface of the guide wire is partially raised (the raised portion and the recessed portion are formed), the outer surface of the guide wire and the inside of the treatment instrument such as a catheter are formed. The contact area with the lumen and the lumen of the endoscope is reduced, the frictional resistance (sliding resistance) is reduced, and the slidability is improved. Thereby, the guide wire excellent in operability can be provided.

  In addition, since the raised portion forming layer is provided as an inner layer, and thereby the outer surface of the guide wire is partially raised, the outer surface of the guide wire can be smoothed. It can be rounded. Thereby, slidability is further improved and safety is high.

It is a longitudinal cross-sectional view which shows the 1st reference example of the guide wire of this invention. It is a longitudinal cross-sectional view which shows the part of the vicinity of the outer surface of the guide wire shown in FIG. It is a longitudinal cross-sectional view which shows the part of the vicinity of the outer surface in the 2nd reference example of the guide wire of this invention. FIG. 4 is a view for explaining the guide wire manufacturing method shown in FIG. 3, and is a longitudinal sectional view showing a portion in the vicinity of the outer surface of the guide wire. It is a longitudinal cross-sectional view which shows the part of the outer surface vicinity in the 3rd reference example of the guide wire of this invention. It is a longitudinal cross-sectional view which shows the part of the vicinity of the outer surface in 1st Embodiment of the guide wire of this invention. It is a longitudinal cross-sectional view which shows the part of the vicinity of the outer surface in the 4th reference example of the guide wire of this invention. It is a fragmentary longitudinal cross-section which shows 2nd Embodiment of the guide wire of this invention. It is a longitudinal cross-sectional view which shows the part of the outer surface of the guide wire shown in FIG.

  Hereinafter, the guide wire of the present invention will be described in detail based on preferred embodiments and reference examples shown in the accompanying drawings.

<First Reference Example>
FIG. 1 is a longitudinal sectional view showing a first reference example of the guide wire of the present invention, and FIG. 2 is a longitudinal sectional view showing a portion near the outer surface of the guide wire shown in FIG. For convenience of explanation, the right side in FIG. 1 is referred to as “base end” and the left side is referred to as “tip”. Further, in FIG. 1, for ease of understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated and schematically illustrated. The ratio is different from the actual.

  As shown in FIG. 1, a guide wire 1 has a wire body 2 composed of a core wire (wire material) 3 having flexibility or flexibility, and a color different from that of the core wire 3 (wire body 2). 1 is provided with a raised portion forming layer 4 that partially raises the outer surface of 1, and a coating layer 5 having transparency (light transmittance) to such an extent that the raised portion forming layer 4 can be visually recognized.

  In this reference example, the wire body 2 is composed of a single continuous core wire 3, and the cross-sectional shape thereof is circular. However, in the present invention, the wire body 2 is not limited to this, and the wire body 2 may be formed by joining a plurality of core wires (wires) made of the same or different materials, for example, by welding or brazing, and other components are provided. It may be done.

  The total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm. The outer diameter of the guide wire 1 is not particularly limited, but is preferably about 0.2 to 1.2 mm.

  The core wire 3 extends over almost the entire length of the guide wire 1, a main body portion 32 corresponding to the main body portion of the guide wire 1, a tapered portion 34 located on the distal end side thereof, and a small diameter portion located on the distal end side thereof. 36. The outer diameter of the main body portion 32 is substantially constant, the outer diameter of the tapered portion 34 is gradually reduced toward the tip direction (tapered), and the outer diameter of the small-diameter portion 36 is substantially the same. It is constant.

  By providing the taper portion 34 on the core wire 3, the flexibility of the core wire 3 gradually (continuously) from the vicinity of the boundary portion (taper portion base end 341) between the main body portion 32 and the taper portion 34 toward the distal direction. As a result, the flexibility of the guide wire 1 increases, so that the operability and safety when inserted into the living body are improved.

  Moreover, by having the small diameter part 36 in the front end side of the taper part 34, the cutting edge flexible part can be lengthened, and the effect that the cutting edge part becomes more flexible arises.

_{D 1} (the outer diameter of = tapered portion proximal end 341) the outer diameter of the main body portion 32 of the core wire 3 is not particularly limited, is preferably about 0.3 to 1.0 mm, 0.4-0.7 mm More preferably, it is about.

_{D 2} (the outer diameter of = tapered tip 342) the outer diameter of the small-diameter portion 36 of the core wire 3 is not particularly limited, it is preferably about 0.05 to 0.3 mm, about 0.1~0.2mm Is more preferable. The outer diameter of the small-diameter portion 36 is not limited to a constant value, and the outer diameter may gradually decrease toward the tip.

  The length of the tapered portion 34 varies depending on the application and type of the guide wire 1 and is not particularly limited, but is preferably about 10 to 300 mm, more preferably about 30 to 250 mm.

  Moreover, the length of the small diameter part 36 is not specifically limited, However, Preferably it is about 0-100 mm, More preferably, it can be about 10-50 mm.

  In addition, the taper angle (decrease rate of the outer diameter) of the taper portion 34 may be constant along the longitudinal direction of the core wire 3 (wire body 2), or there may be a portion that varies along the longitudinal direction. Moreover, the taper part 34 may be provided not only in one place but in two or more places.

  In addition, minute irregularities are formed on the outer surface of the core wire 3, particularly on the outer surface of the core wire 3 where the bulge-forming layer 4 is not formed in the bulge-forming region 40, which will be described later. (It is preferable that unevenness that is sufficiently small with respect to a raised portion 81 and a recessed portion 82 described later) is formed. Thereby, especially the adhesiveness of the core wire 3 and the coating layer 5 improves, and peeling of the coating layer 5 can be prevented.

  Examples of the constituent material of the core wire 3 include various metal materials such as superelastic alloys such as stainless steel, Ni—Ti alloy, Ni—Al alloy, Cu—Zn alloy, and relatively high rigidity resin materials. These can be used, and one or more of these can be used in combination.

  Here, in the present invention, the use of the guide wire 1 is not particularly limited. For example, the guide wire 1 is used through an endoscope, and more specifically, is inserted into the lumen of the endoscope. The present invention can be applied to a guide wire used to guide a catheter to a target site such as a living body lumen (hereinafter referred to as “transendoscopic guide wire”). Hereinafter, in this reference example, a case where the guide wire 1 is applied to a transendoscopic guide wire will be described as a representative example.

  In a transendoscopy guide wire, a visual marker is provided on the outer surface of the guide wire, and the visual marker is visually recognized through the endoscope. In the present reference example, the raised portion forming layer 4 functions as a means for partially raising the outer surface of the guide wire 1 (providing the raised portion 81 and the recessed portion 82) and also functions as a visual marker.

  The guide wire 1 is provided with a raised portion forming region (formed region) 40 in which the raised portion forming layer 4 is formed, and the outer periphery of the core wire 3 (wire body 2) in the raised portion forming region 40 ( A protruding portion forming layer 4 is partially provided on the outer surface. The raised portion forming layer 4 has a color different from the outer surface of the core wire 3 (wire body 2), and also functions as a visual marker.

  The bulge formation region 40 may be the whole (may be over the entire length) or may be a part along the longitudinal direction of the core wire 3. In this reference example, the raised portion forming region 40 extends over the entire length of the core wire 3.

  In addition, when setting the protruding part formation area 40 to a part of core wire 3, it is preferable that the protruding part formation area 40 is set from the front-end | tip of the core wire 3, and the longitudinal direction of the protruding part formation area 40. Is preferably 5 cm or more, more preferably about 10 to 50 cm, and still more preferably about 20 to 40 cm.

