JP2014188212A - Medical instrument, and manufacturing method for medical instrument - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a medical instrument that allows a sub-tube for inserting an operation wire to be fixed in a tubular body without being detached.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; multiple resin sub-tubes 40 that are arranged opposite to the outside of the wire reinforcing layer 30 and each of which defines a sub-lumen 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-tubes 40. An operation wire 60 is inserted into the sub-lumen and has a tip connected to a distal portion DE 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. The facing sub-tubes 40 in a catheter 100 meander in a circumferential direction of the main lumen 20 in a manner corresponding to each other.

Description

  The present invention relates to a medical device 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. .

  In the catheter of Patent Document 1, two polymer tubes (hereinafter referred to as subtubes) having wire lumens (hereinafter referred to as sublumens) are laid along the outer surface of a thin inner layer made of a fluorine-based resin material or the like. An operation line is inserted into the sub tube. In forming a tubular body (sheath) in Patent Document 1, a pressurized fluid is injected into the inside of the wire lumen to resist the compressive force applied to the wire lumen during thermoforming of the tubular body. To maintain the inner diameter.

JP 2006-192269 A

  However, since the compressive force applied at the time of thermoforming the tubular body is large, it is difficult to increase the pressure of the pressurized fluid enough to offset this. In addition, it is difficult to implement the method of Patent Document 1 such that if the internal pressure of the sub-tube is increased by the pressurized fluid just before the tubular body is compressed, the sub-tube bursts. If the compressive force applied during the thermoforming of the tubular body is reduced, poor adhesion between the subtube and the tubular body may occur, and the subtube may peel off when the tubular body is bent. When the operation line is pulled to bend the tubular body, the sub-tube is eccentric from the axis and located outside or inside the bend, so the path length from the proximal end to the distal end is different from the axis This is because a shearing force is generated at the interface between the tubular body and the sub-tube.

  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 fix a sub-tube for inserting an operation line to a tubular body without peeling, and a method for manufacturing the same. .

  According to the present invention, a wire reinforcing layer formed by winding a reinforcing wire around the main lumen and a plurality of sub-lumens arranged opposite to the outside of the wire reinforcing layer and having a smaller diameter than the main lumen. A long tubular body including a resin-made subtube, a resin outer layer containing the wire reinforcing layer and the subtube, and a distal end that is movably inserted into the sublumen. An operation line connected to the distal portion of the tubular body, and an operation portion that pulls the operation line to bend the distal portion of the tubular body, and a plurality of the subtubes facing each other, Corresponding to each other, a medical device is provided which meanders in the circumferential direction of the main lumen.

  In the medical device of the present invention, the subtube into which the operation line is inserted meanders and extends in the circumferential direction of the main lumen. Here, the tensile force and the compressive force generated at the interface between the tubular main body and the sub-tube when the operation line is pulled are generated in the axial direction of the tubular main body. On the other hand, according to the present invention, a part of the tensile force and compressive force described above acts not in the extending direction of the subtube but in the width direction of the subtube. Since peeling at the interface of the sub-tube occurs due to a tensile force or a compressive force acting in the extending direction of the sub-tube, the occurrence of peeling can be reduced according to the present invention. In addition, since the plurality of opposing subtubes meander in correspondence with each other, both peeling of the interface caused by the compressive force generated inside the bent tubular body and the tensile force generated outside can be reduced. be able to.

  Furthermore, according to the present invention, a step of preparing an inner structure including a main core wire and a wire reinforcing layer in which a reinforcing wire is wound around the main core wire, and a resin-made subtube are respectively coated. A plurality of sub-core wires are arranged along the main core line so as to face the outer peripheral surface of the wire reinforcing layer, and the sub-core wires meander in the circumferential direction of the main core wire in correspondence with each other. A step of co-winding the sub-tube and the wire reinforcing layer with a holding wire while relatively moving the core wire and the main core wire; and the co-winding the sub-tube, the wire reinforcing layer, and the holding wire A step of forming a tubular body so as to enclose, a step of extending and reducing the diameter of the sub-core wire to peel from the sub-tube to form a sub-lumen, and a step of removing the main core wire from the tubular body to remove the main tube. Forming a method of manufacturing a medical device comprising is provided.

  ADVANTAGE OF THE INVENTION According to this invention, it is possible to fix easily the subtube for inserting an operation line in a medical device without peeling with respect to a tubular main body.

It is a cross-sectional view of the distal end portion of the catheter of the embodiment of the present invention. It is the II-II sectional view taken on the line of FIG. FIG. 3A is a schematic side view of the tubular main body developed along line III-III in FIG. FIG. 3B is a schematic side view in which a tubular body according to a modification is developed. It is a partial side view which shows typically the positional relationship of the subtube and reinforcement wire which meander. Fig.5 (a) is the whole side view of the catheter of embodiment of this invention. FIG. 5B is an overall side view of the catheter showing a state where the wheel operation unit is operated in one direction. FIG. 5C is an overall side view of the catheter showing a state where the wheel operation unit is operated in the other direction. It is a longitudinal cross-sectional view of the inner structure which formed the inner layer and the wire reinforcement layer around the main core wire. It is a side view of the cored tube which formed the subtube around the subcore wire. It is a perspective view which shows typically the winding process of a holding wire.

  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.

  An outline of the medical device of the present embodiment will be described with reference to FIGS. 1 to 4. In this embodiment, a catheter is illustrated as a medical device. The present invention can be applied to endoscopes and other medical devices that can bend a distal portion by pulling an operation line in addition to a catheter.

  FIG. 1 is a cross-sectional view (transverse cross-sectional view) in which a distal portion of the catheter 100 of the present embodiment is cut perpendicular to the longitudinal direction. 2 is a cross-sectional view (longitudinal cross-sectional view) obtained by cutting the distal portion DE of the catheter 100 along the longitudinal direction, and is a cross-sectional view taken along the line II-II in FIG. Fig.3 (a) is a side surface schematic diagram of the tubular main body 10 expand | deployed by the III-III line | wire of FIG. The second marker 16, the inner layer 24, the outer layer 50, the wire reinforcing layer 30, and the second reinforcing layer 80 are not shown. FIG. 3B is a schematic side view of a modified tubular body 10 developed. FIG. 4 is a partial side view schematically showing the positional relationship between the meandering subtube 40 and the reinforcing wire 32.

