Catheter and method for producing catheter

Abstract

A catheter 1 includes a catheter tube 2 and a hub 3. The outer surface side of a rear end part of the tube 2 is made of a thermoplastic resin containing an electromagnetic wave-absorbing material, and the hub 3 is made of a plastic resin having electromagnetic wave permeability and thermally fusible with the resin forming the tube. A rear end part 26 of the tube 2 is fixed to the hub within an inner cavity 30 of the hub by an annular fused part 5 formed by an annular melted-and-solidified part 71 of the resin forming the outer surface of the tube. The method for producing the catheter involves a fusing and fixing step of radiating an electromagnetic wave from the outside of the hub to the rear end part of the catheter tube, and melting and fusing a part of the rear end part of the catheter tube in an annular shape.

Description

Catheter and method for manufacturing the same

[0001] The present invention relates to a catheter having a catheter tube and a hub fixed to the rear end thereof, and a method for manufacturing the same.

[0002] Catheters comprising a catheter tube and a hub fixed to its rear end have been manufactured and sold. The catheter tube is typically made of a soft thermoplastic resin, while the hub is typically made of a hard resin. The rear end of the catheter tube is inserted into the lumen of the hub and secured thereto. A common method of securing the catheter tube is by using an adhesive. However, there is a possibility that uncured adhesive may remain or that the adhesive may flow into the lumen of the catheter tube or hub, so securing without using an adhesive is preferable. The applicant of the present application has proposed a catheter disclosed in Patent Document 1 (Japanese Patent Laid-Open Publication No. 2001-224693). The catheter disclosed in Patent Document 1 is an intravascular catheter equipped with a catheter portion and an inner needle that penetrates the catheter portion, and a flexible resin member is provided at the proximal end of the catheter portion so as to encompass the outer surface of the catheter. Patent Document 1 also discloses that "methods for bonding the catheter portion 1 and the flexible resin member include injecting an adhesive into the gap between the outer surface of the catheter portion and the inner surface of the flexible resin member and then curing it, or applying an adhesive to the outer surface of the catheter portion in advance and then covering it with the flexible resin member and then curing it. However, it is more preferable to use a photocurable adhesive, and one method is to irradiate the adhesive from the opening or the outside with radiation to cure it, but this is not limited to this. Furthermore, fusion and bonding may also be performed by heat fusion, high-frequency induction heating, high-frequency dielectric heating, etc., which is more preferable because this improves the circuit's restoring force after it is released from the blocked state."

[0003] JP 2001-224693 (US 2001-014787A, EP 1125596A)

[0004] As shown in Figures 1 to 4 of Patent Document 1, a hub portion 9 is disposed on the proximal end side of the flexible resin members 4, 11. Methods of bonding the catheter portion 1 and the flexible resin member include fusion bonding by heat fusion, high-frequency induction heating, high-frequency dielectric heating, etc. However, there is no specific description of fusion bonding by heat fusion, high-frequency induction heating, high-frequency dielectric heating, etc. A catheter portion formed from a thermoplastic resin cannot be heated well by high-frequency induction heating or high-frequency dielectric heating, and the catheter and hub cannot be bonded well.

[0005] Therefore, an object of the present invention is to provide a catheter in which a catheter tube made of a thermoplastic resin and a hub made of a thermoplastic resin are well fixed to each other by a molten and solidified portion of the resin formed between them without using an adhesive, and a method for manufacturing the catheter.

[0006] The above object can be achieved by the following: A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein at least the outer surface side of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface of the tube that contains an electromagnetic wave absorbing material, the hub is formed from a thermoplastic resin for forming the hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube, and the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing an annular fused portion of the thermoplastic resin for forming the outer surface of the tube that is formed within the cavity of the hub with the thermoplastic resin for forming the hub that forms the inner surface of the cavity of the hub.

[0007] The above object is achieved by the following: A method for manufacturing a catheter including a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, and a hub having a cavity capable of accommodating the rear end of the catheter tube, the method comprising: a catheter tube preparation step of preparing a catheter tube having at least the outer surface side of the rear end formed from a thermoplastic resin for forming a tube outer surface that contains an electromagnetic wave absorbing material; a hub preparation step of preparing a hub formed from a thermoplastic resin for forming a hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the tube outer surface; and a fusion fixing step of inserting the rear end of the catheter tube into the cavity of the hub, irradiating electromagnetic waves from outside the hub around the entire circumference of a side surface of a portion of the rear end of the catheter tube, thereby annularly melting the portion of the rear end of the catheter tube and fusing the inner surface of the cavity of the hub to the portion of the rear end of the catheter tube.

[0008] The above object can also be achieved by the following: A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein the catheter has a covering member covering the outer circumferential surface of part of the rear end of the catheter tube, the covering member being formed from a thermoplastic resin for forming the covering member that contains an electromagnetic wave absorbing material, the hub being formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties with the thermoplastic resin for forming the covering member, the part of the rear end of the catheter tube covered with the covering member extending into the tip end of the hub, and the catheter being fixed to the hub by an annular molten and solidified portion of the thermoplastic resin for forming the covering member formed in the cavity of the hub being annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the cavity of the hub.

[0009] The above objectives are also achieved by the following: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; a covering member covering a portion of the outer circumferential surface of the rear end of the catheter tube; and a hub having a lumen capable of accommodating the rear end of the catheter tube covered with the covering member, the method comprising the steps of: a covering member preparing step of preparing a covering member capable of covering a portion of the outer circumferential surface of the rear end of the catheter tube and formed from a covering member-forming thermoplastic resin containing an electromagnetic wave absorbing material; a hub preparing step of preparing a hub formed from a hub-forming thermoplastic resin that is electromagnetic wave transparent and has thermal fusion properties with the covering member-forming thermoplastic resin; and a fusion fixing step of irradiating electromagnetic waves in an annular pattern from a side of the hub toward the covering member with the rear end of the catheter tube covered with the covering member inserted into the lumen of the hub, thereby annularly melting the covering member and fusing and fixing the covering member to the inner surface of the lumen of the hub.

[0010] FIG. 1 is a front view of a catheter according to an embodiment of the present invention. FIG. 2 is an enlarged cross-sectional view of the rear end portion of the catheter shown in FIG. 1. FIG. 3 is an enlarged longitudinal cross-sectional view of the rear end portion of the catheter shown in FIG. 1. FIG. 4 is an enlarged cross-sectional view taken along line A-A in FIG. 3. FIG. 5 is an enlarged longitudinal cross-sectional view of a catheter tube used in a catheter according to an embodiment of the present invention. FIG. 6 is a partial enlarged cross-sectional view of a hub in the catheter shown in FIG. 2. FIG. 7 is an enlarged cross-sectional view of a connection between the catheter tube and the hub in the catheter shown in FIG. 2. FIG. 8 is an enlarged cross-sectional view of a connection between the catheter tube and the hub in a catheter according to another embodiment of the present invention. FIG. 9 is an enlarged cross-sectional view of a connection between the catheter tube and the hub in a catheter according to another embodiment of the present invention. FIG. 10 is a partial enlarged cross-sectional view of a hub in the catheter shown in FIG. 9. FIG. 11 is an enlarged cross-sectional view of a connection between the catheter tube and the hub in the catheter shown in FIG. 9. FIG. 12 is an enlarged cross-sectional view of a connection between the catheter tube and the hub in a catheter according to another embodiment of the present invention. FIG. 13 is an explanatory diagram of a step of connecting a catheter tube and a hub in a method of manufacturing a catheter according to an embodiment of the present invention. FIG. 14 is an explanatory diagram of a step of connecting a catheter tube and a hub in a method of manufacturing a catheter according to the embodiment of the present invention. FIG. 15 is an explanatory diagram of the step of connecting the catheter tube and the hub in the method of manufacturing the catheter of the embodiment shown in FIG. 13 . FIG. 16 is an explanatory diagram of the step of connecting the catheter tube and the hub in the method of manufacturing a catheter of another embodiment of the present invention. FIG. 17 is an explanatory diagram of the step of connecting the catheter tube and the hub in the method of manufacturing a catheter of another embodiment of the present invention. FIG. 18 is an explanatory diagram of the step of connecting the catheter tube and the hub in the method of manufacturing a catheter of another embodiment of the present invention. FIG. 19 is an enlarged sectional view of the connection portion of the catheter tube and the hub in a catheter of another embodiment of the present invention. FIG. 20 is an enlarged sectional view taken along line B-B in FIG. 19 . FIG. 21 is an enlarged sectional view of the connection portion of the catheter tube and the hub of the catheter shown in FIG. 19 . FIG. 22 is an explanatory view for explaining the connection portion of the catheter tube and the hub in a catheter of another embodiment of the present invention. FIG. 23 is an enlarged sectional view of the connection portion of the catheter tube and the hub in a catheter of another embodiment of the present invention.FIG. 24 is an explanatory view of a step of fusion-fixing the catheter tube and the hub in the method of manufacturing a catheter according to an embodiment of the present invention.

[0011] The catheter of the present invention will be described using the embodiment shown in the drawings. The catheter 1 of the present invention comprises a catheter tube 2 having a lumen 20, a distal opening 27 communicating with the lumen 20, and a proximal opening communicating with the lumen 20, and a hub 3 having an inner cavity 30 capable of accommodating the proximal end of the catheter tube 2.

[0012] At least the outer surface side of the rear end of the catheter tube 2 is formed from a thermoplastic resin for forming the tube outer surface side that contains an electromagnetic wave absorbing material, and the hub 3 is formed from a thermoplastic resin for forming the hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the tube outer surface side. The rear end 26 of the catheter tube 2 is fixed to the hub 3 by an annular fused portion 5 formed by annularly fusing an annular molten and solidified portion 51 of the thermoplastic resin for forming the tube outer surface side that is formed in the inner cavity 30 of the hub 3 (inside the storage portion (expanded diameter portion) 35) with the hub-forming thermoplastic resin that forms the inner surface of the inner cavity 30 of the hub 3.

[0013] 1 to 4, the catheter 1 of this embodiment comprises a catheter tube 2, a hub 3 fixed to the rear end of the catheter tube 2, and an anti-kink tube 4. The outer diameter of the catheter tube 2 is not particularly limited, but is usually preferably 0.8 to 3.0 mm, and more preferably 1.0 to 2.5 mm. The wall thickness of the catheter tube 2 is also not particularly limited, but is usually preferably 0.1 to 0.7 mm, and more preferably 0.15 to 0.5 mm.

[0014] The catheter of the present invention can be used, for example, as a catheter for angiography of the heart or its surrounding tissues, a catheter for imaging biological organs such as the liver, pancreas, and bile duct, a catheter for administering drugs to biological organs such as the heart, cerebral blood vessels, liver, pancreas, and bile duct, and an embolization catheter for embolizing cerebral blood vessels, etc.

[0015] As shown in Fig. 5, the catheter tube 2 in this embodiment includes a distal opening 27, a proximal opening, an outer layer 21, an inner layer 22, and a reinforcing member 23 that extend throughout the catheter tube 2. In this embodiment, the distal opening 27 is a distal opening. However, the distal opening may be one or more side openings provided at the distal end. In this embodiment, the proximal opening is a proximal opening that opens at the proximal end 26.

[0016] In the catheter 1 of this embodiment, the inner layer 22 forms the inner surface of the lumen 20 and the catheter tube 2, and is made of the same material and has a substantially uniform thickness from the distal end to the proximal end. The thickness of the inner layer 22 is preferably 0.05 to 0.2 mm, and more preferably 0.10 to 0.17 mm.

[0017] Preferred materials for forming the inner layer 22 include thermoplastic resins such as polyurethane, polyamide, modified polyethylene ether polyamide imide, polyetherimide, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefin (e.g., ultra-high molecular weight polyethylene, polypropylene), thermoplastic elastomers such as polyester-based elastomers (e.g., polyethylene terephthalate elastomer), polyamide elastomer, urethane-based elastomers (e.g., polyurethane elastomer), olefin-based elastomers (e.g., polyethylene elastomer, polypropylene elastomer), and fluororesin-based elastomers, or mixtures thereof. In particular, a mixture of polyurethane and polyamide elastomer is preferred.

[0018] The material constituting the inner layer 22 may also contain a radiopaque material such as barium sulfate, bismuth oxide, tungsten, or metal powder (e.g., tungsten, iron, platinum, gold, tungsten, tantalum, or iridium). Preferably, the radiopaque material also functions as an electromagnetic wave absorbing material. The material constituting the inner layer 22 may also contain an electromagnetic wave absorbing material such as barium sulfate, bismuth oxide, carbon black (carbon molecules), metal hexaboride compounds, or tungsten oxide-based compounds. Preferably, the electromagnetic wave absorbing material used is also an radiopaque material.

[0019] Furthermore, the material forming the inner layer 22 may have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing pigment. Examples of the electromagnetic wave absorbing pigment include inorganic carbon such as carbon black, ceramics, black pigments, black dyes, inorganic pigments, for example, at least one metal selected from the group consisting of Fe, Cr, Mn, Co, Ni, and Cu, or compounds such as oxides containing the above metals.

[0020] In the catheter 1 of this embodiment, the catheter tube 2 includes a reinforcing member 23. The reinforcing member 23 is preferably located within the outer layer 21. In this embodiment, the reinforcing member 23 is provided on the outer surface of the inner layer 22, and the outer layer 21 is formed so as to cover the inner layer 22 and the reinforcing member 23.

[0021] In addition, in the catheter 1 of this embodiment, the reinforcement body 23 is formed by winding a wire around the outer surface of the inner layer 22. The wire reinforcement body (wire-wound reinforcement body) 23 is preferably formed by winding thin metal wires around the outer surface of the inner layer in a mesh-like or spiral pattern. In particular, the wire-wound reinforcement body 23 is preferably formed by a mesh-like braid (braid) made of interwoven thin wires. Specifically, it is preferably a braid formed by intersecting a plurality of thin wires wound in a first spiral direction at intervals along the axial direction of the inner layer 22 with a plurality of thin wires wound in a second spiral direction different from the first spiral direction at intervals along the axial direction of the inner layer 22.

[0022] The wire forming the reinforcing member 23 is preferably a metal wire, and examples thereof include stainless steel wire, amorphous alloy wire, and X-ray opaque metal wires such as platinum, gold, tungsten, tantalum, and iridium. The amorphous alloy wire is preferably an amorphous alloy wire formed using an iron-silicon-boron alloy, a cobalt-silicon-boron alloy, or an iron-cobalt-chromium-molybdenum-silicon-boron alloy. The wire forming the reinforcing member 23 is preferably a stainless steel wire.

