WO2011081134A1

WO2011081134A1 - Guide wire

Info

Publication number: WO2011081134A1
Application number: PCT/JP2010/073564
Authority: WO
Inventors: 豊田野
Original assignee: テルモ株式会社
Priority date: 2009-12-28
Filing date: 2010-12-27
Publication date: 2011-07-07
Also published as: CN202859876U; JP5451779B2; JPWO2011081134A1

Abstract

Disclosed is a guide wire provided with a flexible linear core wire and a flexible coating material that coats the outer surface of the core wire. The end of the core wire is provided with a taper section, the diameter of which progressively decreases towards the end of the core wire. The end of the coating material is provided with a deformed section that is bent or curved in at least one direction. The end of the core wire is located either near the base end of the deformed section or in the middle of the deformed section, and from there to the end, the guide wire consists of the coating material only.

Description

Guide wire

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. A wire is used (for example, refer patent document 1).

The guide wire of Patent Document 1 has a linear core part (core material) and a covering part that covers the outer periphery of the core part. In this guide wire, the core portion is in a state where the tip end is located to the vicinity of the tip end of the guide wire itself, that is, it is embedded in almost the entire guide wire (see FIG. 13). Therefore, the guide wire has a relatively high rigidity (hardness) at the tip portion.

As shown in FIG. 13, when such a guide wire of Patent Document 1 is inserted into a living body lumen toward a target site and there is another lumen branched from the lumen (hereinafter referred to as “side branch”). When the guide wire is pushed forward, there is a problem that the tip portion of the guide wire may get into the side branch.

International Publication No. 2007/105531

An object of the present invention is to provide a guide wire that can reliably prevent intrusion into another living body lumen branched from the living body lumen toward the target site.

In order to achieve the above object, the present invention provides:
A guide wire comprising: a flexible core wire; and an outer periphery of the core wire, and a flexible covering material,
The core wire includes a tapered portion whose outer diameter gradually decreases toward the tip at a portion on a tip side thereof,
The covering material includes a deformed portion having a portion curved or bent in at least one direction at a tip portion thereof,
The guide wire is characterized in that a distal end of the core wire is located in the vicinity of the proximal end side of the deformable portion or in the middle of the deformable portion, and the distal end side is constituted only by the covering material.

According to the present invention, the deformation of the deformable portion is suppressed so that it can be easily deformed, and the deformed state is easily maintained when deformed. Accordingly, when the guide wire is inserted into the living body lumen toward the target site, the deforming portion is deformed by being restricted by the wall portion that defines the living body lumen toward the target site. The guide wire in a state where the deformed portion is deformed can be pushed toward the target portion. Even when there is another living body lumen branched from the living body lumen toward the target site, the shape of the deforming portion and the deformation portion having high flexibility are combined, and the deforming portion becomes another living body lumen. When trying to cross (pass), it is reliably prevented from entering the other biological lumen. As a result, the deformable portion can surely cross another living body lumen, and thus reach the target site.

In the guide wire of the present invention, it is preferable that the relationship L ≧ 3d is satisfied, where L is the distance from the tip of the core wire to the tip of the deformed portion and the average outer diameter of the guide wire is φd. .

Thereby, the deformed portion becomes more flexible than the base end where the core wire exists, and can be easily deformed. Further, compared to a conventional guide wire in which a core wire is embedded in almost the entire deformed portion, the deformed portion has a suppressed rigidity, and the deformed state is easily maintained when deformed.

In the guide wire of the present invention, it is preferable that the proximal end of the tapered portion is located closer to the proximal end than the deformed portion.

Thus, the deformed portion has its rigidity gradually reduced toward the tip.

In the guide wire of the present invention, it is preferable that the tip of the tapered portion is located in the middle of the deformed portion.

Thus, the deformed portion has its rigidity gradually reduced toward the tip.

In the guide wire of the present invention, it is preferable that the covering material is made of a resin material.

This makes the coating material excellent in flexibility and adhesion to the core wire.

In the guide wire of the present invention, the guide wire of the present invention has a linear portion that forms a straight line on the proximal end side of the deformable portion,
The deforming portion preferably has a curved portion that is curved so that a minimum angle formed with the linear portion is 90 degrees or less.

As a result, the guide wire can be pushed straight forward, and even when the tip of the guide wire hits another living body lumen branched from the living body lumen, the deformed portion is inverted, and the other living body lumen is lost. Can be prevented.

