JP5979894B2 - Guide wire - Google Patents

Description

  The present invention relates to a guide wire.

  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.

  As such a guide wire, a guide wire having a long wire main body, a resin coating layer covering the distal end portion of the wire main body, and an annular member disposed on the base end side of the resin coating layer is known. (For example, refer to Patent Document 1 and Patent Document 2). The guide wires described in these patent documents prevent the resin coating layer from turning up by defining the base outer diameter of the resin coating layer and the tip outer diameter of the annular member. Was demanded.

JP 2008-307367 A WO2011 / 118443

  An object of the present invention is a guide that can reliably prevent a medical device such as a catheter or the like used in combination with a guide wire from being turned over at the base end side of the covering layer. To provide a wire.

Such an object is achieved by the present invention described in (1), (2) and (4) below, and (3) is preferred.
(1) A guide wire comprising a flexible long wire body, and a distal end side coating layer that covers a distal end portion of the wire body and is made of a resin material,
A cylindrical member that is inserted through the wire main body and has a distal end portion located at a proximal end portion of the distal end side coating layer;
Covering the outer surface of the tubular member, and having a hydrophilic lubricating layer composed of a hydrophilic material,
Unevenness is formed on the outer surface of the cylindrical member,
The proximal end portion of the distal end side coating layer has a tapered shape with an outer diameter gradually decreasing toward the proximal end side,
The diameter of the inner periphery of the tubular member is larger than the diameter of the outer periphery at the portion where the tubular member of the wire body is located,
Clearance said and enters the proximal end of the distal coating layer between the inner peripheral and outer peripheral of the wire body of the tubular member,
The cylindrical member has a protrusion that protrudes from the inner periphery toward the outer periphery of the wire body, and the protrusion is fixed to the wire body by contacting the wire body.
A guide wire characterized in that a portion of the cylindrical member that overlaps the protruding portion has lower rigidity than a portion that does not overlap the protruding portion .

  (2) The guide wire according to (1), wherein a plurality of concave portions are formed on an outer surface of the cylindrical member, and the concave and convex portions are formed by the plurality of concave portions.

  (3) The guide wire according to (2), wherein the recess is formed by a melted portion in which a part of the cylindrical member is recessed and deformed toward the wire main body by melting.

  (4) The guide wire according to (2), wherein the hydrophilic lubricating layer enters the recess.

  According to the present invention, since the cylindrical member is located at the proximal end portion of the distal end side coating layer, the tip side coating layer can be prevented from being turned up. Furthermore, the outer surface of the cylindrical member is covered with a hydrophilic lubricating layer, and the hydrophilic lubricating layer exhibits lubricity by wetting (water absorption) and reduces frictional resistance (sliding resistance) with the inner wall of the blood vessel. To do. Thereby, the slidability of the guide wire with respect to the inner wall of the blood vessel is improved, and the operability of the guide wire is further improved. In particular, in the present invention, irregularities are formed on the outer surface of the cylindrical member, and when the hydrophilic lubricating layer enters the irregularities, the adhesion of the hydrophilic lubricating layer to the cylindrical member is increased, and hydrophilicity is increased. The peeling of the lubricating layer from the tubular member can be prevented or suppressed.

It is a longitudinal cross-sectional view which shows 1st Embodiment of the guide wire of this invention. It is an expanded sectional view of the cylindrical member which the guide wire shown in FIG. It is sectional drawing which shows an example of the manufacturing method of the cylindrical member shown in FIG. It is sectional drawing which shows the cylindrical member which 2nd Embodiment of the guide wire of this invention has. It is sectional drawing which shows the cylindrical member which 3rd Embodiment of the guide wire of this invention has.

  Hereinafter, the guide wire of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.

<First Embodiment>
First, a first embodiment of the guide wire of the present invention will be described.

  FIG. 1 is a longitudinal sectional view showing a first embodiment of the guide wire of the present invention, FIG. 2 is an enlarged sectional view of a cylindrical member included in the guide wire shown in FIG. 1, and FIG. 3 is a cylindrical shape shown in FIG. It is a figure which shows an example of the manufacturing method of a member.

  In the following, for convenience of explanation, the right side in FIG. 1 (the same applies to FIGS. 2 and 3 described later) is referred to as “base end”, and the left side is referred to as “tip”. In each drawing, 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 direction ratio is different from the actual one.

  A guide wire 1 shown in FIGS. 1 and 2 is a guide wire for a catheter used by being inserted into a lumen of a catheter (including an endoscope), and includes a long wire body 2 and a spiral coil 4. A distal end side coating layer 6 (hereinafter referred to as “resin coating layer 6”), a cylindrical member 7 projecting from the wire body 2, and a hydrophilic lubricating layer 10 covering the outer surface of the cylindrical member 7 And have.

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

(Wire body)
As shown in FIG. 1, the wire body 2 includes a first wire 21 disposed on the distal end side and a second wire 22 disposed on the proximal end side of the first wire 21. The first wire 21 and the second wire 22 are firmly connected by welding.

