JPH01121064A - Catheter - Google Patents

Abstract

PURPOSE:To improve transmission property of torque by a method wherein a rigidity imparting body made of metal wires is composed of amorphous alloy wires. CONSTITUTION:A catheter 1 is composed of an inside tube 5 having a rigidity imparting body 3 comprising amorphous alloy wires extending in the axial direction, and an outside tube 6 which forms the tip part projecting from the inside tube 5, and covers the outside face of the inside tube 5; the catheter 1 has a lumen 2 penetrating its inside. The rigidity imparting body 3 is embedded in the outer face of the resin which forms the inside tube 5, or in the thickness thereof; the inside tube 5 is formed of a thermoplastic resin, the rigidity imparting body 3 is embedded in the outside wall of the inside tube 5 by heating from outside the inside tube 5 around which a rigidity imparting body is wound around. Amorphous alloy wires to be used as the rigidity imparting body 3 is formed of an iron-silicon-boron alloy, a cobalt-silicon-boron alloy etc. No bending nor crush occurs in the catheter, a good transmitting property of torque may be improved in it.

Description

DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to catheters such as body cavity insertion catheters, endotracheal tubes, blood vessel insertion catheters, for example, angiography catheters.

[Prior Art] Conventionally, catheters such as endotracheal tubes inserted into and left in the body, particularly body cavities, such as the trachea, Thoracic catheters, Trotzker catheters, and drain tubes inserted into and left in the thoracic cavity and abdominal cavity, have been used. A thick catheter was used to prevent bending or crushing. However, due to the need for minimally invasive catheters to reduce the pain caused by puncturing into the body or body cavities, and in order to efficiently drain body fluids and inject medical solutions efficiently, the lumen area is wide. In addition, in order to form a thin-walled catheter with a small outer diameter and to have the necessary strength, a catheter made of a thermoplastic resin having a certain degree of rigidity is sometimes used. In that case, on the other hand, due to the rigidity of the resin forming the catheter, there was a possibility of damaging the tissue at the indwelling site after puncturing.

Therefore, catheters used for the above purposes, as well as angiography catheters and vascular dilation catheters that are inserted into blood vessels, are made of a somewhat soft thermoplastic resin. A rigidity imparting body made of metal wire (-stainless steel wire for boat fishing) is provided around the outer periphery of the body to maintain a high degree of flexibility (2. It also suppresses bending and crushing, and also improves torque transmission. Catheters with improved performance can now be considered.

Furthermore, in the case of vascular dilation catheters, the Grüntig type and the Shinbson-Robert type have conventionally been used as catheters with dilating bodies for dilating intravascular stenoses. The above-mentioned Grüntig type has an expander attached near the tip of a catheter tube that has two lumens, one of the two lumens is a passage for the guide wire and tip pressure measurement released at the tip, and the other is the expander. This is a flow path that communicates with the expansion body on the wall end side and injects a vascular contrast agent or the like under pressure to inflate the expansion body. and,
The catheter is made of flexible synthetic resin.

Also, what is called the Simon-Robert type,
It has a coaxial double structure consisting of an inner tube that forms a first lumen with an open tip, and an outer tube that forms a second lumen between the inner tube and has an expansion body attached to the tip. A very thin metal pipe is installed in the second lumen to remove air bubbles. In this type of catheter,
Similar to the Grüntig type catheter mentioned above, the catheter is made of flexible synthetic resin.

[Problems to be Solved by the Invention] However, in the catheter having the above-mentioned stiffening body made of metal wire,
Until now, when advancing the catheter, the outer diameter of the catheter had to be made thinner while maintaining a constant inner diameter, and the catheter had to be made thinner. Constituent metal wires (e.g.
(Stainless steel wire) Must be thinner than B. However, it is not easy to reduce the diameter of general metal wires (e.g., stainless steel wires), and furthermore, when processing them into smaller diameters, an annealing process is frequently performed, and as a result, the created metal wire has the problem that it is soft and has reduced mechanical properties such as tensile strength and bending rigidity, and a stiffening body using a metal wire with such reduced mechanical properties may cause the catheter to be bent or crushed. In addition, there is a high risk that the metal wire will break inside the catheter, so it is necessary to provide a stiffening body made of a metal wire that is not very thin. Therefore, it was not possible to make the catheter sufficiently thin. Also,
The Grüntig type and Shinbson-Ropart type catheters described above are made of flexible synthetic resin so that they can be inserted into blood vessels. However, since it is made of flexible synthetic resin, it can be inserted into blood vessels and is less likely to cause damage to the blood vessel wall, but due to its flexibility, there is a risk that the catheter may bend during blood vessel insertion, and the tip of the catheter When delicately moving or rotating the catheter, the proximal end of the catheter is moved or rotated to transmit the torque to the tip. Due to its nature, it is absorbed, and it has the disadvantage that it is difficult to transmit to the tip, making it difficult to operate finely.

