JPH11276592A - Catheter and medical tube - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter and a medical tube that decrease the generation of a kink between either parts to which rigidity is given or not given without lowering its torque conductivity by the part to which rigidity is given and to enable easy insertion into organisms. SOLUTION: The catheter 1 consists of a lumen 8, a top opening 6 that connects with the lumen 8, a main body 2 that mounts the part 5 to which rigidity is given and that is made of linear material 11, a top end 3 to which rigidity is not given and a catheter tube that has side holes 4 that connect with the lumen 8. At least one of the side holes 4 exists at the end of the main body 2 while the linear material 11 which composes the part 5 to which rigidity is given is in series without being cut inside the openings of the side holes 4.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to, for example, a catheter for angiography of a heart or its surrounding tissue, an imaging catheter for a living organ such as a liver, a pancreas or a bile duct, a catheter for administering a drug into a heart or a cerebral blood vessel, a cerebral blood vessel, and the like. Intravascular catheters such as embolization catheters for embolization, thoracic catheters inserted into and placed in the thoracic cavity, abdominal cavity, etc., trocar catheters, drain tubes, tracheal tubes inserted into the trachea, endotracheal tubes placed there Medical tubes.

[0002]

2. Description of the Related Art Hitherto, catheters of the Judkins type and Amplatz type have been used as catheters for coronary angiography, and pigtail type catheters have been used as catheters for left ventricular imaging. . For example, a pigtail catheter is introduced into a blood vessel from a femoral artery by the Seldinger method or the sheath method. A guide wire is inserted into the catheter, and by performing operations such as moving the catheter forward and backward and rotating with the guide wire, the bifurcation of the blood vessel is selected and reached to the ascending artery. Insert part into left ventricle. Then, in this state, a contrast agent is supplied from the proximal end side of the catheter, and the contrast agent is ejected from the distal end portion of the catheter into the left ventricle to image the left ventricle. Further, the endotracheal tube communicates with the inside of the cuff, with a tube body having a lumen therein, an inflatable cuff provided to annularly surround a part of the outer peripheral surface near the distal end of the tube body, And a cuff inflation lumen provided in parallel with the lumen of the tube body.

[0003] Some conventional imaging catheters and medical tubes have a rigidity-imparting body made of a metal wire. Some conventional contrast catheters and endotracheal tubes have a side hole. By providing the stiffness imparting member, the force applied at the proximal end of the catheter or the tube can be reliably transmitted to the distal end side, and so-called torque transmission is enhanced. However, in a catheter and a medical tube, it is general that a rigidity-imparting body is not provided at the distal end in order to impart a certain degree of flexibility to the distal end. For this reason, there was a case where a kink occurred in a portion where the rigidity imparting member no longer exists. Further, it is conceivable to provide a side hole at the end of the portion where the stiffener is present to reduce the physical properties. However, in this case, the stiffener is divided by the side hole, so that the torque transmission is reduced.

[0004]

SUMMARY OF THE INVENTION An object of the present invention is to reduce the occurrence of kinks between a portion provided with a stiffener and a portion not provided with the stiffener without reducing torque transmission by the stiffener. It is intended to provide a catheter and a medical tube which can be easily inserted into a living body.

[0005]

Means for achieving the above object are as follows: a lumen, a distal end opening communicating with the lumen, a main body extending in the axial direction and having a stiffness imparting body formed by a linear body; A catheter tube having a side hole communicating with the lumen, wherein at least one of the side holes is
A catheter which is located at a distal end of the main body and in which a linear body constituting the stiffening body is continuous without being cut inside the opening of the side hole.

[0006] It is preferable that the catheter tube has a distal end that does not include the rigidity imparting body. Further, two or more side holes may be provided. Further, a side hole may be formed at a tip end portion not provided with the rigidity imparting body. Further, the distal end portion of the catheter may be a curved deforming portion curved in a loop shape. The side holes are preferably formed by laser processing. Further, two or more side holes may be provided.

In order to achieve the above object, a catheter tube having a lumen and an opening communicating with the lumen is provided. The catheter tube includes an inner layer, an outer layer covering the inner layer, and the inner layer or the inner layer. And a body provided with an axially extending stiffening body formed by a linear body provided between the outer layers, and a tip not having a stiffening body, and further having a tip of the inner layer, It is a deformable part with slits or many pores,
In addition, the linear body constituting the stiffness imparting body in the slit or the pore portion is a catheter that is continuous without being cut.

In order to achieve the above object, there is provided a catheter tube having a lumen and an opening communicating with the lumen, and the catheter tube is formed of a linear body and has a rigidity extending body extending in an axial direction. An inner layer having an inner layer, an outer layer covering the inner layer, and a tip not having a stiffener, and further, the tip of the inner layer is deformable having a slit or a large number of pores. And a linear body constituting the stiffness imparting body is continuous without being cut inside the slit or the pore.

Preferably, the slit is a spiral slit. Further, it is preferable that the slit or the pore is formed by laser processing.

In order to achieve the above object, a lumen, a distal end opening communicating with the lumen, a body extending in the axial direction and having a rigidity-imparting body formed of a linear body, and communicating with the lumen are provided. And at least one of the side holes is located at an end of the main body, and a linear body constituting the stiffening member is cut inside the opening of the side hole. It is a continuous medical tube.
The medical tube is, for example, an endotracheal tube.

Further, in all of the above catheters and medical tubes, the linear body is preferably a metal wire. Furthermore, it is preferable that the stiffness imparting body is formed in a mesh shape by a plurality of linear bodies. And it is preferable that the said rigidity provision body is buried in the thickness of the said catheter tube except the said slit or a pore part. Further, the stiffness imparting body may be formed of a linear body composed of a plurality of metal wires. Further, it is preferable that the side holes are formed by laser processing using an excimer laser having an oscillation wavelength of 248 nm or less.

[0012]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS A catheter according to the present invention will be described below with reference to an embodiment shown in the accompanying drawings. FIG. 1 is a partially omitted front view of an embodiment of the catheter of the present invention. FIG.
FIG. 2 is an enlarged sectional view of a distal end portion of the catheter shown in FIG. The catheter 1 of the present invention includes a lumen 8, a distal end opening 6 communicating with the lumen, an axially extending linear body 11.
And a catheter tube 10 having a side hole 4 communicating with a lumen. Then, at least one of the side holes 4 is located at the end of the main body 2, and the linear body 11 constituting the rigidity imparting body 5 is continuously cut inside the opening of the side hole 4 without being cut. I have.

The catheter 1 of this embodiment is an in-vivo contrast catheter, and as shown in FIG.
And main body 2 provided with rigidity imparting body 5
A catheter tube 10 having a side hole forming portion 15 provided at a distal end portion of the main body 2, and a hub 9 provided at a proximal end of the catheter tube 10.

The main body 2 is substantially linear as shown in FIG. 1, and has a rigidity imparting member 5 extending in the axial direction of the main body 2 as shown in FIG. This rigidity imparting body 5
Is provided, it is possible to prevent the catheter 1 from being bent at the main body 2 and to further enhance the torque transmission of the catheter. Therefore, by providing the stiffness imparting member 5, the catheter body is prevented from being bent at the bending portion, and the force (for example, torque, pushing force) applied at the catheter body base end portion is surely applied to the distal end portion 3. Is transmitted to

A synthetic resin (for example,
A hub 9 made of polycarbonate (polypropylene) is attached. The hub 9 has a rear end portion to which a contrast agent injector (for example, a syringe) can be attached.

Then, in the catheter 1 of this embodiment,
The catheter tube 10 is formed by an inner layer 16 forming the lumen 8 penetrating from the base end to the distal end, and an outer layer 17 covering the inner layer 16. And the main body 2
The inner layer 16 has a stiffness imparting body 5.

The material for forming the inner layer 16 is preferably a material having a certain degree of flexibility, for example, a polyolefin elastomer using polyethylene, polypropylene, ethylene-propylene copolymer or the like, polyvinyl chloride, ethylene-vinyl acetate copolymer. Thermoplastic resins such as polymers, polyamide elastomers and polyurethanes, silicone rubber, latex rubber and the like can be used. Preference is given to polyamide elastomers or polyurethanes softened by a plasticizer such as paraoxybenzoic ethylhexyl (POBO), and furthermore, to X-ray opaque substances (for example, barium sulfate, bismuth subcarbonate,
Tungsten powder) may be mixed. The thickness of the inner layer 16 is 0.1 to 0.3 mm, preferably 0.18 to 0.2 mm.
3 mm. Further, the inner layer 16 is provided with the rigidity imparting member 5 extending in the axial direction except for the distal end from the proximal end as described above. As shown in FIGS. 1 and 2, the distal end portion 3 is not provided with the above-described stiffness imparting body 5.

