WO2014162391A1

WO2014162391A1 - Guide wire

Info

Publication number: WO2014162391A1
Application number: PCT/JP2013/059832
Authority: WO
Inventors: 豊田野
Original assignee: テルモ株式会社
Priority date: 2013-04-01
Filing date: 2013-04-01
Publication date: 2014-10-09

Abstract

A guide wire (1) comprises a flexible wire main body (11) and a distal end member (10) which passes through the distal end of the wire main body (11) and is composed of a wire formed into a tubular shape. The distal end member (10) comprises a first tubular member (4) which is formed with a wire (41) at least the periphery of which is composed of a resin material and a second tubular member (5) which is provided on a base end side of the first tubular member (4) and is formed with a second wire (51) that is composed of a metal material. Further, the length of the first tubular member (4) in the longitudinal direction is shorter than the length of the second tubular member (5) in the longitudinal direction.

Description

Guide wire

The present invention relates to a guide wire.

The guide wire is used to guide a catheter used for treatment of a site where surgical operation is difficult, treatment for the purpose of minimally invasive to the human body, or examination such as cardiac angiography. For example, when performing PCI (Percutaneous Coronary Intervention), the distal end of the guide wire is projected from the distal end of the balloon catheter under fluoroscopy, and the coronary artery that is the target site together with the balloon catheter. The tip of the balloon catheter is guided to the vicinity of the blood vessel stenosis.

As a guide wire used for such treatment, for example, a guide wire described in Patent Document 1 is known. The guide wire includes a flexible wire body, a coil that is installed so as to cover the outer periphery of the distal end portion of the wire body, and a resin coating layer that covers the wire body and the outermost surface of the coil. (Synthetic resin covering member, hydrophilic lubricating layer). With this resin coating layer, when the guide wire is inserted into a blood vessel or the like, damage to the blood vessel wall due to contact of the guide wire with the blood vessel wall can be prevented, and safety is improved.
The guide wire described in Patent Document 1 is excellent in flexibility because the wire body and the coil are made of a resin material. However, since it is excellent in flexibility, operability (pushability and torque transmission) is reduced.

On the other hand, when the coil is made of a metal material, appropriate bending rigidity and torsional rigidity can be obtained, and the operability is excellent. However, there is a problem that the resin coating layer located on the outermost surface is easily peeled compared to the case where the coil is made of a resin material.
As described above, it is difficult for the guide wire to prevent the resin coating layer from peeling while achieving both flexibility and operability.

JP-T-2004-517694

An object of the present invention is to provide a guide wire that has excellent operability and can prevent peeling of the hydrophilic lubricating layer when, for example, a hydrophilic lubricating layer having hydrophilicity is coated.

Such an object is achieved by the present inventions (1) to (15) below.
(1) a flexible wire body;
A cylindrical member that is inserted into the tip of the wire body and is formed by processing the wire into a cylindrical shape;
The cylindrical member is provided with a first cylindrical member formed by processing a first wire whose outer peripheral portion is made of a resin material, and a base material side of the first cylindrical member. And a second tubular member formed by processing the second wire rod constituted by the guide wire.

(2) The guide wire according to (1), wherein the guide wire has an overlapping portion where a proximal end portion of the first cylindrical member and a distal end portion of the second cylindrical member overlap each other.

(3) In the above (2), the overlapping portion is in a state in which a proximal end portion of the first cylindrical member is located inside a distal end portion of the second cylindrical member. Guide wire.

(4) The overlapping portion according to (2), wherein the base end portion of the first cylindrical member is positioned outside the distal end portion of the second cylindrical member. Guide wire.

(5) The guide wire according to (2), wherein the overlapping portion is in a state where the first wire and the second wire are engaged with each other.

(6) Any of the above (1) to (5), wherein the first wire has a core made of a metal material and a coating layer made of the resin material covering the outer periphery of the core. The guide wire according to item 1.

(7) The first wire has a base end side exposed portion where the core member is exposed at a base end portion thereof,
The guide wire according to (6), wherein the proximal end side exposed portion and the distal end portion of the second wire are fixed.

(8) The first wire has a tip side exposed portion where the core material is exposed at a tip portion thereof,
The guide wire according to (6) or (7), wherein the distal end side exposed portion and the distal end portion of the wire body are fixed.

(9) The wire main body has an outer diameter reduced portion whose outer diameter is reduced toward the tip side in the middle of the longitudinal direction,
The guide wire according to any one of (2) to (8), wherein at least a part of the overlapping portion overlaps the outer diameter reduced portion.

(10) having a fixing member for fixing the cylindrical member to the wire body;
The guide wire according to any one of (1) to (9), wherein the fixing member is provided near a boundary between the first cylindrical member and the second cylindrical member.

(11) The guide wire according to any one of (1) to (10), wherein the first cylindrical member has X-ray contrast properties.

