JP2014188216A - Medical instrument, and manufacturing method for medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical instrument that allows a sub-lumen for inserting an operation wire to be easily and accurately formed along an axis line.SOLUTION: A long tubular body 10 includes: a wire reinforcing layer 30 that is formed by winding a reinforcing wire 32 around a main lumen 20; a resin sub-tube 40 that is arranged outside the wire reinforcing layer 30 and defines a sub-lumen 42 having a diameter smaller than that of the main lumen 20; and a resin outer layer 50 that contains the wire reinforcing layer 30 and the sub-tube 40. An operation wire 60 is inserted into the sub-lumen 42 in a movable manner and has a tip connected to a distal portion of the tubular body 10. An operation unit bends the distal portion DE of the tubular body 10 by applying a traction operation to the operation wire 60. In a catheter 100, a bond portion 56 for bonding the sub-tube 40 and an outer surface of the wire reinforcing layer 30 is provided in a form of extending in a longitudinal direction of the tubular body 10.

Description

  The present invention relates to a medical device such as a catheter and a method for manufacturing the medical device.

  Various lengthy medical devices that introduce media and devices into body cavities such as catheters and endoscopes are known. In recent years, not only endoscopes but also catheters have been provided that can manipulate the direction of entry into a body cavity by bending the distal end.

  For example, Patent Document 1 discloses a catheter in which two wire lumens (sublumen: sublumen) having a smaller diameter are provided 180 degrees opposite each other around a central lumen (main lumen: main lumen). Is described. A deflection wire (hereinafter referred to as an operation line) is inserted into the sub-lumen, and the distal end of the catheter is bent by pulling the operation line by operating the operation handle on the proximal end side. .

  More specifically, in the catheter of Patent Document 1, two polymer tubes each having a wire lumen (hereinafter referred to as a secondary lumen) are laid along the outer surface of a thin inner layer made of a fluorine resin material or the like. The operation line is inserted inside the polymer tube. Patent Document 1 describes several methods for laying the auxiliary lumen around the inner layer along the axis. The first method is a method in which a polymer tube is pre-extruded and arranged along the inner layer. The second method is a method of extruding a polymer tube along an outer surface of the mandrel while feeding a core wire having an inner layer formed around the mandrel. The third method is a method of forming a secondary lumen by injecting a pressurized fluid into a molten resin at the time of extrusion molding of an inner layer without molding a polymer tube.

  In Patent Document 1, a cylindrical wire knitted body (hereinafter referred to as a wire reinforcing layer) is further tightened around the auxiliary lumen. In the case of the above third method, a wire is reinforced by braiding multiple wires around the inner layer in the case of the third method and around the polymer tube laid along the inner layer in the case of the first or second method. Create a layer and tighten this. After that, a catheter sheath is prepared by impregnating the wire reinforcing layer with molten resin for forming the outer layer.

JP 2006-192269 A

  The polymer tube defines a path for guiding the operation line from the distal end to the proximal end of the catheter. Therefore, when the polymer tube is meandering around the inner layer, friction is generated by contacting the inner wall surface of the polymer tube when the operation line is pulled. When friction occurs between the operation line and the inner wall surface of the polymer tube, various problems occur. First, the operation line is worn and easily broken. Then, the inner wall surface of the polymer tube is worn and roughened, and the friction is further increased. Further, since the sliding resistance of the operation line increases, the pulled operation line is held by static friction with the inner wall surface of the polymer tube, and it becomes difficult to return the bending of the distal end of the catheter.

  However, with the method disclosed in Patent Document 1, it is extremely difficult to form the secondary lumen straight. This is because, in the case of the above first or second method, it is difficult to braid the wire reinforcement layer while laying the polymer tube on the surface of the inner layer along the axis of the catheter, and further tighten the wire reinforcement layer. It is. When the wire reinforcing layer is braided with multiple wires and further tightened, it is inevitable that an external force is applied to the secondary lumen in the circumferential direction of the inner layer. It is difficult to keep it straight and parallel. Further, in the case of the third method, it is not easy to extrude the inner layer while forming the secondary lumen straight inside the entire length of the long catheter. This is because the injection pressure of the pressurized fluid inevitably varies with time, so that it is difficult to strictly maintain the position where the secondary lumen is formed inside the uncured molten inner layer.

  In addition, although the catheter was illustrated and demonstrated here, the same subject is a subject which arises in the whole medical device which operates not only with a catheter but with an operation line.

  The present invention has been made in view of the above problems, and provides a medical device that can easily and accurately form a secondary lumen for inserting an operation line along an axis, and a method for manufacturing the same. .

  According to the present invention, a wire reinforcing layer formed by winding a reinforcing wire around a main lumen, and a resin-made subtube that is disposed outside the wire reinforcing layer and defines a sub-lumen having a smaller diameter than the main lumen. A long tubular body including a wire reinforcing layer and a resin outer layer containing the sub-tube, and a distal end of the tubular body movably inserted into the sub-lumen. A connecting portion for bonding the sub-tube and the outer surface of the wire reinforcing layer, comprising: a connected operation line; and an operation portion that pulls the operation line to bend the distal portion of the tubular body. Is provided so as to extend in the longitudinal direction of the tubular main body.

  According to said medical device, the junction part which adhere | attaches a subtube and the outer surface of a wire reinforcement layer is extended and provided in the longitudinal direction of the tubular main body. For this reason, the arrangement position of the subtube arranged outside the wire reinforcing layer can be accurately maintained along the axis.

  Furthermore, according to this invention, the manufacturing method of the medical device mentioned above is provided. That is, according to the present invention, a step of forming a wire reinforcing layer by winding a reinforcing wire around the main core wire, and applying a resin material to the peripheral surface of the wire reinforcing layer along the main core wire for bonding Forming a portion and bonding a resin-made subtube into which the sub-core wire is inserted to the joint portion, and covering an outer layer resin tube made of a thermoplastic resin around the wire reinforcing layer and the subtube And a step of heating and pressurizing the outer layer resin tube to shape an outer layer containing the subtube, and a step of extending and reducing the diameter of the sub-core wire to separate from the sub-tube to form a sub-lumen. And a step of removing the main core wire from the wire reinforcing layer to form a main lumen.

  ADVANTAGE OF THE INVENTION According to this invention, the technique which forms the auxiliary | assistant lumen | tube for penetrating an operation line in a medical device easily along the axis line with sufficient precision is provided.