As shown in FIG. 2, the stiffener 5 includes the inner layer 16 or the stiffener 5 provided between the inner layer 16 and the outer layer 17. The stiffness imparting body 5 is formed in a mesh shape by a linear body 11 composed of a plurality of metal wires. Further, in this embodiment, the stiffness imparting body 5 is
6 is buried in the outer surface or the thickness of the resin forming the resin.
In particular, in FIG. 2, the inner layer 16 is formed of a thermoplastic resin, and the inner layer 1 around which the stiffness imparting body 5 is wound.
The stiffness imparting body 5 is buried in the outer wall of the inner layer 16 by heating the inner layer 6 from the outside (for example, inserting the inner layer 16 through a heating die).

As the linear body 11 forming the stiffness imparting body 5, a metal wire is suitable, for example, a stainless steel wire, an amorphous alloy wire or the like is preferable. As the amorphous alloy wire, an iron-silicon-boron alloy, Cobalt-silicon-boron alloy, iron-cobalt-chromium-molybdenum-
An amorphous alloy wire formed using a silicon-boron alloy or the like can be suitably used. The amorphous alloy wire has an amorphous structure formed by extruding the above-described metal into a line and rapidly cooling the formed amorphous alloy wire. The diameter is reduced by passing through a die. The amorphous alloy wire has a high tensile strength, a wide elastic deformation region, and is excellent in heat resistance, corrosion resistance, and fatigue resistance. For amorphous alloy wire, wire diameter 5 ~
30 μm, more preferably 10 to 20 μm, is suitable. In addition, as a stainless wire, a wire diameter of 20 to 80 μm
m, more preferably 30 to 70 μm, especially 40 to 5 μm.
0 μm is preferred. Further, a plurality of, for example, 3 to 7 metal wires (for example, an amorphous alloy wire or a stainless steel wire) having a wire diameter of 1 to 10 μm, more preferably 2 to 5 μm are twisted to form a single linear body of 10 to 20 μm. 11 may be used.

The area of the side hole 4 is preferably 0.8 mm ² or less. Hole diameter of side hole 4 (average hole diameter)
Is preferably about 0.06 to 1.0 mm, and particularly preferably about 0.1 to 0.9 mm. Further, the maximum length of the side hole is longer than the wire diameter of the linear body 11, so that the side hole is not closed by the linear body. Specifically, when the side hole 4 is circular, the diameter of the side hole 4 is preferably larger than the diameter of the linear body 11 of the rigidity imparting body 5, and particularly preferably about 4 to 20 times. In addition, the side hole 4 may not be a perfect circle, for example, an ellipse or an ellipse long in the axial direction of the catheter, a square, a rectangle,
It may be a polygon such as a rhombus, a triangle, or a pentagon. The number of side holes is preferably about 1 to 1080.

The linear members 11 constituting the rigidity imparting member 5 are continuous inside the openings of the side holes 4 without being cut. For this reason, there is no sudden change in physical properties at the side hole, kink is prevented at the side hole, and there is no disconnection of the stiffness imparting body 5 at the side hole. The force applied at the base end can be reliably transmitted.

Further, the surface of the linear body 11 is preferably coated with a biocompatible metal. Examples of the biocompatible metal include gold, silver, platinum, and titanium. As a method of coating the surface of the linear body 11 with a metal,
Gold plating using the electroplating method, stainless steel plating using the vapor deposition method, silicon carbide using the sputtering method,
Titanium nitride plating, gold plating and the like are conceivable.

The linear body 11 has a spiral shape, and the pitch thereof is preferably about 0.3 to 1.0 mm. In addition, the pitch is uniform throughout, and the pitch of the other portion (base end portion) of the main body 2 is longer than the pitch of the rigidity imparting body at the distal end of the main body 2. May be. By doing so, the rigidity of the other part of the main body 2 can be increased as compared with the end of the main body 2. The pitch of the stiffener in the other part of the main body is 1.1 times or more the pitch of the stiffener in the end of the main body 2.
It is preferably 2.5 times.

The outer layer 17 is, as shown in FIG.
To form the outer surface of the catheter 1. Outer layer 17
As a material for forming the inner layer, a material having adhesiveness to the inner layer forming material is preferable, and a material having the same or similar properties to the resin used for forming the inner layer is preferable. For example, thermoplastic resins such as polyethylene, polypropylene, polyolefin using ethylene-propylene copolymer, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, polyurethane, silicone rubber, latex rubber and the like can be used. Preferably a polyamide elastomer or polyurethane softened by a plasticizer such as paraoxybenzoic ethylhexyl (POBO),
Further, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate, tungsten powder) or the like may be mixed in these materials. However, in order to make the outer surface of the catheter smooth, the outer layer 17 is required. Preferably, the X-ray opaque substance is mixed only in the inner layer 16 without mixing the X-ray opaque substance.

Further, the outer surface of the catheter tube 10 may be coated with a resin having biocompatibility, especially antithrombotic properties, for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (eg, HEMA). -St-HEMA block copolymer) can be used. In particular, when a material in which an X-ray opaque substance is mixed is used for the outer layer 17, it is preferable to perform the above-described coating in order to eliminate the roughness of the outer surface due to the X-ray opaque substance. It is preferred that the material used for forming the outer layer 17 be thinly coated.

The outer diameter of the main body 2 of the catheter is 1.0 to 4.0 mm, more preferably 1.3 to 3.0 mm.
5 mm, and the outer diameter of the tip 3 is 0.9 to 3.6 m.
m, more preferably 1.2 to 3.0 mm.

At the distal end of the main body 2 of the catheter, there is a side hole forming portion 15, and this side hole forming portion 15 has
Two facing side holes 4 are provided. Further, the linear members 11 constituting the rigidity imparting member 5 are continuous without being cut inside the openings of the side holes 4. For this reason,
There is no sudden change in physical properties at the side hole portion, kink is prevented at the side hole portion, and the stiffener 5 at the side hole portion is provided.
Therefore, the force applied at the proximal end of the catheter to the distal end side from the side hole can be reliably transmitted.

Further, in this embodiment, the linear members 11 constituting the rigidity imparting member 5 intersect inside the opening of the side hole 4. In other words, the side hole 4 is provided at a portion where the linear bodies 11 constituting the rigidity imparting body 5 intersect. By doing so, the strength reduction at the side hole portion can be further reduced. In this embodiment, all of the two side holes are formed in the main body 2, but the front end 3 may be provided with side holes. The distal end 3 is preferably flexible, and thus the distal end 3 is not provided with the rigidity imparting body 5.

In the above description, the inner layer and the outer layer have a two-layer structure. However, the present invention is not limited to this. The inner layer, the intermediate layer and the outer layer have a three-layer structure.
It may be formed integrally with synthetic resin.

Further, the catheter of the present invention is not limited to the catheter for angiography as described above, but can be used for embolization of a catheter for cardiac or cerebral angiography, a catheter for administration of a drug for intracardiac or cerebral vascular, a cerebral blood vessel, and the like. It is used as an intravascular insertion catheter such as an embolization catheter for rubbing.

In particular, when the catheter of the present invention is applied to a catheter (embolization catheter) for injecting an embolic substance (for example, a dimethyl sulfoxide solution of cyanoacrylate or ethylene-vinyl alcohol copolymer) into cerebral blood vessels. Preferably, the material for forming the synthetic resin layer 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.

Next, the catheter shown in FIGS. 3 and 4 will be described. This catheter is an angiographic catheter. The imaging catheter 20 of this embodiment is used for imaging living organs such as cardiovascular, liver, pancreas, and bile duct. The contrast catheter 20 of this embodiment is a cardiovascular contrast catheter, and includes a pigtail-shaped curved deformation portion 32 at the distal end portion 23. The catheter 20
A curved deformation portion 32 having flexibility as a whole and having its distal end portion 23 bent and deformed in a loop without applying an external force.
have.

Specifically, the catheter 20 includes a catheter tube 21 and a hub 19 fixed to a proximal end of the catheter tube 21. The catheter tube 21
From the distal end side, there are provided a distal end portion 23 not provided with the stiffness imparting body 5, a main body portion 22 provided with the stiffness imparting body 5, and a side hole forming portion 15 located at an end of the main body portion 22. In the side hole forming part 15,
A large number of side holes 4 are formed, and a linear body 11 constituting the stiffener 5 is continuous inside the opening of the side hole 4 without being cut.