  The raised portion forming layer 4 is made of a material containing a resin and a pigment. The color of the raised portion forming layer 4 is mainly determined by the type and characteristics of the pigment contained in the raised portion forming layer 4, the composition and properties of the resin material (particularly color tone, etc.), and the pigment content. It is possible to set freely by adjusting.

  Here, in order to recognize the movement of the guide wire 1 through the endoscope, the color of the raised portion forming layer 4 is one of important elements, and this is the reason for the core wire 3 (wire body 2) as a base. Combinations with colors should be considered.

  As an example, when the core wire 3 or its oxide film is silver white (metallic color), gray or black, and the raised portion forming layer 4 is red or yellow, the difference in brightness of both colors is large (high contrast Thereby, the visibility of the raised portion forming layer 4 is high and preferable. Similarly, when the two colors have a complementary color relationship, for example, the visibility of the raised portion forming layer 4 is high and preferable. Also, for example, clear contrast such as yellow, yellow-green, orange, etc. for black or dark colors (charcoal gray, dark brown, dark blue, purple, etc.), red, orange, pink, etc. for blue It is particularly preferable to select a combination that expresses. Further, similar colors with different shades, for example, amber and light blue, red beans and pink may be used.

  Although it does not specifically limit as resin contained in the constituent material of the protruding part formation layer 4, It is preferable that it is following (1) or (2).

  (1) As a resin contained in the constituent material of the raised portion forming layer 4, it is preferable to use a resin (heat-resistant resin) having a melting point of 200 ° C. or higher, and more preferably a resin having a melting point of about 200 to 300 ° C. .

  Examples of the resin having a melting point of 200 ° C. or higher include polysulfone, polyimide, polyether ether ketone, polyarylene ketone, polyphenylene sulfide, polyarylene sulfide, polyamideimide, polyetherimide, polyimidesulfone, polyallylsulfone, and poloallyl. Fluorine resins such as ether sulfone, polyester, polyether sulfone, polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and the like. They can be used in combination.

  (2) As the resin contained in the constituent material of the raised portion forming layer 4, it is preferable to use a thermosetting resin.

  Examples of the thermosetting resin include epoxy resins, phenol resins, polyesters (unsaturated polyesters), polyimides, silicone resins, polyurethanes, and the like, and one or more of these can be used in combination. .

  In addition, the content of the pigment in the raised portion forming layer 4 depends on the type and characteristics of the pigment and the composition and properties of the resin material, but in order to obtain a good color, The amount is preferably about 10 to 99% by weight, and more preferably about 50 to 95% by weight.

  The pigment in the raised portion forming layer 4 is preferably dispersed uniformly, but may be unevenly distributed on the outer surface side of the raised portion forming layer 4, for example.

  In addition, a pigment may be used individually by 1 type and may use 2 or more types together (especially mixing).

  The shape (pattern) and dimensions of the raised portion forming layer 4 are not particularly limited, and are appropriately set according to the shapes (pattern) and dimensions of the raised portions 81 and the recessed portions 82 to be formed. The thickness of is preferably about 1 to 30 μm, and more preferably about 2 to 10 μm. Thereby, the diameter of the guide wire 1 can be reduced.

  In the illustrated configuration, the raised portion forming layer 4 is provided in a spiral shape. In the case of the spiral (or annular) raised portion forming layer 4, the width is preferably about 0.3 to 10 mm, and the pitch (interval) is preferably about 0.5 to 10 mm.

  It should be noted that the shape of the raised portion forming layer 4 is not limited to a spiral shape or an annular shape, and when configured to function as a visual marker, it may be a visible pattern, specifically, a visible width. Or a discontinuous body having a visible area. For example, in addition to a straight line, a waveform, a polka dot pattern, a lattice pattern (lattice shape), a mesh pattern, and the like, any number, character, symbol, scale, etc. can be used as long as it can be visually recognized. Further, the position may be confirmed by combining two or more different patterns (patterns) such as providing an annular raised portion forming layer 4 following the spiral shape.

  The pigment may be either an inorganic pigment or an organic pigment, but is preferably an inorganic pigment from the viewpoint of heat resistance. As the inorganic pigment, carbon black, mica, titanium dioxide, nickel titanium yellow, Prussian blue, milory blue, cobalt blue, ultramarine, viridian and the like can be used.

  The covering layer 5 has transparency (light transmittance) that allows the protruding portion forming layer 4 to be visually recognized, and covers the protruding portion forming layer 4 and the core wire 3 (wire body 2) at least in the protruding portion forming region 40. is doing. In this reference example, the coating layer 5 covers the entire raised portion forming layer 4 and the core wire 3 (over the entire length).

  Then, on the outer surface of the covering layer 5 (the outer surface of the guide wire 1), the portion where the raised portion forming layer 4 is provided is raised relative to the portion where the raised portion forming layer 4 is not provided. That is, a raised portion (a raised portion) (convex portion) 81 is formed in a portion where the raised portion forming layer 4 is provided, and a recessed portion (recessed portion) is formed in a portion where the raised portion forming layer 4 is not provided. (Recessed portion) 82 is formed. This is because the thickness of the covering layer 5 is relatively thin, and the outer surface of the covering layer 5 is affected by the raised portion forming layer 4 and rises corresponding to the shape and pattern of the raised portion forming layer 4. (It becomes a corresponding shape).

  As a result, the contact area between the outer surface of the covering layer 5 and the lumen of the catheter or the lumen of the endoscope is reduced, the frictional resistance (sliding resistance) is reduced, and the slidability is improved. The operability is good.

  Further, the raised portion 81 and the recessed portion 82 are not formed by directly processing the covering layer 5 but are formed by the influence of the raised portion forming layer 4 immediately below the covering layer 5. There are no sharp corners or apexes on the outer surface, and the outer surface becomes smooth. That is, the raised portion 81 and the recessed portion 82 are rounded. As a result, the slidability is further improved and the safety is very high.

  Further, the shape (pattern) and dimensions of the raised portion 81 and the recessed portion 82 are not particularly limited, but the raised portion 81 is formed in a spiral shape in the illustrated configuration.

  When the raised portions 81 and the recessed portions 82 are alternately formed along the longitudinal direction of the core wire 3 (wire body 2), such as a spiral shape or an annular shape, the longitudinal direction of the core wire 3 (wire body 2) The distance (pitch) a between the ridges 81 adjacent to each other is preferably about 0.5 to 10 mm, and more preferably about 1 to 5 mm.

In addition, the height (average height) h of the raised portion 81 is preferably about 1 to 30 μm, and more preferably about 2 to 10 μm.
The covering layer 5 is made of a material containing a resin.

  The resin contained in the constituent material of the covering layer 5 is not particularly limited, but at least one of them is preferably a resin having compatibility with the resin contained in the constituent material of the raised portion forming layer 4. . That is, it is preferable that the constituent material of the coating layer 5 and the constituent material of the raised portion forming layer 4 contain compatible resins. As a result, the raised portion forming layer 4 and the covering layer 5 are firmly adhered (bonded), thereby preventing peeling of the covering layer 5 even when bending or twisting acts repeatedly on the guide wire 1. Can do.

  Here, having compatibility means that the thermodynamic mutual solubility is good, in other words, that it is not easily separated between the two after curing.

  As a combination of compatible resins, the same type (common) (same) resins may be different types of resins, and different types of resins may be combined. Common (identical) groups such as those having "imide groups" such as etherimide and polyimide, polyamideimide and polyetherimide, and those having "sulfone groups" such as polysulfone and polyethersulfone. The thing which has.

