JPH1119216A - Catheter and manufacture of catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To reduce the diameter so as to facilitate manufacture and improve operability and functional performance for every kind of treatment by fusing and joining the tips of at least one pair of tubes formed of materials made mutually soluble by heat fusing in such a manner that the fusing and joining width in the axial direction of a catheter is a specified value or less. SOLUTION: A catheter 1 is formed to be a multiple structure by at least one pair of a first tube 2 and a second tube 3 formed of materials made mutually soluble by heat fusing. The respective tips of both tubes 2, 3 are fused and joined, and the fusing and joining width in the axial direction of the catheter is set to 3 mm or less. Both tubes 2, 3 are respectively taken as an inner tube 2 and an outer tube 3, and the catheter main body 10 is formed by both tubes and a spreader 4, and a first lumen where a guide wire is passed is formed in the inner tube 2. The thus formed catheter can be applied to a catheter with a spreader for percutaneous transluminal angioplasty, a catheter for IABP or the like.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

The present invention relates to a catheter having a multi-tube structure and a method for manufacturing the same, and more particularly, to a catheter used in percutaneous transluminal coronary angioplasty (PTCA) and a method for manufacturing the same.

[0002]

2. Description of the Related Art A catheter is guided, for example, by a guide wire or the like, inserted into a body cavity such as a blood vessel, and advanced while controlling the direction of the tip thereof to reach a target site. Various treatments and tests can be performed.

In this catheter, as one method corresponding to advanced treatment and examination, a plurality of lumens are formed by multiplexing tubes constituting a shaft, and each of these lumens is used for various functions. It is possible. For this, it is desirable that these multiplexed tubes behave in one piece.

[0004] Therefore, by fixing the pipes at arbitrary positions in a pinpoint manner, that is, by narrowing the fixing area of both the pipes as much as possible, the operability and the function of the catheter are not reduced. It is considered that a catheter having excellent functionality can be obtained.

On the other hand, in a conventional method for producing such a catheter having a multi-tube structure, a method of fixing the tubes using an adhesive or a multi-lumen extrusion molding method is generally used. is there.

[0006]

When the multi-lumen extrusion molding method is employed, for example, there are the following problems.

[0007] Since sophisticated equipment and precise setting of conditions are required, the operation requires skill and the production cost is increased.

[0008] Since a plurality of lumens are formed in one tube, there is a limit in reducing the diameter.

Also, the method using an adhesive has the following problems.

[0010] Since high technology and processing are required, the operation requires skill and the production cost is increased.

Since the adhesive portion becomes hard, the hardness of the catheter is locally changed, and the operability and functionality of the catheter are reduced. In addition, there is a possibility that blood vessels and the like may be damaged by the hard portion.

[0012] It becomes easy to be broken near the bonded portion where the hardness changes drastically.

Since a clearance for filling the adhesive is required, the dimensions of the tube are restricted.

[0014] The adhesive is vulnerable to changes over time, and the tubes that have been joined to each other are likely to come off when the adhesive is removed due to external force or the like.

Therefore, the present invention relates to a catheter having a plurality of lumens, which is easy to manufacture, can reduce the diameter, and
An object of the present invention is to provide a catheter excellent in operability and functionality and capable of performing advanced various treatments and examinations using each of the lumens in various roles without fear of deterioration over time, and a method of manufacturing the same. And

Further, the present invention relates to a catheter having a multi-tube structure, in which tubes can be fixed in a narrow area as much as possible without local hardening, and there is a possibility that a blood vessel or the like may be damaged or bent. An object of the present invention is to provide a catheter having excellent operability and functionality, and a method of manufacturing the catheter, in which a tube and a tube can behave integrally with each other.

[0017]

SUMMARY OF THE INVENTION An object of the present invention is to provide a multi-tube catheter having at least a first tube and a second tube, wherein the first tube and the second tube are provided. Are formed of materials that are mutually soluble at the time of heating and melting, and the tip of the first tube and the tip of the second tube are fusion-bonded to each other. A fusion bonding width of the fusion bonding portion in a catheter axial direction of 3 mm or less.