  The method for welding the first wire 21 and the second wire 22 is not particularly limited, and examples thereof include butt resistance welding such as spot welding using a laser and butt seam welding. Is preferred.

  The first wire 21 is a wire having elasticity. Although the length of the 1st wire 21 is not specifically limited, It is preferable that it is about 20-1000 mm.

  In the present embodiment, the first wire 21 has outer diameter constant portions 211 and 212 whose outer diameters are constant in the longitudinal direction at both ends thereof, and toward the distal direction between the outer diameter constant portions 211 and 212. A tapered portion (first outer diameter gradually decreasing portion) 213 whose outer diameter gradually decreases is provided.

  By having such a tapered portion 213, the rigidity (bending rigidity, torsional rigidity) of the first wire 21 can be gradually decreased toward the distal end direction, and as a result, the guide wire 1 is good at the distal end section. With such flexibility, followability to blood vessels and safety can be improved, and bending and the like can be prevented.

  Although the length of the taper part 213 is not specifically limited, It is preferable that it is about 10-1000 mm, and it is more preferable that it is about 20-300 mm. When it is in the above range, the change in rigidity along the longitudinal direction can be made more gradual.

  In this embodiment, the taper portion 213 has a tapered shape in which the outer diameter continuously decreases at a substantially constant decrease rate in the distal direction. In other words, the taper angle of the taper portion 213 is substantially constant along the longitudinal direction. Thereby, in the guide wire 1, the change of the rigidity along the longitudinal direction can be made more gradual.

  Unlike such a configuration, the taper angle of the taper portion 213 may change along the longitudinal direction. For example, a portion where the taper angle is relatively large and a portion where the taper angle is relatively small are alternately repeated a plurality of times. It may also be formed. In that case, there may be a portion where the taper angle of the taper portion 213 becomes zero.

  The constituent material of the first wire 21 is preferably made of a metal material, for example, stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F). SUS302, etc.) and various metal materials such as pseudo-elastic alloys (including superelastic alloys) can be used, but superelastic alloys are preferred. Since the superelastic alloy is relatively flexible and has a resilience and is difficult to bend, the guide wire 1 is sufficiently formed in the tip side portion by forming the first wire 21 with the superelastic alloy. Flexibility and resilience to bending can be obtained, followability to a blood vessel that is curved and bent in a complicated manner is improved, and more excellent operability can be obtained, and even if the first wire 21 repeats bending and bending deformation, Since the 1 wire 21 is not bent due to the restoring property, it is possible to prevent the operability from being deteriorated due to the bent wire being attached to the first wire 21 during use of the guide wire 1.

  Pseudoelastic alloys include those with stress-strain curves of any shape, including those where the transformation point of As, Af, Ms, Mf, etc. can be measured remarkably, and those that cannot be measured, and are greatly deformed by stress. Anything that almost returns to its original shape by removing stress is included.

  The preferred composition of the superelastic alloy is Ni-Ti alloy such as Ni-Ti alloy of 49-52 atomic% Ni, Cu-Zn alloy of 38.5-41.5 wt% Zn, 1-10 wt% X Cu-Zn-X alloy (X is at least one of Be, Si, Sn, Al, and Ga), 36-38 atomic% Al-Ni-Al alloy, and the like. Of these, the Ni-Ti alloy is particularly preferable.

  The distal end portion of the second wire 22 is connected to the proximal end portion of the first wire 21. The second wire 22 is a wire having elasticity. The length of the second wire 22 is not particularly limited, but is preferably about 20 to 4800 mm.

  In the present embodiment, the second wire 22 has outer diameter constant portions 221 and 222 whose outer diameters are constant in the longitudinal direction at both ends thereof, and toward the distal direction between the outer diameter constant portions 221 and 222. A tapered portion (second outer diameter gradually decreasing portion) 223 whose outer diameter gradually decreases is provided. Note that the outer diameter of the constant outer diameter portion 221 is substantially equal to the outer diameter of the constant outer diameter portion 212 of the first wire 21.

  Since the second wire 22 has the tapered portion 223, the rigidity (bending rigidity, torsional rigidity) of the second wire 22 can be gradually decreased toward the distal end, and as a result, the guide wire 1 is inserted into the living body. The operability and safety when doing so are improved.

  In the present embodiment, the tapered portion 223 has a tapered shape in which the outer diameter continuously decreases at a substantially constant decreasing rate in the distal direction. In other words, the taper angle of the taper portion 223 is substantially constant along the longitudinal direction. Thereby, in the guide wire 1, the change of the rigidity along the longitudinal direction can be made more gradual.

  Note that, unlike such a configuration, the taper angle of the taper portion 223 may change along the longitudinal direction. For example, a portion having a relatively large taper angle and a portion having a relatively small taper angle are alternately repeated a plurality of times. It may also be formed. In that case, there may be a portion where the taper angle of the taper portion 223 becomes zero.

  The constituent material (material) of the second wire 22 is preferably made of a metal material, such as stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, SUS444, SUS429, SUS430F, all types of SUS such as SUS302), various metal materials such as piano wire, cobalt-based alloy, and pseudoelastic alloy can be used.