It is a cross-sectional view of the distal portion of the catheter of the first embodiment of the present invention. It is the II-II sectional view taken on the line of FIG. FIG. 3A is an overall side view of the catheter according to the embodiment of the present invention. FIG. 3B is an overall side view of the catheter showing a state where the wheel operation unit is operated in one direction. FIG. 3C is an overall side view of the catheter showing a state in which the wheel operation unit is operated in the other direction. It is a cross-sectional view of the distal portion of the catheter of the second embodiment of the present invention. It is a longitudinal cross-sectional view which shows a subtube bonding process. It is a longitudinal cross-sectional view which shows a 1st outer layer shaping process. It is a longitudinal cross-sectional view which shows a 2nd outer layer shaping process.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same components are denoted by the same reference numerals, and detailed description thereof is omitted as appropriate so as not to overlap.

<First embodiment>
With reference to FIG. 1 and FIG. 2, the outline | summary of the medical device of this embodiment is demonstrated. The catheter 100 is illustrated as a medical device. In addition to the catheter 100, the present invention can be applied to endoscopes and other medical devices that can bend the distal portion DE by pulling the operation line 60.

  FIG. 1 is a cross-sectional view (cross-sectional view) in which the distal end portion of the catheter 100 is cut perpendicular to the longitudinal direction. 2 is a cross-sectional view (longitudinal cross-sectional view) of the distal portion DE of the catheter 100 taken along the longitudinal direction (axial direction), and is a cross-sectional view taken along the line II-II in FIG.

The catheter 100 of the present embodiment includes a long tubular body 10, an operation line 60, and an operation unit 90. The tubular body 10 includes a wire reinforcing layer 30 formed by winding a reinforcing wire 32 around the main lumen 20 and a resin that is disposed outside the wire reinforcing layer 30 and defines a sub-lumen 42 having a smaller diameter than the main lumen 20. And a resin outer layer 50 enclosing the wire reinforcing layer 30 and the subtube 40. The operation line 60 is movably inserted into the sub-lumen 42 and has a distal end connected to the distal portion DE of the tubular body 10. The operation unit 90 pulls the operation line 60 to bend the distal portion DE of the tubular body 10.
The catheter 100 of the present embodiment is characterized in that a joint portion 56 that bonds the sub-tube 40 and the outer surface of the wire reinforcing layer 30 extends in the longitudinal direction of the tubular body 10.

  Hereinafter, this embodiment will be described in detail. The catheter 100 of this embodiment is an intravascular catheter that is used by inserting the tubular body 10 into a blood vessel.

  The tubular main body 10 is also called a sheath, and is a hollow tubular and long member having a main lumen 20 formed therein. More specifically, the tubular body 10 is formed with an outer diameter and a length that allow entry into any of the eight sub-regions of the liver.

  The tubular body 10 has a laminated structure. The tubular body 10 is configured by laminating an inner layer 24, a first outer layer 52, and a second outer layer 54 in order from the inner diameter side with the main lumen 20 as the center. A hydrophilic layer (not shown) is formed on the outer surface of the second outer layer 54. The inner layer 24, the first outer layer 52, and the second outer layer 54 are made of a flexible resin material, and each has an annular shape and a substantially uniform thickness. The first outer layer 52 and the second outer layer 54 may be collectively referred to as the outer layer 50.

  The inner layer 24 is the innermost layer of the tubular body 10, and the main lumen 20 is defined by the inner wall surface thereof. The cross-sectional shape of the main lumen 20 is not particularly limited, but is circular in this embodiment. In the case of the main lumen 20 having a circular cross section, the diameter may be uniform over the longitudinal direction of the tubular body 10 or may vary depending on the position in the longitudinal direction. For example, in a part or all of the length region of the tubular main body 10, the diameter of the main lumen 20 can be tapered so as to continuously expand from the distal end to the proximal end.

  Examples of the material of the inner layer 24 include a fluorine-based thermoplastic polymer material. Specific examples of the fluorine-based thermoplastic polymer material include polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), and perfluoroalkoxy fluororesin (PFA). By configuring the inner layer 24 with such a fluorine-based polymer material, the delivery property when supplying a drug solution or the like through the main lumen 20 is improved. Further, when the guide wire is inserted into the main lumen 20, the sliding resistance of the guide wire is reduced.

  The outer layer 50 constitutes the main wall thickness of the tubular body 10. The outer layer 50 of the present embodiment includes a first outer layer 52 having an annular cross section that encloses the wire reinforcing layer 30 and the subtube 40, and a cross sectional circle that is provided around the first outer layer 52 and encloses the second reinforcing layer 80. And an annular second outer layer 54. A second reinforcing layer 80 is provided inside the second outer layer 54. The second reinforcing layer 80 is in contact with the outer surface of the first outer layer 52. The wire reinforcing layer 30 and the second reinforcing layer 80 are disposed coaxially with the tubular main body 10.

As the material of the outer layer 50, a thermoplastic polymer material can be used. As this thermoplastic polymer material, polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), polyamide elastomer (PAE), polyether block amide (PEBA), etc. Mention may be made of nylon elastomers, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC) or polypropylene (PP).
The outer layer 50 may be mixed with an inorganic filler. Examples of the inorganic filler include contrast agents such as barium sulfate and bismuth subcarbonate. By mixing a contrast agent in the outer layer 50, the X-ray contrast property of the tubular body 10 in the body cavity can be improved.

  The first outer layer 52 and the second outer layer 54 may be made of the same type of resin material. Thereby, it is excellent in the adhesiveness of an interface. The first outer layer 52 and the second outer layer 54 are made of the same or different resin material. Although the boundary surface between the first outer layer 52 and the second outer layer 54 is clearly shown in FIG. 1, the present invention is not limited to this. When the 1st outer layer 52 and the 2nd outer layer 54 are comprised with the same resin material, the interface of both layers may be united naturally. That is, the outer layer 50 of the present embodiment may be formed of a multilayer in which the first outer layer 52 and the second outer layer 54 are distinguishable from each other, or the first outer layer 52 and the second outer layer 54 are integrated. It may be configured as a single layer.

Here, the two resin materials being the same means that the resin type and the polymerization degree are common. It is allowed that the hardness of the resin material varies depending on the mixing ratio of the filler such as a contrast agent. In the present embodiment, the hardness of the resin material means durometer hardness.
Moreover, two resin materials being the same kind means that the two resin materials are both polyether block amide (PEBA), and the like, and the degree of polymerization is allowed to be different.

  As shown in FIG. 2, the tubular main body 10 has a first region 11 and a second region 12 on the proximal side of the first region 11. In the outer layer 50, the hardness of the resin material of the first region 11 and the second region 12 is different from each other.

  The first region 11 and the second region 12 of the outer layer 50 may be made of the same kind of resin material having different hardnesses or different kinds of resin materials.