In order to compensate for these drawbacks, a metal wire (for example, a stainless wire ), we investigated a catheter equipped with a stiffening body. However, common metal wires (especially stainless steel wires) are often subjected to an annealing process when processed into small diameters, and as a result, the produced metal wires are soft and have poor mechanical properties such as tensile strength and bending rigidity. There is a problem that properties deteriorate, and with a stiffening body using a metal wire with such reduced mechanical properties, it is difficult to prevent the catheter from bending or being crushed, and to maintain torque transmittance. In addition, there is a high risk that the metal wire will break inside the catheter. Therefore, it is necessary to provide a rigidity imparting body made of metal wire that is not very thin. Therefore, it is necessary to make the catheter sufficiently thin. I couldn't do it.

SUMMARY OF THE INVENTION Therefore, an object of the present invention is to solve the above-mentioned problems of the prior art, to suppress bending or crushing of the catheter even if a stiffening body made of a sufficiently thin metal wire is used, and to improve torque transmittance. The purpose of the present invention is to provide a catheter that can be maintained or improved, and that can be made sufficiently thin by using a thin metal wire.

[Means for Solving the Problems] What achieves the above object is a catheter having a lumen inside and a stiffening body made of a metal wire extending in the axial direction, the stiffening body made of the metal wire. is a catheter made of amorphous alloy wire.

Furthermore, it is preferable that the rigidity imparting body is formed into a mesh shape using the amorphous metal wire. The amorphous alloy may be an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, or an iron-silicon-boron alloy.
Preferably, it is a cobalt-chromium-molybdenum-silicon-boron amorphous alloy.

Furthermore, it is preferable that the rigidity imparting body made of the amorphous alloy wire is embedded in the outer surface or inside of the catheter.

Furthermore, the distal end portion of the catheter may be formed with a portion that does not have a stiffening body made of the amorphous alloy wire. Further, the outer surface of the catheter may be coated with a synthetic resin. Further, the catheter is, for example, a catheter inserted into a blood vessel.

Furthermore, what solves the above problems includes an inner tube having a first lumen with an open tip, and a first lumen provided coaxially with the inner tube and located at a position set back a predetermined distance from the tip of the inner tube. an outer tube forming a second lumen between the outer tube and the outer surface of the inner tube; and a distal end and a proximal end, the proximal end being attached to the outer tube, and the distal end being attached to the outer tube. a collapsible or collapsible expander attached to the inner tube and communicating with a second lumen near the proximal end; and a collapsible expander attached to the inner tube and communicating with the first lumen at the proximal end of the inner tube a first opening that communicates with the second lumen provided at the proximal end of the outer tube, and a second opening that communicates with the second lumen provided at the proximal end of the outer tube; This is a catheter with an expandable body having a rigidity imparting body made of an amorphous alloy wire extending in the direction.

Furthermore, it is preferable that the rigidity imparting body is formed into a mesh shape using the amorphous metal wire. Further, it is preferable that the first opening and the second opening are provided in a branch hub attached to the proximal ends of the inner tube and the outer tube. Further, the stiffening body made of the amorphous alloy wire is provided, for example, in the inner tube. Further, the rigidity imparting body made of the amorphous alloy wire is provided, for example, in the outer tube. Furthermore, the stiffening body made of the amorphous alloy wire may be provided in both the inner tube and the outer tube. Furthermore, it is preferable that the stiffening body made of the amorphous alloy wire is embedded in the inner tube or the outer tube.

Furthermore, it is preferable that the rigidity imparting body made of the amorphous alloy wire is embedded in the outer surface or inside of the inner tube or the outer tube. Furthermore, it is preferable that the amorphous alloy is an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, or an iron-cobalt-chromium-molybdenum silicon-boron amorphous alloy.

The catheter of the present invention will be explained using embodiments shown in the drawings.

The catheter 1 of the present invention has a lumen 2 therein, and further has a stiffening body 3 made of an amorphous alloy wire extending in the axial direction.

Therefore, the present invention will be explained with reference to FIG. 1, which shows a partial cross-sectional view of an embodiment applied to an angiography catheter.