By providing the stiffness imparting member 5, it is possible to prevent the catheter 20 from being bent at the main body 22 and to further enhance the torque transmission of the catheter. Therefore, the provision of the rigidity imparting member 5 prevents the catheter main body from being bent at the bending portion, and furthermore, a force (for example, a pushing force) applied at the proximal end of the catheter.
Is reliably transmitted to the tip 23. Furthermore, since the linear members 11 constituting the rigidity imparting member 5 are continuous without being cut inside the opening of the side hole 4, there is no sudden change in physical properties at the side hole portion. Since the kink is prevented and the rigidity imparting body 5 is not broken at the side hole, the force applied at the proximal end of the catheter to the distal end side from the side hole can be reliably transmitted. Further, since the discharged contrast agent is dispersed by the stiffness imparting member 5 located at the opening of the side hole, the dispersibility of the contrast agent is improved, and good contrast can be achieved. Further, the contrast agent flow (contrast agent jet) discharged from one side hole 4 is weakened by colliding with the stiffness imparting body 5, so that the irritation of the living tissue by the contrast agent flow is also weak.

In the catheter 20, the main body 22 of the catheter tube is formed by an inner layer 46 forming the lumen 8 penetrating from the base end to the distal end, and an outer layer 47 covering the inner layer 46. The inner layer 46 of the main body 22 has the stiffness imparting body 5.

The material for forming the inner layer 46 is preferably a material having a certain degree of flexibility. For example, polyolefins such as polyethylene, polypropylene and ethylene-vinyl acetate copolymer, or polyolefin-based elastomers thereof, polyamide-based resins (for example, nylon) 1
1, nylon 12, nylon 6), polyester-based polyamide resin (for example, product name: GREAK manufactured by DIC), polyether-based polyamide resin (for example, product name: Pebax, manufactured by Atochem), paraoxybenzoic ethylhexyl Polyamide elastomer, polyurethane, A, which has been softened by a plasticizer such as (POBO)
BS resin, fluorine resin (PFA, PTFE, ETFE
Or a synthetic resin such as a soft fluorine resin, a polyimide, a shape memory resin, or a polymer blend or a polymer alloy (for example, a polymer alloy of a polyamide elastomer and a polyurethane) containing these. Further, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate, tungsten powder) or the like may be mixed into these materials. The thickness of the inner layer 46 is 0.0
It is 5 to 0.3 mm, preferably 0.08 to 0.23 mm. Further, the inner layer 46 is provided with a stiffness imparting body 5 extending from the base end to the axial end side.

As shown in FIG. 4, the stiffness imparting member 5 is preferably formed in a mesh shape by a linear member 11 composed of a plurality of metal wires. Further, the stiffness imparting body 5 is buried in the outer surface or the thickness of the resin forming the inner layer 46. In particular, in the one shown in FIG.
Is buried in the outer wall of the inner layer 46 by heating the inner layer 46 wound around the stiffener 5 from the outside (for example, inserting the inner layer 46 through a heating die). Let me.

As the linear body 11 forming the stiffness imparting member 5, a metal wire is suitable, for example, a stainless steel wire or an amorphous alloy wire is preferable. As the amorphous alloy wire, an iron-silicon-boron alloy, Cobalt-silicon-boron alloy, iron-cobalt-chromium-molybdenum-
An amorphous alloy wire formed using a silicon-boron alloy or the like can be suitably used. The amorphous alloy wire has an amorphous structure formed by extruding the above-described metal into a line and rapidly cooling the formed amorphous alloy wire. The diameter is reduced by passing through a die. The amorphous alloy wire has a high tensile strength, a wide elastic deformation region, and is excellent in heat resistance, corrosion resistance, and fatigue resistance. For amorphous alloy wire, wire diameter 5 ~
30 μm, more preferably 10 to 20 μm, is suitable. In addition, as a stainless wire, a wire diameter of 20 to 80 μm
m, more preferably 30 to 70 μm, especially 40 to 5 μm.
0 μm is preferred. Further, a plurality of, for example, 3 to 7 metal wires (for example, an amorphous alloy wire or a stainless steel wire) having a wire diameter of 1 to 10 μm, more preferably 2 to 5 μm are twisted to form a single linear body of 10 to 20 μm. 11 may be used.

Further, the linear body 11 has a spiral shape, and its pitch is preferably about 0.3 to 1.0 mm. The pitch is uniform as a whole as shown in FIG. 3, and furthermore, as compared with the stiffener 5a at the distal end of the main body 22, like the catheter 30 shown in FIG. The stiffness imparting body 5b of the portion may have a longer pitch. By doing so, the rigidity of the other parts can be made higher than the end of the main body 22. In this case, it is preferable that the pitch of the stiffening member 5b at the other part of the main body 22 is 1.1 to 2.5 times the pitch of the stiffening member 5a at the end of the main body 22.

The linear member 11 constituting the rigidity imparting member 5
Is preferably coated with a biocompatible metal. Examples of the biocompatible metal include gold, silver, platinum, and titanium. As a method of coating the surface of the linear body 11 with a metal, gold plating using an electroplating method,
Stainless steel plating using an evaporation method, silicon carbide using a sputtering method, titanium nitride plating, gold plating, and the like can be considered.

The outer layer 47 is, as shown in FIG.
To form the outer surface of the catheter 20. Outer layer 4
As the forming material of No. 7, a material having adhesiveness to the inner layer forming material is preferable, and a material which is the same or similar to the resin used for forming the inner layer is preferable. For example, thermoplastic resins such as polyethylene, polypropylene, polyolefin using ethylene-propylene copolymer, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, polyurethane, silicone rubber, latex rubber and the like can be used. Preferably, it is a polyamide elastomer or polyurethane softened by a plasticizer such as paraoxybenzoic ethylhexyl (POBO), and furthermore, in these materials, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate, tungsten powder) However, in order to make the outer surface of the catheter smooth, it is necessary not to mix the radiopaque substance in the outer layer 47 but to mix the radiopaque substance only in the inner layer 46. Is preferred.

The outer diameter of the catheter body 22 is 1.0 to 4.0 mm, more preferably 1.3 to 4.0 mm.
3.5 mm, and the outer diameter of the tip 23 is 0.9 to 0.9 mm.
It is 3.6 mm, more preferably 1.2 to 3.0 mm.

At the distal end of the main body 22 of the catheter, there is a side hole forming portion 15, and a plurality of side hole forming portions 15 are arranged so as to be dispersed throughout the side hole forming portion 15 (this embodiment). (Six in the figures) are provided so as to form a spiral arrangement. For this reason, the side holes 4 are provided so as to be substantially evenly distributed over the entire side hole forming portion 15.

The area of the side hole 4 is preferably 0.8 mm ² or less. Hole diameter of side hole 4 (average hole diameter)
Is preferably about 0.06 to 1.0 mm, and particularly preferably about 0.1 to 0.9 mm. Further, the maximum length of the side hole is longer than the wire diameter of the linear body 11, so that the side hole is not closed by the linear body. Specifically, when the side hole 4 is circular, the diameter of the side hole 4 is preferably larger than the diameter of the linear body 11 of the rigidity imparting body 5, and particularly preferably about 4 to 20 times. In addition, the side hole 4 may not be a perfect circle, for example, an ellipse or an ellipse long in the axial direction of the catheter, a square, a rectangle,
It may be a polygon such as a rhombus, a triangle, or a pentagon. The number of side holes is preferably about 1 to 1080. Side hole forming part 15
Is preferably about 5 to 80 mm, more preferably about 10 to 45 mm.

The linear members 11 constituting the rigidity imparting member 5 are continuous inside the openings of the side holes 4 without being cut. For this reason, there is no sudden change in physical properties at the side hole, kink is prevented at the side hole, and there is no disconnection of the stiffness imparting body 5 at the side hole. The force applied at the base end can be reliably transmitted.

Further, the side hole 4 is provided with an amount Q1 of the contrast agent ejected from the distal end opening 36 during one injection of the contrast agent, and
The side hole flow rate = Q2 / (Q1 + Q2), which is the ratio to the total weight Q2 of the contrast agent ejected from each side hole 4, is 0.25 to 0.25.
Preferably, it is formed to be 0.8. In particular, the side hole flow rate ratio is preferably from 0.3 to 0.8, more preferably from 0.5 to 0.75, and most preferably from 0.6 to 0.75. In addition, the above numerical value is a viscosity of 10.6 c. p. This is the value when the contrast agent (37 ° C.) is injected from the rear end of the catheter 20 under the conditions of the total injection flow rate: 36 ml, the pressure: 1000 psi, and the flow rate: 12 ml / sec.

Further, in this embodiment, the linear members 11 constituting the stiffening member 5 intersect inside the opening of the side hole 4. In other words, the side hole 4 is provided at a portion where the linear bodies 11 constituting the rigidity imparting body 5 intersect. By doing so, the strength reduction at the side hole portion can be further reduced. The distal end portion 23 is preferably flexible, and therefore, the rigidity imparting body 5 is not provided on the distal end portion 23.

In the above description, the inner layer and the outer layer have a two-layer structure. However, the present invention is not limited to this. The inner layer, the intermediate layer and the outer layer have a three-layer structure.
It may be formed integrally with synthetic resin.