  In this embodiment, the 1st area | region 11 and the 2nd area | region 12 of the outer layer 50 consist of the same kind of resin material from which hardness differs. Further, the first region 11 and the second region 12 are different in the amount of contrast medium mixed. Here, when a contrast agent such as barium sulfate or bismuth carbonate is blended in the outer layer 50, the hardness of the outer layer 50 increases in accordance with the blending amount. A contrast agent is mixed in the second region 12 of the outer layer 50. The first region 11 of the outer layer 50 is not mixed with the contrast agent or the amount of contrast agent mixed is smaller than that of the second region 12. Thereby, the hardness of the outer layer 50 of the 1st area | region 11 and the 2nd area | region 12 can be made to differ further notably. For this reason, when the operation line 60 is pulled, the curvature of the second region 12 can be suppressed and the first region 11 can be bent significantly. Thereby, when bending the distal part DE of the tubular main body 10 inside a thin blood vessel, the most advanced first region 11 can be bent sharply, and the blood vessel selection performance of the catheter 100 is improved.

  In the tubular main body 10 of the present embodiment, the first region 11 and the second region 12 are switched on the distal side of the second marker 16 described later. A transition region having intermediate characteristics between the first region 11 and the second region 12 may exist.

  The wire reinforcing layer 30 is a protective layer that is provided on the inner diameter side of the operation line 60 in the tubular body 10 and protects the inner layer 24. The presence of the wire reinforcing layer 30 on the inner diameter side of the operation line 60 prevents the operation line 60 from being exposed to the main lumen 20 by breaking the first outer layer 52 and the inner layer 24.

  The wire reinforcing layer 30 is formed by winding a reinforcing wire 32. The material of the reinforcing wire 32 includes a metal material such as tungsten (W), stainless steel (SUS), nickel titanium alloy, steel, titanium, copper, titanium alloy or copper alloy, as well as the inner layer 24 and the first outer layer 52. Also, a resin material such as polyimide (PI), polyamideimide (PAI) or polyethylene terephthalate (PET) having high shear strength can be used. In this embodiment, the reinforcing wire 32 is a fine stainless steel wire.

  The wire reinforcing layer 30 is formed by winding a reinforcing wire 32 in a coiled or mesh shape. The number of the reinforcing wires 32, the coil pitch, and the number of meshes are not particularly limited.

  Among these, the blade layer which braided the reinforcement wire 32 is illustrated as the wire reinforcement layer 30 of this embodiment. Here, the number of meshes of the wire reinforcing layer 30 refers to the number of intersections (number of eyes) per unit length (1 inch) viewed in the extending direction of the reinforcing wires 32. The outer layer 50 (first outer layer 52) impregnates the wire reinforcing layer 30.

  The reinforcing wire 32 is wound obliquely around the inner layer 24. An angle formed by the extending direction of the reinforcing wire 32 with respect to the radial direction of the inner layer 24 is referred to as a pitch angle of the reinforcing wire 32. When the reinforcing wires 32 are wound at a dense pitch, the pitch angle becomes a small angle. Conversely, when the reinforcing wire 32 is wound at a shallow angle along the axial center of the tubular body 10, the pitch angle is a large angle close to 90 degrees. The pitch angle of the reinforcing wire 32 of the present embodiment is not particularly limited, but can be 30 degrees or more, preferably 45 degrees or more and 75 degrees or less.

The parameter represented by the following mathematical formula (1) is referred to as the opening size of the wire reinforcing layer 30 viewed in the extending direction of the reinforcing wire 32.
Opening dimension in the wire extending direction = unit length (1 inch) / number of meshes−wire diameter of the wire (1)

A parameter represented by the following mathematical formula (2) is referred to as a circumferential opening dimension W (see FIG. 1) of the wire reinforcing layer 30.
Circumferential opening dimension W = (unit length (1 inch) / number of meshes−wire diameter of reinforcing wire 32) × √2 (2)
The opening dimension W in the circumferential direction of the wire reinforcing layer 30 is the length of a diagonal line when the opening shape of the wire reinforcing layer 30 viewed in the extending direction of the reinforcing wire 32 is regarded as a square.

  As shown in FIG. 1, the opening dimension W in the circumferential direction of the wire reinforcing layer 30 (blade layer) represented by the above formula (2) is larger than the outer diameter of the sub-tube 40.

The subtube 40 is a hollow tubular member that defines a secondary lumen 42. The subtube 40 is embedded in the outer layer 50 (first outer layer 52). The subtube 40 can be made of, for example, a thermoplastic polymer material. Examples of the thermoplastic polymer material include low friction resin materials such as polytetrafluoroethylene (PTFE), polyetheretherketone (PEEK), or tetrafluoroethylene / hexafluoropropylene copolymer (FEP).
The subtube 40 is made of a material having a higher bending rigidity and tensile elastic modulus than the outer layer 50.

  The outer surface of the sub-tube 40 is subjected to etching treatment such as metal sodium treatment or plasma treatment. Thereby, the adhesiveness of the subtube 40 and the outer layer 50 is improved.

As shown in FIG. 1, a plurality of sub-tubes 40 (40a, 40b) are arranged around the wire reinforcement layer 30 so as to face each other, and operation lines 60 are provided on at least two of the plurality of sub-tubes 40a, 40b. Each is inserted. More specifically, in the catheter 100 of this embodiment, the two subtubes 40a and 40b are arranged around the wire reinforcing layer 30 so as to face each other by 180 degrees. In the case where three or four subtubes 40 are disposed instead of the present embodiment, they can be disposed opposite to the periphery of the wire reinforcing layer 30 at intervals of 120 degrees or 90 degrees.
These subtubes 40 are arranged in parallel to the axial direction of the tubular body 10.

(About joints)
The joint part 56 which adhere | attaches the subtube 40 and the outer surface of the wire reinforcement layer 30 is demonstrated. As shown in FIG. 1, the joint portion 56 has a width dimension larger than the diameter of the subtube 40 and is disposed between the subtube 40 and the inner layer 24.

  The outer surface of the joining portion 56 is in close contact with the outer peripheral surface of the subtube 40. More specifically, the outer surface of the joint portion 56 has a concave shape corresponding to the peripheral surface on the inner diameter side of the sub-tube 40, and the joint portion 56 and the sub-tube 40 are surface-joined.

As shown in FIG. 2, the joining portion 56 is provided in a line shape extending in the axial direction (left-right direction in FIG. 2) at the lower portion of the subtube 40 and impregnates the wire reinforcing layer 30. . The lower part of the sub tube 40 is the inner diameter side of the sub tube 40. Since the joining portion 56 is fixed to the subtube 40 while being anchored to the wire reinforcing layer 30, even when a load is applied to the subtube 40 by pulling the operation line 60, the subtube 40 and the outer layer 50 are connected. The interface with the film does not peel off.
Here, the line shape includes a continuous straight line shape and a dotted line shape composed of discrete multiple points. That is, the joining portion 56 may be provided continuously from the distal end to the proximal end of the subtube 40 or may be provided discretely.