  The content of the compatible resin in the raised portion forming layer 4 is preferably about 1 to 90% by weight and more preferably about 5 to 50% by weight with respect to the entire raised portion forming layer 4. preferable. Thereby, the adhesiveness of the protruding part formation layer 4 and the coating layer 5 can be improved.

  The content of the compatible resin in the coating layer 5 is preferably about 1 to 50% by weight, and more preferably about 3 to 35% by weight with respect to the entire coating layer 5. Thereby, the adhesiveness of the protruding part formation layer 4 and the coating layer 5 can be improved.

  The thickness of the coating layer 5 is not particularly limited and is appropriately set according to the dimensions of the raised portions 81 and the recessed portions 82 to be formed, but is preferably about 1 to 20 μm, and is preferably about 2 to 10 μm. Is more preferable.

  Further, the total value of the thickness of the covering layer 5 and the thickness of the raised portion forming layer 4 is not particularly limited, but the total value of the thickness of the covering layer 5 and the thickness of the raised portion forming layer 4 in the raised portion 81 is The thickness is preferably 50 μm or less, more preferably about 2 to 40 μm, and still more preferably about 4 to 20 μm.

  Thereby, the diameter of the guide wire 1 can be reduced. In addition, in the conventional visual marker formed by attaching a hollow tube having a colored spiral stripe pattern or a plurality of stripe patterns by heat shrinking from above the core wire and wrapping it, the thickness becomes about 100 μm. Although it is difficult to realize the above thickness, in the present reference example, the raised portion forming layer 4 and the coating having the above thickness can be easily and reliably formed by the above configuration (structure) and the manufacturing method described later. Layer 5 can be formed.

  In addition, description of the manufacturing method of the guide wire 1 is abbreviate | omitted here, and it demonstrates together in description of the manufacturing method of the guide wire 1 in the 2nd reference example mentioned later.

  As described above, according to this guide wire 1, since the raised portion 81 and the recessed portion 82 are formed on the outer surface of the guide wire 1, the outer surface of the covering layer 5, the lumen of the catheter, The contact area with the lumen of the endoscope is reduced, the frictional resistance (sliding resistance) is reduced, and the slidability is improved. Thereby, the guide wire excellent in operability can be provided.

  Further, the raised portion 81 and the recessed portion 82 are not formed by directly processing the covering layer 5 but are formed by the influence of the raised portion forming layer 4 immediately below the covering layer 5. No sharp corners, tops, or the like are formed on the outer surface, and the outer surface is smooth, and the raised portion 81 and the recessed portion 82 are rounded. As a result, the slidability is further improved and the safety is very high.

  Further, in this guide wire 1, the diameter can be reduced, and the color of the raised portion forming layer 4 can be adjusted by the type of pigment contained in the raised portion forming layer 4, the composition of the resin material, the content of the pigment, and the like. Thus, any color can be easily set. For this reason, the range of selection of the color of the visual marker is wide, and the raised portion forming layer 4 with good visibility can be provided for the core wire 3 (wire body 2) of various colors. Thereby, the guide wire 1 which has the visual recognition marker excellent in visibility can be provided.

  In addition, since the constituent material of the covering layer 5 and the constituent material of the raised portion forming layer 4 contain mutually compatible resins (for example, a common resin), the raised portion forming layer 4 and the covered layer 5 Are firmly adhered (bonded), and even when bending or twisting is repeatedly applied to the guide wire 1, peeling of the coating layer 5 can be prevented.

  In the present invention, the raised portion forming layer 4 may not function as a visual marker. In this case, the constituent material of the raised portion forming layer 4 may not contain a pigment. That is, the raised portion forming layer 4 may have, for example, the same color as the core wire 3 (wire body 2), may be transparent, or may be opaque. Moreover, the coating layer 5 may be opaque, for example. Further, the shape of the raised portion forming layer 4 may be a shape whose position cannot be confirmed, for example.

  Moreover, in this reference example, the wire main body 2 is comprised by the core wire 3, and the protruding part formation layer 4 and the coating layer 5 are directly provided in the outer surface of the core wire 3, However, In this invention, it is limited to this. For example, one or a plurality of layers may be provided on the outer surface of the core wire 3, and the raised portion forming layer 4 and the covering layer 5 may be provided on the outer surface of the layer. That is, the wire main body 2 may be provided on the outer periphery of the core wire 3 and may have one or a plurality of layers that cover a part or the whole of the outer periphery.

<Second Reference Example>
FIG. 3 is a longitudinal sectional view showing a portion in the vicinity of the outer surface in the second reference example of the guide wire of the present invention, and FIG. 4 is a view for explaining a method of manufacturing the guide wire shown in FIG. It is a longitudinal cross-sectional view which shows the part of the vicinity of the outer surface of a guide wire.

  Hereinafter, the guide wire 1 of the second reference example will be described focusing on the differences from the first reference example described above, and the description of the same matters will be omitted.

  As shown in FIG. 3, the guide wire 1 of the second reference example includes an outer layer 6 that covers the covering layer 5 and has transparency (light transmittance) that allows the protruding portion forming layer 4 to be visually recognized. . The outer layer 6 may cover a part of the coating layer 5 or may cover the entire layer (over the entire length). Then, on the outer surface of the outer layer 6 (the outer surface of the guide wire 1), the portion where the raised portion forming layer 4 is provided is raised relative to the portion where the raised portion forming layer 4 is not provided, and the raised portion 81 is provided. And the hollow part 82 is formed.

  The outer layer 6 can be formed for various purposes. As an example, the outer layer 6 reduces the friction (sliding resistance) of the guide wire 1 and improves the slidability, thereby improving the operability of the guide wire 1. It is possible to improve.

  In order to reduce the friction (sliding resistance) of the guide wire 1, it is preferable that the constituent material of the outer layer 6 contains a resin (second resin) that can reduce friction as described below. . As a result, the frictional resistance (sliding resistance) with the lumen of the catheter and the lumen of the endoscope used together with the guide wire 1 is reduced and the slidability is improved, and the lumen of the catheter and the lumen of the endoscope are improved. The operability of the guide wire 1 becomes better. Further, since the sliding resistance of the guide wire 1 is lowered, when the guide wire 1 is moved and / or rotated by the lumen of the catheter or the lumen of the endoscope, the guide wire 1 is not kinked (bent) or twisted. It can prevent more reliably.

  The thickness of the outer layer 6 is not particularly limited, but is preferably about 1 to 15 μm, and more preferably about 2 to 10 μm. If the thickness of the outer layer 6 is too thick, the physical characteristics of the guide wire 1 may be affected, and it is disadvantageous for reducing the diameter of the guide wire 1.

  The raised portion forming layer 4 of the guide wire 1 is made of a material containing a first resin and a pigment. The covering layer 5 is made of a material including a resin compatible with the first resin and a second resin different from the compatible resin, preferably the first resin and , And a second resin different from the first resin. The outer layer 6 is made of a material containing a resin compatible with the second resin, preferably a material containing the second resin.

  Thereby, the coating layer 5 functions as an adhesive layer (adhesive) that adheres the raised portion forming layer 4 and the outer layer 6. For this reason, even if it uses resin which is hard to adhere | attach on another member as 2nd resin contained in the outer layer 6, peeling of the outer layer 6 can be prevented. That is, since the constituent material of the covering layer 5 and the constituent material of the raised portion forming layer 4 contain mutually compatible resins, in particular, a common resin (first resin), the raised portion forming layer 4 and the covering layer 5 are firmly adhered (bonded), and the constituent material of the outer layer 6 and the constituent material of the covering layer 5 are compatible with each other, particularly a common resin (second resin). ), The covering layer 5 and the outer layer 6 are firmly adhered to each other, thereby preventing the covering layer 5 and the outer layer 6 from being peeled even when the guide wire 1 is repeatedly bent or twisted. can do.