(12) The guide wire according to any one of (1) to (11), wherein the first cylindrical member and the second cylindrical member are covered with a hydrophilic material.

(13) The guide according to any one of (1) to (12), wherein a length of the first tubular member in a longitudinal direction is shorter than a length of the second tubular member in a longitudinal direction. Wire.

(14) The first cylindrical member is configured by a coil formed by spirally winding the first wire.
The guide wire according to any one of (1) to (13), wherein the second cylindrical member is configured by a coil formed by spirally winding the second wire.

(15) The guide wire according to any one of (1) to (13), wherein the first cylindrical member is configured by a braid formed by crossing the first wire rods into a net shape. .

According to the present invention, since at least the outer peripheral portion has the first cylindrical member made of a resin material and the second cylindrical member made of a metal material, it has excellent flexibility and operability. For example, when a hydrophilic lubricating layer having hydrophilicity is coated, a guide wire that can prevent the hydrophilic lubricating layer from peeling off can be provided.

In addition, when the first cylindrical member and the second cylindrical member have an overlapping portion, the flexibility of the guide wire can be gradually increased toward the distal end side. Thereby, it is possible to prevent the guide wire from being bent sharply.

FIG. 1 is a schematic configuration diagram (partial cross-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 side view showing the first tubular member of the 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 cross-sectional view of the wire constituting the first tubular member shown in FIG.

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 schematic configuration diagram (partial cross-sectional view) showing a first embodiment of the guide wire of the present invention. In the following, for convenience of explanation, the left side with respect to the major axis direction in FIG. 1 is referred to as “tip” and the right side is referred to as “base end”. Further, in FIG. 1, for easy understanding, the length direction of the guide wire is shortened and the radial direction (thickness direction) of the guide wire is exaggerated and schematically illustrated. The ratio of directions is different from the actual ratio (the same applies to FIG. 2 and thereafter).

A guide wire 1 shown in FIG. 1 is a guide wire for a catheter that is used by being inserted into the lumen of a catheter (including an endoscope), and includes a first wire 2 disposed on the distal end side, and a first wire 2. A flexible wire main body 11 formed by joining (connecting) the second wire 3 arranged on the base end side of the wire and a distal end portion of the wire main body 11 are inserted, and the wire is processed into a cylindrical shape. It has a tip member (tubular member) 10. The distal end member 10 includes a coil (first cylindrical member) 4 and a coil (second cylindrical member) 5 provided on the proximal end side of the coil 4. The coil 4 and the coil 5 are fixed to the wire body 11 by fixing

members

12, 13, and 14.

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

The first wire 2 is composed of a wire material (core material) having flexibility or elasticity. The length of the first wire 2 is not particularly limited, but is preferably about 20 to 1000 mm.

In the present embodiment, the first wire 2 includes a portion having a constant outer diameter (a constant outer diameter portion) and a tapered portion (the outer diameter gradually decreasing portion) in which the outer diameter gradually decreases in the distal direction. Taper portion). In the illustrated configuration, the outer diameter of the first wire 2 is larger than that of the outer diameter constant portion 25, the tapered portion (outer diameter enlarged portion) 24, and the outer diameter constant portion 25 in order from the proximal end side to the distal end side. It has a small constant outer diameter portion 23, a tapered portion (main body side tapered portion) 22, and a most advanced portion 21.

By having the

taper portions

22 and 24, the rigidity (bending rigidity and torsional rigidity) of the first wire 2 can be gradually decreased toward the distal end direction. As a result, the guide wire 1 has a favorable distal end portion. Flexibility can be obtained, and followability and safety to a body lumen (body cavity) such as a blood vessel can be improved, and bending can also be prevented.

The taper angles of the taper portions 22 and 24 (the reduction rate of the outer diameter) are constant along the longitudinal direction of the wire body 11 (hereinafter, simply referred to as “longitudinal direction”), but vary along the longitudinal direction. There may be. For example, a portion in which a taper angle (an outer diameter reduction rate) and a relatively small portion are alternately formed a plurality of times may be used.

The most advanced portion 21 can be, for example, a constant outer diameter portion having a smaller outer diameter than the constant outer diameter portion 23.

Further, the forefront portion 21 may be configured to have, for example, a flat plate shape (ribbon shape) and can be used after being deformed (reshaped: shaped) into a desired shape. In general, a guide wire is used by a doctor by bending a distal end portion of a guide wire into a desired shape in advance so that the distal end portion of a guiding catheter or the like corresponds to a blood vessel shape or smoothly guides a blood vessel branch. In some cases, bending the distal end portion of the guide wire into a desired shape is referred to as reshaping. And by providing this forefront part 21, reshaping can be performed easily and reliably, and the operativity at the time of inserting the guide wire 1 in a living body improves markedly.