Further, in the guide wire of the present invention, it is preferable that the curved portion has an arc shape and satisfies a relationship of R> d when the radius of curvature is R.

Thereby, when the guide wire is inserted into the living body lumen, the deformed portion can be easily deployed, and thus the deployed guide wire can be pushed forward.

Further, in the guide wire of the present invention, it has a linear portion that forms a straight line on the base end side of the deformable portion,
It is preferable that the deformed portion has a bent portion that is bent so that a minimum angle formed with the linear portion is 90 degrees or less.

Moreover, in the guide wire of the present invention, it is preferable that the distal end of the core wire is positioned on the proximal end side with respect to the vertex of the deformed portion.

This makes the deformed part more flexible as a whole.

In the guide wire of the present invention, it is preferable that the deforming portion has a plurality of bending portions that are bent in opposite directions along the longitudinal direction thereof.

Thereby, the shape of the deformed portion is particularly suitable for use in TRI (Trans-Radial coronary intervention).

In the guide wire of the present invention, it is preferable that the core wire has a protruding portion that is formed on the tip side of the tapered portion and protrudes in a direction perpendicular to the longitudinal direction of the core wire.

As a result, the protruding portion is engaged with the covering material, and for example, when the push-pull operation with respect to the guide wire is repeated, the core wire is reliably prevented from coming out of the covering material, that is, being displaced. Can do.

Moreover, in the guide wire of the present invention, it is preferable that the protruding portion is constituted by a diameter-expanded portion whose outer diameter is increased.

As a result, the protruding portion is engaged with the covering material, and, for example, when the push-pull operation with respect to the guide wire is repeated, the core wire is more reliably prevented from coming out of the covering material, that is, being displaced. be able to.

In the guide wire of the present invention, it is preferable that the projecting portion is a flat plate portion.

As a result, the protruding portion engages with the covering material. For example, when the guide wire is rotated around its axis, even if the rotational force acts on the core wire more than the covering material, the core wire It is possible to reliably prevent the coating material from rotating, that is, shifting.

In the guide wire of the present invention, it is preferable that the protruding portion is a key-shaped portion.

Thereby, for example, when the bending portion receives a pressing force from the wall portion defining the living body lumen and tries to bend further inside the bending, the protruding portion prevents the bending deformation of the bending portion from being hindered. Can do.

In the guide wire of the present invention, it is preferable that at least the tip side portion of the core wire is made of a Ni—Ti alloy in the guide wire of the present invention.

Thereby, it is possible to reduce the diameter while sufficiently preventing the occurrence of buckling in the guide wire, and to have sufficient flexibility and elasticity for the guide wire to be inserted into a predetermined portion. it can.

FIG. 1 is a longitudinal sectional view showing a first embodiment of the guide wire of the present invention. FIG. 2 is a longitudinal sectional view showing a second embodiment of the guide wire of the present invention. FIG. 3 is a longitudinal sectional view showing a third embodiment of the guide wire of the present invention. FIG. 4 is a longitudinal sectional view showing a fourth embodiment of the guide wire of the present invention. FIG. 5 is a longitudinal sectional view showing a fifth embodiment of the guide wire of the present invention. FIG. 6 is a longitudinal sectional view showing a sixth embodiment of the guide wire of the present invention. FIG. 7 is a longitudinal sectional view showing a seventh embodiment of the guide wire of the present invention. FIG. 8 is a longitudinal sectional view showing another configuration example of the enlarged diameter portion. FIG. 9 is a longitudinal sectional view showing another configuration example of the enlarged diameter portion. FIG. 10 is a longitudinal sectional view and an auxiliary projection view showing an eighth embodiment of the guide wire of the present invention. FIG. 11 is a longitudinal sectional view showing a ninth embodiment of the guide wire of the present invention. FIG. 12 is a longitudinal sectional view showing a use state of the guide wire shown in FIG. FIG. 13 is a longitudinal cross-sectional view showing a use state of a conventional guide wire.

Hereinafter, the guide wire of the present invention will be described in detail based on preferred embodiments 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, and FIG. 12 is a longitudinal sectional view showing a usage state of the guide wire shown in FIG. In the following, for convenience of explanation, the right side in FIGS. 1 and 12 (the same applies to FIGS. 2 to 13) is referred to as “base end”, and the left side is referred to as “tip”.

