JPH09192235A - Blood vessel expander and catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a blood vessel expander and a catheter that are less likely to kink near their junction even if the blood vessel expander or the catheter uses a tube formed by the joining together of two tubes with different rigidities. SOLUTION: This blood vessel expander 1 includes an inner tube 5, an outer tube 2 provided coaxial with the inner tube 5, and an expander 9 attached to the outer tube 2 at its first end and to the inner tube 5 at the second end. The outer tube 2 consists of a second-end tube 3 and a first-end tube 4 secured to the second-end tube 3, the end of the first-end tube 4 serving as an entering end-tube part entering the first end of the second-end tube and having a number of slits or pores.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a vasodilator for expanding a stenosis and improving blood flow on the peripheral side of the stenosis in order to treat the stenosis in the blood vessel. It concerns a catheter. The present invention also relates to a catheter that is inserted into a small-diameter blood vessel, such as a cerebral blood vessel or a heart blood vessel, for treatment, examination, or the like.

[0002]

2. Description of the Related Art In recent years, the advent of microcatheters has enabled the treatment and diagnosis of microvessels or blood vessels, which has been impossible with conventional catheters. As a microcatheter, for example, a percutaneous transluminal coronary angioplasty device (PTCA catheter) used for myocardial infarction or angina, or a blood vessel applied to an aneurysm, arteriovenous malformation tumor, malignant tumor, or the like There are catheters for embolization. As for the catheter tube constituting these instruments and catheters, it is preferable that the distal portion of the catheter is more flexible than the proximal portion. Therefore, for example, there is a catheter (Japanese Patent Laid-Open No. 3-207376) in which tubes of different rigidity are joined.

[0003]

However, in the above-mentioned Japanese Patent Laid-Open No. 3-207376, a kink or the like is likely to occur due to the difference in rigidity at the joint. Therefore, the present invention provides a vasodilator and a catheter that are less likely to cause kinks near the joint even if the vasodilator or catheter uses a tube body in which two tubes having different rigidity are joined. is there.

[0004]

[Means for Solving the Problems] To achieve the above object, an inner tube having a first lumen having an opening at the tip and an inner tube provided coaxially with the inner tube are retracted by a predetermined length from the tip of the inner tube. An outer tube having a distal end at a predetermined position and forming a second lumen between the outer tube and the outer surface of the inner tube, and a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, A contractible or foldable expansion body having the distal end attached to the inner pipe and communicating with a second lumen near the base end, and the first end provided on the base end of the inner pipe. A vasodilator having a first opening communicating with a lumen and a second opening communicating with the second lumen provided at a proximal end of the outer tube, wherein the outer tube comprises: Tip side tube,
The distal end side tube is a fixed proximal end side tube, and the distal end portion of the proximal end side tube is a distal end side tube intrusion part that has penetrated into the proximal end part of the distal end side tube, and the proximal end The side tube entry portion is a vasodilator that has slits or multiple pores.

Further, what achieves the above-mentioned object is that an inner tube having a first lumen whose tip is open, and a tube provided coaxially with the inner tube and retracted by a predetermined length from the tip of the inner tube. And an outer tube forming a second lumen between the outer tube and the outer surface of the inner tube, and a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, and the distal end portion being A contractible or foldable expansion body attached to the inner pipe and communicating with a second lumen near the proximal end, and communicating with the first lumen provided at the proximal end of the inner pipe. A vasodilator having a first opening and a second opening communicating with the second lumen provided at the proximal end of the outer tube, wherein the outer tube is a distal tube. A distal end tube to which the distal end tube is fixed, The fixed portion of the side tube is provided with a connection tube that has penetrated into both tubes, and at least the distal tube penetration portion that has penetrated into the proximal end portion of the distal tube of the connection tube has slits or a large number of thin tubes. A vasodilator having a hole.

Further, what achieves the above-mentioned object is a catheter having at least a distal end side tube and a proximal end side tube fixed to the distal end side tube, wherein the distal end portion of the proximal end side tube is the distal end side. It is a distal-side tube penetration portion that has penetrated into the proximal end portion of the tube, and the tube penetration portion is a catheter having slits or a large number of pores.

Further, what achieves the above object is a catheter having at least a distal tube and a proximal tube fixed to the distal tube, wherein the distal tube and the proximal tube are fixed to each other. A connecting tube that penetrates into both tubes is provided in the section, and a slit or a large number of pores are provided in the distal tube entering section that penetrates into at least the proximal end of the distal tube of the connecting tube. It is a catheter.

The slit is, for example, a spiral slit. The slit is a slit extending from the tip of the proximal tube to the proximal side in parallel with the axis of the proximal tube. In addition, it is preferable that the base end portion of the distal end side tube intrusion portion does not have the slit or the large number of pores. Further, it is preferable that the tip end portion of the tip end side tube entry portion is not fixed to the tip end side tube. Further, a slit or a large number of pores may be provided at the tip of the proximal tube intruding portion of the connecting tube.

[0009]

DESCRIPTION OF THE PREFERRED EMBODIMENTS The blood vessel dilating device of the present invention will be described with reference to the embodiments shown in the drawings. FIG. 1 is a partially omitted external view of an embodiment of the vasodilator according to the present invention. FIG. 2 is an enlarged cross-sectional view of the distal end portion of the vasodilator shown in FIG. FIG. 3 is an enlarged cross-sectional view of a joint portion of the vasodilator according to the embodiment of the present invention. FIG. 4 is an enlarged cross-sectional view of a joint portion of a vasodilator according to another embodiment of the present invention. FIG. 5 is an enlarged cross-sectional view of a joint portion of a vasodilator according to another embodiment of the present invention. FIG.
FIG. 3 is a cross-sectional view of a proximal end portion of an embodiment of the vasodilator according to the present invention. FIG. 7 is an enlarged cross-sectional view of a joint portion of a vasodilator according to another embodiment of the present invention.

The vasodilator (catheter for vasodilation) 1 of the present invention is provided with an inner tube 5 having a first lumen 5a whose tip is open, and an inner tube 5 provided coaxially with the inner tube 5. The outer tube 2 has a tip at a position retracted by a predetermined length and forms a second lumen 6 between the outer tube 2 and the outer surface of the inner tube 5, and a tip and a base end. A distal end is attached to the inner pipe 5, and a contractable or foldable expansion body 9 that communicates with the second lumen 6 near the proximal end is provided on the proximal end of the inner pipe 5. First lumen 5
a first opening 10 communicating with a, and a second opening 11 provided at the base end of the outer tube 2 and communicating with the second lumen 6.
And Then, the outer tube 2 and the tip side tube 3 are
It consists of a proximal end tube 4 fixed to the distal end tube 3, and the distal end of the proximal end tube 4 is a distal end tube penetration part 4a that penetrates into the proximal end part of the distal end tube, and this tube The penetration part 4 a has a slit 41 or a large number of pores 42.

A description will be given below with reference to the drawings. As shown in FIG. 1, the vasodilator according to the present invention is formed by a vasodilator body having an inner tube 1, an outer tube 2 and an expander 9, and a branch hub 20. The vasodilator (the main body of the vasodilator) includes a distal end portion 6, a proximal end portion 8 and a joint portion 7 between them. The outer tube 2 includes a tube body 2 formed of a distal end tube 6 formed of a relatively flexible material and a proximal end tube 8 formed of a material having higher rigidity than the distal end tube. A branch hub 20 is fixed to the proximal end of the proximal tube 8 (tube body 2). The tube body 2 is joined at the joining portion 7.

The tip of the outer tube 2, in other words, the tip of the tip-side tube 6 is located at the base end side by a predetermined distance from the tip of the inner tube 5 described later, and the tip-side tube 6 is, as shown in FIG. The central portion has a taper portion whose diameter decreases toward the tip side, and the outer diameter changes gently. In this way, by making the distal end portion of the distal end side tube thin, insertion into the blood vessel becomes easier. Since the tip portion is made of synthetic resin, it has sufficient flexibility, and the tip portion of the intrusion portion 4a into the tip side tube, which is the boundary portion between the main body portion and the tip portion, has another portion. Compared with the flexible deformable part, it prevents bending at the boundary between the highly rigid base tube and the flexible distal tube.

The length of the distal tube 3 of the outer tube 2 is 50 to 2000 mm, more preferably 100 to 5 mm.
00 mm, outer diameter is 0.5 to 1.5 mm, more preferably 0.8 to 1.1 mm, wall thickness 25 to 200 μm, and more preferably 50 to 100 μm. The difference between the outer diameter of the inner tube 5 described later and the inner diameter of the distal tube 3 is 0.0
It is 5 to 0.50 mm, preferably 0.1 to 0.40 mm. Further, the difference between the outer diameter of the distal end portion of the distal end side tube and the outer diameter of the proximal end portion is preferably 0 to 0.5 mm, and particularly 0 to
0.3 mm is preferred.