The length of the most advanced portion 21 is not particularly limited, but is preferably about 5 to 200 mm, and more preferably about 10 to 150 mm. In particular, when the most advanced portion 21 is reshaped and used, if the length of the most advanced portion 21 is too long, the operability of the guide wire 1 may be lowered depending on the constituent material. If the length of 21 is too short, the shape of the distal end portion of the guide wire 1 may not be a desired shape.

The constituent material (material) of the first wire 2 is not particularly limited. For example, various metal materials such as Ni—Ti alloy and stainless steel can be used. Preferably). More preferably, it is a superelastic alloy. Since the superelastic alloy is relatively flexible and has a resilience and is difficult to bend, the guide wire 1 can be sufficiently formed in the tip side portion by configuring the first wire 2 with the superelastic alloy. Flexibility and resilience to bending can be obtained, follow-up to complicatedly curved and bent blood vessels can be improved, and more excellent operability can be obtained. Even if the first wire 2 repeatedly bends and bends, Since the 1 wire 2 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 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. Note that a superelastic alloy typified by a Ni—Ti alloy is excellent in the adhesion of the resin coating layer when used with a resin coating layer.

The distal end of the second wire 3 is joined (connected) to the proximal end of the first wire 2 (the proximal end of the constant outer diameter portion 25). The second wire 3 is composed of a wire material (core material) having flexibility or elasticity. The length of the second wire 3 is not particularly limited, but is preferably about 20 to 4800 mm, and more preferably about 1400 to 3000 mm.

The average outer diameter of the second wire 3 is larger than the average outer diameter of the first wire 2. As a result, the guide wire 1 is more flexible on the first wire 2 on the distal end side and more rigid on the second wire 3 on the proximal end side. It is possible to achieve both flexibility and excellent operability (pushability, torque transmission, etc.).

The joining method of the 1st wire 2 and the 2nd wire 3 is not specifically limited, For example, although various methods, such as welding and brazing, can be used, the 1st wire 2 and the 2nd wire 3 are welding. It is preferable that they are joined together.

Further, the welding method is not particularly limited, and examples thereof include friction welding, butt resistance welding such as spot welding using a laser and upset welding, and the like, because relatively simple and high joint strength can be obtained. Butt resistance welding is particularly preferred.

The second wire 3 is made of a material different from that of the first wire 2, and in particular, the elastic modulus (Young's modulus (longitudinal elastic modulus), rigidity (transverse elastic modulus), volume elasticity) than the constituent material of the first wire 2. It is preferable that it is made of a material having a high rate. Thereby, moderate rigidity is obtained for the second wire 3, the guide wire 1 becomes so-called firm, the pushability and torque transmission performance are improved, and more excellent insertion operability is obtained.

The constituent material (raw material) of the second wire 3 is not particularly limited as long as it is different from the first wire 2, and stainless steel (for example, SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405, SUS430, SUS434, Various metal materials such as SUS444, SUS429, SUS430F, SUS302, etc.), piano wire, cobalt alloy, pseudoelastic alloy, etc. can be used, but stainless steel or cobalt alloy is preferable, and stainless steel is preferable. More preferably, it is steel. By configuring the second wire 3 with stainless steel or a cobalt-based alloy, the guide wire 1 can obtain better pushability and torque transmission.

In the present embodiment, the wire body 11 is obtained by joining the first wire 2 and the second wire 3, but is not limited thereto, and may be configured by, for example, one continuous wire. .

As shown in FIG. 1, a coil 4 having a constant outer diameter and inner diameter is installed on the outer periphery of the distal end portion of the wire body 11. The coil 4 is a member formed by spirally winding (processing) a wire rod (first wire rod) 41 having a circular cross-sectional shape, and is the tip of the wire body 11, that is, the first wire 2. It is installed so as to cover the most distal end portion 21 and the portion excluding the proximal end portion of the tapered portion 22. Further, the first wire 2 is inserted in a substantially central portion inside the coil 4 in a non-contact manner.

The length of the coil 4 (length in the longitudinal direction of the wire body 11) L1 is preferably 5 to 200 mm, and more preferably 10 to 50 mm.

Such a coil 4 is made of a resin material. Examples of the resin material include various curable resins such as various thermoplastic resins, thermosetting resins, and photocurable resins.

Specifically, for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, polyvinyl chloride, polystyrene, polyamide, polyimide, polycarbonate, poly- (4-methylpentene-1), ionomer, acrylic resin, Polyesters such as polymethyl methacrylate, acrylonitrile-butadiene-styrene copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), butadiene-styrene copolymer, polyethylene terephthalate (PET), polybutylene terephthalate (PBT) , Polyether, polyetherketone (PEK), polyetheretherketone (PEEK), polyetherimide, polyacetal (POM), polyphenylene oxide, polysulfone, poly Ether sulfone, polyphenylene sulfide, polyarylate, aromatic polyester (liquid crystal polymer), polytetrafluoroethylene, polyvinylidene fluoride, other fluororesins, epoxy resins, phenol resins, urea resins, melamine resins, silicone resins, polyurethane, etc. Or a copolymer, a blend, a polymer alloy, etc. which mainly have these are mentioned, Among these, it can use combining 1 type (s) or 2 or more types.