First, the outline | summary of the catheter 100 of this embodiment is demonstrated.
The catheter 100 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 sub-lumen 42 that is disposed opposite to the outside of the wire reinforcing layer 30 and has a smaller diameter than the main lumen 20. A plurality of resin-made subtubes 40 that respectively define each other, and a resin-made outer layer 50 that includes the wire reinforcing layer 30 and the subtubes 40 are included. 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 plurality of opposing subtubes 40 (40a, 40b) meander in the circumferential direction of the main lumen 20 corresponding to each other.

  Hereinafter, this embodiment will be described in detail. The catheter 100 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 according to the present embodiment includes a first outer layer 52 having an annular cross section that encloses the holding wire 70 and a second outer layer having an annular cross section that is provided around the first outer layer 52 and encloses the second reinforcing layer 80. 54 (see FIG. 1).

  Inside the first outer layer 52 corresponding to the inner layer of the outer layer 50, a wire reinforcing layer 30, a sub tube 40, and a holding wire 70 are provided in order from the inner diameter side. A second reinforcing layer 80 is provided inside the second outer layer 54 corresponding to the outer layer of the outer layer 50. 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. The second reinforcing layer 80 is disposed so as to surround the wire reinforcing layer 30 and the subtube 40 so as to surround them.

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 are made of the same or different resin materials. 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 kind of 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.

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. 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. Moreover, the parameter represented by the following mathematical formula (1) is referred to as an 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)

  For the second reinforcing layer 80 described later, the opening size of the second reinforcing layer 80 as viewed in the extending direction of the second reinforcing wire 82 is defined by the above mathematical formula (1).

  The wire reinforcing layer 30 of the present embodiment shown in FIG. 1 is braided by 16 16 reinforcing wires 32 spirally wound in opposite directions. Thereby, eight intersections 34 (see FIG. 4) between the reinforcing wires 32 are formed in the circumferential direction of the tubular main body 10. That is, eight reinforcing wires 32 are wound in a right spiral from the distal end of the tubular body 10 toward the base end, and the other eight reinforcing wires 32 are wound in a left spiral. The right helix means winding in the right screw direction with the direction from the distal end to the proximal end of the tubular body 10 as the screwing direction. The left helix refers to winding in the left screw direction with respect to this screwing direction. However, in place of the present embodiment, the number of right spiral reinforcing wires 32 and the number of left spiral reinforcing wires 32 may be different from each other.

As shown in FIG. 4, 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.
Here, the parameter represented by the following mathematical formula (2) is referred to as a circumferential opening size W of the wire reinforcing layer 30 (see FIGS. 1 and 4).
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.

  The wire reinforcing layer 30 of the present embodiment is a blade layer formed by braiding multiple reinforcing wires 32. The number of the reinforcing wires 32 constituting the wire reinforcing layer 30 is not particularly limited.

  When the number of right and left spiral reinforcing wires 32 is the same and the winding pitch is the same as in the present embodiment, the mesh intersection 34 between the reinforcing wires 32 is at the tubular body 10 as shown in FIG. They are arranged in a straight line in the axial direction (left-right direction in FIG. 4).

As shown in FIGS. 1 and 4, the opening size W in the circumferential direction of the wire reinforcing layer 30 (blade layer) represented by the above mathematical formula (2) is larger than the outer diameter of the sub-tube 40.
Therefore, if the extending direction of the subtube 40 is a straight line in the axial direction, depending on the delicate positional relationship between the intersection 34 of the wire reinforcing layer 30 and the subtube 40, the intersection of the subtube 40 is aligned in the axial direction. 34, it is arranged immediately above the intersection point 34, or conversely, it is arranged without overlapping the mesh intersection point 34 at all.

In the present embodiment, the reinforcing wire 32 is fitted into the inner diameter side surface of the sub tube 40. Thereby, the subtube 40 is firmly fixed to the outer layer 50 via the reinforcing wire 32, and the peeling is suppressed. Here, the fact that the reinforcing wire 32 is fitted on the surface of the subtube 40 means that, in at least one cross section of the tubular body 10, a part or all of the cross section of the reinforcing wire 32 is on the outer periphery of the subtube 40. It is located inside the virtual surface (virtual outline). The virtual surface (virtual outline) of the outer periphery of the subtube 40 is a virtual outer peripheral surface of the subtube 40 when the reinforcing wire 32 is not inserted. The virtual outer shape of the subtube 40 can be obtained from the outer peripheral surface of another portion that is close to the insertion portion of the reinforcing wire 32 in the subtube 40 in the axial direction. When the subtube 40 is disposed immediately above the intersection 34 where the reinforcing wires 32 intersect, the depth of insertion of the reinforcing wire 32 into the inner diameter side surface of the subtube 40 is relatively large. On the other hand, when the subtube 40 is disposed directly above the intermediate portion of the reinforcing wire 32 other than the intersection point 34, the insertion depth of the reinforcing wire 32 with respect to the inner diameter side surface of the subtube 40 is relatively small.
Therefore, the insertion depth of the reinforcing wire 32 with respect to the sub tube 40 increases or decreases depending on the delicate positional relationship between the intersection 34 of the wire reinforcing layer 30 and the sub tube 40 as described above. For this reason, the anchor property of the wire reinforcement layer 30 with respect to the subtube 40 will fluctuate | variate greatly for every individual of the catheter 100. FIG. In other words, when the arrangement direction of the intersections 34 of the mesh of the wire reinforcing layer 30 and the extending direction of the subtube 40 are parallel, the subtube 40 is caused by a delicate positional relationship between the intersection 34 and the subtube 40. The peel strength between the outer layer 50 and the outer layer 50 varies.
In addition, the fact that the reinforcing wire 32 is fitted in the peripheral surface of the sub-tube 40 includes at least the following two states. The first state is a state in which the subtube 40 is locally thin at the portion where the reinforcing wire 32 is inserted. The sub-tube 40 of the present embodiment is locally thin while maintaining a circular cross-sectional shape.
The second state is a state in which the cross-sectional shape of the sub-tube 40 is a concave shape as a whole while the thickness is uniform over the entire circumference. In other words, in the second state, the cross-sectional shape of the sub-tube 40 is a concave shape such as a concave circular shape or a concave elliptical shape (kidney shape or curved ball shape). The state in which the reinforcing wire 32 is fitted in the recessed portion is also said that the reinforcing wire 32 is fitted in the peripheral surface of the sub-tube 40.
The above-described insertion depth of the reinforcing wire 32 refers to a virtual surface (virtual outline) on the outer periphery of the subtube 40 in the cross section of the insertion portion of the reinforcing wire 32 to the deepest portion of the inserted reinforcing wire 32. Say distance.

