JP2013158541A - Guide wire - Google Patents

Abstract

Provided is a guide wire capable of reliably preventing a medical device such as a catheter used in combination with a guide wire from being turned over at a proximal end portion of a distal end member. To do.
A guide wire (1) includes a long flexible wire body (2), a distal end member (6) made of a resin material that covers a distal end portion of the wire body (2), and a proximal end (63) of the distal end member (6). And a hydrophilic lubricating layer 10 formed of a hydrophilic material. Further, the hydrophilic lubricating layer 10 has a tapered shape in which the outer diameter gradually decreases toward the proximal end side.
[Selection] Figure 1

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 inventions (1) to (6) below.
(1) A guide wire comprising a flexible long wire body and a tip member that covers the tip of the wire body and is made of a resin material,
A guide wire having a hydrophilic lubricating layer formed so as to cover a proximal end of the distal end member and made of a hydrophilic material.

  (2) The guide wire according to (1), wherein at least a base end portion of the hydrophilic lubricating layer has a tapered shape in which an outer diameter gradually decreases toward the base end side.

  (3) The guide wire according to (1) or (2), wherein a maximum outer diameter of the hydrophilic lubricating layer is smaller than a maximum outer diameter of the tip member.

(4) The proximal end portion of the distal end member has a tapered shape in which the outer diameter gradually decreases toward the proximal end side,
The guide wire according to any one of (1) to (3), wherein a distal end of the hydrophilic lubricating layer is located at a tapered portion of a distal end member.

(5) The wire main body is located on the distal end side, is located on the proximal end side with respect to the first outer diameter constant portion, the first outer diameter constant portion having a constant outer diameter in the longitudinal direction, and the first outer A second outer diameter constant portion having an outer diameter larger than the constant diameter portion and having a constant outer diameter in the longitudinal direction; and the outer diameter is located between the first outer diameter constant portion and the second outer diameter constant portion. Has a tapered portion that gradually decreases toward the tip side,
The guide wire according to any one of (1) to (4), wherein a proximal end of the distal end member is located in the second constant outer diameter portion.

  (6) The guide wire according to any one of (1) to (5), wherein the resin material is mainly urethane resin.

  According to the present invention, a medical device (typically referred to as “catheter”) such as a catheter used in combination with a guide wire is directed along the guide wire to the target site in the body lumen in the distal direction. When pushing forward, the distal end of the catheter slides on the hydrophilic lubricating layer, and finally comes into contact with the distal end member. Even when an external force is exerted on the proximal end of the distal end member by the distal end of the catheter during the movement of the catheter described above, the proximal end of the distal end member is covered with the hydrophilic lubricating layer, and the proximal end surface is easy to slip. The force exerted by the catheter does not develop to escape. Therefore, it is reliably prevented that the distal end of the catheter is turned up due to the distal end of the catheter being caught.

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

  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>
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 protruding portion of the guide wire shown in FIG. 1, and FIG. 3 is a view of the guide wire shown in FIG. It is sectional drawing which shows an example of a manufacturing method.

  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 the “base end”, and the left side is referred to as the “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 to 3 is a guide wire for a catheter that is used by being inserted into the lumen of a catheter (including an endoscope). Such a guide wire 1 has a long wire body 2, a spiral coil 4, a tip member 6, a tip side coating layer 7, a hydrophilic lubricating layer 10, and a coating layer 9. Yes.

  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 is located at both ends thereof, and the first outer diameter constant portion 211 and the second outer diameter constant portion 212 whose outer diameter is constant in the longitudinal direction, and the first outer diameter constant portion 211. And a taper portion 213 whose outer diameter gradually decreases toward the distal end. The outer diameter of the second outer diameter constant portion 212 is configured to be larger than the outer diameter of the first outer diameter constant portion 211.

  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. The outer diameter of the constant outer diameter portion 221 is substantially equal to the outer diameter of the second outer diameter constant 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.

Further, as a specific combination of the first wire 21 and the second wire 22, in addition to the above combination, the first wire 21 is made of a superelastic alloy (Ni—Ti alloy), and the second wire 22. Is preferably made of stainless steel. Thereby, the effect mentioned above becomes further remarkable.
The wire body 2 has been described above.

(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 a fixing material 31, and the distal end portion of the coil 4 is a first outer diameter constant portion of the wire body 2 via a fixing material 32. 211 is fixed. The fixing materials 31 and 32 are each made of, for example, solder (brazing material) or various adhesives.

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

  The tip member 6 can be formed for various purposes. As an example, the tip member 6 is improved in slidability to improve the operability of the guide wire 1, 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 tip surface 61 of such a tip member 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 proximal end portion of the distal end member 6 is configured by a tapered portion 62 whose outer diameter gradually decreases toward the proximal end side.