A guide wire 1 shown in FIG. 1 is a guide wire for a catheter that is used by being inserted through a catheter. For example, TRI (Trans-Radial coronary Intervention), which is a technique for performing treatment by inserting a catheter from a wrist (arm): It can be used for transradial coronary intervention). In TRI, when the catheter is inserted into the blood vessel (biological lumen) 20 toward the target site, the guide wire 1 is inserted into the blood vessel 20 prior to the catheter. And the front-end | tip part (deformation part 4) of the guide wire 1 is detained in the target site | part. The catheter can reach the target site following (guided to) the guide wire 1 that has been placed.

The guide wire 1 includes a core wire 2 composed of a flexible or flexible core wire (long core material: core) and a covering material (covering layer) 3 covering the core wire 2. Has been. The total length of the guide wire 1 is not particularly limited, but is preferably about 200 to 5000 mm.

The core wire 2 embedded in the guide wire 1 is composed of a single continuous wire. The core wire 2 includes a main body portion 21 located on the proximal end side and a tapered portion 23 provided on the distal end side of the main body portion 21.

The outer diameter of the main body 21 is constant over almost the entire region in the longitudinal direction. Moreover, it is preferable that the cross-sectional shape of the main-body part 21 is circular, However, It is not limited to this, For example, you may comprise square.

A tapered portion 23 is provided on the front end side of the main body 21 without any step difference from the main body 21. The taper portion 23 is a portion whose outer diameter gradually decreases toward the tip. The cross-sectional shape of the taper portion 23 is circular, similar to the cross-sectional shape of the main body portion 21. Since the core wire 2 has the taper part 23, the rigidity (bending rigidity, torsional rigidity) of the core line 2 can be gradually decreased toward the distal end direction. As a result, the guide wire 1 has good flexibility at the distal end thereof, improves followability to the blood vessel 20 and safety, and can prevent bending and the like.

Further, as the constituent material of the core wire 2, an alloy (including a superelastic alloy) exhibiting pseudoelasticity can be used, and a superelastic alloy is particularly preferable as an alloy exhibiting pseudoelasticity.

Since the superelastic alloy is rich in flexibility, has resilience, and is difficult to bend, the guide wire 1 is formed on the distal end side by configuring the core wire 2 (particularly, the distal end thereof) with the superelastic alloy. Sufficient flexibility in the part and resilience to bending can be obtained, follow-up performance to the blood vessel 20 that is curved and bent in a complicated manner is improved, and more excellent operability is obtained, and the core wire 2 is bent and bent. Even if it repeats, since the bending habit is not attached by the restoring property with which the core wire 2 is provided, it is possible to prevent a decrease in operability due to the bending habit of the core wire 2 during use of the guide wire 1.

Pseudoelastic alloys include any shape of stress-strain curve due to tension, including those where the transformation point of As, Af, Ms, Mf, etc. can be remarkably measured, and those that cannot be measured. However, everything that returns to its original shape by removing stress is included.

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

As a constituent material of the core wire 2, in addition to the Ni—Ti alloy, a cobalt alloy which is an alloy exhibiting the same pseudoelasticity can be used. The cobalt-based alloy has a high elastic modulus when it is formed into an elongated wire, and has an appropriate elastic limit. For this reason, the wire comprised by the cobalt type alloy is excellent in torque transferability, and problems, such as buckling, do not arise very much. 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. By using an alloy having such a composition, the above-described effects become more remarkable. 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.

In addition, in the guide wire 1, the process (roughening process, a chemical process, heat processing, etc.) for improving the adhesiveness with the coating | covering material 3 may be performed to the outer peripheral surface (surface) of the core wire 2. FIG. .

The outer peripheral surface of the core wire 2 is provided with a flexible covering material 3 that covers the whole. Furthermore, the covering material 3 is provided beyond the tip 231 of the core wire 2 (tapered portion 23), and the portion (tip portion) beyond which the core wire 2 does not exist constitutes a deformed portion 4 described later. .

The covering material 3 can be formed for various purposes. For example, it can be formed for the purpose of reducing the friction (sliding resistance) of the guide wire 1 and improving the slidability. Thereby, the operativity of the guide wire 1 improves.