[0023] The wire used to form the wire-wound reinforcement preferably has a diameter of approximately 0.01 to 0.05 mm. The wire winding pitch is preferably 0.2 to 0.8 mm, and more preferably 0.3 to 0.6 mm. The material forming the reinforcement 23 may be an electromagnetic wave absorbing material. The metal material of the metal wire described above has electromagnetic wave absorbing properties.

[0024] In this embodiment, the catheter tube 2 preferably includes a radiopaque marker 24 provided to encase the tip of the reinforcing member 23. The radiopaque marker 24 is preferably formed from an X-ray opaque material (e.g., gold, platinum, tungsten, or an alloy thereof, or a silver-palladium alloy, a platinum-iridium alloy, etc.). This allows the tip of the catheter 1 to be confirmed by X-ray imaging.

[0025] In the catheter 1 of this embodiment, the outer layer 21 extends from the distal end to the proximal end of the catheter tube 2, forming the outer surface of the catheter tube 2. In the catheter 1 of this embodiment, the distal end of the outer layer 21 of the catheter tube 2 is provided with a distal end portion 25 that is more flexible than the main body portion (portion excluding the distal end) of the outer layer 21. The length of the distal end portion 25 is preferably 3.0 to 7.0 mm.

[0026] As for the material for forming the outer layer 21, at least the thermoplastic resin for forming the outer surface of the outer layer 21 at the annular fusion portion 5 with the hub 3 is formed from a thermoplastic resin containing an electromagnetic wave absorbing material. The thermoplastic resin for forming the outer surface of the outer layer 21 at the annular fusion portion 5 with the hub 3 is one that heats (generates heat) and melts when it absorbs electromagnetic waves. Furthermore, it is preferable that the thermoplastic resin for forming the outer surface of the outer layer 21 at the annular fusion portion 5 with the hub 3 is one that heats (generates heat), melts, and expands when it absorbs electromagnetic waves.

[0027] Preferred materials (base materials) for the outer layer 21 include polyurethane, polyamide, modified polyethylene ether polyamide imide, polyetherimide, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefin (e.g., ultra-high molecular weight polyethylene, polypropylene), and thermoplastic elastomers. Preferred thermoplastic elastomers include polyester elastomers (e.g., polyethylene terephthalate elastomer), nylon elastomers (e.g., polyamide elastomer), urethane elastomers (e.g., polyurethane elastomer), olefin elastomers (e.g., polyethylene elastomer, polypropylene elastomer), fluororesin elastomers, and mixtures thereof. Particularly preferred materials for the outer layer 21 include polyamide elastomers, thermoplastic resins containing polyamide elastomers, thermoplastic resins primarily composed of polyamide elastomers, and mixed thermoplastic resins of polyamide elastomer and polyurethane.

[0028] The material forming the outer layer 21 is preferably softer than the material forming the inner layer 22. The material forming the outer layer 21 may also have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing material. Examples of the electromagnetic wave absorbing material include powders of barium sulfate, bismuth oxide, metals (e.g., tungsten, iron, platinum, gold, tungsten, tantalum, and iridium), carbon black (carbon molecules), metal hexaboride compounds, and tungsten oxide-based compounds. The electromagnetic wave absorbing material used is preferably also an X-ray opaque material.

[0029] Furthermore, the material forming the outer layer 21 may have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing pigment. Examples of the electromagnetic wave absorbing pigment include inorganic carbon such as carbon black, ceramics, black pigments, black dyes, inorganic pigments, for example, at least one metal selected from the group consisting of Fe, Cr, Mn, Co, Ni, and Cu, or compounds such as oxides containing the above metals.

[0030] In this embodiment, the entire material forming the outer layer 21 contains an electromagnetic wave absorbing material. Therefore, the entire portion of the outer layer 21 that is irradiated with electromagnetic waves generates heat when absorbing electromagnetic waves. Alternatively, the rear end of the outer layer 21, specifically at least the portion that will become the annular fused portion 5, may contain an electromagnetic wave absorbing material and generate heat when absorbing electromagnetic waves. Alternatively, only the thermoplastic resin forming the outer surface of the tube of the outer layer 21 at the annular fused portion 5 with the hub 3 may contain an electromagnetic wave absorbing material.

[0031] Furthermore, the material forming the outer layer 21 of the catheter tube 2 preferably contains a composite electromagnetic wave absorbing material. In this embodiment, the resin forming the outer layer 21 contains powder of an electromagnetic wave absorbing material, and further includes a reinforcing body made of an electromagnetic wave absorbing material. Furthermore, the electromagnetic wave absorbing material contains powder of an X-ray contrast agent having electromagnetic wave absorbing properties and a pigment having electromagnetic wave absorbing properties. Therefore, the outer layer 21 has good electromagnetic wave absorption properties and exothermic melting properties due to the absorbed electromagnetic waves.

[0032] The content of the electromagnetic wave absorbing material (powder) in the thermoplastic resin containing the electromagnetic wave absorbing material is preferably 10 to 60 parts by weight, and particularly preferably 30 to 50 parts by weight, of the electromagnetic wave absorbing material per 100 parts by weight of the outer layer forming material (including the electromagnetic wave absorbing material).

[0033] The electromagnetic waves include heat, microwaves, visible light, and infrared rays. Infrared rays are near-infrared rays with wavelengths of approximately 0.7 to 2.5 μm, mid-infrared rays with wavelengths of approximately 2.5 to 4 μm, or far-infrared rays with wavelengths of approximately 4 to 1000 μm. The electromagnetic waves may be near-infrared rays, mid-infrared rays, or far-infrared rays alone or in combination of two or more types, or may include visible light or microwaves.

[0034] The method of irradiating electromagnetic waves is not particularly limited, but may be any method capable of irradiating electromagnetic waves, such as laser light irradiation, light emitting diode irradiation, halogen lamp irradiation, or infrared irradiation. Laser light irradiation is particularly preferred as the method of irradiating electromagnetic waves. Laser light irradiation can locally focus high-energy-density light with a uniform wavelength, making it possible to heat and melt the portion that will become the annular fused portion 5 (the outer layer 21 of the catheter tube 2) in a short time. Examples of lasers include YAG laser, ruby ​​laser, glass laser, and YVO ４ Laser, LD laser, solid-state laser such as fiber laser, liquid laser such as dye laser, CO ２ Examples of the laser include gas lasers such as lasers, excimer lasers, Ar lasers, and He--Ne lasers, semiconductor lasers, and free electron lasers.

[0035] A hub 3 is fixed to the proximal end of the catheter tube 2. The hub 3 has a shape and structure as shown in Figures 1 to 4 and 6. Specifically, the hub 3 has a through lumen (internal passage) 30 and a cylindrical main body 31 having two wing portions 34 on its sides, a storage portion 35 provided within the distal end of the main body 31 for storing the rear end of the catheter tube 2, an annular protrusion 36 provided at the rear end of the storage portion 35, a cylindrical distal end portion 33 extending distally from the main body 31, a cylindrical rear end portion 38 extending rearward from the main body 31, and a rib connection portion 32 provided on the outer surface of the rear end of the hub 3. A medical device such as a syringe can be attached to the connection portion 32.

[0036] 1, 4, and 6, the main body 31 is cylindrical, and the tip end of the main body 31 has an outer diameter larger than that of the cylindrical tip end 33. The tip end of the main body 31 has a portion extending with substantially the same outer diameter as the main body 31, and a tip end at the rear end of the same outer diameter portion, and is equipped with two wing portions 34 that protrude in a flat plate shape toward the sides of the main body 31. The two wing portions 34 terminate at the tip end of a cylindrical rear end 38 that extends rearward from the main body 31.

[0037] The hub 3 is formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has heat-sealing properties with the thermoplastic resin for forming the outer surface of the tube (specifically, the outer layer resin). Preferably, the material for forming the hub 3 is electromagnetically transparent and has heat-sealing properties and compatibility with the thermoplastic resin for forming the outer surface of the tube (specifically, the outer layer resin).

[0038] The hub 3 is formed from an electromagnetically transparent thermoplastic resin such as polyamide, polyurethane, modified polyethylene ether polyamide imide, polyetherimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), or polyolefin (e.g., ultra-high molecular weight polyethylene, polypropylene). The hub 3 is preferably formed from a transparent, hard, or semi-hard resin. The hub 3 is preferably formed from a material that does not contain an electromagnetic wave absorbing material.

[0039] When polyamide elastomer, thermoplastic resin containing polyamide elastomer, thermoplastic resin mainly composed of polyamide elastomer, or mixed thermoplastic resin of polyamide elastomer and polyurethane is used as the material for forming the outer layer 21 (thermoplastic resin for forming the outer surface side of the tube), the material for forming the hub 3 is preferably polyamide, which has good heat-fusion properties and compatibility with these materials.

[0040] Examples of polyamides that can be used include polyamide 6 (a polyamide obtained by ring-opening polycondensation of caprolactam), polyamide 11 (a polyamide obtained by ring-opening polycondensation of undecane lactam), polyamide 12 (a polyamide obtained by ring-opening polycondensation of lauryllactam), and polyamide 1010 (a polyamide obtained by copolymerization of sebacic acid and 1,10-decanediamine).

[0041] In the above-described hub 3, the entire hub 3 is formed from a thermoplastic resin that is electromagnetically transparent and has heat fusion properties and preferably compatibility with the thermoplastic resin used to form the outer surface of the tube (specifically, the resin used to form the outer layer). However, the hub 3 may be formed such that only the portion that is fused to the thermoplastic resin used to form the outer surface of the tube, in other words, the portion that becomes the annular inner surface of the portion that forms the annular fused portion 5, is formed from a thermoplastic resin that is electromagnetically transparent and has heat fusion properties and compatibility with the thermoplastic resin used to form the outer surface of the tube.

[0042] The internal shape of the hub 3 will be described with reference to Figures 2, 3, and 6. As shown in Figure 6, the hub 3 has a storage section 35, which is a cylindrical space that expands slightly in diameter toward the tip by an annular protrusion 36 formed in the lumen 30, for storing the rear end of the catheter tube 2. The rear end 26 of the catheter tube 2 inserted into this storage section 35 abuts against the protrusion 36. The lumen 30 also has a tapered section rearward of the protrusion 36, which expands in diameter toward the rear end. As shown in Figures 3 and 4, the hub 3 also has a cylindrical rear end section 38 that extends rearward from the rear end of the tapered section of the lumen 30, maintaining the same inner diameter.

[0043] Next, the manner in which the hub 3 and the rear end of the catheter tube 2 in the catheter 1 of the present invention are fixed to each other will be described with reference to Figures 4, 7, and 13. As shown in Figure 13, the inner diameter of the housing portion 35 of the hub 3 is larger than the outer diameter of the rear end of the catheter tube 2, and when the rear end of the catheter tube 2 is inserted into the housing portion 35 of the hub 3, a cylindrical gap 37 is formed between the inner surface of the housing portion of the hub 3 and the outer surface of the outer layer 21 of the catheter tube 2.

[0044] The inner diameter of the cylindrical cavity 37 increases toward the tip of the hub 3. The thickness of the cylindrical cavity 37, in other words, the difference between the inner diameter of the storage section 35 of the hub 3 and the outer diameter of the rear end of the catheter tube 2, is preferably 0 to 0.05 mm, and more preferably 0.01 to 0.03 mm. The difference in inner diameter between the front and rear ends of the storage section 35 of the hub 3 is preferably 0.01 to 0.1 mm, and more preferably 0.03 to 0.05 mm.

[0045] 4 and 7 , a portion of the rear end of the catheter tube 2 housed in the housing portion 35 of the hub 3 forms an annular fused portion 5, and the hub 3 and the catheter tube 2 are fixed together in an annular shape. The annular fused portion 5 is formed by annularly fusing an annular molten and solidified portion 51 of the thermoplastic resin for forming the outer surface of the tube, which is formed in the lumen portion 30 of the hub 3 (in the housing portion (expanded diameter portion) 35) with the hub-forming thermoplastic resin that forms the inner surface of the lumen portion 30 (housing portion 35) of the hub 3.

[0046] In the catheter of this embodiment, as shown in Figures 4 and 7, the annular fused portion 5 (annular melt-solidified portion 51) is formed in the central portion of the storage portion 35, with a gap 37a in front of the annular fused portion 5, which is a remaining portion of the storage portion 35, and a gap 37b in back of the annular fused portion 5, which is also a remaining portion of the storage portion 35. The axial length of the annular fused portion 5 in the catheter tube 2 is preferably 2 to 10 mm, and more preferably 4 to 8 mm. The axial length of the annular fused portion 5 in the catheter tube 2 is also preferably 1 to 5 times the outer diameter of the catheter tube 2, and more preferably 2 to 4 times.

[0047] The portion of the catheter tube 2 where the annular fused portion 51 is formed is larger in diameter than the portion of the catheter tube 2 axially forward of the annular fused portion 51. In other words, the annular fused portion 5 of the catheter tube 2 is larger in diameter than the portion axially forward of the annular fused portion 5. Furthermore, the annular fused portion 51 is a volumetrically expanded portion where the volume of the catheter tube 2 is partially expanded. The annular fused portion 51 is a heat-generating fused portion that generates heat, melts, and solidifies due to electromagnetic wave absorption. Furthermore, the annular fused portion 5 is formed by fusing the annular fused portion 51 on the catheter tube 2 side with the fused portion on the hub 3 side that is in contact with the annular fused portion 51.

[0048] In this embodiment of the catheter, the material forming the outer layer 21 (the thermoplastic resin forming the outer surface of the tube) contains an electromagnetic wave-absorbing material, and when irradiated with electromagnetic waves, it absorbs the electromagnetic waves, generates heat, and melts. The resin used to form the outer layer 21 expands upon melting. Therefore, when the thermoplastic resin forming the outer surface of the tube of the outer layer 21 is irradiated with electromagnetic waves in a predetermined axial direction, the irradiated portion absorbs the electromagnetic waves, generates heat, melts, expands, and flows into the storage section 35, partially filling the storage section 35 with the molten resin in a circular shape, as shown in FIGS. 4 and 7 .