Further, it is preferable that particles (filler) made of an X-ray opaque material (material having X-ray contrast properties) be dispersed in the wire 41. Thereby, X-ray contrast property is obtained for the guide wire 1, and the guide wire 1 can be inserted into the living body while confirming the position of the tip under fluoroscopy. The content of the radiopaque material is usually about 20 to 95% by weight, more preferably about 40 to 80% by weight, although it depends on the type of the radiopaque material.

Since the coil 4 is made of the resin material as described above, the coil 4 has relatively low rigidity. That is, the coil 4 is relatively flexible. Thus, the coil 4 is responsible for enhancing the flexibility of the distal end portion of the guide wire 1.

The constituent material of the particles is not particularly limited as long as it is an X-ray opaque material. For example, noble metals such as gold, platinum and tungsten or alloys containing them (for example, platinum-iridium alloys), other various metals, or carbonic acid Examples include barium and barium sulfate.

As shown in FIG. 1, a coil 5 is provided on the proximal end side of the coil 4 and on the outer periphery of the wire body 11. The coil 5 is a member formed by spirally winding (processing) a wire (second wire) 51 having a circular cross section. In the configuration shown in FIG. 1, the coil 5 is installed so as to cover the proximal end portion of the tapered portion 22, the constant outer diameter portion 23, and the tapered portion 24 of the first wire 2, but covers the tapered portion. The length of the coil 5 may be as long as the distal end portion of the coil 5 is present on the proximal end side of the taper portion 22.

Further, the first wire 2 is inserted in a substantially central part inside the coil 5 in a non-contact manner. The inner diameter and outer diameter of the coil 4 and the coil 5 are substantially equal. Thereby, in the boundary part of the coil 4 and the coil 5, the internal peripheral surface of the coil 4 and the internal peripheral surface of the coil 5 are continuing without a level | step difference producing. In addition, at the boundary between the coil 4 and the coil 5, the outer peripheral surface of the coil 4 and the outer peripheral surface of the coil 5 are continuous without causing a step. Thereby, the outer peripheral surface of the tip member 10 becomes smooth, and can be prevented from being caught on, for example, a blood vessel wall.

Such a coil 5 is made of a metal material. Examples of the metal material include stainless steel, superelastic alloy, cobalt-based alloy, noble metals such as gold, platinum, and tungsten, or alloys containing them (for example, platinum-iridium alloy). In particular, when it is made of an X-ray opaque material such as a noble metal, in addition to the coil 4, the X-ray contrast can be obtained in the coil 5, and the position of the tip can be confirmed more reliably under X-ray fluoroscopy. However, it can be inserted into a living body, which is preferable.

Since the coil 5 is made of a metal material, the coil 5 has higher rigidity than the coil 4. Thus, the coil 5 is responsible for enhancing the pushability and torque transmission of the distal end portion of the guide wire 1.

The length of the coil 5 (length in the longitudinal direction of the wire body 11) L2 is equal to or longer than the length L1 of the coil 4. The length L2 of the coil 5 is preferably 10 to 500 mm, more preferably 50 to 300 mm. Thereby, when a rotational force / pushing force is applied to the proximal end side of the guide wire 1, the rotational force / pushing force is reliably transmitted to the tip of the guide wire 1 through the coil 5. Furthermore, since the coil 4 is responsible for enhancing flexibility, the guide wire 1 can achieve both flexibility, pushability and torque transmission as a whole.

In the present embodiment, the wire 41 and the wire 51 each have a circular cross-sectional shape, but may have an elliptical shape, a semicircular shape, a flat shape, a polygonal shape, or the like.

Moreover, the wire diameters of the wire 41 and the wire 51 may be different.
Moreover, although the wire 41 and the wire 51 are respectively wound so that adjacent wire may contact, adjacent wires may be spaced apart and may be formed combining these. In this case, the coil 4 and the coil 5 may be configured such that the number of turns per unit length decreases toward the distal end side so that the flexibility gradually increases toward the distal end side. it can. Thereby, in the guide wire 1, it can prevent that a stress concentrates on the part from which a softness | flexibility changes, and the said part will bend sharply.

In addition, the inner diameter and outer diameter of the coil 4 may have a portion that decreases or expands toward the distal end side, and the inner diameter and outer diameter of the coil 5 similarly decrease or decreases toward the distal end side. You may have the part which expands in diameter.

