JP2019024919A - catheter - Google Patents

Abstract

To provide a catheter capable of improving flexibility of the catheter.SOLUTION: A catheter includes an inner layer 24 formed by a main lumen 20 going through and an outer layer 50 arranged on an outer peripheral surface side around the inner layer 24. A recessed groove 24a is formed on the outer peripheral surface of the inner layer 24 at an end part of the catheter so as to deform the end part of the catheter (a tubular body 10) flexibly. The recessed groove 24a is impregnated with the outer layer 50 formed by a material lower in bending rigidity than a material of the inner layer 24.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a catheter that is inserted into a body.

  In general, a catheter having a bendable distal portion is inserted into a body cavity such as a blood vessel. For example, a catheter capable of bending the distal portion by pulling the operation line has been proposed. According to such a catheter, the insertion direction can be changed by bending the distal portion at the branch point of the body cavity. It becomes possible to select.

  Patent Document 1 describes an example of such a catheter. The catheter described in Patent Document 1 includes a long tubular body, an operation unit that bends a distal portion of the tubular body, and a holding wire.

The tubular main body includes a wire reinforcing layer formed by winding a reinforcing wire around a main lumen (described as a main lumen in the same document), and a sub-lumen having a smaller diameter than the main lumen disposed outside the wire reinforcing layer. In this document, a sublumen tube (denoted as a subtube in the same document) that defines a secondary lumen), an outer layer that encloses the wire reinforcing layer and the sublumen tube, and an outer line that is outside the operation line. And a second reinforcing layer that is provided on the radial side and protects the outer layer, the second reinforcing wire braided in a mesh shape.
The holding wire is a wire that is included in the outer layer and winds the sub-lumen tube and the wire reinforcing layer together.

JP 2014-171635 A

The catheter needs a certain degree of rigidity in order to advance in the body cavity, or in the case where an operation line is provided, in order to improve followability by the operation line. For this reason, the catheter has a wire reinforcing layer and a second reinforcing layer as described above, and a material having a high resin hardness is used for the inner layer.
On the other hand, as the catheter is used for various applications in the medical field, it is necessary to improve the flexibility along the branch point of the body cavity. For this reason, the catheter provided with a flexibility was calculated | required.

  This invention is made | formed in view of said subject, and provides the catheter which can improve the flexibility of a catheter.

  According to the present invention, there is provided a catheter comprising an inner layer formed by penetrating a main lumen and an outer layer disposed around the inner layer, the outer surface of the inner layer at the distal end portion of the catheter The catheter is characterized in that a concave groove is formed, and the concave groove is impregnated with a material having lower bending rigidity than the material of the inner layer.

  Since the inner layer is thinned by a concave groove, and the concave groove is impregnated with a material having a lower bending rigidity than the inner layer material, the flexibility of the catheter can be improved.

1 is an overall side view of a catheter according to an embodiment of the present invention. It is a longitudinal cross-sectional view of the distal end portion of the catheter. It is a side view which shows the state before forming the outer layer in the front-end | tip part of a catheter. It is the sectional view on the AA line of FIG. FIG. 3 is a sectional view taken along line B-B in FIG. 2. It is CC sectional view taken on the line of FIG. It is a typical enlarged view which expands and shows the circumference of a ditch. It is the whole catheter side view which shows the state which operated the wheel operation part in one direction. It is the whole catheter side view which shows the state which operated the wheel operation part to the other direction. It is a longitudinal cross-sectional view which shows the state which wound the wire reinforcement layer to the inner layer. It is a longitudinal cross-sectional view which shows the state which fixed the 1st marker and the 2nd marker to the upper layer of the wire reinforcement layer. It is a longitudinal cross-sectional view which shows the state which removed the wire reinforcement layer in the area | region between a 1st marker and a 2nd marker from the structure of FIG. It is a longitudinal cross-sectional view which shows the state which has arrange | positioned the sublumen tube in the structure of FIG. It is a longitudinal cross-sectional view which shows the state which wound the holding wire to the structure of FIG. It is a longitudinal cross-sectional view which shows the state which formed the outer layer in the structure of FIG. In the configuration of FIG. 15, the distal outer layer is removed, the sub-core wire is removed from the sub-lumen tube, the operation line is inserted into the sub-lumen tube, and the end of the operation line is fixed to the first marker. FIG. It is a longitudinal cross-sectional view which shows the state which formed the outer layer in the removal part of the outer layer of the distal side about the structure of FIG.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that in all the drawings, the same components are denoted by the same reference numerals, and redundant description will be omitted as appropriate.
The embodiment described below is merely an example for facilitating the understanding of the present invention, and does not limit the present invention. That is, the shape, dimensions, arrangement, and the like of the members described below can be changed and improved without departing from the spirit of the present invention, and the present invention naturally includes equivalents thereof.
Moreover, in all drawings, the same code | symbol is attached | subjected to the same component, and the overlapping description is abbreviate | omitted suitably. In the following, the distal side of the catheter is also referred to as the distal side or the front side, and the proximal side is also referred to as the proximal side or the rear side.