[0049] Furthermore, the molten resin comes into annular contact with the inner surface of the storage portion 35, which is part of the lumen 30 of the hub 3 at that portion. The inner surface of the storage portion 35 of the hub 3, which comes into contact with the molten thermoplastic resin for forming the outer surface side of the tube of the outer layer 21, is heated. Since the resin forming the hub 3 is formed from a resin that has thermal fusion properties with the material for forming the outer layer 21 (thermoplastic resin for forming the outer surface side of the tube), the hub 3 and the outer layer 21 of the catheter tube 2 are annularly fused together by the annular molten and solidified portion 51, as shown in FIG.

[0050] It is preferable that the increase in volume of the resin forming the outer layer 21 (the thermoplastic resin for forming the outer surface side of the tube) upon melting is larger than the volume of the clearance (gap 37) between the outer surface of the catheter tube 2 and the storage section 35 of the hub 3 at that part before the annular fused portion 5 is formed.

[0051] In the catheter 1 of this embodiment, the resin forming the inner surface of the housing portion 35 of the hub 3 that comes into contact with the molten thermoplastic resin forming the outer surface of the tube, the outer layer 21, is heated and melted, and as shown in Figure 4, the thermoplastic resin forming the outer surface of the tube, the outer layer 21, and the resin forming the inner surface of the housing portion 35 of the hub 3, are compatible with each other at the boundary between them, and are melt-fused together in an annular shape in the annular fused-solidified portion 51. In the catheter 1 of this embodiment, as shown in Figures 4 and 7, the annular fused-solidified portion 51 maintains the fused state between the hub 3 and the outer layer 21 of the catheter tube 2 even after cooling.

[0052] 2, 3, and 7, the catheter 1 of this embodiment is further provided with a kink prevention tube 4 provided to cover the rear end of the catheter tube 2 exposed from the hub 3. The kink prevention tube 4 has a rear portion 41 that covers the cylindrical tip portion 33 of the hub 3, and a small-diameter tip portion 42 that encases the rear end of the catheter tube 2 protruding from the cylindrical tip portion 33 of the hub 3. The tip portion 42 of the kink prevention tube 4 is in close contact with the outer surface of the base end of the catheter tube 2. The provision of such a kink prevention tube 4 prevents kinking of the catheter tube 2 at the tip of the hub 3.

[0053] 7, in the catheter 1 of this embodiment, the tip of the annular fused portion 5 (annular fused and solidified portion 51) is located, in the axial direction of the catheter, closer to the rear end of the catheter than the rear end of the kink prevention tube 4. Therefore, there is no overlapping portion between the annular fused portion 5 (annular fused and solidified portion 51) and the kink prevention tube 4 in the axial direction of the catheter.

[0054] The kink prevention tube 4 is preferably flexible or elastic. The kink prevention tube 4 may be made of elastomers such as olefin elastomers, amide elastomers, and styrene elastomers, synthetic rubbers such as urethane rubber, silicone rubber, and butadiene rubber, and natural rubbers such as latex rubber. The kink prevention tube 4 is preferably made of a material that is electromagnetically transparent.

[0055] The manner in which the hub 3 and the rear end of the catheter tube 2 in the catheter of the present invention are fixed to each other may be the same as that of the catheter 1a of the embodiment shown in Fig. 8. The catheter 1a of the embodiment shown in Fig. 8 differs from the catheter 1 of the above-described embodiment only in the manner in which the hub 3 and the catheter tube 2 are fixed to each other. In the catheter 1a of this embodiment, as shown in Fig. 8, the annular fused portion 5a is formed at the rear end of the storage portion 35, and a gap 37, which is the remaining portion of the storage portion 35, is formed in front of the annular fused portion 5a.

[0056] In the catheter 1a of this embodiment, the rear end of the catheter tube 2 has a rear end surface that is perpendicular to the axial direction, and the rear end surface of the storage section 35 of the hub 3 (the distal end surface of the protruding section 36 of the lumen 30) faces the rear end surface of the catheter tube 2. The rear end surface of the storage section 35 of the hub 3 (the distal end surface of the protruding section 36 of the lumen 30) that faces the rear end surface of the catheter tube 2 may be in contact with each other, or may have a gap (a small gap) therebetween.

[0057] The rear end surface of the catheter tube 2 is fixed to the hub 3 by a rear end surface annular fused portion 5c formed by annularly fusing a portion of the thermoplastic resin for forming the rear end surface of the catheter tube 2 with the hub-forming thermoplastic resin that forms the rear end surface of the lumen of the hub 3. Specifically, the rear end surface of the catheter tube 2 includes the rear end surface annular fused portion 5c formed by annularly fusing a portion of the annular molten and solidified portion 51 of the thermoplastic resin for forming the rear end surface of the catheter tube 2, which is formed in the lumen 30 (inside the storage portion 35) of the hub 3, with the hub-forming thermoplastic resin that forms the rear end surface of the storage portion 35 of the hub 3 (the distal end surface of the protruding portion 36 of the lumen 30).

[0058] In this embodiment, the rear end surface (annular rear end surface) of the catheter tube 2 is irradiated with electromagnetic waves, and the rear end surface of the outer layer 21 also absorbs the electromagnetic waves, generating heat and melting. The molten resin then heats and melts the rear end surface (the distal end surface of the protruding portion 36 of the lumen 30) of the housing portion 35 of the hub 3. As a result, the annular rear end surface of the catheter tube 2, and particularly the rear end surface of the outer layer 21, is fused and fixed to the annular rear end surface of the housing portion 35 of the hub 3 (the distal end surface of the protruding portion 36 of the lumen 30).

[0059] The radially outer end of the rear end surface annular fused portion 5c is continuous with the rear end of the annular fused portion 5a. The radially inner end of the annular fused portion 5c extends flush with the inner surfaces of the lumen 20 and the inner cavity 30 of the hub 3. This makes it possible for the rear end surface annular fused portion 5c to prevent blood from entering or remaining in the lumen 20 and the inner cavity 30 of the hub 3, regardless of the presence of a gap between the outer layer 21 of the catheter tube 2 and the inner surface of the storage portion 35 of the hub 3.

[0060] In this embodiment, the catheter may have the rear end surface annular fused portion 5c, but the rear portion of the annular fused portion 5a may not reach the rear end of the catheter tube (in other words, it may not contact the distal end surface of the protruding portion 36 of the lumen 30). In this case, as with the catheter 1 of the embodiment shown in FIG. 7 and described above, there is a gap between the annular fused portion 5a and the rear end surface annular fused portion 5c. Although the catheter of this embodiment has a gap in front of the annular fused portion 5a as shown in FIG. 8, the distal end of the annular fused portion 5a may extend to the storage portion 35 of the cylindrical distal end portion 33 of the hub 3, thereby eliminating the gap described above. In this embodiment, the rear end of the annular fused portion 5a contacts the distal end surface of the protruding portion 36 of the lumen 30 to form the rear end surface annular fused portion 5c, as described above. However, the rear end of the annular fused portion 5a may not contact the distal end surface of the protruding portion 36 of the lumen 30, but may have a gap.

[0061] In the catheter 1a of this embodiment, the axial length of the catheter tube 2 at the annular fused portion 5a is preferably 2 to 10 mm, more preferably 4 to 8 mm, and is preferably 1 to 5 times the outer diameter of the catheter tube 2, more preferably 2 to 4 times.

[0062] The mode of attachment between the hub and the rear end of the catheter tube in the catheter of the present invention may be like that of the catheter 1b of the embodiment shown in Figures 9 to 11. The catheter 1b of the embodiment shown in Figures 9 to 11 and the catheter 1 of the above-mentioned embodiment have the same basic configuration. The catheter 1b of this embodiment has a tubular member 6 whose rear end enters the distal end of the lumen 30 of the hub 3b and through which the catheter tube 2 passes. The tubular member 6 is formed from a thermoplastic resin for forming the tubular member that contains an electromagnetic wave absorbing material. The rear side of the tubular member 6 is fixed to the hub 3b by an annular fused and solidified portion 51c of the thermoplastic resin for forming the tubular member formed in the lumen 30 of the hub 3b being annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the lumen 30 of the hub 3b.

[0063] The internal shape of the hub 3b will be described with reference to Figures 9 to 11. As shown in Figure 10, the hub 3b has a storage section 35, which is a cylindrical space that expands slightly in diameter toward the tip due to an annular protrusion 36 formed in the lumen 30, and which stores the rear end of the catheter tube 2. The storage section 35 further has a distal enlarged diameter section 35a. The rear end of the distal enlarged diameter section 35a also has a short tapered section that expands in diameter toward the tip.

[0064] The rear end 26 of the catheter tube 2 inserted into this storage section 35 abuts against the protruding section 36. The lumen 30 has a tapered section rearward of the protruding section 36, the diameter of which increases toward the rear end. The hub 3b also has a cylindrical rear end 38 that extends rearward from the rear end of the tapered section of the lumen 30 with the same inner diameter.

[0065] 9 and 11, the catheter 1b has a tubular member 6 with its rear end inserted into the expanded distal end portion 35a of the storage section 35 of the hub 3b. The rear end of the tubular member 6 abuts near the boundary between the expanded distal end portion 35a and the tapered section of the lumen 30. In this embodiment, the distal end of the tubular member 6 protrudes beyond the distal end portion 33 of the hub 3b. The catheter tube 2 passes through the tubular member 6, with its rear end positioned within the rear end portion of the storage section 35.

[0066] Next, the manner in which the hub 3b and the rear end of the catheter tube 2 in the catheter 1b of this embodiment are fixed to each other will be described with reference to Figure 11. The inner diameter of the rear end of the housing section 35 of the hub 3b is larger than the outer diameter of the rear end of the catheter tube 2, and when the rear end of the catheter tube 2 is inserted into the housing section 35 of the hub 3b, a cylindrical gap 37 is formed between the inner surface of the housing section of the hub 3b and the outer surface of the outer layer 21 of the catheter tube 2.

[0067] 11 , in the catheter 1b of this embodiment, an annular fused portion 5b is formed on the front side of the rear end of the catheter tube 2 housed in the housing portion 35 of the hub 3b and on the rear side of the tubular member 6. The annular fused portion 5b is formed by an annular fused portion 51. The annular fused portion 51 includes an annular central fused portion 51a that fuses the outer surface of the outer layer 21, the inner surface of the hub 3, and the rear end surface of the tubular member 6, an annular front fused portion 51b located in front of the central fused portion 51a that fuses the outer surface of the rear side of the tubular member 6 to the inner surface of the hub 3, and an annular rear fused portion 51c located behind the central fused portion 51a that fuses the outer surface of the outer layer 21 to the inner surface of the hub 3. Therefore, the tubular member 6 is fused to the hub 3 by the front fused portion 51b, the outer surface of the outer layer 21 is fused to the inner surface of the hub 3 by the rear fused portion 51c, and the central fused portion 51a is fused to the outer surface of the outer layer 21, the inner surface of the hub 3, and the rear end surface of the tubular member 6. In the catheter 1b of this embodiment, as shown in Figure 11, the annular fused portion 5b is formed from the center to the front of the storage portion 35, and a void portion 37, which is the remaining portion of the storage portion 35, is formed behind the annular fused portion 5b.

[0068] The axial length of the annular fused portion 5b (annular fused portion 51) of the catheter tube 2 is preferably 2 to 4 mm, particularly preferably 2 to 3 mm. The axial length of the catheter tube 2 including the central fused portion 51a and the rear fused portion 51c is preferably 5 to 10 mm, particularly preferably 6 to 8 mm. The axial length of the front fused portion 51b is preferably 2 to 4 mm, particularly preferably 2 to 3 mm.

[0069] Also in this embodiment, the annular molten and solidified portions (central molten and solidified portion 51a and rear molten and solidified portion 51c) on the catheter tube 2 are expanded in diameter from the axial rear side of the annular molten and solidified portion. Furthermore, the central molten and solidified portion 51a and rear molten and solidified portion 51c are volumetrically expanded portions in which the volume of the catheter tube 2 is partially expanded. The central molten and solidified portion 51a and rear molten and solidified portion 51c are exothermic molten and solidified portions formed by absorbing electromagnetic waves. Furthermore, the central molten and solidified portion 51a and rear molten and solidified portion 51c are formed by fusion of the molten and solidified portions on the hub 3b side that come into contact with these portions.

[0070] In the catheter 1b of this embodiment, the annular molten solidified portion (front molten solidified portion 51b) on the tubular member 6 has an expanded diameter portion extending axially forward from the front molten solidified portion 51b. Furthermore, the front molten solidified portion 51b is a volumetrically expanded portion in which the volume of the tubular member 6 is partially expanded. The front molten solidified portion 51b is a heat-generating molten solidified portion formed by absorbing electromagnetic waves. Furthermore, the front molten solidified portion 51b is formed by fusing the molten solidified portion on the hub 3b side that comes into contact with this portion.

[0071] The length of the tubular member 6 is preferably 20 to 50 mm, and more preferably 30 to 40 mm. The length of the tubular member 6 inserted into the hub 3 is preferably 1 to 5 mm, and more preferably 2 to 4 mm. The difference between the inner diameter of the cylindrical cavity 37 and the outer diameter of the rear side of the catheter tube 2 before fusion is preferably 0 to 0.05 mm, and more preferably 0.01 to 0.03 mm. The difference between the outer diameter of the tubular member 6 and the inner diameter of the expanded diameter tip portion 35a of the hub 3 is preferably 0 to 0.05 mm, and more preferably 0.01 to 0.03 mm.

[0072] Furthermore, it is preferable that the volume increase of the resin forming the tubular member 6 when melted is larger than the volume of the clearance (void) between the outer surface of the tubular member 6 at the front molten solidified portion 51b and the expanded diameter portion 35a at the tip of the storage portion of the hub 3b before the formation of the front molten solidified portion 51b.

[0073] Examples of preferred materials (base materials) for the tubular member 6 include polyurethane, polyamide, modified polyethylene ether polyamide imide, polyetherimide, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefin (e.g., ultra-high molecular weight polyethylene, polypropylene), and thermoplastic elastomers. Preferred thermoplastic elastomers include polyester elastomers (e.g., polyethylene terephthalate elastomer), nylon elastomers (e.g., polyamide elastomer), urethane elastomers (e.g., polyurethane elastomer), olefin elastomers (e.g., polyethylene elastomer, polypropylene elastomer), fluororesin elastomers, and mixtures thereof. Particularly preferred materials for the tubular member 6 include polyamide elastomers, thermoplastic resins containing polyamide elastomers, thermoplastic resins primarily composed of polyamide elastomers, and thermoplastic resin mixtures of polyamide elastomer and polyurethane.