As shown in FIG. 1, the distal end portion of the coil 4 is fixed to the most distal end portion 21 by the fixing member 12, and the proximal end portion of the coil 4 is fixed to the tapered portion 22 by the fixing member 13. On the other hand, the distal end portion of the coil 5 is fixed to the tapered portion 22 by the fixing member 13, and the proximal end portion of the coil 5 is fixed to the tapered portion 24 by the fixing member 14. As described above, the fixing member 13 fixes the proximal end portion of the coil 4 and the distal end portion of the coil 5 together to the tapered portion 22.

Since the fixing

members

12 and 13 fix a member made of a resin material and a member made of a metal material, the fixing

members

12 and 13 are preferably made of an adhesive. In order to prevent damage to the inner wall of a body cavity such as a blood vessel, the distal end surface of the fixing member 12 is preferably rounded.

Examples of this adhesive include epoxy adhesives, acrylic adhesives, rubber adhesives, urethane adhesives, silicon adhesives, and the like, and one or more of these are combined. Can be used. It is also possible to melt the resin material of the coil 4 and use the melted portion as a fixing member.

Since the fixing member 14 fixes members made of a metal material, the fixing member 14 is preferably made of solder (brazing material).

As shown in FIG. 1, the guide wire 1 is covered with a hydrophilic lubricating layer 7 made of a hydrophilic material so as to cover the tip member 10 and the first wire 2. As a result, the hydrophilic material is wetted to generate lubricity, and the slidability is improved on the outer peripheral surface of the distal end portion of the guide wire 1.

Examples of the hydrophilic material (the constituent material of the hydrophilic lubricating layer 7) include, for example, a cellulose-based polymer material, a polyethylene oxide-based polymer material, and a maleic anhydride-based polymer material (for example, a methyl vinyl ether-maleic anhydride copolymer). Maleic anhydride copolymer), acrylamide polymer (for example, polyacrylamide, polyglycidyl methacrylate-dimethylacrylamide (PGMA-DMAA) block copolymer), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, etc. Is mentioned.

By disposing such a hydrophilic lubricating layer 7, the frictional resistance (sliding resistance) with the inner wall of the catheter used together with the guide wire 1 is reduced. Therefore, the slidability of the guide wire 1 is improved, and the operability of the guide wire 1 in the catheter becomes better.

Further, as described above, since the coil 4 is made of a resin material, the adhesion (compatibility) with the hydrophilic lubricating layer 7 is higher than that of the case where the coil 4 is made of a metal material. As a result, the coil 4 and the hydrophilic lubricating layer 7 are firmly adhered (bonded), and therefore the hydrophilic lubricating layer 7 is peeled off from the coil 4 even when bending or twisting is repeatedly applied to the coil 4. Can be prevented. For this reason, in the coil 4, high hydrophilicity is maintained over a long period of time. Thus, the coil 4 is also responsible for enhancing the durability of the hydrophilic lubricating layer 7 in the guide wire 1.

The guide wire 1 also has

resin coating layers

8 and 9 that cover all or part of the outer peripheral surface (outer surface) of the wire body 11. In the configuration shown in the drawing, a resin coating layer 9 is provided on the outer periphery of the joint portion 6 of the wire main body 11, and a resin coating layer 8 is provided on the outer peripheral portion of the proximal end side.

The

resin coating layers

8 and 9 can be formed for various purposes. For example, the

resin coating layers

8 and 9 can reduce the friction (sliding resistance) of the guide wire 1 and improve the slidability. The operability may be improved.

In order to reduce the friction (sliding resistance) of the guide wire 1, the

resin coating layers

8 and 9 are preferably made of a material capable of reducing friction as described below. Thereby, the frictional resistance (sliding resistance) with the inner wall of the catheter used together with the guide wire 1 is reduced, the slidability is improved, and the operability of the guide wire 1 in the catheter becomes better. Further, since the sliding resistance of the guide wire 1 is lowered, when the guide wire 1 is moved and / or rotated in the catheter, the guide wire 1 is kinked (bent) or twisted, in particular, with the first wire 2 and the second wire. Kinks and twists in the vicinity of the joint portion (joint surface) 6 of the two wires 3 can be more reliably prevented.

Examples of the material constituting the

resin coating layers

8 and 9 include polyolefins such as polyethylene and polypropylene, polyvinyl chloride, polyester (PET, PBT, etc.), polyamide, polyimide, polyurethane, polystyrene, polycarbonate, silicone resin, fluorine resin ( PTFE, ETFE, etc.) or a composite material thereof.

In particular, when a fluorine-based resin (or a composite material containing the same) is used, the frictional resistance (sliding resistance) between the guide wire 1 and the inner wall of the catheter is more effectively reduced, and slidability is improved. This can improve the operability of the guide wire 1 in the catheter. In addition, this makes it possible to more reliably prevent kinking (bending) and twisting of the guide wire 1, particularly kinking and twisting in the vicinity of the welded portion, when the guide wire 1 is moved and / or rotated in the catheter.