An organic adhesive, specifically, a normal temperature curable adhesive, a thermosetting adhesive, a solution adhesive, or a hot melt adhesive can be used for the bonding portion 56 of the present embodiment.
Room temperature curing adhesives include reactive adhesives such as cyanoacrylate adhesives, silicone adhesives, epoxy resin adhesives or acrylic resin adhesives, and UV curable adhesives such as urethane acrylates and epoxy acrylates. An agent can be used. In particular, a cyanoacrylate-based instantaneous adhesive is preferably used because of its high curing speed.
An epoxy resin adhesive can be used as the thermosetting adhesive.
Solution type adhesives include acrylic resin emulsion adhesives, α-olefin adhesives, urethane resin solvent adhesives, ethylene-vinyl acetate resin emulsion adhesives, vinyl acetate resin emulsion adhesives or polyvinyl acetate resin solution adhesives. Agents can be exemplified.
Examples of the hot melt adhesive include ethylene-vinyl acetate resin hot melt adhesive, polyurethane resin hot melt adhesive, and polyolefin resin hot melt adhesive.

  The joint portion 56 of the present embodiment is a cured organic adhesive, and the resin material thereof is different from the first region 11 or the second region 12 of the outer layer 50. A resin material having a melting point after curing higher than that of the outer layer 50 (first outer layer 52) is used for the bonding portion 56 of the present embodiment. Thereby, as will be described later, when the outer layer 50 (first outer layer 52) is thermoformed in the first outer layer shaping step, the subtube 40 is not detached from the joint portion 56 and the wire reinforcing layer 30. For this reason, the subtube 40 can be embedded in the outer layer 50 (first outer layer 52) while maintaining the linear shape of the subtube 40.

  As shown in FIG. 2, the joining portion 56 of the present embodiment is composed of the same resin material over the first region 11 and the second region 12. However, as in a second embodiment to be described later, one joining portion 56 may be composed of a plurality of different resin materials.

  The operation line 60 is loosely inserted in the sub tube 40 so as to be slidable. The distal end portion of the operation line 60 is fixed to the distal portion DE of the tubular main body 10. The tip of the operation line 60 may be fixed to the first marker 14 described later, or may be embedded and fixed in the outer layer 50. By pulling the operation line 60 to the proximal end side, a tensile force is applied to a position that is eccentric with respect to the axial center of the tubular body 10, so that the tubular body 10 bends. Since the operation line 60 of the present embodiment is extremely thin and highly flexible, even if the operation line 60 is pushed distally, a pushing force is not substantially applied to the distal portion DE of the tubular body 10.

The operation wire 60 may be formed of a single wire, but may be a stranded wire formed by twisting a plurality of thin wires.
As the operation wire 60, low carbon steel (piano wire), stainless steel (SUS), steel wire coated with corrosion resistance, titanium or a titanium alloy, or metal wire such as tungsten can be used. In addition, the operation line 60 includes polyvinylidene fluoride (PVDF), high density polyethylene (HDPE), poly (paraphenylenebenzobisoxazole) (PBO), polyetheretherketone (PEEK), polyphenylene sulfide (PPS), Polymer fibers such as polybutylene terephthalate (PBT), polyimide (PI), polytetrafluoroethylene (PTFE), or boron fiber can be used.

  The tubular main body 10 includes a second reinforcing layer 80 formed by winding a second reinforcing wire 82 in a circular cross section so as to surround the outside of the plurality of sub-tubes 40 (40a, 40b). The second reinforcing layer 80 is a protective layer that is provided on the outer diameter side of the operation line 60 in the tubular body 10 and protects the second outer layer 54. The presence of the second reinforcing layer 80 on the outer diameter side of the operation line 60 prevents the operation line 60 from being exposed to the outside of the tubular body 10 by breaking the second outer layer 54 and the hydrophilic layer (not shown). To do. That is, the tubular body 10 of this embodiment includes two metal layers, the wire reinforcing layer 30 and the second reinforcing layer 80.

  The second reinforcing layer 80 is formed by winding the second reinforcing wire 82 into a coil or mesh shape. For the second reinforcing wire 82, the above-described materials exemplified as the reinforcing wire 32 of the wire reinforcing layer 30 can be used. The second reinforcing wire 82 and the reinforcing wire 32 may be made of the same material or different materials. In the present embodiment, as the second reinforcing wire 82, a blade layer in which fine wires made of the same material (stainless steel) as the reinforcing wire 32 are braided in a mesh shape is illustrated.

  The proximal ends of the wire reinforcing layer 30 and the second reinforcing layer 80 are located at the proximal end of the tubular body 10, that is, inside the operation portion 90.

  A distal portion DE of the tubular body 10 is provided with a first marker 14 and a second marker 16 located on the proximal side of the first marker 14. The first marker 14 is disposed in the first region 11 of the tubular body 10, and the second marker 16 is disposed in the second region 12. The first marker 14 and the second marker 16 are ring-shaped members made of a material that does not transmit radiation such as X-rays such as platinum.

  As described above, the second marker 16 is provided at the boundary between the first region 11 and the second region 12 of the tubular body 10. Then, the hardness of the outer layer 50 is significantly different between the first region 11 and the second region 12 with the distal side of the second marker 16 as a boundary. For this reason, under radiation (X-ray) observation, the second marker 16 shows the base end of bending.

  The distal end portion of the operation line 60 is fixed to a portion of the tubular body 10 that is more distal than the second marker 16. By pulling the operation line 60, the first region 11 distal to the second marker 16 in the distal portion DE is bent. By pulling the operation line 60 and bending the first region 11 of the tubular body 10 with the second marker 16 positioned slightly in front of the blood vessel branch, the first marker 14 at the tip can be easily formed into a predetermined blood vessel. This state can be observed and radiation (X-rays) can be observed.

  In the catheter 100 of this embodiment, the distal end portion of the operation line 60 is fixed to the first marker 14. The mode of fixing the operation line 60 to the first marker 14 is not particularly limited, and examples thereof include solder bonding, heat fusion, adhesion with an adhesive, and mechanical engagement between the operation line 60 and the first marker 14. .

  The inner diameter of the second marker 16 is larger than the inner diameter of the first marker 14. The first marker 14 is disposed so as to be in contact with or substantially in contact with the outer surface of the wire reinforcing layer 30. The inner diameter of the first marker 14 is larger than the outer diameter of the wire reinforcing layer 30 and smaller than the inner diameter of the second reinforcing layer 80. The second marker 16 is disposed so as to be in contact with or substantially in contact with the outer surface of the second reinforcing layer 80. The inner diameter of the second marker 16 is larger than the outer diameter of the second reinforcing layer 80.

  The distal end of the inner layer 24 may reach the distal end of the tubular body 10 or may terminate proximally relative to the distal end. The position where the inner layer 24 terminates may be inside the region where the first marker 14 is disposed.