Further, the tip portion 23 having the curved deformation portion 32
Is preferably more flexible than the main body 22. In this case, as a material for forming the distal end portion 23, the main body 2
A softer material, that is, a material having higher flexibility, is selected from the forming material of No. 2. In addition, in order to facilitate connection with the main body portion 22 and increase bonding strength, it is preferable that the resin forming the distal end portion 23 and the resin forming the main body portion 22 have good compatibility. Good compatibility
It indicates that thermodynamic mutual solubility is good, in other words, it indicates that there is no separation between the two after curing.

As a combination of resins, it is desirable that both resins have the same system. For example, a nylon 12 or a polyether polyamide block copolymer is selected as a material for forming the main body 22, and a polyether polyamide block copolymer having higher flexibility than the polyether polyamide block copolymer as a material for forming the tip portion 23. And a polyamide-based resin for both, and a polyolefin-based elastomer (for example, polyethylene elastomer) as a material for forming the main body 22.
Is selected, and a polyolefin-based elastomer (for example, polyethylene elastomer) having higher flexibility than the polyolefin-based elastomer is selected as a material for forming the tip portion 23, and both are made of a polyolefin-based resin. The main body 22 is formed of a polyester-based elastomer (for example, a soft-segment having a soft segment and a hard segment and the soft-segment having the soft segment portion). Part 23
(A polyester elastomer less than the forming material of the main body portion 22).
Selecting a plasticized vinyl chloride resin as a material for forming the tip portion 23, selecting a highly plasticized vinyl chloride resin having higher flexibility than the plasticized vinyl chloride resin as a material for forming the tip portion 23, and using both as a vinyl chloride resin. It is conceivable that polyurethane is selected as a material for forming the distal end portion 23, a polymer alloy of polyamide elastomer and polyurethane is selected as a material for forming the main body portion 22, and both are made of polyurethane.

Further, the catheter 20 has a distal end 23,
An outer layer covering the whole of the main body 22 and the side hole forming portion 15 may be provided. As a material for forming the outer layer, a material having adhesiveness to the material for forming the tip portion and the material for forming the main body is preferable. Specifically, the same or similar materials as those forming materials are preferable. For example, thermoplastic resins such as polyethylene, polypropylene, polyolefin using ethylene-propylene copolymer, polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, polyurethane, silicone rubber, latex rubber and the like can be used. Preferably, a polyamide elastomer or polyurethane softened by a plasticizer such as paraoxybenzoic ethylhexyl (POBO) can be used. Then, in order to make the outer surface of the catheter 20 smooth, it is preferable not to mix an X-ray opaque substance in the outer layer.

Further, the outer surface of the catheter tube 21 may be coated with a resin having biocompatibility, in particular, antithrombotic property. For example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) can be used. In particular, when a material in which an X-ray opaque substance is mixed is used for the outer layer 47, it is preferable to perform the above coating in order to eliminate the roughness of the outer surface due to the X-ray opaque substance. It is preferable that the material used for forming the outer layer 47 be thinly coated.

Inside the catheter 20, there is formed a lumen 8 extending from the rear end to the front end and serving as a flow path for a liquid such as a contrast medium. The lumen 8 opens at the distal end of the catheter 20 and forms a distal opening 36. Note that a guide wire (not shown) is inserted into the lumen 8 when the catheter 20 is inserted into a living body or the like. In the catheter 20 of this embodiment, the distal end opening 36 formed at the distal end of the curved deformation portion 32 is
Is substantially parallel to the lumen 8 of the main body 22 and faces the distal end of the catheter 20. For this reason, the curved deformation portion 3
If the shape of 2 is maintained as it is, the contrast agent is discharged from the distal end opening 36 so as to be substantially parallel to the lumen 8 (axis) of the catheter 20.

The outer diameter of the catheter 20 is not particularly limited, but is usually preferably about 0.8 to 3.0 mm, and
It is more preferably about 0 to 2.5 mm. The thickness of the catheter 20 is not particularly limited, but is usually 0.1 to
About 0.7 mm is preferable, and about 0.15 to 0.5 mm is more preferable. Radius (curvature radius) of the curved deformation part 32
Is preferably about 3.0 to 15 mm, particularly preferably 3.0 to 8.0 mm.

The side hole 4 of the catheter 20 is
2 is formed at a position closer to the rear end of the catheter 20 than the rearmost position. In other words, the side hole 4 is formed at a position where the tangent line X drawn from the rearmost end position of the curved deformation portion 32 is the same as the position crossing the catheter tube 21 or at the rear end side. In addition, the side hole 4 has a rear end side of about 0 to 10 mm from a position where a tangent line X drawn from the rearmost end position of the curved deformation portion 32 crosses the catheter tube 21,
Preferably 1 to 10 mm, particularly preferably 1 to 8 m
It is preferable that it is formed by a portion on the m rear end side.

The distal end opening formed at the distal end of the curved deformation portion is inclined at a predetermined angle with respect to the axial direction of the main body portion 22 (in other words, the side hole forming portion 15) of the catheter tube and faces the distal direction. It may be something. That is, the perpendicular drawn from the center of the opening surface of the tip opening 36 is the side hole forming portion 1.
5 may be crossed diagonally forward.
In this case, if the curved deformed part maintains the shape as it is, the contrast agent flows from the distal end opening to the lumen (axis) of the catheter.
Is discharged diagonally forward.

A hub 19 made of a hard synthetic resin (for example, polycarbonate, polypropylene, nylon) is attached to the proximal end of the catheter tube 21. The hub 19 has a rear end to which a contrast agent injector (for example, a syringe) can be attached.

The side hole 4 is preferably formed by laser processing because the side hole 4 is easy to form, excellent in shape, and excellent in dimensional accuracy. Among laser processing, processing using a laser whose oscillation wavelength is in the ultraviolet region is particularly preferable. In particular, the excimer laser as described above is preferable. By using such a laser,
The side hole can be formed without cutting the linear body 11 forming the rigidity imparting body 5.

The form of the catheter is not limited to the one described above, and may be, for example, a catheter 40 shown in FIGS. 6 and 7. The difference between this catheter and the catheter shown in FIGS. 3 and 4 is that
Only the position of the tip end of the stiffness imparting member 5 is the same as that described above in other respects.

In the catheter 40, the stiffener 5
Does not reach the tip of the side hole forming portion 15, and the stiffness imparting body 5 does not exist in the side hole portion of the tip side portion of the side hole forming portion 15. For this reason, this catheter is
The end portion of the second end portion has a portion where the stiffness imparting member 5 does not exist, and a side hole 14 formed in that portion. Thus, by providing a portion provided with the side hole 14 without the rigidity imparting member 5 at the most distal end of the main body 22, a more flexible portion is formed at the most distal end of the main body 22 than other main body portions. As a result, the change in the physical properties at the boundary between the flexible distal end portion 23 and the main body portion 22 becomes gradual, and the kink between them becomes less.

Further, as in the catheter shown in FIG.
The end portion of the main body 22 at the outermost end where the stiffener 5 does not exist may be provided with a large number of side holes 14a having a smaller opening area than the side holes 4 of the portion provided with the stiffener 5. By doing so, the above-described kink suppressing action is further enhanced, and the dispersibility of the contrast agent is further improved. The area of the side hole 14a formed at the foremost end of the end of the main body 22 is 0.003 mm ^{2 to} 0.1 mm.
It is preferable to set it to about 3 mm ² . In particular, 0.008m
It is preferably set to m ² ~0.28mm ^2, more preferably 0.05mm ² ~0.25mm ^2. Further, the hole diameter (average hole diameter) of the side holes is preferably about 0.06 to 0.6 mm, and is 0.1 to 0.5 mm.
It is preferable to set the thickness to about 0.2 to 0.5 mm. The distance (average distance) between the side holes is preferably about 0.3 to 10 mm, and more preferably about 0.5 to 8.0 mm.

Next, the catheter 50 of the present invention shown in FIGS. 9 and 10 will be described using an embodiment shown in the drawings. The catheter 50 has a catheter tube 51 having a lumen 58 and an opening 56 communicating with the lumen 58. The catheter tube 51 includes an inner layer 66 and an inner layer 6.
The body 52 and the stiffener 5 provided with the outer layer 67 covering the inner layer 6 and the stiffener 5 extending in the axial direction formed by the linear body 11 and provided between the inner layer 66 or the inner layer 66 and the outer layer 67 are not provided. A tip portion 53;
6 is a deformable portion 55 having a slit 54. Then, the linear body 11 constituting the stiffness imparting body 5 is continuous at the slit 54 without being cut. In particular, in the catheter 50, the stiffness imparting body 5 is provided in the inner layer 66, and the linear body 11 constituting the stiffness imparting body 5 is continuous inside the slit 54 without being cut.