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.
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 wire diameters of the second reinforcing wire 82 and the reinforcing wire 32 may be the same or different. In the present embodiment, the second reinforcing wire 82 and the reinforcing wire 32 have the same wire diameter.
Further, the size of the number of the reinforcing wires 32 constituting the wire reinforcing layer 30 and the number of the second reinforcing wires 82 constituting the second reinforcing layer 80 are not particularly limited, but are the same in this embodiment. In FIG. 1, both of the wire reinforcing layer 30 and the second reinforcing layer 80 are illustrated as blade layers made of 16 wires (reinforcing wires 32 and second reinforcing wires 82).

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 thickness of the subtube 40 is smaller than both the holding wire 70 and the operation wire 60. Further, the wire diameter of the holding wire 70 is smaller than the wire diameter of the operation wire 60.

  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.

  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. 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. The number of fine wires constituting one stranded wire of the operation wire 60 is not particularly limited, but is preferably 3 or more. A preferable example of the number of thin wires is seven or three.
When the operation line 60 is a single wire, the diameter of the single line is referred to as the wire diameter of the operation line 60. When the operation wire 60 is a stranded wire obtained by twisting a plurality of strands, the diameter of a circumscribed circle including the plurality of strands is referred to as the wire diameter of the operation wire 60.

  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 outer layer 50 of the present embodiment includes a holding wire 70 that winds the plurality of subtubes 40 and the wire reinforcing layer 30 together. The holding wire 70 is a coil obtained by spirally winding one or more strands around the sub-tube 40, or a blade obtained by braiding a plurality of strands in a mesh shape. Among these, the holding wire 70 of this embodiment is a coil, and more specifically, a multi-strand coil in which a plurality of strands are wound in a multi-strand.

  The holding wire 70 is spirally wound so as to surround the outer sides of the pair of subtubes 40 a and 40 b disposed to face the periphery of the main lumen 20. The holding wire 70 is wound in a substantially rhombus shape in contact with the outer peripheral surface of the two sub tubes 40 a and 40 b and the outer surface of the wire reinforcing layer 30. In FIG. 1, the holding wire 70 whose winding shape forms a substantially rhombus is illustrated by a broken line. In this approximately rhombus, the direction in which the sub tubes 40a and 40b are arranged (the vertical direction in FIG. 1) is the major axis direction. The holding wire 70 is in contact with the peripheral surface of the sub-tube 40, specifically, the outer surface that is opposite to the axis of the main lumen 20. Here, the approximate rhombus means that the first diagonal line is longer than the second diagonal line, and the first diagonal line and the second diagonal line are substantially orthogonal. The approximate rhombus herein includes, in addition to the rhombus, a flat shape such as a kite shape and a flat hexagon and a flat octagon as shown in FIG. The substantially elliptical shape includes an elliptical shape such as an oval shape as well as an elliptical shape or an oval shape.

  When viewed in the longitudinal direction of the tubular body 10, the holding wire 70 is wound over substantially the entire length of the sub tubes 40 a and 40 b. Thereby, in a state where the pair of sub-tubes 40a and 40b is kept parallel to the axial direction of the tubular main body 10 along the surface of the wire reinforcement layer 30, the wire reinforcing layer 30 and the sub-tubes 40a and 40b are held by the holding wire 70. The relative position is fixed.

As the material of the holding wire 70, any of the metal materials and resin materials described above that can be used as the reinforcing wire 32 can be used. In the present embodiment, the holding wire 70 is made of a material different from that of the reinforcing wire 32. The ductility of the holding wire 70 is preferably higher than the ductility of the reinforcing wire 32. Specifically, austenitic soft stainless steel (W1 or W2), which is a dull material, or copper or copper alloy is used for the holding wire 70, while tungsten or stainless spring steel can be used for the reinforcing wire 32. .
By using a highly ductile material for the holding wire 70, the holding wire 70 is loosened when the holding wire 70 is coiled or braided into a mesh shape (coil winding in this embodiment) around the sub-tube 40. The sub-tube 40 is fixed by being stretched and deformed plastically. On the other hand, since the wire reinforcing layer 30 is a member that prevents the occurrence of kinks in the tubular body 10 as will be described later, it is preferable to use a spring material having a high elastic restoring force.

  Hereinafter, the relationship between the wire reinforcing layer 30 and the subtube 40 will be described in more detail.

  As shown in FIG. 1, two subtubes 40 a and 40 b are arranged around the wire reinforcing layer 30 so as to face each other by 180 degrees, and the operation lines 60 are inserted into the two subtubes 40, respectively. . The two sub tubes 40 are arranged on the same circumference so as to surround the main lumen 20. The two sub tubes 40 a and 40 b meander in correspondence with each other in a state substantially parallel to the axial direction of the tubular body 10.

  FIG. 3A is a development view of the tubular body 10 of FIG. The 0 ° line and the 360 ° line shown in FIG. 3A are connected to each other (see FIG. 1). The holding wire 70 holds the meandering shape of the sub tubes 40a and 40b by pressing the sub tube 40 against the tubular body 10 with a predetermined winding tension.