  Among these, the cobalt-based alloy has a high elastic modulus when used as a wire and has an appropriate elastic limit. For this reason, the 2nd wire 22 comprised by the cobalt type alloy has the outstanding outstanding torque transmission property, and hardly produces problems, such as buckling. Any cobalt-based alloy may be used as long as it contains Co as a constituent element, but it contains Co as a main component (Co-based alloy: Co content in the elements constituting the alloy) Is preferable, and a Co—Ni—Cr alloy is more preferably used. Since an alloy having such a composition has plasticity even when deformed at room temperature, it can be easily deformed into a desired shape, for example, at the time of use. In addition, an alloy having such a composition has a high elastic modulus and can be cold-formed even as a high elastic limit, and by reducing the diameter while sufficiently preventing buckling from occurring due to the high elastic limit. And can have sufficient flexibility and rigidity to be inserted into a predetermined portion.

  Further, when stainless steel is used as the constituent material of the second wire 22, the guide wire 1 can obtain better pushability and torque transmission.

  In the guide wire 1, the first wire 21 and the second wire 22 are made of the same kind of alloy. The alloy may be an alloy exhibiting pseudoelasticity, for example, a Ni—Ti alloy.

  In the guide wire 1, the first wire 21 and the second wire 22 may be made of different kinds of alloys. In this case, the first wire 21 is preferably made of a material having a smaller elastic modulus than the constituent material of the second wire 22. As a result, the guide wire 1 has excellent flexibility at the distal end portion and abundant rigidity (bending rigidity, torsional rigidity) at the proximal end portion. As a result, the guide wire 1 obtains excellent pushability and torque transmission and secures good operability, while obtaining good flexibility and restoration on the distal end side, followability to blood vessels, and safety. Will improve.

(coil)
A coil 4 extends and is disposed on the outer periphery of the distal end portion of the wire body 2. The coil 4 is a member formed by winding a wire in a spiral shape, and covers the outer periphery of the distal end portion of the wire body 2. The wire body 2 is inserted through a substantially central portion inside the coil 4. In the guide wire 1, the coil 4 is in contact with the wire body 2, that is, is in close contact with the outer periphery of the wire body 2, but is not limited to this, and is separated from the outer periphery of the wire body 2, for example. It may be.

  Further, in the guide wire 1, the coil 4 has no gap between the spirally wound strands in a state where no external force is applied, and unlike the drawing, the coil 4 is spirally wound in a state where no external force is applied. There may be a gap between the turned strands.

  The coil 4 is preferably made of a radiopaque metal material (a material having X-ray contrast properties). As the material, for example, a noble metal such as gold, platinum, tungsten, or an alloy containing these ( For example, platinum-iridium alloy). Since the guide wire 1 is made of an X-ray opaque material, X-ray contrast can be obtained in the guide wire 1, and the guide wire 1 can be inserted into the living body while confirming the position of the tip under X-ray fluoroscopy.

  The proximal end portion of the coil 4 is fixed to the tapered portion 213 of the wire body 2 via the fixing material 31, and the distal end portion of the coil 4 is connected to the constant outer diameter portion 211 of the wire body 2 via the fixing material 32. It is fixed. Each of the fixing materials 31 and 32 is made of, for example, various adhesives or solder (brazing material).

(Resin coating layer)
Further, the guide wire 1 has a resin coating layer 6 that collectively covers the distal end portion of the wire body 2, the coil 4, and the fixing materials 31 and 32. The resin coating layer 6 is in close contact with the outer periphery of the distal end portion of the wire body 2. In the present embodiment, the resin coating layer 6 does not enter the coil 4, but may enter the coil 4.

  The resin coating layer 6 can be formed for various purposes. As an example, the resin coating layer 6 can improve operability of the guide wire 1 by improving slidability, and safety when the guide wire 1 is inserted into a blood vessel or the like. It can be provided for the purpose of improving the property.

  Such a resin coating layer 6 is made of a flexible material (soft material, elastic material), and the material is not particularly limited. For example, polyolefin such as polyethylene and polypropylene, polyvinyl chloride, Polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluorine resin (PTFE, ETFE, PFA, etc.), or composite materials thereof, and various rubber materials such as latex rubber and silicone rubber Or a composite material in which two or more of these are combined. Of these materials, urethane resins are particularly preferable. When the resin coating layer 6 is mainly composed of a urethane resin, the flexibility of the distal end portion of the guide wire 1 is further improved, so that the inner wall of the blood vessel is more reliably damaged when inserted into the blood vessel or the like. The safety is extremely high.

  Further, the tip surface 61 of the resin coating layer 6 is rounded. Thereby, damage to the inner wall of a body cavity such as a blood vessel can be prevented at the distal end surface 61. Further, the base end 63 of the resin coating layer 6 is located in the outer diameter constant portion 212 of the wire body 2 (first wire 21).