The catheter 1 of this embodiment includes an inner tube 5 having a stiffening body 3 made of an amorphous alloy wire extending in the axial direction, and a distal end portion protruding from the distal end of the inner tube 5 as a portion not having the stiffening body. and an outer tube 6 that covers the outer surface of the inner tube 5. The inside of the catheter 1 has a lumen 2 that penetrates from its proximal end to its distal end.

The material for forming the inner tube 5 is preferably one having a certain degree of flexibility, such as polyolefin elastomer using polyethylene, polypropylene, ethylene-propylene copolymer, etc., polyvinyl chloride, ethylene-vinyl acetate copolymer, etc. 1. Thermoplastic resins such as polyamide elastomer and polyurethane, silicone rubber, latex rubber, etc. can be used, preferably polyamide elastomer or polyurethane made flexible with a plasticizer such as roseoxybenzoic ethylhexyl (POBO), and further, An X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate), etc. may be mixed into these materials.

Further, the inner tube 5 is provided with a rigidity imparting body 3 made of an amorphous alloy wire extending in the axial direction. The rigidity imparting body 3 is formed into a mesh shape using a plurality of amorphous alloy wires.

This rigidity imparting body 3 is for preventing the catheter body from bending at the bending portion and further increasing the torque performance of the catheter body.

Therefore, by providing this stiffening body 3, it is possible to prevent the catheter body from bending at the bending part, and further, when the catheter body is rotated at the proximal end of the catheter body, the rotation is reliably transmitted to the distal end. Something happens.

Furthermore, this rigidity imparting body 3 is buried in the outer surface or thickness of the resin forming the inner tube 5. In particular, in the one shown in FIG. 1, the inner tube 5 is formed of a thermoplastic resin, and The stiffener 3 is embedded in the outer wall of the inner tube 5 by heating the inner tube 5 around which the stiffener is wound from the outside (for example, by inserting the inner tube 5 through a heating die). The stiffening body 3 is preferably mesh-shaped, and the amorphous alloy wire used is iron-silicon-boron alloy, cobalt-silicon-boron alloy, iron-cobalt-
An amorphous alloy wire formed using a chromium-molybdenum-silicon-boron alloy or the like can be suitably used.

Amorphous alloy wire has an amorphous structure formed by extruding the above-mentioned metal into a linear shape and rapidly cooling it. The diameter is reduced by passing it through a die. Amorphous alloy wire has high tensile strength, wide elastic deformation range, and excellent heat resistance, corrosion resistance, and fatigue resistance.

Stainless steel wire, which has been conventionally used as a rigidity imparting body to impart rigidity to catheters, does not easily break when wrapped around the outer surface of the catheter, and the wound rigidity imparting body does not bend or bend the catheter. In order to prevent this and ensure sufficient torque transmission, it was necessary to use stainless steel wire with a wire diameter of 50 μm or more. The stiffening body is preferably embedded in the resin that forms the catheter, and therefore, the wall thickness of the portion having the stiffening body that forms the catheter is at least twice the diameter of the stainless steel wire. It was necessary. On the other hand, when an amorphous alloy wire is used, it does not easily break when wrapped around the outer surface of the catheter, and the stiffening body that is wrapped around it prevents the catheter from bending and provides sufficient torque transmission performance. In order to achieve this, the purpose can be achieved if the wire diameter is about 20 μm, and by using an amorphous alloy wire, the wall thickness of the inner tube 5 can be made thinner, and the inner diameter can be reduced. It is possible to measure the expansion of

The amorphous alloy wire has a wire diameter of 5 to 30 μm, more preferably 10 to 20 μm, and a wire diameter of 1 to 1
A plurality of pieces of 0μ order, more preferably 2 to 5μ,
For example, it is preferable to twist 3 to 7 strands to form one linear body with a shoulder length of lθ to 20μ.

Moreover, the wall thickness of the inner tube 5 is 0.03 to 0.25 mm, preferably 0.05 to 0.2 x m.

The outer tube 6 does not have the rigidity imparting body 3 and consists of a distal end portion that protrudes from the distal end of the inner tube 5 and a covering portion that covers the outer surface of the inner tube 5. The outer diameter of the tip portion is smaller than that of the other portions. The material for forming the outer tube 6 is preferably one that has adhesive properties with the inner tube 5, and is preferably the same as or similar to the resin used to form the inner tube 5.