  A hydrophilic layer (not shown) formed on the outer surface of the second outer layer 54 constitutes the outermost layer of the catheter 100. The hydrophilic layer may be formed over the entire length of the tubular body 10 or may be formed only in a partial length region on the tip side including the distal portion DE. The hydrophilic layer is made of, for example, a maleic anhydride polymer such as polyvinyl alcohol (PVA) or a copolymer thereof, or a hydrophilic resin material such as polyvinyl pyrrolidone.

The typical dimension of the component of the catheter 100 of this embodiment is demonstrated.
The diameter of the main lumen 20 can be 400 μm to 600 μm (including an upper limit value and a lower limit value, the same applies hereinafter), the inner layer 24 can have a thickness of 5 μm to 30 μm, and the outer layer 50 can have a thickness of 10 μm to 200 μm. The thickness of the subtube 40 is thinner than the inner layer 24 and can be 1 μm to 10 μm. The inner diameter of the wire reinforcing layer 30 is 410 μm to 660 μm, the outer diameter of the wire reinforcing layer 30 is 450 μm to 740 μm, the inner diameter of the second reinforcing layer 80 is 560 μm to 920 μm, and the outer diameter of the second reinforcing layer 80 is 600 μm to 940 μm. Can do.
The inner diameter of the first marker 14 may be 450 μm to 740 μm, the outer diameter of the first marker 14 may be 490 μm to 820 μm, the inner diameter of the second marker 16 may be 600 μm to 940 μm, and the outer diameter of the second marker 16 may be 640 μm to 960 μm. . The width dimension of the first marker 14 (the dimension in the longitudinal direction of the tubular body 10) can be 0.3 mm to 2.0 mm, and the width dimension of the second marker 16 can be 0.3 mm to 2.0 mm.
The radius (distance) from the axial center of the catheter 100 to the center of the subtube 40 can be 300 μm to 450 μm, the inner diameter (diameter) of the subtube 40 can be 40 μm to 100 μm, and the thickness of the operation line 60 can be 25 μm to 60 μm. .
The tubular body 10 has a diameter of 700 μm to 980 μm, that is, an outer diameter of less than 1 mm, and can be inserted into a blood vessel such as a celiac artery.

  Fig.3 (a) is the whole side view of the catheter 100 of this embodiment. FIG. 3B is an overall side view of the catheter 100 showing a state in which the wheel operation unit 92 is operated in one direction (clockwise in FIG. 3). FIG. 3C is an overall side view of the catheter 100 showing a state in which the wheel operation unit 92 is operated in the other direction (counterclockwise in FIG. 3).

  The operation unit 90 illustrated in FIG. 3A includes a main body case 94 that is gripped by a user's hand, and a wheel operation unit 92 that is provided to be rotatable with respect to the main body case 94. The proximal end portion of the tubular main body 10 is introduced into the main body case 94.

  The catheter 100 includes a hub 96 provided in communication with the main lumen 20 of the tubular body 10. A syringe (not shown) is attached to the hub 96. The hub 96 is provided at the rear end of the main body case 94, and a syringe is mounted from the rear of the hub 96 (right side in FIG. 3A). By injecting a drug solution or the like into the hub 96 with a syringe, the drug solution or the like can be supplied into the body cavity of the patient via the main lumen 20.

  The tubular main body 10 has a side hole that communicates with the sub-tube 40 from the outer peripheral surface inside the front end portion of the main body case 94. The operation line 60 (see FIGS. 1 and 2) is drawn out of the tubular body 10 through this side hole. The proximal end portion of the drawn operation line 60 is directly or indirectly connected to the wheel operation unit 92. By rotating the wheel operation unit 92 in either direction, one of the two operation lines 60 can be pulled to the base end side to apply tension, and the other can be loosened. Thereby, the pulled operation line 60 bends the distal portion DE of the catheter 100. Specifically, as shown in FIG. 3B, when the wheel operation portion 92 is rotated in one direction (clockwise), one operation line 60 is pulled to the proximal end side, and the distal portion of the tubular main body 10 is pulled. DE bends. As shown in FIG. 3C, when the wheel operating portion 92 is rotated in the other direction (counterclockwise) around the rotation axis, the other operation line 60 is pulled to the proximal end side and the distal portion DE is reversed. Bend in the direction. Thus, by selectively pulling the two operation lines 60, the distal portion DE of the catheter 100 can be selectively bent in the first or second direction included in the same plane. .

<Second embodiment>
FIG. 4 is a cross-sectional view of the distal portion DE of the catheter 100 according to the second embodiment of the present invention.

The catheter 100 of the present embodiment is common to the first embodiment in that the tubular body 10 includes a first region 11 and a second region 12 on the proximal side of the first region 11. To do. Further, the first embodiment is also common to the first embodiment in that the resin regions of the first region 11 and the second region 12 in the outer layer 50 have different hardnesses.
The tubular body 10 of the present embodiment further has a third region 13 on the proximal side of the second region 12. The hardness of the outer layer 50 is the lowest in the first region 11 and increases stepwise in the order of the second region 12 and the third region 13.

  Similar to the first embodiment, the first region 11 and the second region 12 of the outer layer 50 are made of the same kind of resin material (eg, polyether block amide) having different hardness. The third region 13 is also made of the same kind of resin material with higher hardness. The joining portion 56 (56a, 56b) of the present embodiment is made of the same type of resin material (for example, polyether block amide) as the first region 11 and the second region 12 of the outer layer 50.

Furthermore, in the catheter 100 of the present embodiment, the joint portion 56 is provided in one of the first region 11 or the second region 12, and the joint portion 56 is the same as the other of the first region 11 or the second region 12. This is different from the first embodiment in that it is made of a resin material.
Specifically, the joining portion 56a of the present embodiment is made of the same resin material as the second region 12 of the outer layer 50 (the material of the first outer layer resin tube 52b described later). That is, the joining portion 56 a is a material different from that of the first region 11 and the third region 13 of the outer layer 50 and is the same material as that of the second region 12. And the junction part 56a and the 1st area | region 11, the 2nd area | region 12, and the 3rd area | region 13 of the outer layer 50 mutually consist of the same kind of resin material.
As shown in FIG. 4, with respect to the first region 11 and the third region 13, since the joint portions 56 a and 56 c are provided with a material different from that of the outer layer 50, the outer layer 50 and the joint portion 56 a, with the subtube 40 as a boundary. An interface with 56c is formed.

  And regarding the 2nd area | region 12, the junction part 56b is comprised integrally with the same resin material as the outer layer 50, and the interface of the junction part 56b and the outer layer 50 is not formed substantially. That is, with respect to the second region 12 of the tubular body 10, there is substantially no site that can be recognized as the joint portion 56 b in distinction from the outer layer 50. In this sense, it can be seen that the joint portion 56 is formed in the first region 11 and the third region 13 (joint portions 56a and 56c) and is not formed in the second region 12.