  Further, the proximal end 63 of the distal end member 6 is located at the second outer diameter constant portion 212 of the first wire 21. Thus, by positioning the proximal end 63 of the distal end member 6 at the second outer diameter constant portion 212 which is the thickest outer portion of the first wire 21 and has a high rigidity, for example, the guide wire 1 It is possible to effectively prevent the proximal end portion of the distal end member 6 from being turned up from the first wire 21 when it is curved. As will be described later, turning of the proximal end portion of the distal end member 6 is prevented by the hydrophilic lubricating layer 10. However, by making the position of the proximal end 63 of the distal end member 6 as described above, hydrophilicity is improved. The effect becomes more remarkable by the synergistic effect with the lubricating layer 10. Note that the base end 63 may be positioned in the tapered portion 62.

  Such a tip member 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, various rubber materials such as latex rubber, silicone rubber, Or the composite material which combined 2 or more among these is mentioned. Of these materials, urethane resins are particularly preferable. When the distal end member 6 is mainly made of 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 or the like can be more reliably damaged when inserted into the blood vessel or the like. Can be prevented, and the safety is extremely high.

  Further, particles (fillers) made of a radiopaque material may be dispersed in the tip member 6. 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 tip member 6 is not particularly limited, and is appropriately determined in consideration of the purpose of forming the tip member 6, the constituent material, the forming method, and the like. Usually, the average thickness is about 5 to 500 μm. It is preferable that the thickness is about 10 to 350 μm. The tip member 6 may be a laminate of two or more layers.

(Tip side coating layer)
A tip side coating layer 7 is formed so as to cover the outer surface of the tip member 6 described above. The distal-side coating layer 7 is made of a material that can reduce frictional resistance (sliding resistance) with the inner wall of the blood vessel or the inner wall of the catheter, and the material is not particularly limited. For example, the cellulosic polymer substance, Polyethylene oxide polymer materials, maleic anhydride polymer materials (eg, maleic anhydride copolymers such as methyl vinyl ether-maleic anhydride copolymer), acrylamide polymer materials (eg, polyacrylamide, polyglycidyl) And a hydrophilic material such as methacrylate-dimethylacrylamide (PGMA-DMAA block copolymer), water-soluble nylon, polyvinyl alcohol, and polyvinylpyrrolidone.

  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.

  Here, the distal end side coating layer 7 covers only the distal end side of the distal end member 6. That is, the tapered portion 62 of the tip member 6 is not covered with the tip side coating layer 7 but exposed from the tip side coating layer 7. Thus, by not forming the front end side coating layer 7 on the tapered portion 62, the hydrophilic lubricating layer 10 can be formed in contact with the outer surface of the front end member 6. Therefore, the adhesion of the hydrophilic lubricating layer 10 to the tip member 6 can be improved, and the strength of the hydrophilic lubricating layer 10 can be increased.

(Hydrophilic lubrication layer)
The hydrophilic lubricating layer 10 is formed so as to cover the base end 63 of the tip member 6 described above. That is, the hydrophilic lubricating layer 10 is formed in the base end 63 and the region including the front end side and the base end side. As described above, the hydrophilic lubricating layer 10 covers the proximal end 63 of the distal end member 6, thereby preventing the proximal end portion of the distal end member 6 from being peeled from the wire body 2. Furthermore, the distal end of the catheter moving from the proximal end side is prevented from coming into contact with the proximal end 63. Therefore, by having such a hydrophilic lubricating layer 10, the guide wire 1 can be obtained that can prevent the tip end portion of the tip member 6 from being turned over and the catheter can be caught and can exhibit excellent operability. Specifically, even if an external force is exerted on the proximal end 63 of the distal end member 6 by the distal end of the catheter that has moved, the proximal end 63 of the distal end member 6 is covered with the hydrophilic lubricating layer 10, and the surface of the proximal end 63 Because it is slippery, the force exerted by the catheter escapes and does not develop to turn. Therefore, it is reliably prevented that the distal end of the catheter 6 is turned over and the proximal end 63 of the distal end member 6 is turned up.

  In particular, the hydrophilic lubricating layer 10 is directly coated on the base end 63 of the distal end member 6 and further extends smoothly so as to be directly coated on the surface of the wire body 2. Thereby, even if the distal end of the catheter slides on the surface of the wire main body 2, the hydrophilic lubricating layer 10 following the proximal end 63 of the distal end member 6 from the wire main body 2 can be prevented from turning over.