  The plurality of sub tubes 40a and 40b meander in the circumferential direction (vertical direction in FIG. 3A) of the main lumen 20 (see FIG. 2) corresponding to each other. Here, the subtubes 40a and 40b meander in correspondence with each other. These subtubes 40a and 40b are in the circumferential direction (spiral direction) of the main lumen 20 at substantially the same position in the longitudinal direction of the tubular body 10. Are curved in the same direction or in the opposite direction. The subtubes 40a and 40b of this embodiment shown in FIG. 3A are curved in parallel in the same phase in the same direction in the circumferential direction of the main lumen 20. In addition, the plurality of sub-tubes 40a and 40b are curved in parallel in the same circumferential direction of the main lumen 20 while maintaining a predetermined phase difference. Correspondingly meandering.

  FIG. 3B is a schematic side view of the tubular main body 10 according to a modification of the present embodiment. This modification is different from the present embodiment in that the plurality of sub-tubes 40a and 40b are curved in parallel in the same phase in the opposite direction of the circumferential direction of the main lumen 20. The state of this modification is one mode in which a plurality of sub-tubes 40a and 40b meander in correspondence with each other. Further, instead of this modification, the plurality of sub-tubes 40a, 40b may be curved in parallel in the opposite direction of the circumferential direction of the main lumen 20 while maintaining a predetermined phase difference. The tubes 40a and 40b meander to correspond to each other.

  That is, the plurality of opposing sub-tubes 40a and 40b of the present embodiment are arranged around the circumference of the main lumen 20 with the direction (left-right direction in FIG. 1) intersecting the opposing direction (up-down direction in FIG. They meander in the same direction or in the opposite direction.

  In other words, the plurality of opposing sub-tubes 40a and 40b of the present embodiment are mirror-symmetrical with respect to a symmetry plane that is point-symmetric with respect to the center of the main lumen 20 or that passes through the center of the main lumen 20 and has the opposing direction as a normal direction. It is meandering symmetrically. This plane of symmetry corresponds to a 180 ° line in the developed views of FIGS. 3 (a) and 3 (b).

In the tubular main body 10 of the present embodiment shown in FIG. 3A, the plurality of sub-tubes 40a and 40b are arranged around the main lumen 20 while facing each other at an equal distance of 180 degrees in the opposite directions in the swinging direction. Meandering to twist. For this reason, when it sees in the expanded view of Fig.3 (a), the subtubes 40a and 40b meander in the same direction. In other words, the plurality of sub tubes 40 a and 40 b meander in a point-symmetric manner with respect to the center (axial center) of the main lumen 20.
On the other hand, in the tubular main body 10 of the modification shown in FIG. 3B, the plurality of sub-tubes 40a and 40b approach and move away from each other around the main lumen 20 in the same direction in the swing direction. Meandering. For this reason, when it sees in the expanded view of FIG.3 (b), the subtubes 40a and 40b meander in the reverse direction. In other words, the plurality of sub-tubes 40 a and 40 b meander on the mirror surface with respect to the symmetry plane of the main lumen 20.

  As shown in FIG. 1, the first outer layer 52 is impregnated between the wire reinforcing layer 30 and the subtube 40. Thereby, the inner layer 24, the wire reinforcement layer 30, and the subtube 40 are integrally fixed. When the tubular body 10 is bent from this state, a tensile force acts on the outside of the bend, and a compressive force acts on the inside. When the subtube 40 and the outer layer 50 are made of materials having different bending rigidity and tensile elastic modulus, when the tubular body 10 is bent, a shearing force is generated at the interface between the subtube 40 and the outer layer 50, It becomes a factor of peeling at the interface with the outer layer 50 (hereinafter referred to as interface peeling).

  On the other hand, in the catheter 100 of this embodiment, the subtube 40 is slightly meandering in the circumferential direction of the main lumen 20. For this reason, since the tensile force and the compressive force resulting from the bending of the tubular body 10 have components in the width direction as well as the longitudinal direction of the subtube 40, the shearing force at the interface between the subtube 40 and the outer layer 50 is reduced. It reduces and the interfacial peeling is suppressed.

  The meandering width SW of the sub-tube 40 of the present embodiment is less than 180 degrees in terms of the turning angle of the main lumen 20. The meandering width SW referred to here is a swing width in the circumferential direction of the main lumen 20 in one cycle of the subtube 40 meandering over a plurality of cycles. When the meandering width SW of the sub tube 40 is excessive, friction between the sub tube 40 and the operation line 60 inserted into the sub tube 40 increases. Therefore, the meandering width SW of the subtube 40 is more preferably less than 90 degrees in terms of the turning angle of the tubular body 10. Further, the meandering width SW of the sub-tube 40 may be smaller than the opening size in the circumferential direction of the wire reinforcing layer 30. 3A, 3B, and 4, the meandering width SW is exaggerated.

  Further, the meandering width SW of the sub-tube 40 may be larger than one half of the opening size in the circumferential direction of the wire reinforcing layer 30. Thereby, as shown in FIG. 4, the sub-tube 40 passes immediately above any of the intersections 34 regardless of the positional relationship with the openings of the wire reinforcing layer 30. Thereby, the insertion depth of the reinforcing wire 32 to the inner diameter side surface of the subtube 40 is stabilized for each individual catheter 100. The meandering width SW of the subtube 40 is a deflection dimension of the subtube 40 viewed in the circumferential direction of the main lumen 20.

  The subtube 40 may meander through the entire longitudinal direction of the tubular body 10 or may meander only in a partial length region.

  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 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. By using the positions of the two markers of the first marker 14 and the second marker 16 as an index, the position of the distal end of the tubular body 10 in the body cavity (blood vessel) can be visually confirmed under radiation (X-ray) observation. Thereby, the optimal timing for performing the bending operation of the catheter 100 can be easily determined.

  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 distal portion of the distal portion DE with respect to the second marker 16 is bent. 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.