  The wire reinforcing layer 30 is a blade layer obtained by braiding the reinforcing wire 32 as in the first embodiment. The joining portion 56 is provided in a line shape extending in the axial direction at the lower portion of the sub-tube 40 and impregnates the wire reinforcing layer 30.

According to the present embodiment, particularly in the second region 12, the joint portion 56 and the outer layer 50 are firmly integrated. For this reason, even when a load is applied to the subtube 40 by pulling the operation line 60 or the like, the outer layer 50 and the joint portion 56 are not separated from each other, and the subtube 40 can be held well. Moreover, since the joining part 56 and the outer layer 50 are the same kind of resin material, the joining part 56 is also in a state where the joining part 56 and the outer layer 50 are well joined at the interface in the first region 11 and the third region 13. Anchored to the reinforcing layer 30. Even if peeling occurs at the interface between the joint portion 56 and the outer layer 50 in the first region 11 or the third region 13, since the interface does not substantially exist in the second region 12, the progress of peeling occurs. It stops and the peeling strength as the whole tubular main body 10 improves.
Moreover, the joint part 56 is made common with the material of a part (second region 12) of the outer layer 50, whereby the total number of parts of the catheter 100 can be reduced.

〔Production method〕
Next, with reference to FIGS. 5-7, the manufacturing method of the catheter 100 of said 2nd embodiment is demonstrated.
FIG. 5 is a longitudinal sectional view showing the sub-tube bonding step, and shows a state in which the joining portion 56 is provided on the inner structure 26 in which the inner layer 24 and the wire reinforcing layer 30 are formed around the main core wire 22.
FIG. 6 is a longitudinal sectional view showing the first outer layer shaping step, in which the cored tube 46 in which the subtube 40 is formed around the subcore wire 44 is fixed to the joint portion 56 and then the first outer layer resin pipes 52a to 52a. The state which coat | covered 52c is shown.
FIG. 7 is a longitudinal sectional view showing the second outer layer shaping step, and shows a state in which the second outer layer resin pipe 54a is covered after the second reinforcing wire 82 is braided on the surface of the first outer layer 52.

  First, an outline of a method for manufacturing the catheter 100, which is a medical device of the present embodiment (hereinafter sometimes referred to as the present manufacturing method), will be described.

The manufacturing method includes an inner reinforcing layer forming step, a sub-tube bonding step, an outer layer covering step, an outer layer shaping step, a sub-lumen forming step, and a main lumen forming step. The one or more steps can be repeated once or a plurality of times.
In the inner reinforcing layer creation step, the wire reinforcing layer 30 is formed by winding the reinforcing wire 32 around the main core wire 22.
In the sub-tube bonding step, a resin material is applied to the peripheral surface of the wire reinforcing layer 30 along the main core wire 22 to form the joint portion 56, and the resin sub-tube 40 through which the sub-core wire 44 is inserted is bonded. Adhere to part 56.
In the outer layer covering step, the outer layer resin tube 50T made of a thermoplastic resin is covered around the wire reinforcing layer 30 and the sub tube 40.
In the outer layer shaping step, the outer layer resin tube 50T is heated and pressurized to shape the outer layer 50 containing the subtube 40.
In the secondary lumen forming step, the secondary core wire 44 is expanded and contracted and peeled from the secondary tube 40 to form the secondary lumen 42.
In the main lumen forming step, the main core wire 22 is removed from the wire reinforcing layer 30 to form the main lumen 20.

In this manufacturing method, the outer layer covering step and the outer layer shaping step are performed over at least two rounds in this order. Specifically, after performing the first outer layer coating step and the first outer layer shaping step, the second outer layer coating step and the second outer layer shaping step are further performed.
The outer resin tube 50T is an annular or tubular member made of a thermoplastic resin, and includes first outer resin tubes 52a to 52c and a second outer resin tube 54a.

Hereinafter, this production method will be described in detail.
In the inner reinforcing layer creating step, first, the inner layer 24 is formed around the main core wire 22. The main core wire 22 is a mandrel (core material), and is a wire material having a circular cross section that defines the main lumen 20. The material of the main core wire 22 is not particularly limited, but stainless steel can be used. The inner layer 24 can be formed by dipping the main core wire 22 in a coating liquid in which a fluorine-based polymer such as polytetrafluoroethylene (PTFE) is dispersed in a solvent and then drying.
Next, a multi-strand reinforcing wire 32 is braided into a mesh shape on the outer surface of the inner layer 24 to form the wire reinforcing layer 30.
As shown in FIG. 5, the first marker 14 is caulked and fixed around the tip of the reinforcing wire 32, and then the reinforcing wire 32 is excised on the distal side of the first marker 14.
Thus, the inner structure 26 is created.

  The cored tube 46 shown in FIG. 6 is created simultaneously with the inner reinforcing layer creating step or before and after the inner reinforcing layer creating step. The cored tube 46 is formed by coating the subtube 40 around the peripheral surface of the subcore wire 44. The secondary core wire 44 is a wire having a circular cross section that defines the secondary lumen 42. The material of the sub core wire 44 is not particularly limited, but the same kind of stainless steel as that of the main core wire 22 can be used. The sub-core wire 44 has a smaller diameter than the main core wire 22. The wall thickness of the subtube 40 is preferably thinner than the inner layer 24. When the subtube 40 is made of a fluorine-based polymer such as polytetrafluoroethylene (PTFE), the subtube 40 can be formed by dipping the sub-core wire 44 in a coating liquid in which the polymer is dispersed in a solvent and then drying. As a result, the very thin sub-tube 40 can be formed in close contact with the sub-core wire 44. However, after drawing into a tube shape so that the inner diameter of the sub-tube 40 is larger than the outer diameter of the sub-core wire 44, the sub-tube 40 is covered around the sub-core wire 44 to create a cored tube 46. May be.

In the sub-tube bonding step, as shown in FIG. 5, the joining portion 56 is applied with a thickness for embedding the reinforcing wire 32 of the wire reinforcing layer 30. In the present embodiment, the same resin material as that of a first outer layer resin tube 52 b described later is heated and melted and applied to the peripheral surface of the wire reinforcing layer 30 in a continuous line shape along the main core wire 22. Thereby, the joining part 56 is formed. In the present embodiment, the bonding portion 56 is formed so as to face the periphery of the wire reinforcing layer 30 by 180 degrees.
In the sub-tube bonding step, the sub-tube 40 on the surface of the cored tube 46 is bonded to the uncured joint portion 56. The sub-tube bonding step can be performed at room temperature or under heating. That is, at the same time as the molten resin identical to the first outer resin pipe 52b is applied to the peripheral surface of the wire reinforcing layer 30 at room temperature, the cored tube 46 is adhesively bonded onto the applied molten resin. May be. Alternatively, after the molten resin is applied in a line shape and the joining portion 56 is once cured, the cored tube 46 is pressed and fixed on the joining portion 56 using a jig (not shown). Alternatively, the cored tube 46 may be bonded and bonded by remelting the joint 56 under heating at or above the melting point of the joint 56.