  The content of the first resin in the raised portion forming layer 4 is preferably 50% by weight or more, more preferably about 1 to 90% by weight with respect to the entire raised portion forming layer 4, More preferably, it is about 50% by weight. Thereby, the adhesiveness of the protruding part formation layer 4 and the coating layer 5 can be improved.

  Further, the content of the resin (for example, the first resin) having compatibility with the first resin in the coating layer 5 is preferably about 1 to 50% by weight with respect to the entire coating layer 5, More preferably, it is about 3 to 35% by weight. Thereby, the adhesiveness of the protruding part formation layer 4 and the coating layer 5 can be improved.

  The content of the second resin in the coating layer 5 is preferably 50% by weight or more, more preferably about 50 to 99% by weight, and 65 to 97% by weight with respect to the entire coating layer 5. More preferably, it is about%. Thereby, the adhesiveness of the coating layer 5 and the outer layer 6 can be improved.

  Further, the content of the resin (for example, the second resin) having compatibility with the second resin in the outer layer 6 is preferably about 1 to 30% by weight with respect to the entire outer layer 6, More preferably, it is about 20% by weight. Moreover, it is also preferable that the outer layer 6 is composed of a resin having compatibility with the second resin, in particular, the second resin. Thereby, the friction (sliding resistance) of the guide wire 1 can be further reduced while improving the adhesion between the coating layer 5 and the outer layer 6.

  Although it does not specifically limit as 1st resin, It is preferable that it is following (1) or (2).

  (1) As the first resin, it is preferable to use a resin (heat-resistant resin) having a melting point of 200 ° C. or higher, and it is more preferable to use a resin having a melting point of about 200 to 300 ° C.

  Examples of the resin having a melting point of 200 ° C. or higher include polysulfone, polyimide, polyether ether ketone, polyarylene ketone, polyphenylene sulfide, polyarylene sulfide, polyamideimide, polyetherimide, polyimidesulfone, polyallylsulfone, and poloallyl. Examples include ether sulfone, polyester, and polyether sulfone.

(2) It is preferable to use a thermosetting resin as the first resin.
Examples of the thermosetting resin include epoxy resins, phenol resins, polyesters (unsaturated polyesters), polyimides, silicone resins, polyurethanes, and the like, and one or more of these can be used in combination. .

Examples of the second resin for reducing the friction (sliding resistance) of the guide wire 1 include polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and tetrafluoroethylene. -Fluorocarbon resins such as perfluoroalkyl vinyl ether copolymer (PFA).
Next, a method for manufacturing the guide wire 1 will be described.

<1>
Liquid material for the raised portion forming layer 4 composed of the constituent material of the raised portion forming layer 4 and a solvent (liquid material for the raised portion forming layer), and the covering composed of the constituent material of the covering layer 5, the solvent, and the like A liquid material for the layer 5 (liquid material for the coating layer) and a liquid material for the outer layer 6 (liquid material for the outer layer) composed of the constituent material of the outer layer 6 and a solvent are prepared.

  First, a liquid material for a raised portion forming layer is applied in the raised portion forming region 40 on the outer periphery of the core wire 3 (wire body 2) (over the entire length of the core wire 3 in this reference example), and the coating film (coating film). Form. In this case, the liquid material for the raised portion forming layer is applied to the entire raised portion forming region 40 (all regions) to form the coating film. And the said coating film is dried.

  Since the dimensions of each part such as the thicknesses of the raised portion forming layer 4, the covering layer 5, and the outer layer 6 have already been described, the description thereof is omitted here.

<2>
The coating film formed of the liquid material for the raised portion forming layer is partially removed, and the pattern of the raised portion forming layer 4 is formed.

  Moreover, when removing this coating film, at the same time, the portion of the outer surface of the core wire 3 from which the coating film has been removed (the coating layer 5 of the portion where the raised portion forming layer 4 in the raised portion forming region 40 is not formed). It is preferable to form minute irregularities on the surface immediately below.

  Thereby, the adhesiveness of the core wire 3 and the coating layer 5 improves, and peeling of the coating layer 5 can be prevented. Further, when removing the coating film, minute irregularities are formed at the same time, so that the manufacturing process is not increased.

  The method of removing the coating film of the liquid material for the raised portion forming layer is not particularly limited. For example, a method of grinding (cutting) using a grinding tool (cutting tool) such as a grinder, a laser irradiation apparatus, and a laser The method of removing by irradiating light can be used. By using these methods, when removing the coating film, the minute unevenness can be formed at the same time.

  In addition, as shown in FIG. 4, when the coating film 41 of the liquid material for the raised portion forming layer is ground with the grinding tool, the edge portion (edge) of the coating film 41 after grinding is used. Part) 42 becomes gentle (rounded). Thereby, it is possible to prevent air bubbles from remaining in the removal portion 43 of the coating film 41 in the step of applying the coating layer liquid material described later, and the coating layer liquid material is applied to the entire removal portion 43. Can be filled. Thereby, peeling of the coating layer 5 can be prevented more reliably.

<3>
The coating layer liquid material is applied over the entire length of the core wire 3 to the coating film of the raised portion forming layer liquid material and the outer periphery of the core wire 3 to form the coating film (coating film). Thereby, the coating film of the liquid material for the bulging portion forming layer and the core wire 3 are covered over the entire length of the core wire 3 by the coating film of the liquid material for the coating layer. And the coating film of the liquid material for said coating layers is dried.

<4>
The outer layer liquid material is applied to the outer periphery of the coating layer liquid material coating over the entire length of the core wire 3 to form the coating film (coating film). Thereby, the coating film of the liquid material for coating layer is covered over the entire length of the core wire 3 by the coating film of the liquid material for outer layer. And the coating film of the liquid material for outer layers is dried. In the first reference example described above, this step <4> is omitted.

<5>
Each coating film formed (laminated) on the core wire 3 is baked (heated) to form the raised portion forming layer 4, the coating layer 5, and the outer layer 6.

  Each condition (baking temperature, treatment time, etc.) in this treatment is not particularly limited. For example, the constituent material of the raised portion forming layer 4, the coating layer 5 and the outer layer 6 (for example, the composition of the resin material, etc.) Although it sets suitably according to various conditions, it is preferable that a calcination temperature is about 330-600 degreeC, and it is more preferable that it is about 380-500 degreeC. Moreover, it is preferable that processing time (baking time) is about 1 to 60 minutes, and it is more preferable that it is about 3 to 30 minutes.

  And if necessary, a hydrophilic lubricating coating, a hydrophobic lubricating coating, etc. are provided, and the guide wire 1 is obtained.

  According to this guide wire 1, the same effect as the guide wire 1 of the first reference example described above can be obtained.

  In addition, when the protruding part formation layer 4 does not need to function as a visual marker, the outer layer 6 may be opaque, for example.

<Third reference example>
FIG. 5 is a longitudinal sectional view showing a portion in the vicinity of the outer surface in the third reference example of the guide wire of the present invention.

  Hereinafter, the guide wire 1 of the third reference example will be described focusing on the differences from the first reference example described above, and the description of the same matters will be omitted.

  In the guide wire 1 of the third reference example shown in FIG. 5, the covering layer 5 has a function of reducing the friction (sliding resistance) of the guide wire 1, thereby improving the slidability of the guide wire 1. Thus, the operability of the guide wire 1 is improved.