[0074] The material forming the tubular member 6 may also have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing material. Examples of such electromagnetic wave absorbing materials include barium sulfate, bismuth oxide, metal powders (e.g., tungsten, iron, platinum, gold, tungsten, tantalum, and iridium), carbon black (carbon molecules), metal hexaboride compounds, and tungsten oxide-based compounds. It is also preferable that the electromagnetic wave absorbing material used is also radiopaque. Furthermore, the material forming the tubular member 6 may have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing pigment. Examples of such electromagnetic wave absorbing pigments include inorganic carbon such as carbon black, ceramics, black pigments, black dyes, and inorganic pigments, such as at least one metal selected from the group consisting of Fe, Cr, Mn, Co, Ni, and Cu, or compounds such as oxides containing such metals.

[0075] The catheter tube 2 and the hub 3b may be fixed in a manner similar to that of a catheter 1c of an embodiment shown in Fig. 12. This catheter 1c has the same basic configuration as the catheter 1b described above. In the catheter 1c of this embodiment, as in the catheter 1b, the annular fused portion 5c is formed by an annular fused portion 51. The annular fused portion 51 includes an annular central fused portion 51a that fuses the outer surface of the outer layer 21, the inner surface of the hub 3b, and the rear end surface of the tubular member 6, an annular front fused portion 51b located in front of the central fused portion 51a that fuses the outer surface of the rear side of the tubular member 6 to the inner surface of the hub 3b, and an annular rear fused portion 51c located behind the central fused portion 51a that fuses the outer surface of the outer layer 21 to the inner surface of the hub 3b.

[0076] 12, the rear molten and solidified portion 51c extends to the rear end of the catheter tube 2. Furthermore, in the catheter 1c of this embodiment, the rear end surface of the catheter tube 2 faces the front end surface of the protruding portion 36 of the lumen portion 30. In the stage of arranging the hub 3b and the catheter tube 2 in the fusion and fixing step described below, the rear end surface of the storage portion 35 of the hub 3b (the front end surface of the protruding portion 36 of the lumen portion 30) that faces the rear end surface of the catheter tube 2 may be in contact with the rear end surface of the catheter tube 2, or may have a gap (a small gap) therebetween.

[0077] The rear end surface of the catheter tube 2 is fixed to the hub 3b by a rear end surface annular fused portion 5c formed by annularly fusing a portion of the thermoplastic resin for forming the rear end surface of the catheter tube 2 with the hub-forming thermoplastic resin for forming the rear end surface of the lumen of the hub 3b. Specifically, the rear end surface of the catheter tube 2 includes a rear end surface annular fused portion 51d formed by annularly fusing a portion of the annular molten and solidified portion 51 of the thermoplastic resin for forming the rear end surface of the catheter tube 2, which is formed in the lumen 30 (inside the storage portion 35) of the hub 3b, with the hub-forming thermoplastic resin for forming the rear end surface of the storage portion 35 of the hub 3b (the distal end surface of the protruding portion 36 of the lumen 30). The catheter tube 2 is also fixed to the hub 3b at this portion.

[0078] In this embodiment, the rear end surface (annular rear end surface) of the catheter tube 2 is irradiated with electromagnetic waves, and the rear end surface of the outer layer 21 also absorbs the electromagnetic waves, generating heat and melting. The molten resin then heats and melts the rear end surface of the housing portion 35 of the hub 3b (the distal end surface of the protruding portion 36 of the lumen 30). As a result, the annular rear end surface of the catheter tube 2, particularly the rear end surface of the outer layer 21, is fused and fixed to the annular rear end surface of the housing portion 35 of the hub 3b (the distal end surface of the protruding portion 36 of the lumen 30). The radially outer end of the rear end surface annular fused portion 51d is continuous with the rear end of the rear fused and solidified portion 51c of the annular fused portion 5c. The radially inner end of the rear end surface annular fused portion 51d extends flush with the inner surfaces of the lumen 20 and the lumen 30 of the hub 3b. As a result, regardless of the presence of a gap between the outer layer 21 of the catheter tube 2 and the inner surface of the storage section 35 of the hub 3 b, the rear end surface annular fused section 51 d can prevent blood from entering or remaining in the lumen 20 and the inner cavity 30 of the hub 3 b.

[0079] In the catheter of this embodiment, the rear portion of the rear fused-solidified portion 51c of the catheter having the rear end surface annular fused portion 51d may not reach the rear end of the catheter tube (in other words, it may not come into contact with the distal end surface of the protruding portion 36 of the lumen 30). In this case, the annular fused portion 5c will have a gap behind the rear fused-solidified portion 51c, similar to the catheter 1b of the embodiment shown in Figure 11 and described above.

[0080] Next, a method for manufacturing a catheter of the present invention will be described with reference to Figures 13 to 15. The method for manufacturing a catheter of the present invention is a method for manufacturing a catheter 1 including a catheter tube 2 having a lumen 20, a tip-end opening 27 communicating with the lumen 20, and a rear-end opening communicating with the lumen 20, and a hub 3 having an inner cavity 30 capable of accommodating the rear end of the catheter tube 2.

[0081] The method for manufacturing a catheter of the present invention includes the steps of: preparing a catheter tube 2, at least the outer surface of the rear end of which is formed from a thermoplastic resin for forming the outer surface of the tube that contains an electromagnetic wave absorbing material; preparing a hub 3, which is formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties (and compatibility) with the thermoplastic resin for forming the outer surface of the tube; and fusing and fixing the rear end of the catheter tube 2 to the inner surface of the lumen 30 of the hub 3 by irradiating electromagnetic waves (e.g., laser light) from outside the hub 3 along the entire circumference (annular shape) of a side surface of a portion of the rear end of the catheter tube 2, thereby fusing the portion of the rear end of the catheter tube 2 to the inner surface of the lumen 30 of the hub 3.

[0082] In the method for manufacturing a catheter of the present invention, a preparation step is carried out before the fusion and fixation step, in which at least the outer surface side of the rear end portion of the catheter tube 2 is formed from a thermoplastic resin for forming the outer surface side of the tube that contains an electromagnetic wave absorbing material.

[0083] The catheter tube 2 is prepared as described above. The catheter tube 2 of this embodiment includes an inner layer 22, a reinforcing member 23 provided on the surface of the inner layer, specifically, wound around it, and an outer layer 21 provided on the inner layer 22 including the reinforcing member 23. To prepare such a catheter tube 2, a tube for forming the inner layer 22 is prepared, or a tube is prepared by extruding a thermoplastic resin into a tubular shape on the surface of a core bar and solidifying it, and then winding a wire in a spiral, mesh, or other shape around the outer surface of the resin tube that forms the inner layer to form the reinforcing member 23. The catheter tube 2 can then be prepared by extruding a thermoplastic resin for forming the outer layer 21 into a tubular shape onto the inner layer 22 including the reinforcing member 23. The outer layer 21, at least on the outer surface side of the rear end of the catheter tube 2, is formed from a thermoplastic resin for forming the outer surface of the tube that contains an electromagnetic wave absorbing material. The materials for forming the inner layer 22, reinforcing member 23, and outer layer 21 are the same as those described for the catheter 1.

[0084] Furthermore, in the method for manufacturing a catheter of the present invention, a preparation step is carried out before the fusion and fixation step, in which the hub 3 is formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has heat fusion properties (and compatibility) with the thermoplastic resin for forming the outer surface of the tube.

[0085] The hub 3 can be prepared by, for example, injection molding a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties (and compatibility) with the thermoplastic resin for forming the outer surface of the tube. The material for the hub 3 is the same as that described for the catheter 1.

[0086] Next, a fusion and fixation step is performed to connect the rear end of the catheter tube 2 to the hub 3. In this fusion and fixation step, as shown in Figure 13 , the rear end of the catheter tube 2 is inserted into the storage section 35 of the lumen 30 of the hub 3, and the stylet section 91 of the jig 9 is advanced into the catheter tube 2, and the base section 92 is advanced into the cylindrical rear end section 38 at the rear end of the hub 3 and fixed to the rear end of the cylindrical rear end section 38. In the jig 9, the stylet section 91 is provided so as to extend along the central axis of the base section 92, and the base section 92 and the stylet section 91 are arranged coaxially. Therefore, in the state shown in Figure 13 , the rear end of the catheter tube 2 with the stylet section 91 advanced is arranged coaxially with the storage section 35 of the lumen 30 of the hub 3, and a tubular gap 37 is formed between the outer surface of the rear end of the catheter tube 2 and the inner surface of the storage section 35 of the lumen 30 of the hub 3. Therefore, there is no portion where the outer surface of the rear end of the catheter tube 2 comes into contact with the inner surface of the storage section 35 of the lumen 30 of the hub 3 .

[0087] In this embodiment, the fusion and fixing step involves irradiating the catheter tube 2 with electromagnetic waves while rotating the catheter tube 2 around its axis. For this purpose, the base 92 of the jig 9 is connected to a rotation drive unit (not shown). An electromagnetic wave irradiation device is then prepared for irradiating the hub 3 with electromagnetic waves from outside. A laser light irradiation device 8 is preferably used as the electromagnetic wave irradiation device. In particular, a laser light irradiation device equipped with a galvano scanner is preferably used as the laser light irradiation device 8. The laser light irradiation device equipped with a galvano scanner includes a laser light source (laser oscillator), a galvano scanner, a laser head (electromagnetic wave irradiator) 81 which is a laser irradiation unit, and a control unit.

[0088] The galvanometer scanner includes a galvanometer mirror and a driver. The galvanometer mirror reflects the emitted light toward the outside of the laser head. The driver rotates the galvanometer mirror. The driver is, for example, a motor, and is controlled by the controller. By driving the galvanometer mirror, the laser light to be irradiated onto the area that will become the annular fused portion is scanned in two dimensions. The laser head has an opening through which the emitted light passes, and the opening is closed by protective glass.

[0089] In the manufacturing method of the catheter of this embodiment, as shown in FIGS. 13 and 14 , the fusion and fixation step involves inserting the rear end of the catheter tube 2 into the lumen 30 (inside the storage section 35) of the hub 3, attaching the jig 9, and then rotating the jig 9 around the central axis of the stylet section 91. While the hub 3 and the catheter tube 2 are rotating together, electromagnetic waves (laser light) are irradiated from outside the tip end 33 of the main body 31 of the hub 3 onto the entire circumference (annular shape) of the side surface of the portion of the rear end of the catheter tube 2 that will become the annular fused section 5.

[0090] As described above, in the catheter 1 of this embodiment, the material forming the outer layer 21 (the thermoplastic resin used to form the outer surface of the tube) contains an electromagnetic wave-absorbing material, and the portion irradiated with laser light absorbs the electromagnetic waves, generates heat, and melts. The resin used to form the outer layer 21 expands as it melts and flows into the storage section 35, partially filling the storage section 35 with molten resin, as shown in Figures 15, 4, and 7. The molten resin then contacts the inner surface of the storage section 35, which is part of the lumen 30 of the hub 3. The inner surface of the storage section 35 of the hub 3 that comes into contact with the molten thermoplastic resin used to form the outer surface of the outer layer 21 is heated. Because the resin forming the hub 3 is formed from a resin that is heat-fusible with the material forming the outer layer 21 (the thermoplastic resin used to form the outer surface of the tube), the hub 3 and the outer layer 21 of the catheter tube 2 are annularly fused together at the annular fused portion 5, as shown in Figure 15.

[0091] In this embodiment, the increase in volume of the resin forming the outer layer 21 (the thermoplastic resin for forming the outer surface of the tube) upon melting is greater than the volume of the clearance (gap 37) between the outer surface of the catheter tube 2 and the housing section 35 of the hub 3 at that portion before the annular fused portion 5 is formed. Therefore, the clearance (gap 37) between the outer surface of the catheter tube 2 and the housing section 35 of the hub 3 is filled with the molten outer layer resin, and the molten outer layer resin and the resin forming the inner surface of the housing section 35 of the hub 3 are compatible with each other at their contact (boundary) and are melt-fused into an annular shape. Then, the molten outer layer resin solidifies to form an annular melt-solidified portion 51.

[0092] The electromagnetic wave irradiation method in the fusion and fixing process in this embodiment and all of the following embodiments is preferably laser irradiation as described above, but any method capable of irradiating electromagnetic waves, such as irradiation by a light-emitting diode, halogen lamp irradiation, or infrared irradiation, may be used. Laser irradiation is particularly preferred as the electromagnetic wave irradiation method. Laser irradiation can locally focus high-energy-density light with a uniform wavelength, making it possible to heat and melt the portion that will become the annular fusion portion 5 (the outer layer 21 of the catheter tube 2) in a short period of time. Examples of lasers that can be used include YAG lasers, ruby ​​lasers, glass lasers, and YVO4 lasers. ４ Laser, LD laser, solid-state laser such as fiber laser, liquid laser such as dye laser, CO ２ Examples of the laser include gas lasers such as Ar lasers, excimer lasers, Ar lasers, and He—Ne lasers, semiconductor lasers, and free electron lasers. Fiber lasers are particularly preferred.

[0093] When laser light irradiation is used, the laser irradiation time varies depending on the output, the material forming the outer layer 21, and the like, but is preferably 2 to 15 seconds, and more preferably 4 to 10 seconds. The laser output for laser light irradiation also varies, but is preferably 30 to 50 W, and more preferably 35 to 45 W. The rotation speed of the hub 3 and catheter tube 2 is preferably 30 to 90 revolutions per minute, and more preferably 50 to 70 revolutions per minute. The number of rotations of the hub 3 and catheter tube 2 during the laser irradiation time is preferably 2 to 10, and more preferably 3 to 6 revolutions.