  The hydrophilic lubricating layer 10 has a tip 101 located in the middle of the tapered portion 62 of the tip member 6. As described above, the tapered portion 62 is a portion exposed from the distal end side coating layer 7, and the distal end of the hydrophilic lubricating layer 10 is positioned by positioning the distal end 101 of the hydrophilic lubricating layer 10 in such a portion. The adhesion of the part can be increased.

  The maximum outer diameter of the hydrophilic lubricating layer 10 (that is, the outer diameter of the tip 101) is preferably smaller than the outer diameter (maximum outer diameter) of the tip member 6. Thereby, it can prevent that the hydrophilic lubrication layer 10 protrudes excessively, for example, the excessive contact with the hydrophilic lubrication layer 10 and the inner wall of the blood vessel is suppressed, and the deterioration of operativity can be prevented. The above-mentioned “outer diameter of the hydrophilic lubricating layer 10” refers to the outer diameter in a wet (swelled) state.

  Such a hydrophilic lubricating layer 10 has a tapered shape whose outer diameter gradually decreases toward the proximal end side. Thereby, the catheter moving from the proximal end side can be smoothly guided to the distal end side along the surface of the hydrophilic lubricating layer 10. The taper angle of the hydrophilic lubricating layer 10 is preferably smaller than the taper angle of the taper portion 62 of the tip member 6. Thereby, the guide to the distal end side of the catheter as described above can be performed more smoothly.

  In the present embodiment, the entire length of the hydrophilic lubricating layer 10 in the longitudinal direction is tapered. However, for example, a part of the distal end portion or the proximal end portion may be tapered. Further, the taper angle of the hydrophilic lubricating layer 10 may change along the longitudinal direction, and for example, the taper angle may be gradually increased toward the tip side.

  The length of the hydrophilic lubricating layer 10 is not particularly limited, but is preferably about 0.5 to 2 mm. By setting it as such length, while being able to make the hydrophilic lubrication layer 10 sufficient length to exhibit the function, the manufacturing cost of the guide wire 1 by the hydrophilic lubrication layer 10 becoming excessively long Can be effectively prevented from being increased and operability can be lowered.

  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.

(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. The resin material is not particularly limited. For example, polysulfone, polyimide, polyetheretherketone, polyarylene ketone, polyphenylene sulfide, polyarylene sulfide, polyamideimide, polyateimide, polyimidesulfone, polyallylsulfone, 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 of the outer layer 92 is not particularly limited, but it is preferable to use, for example, a fluorine-based resin material as with the inner layer 91. 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.
The configuration of the guide wire 1 has been described above.

Next, a method for manufacturing the guide wire 1 will be briefly described.
[1]
First, as shown to Fig.3 (a), what fixed the coil 4 by the fixing members 31 and 32 to the wire main body 2 which joined the 1st wire 21 and the 2nd wire 22 by welding is prepared. In FIG. 3A, illustration of the second wire 22, the coil 4, and the fixing members 31, 32 is omitted.

[2]
Next, as shown in FIG. 3 (b), the tip member 6 made of a resin material such as urethane is formed at the tip of the first wire 21, and further, the outer surface of the tip member 6 is covered. A tip side coating layer 7 made of a hydrophilic material is formed. As shown in the figure, at this stage, the tip member 6 is not formed with the tapered portion 62, and the entire outer surface of the tip member 6 is covered with the tip side coating layer 7.

[3]
Next, as shown in FIG. 3C, unnecessary portions are removed using, for example, a file, and the proximal end side of the distal end member 6 is formed into a tapered shape together with the distal end side coating layer 7. Thereby, the taper part 62 exposed from the front end side coating layer 7 is formed. At this time, since the outer surface of the tapered portion 62 of the tip member 6 is roughened by using a file, the adhesion of the hydrophilic lubricating layer 10 formed in the next step can be further increased.

[4]
Next, the hydrophilic lubricating layer 10 made of a hydrophilic material is formed so as to cover the base end 63 of the tip member 6.

  And although not shown in figure, the guide wire 1 is obtained by forming the coating layer 9 in the wire main body 2. FIG.

Second Embodiment
Next, a second embodiment of the guide wire of the present invention will be described.
FIG. 4 is a partially enlarged longitudinal sectional view showing a 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 guide wire of 1st Embodiment, and the description is abbreviate | omitted about the same matter.

  The guide wire of this embodiment is the same as the guide wire of the first embodiment except that the configuration of the hydrophilic lubricating layer is different.