The first tube is inserted inside the second tube, and the fusion joint is formed between an outer surface of the first tube and an inner surface of the second tube. Is preferred. Further, it is preferable that the fusion bonding width is 0.5 to 1 mm.

In order to achieve the above object, there is provided a method for manufacturing a catheter having a multi-tube structure having at least a first tube and a second tube, wherein the first tube and the second tube are provided. Are formed of materials that are mutually soluble at the time of heating and melting, and after arranging the first tube and the second tube so as to overlap each other, irradiating the first tube and the second tube with a light beam. A method for manufacturing a catheter, wherein the second tube is fusion-bonded.

[0020] In the above method, the first tube and the second tube are superposed and arranged, and a heat-shrinkable tube is put on a portion where the first tube and the second tube are to be joined, and a light beam is irradiated. It is preferable that the first tube and the second tube are fusion-bonded while firmly contacting each other.

The above-mentioned object is achieved by the first method.
A first tube having a lumen, and passing through the first tube;
A method of manufacturing a catheter having a coaxial tube structure having at least a second tube forming a second lumen between the first tube and an outer surface of the first tube.
Are formed of materials that are mutually soluble when melted by heating, the first tube is inserted into the inside of the second tube, and a pipe-shaped core having a cutout in a part in a circumferential direction. After gold is inserted into the gap between the first tube and the second tube, a light beam is applied to a position where the notch is disposed, so that the outer surface of the first tube in the catheter circumferential direction. Is fused to a part of the inner surface of the second tube, and a catheter is provided between the other part of the outer surface of the first tube and the other part of the inner surface of the second tube. A method of manufacturing a catheter, comprising forming a second lumen extending in an axial direction.

2 which are mutually soluble during heating and melting
By fusing and fixing the two tubes using a light beam, the joining width in the catheter axial direction can be extremely small, that is, about φ3 mm or less, preferably about φ0.5 to 1.0 mm, that is, pinpoint fixed. Further, it is possible to obtain a catheter excellent in pushability and torque transmission without impairing the flexibility of the distal end portion of the catheter.

The light beam that can be used in the present invention includes, for example, those containing light of multiple wavelengths ranging from visible light to ultraviolet light (white light) and monochromatic lights such as far infrared light and near infrared light. The energy of light can be used.
Of these, it is preferable to use a beam of white light emitted from a xenon lamp, a halogen lamp, or the like, since complicated equipment is not required and handling is simple.

The size (joining diameter) of the region where the light beam is irradiated and fusion-bonded can be appropriately adjusted by changing the focal diameter of the light beam. The smaller the focal diameter, the more concentrated the energy of the light beam, so that the fusion bonding can be performed firmly in a short time.

When a fixed width is provided in the axial direction of the catheter, a tube or a light beam to be joined is moved a necessary distance in the axial direction of the catheter. In addition, if it is desired to secure the catheter with a certain width in the circumferential direction, a tube or light beam that is joined after inserting a metal core into the lumen in the circumferential direction of the catheter should be inserted so that the lumen will not be blocked by heating deformation of the tube. Can be rotated to

[0026]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

FIG. 1 is an overall side view showing an embodiment in which the catheter of the present invention is applied to a catheter used in percutaneous transluminal coronary angioplasty (PTCA). FIG. 2 is a side view of the catheter shown in FIG. FIG. 3 is a partially enlarged perspective view showing a main part.
Is an explanatory view showing a cross-sectional structure of a main part of the catheter shown in FIG. 2, FIG. 4 is an enlarged perspective view of a main part showing another embodiment of the catheter of the present invention, and FIG. FIG. 6 is an explanatory view showing a cross-sectional structure of a main part of the catheter shown in FIG. 5.

The catheter 1 of the present invention has at least a first
A catheter having a multi-tube structure having a second tube 2 and a second tube 3, wherein the first tube 2 and the second tube 3 are formed of materials that are mutually soluble when heated and melted, The distal end of the first tube 2 and the distal end of the second tube 3 are fusion-bonded to each other, and the fusion-bonded width of the fusion-bonded portion in the catheter axial direction is 3 mm or less. It is a feature.