In addition, when a fluororesin (or a composite material containing the same) is used, the wire body 11 can be coated while the resin material is heated by a method such as baking or spraying. Thereby, the adhesiveness between the wire body 11 and the

resin coating layers

8 and 9 is particularly excellent.

Further, if the

resin coating layers

8 and 9 are made of a silicone resin (or a composite material containing the same), the

resin coating layers

8 and 9 are heated when the

resin coating layers

8 and 9 are formed (covered on the wire body 11). Even if it does not exist, the resin coating layer 8 adhered firmly and firmly to the wire body 11 can be formed. That is, when the

resin coating layers

8 and 9 are made of a silicone resin (or a composite material containing the same), a reaction-curing material or the like can be used, so that the

resin coating layers

8 and 9 are formed. It can be performed at room temperature. Thus, by forming the

resin coating layers

8 and 9 at room temperature, the coating can be easily performed, and the guide wire can be operated in a state where the bonding strength at the bonding portion 6 is sufficiently maintained.

The materials constituting the

resin coating layers

8 and 9 may be the same or different.
The thickness of the

resin coating layers

8 and 9 is not particularly limited, and is appropriately determined in consideration of the purpose of forming the resin coating layer 8, the constituent material, the forming method, and the like. Usually, the thickness of the resin coating layer 8 ( The average is preferably about 1 to 100 μm, more preferably about 1 to 30 μm. If the thickness of the

resin coating layers

8 and 9 is too thin, the purpose of forming the

resin coating layers

8 and 9 may not be sufficiently exhibited, and the

resin coating layers

8 and 9 may be peeled off. If the

resin coating layers

8 and 9 are too thick, the physical characteristics of the wire body 11 may be affected, and the resin coating layer 8 may be peeled off.
The

resin coating layers

8 and 9 may be a single layer or a laminate of two or more layers.

In the present invention, the outer peripheral surface (surface) of the wire body 11 is subjected to treatment (roughening, chemical treatment, heat treatment, etc.) for improving the adhesion of the

resin coating layers

8 and 9, or the resin coating layer. An intermediate layer that can improve the adhesion of 8, 9 can also be provided.

Thus, the coil 4 is responsible for enhancing flexibility and improving adhesion with the hydrophilic lubricating layer 7. Moreover, the coil 5 is responsible for enhancing the pushability and torque transmission. The guide wire 1 having such a coil 4 and the coil 5 can achieve both enhancement of flexibility, pushability and torque transmission and prevention of peeling of the hydrophilic lubricating layer 7.

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 according to the present invention will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted. For convenience of explanation, the right side in FIG. 2 is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
This embodiment is the same as the first embodiment except that the shape of the tip member is different.

As shown in FIG. 2, the guide wire 1 has an overlapping portion 100 in which the proximal end portion of the coil 4 and the distal end portion of the coil 5 overlap. Therefore, the distal end member 10 can be divided into a portion 101 excluding the proximal end portion of the coil 4, an overlapping portion 100, and a portion 102 excluding the distal end portion of the coil 5.

The overlapping portion 100 is in a state where the proximal end portion of the coil 4 is located inside the distal end portion of the coil 5. The outer diameter of the coil 4 is substantially equal to the inner diameter of the coil 5. Thereby, in the overlapping part 100, the base end part of the coil 4 and the base end part of the coil 5 are fitted and fixed. Therefore, unlike the above-described first embodiment, the fixing member 13 that fixes the coil 4 and the coil 5 together can be omitted.

By the way, in general, in a guide wire, when the distance between the coil and the wire body is relatively large, when the guide wire is pushed forward in a living body, in the coil, the wire constituting the coil is adjacent to each other. May get on.

However, in the tip member 10, the inner diameter of the coil 4 is smaller than the inner diameter of the coil 5. Thereby, corresponding to the decrease in the outer diameter of the wire main body 11 (so as to follow), the inner diameter of the tip member 10 also decreases stepwise toward the tip. Therefore, the separation distance L3 between the most advanced portion 21 and the inner peripheral surface of the coil 4 can be made small. Further, in the tip member 10, the separation distance L3 can be reduced, and the separation distance between the wire body 11 and the tip member 10 can be made substantially constant along the longitudinal direction thereof. Therefore, in the portion 101, when the guide wire 1 is pushed into the distal end side, the adjacent wire rods 41 and the adjacent wire rods 51 are reliably prevented from climbing. Therefore, the guide wire 1 can be used in a normal state, that is, the pushing force can be reliably transmitted to the tip of the guide wire 1.

<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 of the present invention will be described with reference to this figure, but the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted. For convenience of explanation, the right side in FIG. 3 is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
This embodiment is the same as the second embodiment except that the shape of the tip member is different.

As shown in FIG. 3, the overlapping portion 100 is in a state where the proximal end portion of the coil 4 is located outside the distal end portion of the coil 5. Further, the inner diameter of the coil 4 is substantially equal to the outer diameter of the coil 5. Thereby, the base end part of the coil 4 and the base end part of the coil 5 are fitted and fixed.