  As shown in FIG. 4, in this embodiment, the tip 101 of the hydrophilic lubricating layer 10 is located at the tip of the tapered portion 62 of the tip member 6. That is, the tip 101 of the hydrophilic lubricating layer 10 is located at the boundary between the tip member 6 exposed to the outside and the tip side coating layer 7. Since the taper part 62 is a part exposed from the front end side coating layer 7, the adhesiveness of the front end part of the hydrophilic lubricating layer 10 can be improved. Furthermore, since the entire region of the tapered portion 62 can be covered with the hydrophilic lubricating layer 10, the slidability of the catheter is further improved. Therefore, by having such a hydrophilic lubricating layer 10, it is possible to prevent the tip portion of the tip member 6 from being turned over and the catheter to be caught, and the guide wire 1 can exhibit excellent operability.

<Third Embodiment>
Next, a third embodiment of the guide wire of the present invention will be described.
FIG. 5 is a partially enlarged longitudinal sectional view showing a 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 this embodiment is the same as the guide wire of the first embodiment except that the configuration of the hydrophilic lubricating layer is different.

  As shown in FIG. 5, in the present embodiment, the tip 101 of the hydrophilic lubricating layer 10 is located on the tip side of the tapered portion 62 of the tip member 6. That is, the hydrophilic lubricating layer 10 is formed so as to overlap the entire area of the tapered portion 62 of the distal end member 6 and further the proximal end portion of the distal end side coating layer 7. Thereby, as above-mentioned, the adhesiveness of the hydrophilic lubricating layer 10 can be improved. Moreover, since the whole area of the taper part 62 can be covered with the hydrophilic lubricating layer 10, the slidability of the catheter is further improved. Further, for example, the stepped portion resulting from the difference in the taper angle between the outer peripheral surface of the tapered portion 62 and the outer peripheral surface of the hydrophilic lubricating layer 10 as in the first embodiment does not occur, so that the slidability of the catheter is further improved. Therefore, by having such a hydrophilic lubricating layer 10, it is possible to prevent the tip portion of the tip member 6 from being turned over and the catheter to be caught, and the guide wire 1 can exhibit excellent operability.

  Further, since the boundary A between the tip member 6 and the tip side coating layer 7 exposed to the outside can be covered by the hydrophilic lubricating layer 10, the tip side coating layer 7 from the tip member 6 starting from the boundary A. Turning over can be effectively prevented.

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

  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 configuration in which the proximal end of the distal end member is located in the middle of the outer diameter constant portion of the first wire has been described. However, the position of the proximal end of the distal end member is not limited to this. For example, the proximal end of the tip member may be located in the middle of the first taper portion or in the middle of the second taper portion, the boundary between the first taper portion and the outer diameter constant portion, or the outer diameter constant portion. And the second taper portion.

DESCRIPTION OF SYMBOLS 1 Guide wire 2 Wire main body 21 1st wire 211 1st outer diameter fixed part 212 2nd outer diameter fixed part 213 Tapered part 22 2nd wire 221 Outer diameter fixed part 222 Outer diameter fixed part 223 Tapered part 31 Fixing material 32 Fixing material 4 Coil 6 Tip member 61 Tip surface 62 Tapered portion 63 Base end 7 Tip side coating layer 9 Coating layer 91 Inner layer 92 Outer layer 93 Linear body 94 Convex portion 95 Concave portion 951 Bottom portion 10 Hydrophilic lubricating layer 101 Tip A Boundary

Claims (6)

A guide wire comprising a flexible long wire body and a tip member that covers the tip of the wire body and is made of a resin material,
A guide wire having a hydrophilic lubricating layer formed so as to cover a proximal end of the distal end member and made of a hydrophilic material.   The guide wire according to claim 1, wherein at least a base end portion of the hydrophilic lubricating layer has a tapered shape in which an outer diameter gradually decreases toward the base end side.   The guide wire according to claim 1 or 2, wherein a maximum outer diameter of the hydrophilic lubricating layer is smaller than a maximum outer diameter of the tip member. The proximal end portion of the distal end member has a tapered shape in which the outer diameter gradually decreases toward the proximal end side,
The guide wire according to any one of claims 1 to 3, wherein a distal end of the hydrophilic lubricating layer is located at a tapered portion of a distal end member. The wire main body is located on the distal end side, is located at a proximal end side with respect to the first outer diameter constant portion, the first outer diameter constant portion having a constant outer diameter in the longitudinal direction, and the first outer diameter constant portion. Is located between the second outer diameter constant portion having a larger outer diameter and a constant outer diameter in the longitudinal direction, and between the first outer diameter constant portion and the second outer diameter constant portion, and the outer diameter is on the tip side A taper portion that gradually decreases toward
5. The guide wire according to claim 1, wherein a proximal end of the distal end member is located in the second outer diameter constant portion.   The guide wire according to any one of claims 1 to 5, wherein the resin material is mainly urethane resin.

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