  In the first outer layer covering step, the first outer layer resin tubes 52a to 52c are covered so as to surround the wire reinforcing layer 30 and the cored tube 46 as shown in FIG. The first outer resin tube 52a has the lowest hardness, and the first outer resin tube 52c has the highest hardness. The hardness of the first outer layer resin tube 52b is intermediate between these. The first outer layer resin pipes 52a to 52c are arranged in a line along the longitudinal direction of the inner structure 26 without gaps.

  In the first outer layer shaping step, a heat shrinkable tube (not shown) is coated around the first outer layer resin tubes 52a to 52c in FIG. The melted first outer layer resin tubes 52a to 52c are impregnated in the wire reinforcing layer 30, and the heat shrinkable tube is contracted into a tubular shape to heat-shape the first outer layer 52. Thereby, the first outer layer resin pipes 52a to 52c and the joining portion 56 are melted and joined to each other. At this time, since the joining portion 56 is made of the same resin material as that of the first outer layer resin pipe 52b, the joining portion 56 and the outer layer 50 are naturally integrated with respect to the second region 12 (see FIG. 4).

  That is, in the first outer layer shaping step in which the resin material of the joint portion 56 is thermoplastic and the outer layer 50 (first outer layer 52) is shaped, the joint portion 56 and the outer layer resin pipe 50T (first outer layer resin pipes 52a to 52a- 52c) are melted together and joined together.

  Further, the resin material of the joint portion 56 is the same thermoplastic resin as the outer layer resin tube 50T (first outer layer resin tube 52b). In the first outer layer shaping step, the joining portion 56 and the first outer layer resin pipe 52b are fused and integrated.

  Prior to the second outer layer covering step, as shown in FIG. 7, a second reinforcing layer 80 formed by braiding a plurality of second reinforcing wires 82 is formed on the outer peripheral surface of the first outer layer 52, and this second reinforcing layer is formed. The second marker 16 is attached to the tip of the layer 80. The second reinforcing wire 82 is excised on the distal side of the second marker 16. From this state, the outer layer resin tube 50T (second outer layer resin tube 54a) made of a thermoplastic resin is further covered around the first outer layer 52 embedding the wire reinforcing layer 30 and the subtube 40.

  In FIG. 7, the second outer layer resin pipe 54 a is illustrated as a series of tubular shapes, but the present manufacturing method is not limited thereto. Similarly to the first outer layer resin pipes 52a to 52c, the second outer layer resin pipe 54a may be formed by connecting resin pipes made of different resin materials. More specifically, as the second outer layer resin pipe 54a, a resin pipe in which a plurality of annular or tubular members made of the same resin material as the first outer layer resin pipes 52a to 52c are connected can be used.

  In the second outer layer shaping step, the outer layer 50 containing the sub-tube 40 is coated with a heat-shrinkable tube (not shown) around the outer layer resin tube 50T (second outer layer resin tube 54a) and heated and pressurized. (Second outer layer 54) is shaped. In the second outer layer shaping step, not only the second outer layer resin tube 54a but also the first outer layer 52 molded in the first outer layer shaping step may be remelted. The melted second outer layer resin tube 54a is impregnated into the second reinforcing layer 80 and mixed with the remelted first outer layer 52 to be integrated. In particular, in the second region 12, since the joint portion 56, the first outer layer 52, and the second outer layer 54 are made of the same resin material, the sub-tube 40 and the outer layer 50 are in close contact with each other and tightly bonded.

  As described above, the outer layer 50 (the first outer layer 52 and the second outer layer 54) including the wire reinforcing layer 30, the subtube 40, and the second reinforcing layer 80 is formed.

  In the sub-lumen forming step, the sub-core wire 44 is extended to be reduced in diameter and peeled off from the sub-tube 40. The sub core wire 44 having a reduced diameter is removed from the sub tube 40, and the operation wire 60 is inserted into the sub tube 40.

  In the main lumen forming step, the diameter of the main core wire 22 is reduced by stretching, and the wire reinforcing layer 30, more specifically, the inner layer 24 provided inside the wire reinforcing layer 30 is extracted.

  The sub-lumen formation step and the main lumen formation step may be performed simultaneously, or the main lumen formation step may be performed after the sub-lumen formation step. In the latter case, since the main core wire 22 is inserted into the main lumen 20 in the sub-lumen formation step, the tubular body 10 is suppressed from being stretched and deformed when the sub-core wire 44 is extended. For this reason, the subtube 40 does not extend following the sub-core wire 44. Therefore, the sub-core wire 44 that is smaller in diameter than the main core wire 22 and easily breaks can be satisfactorily removed from the sub-tube 40.

  In this manufacturing method, a hydrophilic layer (not shown) is further formed on the surface of the second outer layer 54, and the operation unit 90 is attached to the proximal end portion of the tubular body 10. As described above, the catheter 100 can be obtained.

  Note that the various components of the present invention do not have to be individually independent, that a plurality of components are formed as one member, and one component is formed of a plurality of members. That a certain component is a part of another component, a part of a certain component overlaps a part of another component, and the like.

  Moreover, although this manufacturing method has described several process in order, the order of the description does not limit the order and timing which perform several processes. For this reason, when carrying out this manufacturing method, the order of the plurality of steps can be changed within a range that does not hinder the contents, and some or all of the execution timings of the plurality of steps overlap each other. Also good.