A material having a certain degree of flexibility is used as a material for forming the tip side tube 3 constituting the outer tube 2. For example, a polyolefin (specifically, polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more thereof), or a crosslinked product or polychlorinated product thereof. Polymer materials such as vinyl, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, silicone rubber and latex rubber, or a mixture thereof are used. Further, the outer surface of the distal tube 3 may be coated with a resin having biocompatibility, particularly antithrombogenicity. Examples of the antithrombotic material include polyhydroxyethyl methacrylate and a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-
HEMA block copolymer) and the like are preferable.

The proximal tube 4 is shown in FIG.
The tube body has substantially the same outer diameter as shown in FIG. The distal end portion 4a of the proximal end side tube 4 has a reduced diameter as shown in FIG. The outer diameter of the distal end portion 4a is substantially the same as the inner diameter of the proximal end portion of the distal end side tube 3. And
The tip end portion 4a is a tip end side tube entry portion 4a that has entered the base end portion of the tip end side tube 3. further,
In this embodiment, the entry portion 4a of the proximal tube has a spiral slit 41.

As the proximal end side tube, one having higher rigidity than the distal end side tube is used. In other words, a flexible tube is used as the above-mentioned tip side tube. As a material for forming the proximal end side tube 4, a relatively rigid plastic or metal tube is used. Examples of the plastic material include polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ionomer, or a mixture of two or more thereof), or a crosslinked product thereof, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester. Polymer materials such as elastomer, polyurethane, polyurethane elastomer, polyimide and fluororesin can be used. It is also possible to use the same material as the tip side tube, and in that case, even if it is the same material, a material (harder) than the material of the tip side tube is used. On the other hand, when the same material is used for the distal tube and the proximal tube, the material forming the distal tube is highly plasticized (for example, a material containing a large amount of plasticizer) or a copolymer. If so, the one with many soft segments is used.

As the metal material, various metals and alloys such as stainless stretchable alloy and super elastic metal (for example, super elastic alloy) can be used. A superelastic alloy is generally called a shape memory alloy and exhibits superelasticity at least at a biological temperature (around 37 ° C.). Particularly preferably, 49
.About.53 atomic% Ni Ti--Ni alloy, 38.5-41.
5 wt% Zn Cu-Zn alloy, 1-10 wt% X C
u-Zn-X alloy (X = Be, Si, Sn, Al, G
a), a superelastic metal body such as a Ni-Al alloy of 36 to 38 atomic% Al is preferably used. Particularly preferred are the above-mentioned Ti-Ni alloys. Further, a Ti-Ni-X alloy (X = Co, Fe, Mn, Cr, V, Al, Nb, W,
B) or a part of the Ti—Ni alloy is reduced to 0.
By using a Ti-Ni-X alloy (X = Cu, Pb, Zr) substituted with 0 to 1 to 30.0% atoms, and selecting the cold working rate and / or the condition of the final heat treatment, The characteristics can be changed as appropriate. Further, by selecting the cold working ratio and / or the condition of the final heat treatment using the above-mentioned Ti-Ni-X alloy, the mechanical properties can be appropriately changed. Superelasticity means that even if a normal metal is deformed (bending, pulling, or compressing) to a region where it is plastically deformed at the operating temperature, it will recover to its original shape without requiring heating after the deformation is released. To do.

The length of the proximal tube 4 is 50
~ 2000 mm, more preferably 100-1700 m
m, the outer diameter is 0.5 to 1.5 mm, and more preferably,
The thickness is 0.8 to 1.1 mm, the wall thickness is 25 to 200 μm, and more preferably 50 to 100 μm. The length of the tip portion (penetration portion) 4a is 1 to 500 mm, more preferably 3 to 300 mm, and the outer diameter is 0.1 to 1.45 m.
m, more preferably 0.4 to 1.05 mm and a wall thickness of 2
5 to 200 μm.

Then, a slit 41 is provided at the entry portion 4a into the distal end side tube (the distal end portion of the proximal end side tube). In this embodiment, the slit 41 has a spiral shape. The number of spiral slits is 1 or 2
It may be more than a book. By providing such a spiral slit 41, the distal end portion (intrusion portion into the distal end side tube) 4a of the proximal end side tube can be more flexibly curved, and the intrusion portion 4a becomes the distal end side tube. Reinforce the base end with flexibility. That is, the tip side tube 3
The portion where the base end portion and the penetration portion 4a overlap each other has intermediate physical properties of physical properties of the distal end side tube 3 and the proximal end side tube 4 alone and the deformability provided by the slit. As a result, the boundary 7 where the tip side tube 3 is independent
a, the kink of the tube is prevented at the boundary 7b where only the proximal tube 4 is formed. In particular, even if a force is applied to the vicinity of the boundary 7a, which is the distal end side tube 3 alone, the penetration portion 4a having the slit is curved, so that the force is dispersed without being concentrated on the boundary 7a. It is difficult for kinks to occur.

The width of the spiral slit 41 formed in the distal end portion 4a of the proximal tube is not uniform because it is determined in consideration of the diameter and wall thickness of the tube. The width of the slit is preferably 1.5 mm or less, and more preferably 1.0 mm or less. Further, the width of the slit is 1 / outer diameter of the distal end portion (penetration portion) 4a of the proximal end side tube.
It is preferably 2 or less. Within the above range, the tube is sufficiently flexible and the tube does not break during use. The pitch of the slits is preferably about 0.3 mm to 5.0 mm, and particularly preferably 0.5 mm to 3.0 mm when the entire pitch is the same. Within the above range, it is sufficiently flexible and does not bend at the tip portion 4a during use. The length of the portion provided with the slit from the tip of the tip portion 4a is determined in consideration of the length of the vasodilator.

The proximal end of the distal tube 3 is fixed to the distal end 4a of the proximal tube with an adhesive 45. In addition, you may fix without using an adhesive only by the fitting force of both. Further, in the case of bonding with an adhesive, it is preferable not to bond the distal end portion of the distal end portion 4a of the proximal end side tube, and it is particularly preferable to bond only the proximal end portion of the distal end portion 4a. In this way, the tip 4
By not fixing the tip portion of a to the tube on the tip side, the deformation of the slit forming portion (deformation of the tip portion) can be made more reliable. Further, it is preferable that no slit is formed at the base end of the tip (entrance) 4a. If there is no slit at the base end portion, the adhesive will not flow into the slit and the adhesion failure due to insufficient inflow of the adhesive at the interface between the distal side tube and the proximal side tube will not occur. Further, it is preferable that the adhesive does not flow into the slit 41 and the slit portion is a void,
In this case, deformation of the slit (deformation of the tip portion 4a) is not hindered by the solidified adhesive.

Intrusion part 4a in a portion where no slit is provided
The length from the base end of is preferably about 0.5 mm to 250 mm, more preferably 1.5 mm to 150 mm. On the contrary, it is preferable that the slit is provided at about 1 / 1.2 to 1/5 of the entire length of the tip portion (penetration portion) 4a. The pitch of the spiral slit 41 is substantially uniform in the one shown in FIG. 3, but it may be short on the tip end side of the slit and long on the base end side of the slit. By doing so, since it becomes flexible toward the tip portion, there is no sudden change in the physical properties, and the curvature of the tip portion becomes more natural. When changing the pitch of the slits, it is preferable that the pitch of the base end portions of the slits is about 1 to 10 times the pitch of the tip end portions of the slits. Further, the width of the slit may be wide at the front end and narrow at the base end.

In addition, instead of the spiral slit as described above, the intrusion part 4a into the distal end side tube (the distal end part of the proximal end side tube) is provided with a portion behind the distal end of the intrusion part 4a as shown in FIG. A slit 43 extending substantially parallel to the axis of the proximal tube may be provided on the end side. By providing a slit that extends substantially parallel to the axis of such a proximal tube,
Tip of proximal tube (entrance to tip tube)
4a can be bent more flexibly, and the penetration portion 4a flexibly reinforces the proximal end portion of the distal tube. As shown in FIG. 5, the slit 43 is formed such that its width gradually becomes smaller toward the rear end side than the front end of the intrusion part 4a, in other words, the width gradually becomes larger toward the front end side. Therefore, the slit width at the tip of the invading portion 4a is the maximum, and the invading portion 4a is easily deformed toward the tip, and the side wall is also easily deformed partially inside or outside. Has become. About 2 to 8 slits 43 are preferably provided at substantially equal intervals. Width of slit tip (width of maximum part)
Is preferably 1.5 mm or less, and the slit length is preferably 0.5 mm to 250 mm, and particularly preferably 1.5 mm to 150 mm. The shape of the slit 43 is not limited to the shape shown in FIG. 5, and may have the same width and extend from the front end toward the rear end. In this case, the slit width is preferably about 1.5 mm, and the slit length is 0.5 mm to 250 mm.
mm is preferable, and 1.5 mm to 150 mm is particularly preferable.

When a metal tube is used as the proximal tube, the slits and pores described later are formed by laser machining (eg, YAG laser), electric discharge machining, chemical etching, cutting, etc., and by using them in combination. be able to. Similarly, when plastic is used, the formation of slits and pores described later can be performed by laser processing, chemical etching, cutting processing, or the like, and the slits can be formed at the same time as tube molding by die molding. . Further, the outer surface of the proximal tube 4 may be coated with a resin having biocompatibility, particularly antithrombogenicity. As the antithrombotic material, for example, polyhydroxyethyl methacrylate,
A copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) and the like are preferable.