  As shown in FIG. 2, the distal end of the wire reinforcing layer 30 reaches the region where the first marker 14 is disposed. The arrangement region of the first marker 14 is a length region in which the first marker 14 is formed when viewed in the axial direction of the tubular main body 10. The same applies to the second marker 16. The distal end of the wire reinforcing layer 30 is located on the distal side of the tubular body 10 with respect to the proximal end of the first marker 14. Further, the distal end of the wire reinforcing layer 30 is located in the vicinity of the distal end of the first marker 14. In this way, the wire reinforcing layer 30 reaches the region where the first marker 14 is disposed, so that the discontinuity of the bending rigidity of the tubular body 10 at the proximal end of the first marker 14 is alleviated and the kink Occurrence is prevented.

  The subtube 40 is disposed so as to be substantially continuous with the proximal side of the first marker 14. There may be a gap between the proximal end of the first marker 14 and the distal end of the subtube 40. The distal end of the sub-tube 40 does not meander, and extends along the axial direction of the tubular body 10 (the left-right direction in FIGS. 3A and 3B) as shown in FIGS. 3A and 3B. It is preferable that it extends. Thereby, when the operation line 60 (see FIGS. 1 and 2) inserted through the sub-tube 40 is pulled, the distal end of the tubular body 10 is bent without being twisted.

  The distal end of the second reinforcing layer 80 is more proximal than the proximal end of the first marker 14 and more distal than the proximal end of the region where the second marker 16 is disposed. The distal end of the second reinforcing layer 80 is located in the vicinity of the distal end of the second marker 16. Thereby, a discontinuity is generated in the bending rigidity of the tubular body 10 at the distal end of the second marker 16. For this reason, when the operation line 60 is pulled, the tubular body 10 can be sharply bent slightly on the distal side of the second marker 16. Even if the tubular body 10 is bent sharply in this way, the wire reinforcing layer 30 is continuously formed up to the region where the first marker 14 is disposed as described above, and thus the tubular body 10 is kinked. There is nothing. In other words, one of the wire reinforcing layer 30 and the second reinforcing layer 80 is continuously formed up to the vicinity of the distal end of the tubular body 10 to prevent kinking, and the other is terminated in the middle of the distal portion DE. The bending position is clearly defined by causing a discontinuity of bending rigidity in the main body 10.

  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.

  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. 5A is an overall side view of the catheter 100 of the present embodiment. FIG. 5B 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. 5). FIG. 5C 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. 5).

  The catheter 100 includes an operation unit 90 that is provided at the proximal end portion of the tubular main body 10 and that individually pulls a plurality of operation lines 60 (see FIG. 1 or FIG. 2). The operation unit 90 includes a main body case 94 that is gripped by the user's hand, and a wheel operation unit 92 that is provided so as 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. Two sub tubes 40 a and 40 b (see FIGS. 1 and 2) through which the operation line 60 is inserted branch from the tubular main body 10 inside the front end portion of the main body case 94. The base end portion of the operation line 60 drawn from each of the sub tubes 40 is connected to the wheel operation portion 92. By rotating the wheel operation unit 92 in either direction, one operation line 60 can be pulled to the proximal 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 (see FIGS. 5B and 5C). Here, the bending of the tubular body 10 includes an aspect in which the tubular body 10 is bent in a “shape” and an aspect in which the tubular body 10 is curved in a bow shape.

  In this way, by selectively pulling the two operation lines 60 by the operation of the operation unit 90 with respect to the wheel operation unit 92, the distal portions DE of the catheter 100 are first or second included in the same plane. It can be selectively bent in two directions.

  An uneven engagement portion is formed on the peripheral surface of the wheel operation portion 92. In the present embodiment, a vertical knurled waveform is illustrated. A recess 95 is formed in the main body case 94 at a position in contact with the wheel operation unit 92. The concave portion 95 is provided with a slider 98 that slides forward and backward toward the wheel operation portion 92. A protrusion 99 is formed at the tip of the slider 98 facing the wheel operation unit 92. The protrusion 99 is smaller than the opening width of the concave-convex engaging portion (vertical knurling) on the peripheral surface of the wheel operating portion 92. When the slider 98 is slid toward the wheel operation unit 92, the protrusion 99 is hooked on the peripheral surface of the wheel operation unit 92 to restrict the rotation of the wheel operation unit 92. Thereby, the bent state of the catheter 100 can be maintained by restricting the rotation of the wheel operation unit 92 in a state where the distal portion DE of the catheter 100 is bent. FIG. 5A shows a state in which the protrusion 99 of the slider 98 and the wheel operation unit 92 are not engaged and the wheel operation unit 92 can rotate. 5 (b) and 5 (c), the protrusion 99 of the slider 98 and the wheel operating portion 92 are engaged to restrict the rotation of the wheel operating portion 92, and the bent state of the distal portion DE is maintained. Indicates the state.

  By rotating the operation unit 90 about the axis of the tubular body 10, the distal portion DE of the tubular body 10 can be torque-rotated at a predetermined angle. By combining the operation of the wheel operation unit 92 and the entire shaft rotation of the operation unit 90, the direction of the distal portion DE of the catheter 100 can be freely controlled.

  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. 5A). 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. Examples of the chemical solution include a contrast agent, a liquid anticancer agent, physiological saline, and NBCA (n-butyl-2-cyanoacrylate) used as an instantaneous adhesive. In addition, medical devices such as embolization coils and beads (emboli globular material) are not limited to liquids.

Various modifications are allowed for this embodiment.
In the above embodiment, the two sub tubes 40a and 40b are illustrated as being disposed around the main lumen 20 so as to face each other by 180 degrees. Instead of this, three or four or more subtubes 40 may be arranged oppositely around the main lumen 20 at equal intervals. In this case, the operation lines 60 may be arranged on all the sub tubes 40 or the operation lines 60 may be arranged on some of the sub tubes 40.

  All of the three or four or more sub-tubes 40 may meander corresponding to each other, or only a part of the number of sub-tubes 40 may meander. Although it is preferable that the operation line 60 is inserted through the corresponding meandering subtube 40, the present invention is not limited to this.

  That is, three or more subtubes 40 are arranged around the wire reinforcing layer 30 so as to face each other, and among these three or more, at least two subtubes in which the operation lines 60 are arbitrarily inserted are arranged. The tubes 40 may meander in the circumferential direction of the main lumen 20 corresponding to each other.