According to such 3rd Embodiment, since the wire 41 comprised with the resin material is located in the outer peripheral side in the overlap part 100, the ratio for which the resin material accounts in the outer peripheral part of the front-end | tip member 10 becomes large. . Thereby, the adhesiveness of the front-end | tip member 10 and the hydrophilic lubricating layer 7 improves more. Therefore, it can prevent more reliably that the hydrophilic lubrication layer 7 peels from the front-end | tip member 10. FIG.

<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 second embodiment described above, and the description of the same matters will be omitted. For convenience of explanation, the right side in FIG. 4 is called “base end”, the left side is called “tip”, the upper side is called “upper”, and the lower side is called “lower”.
This embodiment is the same as the second embodiment except that the shape of the tip member is different.

As shown in FIG. 4, the overlapping portion 100 is disposed so that the wire 41 and the wire 51 are alternately meshed with each other (every other) (screwed). Thereby, the coil 4 and the coil 5 can be arrange | positioned coaxially more correctly at the time of an assembly. Further, when a force that is pulled in the distal direction acts on the guide wire 1, it is possible to effectively prevent the coil 4 and the coil 5 from separating at the overlapping portion 100.

In addition, the overlapping portion 100 is richer in flexibility than the portion 102 and higher in rigidity than the portion 101 because the wire 41 having high flexibility and the wire 51 having relatively high rigidity are mixed. In other words, the tip member 10 has higher flexibility in the order of the portion 102, the overlapping portion 100, and the portion 101. Thereby, the change of the rigidity from the coil 5 to the coil 4 becomes gentle. As a result, the flexibility of the distal end portion of the guide wire 1 can be gradually changed. Therefore, in the guide wire 1, it is possible to prevent stress from being concentrated on a portion where the flexibility changes and the portion to be bent sharply, so that kink resistance and safety are improved.

<Fifth Embodiment>
FIG. 5 is a side view showing the first tubular member of the fifth embodiment of the guide wire of the present invention.

Hereinafter, the fifth embodiment of the guide wire of the present invention will be described with reference to this drawing. However, the description will focus on the differences from the first embodiment described above, and the description of the same matters will be omitted. For convenience of explanation, the right side in FIG. 5 is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
This embodiment is the same as the second embodiment except that the shape of the tip member is different.

In the present embodiment, the first cylindrical member is composed of a braided body 4A formed in a net shape by crossing the wire 41. The braided body 4A has a portion where the wire 41 overlaps in the circumferential direction. Thereby, the rigidity becomes high in the part where the wire 41 has overlapped from the coil 4 which wound the wire 41 spirally. Therefore, the braided body 4 </ b> A has higher rigidity than the coil 4.

Further, in the braided body 4A, the rigidity when rotating in the direction of arrow A in FIG. 5 and the rigidity when rotating in the direction of arrow B in FIG. Therefore, it is possible to obtain the guide wire 1 with more excellent operability.

The braided body 4A may be a combination of a portion in which the wire 41 is spirally wound and a portion in which the wire 41 is crossed and formed in a net shape. The second cylindrical member may also be a braided body that is formed in a net shape by intersecting the wires 51, similarly to the braided body 4A.

<Sixth Embodiment>
FIG. 6 is a longitudinal sectional view showing a sixth embodiment of the guide wire of the present invention, and FIG. 7 is a transverse sectional view of a wire constituting the first tubular member shown in FIG.

Hereinafter, the sixth embodiment of the guide wire of the present invention will be described with reference to this drawing. However, the difference from the first embodiment will be mainly described, and the description of the same matters will be omitted. For convenience of explanation, the right side in FIG. 6 is referred to as “base end”, the left side is referred to as “tip”, the upper side is referred to as “upper”, and the lower side is referred to as “lower”.
This embodiment is the same as the first embodiment except that the shape of the tip member is different.

As shown in FIGS. 6 and 7, the wire 41 </ b> B constituting the coil 4 </ b> B has a core material 42 made of a metal material and a coating layer 43 made of a resin material that covers the outer periphery of the core material 42. ing.

The wire 41B has a tip-side exposed portion 44 where the tip of the core member 42 is exposed at the tip. The tip side exposed portion 44 is a portion where the coating layer 43 is peeled off and the core material 42 is exposed. The distal end side exposed portion 44 is fixed to the distal end portion (the most distal end portion 21) of the wire body 11 via the fixing member 12. Since the distal end side exposed portion 44 is a portion where the core material 42 made of a metal material is exposed, it can be easily and reliably fixed to the wire body 11 with, for example, solder. .