  In such a resin coating layer 6, particles (filler) made of a radiopaque material may be dispersed. In this case, X-ray contrast is obtained in the guide wire 1, and the guide wire 1 can be inserted into the living body while confirming the position of the distal end portion under X-ray fluoroscopy. The radiopaque material is not particularly limited, and examples thereof include noble metals such as platinum and tungsten or alloy materials containing these.

  The thickness of the resin coating layer 6 is not particularly limited, and is appropriately determined in consideration of the purpose of forming the resin coating layer 6, the constituent material, the forming method, and the like. Usually, the average thickness is about 5 to 500 μm. It is preferable that it is about 10-350 micrometers. The resin coating layer 6 may be a laminate of two or more layers.

(Coating layer 9)
The covering layer 9 is formed so as to cover the proximal end portion of the wire body 2, specifically, from the proximal end portion of the second wire to almost the entire area of the tapered portion 223. The covering layer 9 has an inner layer 91, an outer layer 92, and a linear body 93 formed (laminated) in this order on the outer periphery of the wire body 2.

  The inner layer 91 is formed on the outer periphery of the wire body 2. Although it does not specifically limit as a resin material of the inner layer 91, For example, a fluorine resin material is preferable. The inner layer 91 contains two types of fluorine-based resin materials having different compositions. As the two types of resin materials, for example, one is polytetrafluoroethylene (PTFE) and the other is fluoride. It can be ethylene propylene (FEP).

  Furthermore, since the inner layer 91 layer is formed on the outer periphery of the wire body 2, for example, a resin material that functions as a binder is included in the constituent material of the inner layer 91 in order to improve adhesion to the wire body 2. Has been. This resin material is not particularly limited. Examples include polyallyl ether sulfone, polyester, and polyether sulfone.

  In addition, although the thickness of the inner layer 91 is not specifically limited, For example, it is preferable that it is 0.001-0.020 mm, and it is more preferable that it is 0.001-0.010 mm.

  The outer layer 92 is formed on the inner layer 91. The resin material for the outer layer 92 is not particularly limited, but for example, a fluorine resin material is preferably used. As this fluorine resin material, for example, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), or the like can be used.

  The thickness of the outer layer 92 is not particularly limited, but is preferably 0.001 to 0.030 mm, and more preferably 0.001 to 0.015 mm, for example.

  The linear body 93 is formed on the outer layer 92. The linear body 93 is spirally wound (see FIG. 1). Thereby, the linear body 93 is provided over substantially the entire circumference of the second wire 22. Further, the linear body 93 has a loose winding in which adjacent lines are separated from each other. In the present embodiment, the number of linear bodies 93 formed is one or more. When the number of the linear bodies 93 formed is plural, the spiral winding directions of the respective linear bodies 93 may be the same or opposite.

  With such a linear body 93, the second wire 22 (wire body 2) has a plurality of convex portions 94 formed of the linear body 93 on the outer surface thereof and an adjacent convex portion 94 (linear body 93). And a recess 95 formed therebetween.

  Although it does not specifically limit as a resin material in the linear body 93, For example, it is preferable to use a fluorine-type resin material similarly to the inner layer 91. FIG. As this fluorine resin material, for example, polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), or the like can be used.

  In the guide wire 1, the friction coefficient at the convex portion 94 (linear body 93) is smaller than the friction coefficient at the bottom portion 951 (the portion where the outer layer 92 is exposed) of the concave portion 95.

(Cylindrical member)
The cylindrical member 7 is configured by a cylindrical (ring-shaped) member, and is disposed and fixed to the constant outer diameter portion 212 of the wire body 2 (first wire 21). The cylindrical member 7 is provided so as to protrude from the wire body 2 to the outer periphery.

  The inner diameter φd1 of the cylindrical member 7 is slightly larger than the outer diameter φd2 of the constant outer diameter portion 212, that is, the relationship φd1> φd2 is satisfied, and the inner peripheral surface of the cylindrical member 7 and the constant outer diameter portion 212 are satisfied. A gap S is formed between the outer peripheral surface of each of them. The thickness D of the gap S is not particularly limited, but is preferably about 5 to 30 μm. By setting the thickness D of the gap S to such a thickness, the gap S becomes smaller, the sense of unity between the first wire 21 and the tubular member 7 is increased, and the operability is improved. Moreover, since the cylindrical member 7 can move with respect to the wire body 2 in a state where it is not welded, the guide wire 1 can be easily manufactured by a manufacturing method as described later.

  Further, the distal end 71 of the cylindrical member 7 is in contact with the resin coating layer 6, and the proximal end 63 of the resin coating layer 6 enters the inside (gap S) of the cylindrical member 7. In other words, the distal end 71 of the cylindrical member 7 is located on the distal end side with respect to the base end 63 of the resin coating layer 6. Therefore, the base end 63 of the resin coating layer 6 is not exposed on the surface of the guide wire 1 (does not face the outside of the guide wire 1).

  Further, the outer diameter (maximum outer diameter) φd3 of the cylindrical member 7 is larger than the outer diameter φd4 of the portion where the tip 71 of the cylindrical member 7 of the resin coating layer 6 is located. With such a cylindrical member 7, the base end 63 of the resin coating layer 6 is positioned inside the outer peripheral surface of the cylindrical member 7.