Since the main body 52 has the slit 54 at the distal end, the distal end of the inner layer 66 can be bent more flexibly. Therefore, the difference between the physical properties of the inner layer 66 and the physical properties of the outer layer 67 is reduced, so that separation of the two and displacement of the two do not occur, thereby improving the operability of the catheter. Further, the stiffener 5 at the slit portion
, The force applied at the base end of the tube to the distal end side of the deformable portion, which is the slit forming portion, can be reliably transmitted.

The catheter of the present invention is used as an intravascular insertion catheter such as a catheter for cardiac or cerebral angiography, a catheter for administering drugs to the heart or cerebral blood vessels, and the like.

The catheter 50 of this embodiment is an embodiment in which the catheter of the present invention is applied to a cerebral intravascular drug administration catheter. The catheter 50 has a main body 52 and a distal end 53, and further has a lumen 58 and a distal opening 56 that are continuous from the proximal end to the distal end of the catheter 50.

The main body 52 comprises an inner layer 66, an outer layer 67 covering the outer and inner surfaces of the inner layer 66, and the stiffener 5 provided on the inner layer. The tip 53 is formed by fixing a tip forming member made of a synthetic resin to the tip of the main body 52.

As the material of the inner layer 66 and the outer layer 67,
Inner layer 16 and outer layer 1 in catheter 50 described above
The same thing as 7 can be used suitably. And the inner layer 66
Has an outer diameter of 0.4 mm to 1.0 mm, preferably 0.5
mm to 0.8 mm, a wall thickness of 50 μm to 200 μm, preferably 80 μm to 150 μm, and a length of 50 μm to 50 μm.
0 mm to 4000 mm, more preferably 1000 mm to
3000 mm.

As shown in FIG. 10, which is an enlarged cross-sectional view of the distal end portion in FIG. 9, the inner layer 66 is provided with a stiffness imparting member 5 extending in the axial direction from the base end toward the distal end. As shown in FIG. 10, the stiffness imparting body 5 is preferably formed in a mesh shape by a linear body 11 composed of a plurality of metal wires. Further, the stiffness imparting body 5 is buried in the outer surface or the thickness of the resin forming the inner layer 66. In particular, FIG.
The inner layer 66 is formed of a thermoplastic resin, and the inner layer 66 around which the stiffness imparting body 5 is wound is heated from the outside (for example, the inner layer 66 is inserted into a heating die) to form an outer wall of the inner layer 66. The stiffness imparting body 5 is buried.

As the linear body 11 forming the stiffness imparting member 5, a metal wire is suitable, for example, a stainless steel wire, an amorphous alloy wire or the like is preferable. As the amorphous alloy wire, an iron-silicon-boron alloy, Cobalt-silicon-boron alloy, iron-cobalt-chromium-molybdenum-
An amorphous alloy wire formed using a silicon-boron alloy or the like can be suitably used. The amorphous alloy wire has an amorphous structure formed by extruding the above-described metal into a line and rapidly cooling the formed amorphous alloy wire. The diameter is reduced by passing through a die. The amorphous alloy wire has a high tensile strength, a wide elastic deformation region, and is excellent in heat resistance, corrosion resistance, and fatigue resistance. For amorphous alloy wire, wire diameter 5 ~
30 μm, more preferably 10 to 20 μm, is suitable. In addition, as a stainless wire, a wire diameter of 20 to 80 μm
m, more preferably 30 to 70 μm, especially 40 to 5 μm.
0 μm is preferred. Further, a plurality of, for example, 3 to 7 metal wires (for example, an amorphous alloy wire or a stainless steel wire) having a wire diameter of 1 to 10 μm, more preferably 2 to 5 μm are twisted to form a single linear body of 10 to 20 μm. 11 may be used.

Further, the linear body 11 has a spiral shape, and the pitch thereof is preferably about 0.3 to 1.0 mm. Further, the pitch may be uniform as a whole, and the pitch of the stiffening body in the other part of the main body may be longer than that of the stiffening body at the end of the main body. By doing so, the rigidity of the other part of the main body 52 can be made higher than the end of the main body 52. The pitch of the stiffener in the other part of the body 52 is 1.1
It is preferable that it be twice to 2.5 times.

The linear member 11 constituting the rigidity imparting member 5
Is preferably coated with a biocompatible metal. Examples of the biocompatible metal include gold, silver, platinum, and titanium. As a method of coating the surface of the linear body 11 with a metal, gold plating using an electroplating method,
Stainless steel plating using an evaporation method, silicon carbide using a sputtering method, titanium nitride plating, gold plating, and the like can be considered.

Further, as shown in FIG. 10, the tip of the inner layer 66 has a deformable portion 5 having a spiral slit 54.
5, and the linear body 11 constituting the stiffening body 5 is continuous inside the slit 54 without being cut. The number of slits is not limited to one spiral, and may be two or more.

The length of the portion where the slit is provided from the tip of the inner layer 66 is determined in consideration of the length of the catheter and the like. The length of the portion where the slit is provided from the tip of the inner layer 66 is preferably about 100 mm to 1000 mm, and more preferably 150 mm to 500 mm.

Since the width of the slit 54 is determined in consideration of the diameter of the inner layer and the like, it is not uniform. The width of the slit is preferably about 0.1 mm to 1.5 mm,
More preferably, it is 0.5 mm to 1.0 mm. The width of the slit is 1/3 to 1/1 of the outer diameter of the inner layer 66.
The degree is preferred. In the above range, the inner layer 66 is sufficiently flexible and the inner layer 66 does not break during use. Also,
The pitch of the slits 54 is preferably about 0.5 mm to 2.0 mm, particularly preferably 0.5 mm to 1.0 mm when the entire pitch is the same. Within the above range, the inner layer 66 is sufficiently flexible and does not break during use. The length of the portion where the slit is provided from the tip of the inner layer 66 is determined in consideration of the length of the catheter and the like. The length of the portion where the slit is provided from the tip of the inner layer 66 is preferably about 100 mm to 1000 mm, and more preferably 150 mm to 500 mm.

Then, the spiral slit 54 is formed as shown in FIG.
As shown in FIG. 6, the width of the slit 54 is spiral at the distal end and narrow at the proximal end. In particular, in this embodiment, the width of the slit is intermediate between the distal end portion and the proximal end portion. Also,
The width of the slit may be gradually reduced from the distal end toward the proximal end. By doing so, the distal end portion becomes gradually softer, so that the distal end portion of the inner layer 66 has a more natural curvature, and the operability of the catheter is further improved. In such a case, the width of the slit 54 is preferably about 1.0 mm to 2.0 mm at the distal end, and preferably 0.1 mm to 0.5 mm at the proximal end. Also, the width of the slit is ２〜 of the outer diameter of the inner layer 66.
About twice is preferable. In the above range, the inner layer 66 is sufficiently flexible and the inner layer 66 does not break during use.

The pitch of the slits 54 may be the same as the whole pitch, may be longer at the base end than at the front end, or may be shorter at the front end and gradually increased toward the base end. May be. By doing so, the distal end portion becomes gradually softer, so that the distal end portion of the inner layer 66 has a more natural curvature, and the operability of the catheter is further improved. Thus, the slit 54
When the pitch changes, at the tip, 0.5 mm
About 3 mm, and about 5 to 10 mm at the base end. In particular, it is preferable that the intermediate portion between the distal end portion and the proximal end portion has an intermediate pitch between them or the pitch is gradually changed.

The slit 54 is preferably formed by laser processing from the viewpoint of ease of formation, shape and dimensional accuracy. Among laser processing, processing using a laser whose oscillation wavelength is in the ultraviolet region is particularly preferable. In particular, the excimer laser as described above is preferable. By using such a laser, the slit 54 can be formed without cutting the linear body 11 forming the rigidity imparting body 5.

Then, in the slit 54 of the inner layer 66,
Part of the resin material forming the outer layer 67 has not flowed in,
That is, the slit 54 is a gap. If the resin material does not flow into the slit 54, the deformation of the inner layer 66 is not hindered.

In the catheter 50 of this embodiment, the distal end 53 is formed by fixing a distal end forming member 59 made of a synthetic resin to the distal end of the outer layer 67 of the main body 52. Instead of using the tip forming member, the tip 53 may be formed integrally with the outer layer 67 by projecting the outer layer 67 covering the inner layer 66.

Examples of the synthetic resin used for the tip forming member 59 include polyolefin (eg, polyethylene and polypropylene) and polyolefin elastomer (eg, polyethylene elastomer, polypropylene elastomer, elastomer using ethylene-propylene copolymer, etc.). And polyvinyl chloride, ethylene-vinyl acetate copolymer, polyamide elastomer, polyurethane, thermoplastic resin such as fluororesin, silicone rubber, etc., preferably polyethylene, polyamide elastomer or polyurethane.