The inner tube 5 has a first lumen 5a whose tip is open. The first lumen 5a is a lumen for inserting a guide wire, and communicates with a first opening 10 that forms a guide wire port provided in a branch hub 20 described later. The tip of the inner tube 5 may be tapered toward the tip side. By doing so, it becomes easy to insert the vasodilator into the blood vessel.

The material for forming the inner tube 5 is, for example, a polyolefin (eg, polyethylene, polypropylene,
Ethylene-propylene copolymer, ionomer, or a mixture of two or more thereof) or a cross-linked product thereof, such as polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, etc. Plastic materials such as molecular materials, silicone rubber, and latex rubber can be used. The inner tube 5 has a length of 300 to 2000 mm, more preferably 500 to 1600 mm, and an outer diameter of 0.1 to 1.0 m.
m, more preferably 0.3 to 0.7 mm, wall thickness 10
It is 150 μm, and more preferably 20 to 100 μm.

The inner tube 5 is inserted into the outer tube 2, and the tip of the inner tube 5 projects from the outer tube 2. As shown in FIG. 2, the outer surface of the inner tube 5 and the inner surface of the outer tube 2 form a second lumen 2a, which has a sufficient volume. The second lumen 2a communicates with the inside of the expansion body 9 at its tip, and the rear end of the second lumen 2a is used for injecting a fluid (for example, an angiographic agent) for expanding the expansion body. It communicates with the second opening 11 of the branch hub 20 that forms an injection port.

The expandable body 9 is contractible or foldable, and can be folded around the outer circumference of the inner tube 5 when it is not expanded. Further, the expandable body 9 has a substantially cylindrical portion 9c of substantially the same diameter, at least a part of which has a substantially cylindrical shape, so that the narrowed portion of the blood vessel can be easily expanded, and is expandable. The above-mentioned substantially cylindrical portion 9c does not have to be a perfect cylinder and may have a polygonal column shape. And the extension body 9
The rear end 9b is liquid-tightly fixed to the tip of the outer tube 2 by an adhesive or heat fusion, and the tip 9a is the inner tube 5
Similarly, it is liquid-tightly attached to the tip of the. This extension 9
Forms an expansion space 15 between the inner surface of the expansion body 9 and the outer surface of the inner tube 5, as shown in FIG. This expansion space 15
Is communicated with the second lumen 2a over the entire circumference at the rear end. In this way, the rear end of the expansion body 9 communicates with the second lumen having a relatively large volume, so that the second body
It is easy to inject the expansion fluid into the expansion body 9 through the lumen of the.

The expansion body 9 has fixed portions 9a, 9 fixed to the above-mentioned inner pipe 5 and outer pipe 2 in front of and behind the cylindrical portion 9c.
The portion up to b is tapered. As the size of the expansion body 9, the outer diameter of the cylindrical portion when expanded is 1.0 to 10 mm, preferably 1.0 to 5.0 m.
m and a length of 5 to 50 mm, preferably 10 to 40
The length of the entire expansion body is 10 to 70 mm, preferably 15 to 60 mm.

A material having a certain degree of flexibility is preferable as a material for forming the expansion body 9, and examples thereof include polyolefins such as polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, and ionomer. Or this crosslinked one,
Polyester such as polyethylene terephthalate, polyvinyl chloride, polyurethane, polyphenylene sulfide, polyamide, polyamide elastomer, polymer materials such as fluororesin, silicone rubber, latex rubber and the like can be used.

Further, as shown in FIG. 2, it is preferable to provide a marker 14 made of a radiopaque material on the outer surface of the inner tube 5 located at the center of the cylindrical portion of the expansion body 9. The marker 14 is preferably formed by a coil spring or a ring. As a marker forming material,
A material having a high X-ray contrast property, such as Pt, Pt alloy, W,
It is preferable to use W alloy, Ag, Ag alloy, or the like.
Further, the markers are not provided only in the central portion as described above, but two markers may be provided on the outer surface of the inner tube in the portions located at both ends of the cylindrical portion 9c of the expansion body 9.

Further, in the vasodilator 1 of the present invention, the outer surface of the outer tube 2 (the outer surface of the distal end side tube 3, the proximal end side tube 3) is easily inserted into the blood vessel and further into a guide catheter described later. 4 or both of the outer surfaces of 4), when the outer surface of the expandable body 9 comes into contact with blood or the like,
It is preferable to perform a treatment for exhibiting lubricity. Examples of such treatment include hydrophilic polymers such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. The method of coating or fixing may be mentioned.

The branch hub 20, as shown in FIG.
The inner tube hub 22 fixed to the inner tube 5 and having the first opening portion 10 communicating with the lumen 5a to form the guide wire port, and the second lumen forming the injection port communicating with the second lumen. The outer tube hub 23 has an opening 11 and is fixed to the outer tube 2 (base end side tube 4). The outer tube hub 23 and the inner tube hub 22 are fixed. As a material for forming this branch hub, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used.

Then, specifically, the branch hub 20 has a structure as shown in FIG. A bend preventing tube 50 is provided at the end of the outer tube 2. The bending prevention tube 50 has heat shrinkability,
It is formed so that the inner diameter after heat shrinking is slightly smaller than the outer diameter of the outer tube 2, and is fitted to the end portion of the outer tube 2 and is easily attached by shrinking by heating (for example, applying hot air). You can And the bend prevention tube 5
0 is fixed to the outer tube hub 23 by a stop pin 52. In this fixing method, the outer pipe 2 is inserted into the rear end of the outer pipe 2 by inserting a stopper pin 52 having an enlarged rear end portion in which the outer diameter of the portion other than the rear end portion is substantially equal to the inner diameter of the outer pipe 2. It is carried out by inserting it into the outer tube hub 23 from its tip and pushing the projection 53 provided on the inner surface of the outer tube hub 23 until the rear end portion of the stop pin 52 crosses. Further, an adhesive may be applied to the contact surface between the outer tube hub 23 and the bending prevention tube 50 to fix the tube. As a material for forming the outer tube hub, thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be preferably used.

A bending prevention tube 60 is provided at the end of the inner tube 5. The tube 60 is heat-shrinkable and is formed so that the inner diameter after heat-shrinking is slightly smaller than the outer diameter of the inner tube 5, and the tube 60 is fitted to the end portion of the inner tube 5 and heated (for example, It can be attached easily by applying hot air) and shrinking it. And
The inner pipe 5 to which the bending prevention tube 60 is attached is fixed to the inner pipe hub 22. This fixing method is the inner tube 5
An outer diameter of the portion other than the rear end portion is substantially equal to the inner diameter of the inner pipe 5 at the rear end, and a stop pin 62 having an enlarged rear end portion is inserted to insert the inner pipe 5 into the inner pipe hub 22 from the tip thereof. Then
The protrusion 63 provided on the inner surface of the inner tube hub 22 is fixed to the pin 6
It is done by pushing it in until the rear end portion of 2 crosses. Further, an adhesive may be applied to and fixed to the contact surface between the inner tube hub 22 and the bending preventing tube 60. As a material for forming the inner tube hub, a thermoplastic resin such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used. Then, as shown in FIG. 6, the inner pipe hub 2
2 and the outer tube hub 23 are fixed. This fixing is performed by inserting the inner pipe 5 from the rear end of the outer pipe hub 23 attached to the base end portion of the outer pipe 2 and inserting the inner pipe hub 22 and the outer pipe hub 23 into the rear end. It is performed by joining.
Further, at this time, by applying an adhesive to the joint portion between the inner pipe hub 22 and the outer pipe hub 23, it is possible to surely fix the both.

Alternatively, instead of providing the branch hub 20, a tube having a port member having an opening at the rear end may be attached to each of the first lumen and the second lumen in a liquid-tight manner.

Further, in the entry portion 4a into the distal end side tube (the distal end portion of the proximal end side tube) 4a, a large number of pores 42 as shown in FIG. 4 are provided instead of the spiral slit as described above. Yes. Providing such a large number of pores makes it possible for the distal end portion of the proximal end side tube (entrance portion into the distal end side tube) 4a to be more flexibly curved, and
The penetration portion 4a reinforces the proximal end portion of the distal end side tube with flexibility. That is, in the portion where the base end portion of the distal end side tube 3 and the penetration portion 4a overlap, the intermediate physical properties of the physical properties of the independent portion of the distal end side tube 3 and the independent portion of the proximal end side tube 4 and the pores are given. By having the easiness of deformation, it is possible to prevent the kink of the tube at the boundary 7a serving as the distal tube 3 alone and the boundary 7b serving as the proximal tube 4 alone. In particular, even if a force is applied to the vicinity of the boundary 7a for the tip side tube 3 alone, the penetration portion 4a having pores
Since the force is dispersed due to the bending of force, the force is not concentrated on the boundary 7a, and thus a kink at the boundary 7a is unlikely to occur.