Further, the wire rod 41B has a base end side exposed portion 45 where the base end portion of the core member 42 is exposed at the base end portion thereof. The base end side exposed portion 45 is a portion where the coating layer 43 is peeled off and the core member 42 is exposed. The proximal end exposed portion 45 is fixed to the tapered portion 22 of the wire body 11 and the coil 5 via the fixing member 13. Since the base-side exposed portion 45 is a portion where the core material 42 made of a metal material is exposed, for example, it can be easily and securely fixed to the wire body 11 and the coil 5 with solder or the like. can do. Thus, according to this embodiment, since the material which comprises the fixing

members

12, 13, and 14 may be one kind, the guide wire 1 can be manufactured more easily.

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.

In each embodiment, the length of the first cylindrical member is shorter than the length of the second cylindrical member, but the present invention is not limited to this, and the length of the first cylindrical member is the first length. It may be longer than the length of the two cylindrical members.

The guide wire of the present invention has a flexible wire main body, and a cylindrical member that is inserted into the distal end portion of the wire main body and is formed by processing a wire rod into a cylindrical shape, and the cylindrical member includes at least A first cylindrical member formed by processing a first wire having an outer peripheral portion made of a resin material, and a second cylindrical member made of a metal material provided on the base end side of the first cylindrical member. It has the 2nd cylindrical member formed by processing a wire. Thereby, in the guide wire of this invention, it is excellent in a softness | flexibility and operativity, and when coat | covering the hydrophilic lubricating layer which has hydrophilicity, peeling of a hydrophilic lubricating layer can be prevented, for example.
Therefore, the guide wire of the present invention has industrial applicability.

DESCRIPTION OF SYMBOLS 1 Guide wire 11 Wire main body 2 1st wire 21 The most

advanced part

22, 24

Tapered part

23, 25 Constant outer diameter part 3 2nd wire 4, 4B Coil (1st cylindrical member)

4A Braided body

41, 41B Wire rod (first wire rod)
42 Core material 43 Coating layer 44 Front end side exposed portion 45 Base end side exposed portion 5 Coil (second cylindrical member)
51 Wire (second wire)
6 Joining portion 7

Hydrophilic lubricating layer

8, 9 Resin coating layer 10 Tip member (tubular member)
12, 13, 14 Fixing member 100

Overlapping part

101, 102 part L1, L2 Length L3 Separation distance

Claims

A flexible wire body;
A cylindrical member that is inserted into the tip of the wire body and is formed by processing the wire into a cylindrical shape;
The cylindrical member is provided with a first cylindrical member formed by processing a first wire whose outer peripheral portion is made of a resin material, and a base material side of the first cylindrical member. And a second tubular member formed by processing the second wire rod constituted by the guide wire.
The guide wire according to claim 1, wherein the guide wire has an overlapping portion where a proximal end portion of the first cylindrical member and a distal end portion of the second cylindrical member are overlapped.
The guide wire according to claim 2, wherein the overlapping portion is in a state where a base end portion of the first cylindrical member is located inside a distal end portion of the second cylindrical member.
The guide wire according to claim 2, wherein the overlapping portion is in a state where a base end portion of the first cylindrical member is located outside a distal end portion of the second cylindrical member.
The guide wire according to claim 2, wherein the overlapping portion is in a state where the first wire and the second wire are engaged with each other.
The guide according to any one of claims 1 to 5, wherein the first wire has a core made of a metal material and a coating layer made of the resin material covering an outer periphery thereof. Wire.
The first wire has, at the base end portion thereof, a base end side exposed portion where the core material is exposed,
The guide wire according to claim 6, wherein the proximal end side exposed portion and the distal end portion of the second wire are fixed.
The first wire has a tip side exposed portion where the core material is exposed at a tip portion thereof,
The guide wire according to claim 6 or 7, wherein the distal end side exposed portion and the distal end portion of the wire body are fixed.
The wire body has an outer diameter reduced portion whose outer diameter is reduced toward the tip side in the middle of the longitudinal direction,
The guide wire according to any one of claims 2 to 8, wherein at least a part of the overlapping portion overlaps the outer diameter reduced portion.
A fixing member for fixing the cylindrical member to the wire body;
The guide wire according to any one of claims 1 to 9, wherein the fixing member is provided in the vicinity of a boundary between the first cylindrical member and the second cylindrical member.
The guide wire according to any one of claims 1 to 10, wherein the first cylindrical member has an X-ray contrast property.
The guide wire according to any one of claims 1 to 11, wherein the first cylindrical member and the second cylindrical member are covered with a hydrophilic material.
The guide wire according to any one of claims 1 to 12, wherein a length of the first tubular member in a longitudinal direction is shorter than a length of the second tubular member in a longitudinal direction.
The first cylindrical member is composed of a coil formed by spirally winding the first wire.
The guide wire according to any one of claims 1 to 13, wherein the second cylindrical member is configured by a coil formed by spirally winding the second wire rod.
The guide wire according to any one of claims 1 to 13, wherein the first cylindrical member is formed of a braided body formed in a net shape by intersecting the first wire rods.