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

Then, the inner layer 66 and the tip forming member 59
It is preferable to knead a fine powder X-ray opaque substance made of a single metal or a compound such as Ba, W, Bi, etc. in the synthetic resin to form a catheter. The entire position can be easily confirmed.
As the thickness of the outer layer 67 in a portion covered by the inner layer 66,
It is 5-300 μm, preferably 10-200 μm.

The outer diameter of the catheter main body 52 is
0.9 to 7.0 mm, preferably 1.0 to 6.0 mm
It is about. The outer diameter of the tip 53 is 0.4 to 1.0 m
m, preferably about 0.5 mm to 0.8 mm.

Further, the outer surface of the catheter tube 51 may be coated with a resin having biocompatibility, in particular, antithrombotic property. For example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) can be used. In particular, when a synthetic resin tube is made of a material mixed with an X-ray opaque substance,
In order to eliminate the roughness of the outer surface due to the radiopaque substance, it is preferable to perform the above-mentioned coating, and it is preferable that the material is a biocompatible resin, but even if the material used for forming the synthetic resin tube is thinly coated. Good.

Further, when the outer surface of the catheter tube 51 comes into contact with a liquid such as blood, it is preferable to perform a hydrophilizing treatment which exhibits lubricity. Examples of such a hydrophilic treatment include, for example, hydrophilicity such as poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropylcellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, and polyvinylpyrrolidone. Examples of the method include a method of coating a polymer. The hub 9 is fixed to the proximal end of the main body of the catheter 50.

The shape of the slit is not limited to the spiral shape described above, and a plurality of slits may be provided substantially in parallel with the central axis of the inner layer 66 and at substantially equal intervals. By providing such a plurality of slits, the distal end becomes flexible, so that the distal end of the inner layer 66 is more naturally curved, and the operability of the catheter is further improved. In this case, the width of the slit is not uniform since it is determined in consideration of the diameter of the inner layer and the like. The width of the slit is preferably about 0.1 mm to 0.5 mm. The number of slits is preferably 2 to 12. In the above range, the inner layer 6 is sufficiently flexible and used when used.
6 does not break. The length of the slit is 100mm
About 1000 mm, more preferably about 15 mm.
0 mm to 500 mm.

Next, the catheter 60 shown in FIG. 11 will be described. The catheter 60 includes a lumen 58 and
The catheter tube 51 includes an opening 56 communicating with a lumen 58. The catheter tube 51 includes an inner layer 66, an outer layer 67 covering the inner layer 66, and a linear body provided between the inner layer 66 or the inner layer 66 and the outer layer 67. 11, a main body 52 having an axially extending stiffening body 5 formed by 11 and a tip section 53 having no stiffening body 5;
Further, the tip of the inner layer 66 is a deformable portion 55 having a side hole 64. Then, the linear body 11 constituting the rigidity imparting body 5 is continuous at the side hole 64 without being cut. In particular, in the catheter 60, the stiffness imparting body 5 is provided in the inner layer 66, and the linear body 11 constituting the stiffness imparting body 5 is continuous inside the side hole 64 without being cut.

The basic structure of the catheter 60 is the same as that shown in FIGS. 9 and 10, and the same parts are denoted by the same reference numerals. A catheter 60 of this embodiment;
The only difference from the catheter 50 described above is the shape of the distal end of the inner layer 66.

At the tip of the inner layer 66, a number of pores 64 are provided instead of the slits, and the linear body 11 constituting the stiffener 5 is not cut inside the pores 64. It is continuous.

By providing such a large number of pores 64, the distal end of the inner layer 66 can be bent more flexibly. Since the distal end portion of the inner layer 66 is made flexible as described above, the difference between the physical properties of the inner layer 66 and the physical properties of the outer layer 67 and the distal end forming member 59 is reduced. No longer occurs. Therefore, the operability of the catheter is improved. Further, the stiffener 5 at the side hole portion
Therefore, the force applied at the base end of the tube to the distal end side from the deformable portion, which is the side hole forming portion, can be reliably transmitted.

The pore diameter of the pores 64 is determined by the number of pores to be provided,
Since it is determined in consideration of the outer diameter of the inner layer 66 and the like, it is not uniform. Further, the maximum length of the pore 64 is larger than the wire diameter of the linear body 11, so that the pore 64 is not closed by the linear body. Specifically, when the pores 64 are circular, the diameter thereof is preferably larger than the diameter of the linear body 11 of the rigidity imparting body 5, and particularly preferably about 4 to 20 times. Further, the shape of the pores 64 does not need to be a perfect circle but an ellipse, for example, the inner layer 66.
May be elongated in the circumferential direction or axial direction, and may be a polygon (for example, a quadrangle or a pentagon). The area of one pore is preferably about 0.007 to 0.13 mm ² , and the distance between the pores is preferably about 0.1 to 0.5 mm. The hole diameter of the side hole is 0.1 mm to 0.4 m
m, more preferably 0.2 mm to 0.1 mm.
3 mm. The hole diameter is 1/10 to 1 of the outer diameter of the inner layer 66.
/ 3 is preferable.

The length of the portion where the pores 64 are provided from the tip of the inner layer 66 is determined in consideration of the length of the catheter and the like. The length of the portion where the pores 64 are provided from the tip of the inner layer 66 is preferably about 100 mm to 1000 mm, and more preferably 150 mm to 500 mm.

As shown in FIG. 11, the pore 64 preferably has a larger area at the distal end of the inner layer 66 and a smaller area at the proximal end. By doing so, the distal end becomes flexible, so that there is no sudden change in physical properties, the distal end of the inner layer 66 is naturally curved, and the operability of the catheter is further improved.

Further, the number of pores may be gradually increased from the base end toward the distal end. Also in this case, the distal end portion is gradually softened, so that the distal end portion of the inner layer 66 is more naturally curved, and the operability of the catheter is further improved. As described above, when the pore distribution changes, the distance between the pores at the distal end is about 0.1 to 0.2 mm, and the distance at the proximal end is 0.3 to 0.2 mm.
It is preferable that the distance between the pores is about the middle or between the two, or gradually changes in the middle part between the front end part and the base end part.

The method of forming the pores 64 is preferably formed by laser processing, because of its ease of formation, excellent shape and dimensional accuracy. Among laser processing, processing using a laser whose oscillation wavelength is in the ultraviolet region is particularly preferable. In particular, the excimer laser as described above is preferable. By using such a laser, the pores 64 can be formed without cutting the linear body 11 forming the rigidity imparting body 5.

Then, a part of the resin material forming the outer layer 67 does not flow into the pores 64 of the inner layer 66, and the pores 64 are voids. If the resin material does not flow into the pores, the deformation of the inner layer 66 is not hindered.

The formation of the slits 54 and the pores 64 in the inner layer 66 can be performed by the above-described laser processing (for example, YAG laser), electric discharge processing, chemical etching, cutting processing, and the like, and further, in combination. it can.

Next, the medical tube of the present invention will be described. The medical tube 70 of the present invention has a lumen 75.
, A distal end opening 78 communicating with the lumen 75, a body 71 a extending in the axial direction and including the rigidity imparting body 5 formed by the linear body 11, and a side hole 74 communicating with the lumen 75. At least one of the holes is located at the end of the main body 71a, and the stiffener 5
Are continuous without being cut.

Therefore, a description will be given using an embodiment in which the medical tube of the present invention is applied to an endotracheal tube. FIG.
1 is a front view of an embodiment of the endotracheal tube of the present invention, FIG.
FIG. 3 is an enlarged sectional view of a distal end portion of the endotracheal tube shown in FIG. The endotracheal tube 70 includes a tube main body 71 having a lumen 75 therein, an expandable / contractible cuff 72 provided so as to annularly surround a part of the outer peripheral surface near the distal end portion of the tube main body 71, And the inflation lumen 80 of the cuff 72 provided in parallel with the lumen 75 of the tube body 71, and the cuff 72 is formed of a soft resin.

The tube main body 71 is formed of a flexible synthetic resin, and has a lumen 75 penetrating from the distal end to the proximal end for introducing an anesthetic gas, oxygen gas, and the like. As shown in FIGS. 12 and 13, the distal end of the tube main body 71 is used to facilitate insertion into the body.
It is formed in a smooth bevel shape. The other end is provided with a connector 73 for connecting to a gas supply device.

The tube main body 71 extends in the axial direction and has a main body 71a having an inner layer provided with a rigidity-imparting body formed of a linear body and an outer layer covering the inner layer, and a tip end 71b having no rigidity-imparting body. And The main body 71a
It comprises an inner layer 81, an outer layer 82 covering the outer and inner surfaces of the inner layer 81, and a stiffener 5 provided on the inner layer. The distal end portion 71b does not include the rigidity imparting member, and is formed by an inner layer 81 and an outer layer 82 that covers the outer surface of the inner layer 81. The present invention is not limited to this, and the tip may be provided with a tip forming agent formed of a flexible material.