The pore diameter of the pores 42 is the number of pores to be provided,
It is not uniform because it is determined in consideration of the outer diameter of the tip portion 4a and the like. The hole diameter is 0.1 mm to 0.4 m
m is preferable, and more preferably 0.2 mm to 0.
3 mm. Further, the hole diameter is preferably about 1/10 to 1/3 of the outer diameter of the distal end portion of the proximal tube. Within the above range, the tube is sufficiently flexible and the distal end of the proximal tube does not break during use. The distance between the pores is preferably about 0.1 to 0.5 mm. The shape of the pores need not be a perfect circle, but an ellipse, for example, the tip 4
The shape may be an ellipse elongated in the circumferential direction or the axial direction of a, and a polygon (for example, a quadrangle or a pentagon). The area of one pore is preferably about 0.007 mm ^{2 to} 0.13 mm ² , and the distance between pores is preferably about 0.1 to 0.5 mm.

The pores 42 are formed in the distal end portion 4 of the proximal end side tube 4.
The number of a on the tip side may be larger than that on the base side. By doing so, since it becomes flexible toward the tip, there is no sudden change in physical properties, and the curvature of the tip becomes natural. Further, the number of pores 42 may be gradually increased from the base end side of the tip end side 4a toward the tip end side.
By doing so, it becomes soft gradually toward the tip. In this way, when the pore distribution changes,
The distance between the pores at the tip portion is preferably about 0.1 mm to 0.2 mm, and at the base end portion is preferably about 0.3 mm to 0.5 mm, and particularly in the middle portion between the tip portion and the base end portion. It is preferable that the distance between the pores is about the middle of the two or changes gradually. Further, instead of changing the pore size distribution, the pore size of the pore itself is larger on the tip side of the tip side (penetration part) 4a than on the base side. Good.

The proximal end of the distal tube 3 and the distal end 4a of the proximal tube are fixed by an adhesive 45. It should be noted that the fixing may be performed only by the fitting force of both. Further, in the case of bonding with an adhesive, it is preferable not to bond the distal end portion of the distal end portion 4a of the proximal end side tube, and it is particularly preferable to bond only the proximal end portion of the distal end portion 4a. In this way, by not fixing the tip end portion of the tip end portion 4a to the tip end side tube, the deformation of the pore forming portion (deformation of the tip end portion) can be made more reliable. Further, it is preferable that no pore is formed at the base end of the tip (penetration part) 4a. If there are no pores at the base end, the adhesive will not flow into the pores and will not cause adhesion failure due to insufficient flow of the adhesive at the interface between the distal tube and the proximal tube. Further, it is preferable that the adhesive does not flow into the pores 42 and the pores are voids. In such a case, the deformation of the pores by the solidified adhesive (the tip 4a Deformation) is not hindered.

Penetration part 4a of the part where the pore 42 is not provided
The length from the base end of is preferably about 0.5 mm to 250 mm, more preferably 1.5 mm to 150 mm. On the contrary, the pore is 1 / l of the total length of the tip portion (penetration portion) 4a.
It is preferable that about 1.2 to 1/5 is provided.

Next, the blood vessel dilating device shown in FIG. 7 will be described. The basic configuration of the vasodilator is the same as that shown in FIGS. 1 to 6 and described above. The difference is that in the above-described vasodilator 1, the outer tube 2 is composed of the distal tube 3 and the proximal tube 4 fixed to the distal tube 3, and the distal end of the proximal tube 4 is the distal tube. It is the distal end side tube penetration part 4a that has entered the inside of the proximal end part of the above, and the penetration part 4a of the proximal end side tube is provided with a spiral slit 41 or pore 42. The vasodilator comprises a distal tube 3 and a proximal tube 4 fixed to the distal tube, and the fixed portion of the distal tube 3 and the proximal tube 4 has a connection tube that has entered both tubes. 8 is provided, and the spiral slit 8 is provided in the distal end tube intrusion portion 8a that has penetrated into at least the proximal end portion of the distal end side tube of the connection tube.
1a is provided.

The base end of the tip end side tube 3 has substantially the same outer diameter and inner diameter as the tip end of the base end side tube 4, and both are joined at the end face. The connection tube is a tubular body that includes a distal tube entrance portion 8 a that penetrates into the proximal end portion of the distal tube 3 and a proximal tube entrance portion 8 b that penetrates into the distal end portion of the proximal tube 4. The distal tube intrusion portion 8a has an outer diameter substantially the same as the inner diameter of the proximal end portion of the distal tube, and the proximal tube intrusion portion 8b has an outer diameter substantially the same as the inner diameter of the distal end portion of the proximal tube 4. Has become. The length of the tip side tube entry portion 8a is 3 to 2
50 mm is preferable, and 5 to 150 mm is particularly preferable. The length of the proximal tube intruding portion 8b is 3 to
It is preferably 250 mm, and particularly preferably 5 to 150 mm. The total length of the connecting tube is 6 to
600 mm is preferable, and 10 to 200 mm is particularly preferable.

Then, in the tube entrance portion 8a on the tip side,
A spiral slit 81a is provided. The number of slits may be one or two or more. By providing such a spiral slit 81a, the distal tube entrance portion 8a of the connection tube 8 can be more flexibly curved, and kink is less likely to occur at the boundary between the distal tube and the proximal tube. .

Tip side tube entry portion 8 of connection tube 8
The width of the spiral slit 81a formed in a is determined in consideration of the diameter, wall thickness, etc. of the connection tube, and is not uniform. The width of the slit is preferably 1.5 mm or less, and more preferably 1.0 mm or less. The width of the slit is 1/2 of the outer diameter of the connecting tube.
The following is preferred. Within the above range, the tube is sufficiently flexible and the tube does not break during use. Also,
The pitch of the slits is preferably about 0.3 mm to 5.0 mm when the entire pitch is the same, and is particularly preferably 0.
It is preferably 5 mm to 3.0 mm. Within the above range,
It is sufficiently flexible and does not bend at the entry portion 8a during use. The length of the portion where the slit is provided from the tip of the invasion portion 8a is determined in consideration of the length of the vasodilator. Further, as the material of the connecting tube, the same material as the above-mentioned proximal end side tube is used.

Similarly, in the base end side tube entry portion 8b,
A spiral slit 81a is provided. The number of slits may be one or two or more. By providing such a spiral slit 81a, the proximal tube entrance portion 8b of the connection tube 8 can be more flexibly curved, and kink is less likely to occur at the boundary between the distal tube and the proximal tube. Become.

Tube entry portion 8 on the proximal end side of the connection tube 8
The width of the spiral slit 81b formed in b is determined in consideration of the diameter, wall thickness, etc. of the connection tube, and is not uniform. The width of the slit is preferably 1.5 mm or less, and more preferably 1.0 mm or less. The width of the slit is 1/2 of the outer diameter of the connecting tube.
The following is preferred. Within the above range, the tube is sufficiently flexible and the tube does not break during use. Also,
The pitch of the slits is preferably about 0.3 mm to 5.0 mm when the entire pitch is the same, and is particularly preferably 0.
It is preferably 5 mm to 3.0 mm. Within the above range,
It is sufficiently flexible and does not bend at the entry portion 8b during use. The length of the portion where the slit is provided from the tip of the invasion portion 8b is determined in consideration of the length of the vasodilator.

The base end of the tip side tube 3 and the penetration part 8a of the connection tube are fixed by an adhesive 45. Similarly, the distal end portion of the proximal end side tube 4 and the entry portion 8 b of the connection tube are also fixed by the adhesive agent 45. It may be fixed only by the fitting force of both. Further, in the case of bonding with an adhesive, it is preferable not to bond the distal end portion of the intrusion portion 8a and the proximal end portion of the intrusion portion 8b, and particularly, only the central portion 8c of the connection tube 8 is used. Is preferably adhered to the base end of the connection tube and the tip of the base end side tube. In this way, by not fixing the distal end portion of the penetration portion 8a and the proximal end portion of the penetration portion 8b of the connection tube 8 to the respective tubes, the deformation of the penetration portions 8a and 8b of the slit forming portion can be made more reliable. .

Furthermore, the above-mentioned central portion 8 of the connecting tube.
It is preferable that no slit is formed in c.
If there is no slit in the central portion 8c, the adhesive will not flow into the slit, resulting in no defective adhesion due to insufficient inflow of the adhesive into the interface between the distal tube and the proximal tube. Further, in the slits 81a and 81b,
It is preferable that the adhesive does not flow in and the slit portion is a void. In this case, the deformation of the slit forming portion by the solidified adhesive is not hindered.

A portion where no slit is provided (central portion 8
The length of c) is preferably about 1 mm to 500 mm, more preferably 5 mm to 100 mm. On the contrary, the slit is 0.5 to 250
mm is preferable, and more preferably 5 mm to 100
mm.