For example, polyolefins using polyethylene, polypropylene, ethylene-propylene copolymers, etc., polyvinyl chloride, ethylene-vinyl acetate copolymers, polyamide elastomers, thermoplastic resins such as polyurethane, silicone rubber, latex rubber, etc. can be used. Preferably, it is a polyamide elastomer or polyurethane made flexible by a plasticizer such as paraoxybenzoic ethylhexyl (POBO), and further, an X-ray opaque substance (for example, barium sulfate, bismuth subcarbonate), etc. is mixed into these materials. However, in order to make the outer surface of the catheter smooth, it is preferable that the outer tube 6 is not mixed with the X-ray opaque material, and only the inner tube 5 is mixed with the X-ray opaque material. preferable. Furthermore, by selecting a material that is more flexible than the material for forming the inner tube 5, the tip of the catheter l becomes flexible, reducing damage to living tissue during insertion into the body and further during indwelling. Can be done. Furthermore, the outside of the outer tube 6 may be coated with a resin having biocompatibility, particularly antithrombotic properties, such as polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA −
9t-H'EMA block copolymer), etc. can be used. In particular, when the outer tube 6 is made of a material mixed with an X-ray opaque substance, it is preferable to perform the above-mentioned coating to eliminate the roughness of the outer surface caused by the X-ray opaque substance. Although it is preferable that the material used for forming the outer tube 6 be thinly coated, it may be used.

The outer diameter of the portion including the inner tube 5 and outer tube 6 is 1.0 to 4.0txx, more preferably 1.3 to 4.0txx.
3.5*x, and the outer diameter of the tip of the outer tube 6 is 0.
9-3.6xm, more preferably 1.2-3. Oxx
Note that the outer diameter of the distal end of the outer tube may be substantially the same as the overall outer diameter of the catheter. The inner diameter of the tip portion is preferably substantially the same as the inner diameter of the inner tube 5.

Angiography catheter l according to the embodiment of the present invention shown in FIG.
The basic configuration is the same as that shown in Fig. 1, and the difference is that the distal end of the catheter 1 is a curved part, and this curved part has a shape suitable for the target blood vessel into which it is inserted. It has a shape.

In the above explanation, an angiography catheter was used, but the catheter of the present invention is not limited to this, and the catheter of the present invention can be used to continuously inject a medicinal solution into an endotracheal tube, a thoracic catheter, a trotzker catheter, a drain tube, or a blood vessel. It can be used for catheters such as catheters for intravascular indwelling.

Next, a catheter with an expandable body of the present invention will be explained using an embodiment shown in the drawings.

FIG. 3 is an enlarged sectional view of the distal end of an embodiment of the catheter with expandable body of the present invention, and FIG. 4 is a drawing showing the proximal end of the catheter.

A catheter with an expandable body 10 of the present invention includes an inner tube 11 having a first lumen 14 with an open tip, and is provided coaxially with the inner tube 11 and positioned at a position set back from the tip of the inner tube 11 by a predetermined length. an outer tube 12 which is provided and forms a second lumen I6 between it and the outer surface of the inner tube 11; a distal end 17 and a proximal end 18; the proximal end 18 is attached to the outer tube 12; a collapsible or collapsible expander 13 attached to the inner tube 11 and communicating with the second lumen 16 near the proximal end;
a first opening 19 communicating with the lumen 14 of the outer tube 1;
At least one of the inner tube 11 and the outer tube 22 has a rigid tube made of an amorphous alloy wire extending in the axial direction. It has an application body 23.

This will be explained below using the drawings.

In the embodiment of the catheter with expandable body of the present invention shown in FIG. 3, the catheter IO of the present invention is formed by an inner tube 11, an outer tube 12, an expandable body 13, and a branch hub 30.

FIG. 5 shows a cross-sectional view of the inner tube 11 of the vasodilator catheter 10 of the present invention shown in FIG. 3, and the inner tube 11 has a first lumen 14 with an open end. The first lumen I4 is a lumen for inserting the guidewire, and communicates with a first opening 19 forming a guidewire boat provided in the branch hub 30, which will be described later.

The inner tube 11 has an outer diameter of 0.40 to 1.60xz, preferably 0.50 to IJOim, and an inner diameter of 0.25
~1.50xa.

Preferably 0°30-1. LOmm.