[0094] Furthermore, in the catheter manufacturing method according to the embodiment of the present invention, a partial fixing step may be performed prior to the fusion fixing step. The rear end of the catheter tube 2 is then inserted into the lumen 30 (storage section 35) of the hub 3, and electromagnetic waves (laser light) are irradiated from the side of the hub 3 toward the catheter tube 2 to partially (temporarily) fix the catheter tube 2 to the hub 3. Specifically, the state shown in FIG. 13 is prepared, and while the hub 3 and the catheter tube 2 are stationary and not rotated, electromagnetic waves (laser light) are irradiated onto the side of the portion that will become the welded portion 5 between the catheter tube 2 and the hub 3, thereby partially melting the outer layer 21 of the catheter tube 2 and temporarily fixing the catheter tube 2 to the hub 3. The laser irradiation time in the temporary fixing step varies depending on the output, the material forming the outer layer 21, and other factors, but is preferably 0.1 to 1 second, and more preferably 0.2 to 0.5 seconds. The laser output for laser light irradiation also varies, but is preferably 30 to 50 W, and more preferably 35 to 45 W. After the temporary fixing step, the above-described fusion fixing step (full fixing step) is performed. The fusion fixing step (full fixing step) requires a shorter laser irradiation time and a lower rotation speed than when the temporary fixing step is not performed. The manufacturing method of this embodiment allows the catheter tube 2 to be fixed with a lower rotation speed. Therefore, when the distal end of the catheter tube 2 is pre-curved (for example, a Judkins L shape or a Cobra shape in the case of an angiography catheter), the curved shape can be easily handled.

[0095] If the catheter 1 is equipped with a kink prevention tube 4, the kink prevention tube 4 is attached to the outer surfaces of the catheter tube 2 and the hub 3 after the above-mentioned fusion and fixing step. The kink prevention tube 4 is attached so that the expanded rear portion 41 covers the cylindrical tip portion 33 of the hub 3 and the narrowed tip portion 42 encloses the rear end of the catheter tube 2 that protrudes from the cylindrical tip portion 33 of the hub 3. Note that the kink prevention tube 4 may be attached to the outer surfaces of the catheter tube 2 and the hub 3 before the above-mentioned fusion and fixing step.

[0096] 9 to 11, the catheter 1b is prepared in the following manner: the rear end of the catheter tube 2 is inserted into the storage section 35 of the lumen 30 of the hub 3b, the rear end of the tubular member 6, through which the catheter tube 2 passes, is inserted into the expanded-diameter distal end section 35a of the storage section 35 of the hub 3b, and the stylet section 91 of the jig 9 is inserted into the catheter tube 2, and the base section 92 is inserted into the cylindrical rear end section 38 at the rear end of the hub 3b and fixed to the rear end of the cylindrical rear end section 38, as in the above-described embodiment. The stylet section 91 of the jig 9 is provided so as to extend along the central axis of the base section 92, and the base section 92 and stylet section 91 are coaxially arranged. 16 , the rear end of the catheter tube 2 with the stylet portion 91 inserted is disposed coaxially with the housing portion 35 of the lumen 30 of the hub 3, and a tubular gap 37 is formed between the outer surface of the rear end of the catheter tube 2 and the inner surface of the housing portion 35 of the lumen 30 of the hub 3. Therefore, there is no portion where the outer surface of the rear end of the catheter tube 2 and the inner surface of the housing portion 35 of the lumen 30 of the hub 3 come into contact.

[0097] In this embodiment as well, the base 92 of the jig 9 is connected to a rotation drive unit (not shown). In the fusion and fixation process, the jig 9 is rotated about the central axis of the stylet portion 91, and while the hub 3 and the catheter tube 2 are rotated, electromagnetic waves (laser light) are irradiated from the tip of the main body 31 of the hub 3 b and the outside of the tip portion 33 onto the entire circumference (annular shape) of the side surface of the portion that will become the weld portion 5 at the rear end of the catheter tube 2 (the rear end side of the tubular member 6, the tip portion 33 of the hub 3 b, and the tip side of the main body 31 of the hub 3 b).

[0098] In the catheter 1b of this embodiment, as described above, the material forming the outer layer 21 (the thermoplastic resin for forming the outer surface of the tube) and the tubular member 6 contain an electromagnetic wave-absorbing material, and the portion irradiated with laser light absorbs the electromagnetic waves, generates heat, and melts. The resin used to form the outer layer 21 expands upon melting and flows into the storage section 35, partially filling the storage section 35 with molten resin, as shown in FIG. 11. Furthermore, the resin used to form the tubular member 6 absorbs the electromagnetic waves, generates heat, and expands upon melting. As shown in FIG. 11, the resin flows into the gaps between the inner surfaces of the hub 3 and fills the gaps with molten resin. The molten thermoplastic resin for forming the outer layer 21 and the molten resin of the tubular member 6 come into contact with the inner surface of the hub 3b at the corresponding portion, heating the inner surface. The resin forming the hub 3 is formed from a resin that has thermal fusion properties with the materials forming the outer layer 21 and the tubular member 6. Therefore, the hub 3b, the outer layer 21 of the catheter tube 2, and the tubular member 6 are fused together in an annular shape, as shown in FIG. 11, to form an annular melted and solidified portion 51.

[0099] In this embodiment, the increase in volume of the molten resin of the outer layer 21 and the tubular member 6 upon melting is greater than the volume of the clearance (void 37) between the outer surface of the catheter tube 2 and the storage section 35 of the hub 3 b at the annular fused portion 5 (annular melt-solidified portion 51) before the formation of that portion. Therefore, the clearance (void 37) between the outer surfaces of the catheter tube 2 and the tubular member 6 and the storage section 35 of the hub 3 is filled with the molten outer layer forming resin, and further, the molten forming resin and the resin forming the inner surface of the storage section 35 of the hub 3 are compatible with each other at the contact point (boundary) between them, thereby melting and welding them together in an annular shape.

[0100] In the catheter manufacturing method of this embodiment, when laser light irradiation is used, the laser irradiation time varies depending on the output, the materials forming the outer layer 21 and the annular member 6, etc., but is preferably 2 to 15 seconds, and more preferably 4 to 10 seconds. The laser output for laser light irradiation also varies, but is preferably 30 to 50 W, and more preferably 35 to 45 W. The rotation speed of the hub 3b and the catheter tube 2 is preferably 30 to 90 revolutions per minute, and more preferably 50 to 70 revolutions per minute. The number of rotations of the hub 3 and the catheter tube 2 during the laser irradiation time is preferably 2 to 10, and more preferably 3 to 6.

[0101] In the fusion and fixing step in the above-described embodiment, while the hub 3b and the catheter tube 2 are rotated, electromagnetic waves (laser light) are irradiated all around (annularly) on the side surface of the portion that will become the annular fused portion 5b at the rear end of the catheter tube 2. However, the present invention is not limited to this. For example, the fusion and fixing step may involve irradiating electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates electromagnetic waves around the axis of the catheter tube 2. Specifically, while the hub 3b and the catheter tube 2 are stationary, the laser light irradiator may irradiate the laser while rotating around the outer periphery of the catheter tube 2 at a predetermined rotation diameter so that the center of the portion that will become the annular fused portion 5b of the catheter tube 2 is the central axis.

[0102] Furthermore, in the method for manufacturing the catheter of the present invention, a temporary fixing step may be performed before the fusion fixing step, in which the rear end of the tubular member 6 is inserted into the lumen 30 of the hub 3b (inside the storage section 35), the rear end of the catheter tube 2 is penetrated through the tubular member 6 and advanced into the lumen 30 of the hub 3b, and then electromagnetic waves (laser light) are irradiated from the side of the hub 3b toward the rear end of the tubular member 6, thereby temporarily fixing the rear end of the tubular member 6 to the catheter tube 2.

[0103] 16 is prepared, and while the hub 3b and the catheter tube 2 are not rotated but are stationary, electromagnetic waves (laser light) are irradiated onto the side of the portion that will become the welded portion 5 with the tubular member 6 to partially melt the outer layer 21 of the catheter tube 2, thereby performing the temporary fixing step of the tubular member 6 to the catheter tube 2. Note that in the temporary fixing step, the tubular member 6 is preferably temporarily fixed to the catheter tube 2 and the hub 3b. In this case, the tubular member 6 is preferably one that absorbs electromagnetic waves (laser light), generates heat, and melts.

[0104] The laser irradiation time in the temporary fixing step is not uniform depending on the output and the material forming the outer layer 21, but is preferably 0.1 to 1 second, and more preferably 0.2 to 0.5 seconds. The laser output in the laser light irradiation is also not uniform, but is preferably 30 to 50 W, and more preferably 35 to 45 W.

[0105] After the temporary fixing step, as in the above-described embodiment, the jig 9 is rotated about its central axis. With the hub 3b and the catheter tube 2 rotated, a fusion fixing step (full fixing step) is performed in which electromagnetic waves (laser light) are irradiated from outside the distal end 33 of the main body 31 of the hub 3 onto the entire circumference (annular shape) of the side surface of the portion of the rear end of the catheter tube 2 that will become the welded portion 5b. Note that the fusion fixing step (full fixing step) may require a shorter laser irradiation time and a lower rotation speed than when the temporary fixing step described above is not performed. Furthermore, in the catheter manufacturing method of this embodiment, as in the above-described embodiment, a partial fixing step may be performed before the fusion fixing step. This partial fixing step involves inserting the rear end of the catheter tube 2 into the lumen 30 (storage portion 35) of the hub 3, and then irradiating the catheter tube 2 with electromagnetic waves (laser light) from the side surface of the hub 3 toward the catheter tube 2, thereby partially (temporarily) fixing the catheter tube 2 to the hub 3. The partial fixing step between the hub 3 and the catheter tube 2 is as described above.

[0106] The laser irradiation time in this fixation step varies depending on the output, the material forming the outer layer 21, and the like, but is preferably 2 to 15 seconds, and more preferably 4 to 10 seconds. The laser output for laser light irradiation also varies, but is preferably 30 to 50 W, and more preferably 35 to 45 W. The rotation speed of the hub 3 and the catheter tube 2 is preferably 5 to 20 revolutions per minute, and more preferably 10 to 15 revolutions per minute. The number of revolutions of the hub 3 and the catheter tube 2 during the laser irradiation time is preferably 1 to 4, and more preferably 1 to 2. Fixation can be achieved with a small number of revolutions of the catheter tube 2, and when a curved shape is previously formed at the tip of the catheter tube 2 (for example, a Judkins L shape or a Cobra shape in the case of an angiography catheter), the curved shape can be easily handled.

[0107] The fusion and fixing step in the catheter manufacturing method of the present invention may be as shown in Fig. 17. In this embodiment, the fusion and fixing step is performed by using an electromagnetic wave emitting device that emits electromagnetic waves from three or more directions that are equiangularly spaced apart with respect to the axis of the catheter tube, as shown in Fig. 17.

[0108] 17 , a plurality of laser beam irradiators, specifically three or more, are arranged outside the catheter tube 2 at equal angular intervals with respect to the axis (central axis) of the catheter tube 2. In this embodiment, three laser beam irradiators 8a, 8b, and 8c are arranged at equal angles, and the laser heads (electromagnetic wave irradiators) 81 of the three laser beam irradiators 8a, 8b, and 8c can irradiate laser beams onto the entire outer peripheral surface of the portion that will form the annular fused portion 5 of the catheter tube 2. Therefore, no portion is formed in the outer layer 21 that will become the annular fused portion 5 and is not irradiated with laser beams.

[0109] 17, the portion of the outer layer 21 irradiated by the laser head (electromagnetic wave irradiator) 81 located to the side, farther away from the laser head (electromagnetic wave irradiator) 81, overlaps with the portion irradiated by the adjacent laser head (electromagnetic wave irradiator) 81. Therefore, the entire outer peripheral surface of the portion forming the annular fused portion 5 of the catheter tube 2 is irradiated with a sufficient amount of laser light.

[0110] In the fusion and fixation step of this embodiment, similarly to the above-described fusion and fixation step, it is preferable to prepare a state in which the rear end of the catheter tube 2 is inserted into the housing portion 35 of the lumen portion 30 of the hub 3, and further, the stylet portion 91 of the jig 9 advances into the catheter tube 2, and the base portion 92 advances into the cylindrical rear end portion 38 at the rear end of the hub 3 and is fixed to the rear end portion of the cylindrical rear end portion 38, as shown in FIG. 13 .

[0111] Furthermore, the jig 9 is provided with a stylet portion 91 extending along the central axis of the base portion 92, and it is preferable that the base portion 92 and the stylet portion 91 are coaxially disposed. As a result, the rear end of the catheter tube 2 into which the stylet portion 91 has advanced is coaxially disposed with respect to the storage portion 35 of the lumen portion 30 of the hub 3, and a tubular gap 37 is formed between the outer surface of the rear end of the catheter tube 2 and the inner surface of the storage portion 35 of the lumen portion 30 of the hub 3. Therefore, there is no portion where the outer surface of the rear end of the catheter tube 2 and the inner surface of the storage portion 35 of the lumen portion 30 of the hub 3 come into contact.

[0112] Furthermore, when manufacturing the catheter 1b of the embodiment shown in Figures 9 to 11, a method may be used in which an electromagnetic wave emitting body emitting electromagnetic waves irradiates electromagnetic waves from three or more directions at equal angular intervals with respect to the axis of the catheter tube, as shown in Figure 17 above.

[0113] In the fusion and fixing process of the catheter tube 2 and the hub 3, 3b in the catheters 1a, 1c of the embodiments shown in Figures 8 and 12, a laser beam is irradiated onto the rear end of the catheter tube 2, as shown in Figure 18. In Figure 18, the laser head 81, which is located closest to the rear end of the catheter, of the laser beam irradiation device 8 is positioned outside the rear end of the catheter tube 2. Therefore, the rear end of the catheter tube 2 (specifically, the outer surface and rear end face of the outer layer 21) is heated and melted by the laser irradiation. As a result, a part of the annular molten and solidified portion 51 of the thermoplastic resin for forming the rear end face of the catheter tube 2, which is formed in the lumen 30 (in the storage portion 35) of the hub 3, 3b, is annularly fused to the hub-forming thermoplastic resin for forming the rear end face of the storage portion 35 of the hub 3, 3b (the distal end surface of the protruding portion 36 of the lumen 30), thereby forming the rear end face annular fused portion 5c, 51d.

[0114] The mode of attachment between the hub and the rear end of the catheter tube in the catheter of the present invention may be like that of the catheter 1d of the embodiment shown in Figures 19 to 21. The catheter 1d of the embodiment shown in Figures 19 to 21 has the same basic configuration as the catheter 1 of the above-mentioned embodiment.