The spiral slits 81a and 81b are shown in FIG.
However, the pitch is short on both ends of the tube, and the pitch on the center side of the tube is
It may be long. By doing so, since it becomes flexible toward both ends of the tube, there is no sudden change in physical properties, and the bending of both ends of the tube becomes more natural. Regarding the flexibility of the connecting tube, the penetration part 8a
The (connection tube side) is preferably more flexible than the intrusion part 8b (base end side tube side). Therefore, it is preferable that the pitch of the slit 81a is shorter than that of the slit 81b, in other words, the slit length is long. Further, the width of the slit may be wider on the side of 8a than on 8b.

The shape of the distal end of the proximal tube and the configuration other than the connecting tube are the same as those of the above-described embodiment. In addition, in the above embodiment, the intrusion portion 8
Although slits are formed in a and 8b, a slit extending substantially parallel to the axis of the proximal tube may be provided on the rear end side of the tube as shown in FIG. As shown in FIG. 5, the slit in this case has a width that gradually decreases from the tip toward the inside of the tube, in other words,
It is preferable that the width be gradually increased toward the end side. The slits are 2 to 8 at almost equal intervals.
It is preferable that about one piece is provided. The width of the tip of the slit (width of the maximum portion) is preferably 1.5 mm or less, and the length of the slit is 0.5 mm to 25 mm.
0 mm is preferable, and 1.5 mm to 150 mm is particularly preferable. The shape of the slit is not limited to that shown in FIG. 5, and may have the same width and extend from the front end of the tube to the rear end side. In this case, the width of the slit is preferably 1.5 mm or less, and the length of the slit is preferably 0.5 mm to 250 mm, and particularly preferably 1.5 mm to 150 mm.

Further, the intruding portions 8a and 8b of the above-mentioned embodiment are provided.
Instead of the slit in, the pores as described above may be formed. As the pores, those having the above-described shape, size, etc. are suitable. As for the flexibility of the connecting tube even when the pores are provided, the intruding portion 8a (connecting tube side) is more intruding portion 8b (proximal end tube side).
It is preferably more flexible. Therefore, the intrusion part 8a
The existence density of pores is higher than the existence density of pores in the intrusion portion 8b, in other words, it is preferable that the total area of the pores is large. In addition, in the connection tube 8, it is not necessary to provide the slits or pores only in at least the intrusion portion 8a on the distal end side and not provide the slits or pores in the intrusion portion 8b. As a result, it is possible to prevent a kink between the distal end side tube and the proximal end side tube.

Next, the catheter of the present invention will be described with reference to the embodiments shown in the drawings. As shown in FIGS. 8 and 9, the catheter 30 of the present invention is a catheter including at least a distal end side tube 32 and a proximal end side tube 34 fixed to the distal end side tube 32, and the proximal end side tube 34.
Is a distal-side tube intrusion portion 34a that has penetrated into the proximal end portion of the distal-side tube 32, and the proximal-end tube intrusion portion 34a has a spiral slit 35 or a large number of pores 44. Have

The catheter 30 is composed of a catheter body 31 and a hub 35 fixed to the base end thereof.
The front end of 0 is open, the base end of the hub 35 is also open, and a lumen 31a that penetrates from the front end to the base end is provided. The catheter main body 31 includes a distal end side tube 32 and a proximal end side tube 34 fixed to the proximal end of the distal end side tube 32. A reinforcing tube 31b is provided at the proximal end of the catheter body 31, and the proximal ends of the reinforcing tube 31b and the proximal tube 34 are provided at the hub 35.
It is fixed to the surface with an adhesive or the like.

The catheter 30 of the present invention is used in an intravascular vessel such as a catheter for angiography in the heart or the brain, a catheter for administering a drug in the heart or the cerebrovascular, an embolization catheter for embolizing the cerebrovascular, etc. Used as an insertion catheter. The catheter 30 of this embodiment is an embodiment in which the catheter of the present invention is applied to a catheter for intramedullary drug administration. In this embodiment, the tip side tube 32 has a diameter reduced toward the tip, and the tip has a smaller diameter than the other portions. The tip of the catheter (tip of the tip-side tube) is preferably a curved surface without corners in order to prevent damage to the blood vessel wall and improve the operability of the catheter.

Since the tip portion is made of synthetic resin, it has sufficient flexibility, and further, the base end side tube intrusion portion 34a corresponding to the boundary portion between the body portion and the tip portion.
Since the distal end portion of the is a flexible deformable portion compared to other portions, it is possible to prevent bending at the boundary portion between the highly rigid base end side tube and the flexible distal end side tube.

The length of the distal tube 32 is 5
0 to 1000 mm, more preferably 100 to 500 m
m, the outer diameter is 0.4 to 2.0 mm, preferably 0.5
mm-1.5 mm, wall thickness 25-200 μm,
More preferably, it is 50 to 100 μm. The difference between the outer diameter of the distal end of the distal tube and the outer diameter of the proximal end is
It is preferably 0.5 mm or less, and particularly preferably 0.3 mm or less.

As the material for forming the tip side tube 32,
A material having a certain degree of flexibility is used. For example,
Polyolefin (specifically, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer,
Ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more thereof), or cross-linked products thereof, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin,
A polymer material such as a fluororesin elastomer or a mixture thereof is used.

Particularly, when the catheter of the present invention is applied to a catheter (embolization catheter) for injecting an embolic substance (for example, cyanoacrylate, a solution of ethylene-vinyl alcohol copolymer in dimethylsulfoxide) into a cerebral blood vessel. The material for forming the synthetic resin layer is preferably one that is not easily dissolved in a solvent such as dimethyl sulfoxide. As a synthetic resin material used for such a catheter, a material having high solvent resistance, for example, a polyamide elastomer is suitable.

The base end side tube 34 is a tube body having substantially the same outer diameter as shown in FIG. 9 except for the tip end portion. As shown in FIG. 9, the distal end portion 34a of the proximal end side tube 34 has a reduced diameter, and the outer diameter of the distal end portion 34a is substantially the same as the inner diameter of the proximal end portion of the distal end side tube 32. The tip end portion 34a serves as a tip end side tube penetration portion 34a that has entered the base end portion of the tip end side tube 32. Further, in this embodiment, the entry portion 34a of the proximal tube has a spiral slit 33.

As the proximal end side tube, one having higher rigidity than the distal end side tube is used. In other words, a flexible tube is used as the above-mentioned tip side tube. As a material for forming the proximal end side tube 34, a plastic or metal tube having a relatively high rigidity is used. Examples of the plastic material include polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer, ionomer, or a mixture of two or more thereof), or a crosslinked product thereof, polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester. Polymer materials such as elastomer, polyurethane, polyurethane elastomer, polyimide and fluororesin can be used. It is also possible to use the same material as the tip side tube, and in that case, even if it is the same material, a material (harder) than the material of the tip side tube is used. On the other hand, when the same material is used for the distal tube and the proximal tube, the material forming the distal tube is highly plasticized (for example, a material containing a large amount of plasticizer) or a copolymer. If so, the one with many soft segments is used.

In particular, when the catheter of the present invention is applied to a catheter for injecting an embolic substance (for example, cyanoacrylate, a dimethylsulfoxide solution of an ethylene-vinyl alcohol copolymer) into a cerebral blood vessel, a synthetic resin layer is used. The forming material is preferably one that does not easily dissolve in a solvent such as dimethyl sulfoxide. As a synthetic resin material used for such a catheter, a material having high solvent resistance, for example, a polyamide elastomer is suitable.

As the metal material, various metals and alloys such as stainless stretchable alloy and super elastic metal (for example, super elastic alloy) can be used. A superelastic alloy is generally called a shape memory alloy and exhibits superelasticity at least at a biological temperature (around 37 ° C.). Particularly preferably, 49
.About.53 atomic% Ni Ti--Ni alloy, 38.5-41.
5 wt% Zn Cu-Zn alloy, 1-10 wt% X C
u-Zn-X alloy (X = Be, Si, Sn, Al, G
a), a superelastic metal body such as a Ni-Al alloy of 36 to 38 atomic% Al is preferably used. Particularly preferred are the above-mentioned Ti-Ni alloys. Further, a Ti-Ni-X alloy (X = Co, Fe, Mn, Cr, V, Al, Nb, W,
B) or a part of the Ti—Ni alloy is reduced to 0.
By using a Ti-Ni-X alloy (X = Cu, Pb, Zr) substituted with 0 to 1 to 30.0% atoms, and selecting the cold working rate and / or the condition of the final heat treatment, The characteristics can be changed as appropriate. Further, by selecting the cold working ratio and / or the condition of the final heat treatment using the above-mentioned Ti-Ni-X alloy, the mechanical properties can be appropriately changed. Superelasticity means that even if a normal metal is deformed (bending, pulling, or compressing) to a region where it is plastically deformed at the operating temperature, it will recover to its original shape without requiring heating after the deformation is released. To do.

The length of the proximal tube 34 is 5
0 to 2000 mm, more preferably 100 to 1700
mm, the outer diameter of the proximal tube is 0.7 to 7.0 mm,
Preferably, it is about 0.9 to 6.0 mm, and the wall thickness is
10 to 200 μm, more preferably 50 to 100 μm
belongs to. The length of the tip portion 34a is 3 to 50.
0 mm, more preferably 5 to 300 mm, the outer diameter is
0.5-6.0 mm, more preferably 0.7-5.0
mm, and the wall thickness is 30 to 100 μm.