  In order to reduce the friction (sliding resistance) of the guide wire 1, the constituent material of the coating layer 5 contains a resin (second resin) that can reduce friction as described below. preferable. As a result, the frictional resistance (sliding resistance) with the lumen of the catheter and the lumen of the endoscope used together with the guide wire 1 is reduced and the slidability is improved, and the lumen of the catheter and the lumen of the endoscope are improved. The operability of the guide wire 1 becomes better. Further, since the sliding resistance of the guide wire 1 is lowered, when the guide wire 1 is moved and / or rotated by the lumen of the catheter or the lumen of the endoscope, the guide wire 1 is not kinked (bent) or twisted. It can prevent more reliably.

  Further, the raised portion forming layer 4 of the guide wire 1 is made of a material containing a first resin, a second resin different from the first resin, and a pigment. The covering layer 5 is made of a material containing the second resin. That is, a common resin (second resin) is included in the constituent material of the covering layer 5 and the constituent material of the raised portion forming layer 4. Thereby, the protruding portion forming layer 4 and the coating layer 5 are firmly adhered (bonded), and as a result, even if a resin that is difficult to adhere to other members is used as the second resin contained in the coating layer 5, Even when bending or twisting is repeatedly applied to the guide wire 1, it is possible to prevent the covering layer 5 from being peeled off.

  The content of the second resin in the raised portion forming layer 4 is preferably 1 to 30% by weight or more, more preferably about 3 to 20% by weight with respect to the entire raised portion forming layer 4. Thereby, the adhesiveness of the protruding part formation layer 4 and the coating layer 5 can be improved.

  The content of the second resin in the coating layer 5 is preferably about 1 to 30% by weight and more preferably about 3 to 20% by weight with respect to the entire coating layer 5. It is also preferable that the coating layer 5 is made of the second resin. Thereby, the friction (sliding resistance) of the guide wire 1 can be further reduced while improving the adhesion between the raised portion forming layer 4 and the covering layer 5.

  Although it does not specifically limit as 1st resin, It is preferable that it is following (1) or (2).

  (1) As the first resin, it is preferable to use a resin (heat-resistant resin) having a melting point of 200 ° C. or higher, and it is more preferable to use a resin having a melting point of about 200 to 300 ° C.

  Examples of the resin having a melting point of 200 ° C. or higher include polysulfone, polyimide, polyether ether ketone, polyarylene ketone, polyphenylene sulfide, polyarylene sulfide, polyamideimide, polyetherimide, polyimidesulfone, polyallylsulfone, and poloallyl. Examples include ether sulfone, polyester, and polyether sulfone.

(2) It is preferable to use a thermosetting resin as the first resin.
Examples of the thermosetting resin include epoxy resins, phenol resins, polyesters (unsaturated polyesters), polyimides, silicone resins, polyurethanes, and the like, and one or more of these can be used in combination. .

  Examples of the second resin include fluorine resins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and tetrafluoroethylene-perfluoroalkyl vinyl ether copolymer (PFA). Etc.

  Further, in the raised portion forming region 40, the area of the outer surface of the raised portion forming layer 4 is larger than the area of the outer surface of the core wire 3 (the surface immediately below the covering layer 5) where the raised portion forming layer 4 is not formed. It is set large.

  As a result, the contact area between the raised portion forming layer 4 and the covering layer 5 is increased, and the raised portion forming layer 4 and the covering layer 5 are more firmly adhered to each other, thereby preventing the covering layer 5 from being peeled off more reliably. can do.

Further, the area of the outer surface of the raised portion forming layer 4 in the raised portion forming region 40 is S ₁ , and the outer surface of the core wire 3 in the portion of the raised portion forming region 40 where the raised portion forming layer 4 is not formed (of the coating layer 5). The ratio S ₁ / S ₂ is preferably about 1.5 to 10, more preferably about 3 to 8, when the area of the immediately lower surface is S ₂ .

When the S ₁ / S ₂ is larger than the upper limit value, the visibility of the raised portion forming layer 4 may be lowered depending on other conditions, and the S ₁ / S ₂ is lower than the lower limit value. If it is small, the adhesion between the raised portion forming layer 4 and the covering layer 5 may be lowered depending on other conditions.

  According to this guide wire 1, the same effect as the guide wire 1 of the first reference example described above can be obtained.

<First Embodiment>
FIG. 6 is a longitudinal sectional view showing a portion in the vicinity of the outer surface in the first embodiment of the guide wire of the present invention.

  Hereinafter, the guide wire 1 of the first embodiment will be described with a focus on differences from the second reference example described above, and description of similar matters will be omitted.

  As shown in FIG. 6, the guide wire 1 of the first embodiment includes a base layer 7 having a color different from that of the raised portion forming layer 4, and the raised portion forming layer 4 has an outer periphery (underlayer) of the underlayer 7. 7)).

  The underlayer 7 covers the outer periphery of the core wire 3 (wire body 2) at least in the raised portion forming region 40. For example, when the raised portion forming region 40 is set as a part of the core wire 3, the base layer 7 may cover the outer periphery of the core wire 3 only in the raised portion forming region 40. May be covered (over the entire length).

  Further, in the raised layer forming region 40, the covering layer 5 is in close contact with the base layer 7 in a portion where the raised portion forming layer 4 is not provided.

  The raised portion forming layer 4 of the guide wire 1 is made of a material containing a first resin and a pigment, and the base layer 7 is made of a resin compatible with the first resin and a marker forming layer. 4 pigment and a different color pigment, preferably, a material containing the first resin and a different color pigment from the raised portion forming layer 4 pigment. The color of the underlayer 7 is mainly determined by the type and characteristics of the pigment contained in the underlayer 7, the composition and characteristics of the resin material (particularly color tone, etc.), and the pigment content. Therefore, it can be set freely.

  In addition, since the constituent material of the base layer 7 and the constituent material of the raised portion forming layer 4 include a compatible resin, in particular, a common resin (first resin), the base layer 7 and the raised portion are formed. Even when the guide wire 1 is repeatedly subjected to bending or twisting, the protruding portion forming layer 4 can be prevented from being peeled off.

  The content of the resin (for example, the first resin) having compatibility with the first resin in the underlayer 7 is preferably about 1 to 90% by weight with respect to the entire underlayer 7, More preferably, it is about 50% by weight. Thereby, the adhesiveness of the foundation | substrate layer 7 and the protruding part formation layer 4 can be improved.

  In addition, the pigment content in the underlayer 7 depends on the type and characteristics of the pigment and the composition and characteristics of the resin material. % Is preferable, and about 5 to 95% by weight is more preferable.

  The pigment in the underlayer 7 is preferably uniformly dispersed, but may be unevenly distributed, for example, on the outer surface side of the underlayer 7.

  In addition, a pigment may be used individually by 1 type and may use 2 or more types together (especially mixing).

  The thickness of the underlayer 7 is not particularly limited, but is preferably about 1 to 20 μm, and more preferably about 2 to 10 μm.

  According to this guide wire 1, the same effect as the guide wire 1 of the second reference example described above can be obtained.

  In the guide wire 1, the color of the raised portion forming layer 4 can be easily selected by adjusting the type of pigment, the composition of the resin material, the pigment content, and the like contained in the raised portion forming layer 4. The color of the underlayer 7 can be easily changed to any color by adjusting the type of pigment contained in the underlayer 7, the composition of the resin material, the pigment content, and the like. Can be set. For this reason, the selection range of the visible marker and the background color is wide, and a combination of the raised portion forming layer 4 and the base layer 7 having good visibility is selected regardless of the color of the core wire 3 (wire body 2). Can do. Thereby, the guide wire 1 which has the visual recognition marker excellent in visibility can be provided.