The thickness of the portion covering the core wire 2 of the covering material 3 is not particularly limited and is appropriately determined in consideration of the purpose of forming the covering material 3, the constituent material, the forming method, and the like. Is preferably about 30 to 300 μm, more preferably about 50 to 200 μm. If the thickness of the covering material 3 is too thin, the purpose of forming the covering material 3 may not be sufficiently exhibited. Moreover, when the thickness of the coating | covering material 3 is too thick, there exists a possibility of affecting the physical characteristic of the core wire 2. FIG. The covering material 3 may be a laminate of two or more layers.

The covering material 3 is made of a resin material. The resin material is not particularly limited. For example, polyolefin such as polyurethane, polyethylene, polypropylene, and ethylene-propylene copolymer, fluorine resin such as polytetrafluoroethylene, polyester such as polyethylene terephthalate, polyvinyl chloride, polyamide, Examples include polyimide, ethylene-vinyl acetate copolymer, ethylene-ethylene acrylate copolymer, ABS resin, AS resin, butadiene-styrene copolymer, polyisoprene, polybutadiene, etc., one or more of these However, for example, a material having relatively high flexibility such as polyurethane is preferable because of its excellent flexibility and adhesion to the core wire 2.

Moreover, it is preferable that a hydrophilic material is coated on the outer surface of at least the tip of the guide wire 1. 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, block copolymer of polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA)), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone and the like.

Such a hydrophilic material often exhibits lubricity by wetting (water absorption), and reduces frictional resistance (sliding resistance) with the catheter or the inner wall of the endoscope used together with the guide wire 1. Thereby, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the catheter becomes better.

Further, a contrast agent made of metal powder (metal particles) having X-ray contrast properties may be added to a portion located in the deformed portion 4 of the covering material 3. The metal material is not particularly limited, and examples thereof include noble metals such as tungsten, gold, and platinum, and tungsten is particularly preferable. Thereby, when inserting the guide wire 1 into the target site | part of the blood vessel 20 under X-ray fluoroscopy, it can grasp | ascertain reliably where the deformation | transformation part 4 of the guide wire 1 is located in the blood vessel 20. FIG. The average particle diameter (average diameter) of the contrast agent in the covering material 3 is not particularly limited, but is preferably 0.5 to 4.0 μm, for example, and more preferably 1.0 to 1.5 μm. preferable.

As shown in FIG. 1, the guide wire 1 having such a configuration can be divided into a deformed portion 4 located on the distal end side and a linear portion 5 located on the proximal end side.

The straight portion 5 is straight in the natural state and bears most of the guide wire 1. Here, the “natural state” refers to a state where no external force is applied.

The deformed portion 4 is a portion that bears the tip portion of the guide wire 1 (formed at the tip portion) and is deformed into a “J” shape. The deformable portion 4 includes a curved portion 41 and a linear portion 42. The curved portion 41 is a portion that is continuously formed (extends) from the linear portion 5 and is curved in an arc shape in a natural state. Moreover, the linear part 42 is a part which is formed continuously from the curved part 41 and forms a straight line in a natural state. A tip 43 of the linear portion 42 is rounded. Thereby, when the guide wire 1 is inserted into the blood vessel 20, it is possible to more reliably prevent the distal end 43 from damaging the inner wall of the blood vessel 20.

When the guide wire 1 is inserted into the blood vessel 20, the deformed portion 4 having such a configuration is corrected (regulated) by the wall portion of the blood vessel 20, and the degree of bending of the bending portion 41 is in a natural state. Smaller, that is, a shape close to a straight line (see FIG. 12).

Now, in the guide wire 1, the distal end 231 of the core wire 2 is positioned in the immediate vicinity (near the proximal end side) of the proximal end 44 of the deformable portion 4 (curved portion 41). Thereby, the deformation | transformation part 4 becomes what the core wire 2 does not exist, and as mentioned above, the whole is comprised by the part beyond the front-end | tip 231 of the core wire 2 of the coating | covering material 3. FIG. The rigidity of the guide wire 1 is gradually suppressed as the guide wire 1 moves to a portion where the main body portion 21 of the core wire 2 is located, a portion where the taper portion 23 of the core wire 2 is located, and a coreless portion (deformation portion 4). It has become (softens).

Further, in the guide wire 1, when the length of the deformed portion 4, that is, the distance from the distal end 231 of the core wire 2 to the distal end 43 of the deformed portion 4 is L, and the outer diameter of the guide wire 1 is φd, L ≧ 3d This relationship is satisfied, preferably the relationship 10d ≦ L ≦ 100d is satisfied, and more preferably the relationship 50d ≦ L ≦ 100d is satisfied.