The spiral slit 3 is formed in the entry portion 34a into the distal end side tube (the distal end portion of the proximal end side tube).
3 are provided. The number of slits 33 is 1 or 2
It may be more than a book. By providing such a spiral slit 33, the distal end portion (intrusion portion into the distal end side tube) 34a of the proximal end side tube can be more flexibly curved, and the intrusion portion 34a can function as the distal end side tube. Reinforce the base end with flexibility. That is, in the portion where the proximal end portion of the distal end side tube 32 and the intrusion portion 34a overlap, the independent portion of the distal end side tube 32 and the proximal end side tube 3
4 has a physical property intermediate with that of the independent portion of 4 and the deformability provided by the slit, so that the kink of the tube at the boundary 37a serving as the distal tube 32 alone and the boundary 37b serving as the proximal tube 34 alone. Prevent. In particular, even if a force is applied to the vicinity of the boundary 37a, which is the tip end side tube 32 alone, the penetration portion 34a having the slit is curved, so that the force is dispersed without being concentrated on the boundary 37a. It is difficult for kinks to occur.

The width of the spiral slit 33 formed in the distal end portion 34a of the proximal tube is not uniform because it is determined in consideration of the tube diameter and wall thickness. The width of the slit is preferably 1.5 mm or less, and more preferably 1.0 mm or less. The width of the slit is preferably 1/2 or less of the outer diameter of the distal end portion 34a of the proximal tube. Within the above range, the tube is sufficiently flexible and the tube does not break during use. Also, as the pitch of the slits, when the entire pitch is the same,
0.3 mm to 5.0 mm is preferable, especially 0.5 m
It is preferably m to 3.0 mm. Within the above range, it is sufficiently flexible and does not bend at the tip portion 34a during use. Tip 3 of the part where the slit is provided
The length from the tip of 4a is determined in consideration of the length of the catheter and the like.

The base end portion of the tip end side tube 32 and the tip end portion 34a of the base end side tube are fixed by an adhesive 45. It should be noted that the fixing may be performed only by the fitting force of both. Further, in the case of bonding using an adhesive, it is preferable not to bond the distal end portion of the distal end portion 34a of the proximal end side tube, and it is particularly preferable to bond only the proximal end portion of the distal end portion 34a. In this way, by not fixing the tip end portion of the tip end portion 34a to the tip end side tube, the deformation of the slit forming portion (deformation of the tip end portion) can be made more reliable. Further, it is preferable that no slit is formed at the base end portion of the tip end portion (penetration portion) 34a. If there is no slit at the base end portion, the adhesive will not flow into the slit and the adhesion failure due to insufficient inflow of the adhesive at the interface between the distal side tube and the proximal side tube will not occur. Also,
It is preferable that the adhesive does not flow into the slit 33 and the slit portion is a void. In this case, there is no hindrance to the deformation of the slit (deformation of the tip portion 34a) due to the solidified adhesive. .

Intrusion part 34 in the part where no slit is provided
The length of a from the base end is preferably about 0.5 mm to 250 mm, more preferably 1.5 mm to 150 mm. On the contrary, it is preferable that the slit is provided at about 1 / 1.2 to 1/5 of the entire length of the tip portion (penetration portion) 34a. The pitch of the spiral slit 33 is substantially uniform in the one shown in FIG. 9, but it may be short on the tip end side of the slit and long on the base end side of the slit. By doing so, since it becomes flexible toward the tip portion, there is no sudden change in the physical properties, and the curvature of the tip portion becomes more natural. When changing the pitch of the slit, it is preferable that the pitch of the base end portion of the slit is about 1 to 10 times the pitch of the tip end portion of the slit. Further, the width of the slit may be wide at the front end and narrow at the base end.

In addition, instead of the spiral slit as described above, the intruding portion 34a as shown in FIG. 11 is inserted in the intruding portion 34a (the distal end portion of the proximal end tube) into the tip side tube.
A slit 43 that extends substantially parallel to the axis of the proximal tube may be provided on the rear end side of the tip. By providing such a slit extending substantially parallel to the axis of the proximal tube, the distal end portion of the proximal tube (entrance portion into the distal tube) 34a can be more flexibly curved, and The portion 34a flexibly reinforces the proximal end of the distal tube. As shown in FIG. 11, the slit 43 is formed such that its width gradually becomes smaller toward the rear end side than the front end of the intrusion portion 34a, in other words, the width gradually becomes larger toward the front end side. Therefore, the slit width at the tip of the intruding portion 34a is the maximum, and the intruding portion 34a is easily deformed toward the tip, and the side wall is also easily deformed partially inward or outward. Has become. The slits 43 are 2 to 8 at almost equal intervals.
It is preferable that about one piece is provided. The width of the tip of the slit (width of the maximum portion) is preferably 1.5 mm or less, and the length of the slit is 0.5 mm to 25 mm.
0 mm is preferable, and 1.5 mm to 150 mm is particularly preferable. The shape of the slit 43 is not limited to that shown in FIG. 11, and may have the same width and extend from the front end toward the rear end. As the width of the slit in this case,
1.5 mm or less is preferable, and the length of the slit is preferably 0.5 mm to 250 mm, and particularly 1.5
mm-150 mm is preferable.

When a metal tube is used as the proximal end side tube, the slits and the pores described later are formed by laser processing (for example, YAG laser), electric discharge processing, chemical etching, cutting processing, and the combination thereof. be able to. Similarly, when plastic is used, the formation of slits and pores described later can be performed by laser processing, chemical etching, cutting processing, or the like, and the slits can be formed at the same time as tube molding by die molding. .

Further, the outer surfaces of the distal tube 32 and the proximal tube 34 may be coated with a resin having biocompatibility, particularly antithrombogenicity. As the antithrombogenic material, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) and the like are suitable.

In addition, instead of the spiral slits as described above, a large number of pores 4 as shown in FIG. 10 are provided in the entry portion 34a into the distal end side tube (the distal end portion of the proximal end side tube).
4 may be provided. Providing such a large number of pores makes it possible for the distal end portion (intrusion portion into the distal end tube) 34a of the proximal end side tube to be more flexibly curved, and at the same time, this intrusion portion 34a is the base of the distal end side tube. Reinforce the ends with flexibility. That is, in the portion where the proximal end portion of the distal end side tube 32 and the intrusion part 34a overlap, the intermediate physical properties of the physical properties of the independent portion of the distal end side tube 32 and the independent portion of the proximal end side tube 34 and the pores are given. A boundary 37a that serves as the distal end side tube 32 alone and a boundary 37 that serves as the proximal end side tube 34 alone due to having the ease of deformation.
Prevent kink of tube at b. In particular, even if a force is applied to the vicinity of the boundary 37a, which is the distal end side tube 32 alone, the penetration portion 34a having pores is curved,
Since the force is dispersed, a kink at the boundary 37a is unlikely to occur.

The diameter of the pores 44 is the number of pores to be provided,
Since it is determined in consideration of the outer diameter of the tip portion 34a and the like, it is not uniform. The hole diameter is 0.1 mm to 0.4
mm is preferable, and more preferably 0.2 mm to
0.3 mm. Further, the hole diameter is preferably about 1/10 to 1/3 of the outer diameter of the distal end portion of the proximal tube. Within the above range, the tube is sufficiently flexible and the distal end of the proximal tube does not break during use. The distance between the pores is preferably about 0.1 to 0.5 mm. The shape of the pores does not have to be a perfect circle, and may be an ellipse, for example, an ellipse elongated in the circumferential direction or the axial direction of the tip portion 34a, and a polygon (for example, a quadrangle or a pentagon). The area of one pore is preferably about 0.007 mm ^{2 to} 0.13 mm ² , and the distance between the pores is 0.1 to 0.5.
About mm is preferable.

The number of pores 44 may be larger on the distal end side of the distal end portion 34a of the proximal end side tube 34 than on the proximal end portion side. By doing so, since it becomes flexible toward the tip, there is no sudden change in physical properties, and the curvature of the tip becomes natural. Further, the number of pores 44 may be gradually increased from the base end side of the tip end side 34a toward the tip end side. By doing so, it becomes soft gradually toward the tip. In this way, when the pore distribution changes, the distance between the pores at the tip is 0.1 mm to 0.2.
mm, about 0.3 mm to 0.5 mm is suitable at the base end portion, and especially, in the middle portion between the tip end portion and the base end portion, the distance between the pores is about the middle of the two or gradually changes. Is preferred. Also, instead of changing the pore distribution,
The pore size of the pore itself may be larger on the tip side of the tip portion (penetration portion) 34a than on the base end side.