Hereinafter, description will be made with reference to the drawings.

As shown in FIG. 1, a catheter 1 of the present invention comprises a catheter body 10 having an inner tube 2 as a first tube, an outer tube 3 as a second tube, and an expansion body 4, a branch hub. 12
Are formed. In addition, the catheter body 10
Has a small-diameter distal end portion 10a and a main body portion 10b.

The inner tube 2 is a tube having a first lumen 5 through which a guide wire is inserted.

The length of the inner tube 2 is 300 to 200.
0 mm, more preferably 300 to 1500 mm, and an outer diameter of 0.1 to 1.0 mm, more preferably 0.3 to
0.7 mm, wall thickness 10 to 150 μm, more preferably,
It is 20 to 100 μm.

The inner tube 2 is inserted into the outer tube 3, and its tip projects from the outer tube 3. As shown in FIGS. 2 and 3, a second lumen 6 is formed by the outer surface of the inner tube 2 and the inner surface of the outer tube 3 and has a sufficient volume.

The outer tube 3 is a tube body into which the inner tube 2 is inserted and whose tip is located at a position slightly retreated from the tip of the inner tube 2.

The length of the outer tube 3 is 300 to 200.
0 mm, more preferably 300 to 1500 mm, and an outer diameter of 0.5 to 1.5 mm, more preferably 0.7 to
1.1 mm, wall thickness 25 to 200 μm, more preferably
It is 50-100 μm.

In the catheter 1 of this embodiment, the outer tube 2
As shown in FIG. 1, the distal end side (corresponding to the distal end portion 10a of the catheter main body) has a small diameter, and the main body side (corresponding to the main body portion 10b of the catheter main body) has a larger diameter than the distal end side. I have. More specifically, a tapered portion is provided at an intermediate portion of the outer tube 2, the diameter of which is reduced toward the tip of the outer tube 2.

The outer diameter of the outer tube on the distal end side (the distal end portion 10a) is 0.50 to 1.5 mm, preferably 0.60 to 1.5 mm.
1.1 mm. In addition, the outer tube main body side (main body portion 10b)
Has an outer diameter of 0.75 to 1.5 mm, preferably 0.9 to 1.5 mm.
1.1 mm. Such a different-diameter outer tube may be one in which the inner tube distal end side and the outer tube proximal end side are individually formed and joined, one that has been subjected to secondary processing such as drawing-down processing, and one that has been extruded to form a distal end side. May be formed by making the diameter smaller than the body side diameter.

Although not shown, the inner tube 2 may also have a different diameter structure in which the distal end has a smaller diameter than the main body.

As shown in FIGS. 2 and 3 in an enlarged manner, the distal end of the outer tube 3 is fusion-bonded to the distal end of the inner tube 2. Is fixed. Specifically, a fusion bonding portion 32 for fixing the outer tube 2 and the inner tube 3 to each other is formed at the tip of the inner tube 2 and the outer tube 3. Each of the inner tube 2 and the outer tube 3 is formed of a material which is mutually soluble at the time of heating and melting. Thereby, the inner tube 2 and the outer tube 3 can be fused. By doing so, the inner tube 2 and the outer tube 3 are melted and integrated with each other, so that unlike the fixing with an adhesive, the original physical properties of the inner tube 2 and the outer tube 3 are also at the joint. Is maintained, and the catheter can be firmly fixed without affecting the physical properties of the catheter.

As the constituent material of the inner tube 2 and the constituent material of the outer tube 3, those having some flexibility are used. For example, polyolefin (eg, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene A vinyl acetate copolymer, an ionomer, or a mixture of two or more of these), or a crosslinked product thereof, such as polyvinyl chloride, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane, polyurethane elastomer, fluororesin, polyimide, etc. A polymer material having thermoplasticity or a mixture thereof can be used, and among these, materials having mutual solubility at the time of heating and melting can be appropriately selected and used.