[0115] Similar to the catheter 1 described above, the catheter 1d of this embodiment comprises a catheter tube 2 having a lumen 20, a tip-side opening 27 communicating with the lumen 20, and a rear-side opening communicating with the lumen 20, and a hub 3 having an inner cavity 30 capable of accommodating the rear end of the catheter tube 2. The catheter 1d also has a covering member 7 that covers part of the outer circumferential surface of the rear end of the catheter tube 2. The covering member 7 is formed from a thermoplastic resin for forming the covering member that contains an electromagnetic wave absorbing material, and the hub 3 is formed from a thermoplastic resin for forming the hub that is electromagnetic wave absorbing and has thermal adhesive properties with the thermoplastic resin for forming the covering member. 19 to 21 , a portion of the rear end of the catheter tube 2 coated with the coating member 7 extends into the distal end of the hub, and an annular fused portion 71 of the thermoplastic resin for forming the coating member formed in the lumen 30 of the hub 3 (inside the storage section (expanded diameter section) 35) is annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the lumen (expanded diameter section 35) of the hub 3. As a result, the rear end of the catheter tube 2 coated with the coating member 7 is fixed to the hub 3 by the annular fused portion 5 (annular fused portion 71).

[0116] In particular, in the catheter 1d of this embodiment, an annular molten and solidified portion 71 of the thermoplastic resin for forming the covering member is formed within the lumen 30 of the hub 3 over the entire length of the covering member 7. Therefore, the entire covering member 7 is annularly fused to the thermoplastic resin for forming the hub, which forms the inner surface of the lumen 30 of the hub 3. Furthermore, in this embodiment, the covering member 7 covers the entire outer periphery of a portion of the catheter tube.

[0117] 19 to 21, a catheter 1d uses a tubular member 7 through which a catheter tube 2 passes as the covering member 7. In addition, a catheter 1e shown in Fig. 22 uses a band-shaped covering member 7a wrapped around the entire outer periphery of a portion of the catheter tube 2. Furthermore, in a catheter 1f shown in Fig. 23, the inner cavity of the hub (expanded diameter portion 35) expands in diameter toward the tip, and a covering member 7b also expands in diameter toward the tip to fit the inner cavity of the hub.

[0118] 19 to 21 , the catheter 1d of this embodiment includes a catheter tube 2, a hub 3 to which the rear end of the catheter tube 2 is fixed, a covering member 7 that covers part of the outer circumferential surface of the catheter tube 2, and a kink prevention tube 4. The hub 3 of this embodiment is the same as the hub 3 described above, including its internal shape. As shown in FIGS. 19 and 21 , the hub 3 includes a storage section 35, which is a cylindrical space whose diameter expands slightly forward toward the tip, due to an annular protrusion 36 formed in the lumen 30. The storage section 35 is capable of storing the covering member 7 and the rear end of the catheter tube 2.

[0119] The catheter tube 2 of this embodiment is preferably made of the same material as the catheter tube 2 described above. In the catheter 1d of this embodiment, at least the outer surface of the rear end of the catheter tube 2 is preferably formed from a thermoplastic resin for forming the tube outer surface that has thermal fusion properties with the thermoplastic resin for forming the covering member. Similarly to the catheter tube 2 described above, at least the outer surface of the rear end of the catheter tube 2 is preferably formed from a thermoplastic resin for forming the tube outer surface that contains an electromagnetic wave absorbing material. The rear end of the catheter tube 2 is preferably annularly fused to an annular molten and solidified portion 71 (annular fused portion 5) of the thermoplastic resin for forming the covering member formed within the lumen of the hub. The rear end 26 of the catheter tube 2 inserted into the housing 35 abuts against the protruding portion 36. The lumen 30 has a tapered portion rearward from the protruding portion 36, the diameter of which increases toward the rear end. The hub 3 also has a cylindrical rear end 38 that extends rearward from the rear end of the tapered portion of the lumen 30 with the same inner diameter.

[0120] In a catheter 1d according to an embodiment shown in Figures 19 to 21, a tubular member 7 through which a catheter tube 2 passes is used as the covering member 7. As shown in Figures 19 and 21, in the catheter 1d, the tubular member 7 is entirely inserted into the housing portion 35 of the hub 3. In this embodiment, the tubular member 7 is disposed so as to be spaced apart from the front and rear ends of the housing portion 35 of the hub 3. Therefore, a gap is formed between the housing portion 35 of the hub 3 and the outer surface of the catheter tube 2 on the front side of the tubular member 7. A gap is also formed between the housing portion 35 of the hub 3 and the outer surface of the catheter tube 2 on the rear side of the tubular member 7. In this embodiment, the tubular member 7 is located in the axial middle of the housing portion 35 of the hub 3. The catheter tube 2 passes through the tubular member 7, and its rear side is located within the rear end portion of the housing portion 35.

[0121] Next, the manner in which the hub 3 and the rear end of the catheter tube 2 in the catheter 1d of this embodiment are fixed to each other will be described with reference to Figures 19, 21, and 24. The inner diameter of the storage section 35 of the hub 3 is larger than the outer diameter of the tubular member 7, and when the rear end of the catheter tube 2 with the tubular member 7 attached is inserted into the storage section 35 of the hub 3, a small gap 35c (clearance) is formed between the outer surface of the tubular member 7 and the inner surface of the storage section 35 of the hub 3. The aforementioned gap is also formed between the outer surface of the catheter tube 2 and the inner surface of the storage section 35 of the hub 3.

[0122] As shown in Figure 21, in the catheter 1d of this embodiment, the annular fused portion 5 is formed by the covering member (tubular member) 7 housed in the housing portion 35 of the hub 3. The annular fused portion 5 is formed by an outer annular fused-solidified portion 71 formed by melting the tubular member 7. The outer annular fused-solidified portion 71 is annular and fuses the inner surface of the hub 3 to the outer surface of the tubular member 7. In this embodiment, the outer annular fused-solidified portion 71 is formed by the entire outer surface of the tubular member 7. Note that one or more annular fused-solidified portions 71 may be provided at a portion of the tubular member 7 in the axial direction, for example, at the central portion, the tip portion, or the rear portion in the axial direction.

[0123] The annular fused portion 5 preferably includes an inner annular fused-solidified portion 72 formed by melting the tubular member 7. The inner annular fused-solidified portion 72 fuses the outer surface of the catheter tube 2 to the inner surface of the tubular member 7. In this embodiment, the inner annular fused-solidified portion 72 is formed by the entire inner surface of the tubular member 7. One or more inner annular fused-solidified portions 72 may be provided at a portion of the tubular member 7 in the axial direction, such as the central portion, the tip portion, or the rear portion in the axial direction.

[0124] In a catheter 1e of the embodiment shown in FIG. 22 , a strip-shaped covering member 7a is used as the covering member, wrapped around the outer peripheral surface of a portion of the catheter tube 2. The strip-shaped covering member 7a is wrapped around the entire outer peripheral surface of a portion of the catheter tube 2. One end of the strip-shaped covering member 7a faces the other end, with no substantial gap between them (abutment 73). In particular, it is preferable that the one end and the other end of the strip-shaped covering member 7a abut linearly at the abutment 73. In a catheter 1f of the embodiment shown in FIG. 23 , the lumen 35 of the hub 3 expands in diameter toward the distal end, and a covering member 7b is used that also expands in diameter toward the distal end to match the shape of the lumen 35 of the hub. Specifically, as shown in FIG. 23 , a tubular member 7b expanding in diameter toward the distal end is used as the covering member 7b.

[0125] The axial length of the covering member 7 (the above-described tubular member 7, covering member 7a, and tubular member 7b) is preferably 3 to 8 mm, and particularly preferably 3.5 to 7.5 mm. The axial length of the covering member 7 is preferably 1 / 5 to 1 / 2 of the axial length of the storage portion 35 of the hub 3, and particularly preferably 1 / 4 to 1 / 3. The difference between the inner diameter of the cylindrical gap portion 37 and the outer diameter of the covering member 7 before fusion is preferably 0 to 0.05 mm, and more preferably 0.01 to 0.03 mm. The wall thickness of the covering member 7 is preferably 0.01 to 0.05 mm, and more preferably 0.02 to 0.03 mm. The axial length of the annular fused portion 5 (annular melt-solidified portion 71) is preferably 1 / 2 to 1 / 1 of the axial length of the covering member 7, and particularly preferably 2 / 3 to 1 / 1. Specifically, the axial length of the annular fused portion 5 (annular melt-solidified portion 71) is preferably 3 to 8 mm, and more preferably 3.5 to 7.5 mm.

[0126] The covering member 7 is preferably located at a central portion in the axial direction of the storage section 35 of the hub 3. Specifically, any portion of the covering member 7 is preferably located at a central portion in the axial direction of the storage section 35 of the hub 3. The distal end of the covering member 7 is preferably located a predetermined length rearward from the distal end of the storage section 35 of the hub 3. Specifically, the distal end of the covering member 7 is preferably located 0.5 to 3.0 mm rearward from the distal end of the storage section 35 of the hub 3. The rear end of the covering member 7 is preferably located a predetermined length distal from the rear end of the storage section 35 of the hub 3 (the rear end of the catheter tube 2). Specifically, the rear end of the covering member 7 is preferably located 1.0 to 3.0 mm distal from the rear end of the storage section 35 of the hub 3 (the rear end of the catheter tube 2).

[0127] The outer annular fused and solidified portion 71 on the covering member 7 is a volumetrically expanded portion where the volume of the covering member 7 has partially expanded. The annular fused and solidified portion 71 of the covering member 7 is a heat-generated fused and solidified portion formed by absorbing electromagnetic waves. Furthermore, the annular fused portion 5 is formed by fusing the fused and solidified portion on the hub 3 side that contacts this portion. In the catheter 1d of this embodiment, the annular fused portion 5 (outer annular fused and solidified portion 71) on the covering member 7 has a slightly enlarged diameter portion on the axially forward side. Furthermore, the volume of the annular fused portion 5 (outer annular fused and solidified portion 71) on the forward side is a volumetrically expanded portion. Note that it is preferable that the volumetric increase of the resin forming the covering member 7 upon melting is greater than the volume of the clearance (gap) between the outer surface of the covering member 7 and the enlarged diameter portion 35a of the housing tip of the hub 3 at that portion before the annular fused and solidified portion 71 is formed.

[0128] Preferred materials (base materials) for the covering member 7 include polyurethane, polyamide, modified polyethylene ether polyamide imide, polyetherimide, polyimide, polyester (e.g., polyethylene terephthalate, polybutylene terephthalate), polyolefin (e.g., ultra-high molecular weight polyethylene, polypropylene), and thermoplastic elastomers. Preferred thermoplastic elastomers include polyester elastomers (e.g., polyethylene terephthalate elastomer), nylon elastomers (e.g., polyamide elastomer), urethane elastomers (e.g., polyurethane elastomer), olefin elastomers (e.g., polyethylene elastomer, polypropylene elastomer), fluororesin elastomers, and mixtures thereof. Particularly preferred materials for the covering member 7 include polyamide elastomers, thermoplastic resins containing polyamide elastomers, thermoplastic resins primarily composed of polyamide elastomers, and thermoplastic resin mixtures of polyamide elastomer and polyurethane. Furthermore, the material for the covering member 7 preferably has a lower glass transition temperature than the material for the hub 3. Furthermore, it is preferable that the material for forming the covering member 7 has a lower glass transition point than the material for forming the catheter tube 2, particularly the material for forming the outer layer 21 of the catheter tube 2.

[0129] The material forming the covering member 7 may also have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing material. Examples of such electromagnetic wave absorbing materials include barium sulfate, bismuth oxide, metal powders (e.g., tungsten, iron, platinum, gold, tungsten, tantalum, and iridium), carbon black (carbon molecules), metal hexaboride compounds, and tungsten oxide-based compounds. Preferably, the electromagnetic wave absorbing material used is also radiopaque. Furthermore, the material forming the covering member 7 may have electromagnetic wave absorbing properties by containing an electromagnetic wave absorbing pigment. Examples of such electromagnetic wave absorbing pigments include inorganic carbon such as carbon black, ceramics, black pigments, black dyes, and inorganic pigments, such as at least one metal selected from the group consisting of Fe, Cr, Mn, Co, Ni, and Cu, or compounds such as oxides containing such metals.

[0130] 19 to 23, the catheters 1d, 1e, and 1f are preferably manufactured as follows: The manufacturing method of the catheters is a method for manufacturing a catheter comprising a catheter tube 2 having a lumen 20, a tip-end opening 27 communicating with the lumen 20, and a rear-end opening communicating with the lumen 20, a covering member 7 covering part of the outer circumferential surface of the catheter tube 2, and a hub 3 having an inner cavity 35 capable of accommodating the rear end of the catheter tube 2 covered with the covering member 7.

[0131] The catheter manufacturing method of this embodiment includes a covering member preparation step of preparing a covering member 7 capable of covering a portion (preferably the entire circumference) of the outer periphery of the rear end of the catheter tube 2 and formed from a thermoplastic resin containing an electromagnetic wave absorbing material, a hub preparation step of preparing a hub 3 formed from a hub-forming thermoplastic resin that is electromagnetically transparent and has thermal adhesive properties with the thermoplastic resin used to form the covering member, and a fusion fixing step of irradiating electromagnetic waves in a circular pattern from the side of the hub 3 toward the covering member 7 with the rear end of the catheter tube 2 covered with the covering member 7 inserted into the lumen 30 (into the expanded diameter portion 35) of the hub 3, thereby melting the covering member 7 in a circular pattern and fusing it to the inner surface of the lumen 30 (into the expanded diameter portion 35) of the hub 3. The covering member preparation step of preparing the covering member 7 formed from a thermoplastic resin containing an electromagnetic wave absorbing material and the hub preparation step of preparing the hub 3 formed from a hub-forming thermoplastic resin that is electromagnetically transparent and has thermal adhesive properties with the thermoplastic resin used to form the covering member are preferably performed in the same manner as in the above-described embodiment.

[0132] In the fusion and fixing step, the outer surface of the catheter tube 2 and the covering member 7 are preferably fused and fixed by the annularly molten covering member 7. Furthermore, in the fusion and fixing step, similar to the manufacturing method of the above-described embodiment (see FIG. 13 ), a jig 9 is prepared in such a state that the stylet portion 91 of the jig 9 is inserted into the catheter tube 2 and the base portion 92 is inserted into the cylindrical rear end portion 38 at the rear end of the hub 3 and fixed to the rear end portion of the cylindrical rear end portion 38. In the jig 9, the stylet portion 91 is provided so as to extend along the central axis of the base portion 92, and the base portion 92 and the stylet portion 91 are arranged coaxially.