  Note that the first embodiment can also be applied to the first and third reference examples described above.

<Fourth Reference Example>
FIG. 7 is a longitudinal sectional view showing a portion in the vicinity of the outer surface in a fourth reference example of the guide wire of the present invention.

  Hereinafter, the guide wire 1 of the fourth reference example will be described focusing on the differences from the second reference example described above, and the description of the same matters will be omitted.

  In the guide wire 1 of the fourth reference example shown in FIG. 7, the raised portion forming layer 4 does not function as a visual marker and partially raises the outer surface of the guide wire 1 (the raised portion 81 and the recessed portion 82. It is configured to function as a means.

  The raised portion forming layer 4 of the guide wire 1 is coated on the outer periphery (outer surface) of the core wire 3 (wire body 2) in the raised portion forming region 40, and the outer surface side partially protrudes. That is, the protruding portion 44 is partially formed on the outer surface side of the raised portion forming layer 4.

  The protruding portion 44 is a portion corresponding to the raised portion forming layer 4 in the second reference example described above, and a portion (raised portion) where the protruding portion 44 is provided on the outer surface of the outer layer 6 (outer surface of the guide wire 1). The portion corresponding to the protruding portion of the portion forming layer 4) is raised with respect to the portion where the protruding portion 44 is not provided (the portion corresponding to the portion where the protruding portion forming layer 4 does not protrude), and the protruding portion 81 and A recess 82 is formed.

  According to this guide wire 1, the same effects as those of the guide wire 1 of the second reference example described above can be obtained except for the effects relating to the visual marker.

  This fourth reference example can also be applied to the first and third reference examples described above.

Second Embodiment
FIG. 8 is a partial longitudinal sectional view showing a second embodiment of the guide wire of the present invention, and FIG. 9 is a longitudinal sectional view showing a portion in the vicinity of the outer surface of the guide wire shown in FIG. For convenience of explanation, the right side in FIG. 8 is referred to as “base end”, and the left side is referred to as “tip”. Further, in FIG. 8, for easy understanding, the length direction of the guide wire is shortened and the thickness direction of the guide wire is exaggerated and schematically illustrated. The ratio is different from the actual.

  Hereinafter, the guide wire 1 of the second embodiment will be described focusing on the differences from the first reference example described above, and the description of the same matters will be omitted.

  As shown in FIGS. 8 and 9, the guide wire 1 includes a wire main body 2 composed of a core wire (wire material) 3, a spiral coil 12, a resin coating layer 11, and an annular member (step filling member) 9. And a base layer 7, a raised portion forming layer 4, a covering layer 5, and a hydrophilic lubricating layer 13.

  The coil 12 is disposed on the outer periphery of the distal end portion of the core wire 3 (wire body 2), that is, on the outer periphery of the small-diameter portion 36 of the core wire 3 in the illustrated configuration. The coil 12 is a member formed by spirally winding (forming) a wire (thin wire) (wire material), and is installed so as to cover the small diameter portion 36 of the core wire 3 (wire body 2). In the illustrated configuration, adjacent wires of the coil 12 are in contact with each other and are in a so-called densely wound state. That is, the coil 12 (element wire) is wound in a close winding so that adjacent element wires are in contact with each other. These strands generate a force (compression force) that pushes each other in the axial direction of the wire body 2 in a natural state. Here, the “natural state” refers to a state where no external force is applied. Needless to say, the compression force may not be generated in a natural state.

  The coil 12 (element wire) is wound so that the element wire contacts the outer periphery of the small diameter portion 36 of the core wire 3. That is, the inner surface of the coil 12 is in contact with the outer periphery of the small diameter portion 36 of the core wire 3.

  Unlike the illustrated configuration, the small-diameter portion 36 of the core wire 3 may be inserted into the coil 12 without being in contact with the inner surface of the coil 12. That is, the element wire of the coil 12 may be separated from the outer periphery of the core wire 3. The coil 12 may have a gap between the spirally wound strands in a state where no external force is applied.

  The coil 12 is preferably made of a metal material. Examples of the metal material constituting the coil 12 include stainless steel, superelastic alloy, cobalt-based alloy, noble metals such as gold, platinum, tungsten, and alloys containing these (for example, platinum-iridium alloy). In particular, when it is made of an X-ray opaque material such as a noble metal (a material having X-ray contrast properties), the guide wire 1 has X-ray contrast properties, and the tip position is confirmed under X-ray fluoroscopy. However, it can be inserted into a living body, which is preferable. Further, the coil 12 may be composed of different materials on the distal end side and the proximal end side. For example, the distal end side may be constituted by a coil made of an X-ray opaque material, and the proximal end side may be constituted by a coil made of a material that relatively transmits X-rays (such as stainless steel). The total length of the coil 12 is not particularly limited, but is preferably about 5 to 500 mm.

  In this embodiment, the coil 12 has a circular cross section of the strand. However, the present invention is not limited to this, and the cross section of the strand is, for example, elliptical or quadrangular (particularly rectangular). It may be.

  Moreover, the most advanced portion of the core wire 3 has a flat shape. That is, the core wire 3 has a flat portion 37 having a flat shape at the tip of the small diameter portion 36. In the illustrated configuration, the flat portion 37 has a substantially rectangular flat plate shape.

The width of the flat portion 37 (the length in the radial direction of the coil 12) L is set larger than the inner diameter a of the coil 12 (the outer diameter D ₂ of the small diameter portion 36). The flat portion 37 is located on the distal end side of the distal end portion of the coil 12. That is, the coil 12 is disposed between the flat portion 37 and an annular member 9 to be described later, its distal end abuts (engages) with the flat portion 37, and its proximal end is the distal end surface of the annular member 9. 93 abuts.

  Thereby, it can prevent that the coil 12 comes off from the front-end | tip of the core wire 3 (wire main body 2), and detaches | leaves. Thereby, a fixing material for fixing (fixing) the coil 12 to the core wire 3 can be omitted. Needless to say, the coil 12 may be fixed to the core wire 3 by a fixing material such as solder (brazing material) or adhesive. Moreover, the fixing method of the coil 12 is not restricted to these, For example, welding may be sufficient.

  This flat part 37 can be formed by press molding etc., for example. As a specific example, for example, the length of the small-diameter portion 36 of the core wire 3 is increased by the flat portion 37, and press molding is performed on the most distal portion of the core wire 3. Thereby, a flat portion 37 is formed at the tip of the small diameter portion 36.

  The guide wire 1 also has a resin coating layer 11 that covers the distal end portion of the core wire 3 (wire body 2), that is, the small diameter portion 36 and the flat portion 37, and the outer periphery (outer surface) of the coil 12. The resin coating layer 11 is in close contact with the flat portion 37 of the core wire 3 and the outer periphery of the coil 12.

  The resin coating layer 11 can be formed for various purposes. As an example, the resin coating layer 11 can be provided for the purpose of improving safety when the guide wire 1 is inserted into a living body lumen or the like. For this purpose, the resin coating layer 11 is preferably made of a flexible material (soft material, elastic material). The resin coating layer 11 is particularly preferably made of a material that is softer than the underlayer 7, the raised portion forming layer 4, and the coating layer 5 described later.

  Examples of such flexible materials include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, silicone resin, polyurethane elastomer, polyester elastomer, polyamide. Examples thereof include thermoplastic elastomers such as elastomers, various rubber materials such as latex rubber and silicone rubber, or composite materials in which two or more thereof are combined.

  In particular, when the resin coating layer 11 is made of the above-described thermoplastic elastomer or various rubber materials, the flexibility of the distal end portion of the guide wire 1 is further improved. The inner wall or the like can be more reliably prevented from being damaged, and the safety is extremely high.