  Further, the outer diameter φd3 of the cylindrical member 7 is smaller (or the same) as the maximum outer diameter φd5 of the resin coating layer 6. The length of the cylindrical member 7 is also shorter than the length of the resin coating layer 6. Due to such a magnitude relationship, for example, when the guide wire 1 moves in the living body lumen, a cylindrical member is formed on the wall portion where the resin coating layer 6 having high slidability defines the living body lumen at the distal end portion thereof. 7 is preferentially abutted. Thereby, it becomes possible to operate the guide wire 1 without degrading the operability.

  Although it does not specifically limit as length of the cylindrical member 7, It is preferable that it is about 0.5-2 mm. By setting it as such length, while being able to make the cylindrical member 7 sufficient length to exhibit the function, the fall of the operativity of the guide wire 1 by the cylindrical member 7 becoming excessively long. Can be effectively prevented.

  Specifically, the portion S11 of the wire main body 2 where the cylindrical member 7 is provided has higher rigidity than the distal end portion S12 and the proximal end portion S13, and therefore, compared to the portions S12 and S13. Difficult to bend and deform. If the portion S11 which is difficult to bend is long, the operability (particularly followability) of the guide wire 1 may be deteriorated. Therefore, the above-described deterioration in operability can be effectively suppressed by setting the length of the cylindrical member 7 as described above and shortening the portion S11 that is difficult to bend and deform as much as possible.

  Irregularities are formed on the outer surface 73 of the cylindrical member 7. In other words, the outer surface 73 of the cylindrical member 7 is configured by an uneven surface. Such an uneven surface can be obtained by forming a plurality of recesses 75 on the flat outer surface 73. Thus, by forming unevenness on the outer surface 73, the adhesion between the cylindrical member 7 and the hydrophilic lubricating layer 10 is enhanced, and the peeling of the hydrophilic lubricating layer 10 from the cylindrical member 7 is suppressed. be able to. Each recessed part 75 is comprised by the curved concave surface which has a substantially circular outline. In addition, the shape of the recessed part 75 is not limited to this, For example, a polygon may be polygonal and it may be comprised by the bending surface.

  Although it does not specifically limit as a depth (maximum depth) of the recessed part 75, It is preferable that it is about 1-100 micrometers. Thereby, since the unevenness | corrugation which has sufficient undulations can be formed in the outer surface 73, the adhesiveness of the cylindrical member 7 and the hydrophilic lubrication layer 10 becomes higher.

  The tubular member 7 is formed with a plurality of melted portions 77 that are recessed and deformed so as to be convex toward the wire body 2 by melting, and the outer surface 771 of each melted portion 77 constitutes a recess 75. . Further, the inner surface of the melted portion 77 is in pressure contact with the wire body 2, whereby the tubular member 7 is fixed to the wire body 2.

  The melting part 77 can be formed, for example, by irradiating the cylindrical member 7 with energy such as a laser from the outer peripheral side to melt and thermally deform the cylindrical member 7. Specifically, for example, as shown in FIG. 3A, first, a first wire that is not welded to the second wire 22 is prepared, and the cylindrical member 7 is inserted from the proximal end side of the first wire 21. Then, it is brought into contact with the base end of the resin coating layer 6. In this state, the tubular member 7 is slidable with respect to the first wire 21. Next, a laser is irradiated in a spot shape (island shape) to a plurality of locations on the outer surface 73 of the cylindrical member 7. Then, as shown in FIG. 3B, the laser-irradiated portion melts and is thermally deformed so as to be recessed toward the wire body 2, and the melted portion 77 formed by this deformation is formed in the wire body 2 to some extent. Abut (pressure contact) with the pressure of. As a result, the tubular member 7 is caulked to the wire body 2, and the tubular member 7 is fixed to the wire body 2.

  By fixing the cylindrical member 7 to the wire main body 2 by such a melting part 77, the cylindrical member 7 can be fixed to the wire main body 2 without using other members such as an adhesive or solder. Can do. Therefore, the configuration of the guide wire 1 is simplified and the manufacture of the guide wire 1 is facilitated. Further, for example, when the cylindrical member 7 is fixed to the wire body 2 via the adhesive or solder as described above, the gap S must be filled with the adhesive or solder, and the gap S is adhesive. In order to fill with solder, it is necessary to increase the thickness D of the gap S to some extent. Thereby, the shakiness of the cylindrical member 7 with respect to the wire main body 2 becomes large, and the operability may be deteriorated. On the other hand, since the guide wire 1 is fixed by the melting part 77, the thickness D of the gap S can be set smaller, and the occurrence of the above problems can be effectively prevented. it can.

  In addition, since the melted portion 77 is annealed by melting, the portion corresponding to the melted portion 77 of the tubular member 7 has lower rigidity than the other portions. Therefore, the overall rigidity of the cylindrical member 7 is lower than that in the case where the molten portion 77 is not provided, and the cylindrical member 7 can be easily bent.