[0133] In this embodiment as well, the base 92 of the jig 9 is connected to a rotation drive unit (not shown). In the fusion and fixation process, the jig 9 is rotated about the central axis of the stylet portion 91, and while the catheter tube 2 having the hub 3 and the covering member 7 is rotated, electromagnetic waves (laser light) are irradiated from the tip of the main body 31 of the hub 3 and from outside the tip portion 33 onto the entire circumference (annular shape) of the side surface of the portion of the covering member 7 that will become the weld portion 5 (the entire length of the covering member 7).

[0134] As described above, in the catheters 1d, 1e, and 1f of this embodiment, the material forming the covering member 7 is a thermoplastic resin containing an electromagnetic wave absorbing material, and the portion irradiated with laser light absorbs the electromagnetic waves, generates heat, and melts. The resin used to form the covering member 7 absorbs the electromagnetic waves, generates heat, and expands as it melts, flowing into the gap between the inner surfaces of the hub 3 and filling the gap with molten resin. The molten resin of the covering member 7 comes into contact with the inner surface of the hub 3 and heats the inner surface. Because the resin forming the hub 3 is formed from a resin that has thermal fusion properties with the material forming the covering member 7, the hub 3 and the covering member 7 are fused together in an annular shape, forming an annular fused portion 5 and an annular melted and solidified portion 71, as shown in FIG. 21 .

[0135] Furthermore, the molten resin of the covering member 7 comes into contact with the outer layer 21 of the catheter tube 2 and heats the outer surface of the outer layer 21. In this embodiment, the outer layer 21 of the catheter tube 2 is formed from a resin that has thermal fusion properties with the material of the covering member 7, so that the covering member 7 is annularly fused to the outer layer 21 of the catheter tube 2 to form an inner annular fused and solidified portion 72, as shown in Fig. 21. If the material of the outer layer 21 of the catheter tube 2 (the thermoplastic resin for forming the outer surface of the tube) contains an electromagnetic wave absorbing material, it will absorb electromagnetic waves, generate heat, and melt when irradiated with laser light, thereby improving fusion bonding.

[0136] In the catheters 1d, 1e, and 1f of this embodiment, laser light is irradiated onto the covering member 7, as shown in Figure 24. In Figure 24, the laser head 81 of the laser light irradiator 8 located closest to the distal end of the covering member is located at the distal end of the covering member 7 or slightly forward of the distal end. Furthermore, the laser head 81 of the laser light irradiator 8 located closest to the proximal end of the covering member 7 is located at the proximal end of the covering member 7 or slightly rearward of the proximal end. Therefore, the covering member 7 (specifically, the entire covering member 7) is heated and melted by laser irradiation. As a result, the annular fused portion 5 of the thermoplastic resin for forming the covering member 7, which is formed within the lumen 30 (inside the storage portion 35) of the hub 3, is annularly fused to the hub-forming thermoplastic resin that forms the inner surface of the storage portion 35 of the hub 3, thereby forming an annular fused portion 5.

[0137] When laser light irradiation is used in the catheter manufacturing method of this embodiment, the laser irradiation time varies depending on the output, the material forming the covering member 7, etc., but is preferably 2 to 15 seconds, and more preferably 4 to 10 seconds. The laser output for laser light irradiation also varies, but is preferably 30 to 50 W, and more preferably 35 to 45 W. The rotation speed of the hub 3 and catheter tube 2 is preferably 30 to 90 revolutions per minute, and more preferably 50 to 70 revolutions per minute. The number of rotations of the hub 3 and catheter tube 2 during the laser irradiation time is preferably 2 to 10, and more preferably 3 to 6.

[0138] In the fusion and fixing step in the above-described embodiment, while the hub 3 and the catheter tube 2 are rotated, electromagnetic waves (laser light) are irradiated all around (annularly) on the side surface of the portion (covering member 7 portion) that will become the annular fused portion 5 at the rear end of the catheter tube 2. However, the present invention is not limited to this. For example, the fusion and fixing step may involve irradiating electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates electromagnetic waves around the axis of the catheter tube 2. Specifically, while the hub 3 and the catheter tube 2 are stationary, the laser light irradiator may irradiate the laser while rotating around the outer periphery of the catheter tube 2 at a predetermined rotation diameter so that the center of the portion of the catheter tube 2 that will become the annular fused portion 5 (covering member 7 portion) is the central axis.

[0139] The fusion and fixation step in the catheter manufacturing method of the present invention may be as shown in Fig. 17 and described above. In this embodiment, the fusion and fixation step is performed by irradiating electromagnetic waves from an electromagnetic wave emitting body that emits electromagnetic waves from three or more directions that are equiangularly spaced with respect to the axis of the catheter tube, as shown in Fig. 17 and described above.

[0140] 17 , a plurality of laser beam irradiators, specifically three or more, are arranged outside the catheter tube 2 at equal angular intervals with respect to the axis (central axis) of the catheter tube 2. In this embodiment, three laser beam irradiators 8a, 8b, and 8c are arranged at equal angles, and the laser heads (electromagnetic wave irradiators) 81 of the three laser beam irradiators 8a, 8b, and 8c can irradiate laser beams onto the entire outer peripheral surface of the portion that will form the annular fused portion 5 (covering member 7 portion) of the catheter tube 2. Therefore, no portion of the outer layer 21 that will become the annular fused portion 5 is left unirradiated with laser beams.

[0141] The catheter of the present invention comprises a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, and a hub having a lumen capable of accommodating the rear end of the catheter tube. At least the outer surface of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface of the tube that contains an electromagnetic wave absorbing material, the hub is formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube, and the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing a fused portion of the thermoplastic resin for forming the outer surface of the tube formed within the lumen of the hub to the thermoplastic resin for forming the hub that forms the inner surface of the lumen of the hub. Therefore, in this catheter, the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing the annular molten and solidified portion of the thermoplastic resin for forming the outer surface of the tube, which is formed within the lumen of the hub, with the thermoplastic resin for forming the hub, which forms the inner surface of the lumen of the hub. Therefore, the catheter tube and the hub formed from thermoplastic resin are well fixed to each other without the use of adhesive.

[0142] The method for manufacturing a catheter of the present invention is a method for manufacturing a catheter including a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, and a hub having a lumen capable of accommodating the rear end of the catheter tube, and includes the following steps: a catheter tube preparation step of preparing a catheter tube having at least the outer surface of the rear end formed from a thermoplastic resin for forming the outer surface of the tube which contains an electromagnetic wave absorbing material; a hub preparation step of preparing a hub formed from a thermoplastic resin for forming the hub which is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube; and a fusion fixing step of inserting the rear end of the catheter tube into the lumen of the hub, irradiating electromagnetic waves from outside the hub around the entire circumference of the side surface of a portion of the rear end of the catheter tube, thereby annularly melting the portion of the rear end of the catheter tube and fusing the inner surface of the lumen of the hub to the portion of the rear end of the catheter tube. In this catheter manufacturing method, the catheter tube and the thermoplastic resin hub are bonded together by applying electromagnetic waves from outside the hub to the entire circumference of the side surface of a portion of the rear end of the catheter tube, causing a ring-shaped melting of that portion of the rear end of the catheter tube, and fusing the inner surface of the lumen of the hub to that portion of the rear end of the catheter tube. Therefore, a catheter in which the catheter tube and the thermoplastic resin hub are well bonded together can be easily and reliably manufactured without using adhesive.

[0143] Another aspect of the present invention provides a catheter comprising a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, and a hub having a lumen capable of accommodating the rear end of the catheter tube. The catheter has a covering member covering a part of the outer surface of the rear end of the catheter tube, the covering member being formed from a thermoplastic resin for forming the covering member that contains an electromagnetic wave absorbing material, the hub being formed from a thermoplastic resin for forming the hub that is electromagnetic wave absorbing and has thermal adhesive properties with the thermoplastic resin for forming the covering member, the part of the rear end of the catheter tube covered with the covering member extending into the tip end of the hub, and the catheter is fixed to the hub by an annular fused portion of the thermoplastic resin for forming the covering member formed in the lumen of the hub being annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the lumen of the hub. Therefore, in this catheter, the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing the annular molten and solidified portion of the thermoplastic resin for forming the covering member, which is formed within the lumen of the hub, with the thermoplastic resin for forming the hub, which forms the inner surface of the lumen of the hub. Therefore, the catheter tube covered with the covering member and the hub formed from the thermoplastic resin are fixed well without using adhesive.

[0144] a hub having a lumen capable of accommodating the rear end of the catheter tube covered with the covering member; a covering member preparation step of preparing a covering member capable of covering the outer circumferential surface of the rear end of the catheter tube and formed from a thermoplastic resin containing an electromagnetic wave absorbing material; a hub preparation step of preparing a hub formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties with the thermoplastic resin for forming the covering member; and a fusion fixing step of irradiating annular electromagnetic waves from a side of the hub toward the covering member with the rear end of the catheter tube covered with the covering member inserted into the lumen of the hub, thereby annularly melting the covering member and fusing and fixing the covering member to the inner surface of the lumen of the hub. In this catheter manufacturing method, the rear end of the catheter tube coated with a covering member is attached to the hub made of thermoplastic resin by irradiating electromagnetic waves from the outside of the covering member, which is made of thermoplastic resin containing an electromagnetic wave absorbing material, around the entire periphery of the side of the covering member, melting the covering member into a ring shape and fusing the covering member to the inner surface of the lumen of the hub.Therefore, a catheter in which the rear end of the catheter tube coated with a covering member and the hub made of thermoplastic resin are well attached to each other can be easily and reliably manufactured without using adhesive.

[0145] The catheter of the present invention may take the following forms: (1) A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein at least the outer surface of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface of the tube that contains an electromagnetic wave absorbing material, the hub is formed from a thermoplastic resin for forming the hub that is electromagnetically transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube, and the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing a fused portion of the thermoplastic resin for forming the outer surface of the tube that is formed in the cavity of the hub with the thermoplastic resin for forming the hub that forms the inner surface of the cavity of the hub.

[0146] The above catheter may also be implemented as follows. (2) In the catheter described in (1) above, it is preferable that the annular melted and solidified portion of the catheter tube has an expanded diameter portion extending forward in the axial direction of the annular melted and solidified portion. (3) In the catheter described in (1) or (2) above, it is preferable that the annular melted and solidified portion is a volume expansion portion in which the volume of the catheter tube is partially expanded. (4) It is preferable that the annular melted and solidified portion is a heat-generated melted and solidified portion formed by electromagnetic wave absorption. The catheter described in any of (1) to (3) above. (5) In the catheter described in any of (1) to (4) above, it is preferable that the annular fused portion is formed by fusing an annular melted and solidified portion on the catheter tube side with a melted and solidified portion on the hub side that is in contact with the annular melted and solidified portion. (6) In the catheter according to any one of (1) to (5) above, it is preferable that the rear end of the catheter tube has a rear end surface of the catheter tube that is perpendicular to the axial direction, the lumen of the hub has a rear end surface of the lumen of the hub that contacts the rear end surface of the catheter tube, and the rear end surface of the catheter tube is fixed to the hub by a rear end surface annular fused portion that is formed by annularly fusing a part of the thermoplastic resin for forming the rear end surface of the catheter tube with the thermoplastic resin for forming the hub that forms the rear end surface of the lumen of the hub. (7) In the catheter described in any one of (1) to (6) above, the catheter has a tubular member whose rear end enters the distal end of the lumen of the hub and through which the catheter tube passes, the tubular member is formed from a tubular member-forming thermoplastic resin containing an electromagnetic wave absorbing material, and further, it is preferable that the rear side of the tubular member is fixed to the hub by annularly fusing the annular molten solidified portion of the tubular member-forming thermoplastic resin formed in the lumen of the hub with the hub-forming thermoplastic resin that forms the inner surface of the lumen of the hub.(8) In the catheter described in (7) above, it is preferable that the rear end of the catheter tube has a rear end surface of the catheter tube that is perpendicular to the axial direction, the lumen of the hub has a rear end surface of the lumen of the hub that contacts the rear end surface of the catheter tube, and the rear end surface of the catheter tube is fixed to the hub by a rear end surface annular fused portion that is formed by annularly fusing a part of the thermoplastic resin for forming the rear end surface of the catheter tube with the thermoplastic resin for forming the hub that forms the rear end surface of the lumen of the hub.

[0147] The following are embodiments of the method for manufacturing a catheter of the present invention: (9) A method for manufacturing a catheter including a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, and a hub having a cavity capable of accommodating the rear end of the catheter tube, the method comprising: a catheter tube preparation step of preparing a catheter tube having at least the outer surface side of the rear end formed from a thermoplastic resin for forming a tube outer surface that contains an electromagnetic wave absorbing material; a hub preparation step of preparing a hub formed from a thermoplastic resin for forming a hub that is electromagnetically transparent and has thermal fusion properties with the thermoplastic resin for forming the tube outer surface; and a fusion fixing step of inserting the rear end of the catheter tube into the cavity of the hub, irradiating electromagnetic waves from outside the hub around the entire circumference of a side surface of a portion of the rear end of the catheter tube, thereby annularly melting the portion of the rear end of the catheter tube and fusing the inner surface of the cavity of the hub to the portion of the rear end of the catheter tube.