  Moreover, it is preferable that particles (filler) made of an X-ray opaque material (a material having X-ray contrast properties) be dispersed in the resin coating layer 11. Thereby, X-ray contrast property is obtained for the guide wire 1, and the guide wire 1 can be inserted into the living body while confirming the position of the tip under fluoroscopy.

  The material constituting the particles is not particularly limited as long as it is an X-ray opaque material. For example, a noble metal such as gold, platinum, or tungsten, or an alloy containing these (for example, platinum-iridium alloy) can be used.

The thickness of the resin coating layer 11 is not particularly limited, and is appropriately determined in consideration of the purpose of forming the resin coating layer 11, the constituent material, the forming method, and the like. Usually, the thickness (average) is 20 to 20%. The thickness is preferably about 500 μm, more preferably about 30 to 300 μm. If the thickness of the resin coating layer 11 is too thin, the purpose of forming the resin coating layer 11 may not be sufficiently exhibited. Moreover, when the thickness of the resin coating layer 11 is too thick, the physical characteristics of the wire body 2 (guide wire 1) may be affected.
The resin coating layer 11 may be a laminate of two or more layers.

  Further, the tips of the underlayer 7 and the coating layer 5 described later and the base end of the resin coating layer 11 are separated by a predetermined distance (not in contact). An annular member 9 is provided on the proximal end side of the resin coating layer 11 so as to fill a step space between the proximal end portion of the resin coating layer 11 and the wire body 2. The annular member 9 is provided on (in close contact with) the outer periphery of the tapered portion 34 of the core wire 3. Further, the distal end 92 of the annular member 9 is located at the proximal end of the resin coating layer 11, and the proximal end 91 is located at the distal ends of the base layer 7 and the coating layer 5.

  Note that the outer diameter of the base end of the resin coating layer 11 is larger than the outer diameter of the wire body 2 at the base end of the resin coating layer 11, and the step space is generated by a difference between these outer diameters.

  The outer diameter of the distal end 92 of the annular member 9 is substantially equal to the outer diameter of the proximal end of the resin coating layer 11, and the distal end surface 93 of the annular member 9 is joined (adhered) to the proximal end surface 111 of the resin coating layer 11. ing. In this case, the resin coating layer 11 does not cover the annular member 9 beyond the distal end 92 of the annular member 9 toward the proximal end side. That is, a continuous surface without a step is formed between the tip 92 of the annular member 9 and the base end of the resin coating layer 11.

  Further, the outer diameter of the annular member 9 gradually decreases from the distal end side toward the proximal end side (toward the proximal direction), and the outer diameter of the proximal end 91 of the annular member 9 is smaller than the outer diameter of the distal end 92. small. The outer diameter of the base end 91 of the annular member 9 is substantially equal to the outer diameter of the coating layer 5 at the base end 91 of the annular member 9. That is, a continuous surface without a step is formed between the coating layer 5 and the base end 91 of the annular member 9. The outer diameter of the base end 91 of the annular member 9 is smaller than the outer diameter of the main body portion 32 of the core wire 3. The proximal end 91 of the annular member 9 is located on the distal end side with respect to the tapered portion proximal end 341 (see FIG. 1). The annular member 9 has a length of 0.5 to 15 mm.

  Further, the inner diameter of the base end 91 of the annular member 9 is larger than the inner diameter of the distal end 92. This is because the annular member 9 is located at the tapered portion 34 of the core wire 3. The inner diameter of the proximal end 91 may be the same as the inner diameter of the distal end 92.

  The annular member 9 can prevent the proximal end portion of the resin coating layer 11 from being caught by a medical instrument such as a distal end of a catheter used in combination with the guide wire 1 or a raising base of an endoscope. Thereby, it is possible to prevent the resin coating layer 11 from being peeled off. Moreover, the fall of the slidability of the guide wire 1 by the said level | step difference can be prevented.

  The hardness (hardness) of the annular member 9 is preferably set higher than the hardness of the resin coating layer 11. Thereby, it is possible to prevent the annular member 9 from being caught by a medical instrument such as a distal end of a catheter used in combination with the guide wire 1 or an elevator platform.

  Moreover, either one or both of the front end surface 93 and the inner peripheral surface of the annular member 9 may be roughened. When the tip surface 93 of the annular member 9 is roughened, the adhesion to the resin coating layer 11 is improved, and when the inner peripheral surface is roughened, the core wire 3 and the fixing material 14 described later are used. Adhesion with is improved.

  Moreover, it does not specifically limit as a constituent material of the cyclic | annular member 9, For example, various resin materials, various metal materials, etc. can be used. For example, the same constituent material as that of the resin coating layer 11 can be used, or a constituent material different from that of the resin coating layer 11 can be used.

  However, the annular member 9 is preferably made of a metal material (metal) or a hard resin material (resin), and particularly preferably made of a metal material.

  As the hard resin material constituting the annular member 9, for example, polycarbonate, polyamide (nylon), polyethylene terephthalate, polyacetal, polyphenylene sulfide, or the like can be used.

  Moreover, as a metal material which comprises the annular member 9, stainless steel, titanium, a titanium alloy, a Ni-Ti alloy, aluminum, gold | metal | money, platinum etc. can be used, for example. X-ray contrast properties are improved by using precious metals such as gold and platinum, or alloys thereof.

  When the annular member 9 is made of a metal material, the outer periphery of the annular member 9 may be covered with a coating layer (not shown). The constituent material of the coating layer is not particularly limited, and for example, various resin materials, various ceramics, various metal materials, and the like can be used. In particular, it is preferable to use an insulating material.

  The annular member 9 is fixed (fixed) to the core wire 3 (wire body 2) by a fixing material 14 provided on the outer periphery of the tapered portion 34 of the core wire 3.

  As the fixing material 14, for example, solder (brazing material), an adhesive, or the like can be used. In particular, it is preferable to use an insulating adhesive.

  Needless to say, the fixing method of the annular member 9 is not limited to the fixing material.

  Further, in the illustrated configuration, the entire annular member 9 (entire) is located at the tapered portion 34, but not limited to this, even if only a part of the annular member 9 is located at the tapered portion 34. Good.

  The annular member 9 has a function of reducing the difference in rigidity (bending rigidity, torsional rigidity) between the proximal end side and the distal end side from the annular member 9 of the wire body 2. 11 is prevented from rapidly increasing in rigidity, and kink (bending) at the base end of the resin coating layer 11 can be prevented.

  Moreover, it is preferable that at least the outer surface (outer surface) of the distal end portion of the guide wire 1 is covered with a hydrophilic lubricating layer 13 made of a hydrophilic material. In the present embodiment, the outer surface of the guide wire 1 (the annular member 9 of the guide wire 1) in the region from the distal end of the guide wire 1 to the proximal end 91 of the annular member 9 (the distal ends of the base layer 7 and the covering layer 5). The outer surface of the portion on the tip side from the base end 91, that is, the outer surfaces of the resin coating layer 11 and the annular member 9 are covered with the hydrophilic lubricating layer 13. As a result, the hydrophilic material is wetted to produce lubricity, the friction (sliding resistance) of the guide wire 1 is reduced, and the slidability is improved. Therefore, the operability of the guide wire 1 is improved.

  Examples of hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer). Acrylamide polymer substances (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

  Such hydrophilic materials often exhibit lubricity due to wetting (water absorption) and reduce frictional resistance (sliding resistance) between the inner wall of the catheter used with the guide wire 1 and the lumen of the endoscope. . Thereby, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the catheter or the lumen of the endoscope becomes better.