Under such conditions, the deforming portion 4 is more flexible than the proximal end side where the core wire 2 exists, and can be easily deformed as much as it is “coreless”. Moreover, compared with the conventional guide wire (refer FIG. 13) by which the core wire was embed | buried under most parts (substantially whole) of a deformation | transformation part (front-end | tip part), the deformation | transformation part 4 became a thing by which rigidity was suppressed and deformed. At that time, the deformed state is easily maintained.

Furthermore, in the guide wire 1, the deformed portion 4 has a “J” shape as described above. Specifically, the bending portion 41 is bent so that the linear portion 42 is in parallel with the linear portion 5 in a natural state, that is, the angle formed by the tip 43 and the linear portion 5 is 0 degree. Yes.

As illustrated in FIG. 12A, when the guide wire 1 is inserted into the blood vessel 20, the deformable portion 4 is restricted by the inner wall of the blood vessel 20, and thus is substantially straight from the “J” shape. Deform to expand (open) into shape. The guide wire 1 in the state shown in FIG. 12A can be pushed forward.

Then, as shown in FIG. 12B, even when there is a side branch 201 branched from the blood vessel 20, the shape of the deformed portion 4 and the fact that the shape is maintained are combined, so that the deformable portion 4 becomes the side branch 201. When trying to cross (pass), it is reliably prevented from getting into the side branch 201. Thereby, the deformation | transformation part 4 can cross the side branch 201 reliably (refer FIG.12 (c)), and can reach | attain the target site | part of the blood vessel 20. FIG.

Further, when the radius of curvature of the center line of the curved portion 41 is R, it is preferable to satisfy the relationship of R> d, and it is more preferable to satisfy the relationship of d <R ≦ 50d. Thereby, when the guide wire 1 is inserted into the blood vessel 20, the deformable portion 4 can be easily deployed, and thus the guide wire 1 in the deployed state can be pushed forward. Further, even when the distal end 43 of the deformable portion 4 reaches the side branch 201, the deformable portion 4 is flexibly configured so that the deformable portion 4 is inverted to the original “J” shape (natural state). There is also an advantage that side branch intrusion is prevented and the deformed portion 4 exhibits an effect as a support portion with respect to the blood vessel wall.

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

Hereinafter, the second embodiment of the guide wire of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the position of the taper portion of the core wire is different.

In the guide wire 1 </ b> A shown in FIG. 2, a part of the tapered portion 23 of the core wire 2 enters the deformed portion 4. That is, in the guide wire 1A, the taper portion 23 of the core wire 2 has a distal end 231 in the middle of the deformable portion 4 and is located on the proximal side from the apex 412 of the deformable portion 4 (curved portion 41), and The base end 232 is located closer to the base end side than the base end 44 of the deformable portion 4.

Further, the portion (hereinafter referred to as “insertion portion 233”) that enters the deformed portion 4 of the tapered portion 23 is curved in the same manner as the curved portion 41 following the shape of the curved portion 41.

Thus, in the guide wire 1A, the insertion portion 233 of the taper portion 23 constitutes a part of the deformation portion 4. Thereby, although the deformation | transformation part 4 becomes rigid as much as the insertion part 233 has entered, since the insertion part 233 has comprised the taper shape, the said rigidity will fall gradually toward a front-end | tip direction. . Further, the portion of the deformable portion 4 on the tip end side of the tip portion 231 of the taper portion 23 has a lower rigidity than the portion in which the insertion portion 233 of the deformable portion 4 is inserted. Therefore, in the deformable portion 4, the rigidity can be gradually reduced toward the tip.

With the configuration as described above, the operability of the guide wire 1A is improved. In particular, when the deformed portion 4 tries to cross the side branch 201, the side branch 201 can be surely crossed. Intrusion is surely prevented. In addition, it is possible to prevent bending at the deformable portion 4.

The position of the distal end 231 of the core wire 2 is closer to the base end side than the vertex 412 of the deformable portion 4 in the illustrated configuration, but is not limited to this, and if the relationship of L ≧ 3d is satisfied, for example, the deformable portion It may be a position beyond 4 vertices 412.

<Third Embodiment>
FIG. 3 is a longitudinal sectional view showing a third embodiment of the guide wire of the present invention.