As the material of the inner layer 81 and the outer layer 82, the same materials as the inner layer 16 and the outer layer 17 in the catheter 1 described above can be suitably used. The body of the tube body 71 is provided with the stiffness imparting member 5 composed of the linear body 11 as described above.
Is provided. Further, a side hole 74 is formed at the tip of the main body of the tube main body 71, and the side hole 7 is formed.
Inside the opening 4, a linear body 11 constituting the rigidity imparting body 5 is continuous without being cut. For this reason, there is no sudden change in physical properties at the side holes, kink is prevented at the side holes, and there is no disconnection of the rigidity imparting body 5 at the side holes. The force applied at the proximal end of the tube can be reliably transmitted.

As shown in FIG. 13 which is an enlarged sectional view of the distal end portion in FIG. 12, the inner layer 81 is provided with a rigidity imparting member 5 extending in the axial direction except for the distal end portion from the base end portion. As shown in FIG. 13, the stiffness imparting body 5 is preferably formed in a mesh shape by a linear body 11 composed of a plurality of metal wires. In this embodiment, the stiffness imparting member 5 includes an inner layer 81.
And buried in the outer surface or thickness of the resin forming the inner layer. However, the present invention is not limited to this, and the stiffness imparting body may be provided between the inner layer and the outer layer. In particular, in what is shown in FIG. 13, the inner layer 81 is formed of a thermoplastic resin, and the inner layer 81 around which the stiffness imparting body 5 is wound is heated from the outside (for example, the inner layer 81 is inserted into a heating die). The rigidity imparting body 5 is buried in the outer wall of the inner layer 81.

As the linear body 11 forming the stiffness imparting body 5, a metal wire is suitable, for example, a stainless steel wire, an amorphous alloy wire or the like is preferable. As the amorphous alloy wire, an iron-silicon-boron alloy, Cobalt-silicon-boron alloy, iron-cobalt-chromium-molybdenum-
An amorphous alloy wire formed using a silicon-boron alloy or the like can be suitably used. The amorphous alloy wire has an amorphous structure formed by extruding the above-described metal into a line and rapidly cooling the formed amorphous alloy wire. The diameter is reduced by passing through a die. The amorphous alloy wire has a high tensile strength, a wide elastic deformation region, and is excellent in heat resistance, corrosion resistance, and fatigue resistance. For amorphous alloy wire, wire diameter 5 ~
1 mm, more preferably 30 to 0.8 mm is suitable. In addition, as a stainless wire, a wire diameter of 20 μm to 1 m
m, more preferably 30 to 0.8 mm.
Further, the wire diameter is 1 to 10 μm, more preferably 2 to 5 μm.
m (for example, amorphous alloy wire, stainless steel wire), for example, 3 to 7 wires are twisted, and 10 to 20 μm
The single linear member 11 may be used.

Further, the linear body 11 has a spiral shape, and its pitch is preferably about 0.3 to 10 mm.
Further, the pitch may be uniform as a whole, and the pitch of the stiffening body in the other part of the main body may be longer than that of the stiffening body at the end of the main body.
By doing so, the rigidity of the other part of the main body 71a can be made higher than the end of the main body 71a. In this case, it is preferable that the pitch of the stiffeners at the other part of the main body 71a is 1.1 to 2.5 times the pitch of the stiffeners at the end of the main body 71a.

The linear member 11 constituting the rigidity imparting member 5
Is preferably coated with a biocompatible metal. Examples of the biocompatible metal include gold, silver, platinum, and titanium. As a method of coating the surface of the linear body 11 with a metal, gold plating using an electroplating method,
Stainless steel plating using an evaporation method, silicon carbide using a sputtering method, titanium nitride plating, gold plating, and the like can be considered.

Further, a side hole 74 (so-called “Muffy eye”) for preventing airway obstruction is formed at the distal end (the distal end side from the cuff) of the main body of the endotracheal tube 70 as shown in FIGS. ing. The side hole 74 communicates with the lumen 75. Then, the linear body 11 constituting the stiffness imparting body 5 is continuous without being cut inside the side hole 74. Therefore, there is no sudden change in physical properties in the side hole portion, and kink in the side hole portion is prevented,
Since there is no disconnection of the stiffening member 5 at the side hole portion, the force applied at the base end of the tube to the end of the stiffening member can be reliably transmitted.

The side hole 74 has an area of 4 to 65 mm.
It is preferably about ² . Further, the length of the maximum length of the side hole 74 is larger than the wire diameter of the linear body 11, so that the side hole is not closed by the linear body. Specifically, when the side hole 74 is circular, the diameter is larger than the wire diameter of the linear body 11 of the rigidity imparting body 5,
In particular, it is preferably about 8 to 20 times. Also,
The side hole 4 may not be a perfect circle, and may be, for example, an ellipse or an ellipse long in the axial direction of the catheter, a polygon such as a square, a rectangle, a rhombus, a triangle, and a pentagon. Further, two or more side holes may be provided.

The side hole 74 is preferably formed by laser processing because of its ease of formation, excellent shape and excellent dimensional accuracy. Among laser processing, processing using a laser whose oscillation wavelength is in the ultraviolet region is particularly preferable. In particular, the excimer laser as described above is preferable. By using such a laser, the side hole 74 can be formed without cutting the linear body 11 forming the rigidity imparting body 5.

As shown in FIG. 13, an inflation lumen 80 thinner than the lumen 75 is provided on the inner wall forming the tube main body 71 along the axial direction of the lumen 75 of the tube main body 71. The inflation lumen 80 is closed near the center of the cuff. And this inflation lumen 80
Communicates with the internal space of the cuff 72 via a side hole 79 on the outer surface of the tube wall of the tube body 71. The inflation lumen 80 further communicates with the inflation tube 77 via a notch on the outer surface of the tube wall of the tube body 71 at a position near the base end as shown in FIG.

The connection between the inflation tube 77 and the inflation lumen 80 can be achieved by, for example, inserting a preheated mandrel into the inflation lumen, removing the mandrel and simultaneously inserting and fixing the connector into the inflation lumen. In addition, it is performed by a method using an adhesive or the like.

At the rear end of the inflation tube, there is provided a pilot balloon 76 for recognizing the degree of inflation of the cuff. Further, at the rear end of the inflation tube 77, the inside thereof is always closed. An adapter 85 having a check valve is provided.
The adapter 85 can be fitted with a gas injector (e.g., a syringe) for inflating the cuff, and the non-return valve housed inside is released when the gas injector is attached. It is supposed to.

A cuff 72 is provided in the vicinity of the distal end of the tube body 71 so as to expand and contract so as to surround the outer peripheral surface thereof in a ring shape. The cuff 72 is formed of a soft resin, for example, a soft fluororesin or a mixture of a soft fluororesin and a thermoplastic resin.

[0114]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, specific embodiments of the present invention will be described in detail. Example 1 A continuous alloy having a wire diameter of 1.08 mm was coated with a barium sulfate powder added to a polymer alloy of a polyamide elastomer and a polyurethane, and the outer diameter was 1.25 m.
m, a tube having an inner diameter of 1.08 mm was prepared. A metal wire (stainless steel wire, two wire diameters of 40 μm) of which a stiffness imparting body is formed on the outer periphery of the tube is 33
The pitch was 0.45 mm from the part on the rear end side of 16 mm and 16 nets were wound. Next, the tube around which the rigidity-imparting body is wound except for the tip portion is inserted into a heating die, and the rigidity-imparting body is buried in the outer periphery of the tube, and barium sulfate powder is coated on the outer surface with a polyamide alloy of polyurethane and a polymer alloy of polyurethane. A tube having an outer diameter of 1.4 mm and an inner diameter of 1.08 mm was prepared by coating the added material, and a tube obtained by cutting this tube by about 1100 mm was used as a catheter tube. A nylon hub was fixed to the rear end of the catheter tube manufactured as described above. From the position 38 mm proximal from the distal end of the catheter tube, the area is set to 0.
Six side holes of 78 mm ² (circle having a diameter of about 1 mm) were spirally provided. The side holes are formed by using a K of 248 nm in oscillation wavelength.
rF excimer laser (power density 0.
5 kW / cm ² , irradiation time per hole per side 2.3 sec)
By laser processing. The laser processing did not cause ablation of the linear body, the linear body was present in the side hole, and the linear body in the side hole was exposed.

Comparative Example 1 A body-side tube having an outer diameter of 1.4 mm and an inner diameter of 0.93 mm was prepared by adding a barium sulfate powder to a polymer alloy of a polyamide elastomer and a polyurethane, and a rigid portion having a length of 70 mm was provided at the tip. A catheter was prepared in the same manner as in Example 1 except that the one provided with the imparting body non-formed portion was used, and all side holes were provided in the rigidity imparting body non-formed portion.