The distal end of the inner tube 11 is preferably tapered in diameter toward the distal end. This is because it becomes easier to insert the catheter into the blood vessel. The material for forming the inner tube 11 is preferably one that has some degree of flexibility.
For example, polyolefins such as polyethylene, polypropylene, and ethylene-propylene copolymers, thermoplastic resins such as polyvinyl chloride, ethylene-vinyl acetate copolymers, polyamide elastomers, and polyurethanes, silicone rubbers, and latex rubbers can be used, and are preferably used. The above-mentioned thermoplastic resin is preferred, and polyolefin is more preferred.

The outer tube 12 has the inner tube 11 inserted therein, and its distal end is provided at a position slightly retracted from the distal end of the inner tube. As shown in FIG. 6, which is a sectional view taken along line A'-A in FIG. 3, a second lumen 16 is formed by the inner surface of the outer tube 12 and the outer surface of the inner tube 11.

Therefore, the lumen can have a sufficient volume. The second lumen 16 communicates with the inside of the expandable body 13 at its distal end, and the rear end of the second lumen 16 allows fluid (for example, angiographic contrast agent) to inflate the expandable body. It communicates with the second opening 21 of the branch hub 30 forming an injection boat for injection.

The material for forming the outer tube 12 is preferably one that has some degree of flexibility, such as polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyvinyl chloride, ethylene-vinyl acetate copolymer, and polyamide elastomer. , thermoplastic resins such as polyurethane, silicone rubber, latex rubber, etc. can be used.
Preferably, the above-mentioned thermoplastic resin is used, and polyolefin is more preferable.

Further, the outer tube 12 is provided with a rigidity imparting body 23 made of an amorphous alloy wire. Then, the rigidity imparting body 2
3 is formed into a mesh shape by a plurality of amorphous alloy wires. Rigidity imparting body 2 made of amorphous alloy wire
3 is for preventing the catheter body from bending at the bending portion and further increasing the torque performance of the catheter body. Therefore, by providing this rigidity imparting body 23, it is possible to prevent the catheter body from bending at the bending part, and furthermore, when the catheter body is rotated at the proximal end of the catheter body, the rotation is reliably transmitted to the distal end. Furthermore, the ability to follow high-grade stenosis in blood vessels can be improved.

The stiffening body 23 is preferably mesh-shaped, and the amorphous alloy wire described above can be suitably used. The amorphous alloy wire used for the outer tube 12 has a wire diameter of 5 to 45 μm, more preferably,
A plurality of wires with a diameter of 10 to 40μ, more preferably 5 to 30μ, more preferably 10 to 20μ, for example '3~
It is preferable that seven strands are twisted to form one linear body with a shoulder size of 15 to 60 μm.

The wall thickness of the outer tube 12 is 0.05 to 0.75 mm, preferably 0.1 to 0.3 mm.

The rigidity-imparting body 3 can be formed by winding the above-mentioned amorphous alloy wire around the outer tube 12 in a mesh shape, and more preferably, the outer tube 12 is formed of a thermoplastic resin, and the above-mentioned rigidity-imparting body is wound around the outer tube 12. It is preferable to embed the stiffening body 23 in the outer wall of the outer tube 12 by heating the outer tube 12 from the outside (for example, by inserting the outer tube 12 through a heating die). FIG. 6 is a sectional view taken along the line A--A of the catheter with expandable body shown in FIG. 3, and shows that the outer tube 12 is provided with a stiffening body 23. Furthermore, the outer surface of the outer tube 12 is coated with a synthetic resin coating 28.
By providing this coating 28, the rigidity imparting body 23 made of the amorphous alloy wire can be improved.
can be prevented from being exposed to the outside, and the occurrence of blood clots can be reduced. As the synthetic resin used for forming this coating 28, the synthetic resin used for forming the outer tube 12, etc. can be used, and more preferably, a resin having biocompatibility, particularly antithrombotic properties, may be used. for example,
Polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (e.g.
HEMA-S t-HEMA block copolymer) and the like can be suitably used.

The outer tube 12 has an outer diameter of 0.60 to 2.001 m, preferably 0.80 to 1.60 m, and an inner diameter of 0.5 m.
0-1.90ff foot, preferably 0.60-140xx
In particular, the difference between the outer diameter of the inner tube 11 and the inner diameter of the outer tube 12 is 0. lO~0.20xx.

Preferably it is 0.15 to 1.20 liters.

Further, instead of providing a rigidity imparting body on the outer tube 12 as in the catheter shown in FIG. 3, a rigidity imparting body may be provided on the inner tube 11. By providing a rigidity imparting body in the inner tube 11, it is possible to prevent the catheter body from bending at the bending part, and furthermore, it is possible to increase the torque performance of the catheter body, and it is possible to rotate the catheter body at the proximal end of the catheter body. The rotation can be reliably transmitted to the distal end, and the ability to follow high-grade stenosis in the blood vessel can be improved.