  Moreover, it is preferable that the melting part 77 is not welded to the wire body 2. That is, it is preferable that the melting part 77 and the wire body 2 are not integrated by melting. Thereby, the thermal damage to the wire main body 2 is reduced, and the guide wire 1 having excellent operability and reliability can be configured.

  Moreover, it is preferable that the plurality of melted portions 77 (recessed portions 75) are uniformly formed so as to spread over the entire outer surface of the cylindrical member 7. Thereby, the joining state of the cylindrical member 7 and the wire main body 2 becomes uniform as a whole, and the operability of the guide wire 1 is improved. Specifically, since the central axis of the wire main body 2 and the central axis of the cylindrical member 7 can be maintained even when the wire main body 2 is curved, the operability of the guide wire 1 is improved. To do. In addition to this, the adhesion between the hydrophilic lubricating layer 10 and the tubular member 7 can be further enhanced.

  In addition, as for the some fusion | melting part 77, the adjacent things may be spaced apart, and you may contact (a part overlaps). In addition, the shapes and sizes of the plurality of melted portions 77 may be the same or different from each other. Moreover, the some fusion | melting part 77 may be formed regularly, and may be formed irregularly. Further, the melted portion 77 may not be formed so as to spread over the entire outer surface of the cylindrical member 7, for example, any one region of the base end portion, the center portion, and the tip end portion, or these three It may be formed only in two regions selected from the regions.

  The cylindrical member 7 is made of a material harder than the resin material constituting the resin coating layer 6, and a metal material is preferably used as the material. Examples of the metal material include stainless steel, a superelastic alloy, a cobalt-based alloy, a noble metal such as gold, platinum, and tungsten, or an alloy containing these (for example, a platinum-iridium alloy). In particular, it is preferable to use a platinum-iridium alloy from the viewpoint of being hard and easy to process.

  By having such a cylindrical member 7, it is possible to prevent the distal end of the catheter from coming into contact with the base end 63 of the resin coating layer 6 after it passes over the cylindrical member 7 and comes into contact with the resin coating layer 6. Is done. As a result, even if the proximal end 63 is slightly turned, the distal end of the catheter is reliably prevented from being caught on the proximal end 63.

  In the present embodiment, the configuration in which the concave portion 75 is formed by the melted portion 77 has been described, but the method for forming the concave portion 75 is not particularly limited. The recess 75 may be formed, for example, by removing a part of the outer surface of the cylindrical member 7 by various etching methods, or by applying a stress from the outer peripheral side to deform a part of the outer surface 73. You may form, and you may form by forming a hole in an outer peripheral surface with a drill etc.

(Hydrophilic lubrication layer)
A hydrophilic lubricating layer 10 is formed on the outer surface of the cylindrical member 7 described above so as to cover the cylindrical member 7. Since the outer surface 73 of the cylindrical member 7 is constituted by a concavo-convex surface, a wide contact area between the hydrophilic lubricating layer 10 and the cylindrical member 7 can be secured, and the adhesion thereof is improved. In addition, the hydrophilic lubricating layer 10 enters the recess 75, and the anchor effect enhances the adhesion between the hydrophilic lubricating layer 10 and the cylindrical member 7, and the hydrophilic lubricating layer 10 from the cylindrical member 7 also increases. Peeling can be prevented.

  The outer surface of the hydrophilic lubricating layer 10 is a flat surface. Further, the thickness of the hydrophilic lubricating layer 10 (the thickness of the portion excluding the portion entering the recess 75. In other words, [the outer diameter φd6 of the hydrophilic lubricating layer 10] − [the outer diameter φd3 of the cylindrical member]) Although it does not specifically limit as, It is preferable that it is about 2-20 micrometers.

  The hydrophilic lubricating layer 10 is composed of a hydrophilic material. Examples of such hydrophilic materials include cellulose-based polymer materials, polyethylene oxide-based polymer materials, and maleic anhydride-based polymer materials (for example, Maleic anhydride copolymer such as methyl vinyl ether-maleic anhydride copolymer), acrylamide polymer (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble Nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

  In many cases, such a hydrophilic material exhibits lubricity by wetting (water absorption) and reduces frictional resistance (sliding resistance) with the inner wall of the blood vessel or the inner wall of the catheter. Thereby, the slidability of the guide wire 1 with respect to the inner wall of the blood vessel and the inner wall of the catheter is improved, and the operability of the guide wire 1 in the blood vessel and the catheter is further improved.

  In the present embodiment, the hydrophilic lubricating layer 10 is formed so as to cover the distal end surface and the proximal end surface of the tubular member 7 together with the outer surface 73, but the present invention is not limited thereto, and only the outer surface 73 is covered. The cover may be formed such that the distal end surface and the proximal end surface are exposed.

Second Embodiment
Next, a second embodiment of the guide wire of the present invention will be described.
FIG. 4 is a cross-sectional view showing a cylindrical member included in the second embodiment of the guide wire of the present invention.