[0148] The catheter manufacturing method of the present invention may also be embodied as follows: (10) In the catheter manufacturing method described in (9) above, the catheter manufacturing method preferably includes a step of preparing a tubular member, the rear end of which can enter the distal end of the lumen of the hub, the catheter tube can pass through, and which is formed from a tubular-member-forming thermoplastic resin containing an electromagnetic wave absorbing material, and the fusion and fixation step preferably includes inserting the rear side of the tubular member into the lumen of the hub, causing the rear end of the catheter tube to pass through the tubular member and enter the lumen of the hub, and then irradiating electromagnetic waves in a ring shape from a side of the hub toward the rear side of the tubular member and the rear end of the catheter tube protruding from the tubular member, thereby annularly fusing the rear side of the tubular member and a portion of the rear end of the catheter tube, thereby fusion and fixating the tubular member and the catheter tube to the inner surface of the lumen of the hub. (11) In the method for manufacturing a catheter described in (9) or (10) above, it is preferable that the rear end of the catheter tube has a rear end surface of the catheter tube perpendicular to the axial direction, the lumen of the hub has a rear end surface of the lumen of the hub that can abut against the rear end surface of the catheter tube, and the electromagnetic waves are irradiated to the rear end of the catheter tube to heat and melt the rear end of the catheter tube, thereby fusion-fixing the rear end surface of the catheter tube and the rear end surface of the lumen of the hub. (12) In the method for manufacturing a catheter described in any of (9) to (11) above, it is preferable that the fusion-fixing step irradiates the electromagnetic waves while rotating the catheter tube about its axis. (13) In the method for manufacturing a catheter described in any of (9) to (11) above, it is preferable that the fusion-fixing step irradiates the electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates the electromagnetic waves about the axis of the catheter tube.(14) In the method for manufacturing a catheter described in (9) or (10) above, it is preferable that the fusion and fixing step includes irradiating the electromagnetic waves from an electromagnetic wave irradiator that irradiates the electromagnetic waves from three or more directions that are equiangularly spaced with respect to the axis of the catheter tube. (15) In the method for manufacturing a catheter described in any of (9) to (11) above, it is preferable that the method for manufacturing a catheter includes, before the fusion and fixing step, a partial fixing step of inserting the rear end of the catheter tube into the lumen of the hub, and then irradiating electromagnetic waves from a side surface of the hub toward the catheter tube to partially fix the catheter tube to the hub. (16) In the method for manufacturing a catheter described in (10) above, it is preferable that, before the fusion and fixing step, the method for manufacturing a catheter includes inserting a rear end of the tubular member into the lumen of the hub, causing the rear end of the catheter tube to penetrate the tubular member and enter the lumen of the hub, and then irradiating electromagnetic waves from a side surface of the hub toward the rear end of the tubular member to partially fix the rear end of the tubular member to the catheter tube. (17) In the method for manufacturing a catheter described in any of (9) to (16) above, it is preferable that the electromagnetic waves are laser light.

[0149] The catheter of the present invention may also be embodied as follows: (18) A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein the catheter has a covering member covering a part of the outer circumferential surface of the rear end of the catheter tube, the covering member being formed from a covering member-forming thermoplastic resin containing an electromagnetic wave-absorbing material, the hub being formed from a hub-forming thermoplastic resin that is electromagnetic wave-absorbing and has thermal fusion properties with the covering member-forming thermoplastic resin, the part of the rear end of the catheter tube covered with the covering member extending into the tip end of the hub, and the catheter is fixed to the hub by an annular fused portion of the covering member-forming thermoplastic resin formed in the cavity of the hub being annularly fused to the hub-forming thermoplastic resin that forms the inner surface of the cavity of the hub. (19) In the catheter described in (18) above, it is preferable that at least the outer surface side of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface side of the tube that has thermal fusion properties with the thermoplastic resin for forming the covering member, and that the rear end of the catheter tube is annularly fused to a ring-shaped molten and solidified portion of the thermoplastic resin for forming the covering member formed within the lumen of the hub. (20) In the catheter described in (18) or (19) above, it is preferable that the annular molten and solidified portion is a heat-generated molten and solidified portion formed by electromagnetic wave absorption. (21) In any of the catheters described in (18) to (20) above, it is preferable that the covering member has the annular molten and solidified portion formed within the lumen of the hub over its entire length, and is annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the lumen of the hub.

[0150] Furthermore, the following are embodiments of the method for manufacturing a catheter of the present invention. (22) A method for manufacturing a catheter including a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen, a covering member covering a portion of the outer peripheral surface of the rear end of the catheter tube, and a hub having a lumen capable of accommodating the rear end of the catheter tube covered with the covering member, the method comprising the steps of: a covering member preparation step of preparing a covering member capable of covering a portion of the outer peripheral surface of the rear end of the catheter tube and formed from a thermoplastic resin for forming a covering member containing an electromagnetic wave absorbing material; a hub preparation step of preparing a hub 3 formed from a thermoplastic resin for forming a hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the covering member; and a fusion fixing step of irradiating electromagnetic waves in a ring shape from a side of the hub toward the covering member with the rear end of the catheter tube covered with the covering member inserted into the lumen of the hub, thereby annularly melting the covering member and fusing and fixing the covering member to the inner surface of the lumen of the hub. (23) In the catheter manufacturing method described in (22) above, the fusion and fixing step preferably involves fusion and fixing the outer surface of the catheter tube and the covering member by using the annularly melted covering member. (24) In the catheter manufacturing method described in (22) or (23) above, the fusion and fixing step preferably involves irradiating the electromagnetic waves while rotating the catheter tube around its axis. (25) In the catheter manufacturing method described in (22) or (23) above, the fusion and fixing step preferably involves irradiating the electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates the electromagnetic waves around the axis of the catheter tube. (26) In the catheter manufacturing method described in (22) or (23) above, the fusion and fixing step preferably involves irradiating the electromagnetic waves from an electromagnetic wave irradiator that irradiates the electromagnetic waves from three or more directions that are equiangularly spaced with respect to the axis of the catheter tube.(27) In the method for manufacturing a catheter according to any one of (22) to (26) above, the electromagnetic wave is preferably a laser beam.

Claims

1. A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein at least the outer surface of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface of the tube which contains an electromagnetic wave absorbing material; the hub is formed from a thermoplastic resin for forming the hub which is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube; and the rear end of the catheter tube is fixed to the hub by an annular fused portion formed by annularly fusing a fused portion of the thermoplastic resin for forming the outer surface of the tube formed within the cavity of the hub to the thermoplastic resin for forming the hub which forms the inner surface of the cavity of the hub.

2. A catheter according to claim 1, wherein the annular molten solidified portion of the catheter tube has an enlarged diameter portion extending from the axially forward side of the annular molten solidified portion.

3. A catheter according to claim 1 or 2, wherein the annular molten solidified portion is a volume expansion portion in which the volume of the catheter tube is partially expanded.

4. A catheter according to claim 1 or 2, wherein the annular melted and solidified portion is a heat-generating melted and solidified portion formed by absorbing electromagnetic waves.

5. A catheter as described in claim 1 or 2, wherein the annular fused portion is formed by fusing an annular melt-solidified portion on the catheter tube side with a melt-solidified portion on the hub side that comes into contact with the annular melt-solidified portion.

6. A catheter according to claim 1 or 2, wherein the rear end of the catheter tube has a rear end surface of the catheter tube that is perpendicular to the axial direction, the lumen of the hub has a rear end surface of the lumen of the hub that contacts the rear end surface of the catheter tube, and the rear end surface of the catheter tube is fixed to the hub by a rear end surface annular fused portion formed by annularly fusing a portion of the thermoplastic resin used to form the rear end surface of the catheter tube with the thermoplastic resin used to form the hub that forms the rear end surface of the lumen of the hub.

7. A catheter as described in claim 1 or 2, wherein the catheter has a tubular member whose rear end enters the tip of the lumen of the hub and through which the catheter tube passes, the tubular member being formed from a thermoplastic resin for forming the tubular member that contains an electromagnetic wave absorbing material, and further wherein the rear side of the tubular member is fixed to the hub by an annular fused and solidified portion of the thermoplastic resin for forming the tubular member formed within the lumen of the hub fusing annularly with the thermoplastic resin for forming the hub that forms the inner surface of the lumen of the hub.

8. A catheter according to claim 7, wherein the rear end of the catheter tube has a rear end surface of the catheter tube that is perpendicular to the axial direction, the lumen of the hub has a rear end surface of the lumen of the hub that contacts the rear end surface of the catheter tube, and the rear end surface of the catheter tube is fixed to the hub by a rear end surface annular fused portion formed by annularly fusing a portion of the thermoplastic resin for forming the rear end surface of the catheter tube with the thermoplastic resin for forming the hub that forms the rear end surface of the lumen of the hub.

9. A method for manufacturing a catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a lumen capable of accommodating the rear end of the catheter tube, the method comprising: a catheter tube preparation step of preparing a catheter tube having at least the outer surface of the rear end formed from a thermoplastic resin for forming the outer surface of the tube which contains an electromagnetic wave absorbing material; a hub preparation step of preparing a hub formed from a thermoplastic resin for forming the hub which is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the outer surface of the tube; and a fusion fixing step of inserting the rear end of the catheter tube into the lumen of the hub, irradiating electromagnetic waves from outside the hub around the entire side of a portion of the rear end of the catheter tube to melt the portion of the rear end of the catheter tube in an annular shape, and fusing the inner surface of the lumen of the hub to the portion of the rear end of the catheter tube.

10. The method for manufacturing a catheter according to claim 9, further comprising the step of preparing a tubular member, the rear end of which can enter the distal end of the lumen of the hub, the catheter tube can pass through, and which is formed from a thermoplastic resin for forming tubular members containing an electromagnetic wave absorbing material, and the fusion and fixing step comprises inserting the rear side of the tubular member into the lumen of the hub, causing the rear end of the catheter tube to pass through the tubular member and enter the lumen of the hub, and then irradiating electromagnetic waves in a circular pattern from the side of the hub toward the rear side of the tubular member and the rear end of the catheter tube protruding from the tubular member, thereby annularly fusing the rear side of the tubular member and a portion of the rear end of the catheter tube, and fusion and fixing the tubular member and the catheter tube to the inner surface of the lumen of the hub.

11. A method for manufacturing a catheter according to claim 9 or 10, wherein the rear end of the catheter tube has a rear end surface that is perpendicular to the axial direction, the lumen of the hub has a rear end surface that can come into contact with the rear end surface of the catheter tube, and the electromagnetic waves are irradiated onto the rear end of the catheter tube to heat and melt the rear end of the catheter tube, thereby fusion-fixing the rear end surface of the catheter tube and the rear end surface of the lumen of the hub.

12. A method for manufacturing a catheter according to claim 9 or 10, wherein the fusion and fixing step involves irradiating the catheter tube with the electromagnetic waves while rotating the catheter tube around its axis.

13. A method for manufacturing a catheter according to claim 9 or 10, wherein the fusion and fixing step involves irradiating the electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates the electromagnetic waves around the axis of the catheter tube.

14. A method for manufacturing a catheter as described in claim 9 or 10, wherein the fusion and fixation step involves irradiating the electromagnetic waves from an electromagnetic wave irradiator from three or more directions at equal angular intervals relative to the axis of the catheter tube.

15. A method for manufacturing a catheter according to claim 9 or 10, wherein, prior to the fusion and fixing step, the rear end of the catheter tube is inserted into the lumen of the hub, and then electromagnetic waves are irradiated from the side of the hub toward the catheter tube, thereby partially fixing the catheter tube to the hub.

16. A method for manufacturing a catheter according to claim 10, wherein, prior to the fusion and fixing step, the rear end of the tubular member is inserted into the lumen of the hub, and the rear end of the catheter tube penetrates the tubular member and enters the lumen of the hub. After that, electromagnetic waves are irradiated from the side of the hub toward the rear end of the tubular member, thereby partially fixing the rear end of the tubular member to the catheter tube.

17. A method for manufacturing a catheter according to claim 9 or 10, wherein the electromagnetic wave is laser light.

18. A catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; and a hub having a cavity capable of accommodating the rear end of the catheter tube, wherein the catheter has a covering member covering the outer surface of part of the rear end of the catheter tube, the covering member being formed from a thermoplastic resin for forming the covering member that contains an electromagnetic wave absorbing material; the hub is formed from a thermoplastic resin for forming the hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the covering member; the part of the rear end of the catheter tube covered with the covering member extends into the tip of the hub; and the catheter is fixed to the hub by an annular molten and solidified portion of the thermoplastic resin for forming the covering member formed in the cavity of the hub being annularly fused to the thermoplastic resin for forming the hub that forms the inner surface of the cavity of the hub.

19. A catheter as described in claim 18, wherein at least the outer surface of the rear end of the catheter tube is formed from a thermoplastic resin for forming the outer surface of the tube that has thermal fusion properties with the thermoplastic resin for forming the covering member, and the rear end of the catheter tube is annularly fused to the annular molten and solidified portion of the thermoplastic resin for forming the covering member that is formed within the inner cavity of the hub.

20. A catheter as described in claim 18 or 19, wherein the annular melted and solidified portion is a heat-generating melted and solidified portion formed by absorbing electromagnetic waves.

21. A catheter as described in claim 18 or 19, wherein the covering member is an annular molten solidified portion formed within the inner cavity of the hub over the entire length of the covering member, and is annularly fused to the hub-forming thermoplastic resin that forms the inner surface of the inner cavity of the hub.

22. A method for manufacturing a catheter comprising: a catheter tube having a lumen, a tip-side opening communicating with the lumen, and a rear-side opening communicating with the lumen; a covering member covering a portion of the outer circumferential surface of the rear end of the catheter tube; and a hub having an inner cavity capable of accommodating the rear end of the catheter tube covered with the covering member, the method comprising: a covering member preparation step of preparing a covering member capable of covering a portion of the outer circumferential surface of the rear end of the catheter tube and formed from a thermoplastic resin for forming the covering member containing an electromagnetic wave absorbing material; and a hub preparation step of preparing a hub formed from a thermoplastic resin for forming the hub that is electromagnetic wave transparent and has thermal fusion properties with the thermoplastic resin for forming the covering member. a fusion and fixing step of irradiating electromagnetic waves in a circular pattern from a side surface of the hub toward the covering member while the rear end of the catheter tube covered with the covering member is inserted into the lumen of the hub, thereby melting the covering member in a circular pattern and fusing and fixing the inner surface of the lumen of the hub to the rear end of the catheter tube covered with the covering member.

23. A method for manufacturing a catheter according to claim 22, wherein in the fusion and fixing step, the outer surface of the catheter tube and the covering member are fusion-fixed by the annularly melted covering member.

24. A method for manufacturing a catheter according to claim 22 or 23, wherein the fusion and fixing step involves irradiating the catheter tube with the electromagnetic waves while rotating the catheter tube around its axis.

25. A method for manufacturing a catheter as described in claim 22 or 23, wherein the fusion and fixation step involves irradiating the electromagnetic waves while rotating an electromagnetic wave irradiator that irradiates the electromagnetic waves around the axis of the catheter tube.

26. A method for manufacturing a catheter as described in claim 22 or 23, wherein the fusion and fixation step involves irradiating the electromagnetic waves from an electromagnetic wave irradiator from three or more directions at equal angular intervals relative to the axis of the catheter tube.

27. A method for manufacturing a catheter according to claim 22 or 23, wherein the electromagnetic wave is laser light.

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