  By arranging three or more sub-tubes 40 at equal intervals on the same circumference so as to surround the main lumen 20, the bending rigidity of the tubular body 10 becomes equal regardless of the bending direction of the tubular body 10. For this reason, when the tubular body 10 is torque-rotated in a bent state, the distal portion DE can be smoothly oriented in a desired direction.

  The holding wire 70 may be in contact with the outer peripheral surface of each of the three or more sub tubes 40. Thereby, the subtube 40 can be embedded in the outer layer 50 in a state in which the positional relationship in the circumferential direction of the three or more subtubes 40 is fixed by the holding wire 70. In this case, the winding shape of the holding wire 70 may be a rounded N-square shape with each subtube 40 as a corner.

〔Production method〕
Next, with reference to FIGS. 6-8, the manufacturing method of the catheter 100 of this embodiment is demonstrated. FIG. 6 is a longitudinal sectional view of 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. 7 is a side view of the cored tube 46 in which the subtube 40 is formed around the subcore wire 44. FIG. 8 is a perspective view schematically showing the winding process of the holding wire 70.

  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.

This manufacturing method includes an inner structure preparation step, a sub tube holding step, a main body forming step, a sub core wire extraction step, and a main core wire extraction step.
The inner structure preparation step is a step of preparing the inner structure 26 including the main core wire 22 and the wire reinforcing layer 30 in which the reinforcing wire 32 is wound around the main core wire 22.
In the sub-tube holding step, a plurality of sub-core wires 44 respectively covered with the resin sub-tubes 40 are arranged along the main core wire 22 so as to face the outer peripheral surface of the wire reinforcing layer 30. A step of co-winding the sub-tube 40 and the wire reinforcing layer 30 with the holding wire 70 while relatively moving the sub-core wire 44 and the main core wire 22 so as to meander in the circumferential direction of the main lumen 20 corresponding to each other. It is.
The main body forming step is a step of forming the tubular main body 10 so as to include the sub-tube 40, the wire reinforcing layer 30, and the holding wire 70 that are wound together.
The sub-core wire extracting step is a step of forming the sub-lumen 42 by extending and reducing the diameter of the sub-core wire 44 and separating it from the sub-tube 40.
The main core wire extraction step is a step of forming the main lumen 20 by extracting the main core wire 22 from the tubular body 10.

Hereinafter, this production method will be described in detail.
In the inner structure preparation 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 a copper or copper alloy wire material plated with silver can be used. In addition, stainless steel can be used as the material of the main core wire 22. It can be formed by dipping the main core wire 22 in the dispersed coating liquid and drying it.
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. 6, 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. 7 is created simultaneously with the inner structure preparation process or before and after the inner structure preparation process. In the inner structure preparation step, the sub tube 40 is formed on the peripheral surface of the sub core 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 a metal material having a higher strength than the main core wire 22, such as stainless steel, can be used. The sub-core wire 44 has a smaller diameter than the main core wire 22. By using a metal material having a strength higher than that of the main core wire 22 as the sub-core wire 44, the sub-core wire 44 can be suitably peeled off from the sub-tube 40 by extending and reducing the diameter without breaking the sub-core wire 44 in the sub-core wire removing step. 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.
In addition, 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, a cored tube 46 is formed by covering the periphery of the sub-core wire 44. Also good.

  In this manufacturing method, the timing at which the sub-core wire 44 is arranged along the main core wire 22 and the timing at which the sub-core wire 44 and the main core wire 22 are wound together by the holding wire 70 are simultaneous. As shown in FIG. 8, a plurality of (two in the present manufacturing method) cored tubes 46 are sent out along the inner structure 26 through the through holes 112 of the insertion jig 110, and a plurality of winder devices 120 are disposed around the cored tubes 46. The bobbin heads 122 are rotated in the same direction. A holding wire 70 is wound around the bobbin head 122.

In the sub-tube holding step of co-winding with the holding wire 70, the sub core wire 44 and the main core wire 22 are relatively rotated around the main core wire 22 or relatively translated in the radial direction of the main core wire 22. . Specifically, the pair of sub-core wires 44 may be coaxially rotated relative to the main core wire 22. Thereby, the pair of sub-core wires 44 meander in the same direction in the circumferential direction of the main lumen 20 in the same phase. That is, as a result, the tubular body 10 of the present embodiment shown in FIG.
In contrast, the pair of sub-core wires 44 and the main core wire 22 are relatively translated in the radial direction of the main core wire 22 so that the sub-core wires 44 are in contact with each other in the opposite direction of the circumferential direction of the main lumen 20. Meander in the same phase while separating.
By adjusting the relative rotation angle or movement amount of the sub-core wire 44 and the main core wire 22 to a predetermined value, the meandering width SW of the sub-tube 40 meandering in the circumferential direction of the main lumen 20 is made larger than the outer diameter of the sub-tube 40. Can be set to a large predetermined width.

  The main core wire 22 exposed at the tip of the inner structure 26 and the sub-core wires 44 exposed at the tips of a plurality of (two in this manufacturing method) cored tubes 46 are integrated by a jig (not shown). It is fixed to. The main core wire 22 may be provided so as to be rotatable with respect to the jig. In this state, the bobbin head 122 is rotated while pushing the inner structure 26 and the cored tube 46 at a predetermined feed speed with the first marker 14 facing the tip side (upward in FIG. 8). As a result, the holding wire 70 is wound around the wire reinforcing layer 30 and the subtube 40 in a coil shape. By adjusting the feeding speed of the inner structure 26 and the rotational speed of the bobbin head 122, the winding pitch of the holding wire 70 can be increased or decreased.

  As shown in FIG. 8, the insertion jig 110 is formed with a main through hole 114 through which the inner structure 26 is inserted. Two through holes 112 are formed around the main through hole 114 so as to face each other. The hole diameter of the main through-hole 114 is set to be slightly larger than the outer diameter of the inner structure 26 so that the inner structure 26 is loosely inserted.