  Hereinafter, although the guide wire of this embodiment is demonstrated, it demonstrates centering around difference with the syringe of 1st Embodiment, The description is abbreviate | omitted about the same matter.

  The guide wire of the present embodiment is the same as the guide wire of the first embodiment except that the configuration of the cylindrical member is different.

  As shown in FIG. 4, a plurality of recesses 75 are formed on the outer surface 73 of the cylindrical member 7A included in the guide wire 1A of the present embodiment. Moreover, each recessed part 75 is comprised by the through-hole which penetrates the outer surface (outer surface) and inner surface of a cylindrical member.

  The method for forming such a recess 75 is not particularly limited. For example, it can be formed by irradiating energy such as a laser from the outer peripheral side of the cylindrical member 7 as in the first embodiment. Specifically, for example, when the cylindrical member 7 is irradiated with a laser having a longer time and / or higher intensity than the formation of the melted portion 77 described in the first embodiment, a portion irradiated with the laser is melted, Evaporate. Thereby, a through-hole is formed in the portion irradiated with the laser, and the recess 75 is formed. A protrusion 76A that is thermally deformed by the melting and press-contacted with the wire body is formed around the recess 75 (through hole), and the tubular member 7 is fixed to the wire body 2 by the protrusion 76A.

  Thus, by forming the concave portion 75 with a through-hole, the tubular member can be thinned, and the rigidity of the tubular member 7 can be further reduced. Therefore, a decrease in operability of the guide wire 1A can be effectively suppressed.

  Also according to the second embodiment, the same effects as those of the first embodiment described above can be exhibited.

<Third Embodiment>
Next, a third embodiment of the guide wire of the present invention will be described.
FIG. 5 is a cross-sectional view showing a cylindrical member included in the third embodiment of the guide wire of the present invention.

  Hereinafter, although the guide wire of this embodiment is demonstrated, it demonstrates centering around difference with the guide wire of 1st Embodiment, and the description is abbreviate | omitted about the same matter.

  The guide wire of the present embodiment is the same as the guide wire of the first embodiment except that the configuration of the cylindrical member is different.

  As shown in FIG. 5, the guide wire 1 </ b> B of the present embodiment includes a joining member 8 that joins (fixes) the tubular member 7 </ b> B to the wire body 2.

(Cylindrical member)
The base end portion of the cylindrical member 7B is configured by a tapered portion 72 whose outer diameter gradually decreases toward the base end direction. By having such a taper part 72, the rigidity (bending rigidity, torsional rigidity) of the wire main body 2 including the cylindrical member 7B can be gradually changed toward the distal end direction. In addition, the difference in rigidity between the distal end side and the proximal end side can be further reduced with the proximal end of the cylindrical member 7B as a boundary. As a result, the followability of the guide wire 1B to the blood vessel is improved, and bending or the like can be prevented.

  In the present embodiment, the taper angle of the taper portion 72 is substantially constant along the longitudinal direction. Thereby, in the guide wire 1, the change of the rigidity along the longitudinal direction can be made more gradual. In addition, unlike such a configuration, the taper angle of the taper portion 72 may change along the longitudinal direction. For example, a portion where the taper angle is relatively large and a portion where the taper angle is relatively small are alternately repeated a plurality of times. It may also be formed. In that case, there may be a portion where the taper angle of the taper portion 72 becomes zero. Note that the cylindrical member 7B may not have the base end portion configured by the tapered portion 72, and for example, the outer diameter may be constant over the entire length direction of the cylindrical member 7.

  The plurality of concave portions 75 are formed so as to spread over the entire region excluding the tapered portion 72 of the cylindrical member 7B.

(Joining member 8)
First, the joining member 8 is used for joining (fixing) the tubular member 7B to the wire body 2. The joining member 8 has a base portion 81 located on the proximal end side of the cylindrical member 7B and an extending portion 82 that extends from the base portion 81 and enters the gap S. The base 81 is formed so as to come into contact with the base end surface 721 of the cylindrical member 7B and the outer peripheral surface of the wire main body 2, thereby firmly joining the cylindrical member 7B to the wire main body 2. The length of the base 81 is not particularly limited, but is preferably about 0.5 to 2.0 mm.

  One extension 82 extends from the base 81 and fills the base end of the gap S. That is, it is formed between the inner peripheral surface of the proximal end portion of the tubular member 7B and the outer peripheral surface of the wire body 2, and thereby the tubular member 7B is joined to the wire body 2. In addition, the extension part 82 may be formed in the whole area of the gap S.

  As described above, since the contact area between the tubular member 7B and the wire main body 2 via the joining member 8 is increased by having the base 81 and the extending portion 82, the tubular member 7B is more firmly attached to the wire main body 2. Can be joined.

  The base 81 further functions as a step filling member that fills the step between the wire body 2 and the cylindrical member 7B. Specifically, the base 81 is located on the base end side of the cylindrical member 7B, and has a tapered shape whose outer diameter gradually decreases toward the base end. Therefore, the distal end of the catheter is guided to the tubular member 7B along the outer peripheral surface of the base 81. In this way, by filling the step between the wire body 2 and the cylindrical member 7B with the base 81, the catheter can be prevented from being caught. In addition, by making the base portion 81 tapered, the rigidity of the wire body 2 including the base portion 81 can be gradually changed toward the distal end direction.