The proximal end of the distal tube 32 and the distal end 34a of the proximal tube are fixed to each other with an adhesive 45. It should be noted that the fixing may be performed only by the fitting force of both. Further, in the case of bonding using an adhesive, it is preferable not to bond the distal end portion of the distal end portion 34a of the proximal end side tube, and it is particularly preferable to bond only the proximal end portion of the distal end portion 34a. In this way, by not fixing the tip end portion of the tip end portion 34a to the tip end side tube, the deformation of the pore forming portion (deformation of the tip end portion) can be made more reliable. Furthermore, at the base end of the tip (entrance) 34a,
It is preferable that no pore is formed. If there are no pores at the base end, the adhesive will not flow into the pores and will not cause adhesion failure due to insufficient flow of the adhesive at the interface between the distal tube and the proximal tube. In the pores 44,
It is preferable that the adhesive does not flow in and the pores are voids. In this case, the solidified adhesive does not hinder the deformation of the pores (deformation of the tip portion 34a).

The intrusion part 34 in the part where the pores 44 are not provided
The length of a from the base end is preferably about 0.5 mm to 250 mm, more preferably 1.5 mm to 150 mm. On the contrary, it is preferable that the pores are provided at about 1 / 1.2 to 1/5 of the entire length of the tip portion (penetration portion) 34a.

Next, the catheter shown in FIG. 12 will be described. The basic configuration of the catheter is the same as that shown in FIGS. 8 and 9 and described above. The difference is that in the catheter 30 described above, the catheter main body 31 is composed of a distal end side tube 32 and a proximal end side tube 34 fixed to the distal end side tube 32, and the distal end portion of the proximal end side tube 34 is the base of the distal end side tube. Tip side tube entry part 3 that entered the end part
4a, and the entry portion 34 of the proximal end tube
Although a is provided with a spiral slit 41 or a pore 44, in the blood vessel dilation device of this embodiment, the distal end tube 32 and the proximal end tube 34 fixed to the distal end tube are provided. A connection tube 38 that penetrates into both tubes is provided at the fixed portion between the side tube 32 and the proximal tube 34, and the distal tube penetration portion 38a that penetrates into at least the proximal end of the distal tube of the connection tube. Is provided with a spiral slit 39a.

The base end of the tip end side tube 32 has substantially the same outer diameter and inner diameter as the tip end of the base end side tube 34, and both are joined at the end face. The connection tube is
The tubular body is provided with a distal tube entrance portion 38a that penetrates into the proximal end portion of the distal tube 32 and a proximal tube entrance portion 38b that penetrates into the distal end portion of the proximal tube 34. The distal-side tube intrusion portion 38a has an outer diameter that is substantially the same as the inner diameter of the proximal end portion of the distal-side tube, and the proximal-end tube intrusion portion 38b has an outer diameter that is approximately the same as the inner diameter of the distal end portion of the proximal-side tube 34. Has become. Tip side tube entry part 38a
The length of is preferably 3 to 250 mm, and particularly,
5 to 150 mm is suitable. Base side tube entry part 3
The length of 8b is preferably 3 to 250 mm, and particularly preferably 5 to 150 mm. In addition, the total length of the connecting tube is preferably 6 to 600 mm, and particularly preferably 10 to 200 mm.

A spiral slit 39a is provided in the tip side tube entry portion 38a. The number of slits may be one or two or more. By providing such a spiral slit 39a, the distal tube intrusion portion 38a of the connection tube 38 can be more flexibly curved, and kink is less likely to occur at the boundary between the distal tube and the proximal tube. .

The width of the spiral slit 39a formed in the distal tube entry portion 38a of the connection tube 38 is determined in consideration of the diameter and wall thickness of the connection tube.
It's not uniform. The width of the slit is 1.5m
It is preferably m or less, and more preferably 1.0 mm or less. The width of the slit is 1 / outer diameter of the connecting tube.
It is preferably 2 or less. Within the above range, the tube is sufficiently flexible and the tube does not break during use. The pitch of the slits is preferably about 0.3 mm to 5.0 mm, and particularly preferably 0.5 mm to 3.0 mm when the entire pitch is the same. Within the above range, it is sufficiently flexible and does not bend at the entry portion 38a during use. The length of the portion where the slit is provided from the tip of the intrusion portion 38a is determined in consideration of the length of the vasodilator.

Similarly, a spiral slit 39b is also provided in the proximal tube entrance portion 38b. The number of slits may be one or two or more. By providing such a spiral slit 39b, the proximal-side tube entry portion 38b of the connection tube 38 can be more flexibly curved, and kink is less likely to occur at the boundary between the distal-side tube and the proximal-side tube. Become.

The width of the spiral slit 39b formed in the proximal tube entrance portion 38b of the connection tube 38 is determined in consideration of the diameter and wall thickness of the connection tube.
It's not uniform. The width of the slit is 1.5m
It is preferably m or less, and more preferably 1.0 mm or less. The width of the slit is 1 / outer diameter of the connecting tube.
It is preferably 2 or less. Within the above range, the tube is sufficiently flexible and the tube does not break during use. The pitch of the slits is preferably about 0.3 mm to 5.0 mm, and particularly preferably 0.5 mm to 3.0 mm when the entire pitch is the same. Within the above range, it is sufficiently flexible and does not bend at the entry portion 38b during use. The length of the portion where the slit is provided from the tip of the entry portion 38b is determined in consideration of the length of the vasodilator.

The base end portion of the tip side tube 32 and the intrusion portion 38a of the connection tube are fixed by the adhesive 45. Similarly, the distal end portion of the proximal end side tube 34 and the entry portion 38 b of the connection tube are also fixed by the adhesive agent 45. It may be fixed only by the fitting force of both. Further, in the case of bonding using an adhesive, it is preferable not to bond the distal end portion of the penetration portion 38a and the proximal end portion of the penetration portion 38b, and particularly, the central portion 38 of the connection tube 38.
It is preferable to bond the connection tube 38 to the base end of the connection tube and the tip end of the base end side tube only by c.
In this way, by not fixing the tip end portion of the entry portion 38a of the connection tube 38 and the base end portion of the entry portion 38b to the respective tubes, the entry portion 3 of the slit forming portion is formed.
The deformation of 8a and 38b can be made more reliable.

Furthermore, the above-mentioned central portion 3 of the connecting tube.
It is preferable that no slit is formed in 8c. If there is no slit in the central portion 38c, the adhesive will not flow into the slit, resulting in no defective adhesion due to insufficient inflow of the adhesive into the interface between the distal tube and the proximal tube. Further, it is preferable that the adhesive does not flow into the slits 39a and 39b and the slit portion is a void. In this case, the deformation of the slit forming portion by the solidified adhesive is hindered. Nothing.

A portion where no slit is provided (central portion 3
The length of 8c) is preferably about 3 mm to 150 mm,
More preferably, it is 5 mm to 100 mm. On the contrary, the range in which the slits are provided is preferably about 1.5 to 75 mm, more preferably 5 mm to 60 mm, from the ends of the intrusions 38a and 38b. Spiral slit 39
The pitches of a and 39b are almost uniform in FIG. 12, but may be short on both end sides of the tube and long on the center side of the tube. By doing so, since it becomes flexible toward both ends of the tube, there is no sudden change in physical properties, and the bending of both ends of the tube becomes more natural. As for the flexibility of the connection tube, it is preferable that the intrusion portion 38a (connection tube side) is more flexible than the intrusion portion 38b (base end side tube side). For this reason, it is preferable that the slit 39a has an overall shorter pitch than the slit 39b, in other words, the slit length is long.

The shape of the distal end of the proximal tube and the configuration other than the connecting tube are the same as those in the above-described embodiment. It should be noted that in the above embodiment, the intrusion part 38
Although slits are formed in a and 38b, a slit extending substantially parallel to the axis of the proximal tube may be provided on the rear end side of the tube as shown in FIG. As shown in FIG. 11, the slit in this case is formed so that the width becomes gradually smaller from the tip toward the inside of the tube, in other words, the width becomes gradually larger toward the end. preferable. The slits are almost evenly spaced,
It is preferable that about 2 to 8 pieces are provided. The width of the tip of the slit (width of the maximum part) is preferably 1.5 mm or less, and the length of the slit is 0.5 mm.
~ 250 mm is preferred, especially 1.5 mm-150 m
m is preferred. The shape of the slit is not limited to the one shown in FIG. 11, and may have the same width and extend from the front end toward the rear end. In this case, the width of the slit is preferably 1.5 mm or less, and the length of the slit is preferably 0.5 mm to 250 mm, and particularly preferably 1.5 mm to 150 mm.

Further, instead of the spiral slits formed in the intruding portions 38a, 38b, the pores as described above may be formed. As the pores, those having the above-described shape, size, etc. are suitable. Also in the case of providing the pores, as for the flexibility of the connection tube, it is preferable that the intrusion portion 38a (connection tube side) is more flexible than the intrusion portion 38b (base end side tube side). Therefore, the existence density of the pores in the intrusion portion 38a is higher than the existence density of the pores in the intrusion portion 38b, in other words, the total area of the pores is preferably large. Slits or pores may be provided only in the intrusion portion 38a, and slits or pores may not be provided in the intrusion portion 38b.