Preferred combinations of the material of the inner tube 2 and the material of the outer tube 3 include combinations of the same materials such as polyethylene and polyethylene, polyamide and polyamide, polyamide elastomer and polyamide elastomer, and polyurethane and polyurethane. Examples include combinations of polyamide and polyamide elastomer, polyethylene and ethylene-vinyl acetate copolymer, polyester and polyester elastomer, polyurethane and polyurethane elastomer.

The fusion bonding width of the fusion bonding portion 32 in the catheter axial direction (longitudinal direction) is within 3 mm, preferably 0.5 to 1 mm. By setting such a range, the inner tube 2 and the outer tube 3 can be securely fixed, and the inner tube 2 and the outer tube 3 can be integrally moved without impairing the flexibility of the catheter. Therefore, torque transmission, pushability, and followability of the catheter can be improved, and the operability of the catheter can be improved.

In this embodiment, a fusion bonding portion 32 is formed between the outer surface of the inner tube 2 and the inner surface of the outer tube 3. The inner tube 2 and the outer tube 3 are coaxially overlapped with each other, and the outer surface of the inner tube 2 and the inner surface of the outer tube 3 are fusion-bonded over a predetermined length. A catheter having a plurality of lumens that are fusion bonded and have high fixing strength can be obtained.

In the present embodiment, the outer tube 3 is joined to the inner tube 2 only at a part of the inner tube 2 in the circumferential direction, and is not joined at the other part in the circumferential direction. A second lumen 6 is formed between the outer surface of the inner tube 2 and the inner surface of the outer tube 3 in the unjoined portion. By adopting such a structure, the second configuration can be realized with an extremely simple configuration.
A large cross-sectional area of the lumen 6 can be secured. In order to achieve such fixation, it is preferable that about 15 to 55%, preferably 25 to 45%, of the inner tube outer surface and the outer tube inner surface are fusion-bonded to each other.

The position of the joint 32 may be fixed so as to include the distal end of the outer tube 2 or, as shown in FIG. It may be formed at a specified position.

Further, the fusion bonding of the inner tube 2 and the outer tube 3 is not limited to the fixing in a point-like (spot) manner in the catheter axial direction of the outer tube 3 as shown in FIG. As shown in FIG. 4, a certain amount of width may be provided in the axial direction of the catheter and fusion-fixed. 5 and 6
As shown in (1), it may be fixed and joined at a plurality of locations apart from each other in the circumferential direction of the catheter. In the illustrated example, the inner tube 2 and the outer tube 3
Are fusion-bonded, and three fusion-bonded portions 32 are formed. Also in this case, similarly to the embodiment shown in FIG. 2, the second lumen 6 is formed between the outer surface of the inner tube 2 and the inner surface of the outer tube 3 which are not fusion bonded. In the illustrated example, the second lumen 6 is formed between the inner tube 2 and the outer tube 3 at three portions separated by the three fusion bonding portions 32.

The expandable body (balloon) 4 is foldable, and can be folded around the inner tube 2 when not expanded. The expandable body 4 is foldable and has a substantially cylindrical portion having substantially the same diameter and at least a part of which is cylindrical so that the stenotic portion of the blood vessel can be easily expanded. The above-mentioned substantially cylindrical portion does not need to be a perfect cylindrical shape, and may be a polygonal column shape. The expansion body 4 has a proximal end liquid-tightly fixed to a distal end of the outer tube 3 by adhesion or fusion.
In addition, the distal end is similarly fixed to the distal end of the inner tube 2 in a liquid-tight manner.

The interior space formed inside the expansion body 4, that is, between the inner surface of the expansion body 4 and the outer surface of the inner tube 2, communicates with the second lumen 6 at the base end. Thus, the second end having a relatively large volume at the proximal end of the expansion body 4
Since the first lumen 6 communicates with the second lumen, it is easy to inject the inflation fluid into the expansion body 4 from the second lumen.

Regarding the size of the expansion body 4, the outer diameter of the substantially cylindrical portion when expanded is 1.0 to 10 mm, preferably 1.0 to 5.0 mm, and the length is 5 to 50 mm. ,
It is preferably 10 to 40 mm, and the entire length of the expansion body 4 is 10 to 70 mm, preferably 15 to 60 mm.