Further, the rigidity imparting body 23 may be provided on both the inner tube 11 and the outer tube 12.

The expandable body 13 can be contracted or folded, and can be folded around the outer periphery of the inner tube 11 when it is not expanded. The expander 13 is foldable and has a substantially cylindrical portion 13a with substantially the same diameter, at least a portion of which is substantially cylindrical so that a narrowed portion of a blood vessel can be easily dilated. The above-mentioned substantially cylindrical portion does not need to be a perfect cylinder, and may be in the shape of a polygonal column. The proximal end 18 of the expandable body 13 is liquid-tightly fixed to the distal end of the outer tube 12 by adhesive or heat fusion, and the distal end 17 is fixed to the distal end of the inner tube 1 in a liquid-tight manner. tightly attached. This expansion body 13 forms an expansion space 25 between the inner surface of the expansion body 13 and the outer surface of the inner tube 11, as shown in FIG. 7, which is a sectional view taken along line CC in FIG. This expansion space 25 communicates with the second lumen 16 around its entire circumference at the rear end. In this way, since the second lumen having a relatively large volume is communicated with the rear end of the expansion body 13, it is easy to inject the inflation fluid into the expansion body 13 from the second lumen. The material for forming the expansion body 13 is preferably one having a certain degree of flexibility, such as polyolefins such as polyethylene, polypropylene, ethylene-propylene copolymer, polyvinyl chloride, ethylene-vinyl acetate copolymer,
Thermoplastic resins such as cross-linked ethylene-vinyl acetate copolymers, polyamide elastomers, polyurethanes, silicone rubbers, latex rubbers, etc. can be used, and the above-mentioned thermoplastic resins are preferable, and cross-linked ethylene-vinyl acetate copolymers are more preferable. It is a copolymer.

Furthermore, the expansion body 13 has fixed portions 17 with the inner tube 11 and the outer tube 12 described above at the front and rear of the cylindrical portion 13a.
．． The portion up to 18 is tapered. The size of the expansion body 3 is such that the outer diameter of the cylindrical portion when expanded is 1.50 to 35. Oh+m, preferably 2.
00~ao, oo shoulder length, length 10.00~80
．． 0 (lux, preferably 15.00 to 75.001 m
The total length of the extension body 3 is 15.00 to 120.
00ux, preferably 20.00 to 100.00 order.

Also, the outer surface of the inner tube 11 and the position near the rear end side of the part where the expansion body 13 is fixed to the inner tube 11, and the position between the expansion body 13 and the outer tube 1
The position is near the distal side of the fixed part with the expansion body 13.
Preferably, markers 24 made of an X-ray opaque material (for example, gold, platinum, or an alloy thereof) are provided at both ends of the cylindrical portion 13a. This is to enable easy confirmation of the position of the expansion body 13 under X-ray fluoroscopy. As for the form of the marker 24, it is preferable that a ring made of the above-mentioned metal be caulked to the outer surface of the inner tube l. This is because a clear X-ray contrast image can be obtained.

Furthermore, in the catheter with an expandable body of the present invention, in order to facilitate insertion into a blood vessel or into a guide catheter described below, a portion that may come into contact with blood during use is provided.
That is, it is preferable to perform a hydrophilic treatment on the outer surface of the outer tube 12 and the outer surface of the expansion body 13 so that they exhibit lubricity when they come into contact with blood or the like. Such hydrophilic treatment includes, for example, poly(2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, polyvinylpyrrolidone, etc. Examples include a method of coating a polymer.

The branch hub 30 has a first opening 19 that communicates with the first lumen 14 to form a guide wire boat, and communicates with an inner tube hub 32 fixed to the inner tube 11 and a second lumen for injection. Second opening 2 forming a boat
1 and an outer tube hub 33 fixed to the outer tube 12. And these two members are fixed.

The material for forming this branch hub is polycarbonate,
Thermoplastic resins such as polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used.

Alternatively, the branch hub may not be provided, and a tube having a boat member having an opening at its rear end, for example, may be fluid-tightly attached to each of the first lumen and the second lumen.

[Function] Next, using the expandable catheter according to the embodiment of the present invention shown in FIGS. 3 through 7, and referring to FIGS. Explain the action.