  In this manufacturing method, in the sub-tube holding process in which the holding wire 70 is wound together, the inner structure 26 is wound together with the holding wire 70 while the inner structure 26 is axially rotated.

  A gripping tool 126 is attached around the inner structure 26. The gripping tool 126 slidably holds the inner structure 26 that is pushed out at a predetermined feed speed through the main through hole 114. One or both of the gripping tool 126 and the insertion jig 110 are relatively reciprocally rotated by a drive unit (not shown) around the axis of the main core wire 22 in a forward and reverse direction at a predetermined rotation angle. Driven. As a result, as shown in FIG. 3A, the pair of subtubes 40 fed out through the through-hole 112 meander in the same direction in the circumferential direction with respect to the main core wire 22, and the holding tube 70 and the subtubes 40 and The inner structure 26 can be wound together.

  Instead of the above, the insertion jig 110 may be translated relative to the gripper 126 by a drive unit (not shown). Specifically, the insertion jig 110 and the gripping tool 126 may be relatively moved in an intersecting direction with respect to the direction in which the pair of subtubes 40 are arranged, preferably in an orthogonal direction. More specifically, with the inner structure 26 fixed to the winder device 120, the insertion jig 110 may be reciprocally swung in the crossing direction or the orthogonal direction by the driving unit. In this state, the tubular body 10 according to the modification of the present embodiment shown in FIG. 3B can be created by co-winding the sub-tube 40 and the inner structure 26 with the holding wire 70.

  8 illustrates a state in which the gripping tool 126 is provided apart from the insertion jig 110 in the feeding direction of the inner structure 26, the gripping tool 126 is integrated with the insertion jig 110. It may be provided.

As shown in FIG. 8, in this manufacturing method, the two sub-core wires 44 are arranged around the inner structure 26 so as to face each other at intervals of 180 degrees. In addition, when arrange | positioning the three subcore wires 44, it is good to oppose 120 degree | times, and when arrange | positioning the four subcore wires 44, it is good to oppose 90 degree | times. In this manufacturing method, the positions of the plural (two) bobbin heads 122 are adjusted so that the winding points 72 of the multiple (two) holding wires 70 are rotationally symmetrical around the inner structure 26. Thereby, the individual winding tension of the multiple holding wires 70 is offset.
In this state, the sub-core wire 44 is rotated around the axial center relative to the inner structure 26 or is forcibly decentered in the direction orthogonal to the axial center, thereby causing the pair of sub-tubes 40 to meander in a corresponding manner. be able to.

  In this manufacturing method, the oscillation cycle between the inner structure 26 and the sub-core wire 44 may be changed with time. Thereby, the meandering cycle of the subtube 40 can be changed according to the distance from the tip of the tubular body 10. As an example, the meandering cycle may be shortened at the distal portion DE, and the meandering cycle may be lengthened at the intermediate portion or the proximal portion. Thereby, the adhesiveness of the subtube 40 and the outer layer 50 in the distal part DE which bends notably when the operation line 60 is pulled can be improved favorably.

  In addition, although this manufacturing method demonstrated winding together with respect to the main core wire 22, sending out the subcore wire 44, this invention is not restricted above. The sub-core wire 44 and the main core wire 22 may be wound together by the holding wire 70 after the substantially entire length of the sub-core wire 44 is temporarily fixed to the main core wire 22 with a jig or the like in advance.

  In the main body forming step, the tubular main body 10 is formed so as to enclose the inner structure 26, the cored tube 46 and the holding wire 70 (hereinafter, “structure”). First, the first outer layer 52 (see FIG. 1) is formed around the structure. The first outer layer 52 may be formed by coating extrusion in which a molten resin material is applied to the surface of the structure. Alternatively, a resin ring or resin tube formed in an annular shape or a tubular shape in advance may be attached around the structure, and then heat-formed using a heat-shrinkable tube or the like. The first outer layer 52 embeds the subtube 40 and the holding wire 70 fitted therein. As a result, the holding wire 70 anchors both the first outer layer 52 and the subtube 40.

Next, a second reinforcing layer 82 is formed by braiding a second reinforcing wire 82 (see FIG. 2) around the subtube 40 embedded in the first outer layer 52. After the second marker 16 is caulked and fixed around the tip of the second reinforcing layer 80, the second reinforcing wire 82 is excised on the distal side of the second marker 16.
Further, a second outer layer 54 (see FIG. 1) is formed so as to cover the second reinforcing layer 80 and the second marker 16. The second outer layer 54 may be formed by coating extrusion in which a molten resin material is applied and formed on the surface of the second reinforcing layer 80, or a resin ring or resin tube previously formed in an annular shape or a tubular shape is used as the structure. You may heat-shape after mounting around.

  In the sub-core wire extraction step, the sub-core wire 44 is stretched to be reduced in diameter and peeled off from the sub-tube 40. After the diameter-reduced sub-core wire 44 is removed from the sub-tube 40, the operation line 60 is inserted into some or all of the sub-tubes 40 out of the plurality.