The material of the expandable body 4 is preferably a material capable of expanding a stenotic part of a blood vessel and having a certain degree of flexibility. For example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate Polyolefins such as copolymers and ionomers, as well as cross-linked or partially cross-linked products thereof, polyesters such as polyethylene terephthalate, polyester elastomers, polyvinyl chloride, polyurethane, polyurethane elastomers, polyphenylene sulfide, polyamide, polyamide elastomers, and fluoroplastics. Molecular materials, silicone rubber, latex rubber, and the like can be used. Also, a laminated film in which these polymer materials are appropriately laminated can be used.

Further, it is preferable to provide a marker (not shown) on the outer surface of the inner tube at a portion located at the center of the substantially cylindrical portion of the expansion body. Further, a second marker (not shown) may be provided on the outer surface of the inner tube 2 at a portion located at the base end of the substantially cylindrical portion. Further, instead of being provided at the central portion, two may be provided on the outer surface of the inner tube 2 at portions located at both ends of the substantially cylindrical portion of the expansion body 4. The marker is preferably formed by a coil spring or a ring. As a material for forming the marker, a material having a high X-ray contrast property, for example, Pt, Pt alloy, W, W alloy, Au, Au alloy, Ir, Ir alloy, A
g, an Ag alloy or the like can be used.

The branch hub 12 has two branched openings, one of which communicates with the first lumen 5, through which a guide wire can be inserted, and the like.
Used for flushing contrast fluid. The other opening communicates with the second lumen, and a syringe or the like for injecting a fluid for expanding the expansion body is connected to this opening for use. As a material for forming the branch hub 12,
Thermoplastic resins such as polycarbonate, polyamide, polysulfone, polyarylate, and methacrylate-butylene-styrene copolymer can be suitably used.

Further, the catheter of the present invention has the above-mentioned P
It is not limited to a catheter with an expandable body for TCA, for example, a catheter for IABP, an endoscope catheter,
The present invention can be applied to various catheters having a plurality of lumens, such as an ablation catheter and a cardiac output measurement catheter.

Next, a method for manufacturing a catheter of the present invention will be described with reference to an embodiment shown in the drawings.

The method of manufacturing a catheter according to the present invention is a method of manufacturing a catheter having a multi-tube structure having at least a first tube and a second tube, wherein the first tube and the second tube are Each of the first tube and the second tube is formed by irradiating a light beam after arranging the first tube and the second tube so as to be overlapped with each other and forming the first tube and the second tube. The two tubes are fusion bonded.

The method for producing a catheter of the present invention comprises:
A coaxial tube structure having at least a first tube having a first lumen and a second tube passing through the first tube and forming a second lumen between the first tube and an outer surface of the first tube. A method of manufacturing a catheter, wherein the first tube and the second tube are formed of materials that are mutually soluble at the time of heating and melting, and the first tube is connected to the second tube. Insertion,
After inserting a pipe-shaped core having a notch in a part of the circumferential direction into a gap between the first tube and the second tube,
By irradiating a light beam to a position where the cutout portion is arranged, a part of an outer surface of the first tube and a part of an inner surface of the second tube are fusion-bonded in a catheter circumferential direction, and A second lumen extending in the catheter axial direction is formed between another portion of the outer surface of the first tube and another portion of the inner surface of the second tube.

The respective steps will now be described with reference to the catheter shown in FIGS.

FIGS. 7 to 10 are explanatory views showing the steps for explaining the method of manufacturing the catheter of the present invention by taking the case of manufacturing the catheter shown in FIGS. 1 to 3 as an example.
FIG. 11 is an explanatory view showing a shape of a core for manufacturing the catheter shown in FIGS. 5 and 6.

First, the inner tube 2 and the outer tube 3 are respectively
It is formed of materials that are mutually soluble during heating and melting. This formation can be performed by a method in which each of the constituent materials of the inner tube 2 and the outer tube 3 described above is extruded and cut into a predetermined length, or injection molding or the like.