It is preferable to remove as much air as possible from the catheter with an expandable body before performing dilation treatment for a stenosis created in a blood vessel. Therefore, the force of the present invention≠−the second opening 2 of the chill
Attach a suction and injection means such as a syringe to 1, fill the syringe with a liquid (such as a vascular contrast agent), and repeat suction and injection to remove the air in the second lumen and the expansion body and replace it with liquid. .

To insert a catheter with an expandable body, first, a blood vessel is secured in the human body using the Seldingo method, etc., and then a guide wire for the guide catheter (not shown) is placed in the blood vessel.
Insert the guide catheter into the blood vessel along it, and
As shown in the figure, a guide catheter 40 is placed in a coronary artery population 42 having a target lesion, and the guide wire for the guide catheter is removed. As shown in FIG. 8, the expandable body catheter 10 of the present invention, through which the expandable body catheter guide wire 44 is inserted, is inserted through the Y-shaped connector 60 provided at the rear end of the guide catheter 40, and the expandable body catheter 10 of the present invention is inserted through the expandable body catheter guide wire 44. The catheter guide wire 44 for the expandable catheter is inserted into the blood vessel with the guide wire 44 protruding several centimeters from the distal end of the catheter 10. The expandable catheter 10 advances within the guide catheter 40, and as shown in FIG.
and then insert the expandable catheter guide wire 4.
4 to the target lesion area, pass through the stenosis 46, and leave it in place. The expandable catheter IO advances within the blood vessel 45 along the expandable catheter guide wire 44 .

The dilator-equipped catheter 10 that has reached the stenotic part 46 passes through the first
As shown in FIG. 1, the expansion body 13 is positioned within the constriction 46 under X-ray fluoroscopy using the X-ray opaque markers 24, 24 provided on the inner tube 11 as landmarks. Then catheter with expander 1
The injector 64 with a pressure gauge connected to the second opening forming an injection boat of 1
An angiographic contrast medium is injected to a pressure of about 0.0 atm, and the stenotic part 46 is compressed and opened as shown in FIG. and,
The peripheral blood flow is confirmed by injecting a contrast medium from the contrast medium injection boat 62 of the figure 7 connector 60 of the guide catheter 40 and using X-ray contrast. If the blood flow is improved, the expandable catheter 10 and the expandable catheter guide wire 44 are removed, and then the guide catheter is removed and the procedure is stopped by applying pressure.

[Effects of the Invention] The catheter of the present invention has a lumen inside and a stiffening body made of a metal wire extending in the axial direction, wherein the stiffening body made of a metal wire is made of an amorphous alloy wire. Because it is a metal wire, we use amorphous alloy wire, which has high tensile strength and a wide elastic deformation range, and has excellent heat resistance, corrosion resistance, and fatigue resistance. By using a rigidity imparting body, it is possible to suppress bending and crushing of the catheter, and furthermore, it is possible to improve torque transmittance, and furthermore, by using a thin metal wire, the catheter can be made sufficiently thin. Since the necessary inner diameter can be maintained and the outer diameter can be made small, the catheter can be inserted into more peripheral parts of the body.

In addition, the catheter with an expandable body of the present invention includes an inner tube having a first lumen with an open tip, and a distal end disposed coaxially with the inner tube, with the tip disposed at a position set back 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 of the inner tube; and a distal end and a proximal end, the proximal end being attached to the outer tube; a collapsible or collapsible expander attached to the inner tube and communicating with the second lumen near the proximal end; and a collapsible expander attached to the inner tube and communicating with the first lumen provided at the proximal end of the inner tube. a first opening and a second opening communicating with the second lumen provided at the proximal end of the outer tube; In particular, since it has a stiffening body made of an extending amorphous alloy wire,
By having a rigidity imparting body made of amorphous alloy wire, there is no risk of the catheter bending during blood vessel insertion, and furthermore, when performing subtle movement or rotation of the catheter tip, the catheter can be moved delicately at the proximal end of the catheter. The torque can be reliably transmitted to the tip by rotating or rotating, and it has excellent operability.
We use amorphous alloy wire, which has high tensile strength and a wide elastic deformation range, as well as excellent heat resistance, corrosion resistance, and fatigue resistance, and uses a rigidity imparting body made of amorphous alloy wire, which is a sufficiently thin metal wire. Even when the catheter is bent or crushed, the rigidity-imparting body has a wide elastic deformation area, which improves torque transmission, and prevents subtle movements and rotations of the catheter at the proximal end of the catheter. The catheter can be reliably transmitted to the tip, and by inserting a thin metal wire, the catheter can be made sufficiently thin, maintaining the necessary inner diameter and making the outer diameter smaller. It can be inserted into peripheral sites and even into areas of severe stenosis. Furthermore, the second lumen, which communicates with the vicinity of the proximal end of the expandable body and into which the inflation fluid of the expandable body flows, has a relatively large volume because it is formed between the inner tube and the outer tube. Even if the inflation fluid has a large inflow resistance, such as a vascular contrast agent, it can be easily caused to flow in.