  The guide wire 1 includes a base layer 7 having a color different from that of the raised portion forming layer 4, and the raised portion forming layer 4 is partially provided on the outer periphery (on the base layer 7). Yes. As shown in FIG. 8, the raised portion forming layer 4 has a lattice shape. Further, the raised portion forming region 40 is set from the proximal end of the core wire 3 to the middle of the tapered portion 34 (up to a position closer to the proximal end side than the annular member 9). It may be set over the entire length.

  The underlayer 7 covers the outer periphery of the core wire 3 (wire body 2) at least in the raised portion forming region 40. In the present embodiment, the foundation layer 7 is provided from the proximal end of the core wire 3 to the proximal end 91 of the annular member 9. Further, in the raised layer forming region 40, the covering layer 5 is in close contact with the base layer 7 in a portion where the raised portion forming layer 4 is not provided.

  In addition, the foundation layer 7 is not limited thereto, and for example, the outer periphery of the core wire 3 may be covered only in the raised portion forming region 40, and the entire core wire 3 is covered (over the entire length). Also good.

  The underlayer 7 is made of a material containing a resin and a pigment having a different color from the pigment of the marker forming layer 4. The color of the underlayer 7 is mainly determined by the type and characteristics of the pigment contained in the underlayer 7, the composition and characteristics of the resin material (particularly color tone, etc.), and the pigment content. Therefore, it can be set freely.

  In addition, the resin contained in the constituent material of the underlayer 7 is not particularly limited, but at least one of them is a resin having compatibility with the resin contained in the constituent material of the raised portion forming layer 4. Preferably, a common resin is used. That is, it is preferable that the constituent material of the base layer 7 and the constituent material of the raised portion forming layer 4 include compatible resins, and it is more preferable that a common resin is included. As a result, the raised portion forming layer 4 and the underlayer 7 are firmly adhered (bonded), thereby preventing peeling of the raised portion forming layer 4 even when bending or twisting acts repeatedly on the guide wire 1. can do.

  The content of the compatible resin (particularly common resin) in the underlayer 7 is preferably about 1 to 90% by weight, and about 5 to 50% by weight with respect to the entire underlayer 7. Is more preferable. Thereby, the adhesiveness of the foundation | substrate layer 7 and the protruding part formation layer 4 can be improved.

  Moreover, it is preferable that the constituent material of the base layer 7 and the constituent material of the coating layer 5 contain mutually compatible resins, and it is more preferable that a common resin is contained. As a result, the covering layer 5 and the base layer 7 are firmly adhered (bonded) at a portion where the raised portion forming layer 4 is not provided, and thereby bending and twisting repeatedly act on the guide wire 1. However, peeling of the coating layer 5 can be prevented.

  In addition, the pigment content in the underlayer 7 depends on the type and characteristics of the pigment and the composition and characteristics of the resin material. % Is preferable, and about 5 to 95% by weight is more preferable.

  The pigment in the underlayer 7 is preferably uniformly dispersed, but may be unevenly distributed, for example, on the outer surface side of the underlayer 7.

  In addition, a pigment may be used individually by 1 type and may use 2 or more types together (especially mixing).

  The thickness of the underlayer 7 is not particularly limited, but is preferably about 1 to 20 μm, more preferably about 2 to 10 μm, and further preferably about 3 to 8 μm.

The thickness (maximum thickness) d ₁ of the raised portion forming layer 4 is not particularly limited, but is preferably about 1 to 30 μm, more preferably about 2 to 10 μm, and about 3 to 8 μm. More preferably.

Further, the total value of the thickness of the covering layer 5 and the thickness of the raised portion forming layer 4 is not particularly limited, but the total value of the thickness of the covering layer 5 and the thickness of the raised portion forming layer 4 in the raised portion 81 (maximum value). ) _{d 2} may preferably be 50μm or less, more preferably about 2～40Myuemu, more preferably about 4～30Myuemu, particularly preferably about 15 to 25 [mu] m.

  According to this guide wire 1, the same effect as the guide wire 1 of the first reference example described above can be obtained.

  In the guide wire 1, the color of the raised portion forming layer 4 can be easily selected by adjusting the type of pigment, the composition of the resin material, the pigment content, and the like contained in the raised portion forming layer 4. The color of the underlayer 7 can be easily changed to any color by adjusting the type of pigment contained in the underlayer 7, the composition of the resin material, the pigment content, and the like. Can be set. For this reason, the selection range of the visible marker and the background color is wide, and a combination of the raised portion forming layer 4 and the base layer 7 having good visibility is selected regardless of the color of the core wire 3 (wire body 2). Can do. Thereby, the guide wire 1 which has the visual recognition marker excellent in visibility can be provided.

  Note that the second embodiment can also be applied to the second and third reference examples described above.

  As mentioned above, although the guide wire of this invention was demonstrated based on embodiment of illustration and reference example, this invention is not limited to this, The structure of each part is the thing of arbitrary structures which have the same function Can be substituted. Moreover, other arbitrary structures and processes may be added to the present invention.

  Further, the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  Moreover, it is preferable that the guide wire of this invention has a contrast property with respect to X-rays etc. Thereby, the position in the living body can be confirmed. As a method for imparting contrast to the guide wire, for example, a contrast agent (filler made of a material having contrast) may be added to a constituent material of a predetermined portion of a predetermined layer. The contrast agent is not particularly limited as long as it has a contrast function with respect to X-rays or the like, but is preferably composed of at least one of metal powder and metal oxide powder.

  Moreover, the use of the guide wire of the present invention is not limited to that used by being inserted into the lumen of the endoscope (transendoscopic guide wire).

DESCRIPTION OF SYMBOLS 1 Guide wire 2 Wire main body 3 Core wire 32 Main body part 34 Tapered part 341 Tapered part base end 342 Tapered part front end 36 Small diameter part 37 Flat part 4 Raised part forming layer 40 Raised part forming area 41 Coating film 42 Edge part 43 Removing part 44 Projection Part 5 Covering layer 6 Outer layer 7 Base layer 81 Raised part 82 Recessed part 9 Annular member 91 Base end 92 Tip 93 Tip surface 11 Resin coating layer 111 Base end face 12 Coil 13 Hydrophilic lubricating layer 14 Fixing material

Claims (7)

A wire body having a core wire;
An underlayer provided on at least a part of the outer periphery of the wire body;
A raised portion forming layer partially provided on the underlayer;
At least in the region where the raised portion forming layer is formed, the raised portion forming layer and a covering layer covering the wire body,
A guide wire characterized in that, on the outer surface of the guide wire, a portion where the raised portion forming layer is provided is raised relative to a portion where the raised portion forming layer is not provided.   The guide wire according to claim 1, wherein the constituent material of the raised portion forming layer and the constituent material of the foundation layer include mutually compatible resins. The raised portion forming layer has a color different from that of the base layer,
The covering layer has transparency to the extent that the raised portion forming layer is visible,
The guide wire according to claim 1 or 2, wherein the raised portion forming layer is configured to function as a visual marker.   The guide wire according to any one of claims 1 to 3, wherein the covering layer is in close contact with the base layer at a portion where the raised portion forming layer is not provided.   5. The microscopic unevenness is formed on a surface immediately below the covering layer in a portion where the protruding portion forming layer is not formed in a region where the protruding portion forming layer is formed. Guide wire.   The guide wire according to claim 1, wherein the raised portion forming layer is formed in a spiral shape, an annular shape, or a lattice shape.   The guide wire according to any one of claims 1 to 6, wherein the constituent material of the raised portion forming layer and the constituent material of the covering layer contain mutually compatible resins.

Images