  In the main core wire extracting step, the main core wire 22 is extracted from the tubular body 10 to form the main lumen 20. The sub core wire extraction step and the main core wire extraction step may be performed simultaneously, or the main core wire extraction step may be performed after the sub core wire extraction step is performed first. In the latter case, because the main core wire 22 is inserted into the main lumen 20, expansion deformation of the tubular body 10 is suppressed. Therefore, when the sub core wire 44 is extended in the sub core wire extraction process, the sub core wire 44 follows. And the subtube 40 does not extend. For this reason, the sub-core wire 44 which is smaller in diameter than the main core wire 22 and easily breaks can be satisfactorily extracted 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, and a plurality of resins that are arranged opposite to the outside of the wire reinforcing layer and define a sub-lumen having a smaller diameter than the main lumen. An elongated tubular body including a sub tube made of resin, an outer layer made of resin enclosing the wire reinforcing layer and the sub tube, and a distal end of the tubular body that is movably inserted into the sub lumen. An operation line connected to the distal part, and an operation part that pulls the operation line to bend the distal part of the tubular body, and the plurality of opposing subtubes correspond to each other. The medical device is meandering in the circumferential direction of the main lumen.
(2) The plurality of opposing sub-tubes meander in the same direction or in the opposite direction in the circumferential direction of the main lumen with a direction intersecting the opposing direction as a swing direction. Medical equipment.
(3) The plurality of opposing sub-tubes meander point-symmetrically with respect to the center of the main lumen or mirror-symmetrically with respect to a symmetry plane passing through the center and having the opposing direction as a normal direction. ) Or the medical device according to (2).
(4) The meandering width of the subtube meandering in the circumferential direction of the main lumen is less than 180 degrees in terms of the rotation angle of the main lumen, as described in any one of (1) to (3) above Medical equipment.
(5) The medical device according to any one of (1) to (4), further including a holding wire that is included in the outer layer and winds the plurality of subtubes and the wire reinforcing layer together.
(6) The medical device according to (5), wherein the two sub-tubes are disposed 180 degrees around the wire reinforcing layer.
(7) The medical device according to (6), wherein the holding wire is wound in a substantially rhombus in contact with the outer peripheral surface of the two sub-tubes and the outer surface of the wire reinforcing layer. Equipment.
(8) Three or more of the sub-tubes are arranged so as to be opposed to each other around the wire reinforcing layer, and at least two of the three or more sub-tubes correspond to each other and correspond to the main tube. The medical device according to (5) above, meandering in the circumferential direction of the cavity.
(9) The medical device according to (8), wherein the holding wires are in contact with the outer peripheral surfaces of the three or more subtubes.
(10) The medical device according to any one of (5) to (9), wherein the ductility of the holding wire is larger than the ductility of the reinforcing wire.
(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 preparing an inner structure including a main core wire and a wire reinforcing layer in which a reinforcing wire is wound around the main core wire, and a plurality of sub core wires each covered with a resin sub tube Are arranged opposite to the outer peripheral surface of the wire reinforcing layer along the main core wire, and the sub core wires and the main core wires are arranged such that a plurality of the sub core wires meander in the circumferential direction of the main core wire corresponding to each other. The sub-tube and the wire reinforcing layer are co-wound with a holding wire, and the sub-tube and the wire reinforcing layer and the holding wire that are co-wound are tubular. A step of forming a main body, a step of extending and reducing the diameter of the sub-core wire to peel from the sub-tube to form a sub-lumen, and a step of removing the main core wire from the tubular body to form a main lumen. The method of medical equipment, including.
(13) In the co-winding step, the sub-core wire and the main core wire are relatively rotated around the main core wire, or are relatively translated in the radial direction of the main core wire. The method for producing a medical device according to (12), which is characterized in that

DESCRIPTION OF SYMBOLS 10 Tubular main body 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 34 Intersection 40, 40a, 40b Sub tube 42 Sub lumen 44 Sub core wire 46 Core tube 50 outer layer 52 first outer layer 54 second outer layer 60 operation line 70 holding wire 72 winding point 80 second reinforcement layer 82 second reinforcement wire 90 operation unit 92 wheel operation unit 94 main body case 95 recess 96 hub 98 slider 99 projection 100 catheter 110 Insertion jig 112 Through hole 114 Main through hole 120 Winder device 122 Bobbin head 126 Grip tool DE Distal part SW Meander width W Circumferential opening size

Claims (13)

A wire reinforcing layer formed by winding a reinforcing wire around the main lumen, and a plurality of resin subs disposed opposite to the outer side of the wire reinforcing layer and defining a sub-lumen having a smaller diameter than the main lumen. A long tubular body including a tube and a resin outer layer containing the wire reinforcing layer and the subtube;
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 plurality of the opposing subtubes meandering in the circumferential direction of the main lumen corresponding to each other.   The medical device according to claim 1, wherein the plurality of opposing subtubes meander in the same direction or in the opposite direction in the circumferential direction of the main lumen with a direction intersecting the opposing direction as a swing direction.   The plurality of opposing sub-tubes meander symmetrically with respect to a symmetry plane having a point symmetry with respect to the center of the main lumen, or a symmetry plane passing through the center and having the opposite direction as a normal direction. The medical device described.   The medical device according to any one of claims 1 to 3, wherein a meandering width of the sub-tube meandering in a circumferential direction of the main lumen is less than 180 degrees in terms of a turning angle of the main lumen.   The medical device according to any one of claims 1 to 4, further comprising a holding wire that is included in the outer layer and winds the plurality of subtubes and the wire reinforcing layer together.   The medical device according to claim 5, wherein the two sub-tubes are arranged 180 degrees opposite to each other around the wire reinforcing layer.   The medical device according to claim 6, wherein the holding wire is wound in a substantially rhombus shape in contact with a peripheral surface on an outer diameter side of the two sub tubes and an outer surface of the wire reinforcing layer.   Around the wire reinforcing layer, three or more sub-tubes are arranged so as to face each other, and at least two of the three or more sub-tubes correspond to each other around the circumference of the main lumen. The medical device according to claim 5, meandering in a direction.   The medical device according to claim 8, wherein the holding wires are in contact with outer peripheral surfaces of the three or more sub tubes.   The medical device according to any one of claims 5 to 9, wherein the ductility of the holding wire is larger than the ductility of the reinforcing wire.   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. Preparing an inner structure including a main core wire and a wire reinforcing layer in which a reinforcing wire is wound around the main core wire;
A plurality of sub-core wires each covered with a resin-made subtube are arranged to face the outer peripheral surface of the wire reinforcing layer along the main core wires, and the plurality of sub-core wires correspond to each other to correspond to the main core wires. A step of co-winding the sub-tube and the wire reinforcing layer with a holding wire while relatively moving the sub-core wire and the main core wire so as to meander in the circumferential direction;
Forming a tubular body so as to enclose the sub-tube and the wire reinforcing layer and the holding wire which are wound together;
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 tubular body to form a main lumen;
A method of manufacturing a medical device including:   In the co-winding step, the sub-core wire and the main core wire are relatively rotated around the main core wire or relatively translated in the radial direction of the main core wire. The manufacturing method of the medical device of Claim 12.

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