Hereinafter, the third embodiment of the guide wire according to the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the deforming portion is different.

The guide wire 1B shown in FIG. 3 has a configuration in which the linear portion 42 is omitted from the deformable portion 4, that is, the deformable portion 4 is configured by one curved portion 41. In this guide wire 1B, an angle (minimum angle) θ between the distal end 43 of the deformable portion 4 and the linear portion 5 is 90 degrees in a natural state.

In the guide wire 1B having such a configuration, the distal end 43 serves as a support portion for the blood vessel wall, and the guide wire 1B can be pushed straight forward, and the deformable portion 4 is inverted even when the distal end 43 hits the side branch 201. In addition, entry into the side branch 201 can be prevented.

Note that the angle θ is 90 degrees in the illustrated configuration, but is not limited thereto, and may be any size (angle) as long as it is within a range of 0 to 90 degrees.

Further, the position of the distal end 231 of the core wire 2 is close to the proximal end 44 of the deformable portion 4 in the illustrated configuration, but is not limited to this. For example, if the relationship of L ≧ 3d is satisfied, for example, It may be on the way.

<Fourth embodiment>
FIG. 4 is a longitudinal sectional view showing a fourth embodiment of the guide wire of the present invention.

Hereinafter, the fourth embodiment of the guide wire of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the shape (configuration) of the deforming portion is different.

In the guide wire 1 </ b> C shown in FIG. 4, the deformable portion 4 is composed of one bent portion 45 bent in one direction. The bent portion 45 is bent in a natural state so that the angle θ between the tip 43 and the linear portion 5 is preferably 90 degrees or less, more preferably 30 to 60 degrees.

In the guide wire 1C having such a configuration, when the deformed portion 4 passes, for example, a portion where the blood vessel 20 is sharply curved (the radius of curvature is relatively small), the passage is easily and safely performed. In addition, a conventional guide wire having a curved portion at the distal end is difficult to insert into the insertion port of the catheter, but the guide wire 1C can be easily inserted due to the high flexibility of the deformable portion 4. There are also advantages.

In addition, although the deformation | transformation part 4 is comprised by one bending part in the structure of illustration, it is not limited to this, For example, you may have a some bending part bent in the mutually opposite direction. Further, it may have at least one bent portion and one bent portion.

Further, the position of the distal end 231 of the core wire 2 is in the vicinity of the proximal end side of the deformable portion 4 in the illustrated configuration, but is not limited to this. For example, if the relationship of L ≧ 3d is satisfied, for example, It may be on the way.

<Fifth Embodiment>
FIG. 5 is a longitudinal sectional view showing a fifth embodiment of the guide wire of the present invention.

Hereinafter, the fifth embodiment of the guide wire according to the present invention will be described with reference to this figure. However, the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

In the guide wire 1D illustrated in FIG. 5, the deforming portion 4 includes a plurality of (three in the illustrated configuration) bending portions 41 (first bending portion 41a, second bending portion 41b, and third bending in order from the distal end side). Part 41c). The first bending portion 41a, the second bending portion 41b, and the third bending portion 41c are naturally bent in opposite directions along the longitudinal direction of the deformation portion 4.

Further, the first bending portion 41a, the second bending portion 41b, and the third bending portion 41c have different radii of curvature (degrees of bending). That is, the radius of curvature of the first curved portion 41a is smaller than the radius of curvature of the third curved portion 41c. The radius of curvature of the second curved portion 41b is intermediate between the radius of curvature of the first curved portion 41a and the radius of curvature of the third curved portion 41c. Thus, in the deformed portion 4, the radius of curvature increases stepwise toward the base end side.

Further, the distal end 43 of the deformable portion 4 is in a position shifted from the extended line 51 in the distal direction of the linear portion 5 in a natural state.

In the guide wire 1D configured as described above, the shape of the deformed portion 4 is particularly suitable for TRI. In addition, even if the tip 43 is hooked on the side branch 201, there is an advantage that it can be reversed by the second curved portion 41b to prevent intrusion.

In addition, although the deformation | transformation part 4 has the three curved parts 41 in the structure of illustration, it is not limited to this, For example, you may have 2 or 4 or more curved parts 41.

<Sixth Embodiment>
FIG. 6 is a longitudinal sectional view showing a sixth embodiment of the guide wire of the present invention.