Next, as shown in FIG. 7, the inner tube 2 and the outer tube 3 are arranged so as to overlap each other. Specifically, the inner pipe 2 is connected to the outer pipe 3
And the inner tube 2 is made to protrude from the tip of the outer tube 3 so as to be coaxially arranged. As shown in FIGS. 7 and 8, a core metal 71 having a circular cross section is inserted into the inner pipe 2, and further, a pipe-shaped core metal 72 is inserted into a gap between the inner pipe 2 and the outer pipe 3.
Through. The metal core 72 has a notch 7 at a part in the circumferential direction.
2a. The notch 72a is cut out from the distal end of the metal core 72 to a base end in a predetermined length so as to have a ring shape with a half cross section. The shape of the cutout is not limited to the cutout parallel to the axial direction as shown in the figure, but may be cut out obliquely so that the cross-sectional area decreases toward the tip of the metal core 72. It may be formed.

After arranging the two tubes in this way, the step of fusing and joining the two tubes by irradiating a light beam is performed as follows.

First, after aligning the positions of the inner tube 2, the outer tube 3, the core bar 71 and the core bar 72 as described above, as shown in FIG. 9, the core bar 72 is located above the cutout portion 72a. Thus, the heat-shrinkable tube 8 is covered.

The heat-shrinkable tube 8 is made of a stretchable material and has an inner diameter slightly smaller than the outer diameter of the outer tube 3.
This can be created by expanding this radially. Polyolefins such as polyethylene and polypropylene, EAA (ethylene-acrylic acid copolymer),
EVA (ethylene-vinyl acetate copolymer) and the like can be used.

Then, as shown in FIG. 10, the distal end of the cored bar 71 and the portion of the outer tube 3 closer to the base end than the position of the heat-shrinkable tube 8 are set in jigs 91 and 92, and the inner tube 2 is set. A light beam 9 whose focal diameter has been adjusted to a desired size in advance is applied to a position where the cutout 72a of the heat-shrinkable tube 8 is arranged at a position where the outer tube 3 and the outer tube 3 are to be joined. At this time, a xenon lamp is desirable as a light source of the light beam 9. This light is emitted from a light source 931, collected in the device 93, and emitted as a light beam 9 through an optical fiber 94 and a lens 95. If the light amount is adjusted to about 0.9 W so that the irradiation time becomes about 5 seconds, the work becomes stable.

The irradiation of the light beam 9 causes the heat-shrinkable tube 8 to be heated and shrunk, and the outer surface of the inner tube 2 and the inner surface of the outer tube 3 located at the cutout portion 72a are fused and fused. At this time, the contraction force of the heat-shrinkable tube 8 causes the inner surface of the outer tube 3 located above the notch 72a to move to the inner tube 2.
Acts as a force pressing against the outer surface of the This gives 2
The two tubes can be welded and joined while firmly contacting each other, and the two can be joined firmly.

After the heat-shrinkable tube 8, the inner tube 2 and the outer tube 3 are left to cool down to room temperature, the heat-shrinkable tube 8 is removed, and the metal cores 71 and 72 are removed. In this way, as shown in FIGS. 2 and 3, the inner tube 2 and the outer tube 3 fixed to each other through the fusion bonding portion 23.
Is formed.

According to the above, unlike the conventional fixing method using an adhesive, it is possible to provide a catheter having a plurality of lumens excellent in operability and functionality without causing local hardening of the catheter. Can be. Further, the inner tube 2 and the outer tube 3 can be fixed in a pinpoint (substantially dot-like) manner with a small fixing area, and the non-joined portion between the inner tube 2 and the outer tube 3, that is, the size of the second lumen 6 Can be widely secured.

As described above, by fusing a tube to a tube using a light beam, the tube and the tube can be easily fixed in an extremely small area. Specifically, it can be fixed in an extremely pinpoint manner so that the joint width in the catheter axial direction is φ3 mm or less, preferably about φ0.5 to 1.0 mm. Further, unlike conventional fixing with an adhesive, since there is no local hardening, it is possible to obtain a catheter excellent in pushability and torque transmission without impairing the flexibility of the distal end portion of the catheter.