  In particular, in this embodiment, the taper angle of the base portion 81 is substantially equal to the taper angle of the taper portion 72 of the cylindrical member 7B, and the outer peripheral surface of the base portion 81 is continuously connected to the outer peripheral surface of the taper portion 72 of the cylindrical member 7B. doing. That is, the region in the vicinity of the proximal end side and the vicinity of the distal end side across the boundary between the base portion 81 and the cylindrical member 7B is configured as a flat surface without a step. Therefore, it is possible to effectively prevent the tip of the catheter from being caught at the boundary between the base 81 and the cylindrical member 7B.

  Such a joining member 8 is preferably made of a softer material (a material having a lower Young's modulus) than the cylindrical member 7B, and as the material, for example, various adhesives and solder can be used. . Among these, it is preferable to use relatively hard solder. Thereby, the joining member 8 with high mechanical strength can be formed. Moreover, the rigidity of the wire main body 2 including the joining member 8 and the cylindrical member 7B can be gradually changed toward the distal end direction.

  The joining member 8 may be made of a material harder than the cylindrical member 7B (a material having a high Young's modulus). In such a case, the joining member 8 (particularly the extending portion 82) also functions as a reinforcing member that reinforces the cylindrical member 7B. Therefore, for example, the tubular member 7B can be thinned.

(Hydrophilic lubrication layer)
The hydrophilic lubricating layer 10 is formed so as to cover the outer surfaces of the cylindrical member 7B and the joining member 8 (base portion 81).

  Also according to the third embodiment, the same effects as those of the first embodiment described above can be exhibited.

  As mentioned above, although the guide wire of this invention was demonstrated about embodiment of illustration, this invention is not limited to this, Each part which comprises a guide wire is a thing of arbitrary structures which can exhibit the same function. Can be substituted. Moreover, arbitrary components may be added.

  In the above-described embodiment, the wire main body has been described in which two wires are joined. However, the wire main body may be configured by a single wire.

  In the above-described embodiment, the cylindrical member has been described as having a circular shape. However, the cylindrical member has, for example, slits that communicate with the inside and outside of the entire lengthwise direction, that is, has a cross-sectional shape. It may be C-shaped.

  In the above-described embodiment, the gap is formed between the inner surface of the cylindrical member and the outer peripheral surface of the wire main body. However, the present invention is not limited to this, and the inner surface of the cylindrical member and the wire main body are not limited to this. A gap may not be formed between the outer peripheral surface and the outer peripheral surface. That is, the inner diameter of the cylindrical member may be equal to the outer diameter of the portion of the first wire that overlaps the cylindrical member.

1, 1A, 1B Guide wire 2 Wire body 21 First wire 211 Constant outer diameter 212 Constant outer diameter
213 taper part 22 2nd wire 221 constant outer diameter part 222 outer diameter constant part 223 taper part 31 fixing material 32 fixing material 4 coil 6 resin coating layer (front end side coating layer)
61 Tip surface
63 Base end 7, 7A, 7B Cylindrical member 71 Tip 72 Tapered part 721 Base end face 73 Outer surface 75 Recessed part 76A Projection part 77 Melting part 771 Outer surface 8 Joining member 81 Base part 82 Extension part 9 Covering layer 91 Inner layer 92 Outer layer 93 Line Shape 94 Projection 95 Concave 951 Bottom 10 Hydrophilic Lubricating Layer D Thickness S Clearance S11 Part S12 Part S13 Part

Claims (3)

A guide wire comprising a flexible long wire body and a distal end side coating layer that covers the distal end portion of the wire body and is made of a resin material,
A cylindrical member that is inserted through the wire main body and has a distal end portion located at a proximal end portion of the distal end side coating layer;
Covering the outer surface of the tubular member, and having a hydrophilic lubricating layer composed of a hydrophilic material,
Unevenness is formed on the outer surface of the cylindrical member,
The proximal end portion of the distal end side coating layer has a tapered shape with an outer diameter gradually decreasing toward the proximal end side,
The diameter of the inner periphery of the tubular member is larger than the diameter of the outer periphery at the portion where the tubular member of the wire body is located,
Clearance said and enters the proximal end of the distal covering layer between the inner circumference and the outer circumference of the wire body of the tubular member,
The cylindrical member has a protrusion that protrudes from the inner periphery toward the outer periphery of the wire body, and the protrusion is fixed to the wire body by contacting the wire body.
A guide wire characterized in that a portion of the cylindrical member that overlaps the protruding portion has lower rigidity than a portion that does not overlap the protruding portion .   The guide wire according to claim 1, wherein a plurality of recesses are formed on an outer surface of the cylindrical member, and the unevenness is formed by the plurality of recesses.   The guide wire according to claim 2, wherein the hydrophilic lubricating layer enters the recess.

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