Example 2 The distal tube portion of the catheter of Example 1 was heated to produce a loop-shaped curved portion having a radius of curvature of about 6 mm, and a catheter for angiography having a shape as shown in FIG. Was prepared. The side hole is formed on the rear end side from a position where the tangent line X drawn from the rearmost end position of the curved deforming portion is 3 mm rear end side from the position crossing the catheter tube, and the opening at the catheter tip is formed at the end of the catheter. It was almost parallel to the lumen of the main body and facing the distal end of the catheter.

Comparative Example 2 The distal tube portion of the catheter of Comparative Example 1 was heated to produce a loop-shaped curved portion having a radius of curvature of about 6 mm, thereby producing a catheter for angiography. In addition, the side hole is 3 mm from the position where the tangent line X drawn from the rearmost end position of the curved deformation section crosses the catheter tube.
It was formed on the rear end side from the position on the rear end side, and the opening at the distal end of the catheter was almost parallel to the lumen of the main body of the catheter and was directed toward the distal end of the catheter.

(Experiment 1) The breaking strength of the side hole forming portion in the catheters of Example 1 and Comparative Example 1, the resistance when a guide wire was inserted into the catheter, and the flow rate of the contrast agent flowing out of the catheter were measured. The results are shown in Table 1.
As shown in FIG. In the experiment, the contrast agent [viscosity 10.6
c. p. (37 ° C)] Total flow: 36 ml, pressure:
This was performed by injecting from the back end of the catheter at 1000 psi.

[0119]

[Table 1]

(Experiment 2) Using the catheters of Example 2 and Comparative Example 2, experiments were conducted on the dispersibility of the contrast agent and the side hole flow rate ratio. The results were as shown in Table 2. In the experiment, the contrast agent [viscosity 10.6 c. p. (37 ° C.)] was injected from the back end of the catheter under the conditions of a total injection flow rate of 36 ml, a pressure of 1000 psi, and a flow rate of 9 m1 / sec. The dispersibility test of the contrast agent was carried out in the same conditions as described above, with the red ink added to the contrast agent, in a water tank, and the state of dispersion was visually determined. Further, the side hole flow rate ratio is obtained by measuring the amount Q1 of the contrast agent ejected from the front end opening and the total weight Q2 of the contrast agent ejected from each side hole, and calculates the formula Q2 / (Q1 + Q2).
It is a value obtained from the above.

[0121]

[Table 2]

[0122]

According to the catheter of the present invention, there is provided a lumen, a distal end opening communicating with the lumen, a body portion extending in the axial direction and having a rigidity imparting body formed of a linear body, and a side communicating with the lumen. And a catheter tube having a hole, at least one of the side holes is located at a distal end of the main body, and a linear body constituting the stiffener is cut inside the opening of the side hole. It is continuous without being.

As a result, there is no sudden change in physical properties at the side hole portion, kink is prevented at the side hole portion, and there is no disconnection of the rigidity imparting member at the side hole portion. The applied force can be reliably transmitted to the end of the stiffener without being absorbed by the side hole forming portion.

The catheter of the present invention has a catheter tube having a lumen and an opening communicating with the lumen. The catheter tube has an inner layer, an outer layer covering the inner layer, the inner layer, or the inner layer and the outer layer. A body provided with a stiffening member extending in the axial direction formed by a linear member, and a tip not provided with a stiffening member, and further, the tip of the inner layer has a slit or a large number of It is a deformable portion having pores, and the linear body constituting the stiffness imparting body in the slit or the pore portion is continuous without being cut.

As a result, the difference between the physical properties of the inner layer and the outer layer is reduced, the separation of the two layers and the displacement of the two layers do not occur, the operability of the catheter is improved, and the end portion of the rigidity-imparting body is improved. Since kink is prevented and there is no disconnection of the stiffening body at the slit or the pore, the force applied at the proximal end of the catheter is not absorbed by the slit or the pore forming portion, and the distal end of the stiffening body is not absorbed. Can be reliably transmitted.

Further, the medical tube of the present invention comprises a lumen, a distal end opening communicating with the lumen, a main body extending in the axial direction and having a rigidity-imparting body formed of a linear body, and communicating with the lumen. And at least one of the side holes is located at an end of the main body, and a linear body constituting the stiffening member is cut inside the opening of the side hole. It is continuous without.

As a result, there is no sudden change in physical properties at the side hole portion, kink is prevented at the side hole portion, and there is no disconnection of the rigidity imparting member 5 at the side hole portion. Can be reliably transmitted to the end of the rigidity imparting body without being absorbed by the side holes.

[Brief description of the drawings]

FIG. 1 is a partially omitted front view of an embodiment of the catheter of the present invention.

FIG. 2 is an enlarged sectional view of a distal end portion of the catheter shown in FIG.

FIG. 3 is a partially omitted front view of another embodiment of the catheter of the present invention.

FIG. 4 is an enlarged sectional view of a distal end portion of the catheter shown in FIG. 3;

FIG. 5 is a partially omitted front view of another embodiment of the catheter of the present invention.

FIG. 6 is a partially omitted front view of another embodiment of the catheter of the present invention.

FIG. 7 is an enlarged sectional view of a distal end portion of the catheter shown in FIG. 6;

FIG. 8 is an enlarged sectional view of a distal end portion of another embodiment of the catheter of the present invention.

FIG. 9 is a partially omitted front view of another embodiment of the catheter of the present invention.

FIG. 10 is an enlarged sectional view of a distal end portion of the catheter shown in FIG. 9;

FIG. 11 is an enlarged sectional view of a distal end portion of another embodiment of the catheter of the present invention.

FIG. 12 is a front view of an embodiment of the medical tube of the present invention.

FIG. 13 is an enlarged sectional view of the distal end portion of the medical tube shown in FIG.

[Explanation of symbols]

 Reference Signs List 1 catheter 2 main body 3 distal end 4 side hole 5 rigidity imparting body 6 distal opening 8 lumen 9 hub 11 linear body 10 catheter tube

Claims (19)

[Claims] 1. A catheter tube having a lumen, a distal end opening communicating with the lumen, a body portion extending in the axial direction and having a rigidity-imparting body formed of a linear body, and a side hole communicating with the lumen. At least one of the side holes is located at an end of the main body, and a linear body constituting the stiffness imparting body is continuously cut inside the opening of the side hole without being cut. Catheter. 2. The catheter according to claim 1, wherein the catheter tube has a distal end that does not include the stiffener. 3. The catheter according to claim 1, wherein two or more side holes are provided. 4. The catheter according to claim 1, wherein a side hole is also formed at a distal end portion not provided with the rigidity imparting body. 5. The catheter according to claim 1, wherein a distal end portion of the catheter is a curved deformation portion curved in a loop shape. 6. The catheter according to claim 1, wherein the side hole is formed by laser processing. 7. A catheter tube having a lumen and an opening communicating with the lumen, wherein the catheter tube is provided with an inner layer, an outer layer covering the inner layer, and a wire provided between the inner layer or the inner layer and the outer layer. A body provided with a stiffness imparting body extending in the axial direction formed by the body;
A tip portion without a stiffness imparting body, and further, the tip portion of the inner layer is a deformable portion having a slit or a large number of pores, and the stiffness imparting portion of the slit or the pore portion is provided. A catheter, wherein a linear body constituting the body is continuous without being cut. 8. The catheter according to claim 7, wherein the slit is a spiral slit. 9. The catheter according to claim 7, wherein the slit or the pore is formed by laser processing. 10. The linear body is a metal wire.
10. The catheter according to any one of claims 9 to 9. 11. The catheter according to claim 1, wherein the rigidity-imparting body is formed in a mesh shape by a plurality of linear bodies. 12. The catheter according to claim 1, wherein the rigidity imparting body is buried in the thickness of the catheter tube except for the slit or the pore portion. 13. A body having a lumen, a distal end opening communicating with the lumen, a body extending in the axial direction and having a rigidity-imparting body formed by a linear body, and a side hole communicating with the lumen. At least one of the side holes is located at an end of the main body, and a linear body constituting the stiffness imparting body is continuous without being cut inside the opening of the side hole. And medical tubing. 14. The medical tube according to claim 13, wherein the medical tube has a distal end that does not include the rigidity imparting body. 15. The catheter according to claim 13, wherein the side hole is formed by laser processing. 16. The linear body is a metal wire.
16. The medical tube according to any one of items 3 to 15. 17. The medical tube according to claim 13, wherein the rigidity imparting body is formed in a mesh shape by a plurality of linear bodies. 18. The medical tube according to claim 13, wherein the rigidity-imparting body is buried in an outer surface or a thickness of the medical tube except for the side hole. 19. The medical tube according to claim 13, wherein the medical tube is an endotracheal tube.