[0089]

The vasodilator according to the present invention is provided with an inner tube having a first lumen whose tip is open, and is provided coaxially with the inner tube, and the tip is retracted by a predetermined length from the tip of the inner tube. And an outer tube forming a second lumen between the outer tube and the outer surface of the inner tube, and a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, and the distal end portion being A contractible or foldable expansion body attached to the inner pipe and communicating with a second lumen near the proximal end, and communicating with the first lumen provided at the proximal end of the inner pipe. A vasodilator having a first opening and a second opening communicating with the second lumen provided at the proximal end of the outer tube, wherein the outer tube is a distal tube. , A proximal end tube fixed to the distal end side tube, the distal end portion of the proximal end side tube is It has a distal tube incursion that has entered the proximal end portion of the end-side tube, and the tube penetration portion has a slit or number of pores.

In particular, the entry portion into the tip side tube has slits or pores, so that the entry portion into the tip end side tube can be more flexibly curved, and this entry portion is included in the tip end side tube. Knots of the outer pipe at the boundary where the distal end tube is independent and the boundary where the proximal end tube is independent at the part where the proximal end part of the distal end side tube and the penetration part overlap with each other. And prevent deformation of the vasodilator at the joint between the two.

Further, the vasodilator according to the present invention is provided with an inner tube having a first lumen whose end is open, and is coaxially provided with the inner tube, and is located at a position retracted by a predetermined length from the end of the inner tube. And an outer tube forming a second lumen between the outer tube and the outer surface of the inner tube, and a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, and the distal end portion being A contractible or foldable expansion body attached to the inner pipe and communicating with a second lumen near the proximal end, and communicating with the first lumen provided at the proximal end of the inner pipe. A vasodilator having a first opening and a second opening communicating with the second lumen provided at the proximal end of the outer tube, wherein the outer tube is a distal tube. A distal end tube fixed to the distal end tube, the distal end tube and the proximal end tube The tube fixing portion is provided with a connecting tube penetrating into both tubes, and at least the distal tube penetrating portion of the connecting tube penetrating into the proximal end portion of the distal tube has slits or a large number of pores. Is provided.

In particular, the entrance portion of the connecting tube into the tip side tube has slits or pores, so that the entrance portion into the tip side tube can be bent more flexibly, and The proximal end of the distal tube is reinforced with flexibility, and at the part where the proximal end of the distal tube and the intrusion part overlap, kinking of the outer tube at the boundary of the distal tube alone is prevented and both Improve the deformation of the vasodilator at the joint.

The catheter of the present invention is a catheter including at least a distal tube and a proximal tube to which the distal tube is fixed, and the distal end of the proximal tube has a proximal end of the distal tube. It is a tip side tube intrusion part that has penetrated into the inside of the part, and the tube intrusion part has slits or a large number of pores. As a result, the entry portion into the distal tube can be bent more flexibly, and the entry portion reinforces the proximal end portion of the distal tube with flexibility, and the proximal end portion of the distal tube and the entry portion In the overlapping portion, the kink of the catheter is prevented at the boundary where the distal end side tube is independent and the boundary where the proximal end side tube is independent, and the deformation of the catheter at the joint part between them is made good.

The catheter of the present invention is a catheter having at least a distal tube and a proximal tube to which the distal tube is fixed, and the fixed portion of the distal tube and the proximal tube is A connection tube that penetrates into both tubes is provided, and a slit or a large number of pores are provided in the distal tube entrance portion that penetrates at least the proximal end of the distal tube of the connection tube. Therefore, the part of the connecting tube that penetrates into the distal tube can be bent more flexibly, and this part that reinforces the proximal end of the distal tube with flexibility, It is possible to prevent the catheter from kinking at the boundary where the distal end side tube is independent at the portion where the intrusion portion overlaps with each other, and to improve the deformation of the catheter at the joint portion between them.

[Brief description of the drawings]

FIG. 1 is a partially omitted external view of an embodiment of a vasodilator according to the present invention.

FIG. 2 is an enlarged cross-sectional view of a distal end portion of the blood vessel dilating device shown in FIG.

FIG. 3 is an enlarged cross-sectional view of the vicinity of the joint portion of the embodiment of the vasodilator according to the present invention.

FIG. 4 is an enlarged cross-sectional view of the vicinity of a joint portion of another embodiment of the vasodilator according to the present invention.

FIG. 5 is an enlarged cross-sectional view of the vicinity of the joint of another embodiment of the vasodilator according to the present invention.

FIG. 6 is a cross-sectional view of a proximal end portion of an embodiment of the vasodilator according to the present invention.

FIG. 7 is an enlarged cross-sectional view of the vicinity of the joint portion of another embodiment of the vasodilator according to the present invention.

FIG. 8 is a partially omitted external view of an embodiment of the catheter of the present invention.

FIG. 9 is an enlarged cross-sectional view of the vicinity of the joint portion of the embodiment of the catheter of the present invention.

FIG. 10 is an enlarged cross-sectional view of the vicinity of the joint of another embodiment of the catheter of the present invention.

FIG. 11 is an enlarged cross-sectional view of the vicinity of the joint of another embodiment of the catheter of the present invention.

FIG. 12 is an enlarged cross-sectional view of the vicinity of the joint of another embodiment of the catheter of the present invention.

[Explanation of symbols]

 1 Vascular dilation device 2 Outer tube 3 Tip side tube 4 Base end side tube 4a Tip side tube entry part 5 Inner tube 9 Expanded body 33 Slit 39a, 39b Slit 41 Slit 42 Pore 43 Slit 44 Pore 81a, 81b Slit

Claims (14)

[Claims] 1. An inner tube having a first lumen whose tip is open, and an inner tube coaxially provided with the inner tube and having the tip at a position retracted by a predetermined length from the tip of the inner tube, An outer tube forming a second lumen between the outer tube and the outer surface; a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, the distal end portion being attached to the inner pipe; Second near the base end
Contractable or foldable expansion body communicating with the lumen, a first opening communicating with the first lumen, provided at the proximal end of the inner tube, and a proximal end of the outer tube. And a second opening communicating with the second lumen, wherein the outer tube comprises a distal tube and a proximal tube fixed to the distal tube, The distal end of the proximal tube is a distal tube intruding portion that has penetrated into the proximal end of the distal tube, and the proximal tube intruding portion has slits or a large number of pores. A vasodilator that is characterized by being. 2. An inner tube having a first lumen whose tip is open, and an inner tube provided coaxially with the inner tube and having a tip at a position retracted by a predetermined length from the tip of the inner tube. An outer tube forming a second lumen between the outer tube and the outer surface; a distal end portion and a proximal end portion, the proximal end portion being attached to the outer pipe, the distal end portion being attached to the inner pipe; Second near the base end
Expandable body that communicates with the lumen of the inner tube, a first opening that communicates with the first lumen and that is provided at the proximal end of the inner tube, and a proximal end of the outer tube. And a second opening communicating with the second lumen, wherein the outer tube comprises a distal tube and a proximal tube to which the distal tube is fixed, A connection tube that has penetrated into both tubes is provided in the fixed portion between the distal side tube and the proximal side tube, and a distal side tube penetration section that has penetrated into at least the proximal side of the distal side tube of the connection tube. Has
A vasodilator that is provided with slits or a large number of pores. 3. The vasodilator according to claim 1, wherein the slit is a spiral slit. 4. The vasodilator according to claim 1, wherein the slit is a slit extending from the distal end of the proximal tube to the proximal side substantially parallel to the axis of the proximal tube. 5. The base end portion of the tip end side tube entry portion is
The vasodilator according to any one of claims 1 to 4, which has neither the slit nor the large number of pores. 6. The tip end portion of the tip end side tube intrusion portion,
The vasodilator according to any one of claims 1 to 5, which is not fixed to the distal tube. 7. The vasodilator according to claim 2, wherein the rear end portion of the proximal tube-entry portion of the connection tube has slits or a large number of pores. 8. A catheter comprising at least a distal tube and a proximal tube fixed to the distal tube, wherein the distal end of the proximal tube penetrates into the proximal end of the distal tube. A catheter characterized in that it is a distal-side tube intrusion part, and the tube intrusion part has slits or a large number of pores. 9. A catheter comprising at least a distal side tube and a proximal side tube fixed to the distal side tube, wherein the distal side tube and the proximal side tube are fixed to each other in both tubes. A catheter characterized in that a connecting tube that has entered is provided, and that at least the distal tube entering part that has entered the proximal end of the distal tube of the connecting tube is provided with slits or a large number of pores. . 10. The catheter according to claim 8, wherein the slit is a spiral slit. 11. The catheter according to claim 8, wherein the slit is a slit extending from the distal end of the proximal tube to the proximal side substantially parallel to the axis of the proximal tube. 12. The catheter according to claim 8, wherein a proximal end portion of the distal end side tube intrusion portion has neither the slit nor the large number of pores. 13. The catheter according to claim 8, wherein the distal end portion of the distal end side tube entry portion is not fixed to the distal end side tube. 14. The catheter according to claim 9, wherein the rear end portion of the proximal tube intrusion portion of the connection tube has slits or a large number of pores.