[Brief explanation of the drawing]

FIG. 1 is a partial cross-sectional view of one embodiment of the catheter of the present invention, FIG. 2 is a partial cross-sectional view of another embodiment of the catheter of the present invention, and FIG. 3 is a partial cross-sectional view of an embodiment of the catheter of the present invention. FIG. 4 is an enlarged sectional view of the distal end of an embodiment of the catheter with an expandable body of the present invention; FIG. 6 is a sectional view taken along line A-A in FIG. 3, and FIG. 7 is a sectional view taken along line A-A in FIG. 3.
8, 9, 10, and 1.
1 and 12 are drawings showing the operation of the catheter with an expandable body of the present invention. ■...Catheter, 2...Lumen, 3...
- Rigidity imparting body made of amorphous alloy wire, 5... Inner tube, 6... Outer tube, 10... Catheter with expansion body, 11... Inner tube, 12... Outer tube,
13... Expansion body, 14... First lumen, 16... Second lumen, 19... First opening, 21... Second opening, 23... Amorphous Rigidity imparting body made of alloy wire, 30... Branch hub, Zukarasu 2) No. 911

Claims (1)

[Claims] (1) A catheter having a lumen inside and a stiffening body made of a metal wire extending in the axial direction,
A catheter characterized in that the rigidity imparting body made of metal wire is made of an amorphous alloy wire. (2) The catheter according to claim 1, wherein the rigidity imparting body is formed in a mesh shape by the amorphous alloy wire. (3) The amorphous alloy is any one of an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, or an iron-cobalt-chromium-molybdenum-silicon-boron amorphous alloy. The catheter according to item 1 or 2. (3) The rigidity imparting body made of the amorphous alloy wire is
The catheter according to any one of claims 1 to 3, wherein the catheter is embedded in the outer surface or inside of the catheter. (5) The catheter according to any one of claims 1 to 4, wherein a portion not having a stiffening body made of the amorphous alloy wire is formed at the distal end of the catheter. (6) The catheter according to any one of claims 1 to 5, wherein the outer surface of the catheter is coated with a synthetic resin. (7) The catheter according to any one of claims 1 to 6, wherein the catheter is a catheter inserted into a blood vessel. (8) an inner tube having a first lumen with an open tip; and an inner tube provided coaxially with the inner tube, provided at a position set back from the tip of the inner tube by a predetermined length, and connected to the outer surface of the inner tube. between the second
an outer tube forming a lumen, a distal end portion and a proximal end portion, the proximal end portion being attached to the outer tube, the distal end portion being attached to the inner tube, and a second tube near the proximal end portion; a contractible or foldable expander communicating with the second lumen; a first opening provided at the proximal end of the inner tube communicating with the first lumen; and a first opening communicating with the first lumen; a second opening communicating with the provided second lumen, and at least one of the inner tube and the outer tube has a stiffening body made of an amorphous alloy wire extending in the axial direction. A catheter with an expandable body. (9) The catheter with an expandable body according to claim 8, wherein the rigidity imparting body is formed in a mesh shape by the amorphous alloy wire. (10) The first opening and the second opening are provided in a branch hub attached to the proximal ends of the inner tube and the outer tube. The expandable catheter according to item 9. (11) The catheter with an expandable body according to any one of claims 8 to 10, wherein the stiffening body made of the amorphous alloy wire is provided in the inner tube. (12) The catheter with an expandable body according to any one of claims 8 to 10, wherein the stiffening body made of the amorphous alloy wire is provided on the outer tube. (13) The catheter with an expandable body according to any one of claims 8 to 10, wherein the stiffening body made of the amorphous alloy wire is provided in both the inner tube and the outer tube. (14) The expansion body according to any one of claims 8 to 13, wherein the stiffening body made of the amorphous alloy wire is embedded in the outer surface or inside of the inner tube or the outer tube. catheter. (15) The amorphous alloy is an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, or an iron-silicon-boron alloy.
The catheter according to any one of claims 8 to 14, which is a cobalt-chromium-molybdenum-silicon-boron amorphous alloy.