Then, the base end of the separately formed expansion body 4 is attached to the front end of the outer tube 3 by fusing and bonding, and the front end of the expansion body 4 is fused and bonded to the front end of the inner pipe 2. By this, the catheter body 10 shown in FIG. 1 is formed. Then, by attaching a separately formed branch hub 12 to the proximal end of the catheter body 10, the catheter 1 with an expandable body shown in FIG. 1 can be obtained.

In order to fix the inner tube 2 and the outer tube 3 more firmly, when irradiating the light beam 9, a lens 93 is required.
Is moved in the axial direction of the catheter relative to the inner tube 2 and the outer tube 3 or the jigs 91 and 92 are moved in the axial direction of the catheter so as to have a width in the axial direction of the catheter as shown in FIG. It is also possible to make a joint.

The fixing position of the inner tube 2 and the outer tube 3 is not limited to one position in the circumferential direction of the catheter, but may be fixed at a plurality of positions separated in the circumferential direction. For example, instead of the pipe-shaped core 72 described above, as shown in FIG. 11, a pipe-shaped core 72 ′ having a plurality of notches 72 a ′ spaced apart in the circumferential direction is used, and a lens is used for irradiating the light beam 6. When the light beam 9 is irradiated while rotating the inner tube 2 and the outer tube 3 by rotating the inner tube 2 with respect to the inner tube 2 and the outer tube 3 or by rotating the jigs 91 and 92, the notch 72a 'is corresponded. In this position, the inner tube 2 and the outer tube 3 are fusion-bonded, and can be fixed as shown in FIGS.

Although the present invention has been described above with reference to a catheter having a coaxial tube structure having an inner tube and an outer tube and its manufacture, the present invention is not limited to this, and the tubes are arranged in parallel. It can be applied to any type of catheter.
That is, it is also possible to arrange the tubes in parallel and fix the tubes by fusing and joining the outer surfaces adjacent to each other. Further, although the present invention has been described for fixing two tubes, the present invention is not limited to this, and can be applied to a catheter of a type for fixing three or more tubes.

[0073]

The catheter of the present invention has at least a first
A catheter having a multi-tube structure having a first tube and a second tube, wherein the first tube and the second tube are formed of materials that are mutually soluble when melted by heating. The distal end of the first tube and the distal end of the second tube are fusion-bonded to each other, and the fusion-bonded width of the fusion-bonded portion in the catheter axial direction is 3 mm or less. Therefore, a change in hardness due to fixation can be minimized, and there is no risk of damaging blood vessels and the like, and a catheter excellent in operability and functionality such as trackability, kink resistance and pushability can be provided.

The method for producing a catheter of the present invention
A method for manufacturing a catheter having a multi-tube structure having at least a first tube and a second tube, wherein the first tube and the second tube are each made of a material that is soluble in each other when heated and melted. Forming the first tube and the second tube so as to overlap each other, and then irradiating a light beam to fuse and join the first tube and the second tube. I do. For this reason, a catheter having excellent operability and functionality such as trackability, kink resistance, pushability, and the like, which does not require complicated devices and operations, is extremely simple, and has no risk of damaging blood vessels, etc. Can be manufactured.

The method for producing a catheter of the present invention comprises:
A coaxial tube structure having at least a first tube having a first lumen and a second tube passing through the first tube and forming a second lumen between the first tube and an outer surface of the first tube. A method of manufacturing a catheter, wherein the first tube and the second tube are formed of materials that are mutually soluble at the time of heating and melting, and the first tube is connected to the second tube. Insertion,
After inserting a pipe-shaped core having a notch in a part of the circumferential direction into a gap between the first tube and the second tube,
By irradiating a light beam to a position where the cutout portion is arranged, a part of an outer surface of the first tube and a part of an inner surface of the second tube are fusion-bonded in a catheter circumferential direction, and A second lumen extending in the catheter axial direction is formed between another portion of the outer surface of the first tube and another portion of the inner surface of the second tube. For this reason, a complicated apparatus and operation are not required, a very simple process, there is no danger of damaging blood vessels and the like, and a plurality of excellent operability and functionalities such as trackability, kink resistance and pushability are provided. A catheter having a lumen can be manufactured, and a large cross-sectional area of the lumen can be secured.