This embodiment and this manufacturing method include the following technical ideas.
(1) a wire reinforcing layer formed by winding a reinforcing wire around the main lumen, a resin-made subtube that is disposed outside the wire reinforcing layer and defines a sub-lumen having a smaller diameter than the main lumen; A long tubular body including a wire reinforcing layer and a resin outer layer containing the subtube, and a distal end connected to the distal portion of the tubular body movably inserted into the sub-lumen. An operation line, and an operation part that pulls the operation line to bend the distal part of the tubular body, and a joining part that bonds the sub-tube and the outer surface of the wire reinforcing layer is the tubular A medical device characterized by being provided extending in the longitudinal direction of the main body.
(2) The tubular body has a first region and a second region closer to the first region, and the outer layer is made of a resin material of the first region and the second region. The medical device according to (1), wherein the hardnesses are different from each other, and the joint portion is formed of the same resin material across the first region and the second region.
(3) The medical device according to (2), wherein the joint portion is made of a resin material having a melting point higher than that of the outer layer.
(4) The tubular body has a first region and a second region closer to the first region, and the outer layer is made of a resin material of the first region and the second region. Hardness is different from each other, the joint is provided in one of the first region or the second region, and the joint is made of the same resin material as the other of the first region or the second region. The medical device according to (1) or (2), which is configured.
(5) The medical device according to any one of (2) to (4), wherein the first region and the second region of the outer layer are made of the same kind of resin material having different hardness.
(6) The contrast agent is mixed in the second region of the outer layer, and the contrast agent is not mixed in the first region of the outer layer, or the mixing amount of the contrast agent is the second amount. The medical device according to (5) above, wherein the medical device is smaller than the area.
(7) The medical device according to (5) or (6), wherein the joint portion is made of the same type of resin material as the first region and the second region of the outer layer.
(8) The wire reinforcing layer is a blade layer formed by braiding the reinforcing wire, and the joint portion is provided in a line shape extending in the axial direction at a lower portion of the subtube, and the wire reinforcing layer The medical device according to any one of (1) to (7), wherein the layer is impregnated.
(9) From the above (1), a plurality of the sub-tubes are arranged opposite to each other around the wire reinforcing layer, and the operation lines are inserted into at least two of the plurality of sub-tubes, respectively. The medical device according to any one of (8).
(10) The medical device according to (9), further including a second reinforcing layer formed by winding a second reinforcing wire in a circular cross section so as to surround the plurality of sub tubes.
(11) The medical device according to any one of (1) to (10), wherein the medical device further includes a hub provided in communication with the main lumen and to which a syringe is attached.
(12) A step of forming a wire reinforcing layer by winding a reinforcing wire around the main core wire, and forming a joint portion by applying a resin material along the main core wire to the peripheral surface of the wire reinforcing layer A step of adhering a resin-made sub-tube through which a sub-core wire is inserted to the joint, a step of covering an outer-layer resin tube made of a thermoplastic resin around the wire reinforcing layer and the sub-tube, and the outer-layer resin Forming a sub-lumen by heating and pressurizing a tube to form an outer layer containing the sub-tube, extending and reducing the diameter of the sub-core wire, and separating the sub-tube from the sub-tube; and the main core wire Removing the wire from the wire reinforcing layer to form a main lumen.
(13) The medical material according to (12), wherein the resin material of the joint portion is thermoplastic, and the joint portion and the outer layer resin pipe are melted together and joined to each other in the step of shaping the outer layer. Device manufacturing method.
(14) The resin material of the joint portion is the same thermoplastic resin as the outer layer resin tube, and in the step of shaping the outer layer, the joint portion and the outer layer resin tube are fused and integrated (13) The manufacturing method of the medical device as described in 1 ..

DESCRIPTION OF SYMBOLS 10 Tubular main body 11 1st area | region 12 2nd area | region 13 3rd area | region 14 1st marker 16 2nd marker 20 Main lumen 22 Main core wire 24 Inner layer 26 Inner structure 30 Wire reinforcement layer 32 Reinforcement wire 40, 40a, 40b Subtube 42 Sub lumen 44 Sub core wire 46 Core tube 50 Outer layer 50T Outer layer resin tube 52 First outer layer 52a-52c First outer layer resin tube 54 Second outer layer 54a Second outer layer resin tube 56, 56a-56c Joint 60 Operation line 80 First Two reinforcing layers 82 Second reinforcing wire 90 Operating portion 92 Wheel operating portion 94 Main body case 96 Hub 100 Catheter DE Distal portion W Circumferential opening dimension

Claims (14)

A wire reinforcing layer formed by winding a reinforcing wire around the main lumen; a resin-made sub-tube that is disposed outside the wire reinforcing layer and defines a sub-lumen having a smaller diameter than the main lumen; and the wire reinforcing layer And an outer layer made of resin enclosing the subtube, and a long tubular body including:
An operation line that is movably inserted into the sub-lumen and has a tip connected to a distal portion of the tubular body;
An operation portion that pulls the operation line to bend the distal portion of the tubular body, and
A medical device, wherein a joining portion for bonding the sub-tube and the outer surface of the wire reinforcing layer extends in the longitudinal direction of the tubular body. The tubular body has a first region and a second region proximal to the first region;
The outer layer is different in the hardness of the resin material of the first region and the second region,
The medical device according to claim 1, wherein the joint portion is made of the same resin material across the first region and the second region.   The medical device according to claim 2, wherein the joint portion is made of a resin material having a melting point higher than that of the outer layer. The tubular body has a first region and a second region proximal to the first region;
The outer layer is different in the hardness of the resin material of the first region and the second region,
The said joint part is provided in one of said 1st area | region or said 2nd area | region, and the said junction part is comprised with the same resin material as the other of said 1st area | region or said 2nd area | region. The medical device according to 1 or 2.   The medical device according to any one of claims 2 to 4, wherein the first region and the second region of the outer layer are made of the same kind of resin material having different hardness. Contrast agent is mixed in the second region of the outer layer,
The medical device according to claim 5, wherein the contrast medium is not mixed in the first region of the outer layer, or a mixing amount of the contrast agent is smaller than that in the second region.   The medical device according to claim 5 or 6, wherein the joint portion is made of the same type of resin material as the first region and the second region of the outer layer. The wire reinforcing layer is a blade layer braided with the reinforcing wire,
The said joining part is provided in the line shape extended in an axial direction at the lower part of the said subtube, and is impregnating the said wire reinforcement layer, The any one of Claim 1 to 7 characterized by the above-mentioned. Medical device according to item.   The plurality of sub-tubes are arranged to face each other around the wire reinforcing layer, and the operation lines are inserted through at least two of the plurality of sub-tubes, respectively. The medical device according to one item.   The medical device according to claim 9, further comprising a second reinforcing layer formed by winding a second reinforcing wire in a circular cross section so as to surround the plurality of sub tubes.   The medical device according to any one of claims 1 to 10, which is a catheter further provided with a hub provided in communication with the main lumen and to which a syringe is attached. Winding a reinforcing wire around the main core wire to form a wire reinforcing layer;
Applying a resin material along the main core wire to the peripheral surface of the wire reinforcing layer to form a joint, and bonding a resin-made sub-tube through which the sub core wire is inserted;
Coating the outer layer resin tube made of thermoplastic resin around the wire reinforcing layer and the sub-tube;
Forming the outer layer containing the sub-tube by heating and pressurizing the outer-layer resin tube; and
Extending and reducing the diameter of the sub-core wire and separating from the sub-tube to form a sub-lumen;
Removing the main core wire from the wire reinforcing layer to form a main lumen;
A method of manufacturing a medical device including:   The method for manufacturing a medical device according to claim 12, wherein the resin material of the joint portion is thermoplastic, and in the step of shaping the outer layer, the joint portion and the outer resin tube are melted together and joined to each other. .   The medical material according to claim 13, wherein the resin material of the joint portion is the same thermoplastic resin as the outer layer resin tube, and the joint portion and the outer layer resin tube are melted and integrated in the step of shaping the outer layer. Method of manufacturing equipment.

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