Hereinafter, the sixth embodiment of the guide wire of the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

In the guide wire 1E shown in FIG. 6, the deformable portion 4 is divided into a tapered portion 46 whose outer diameter φd gradually decreases in the distal direction and an outer diameter constant portion 47 whose outer diameter φd is constant along the longitudinal direction. be able to. The tapered portion 46 is formed on the distal end side of the constant outer diameter portion 47.

Further, the boundary between the tapered portion 46 and the constant outer diameter portion 47 is in the middle of the curved portion 41. That is, the outer diameter φd of the bending portion 41 gradually decreases from the middle toward the distal end.

In the guide wire 1E configured as described above, the rigidity of the deforming portion 4 is gradually reduced more favorably in the distal direction. Thereby, when the deformation | transformation part 4 deform | transforms, it becomes easy to maintain the deformation | transformation state more reliably. And when this deformation | transformation part 4 tries to cross the side branch 201, it is prevented more reliably that the said deformation | transformation part 4 intrudes into the side branch 201. FIG.

Note that the angle θ is an acute angle, specifically, 90 degrees or less is preferable, and 30 to 60 degrees is more preferable.

<Seventh embodiment>
FIG. 7 is a longitudinal sectional view showing a seventh embodiment of the guide wire of the present invention, and FIGS. 8 and 9 are longitudinal sectional views showing other configuration examples of the enlarged diameter portion.

Hereinafter, the seventh embodiment of the guide wire of the present invention will be described with reference to these drawings, but the description will focus on differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the first embodiment except that the configuration of the core wire is different.

In the guide wire 1F shown in FIG. 7, the core wire 2 further has a protruding portion 24 formed on the tip side of the tapered portion 23. The projecting portion 24 is configured by a diameter-enlarged portion that projects in a direction orthogonal to the longitudinal direction of the core wire 2, that is, the outer diameter is increased. And as a shape of an enlarged diameter part, the spherical shape as shown in FIG. 7, hemispherical shape as shown in FIG. 8, and the bullet shape as shown in FIG. 9 are mentioned, for example. Thus, it is preferable that the front end surface 241 is rounded. Other shapes include a flange shape (disc shape) and the like.

By forming the protruding portion 24 having such a shape, the protruding portion 24 is engaged with the covering material 3. For example, when the push-pull operation with respect to the guide wire 1F is repeated, the core wire 2 is covered. It is possible to reliably prevent the material 3 from slipping out, that is, being displaced. Further, when the pushing operation is performed on the guide wire 1F, even if the pressing force acts on the core wire 2 more than the covering material 3, it is possible to reliably prevent the covering material 3 from being pierced by the protruding portion 24. .

In the configuration shown in FIG. 7, the protruding portion 24 is positioned near the base end 44 of the deformable portion 4. It may be located in the middle.

In addition, the protruding portion 24 may be configured separately from the tapered portion 23, for example, and may be joined to the tapered portion 23, or may be formed integrally with the tapered portion 23. May be. Moreover, when the protrusion part 24 is comprised separately from the taper part 23, the constituent material of the protrusion part 24 and the constituent material of the part after the taper part 23 can be made different.

<Eighth Embodiment>
FIG. 10 is a longitudinal sectional view and an auxiliary projection view showing an eighth embodiment of the guide wire of the present invention.

Hereinafter, the eighth embodiment of the guide wire according to the present invention will be described with reference to this drawing, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

This embodiment is the same as the seventh embodiment except that the shape of the protruding portion is different.

In the guide wire 1G shown in FIG. 10, the protrusion 24 'has a flat plate shape, that is, a ribbon shape (strip shape). Further, the protruding portion 24 ′ is slightly curved in the same direction as the bending portion 41.

By forming the protruding portion 24 ′ having such a shape, the protruding portion 24 ′ is engaged with the covering material 3. For example, when the guide wire 1 G is rotated around its axis, the rotation is performed. Even if the force acts on the core wire 2 more excessively than the covering material 3, it is possible to reliably prevent the core wire 2 from rotating with respect to the covering material 3, that is, shifting.

Further, since the protruding portion 24 ′ can be reshaped, the degree of bending of the portion of the bending portion 41 where the protruding portion 24 ′ is located can be changed. Here, “reshapable” means that the protrusion 24 ′ can be bent into a desired shape and the shape can be maintained.

<Ninth Embodiment>
FIG. 11 is a longitudinal sectional view showing a ninth embodiment of the guide wire of the present invention.