[Brief description of the drawings]

FIG. 1 is an overall side view showing an example in which the catheter of the present invention is applied to a catheter used in percutaneous transluminal coronary angioplasty (PTCA).

FIG. 2 is a partially enlarged perspective view showing a main part of the catheter shown in FIG.

FIG. 3 is an explanatory view showing a cross-sectional structure of a main part of the catheter shown in FIG. 2;

FIG. 4 is an enlarged perspective view of a main part showing another embodiment of the catheter of the present invention.

FIG. 5 is an enlarged perspective view of a main part showing still another embodiment of the catheter of the present invention.

6 is an explanatory diagram showing a cross-sectional structure of a main part of the catheter shown in FIG.

FIG. 7 is an explanatory view showing each step for explaining a method for producing a catheter of the present invention by taking as an example a case of producing the catheter shown in FIGS. 1 to 3;

FIG. 8 is an explanatory view showing each step for explaining a method of manufacturing the catheter of the present invention by taking as an example a case of manufacturing the catheter shown in FIGS. 1 to 3;

FIG. 9 is an explanatory view showing each step for explaining a method for producing a catheter of the present invention by taking as an example a case of producing the catheter shown in FIGS. 1 to 3;

FIG. 10 is an explanatory view showing each step for explaining a method for producing a catheter of the present invention by taking as an example a case of producing the catheter shown in FIGS. 1 to 3;

FIG. 11 is an explanatory view showing a shape of a core for manufacturing the catheter shown in FIG. 5;

[Description of Signs] 1 Catheter 2 Inner tube 3 Outer tube 32 Fusion joint 4 Expansion body 5 First lumen 6 Second lumen 71, 72, 72 'Core 72a, 72a' Notch 8 Heat-shrinkable tube Reference Signs List 9 light beam 91, 92 jig 93 device 931 light source 94 optical fiber 95 lens 10 catheter body 12 branch hub

Claims (6)

[Claims] 1. A catheter having a multi-tube structure having at least a first tube and a second tube, wherein the first tube and the second tube are each soluble in each other when heated and melted. The distal end of the first tube and the distal end of the second tube are fusion-bonded to each other, and the fusion-bonded width of the fusion-bonded portion in the catheter axial direction is A catheter having a diameter of 3 mm or less. 2. The first tube is inserted through the inside of the second tube, and the fusion joint is formed between an outer surface of the first tube and an inner surface of the second tube. The catheter according to claim 1, wherein the catheter is formed. 3. The catheter according to claim 1, wherein the fusion bonding width is 0.5 to 1 mm. 4. A method of manufacturing a catheter having a multi-tube structure having at least a first tube and a second tube, wherein the first tube and the second tube are respectively movable with each other during heating and melting. The first tube and the second tube are fusion-bonded by irradiating a light beam after arranging the first tube and the second tube so as to overlap each other. A method for manufacturing a catheter, comprising: 5. After arranging the first tube and the second tube so as to overlap each other, a heat shrinkable tube is placed over a portion where the first tube and the second tube are to be joined, and the light beam is irradiated to the first tube. The method for manufacturing a catheter according to claim 4, wherein the tube and the second tube are fusion-bonded while firmly contacting each other. 6. A first tube having a first lumen, and a second tube passing through the first tube and forming a second lumen between the first tube and an outer surface of the first tube. A method of manufacturing a catheter having at least a coaxial tube structure, wherein the first tube and the second tube are formed of materials that are mutually soluble at the time of heating and melting, and the first tube is After inserting a pipe-shaped metal core having a notch in a part of the circumferential direction between the first pipe and the second pipe, the notch is disposed after being inserted inside the second pipe. By irradiating the light beam to the set position, a part of the outer surface of the first tube and the second
A second portion extending in the catheter axial direction between the other portion of the outer surface of the first tube and the other portion of the inner surface of the second tube by fusion-bonding a part of the inner surface of the second tube to the other portion. A method for manufacturing a catheter, comprising forming a lumen.