Hereinafter, the ninth embodiment of the guide wire according to the present invention will be described with reference to this figure, but the description will focus on the differences from the above-described embodiment, and the description of the same matters will be omitted.

In the guide wire 1 </ b> H shown in FIG. 11, the protruding portion 24 ″ has a key shape protruding toward the inside of the bending portion 41.

By forming the protruding portion 24 ″ having such a shape, for example, when the bending portion 41 receives a pressing force from the blood vessel wall and tries to bend further inside the bending, the protruding portion 24 ″ is bent. It is possible to prevent the bending of the portion 41 from being obstructed.

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.

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

The core wire is a single continuous wire made of a Ni—Ti alloy, but is not limited to this. For example, the tip side portion is made of a Ni—Ti alloy, and the proximal end The side portion may be made of stainless steel or a single continuous wire made of stainless steel.

In addition, the core wire has a tapered portion at the distal end thereof, but is not limited thereto. For example, a portion having an outer diameter that is constant along the longitudinal direction (external portion) on the distal end side of the tapered portion. It may have a constant diameter portion. In this case, the outer diameter constant portion (second outer diameter constant portion) on the distal end side of the tapered portion has an outer diameter smaller than the outer diameter of the main body portion (first outer diameter constant portion).

Further, the core wire has a tapered portion at the tip thereof, but is not limited to this, for example, the tapered portion is omitted, that is, the outer diameter is constant along the longitudinal direction. Also good.

The guide wire of the present invention is a guide wire comprising a flexible core wire and a covering material that covers the outer periphery of the core wire and has flexibility. The portion includes a tapered portion whose outer diameter gradually decreases toward the tip, the covering material includes a deformed portion having a portion curved or bent in at least one direction at the tip, and the tip of the core wire is deformed. It is located in the vicinity of the base end side of the part or in the middle of the deformed part, and the tip end side is composed only of the covering material. Therefore, it is possible to reliably prevent the guide wire from entering the other living body lumen branched from the living body lumen toward the target site. Therefore, the guide wire of the present invention has industrial applicability.

Claims

A guide wire comprising: a flexible core wire; and an outer periphery of the core wire, and a flexible covering material,
The core wire includes a tapered portion whose outer diameter gradually decreases toward the tip at a portion on a tip side thereof,
The covering material includes a deformed portion having a portion curved or bent in at least one direction at a tip portion thereof,
A guide wire characterized in that a distal end of the core wire is located in the vicinity of the proximal end side of the deformable portion or in the middle of the deformable portion, and the distal end side is composed of only the covering material.
2. The guide wire according to claim 1, wherein a relationship of L ≧ 3d is satisfied, where L is a distance from the tip of the core wire to the tip of the deformed portion, and an average outer diameter of the guide wire is φd.
The guide wire according to claim 1, wherein a proximal end of the tapered portion is located on a proximal end side with respect to the deformable portion.
The guide wire according to claim 1, wherein a tip end of the tapered portion is located in the middle of the deformed portion.
The guide wire according to claim 1, wherein the covering material is made of a resin material.
A linear portion that forms a straight line on the base end side of the deformable portion;
The guide wire according to claim 1, wherein the deformable portion has a curved portion that is curved so that a minimum angle with the linear portion is 90 degrees or less.
The guide wire according to claim 6, wherein the curved portion has an arc shape and satisfies a relationship of R> d, where R is a curvature radius.
A linear portion that forms a straight line on the base end side of the deformable portion;
The guide wire according to claim 1, wherein the deformable portion has a bent portion that is bent so that a minimum angle with the linear portion is 90 degrees or less.
The guide wire according to claim 6, wherein a distal end of the core wire is located on a proximal end side with respect to a vertex of the deformed portion.
The guide wire according to claim 1, wherein the deforming portion has a plurality of bending portions that are bent in opposite directions along the longitudinal direction thereof.
The guide wire according to claim 1, wherein the core wire has a protruding portion that is formed on a tip side of the tapered portion and protrudes in a direction orthogonal to a longitudinal direction of the core wire.
The guide wire according to claim 11, wherein the protruding portion is configured by an enlarged diameter portion having an enlarged outer diameter.
The guide wire according to claim 11, wherein the protruding portion is a flat plate-like portion.
The guide wire according to claim 11, wherein the protruding portion is a key-shaped portion.