<Overall description of the overall configuration and tip of the catheter>
First, the overall configuration of the catheter 1 will be described mainly with reference to FIG. 1, and the distal end portion of the catheter 1 will be described with reference mainly to FIGS. FIG. 1 is an overall side view of a catheter 1 according to an embodiment of the present invention. 2 is a longitudinal sectional view of the distal end portion of the catheter 1, and FIG. 3 is a side view showing a state before the outer layer 50 is formed at the distal end portion of the catheter 1. 4 is a cross-sectional view taken along line AA in FIG. 2, FIG. 5 is a cross-sectional view taken along line BB in FIG. 2, and FIG. 6 is a cross-sectional view taken along line CC in FIG. FIG. 7 is a schematic enlarged view showing the periphery of the concave groove 24a in an enlarged manner.

As shown in FIG. 2, the catheter 1 according to the present embodiment includes an inner layer 24 formed by penetrating a main lumen 20 in a tubular body 10 that is a distal end portion, and an outer layer 50 disposed around the inner layer 24. And comprising.
The contents shown in the drawings are for explaining the present invention. For example, the thicknesses of the first marker 14, the second marker 16, and the reinforcing wire 32 are thinner than those shown in FIG. 2, and the sub-lumen tube 40 is not arranged as bent as shown in FIG.
In FIG. 2 (FIGS. 16 and 17 described later), the operation line 60 is illustrated as being in contact with the inner wall of the sub-lumen tube 40. In practice, however, the sub-lumen tube 40 is not bent as much as shown in FIG. 2, and has a degree of bending that is less than half the radius of the sub-lumen 42 and is displaced in the radial direction. . With such a configuration, in the natural state in which the distal portion DE of the tubular body 10 is not bent, the operation line 60 extends straight without contacting the inner wall of the sub-lumen tube 40. Good.

The outer layer 50 is formed of a resin material in the present embodiment, and is closer to the wire reinforcing layer 30 wound around the inner layer 24, the ring-shaped first marker 14, and the first marker 14. A certain second marker 16 is included. The first marker 14 and the second marker 16 include a metal material that does not transmit radiation, and are provided around the wire reinforcing layer 30. A plurality of markers may be further provided in the tubular main body 10.
Further, in the tubular main body 10, a holding wire 70 for winding the wire reinforcing layer 30, the first marker 14, and the second marker 16 together is provided, and the first marker 14 and the second marker 16 are provided under the holding wire 70. Is provided.

  The catheter 1 of this embodiment includes a wire reinforcing layer 30 formed below the first marker 14 and the second marker 16, and at least a part between the first marker 14 and the second marker 16 is a wire reinforcing layer. 30 non-formation regions.

Furthermore, the catheter 1 of the present embodiment includes a sub-lumen tube 40 that is disposed radially outside the inner layer 24 along the outer peripheral surface of the inner layer 24 and through which the operation line 60 is inserted.
The sub-lumen tube 40 is disposed outside the first marker 14 and the second marker 16 in the radial direction and defines a sub-lumen 42 having a smaller diameter than the main lumen 20.
The catheter 1 is inserted into the distal end of the catheter 1 so as to be movable inside the sub-lumen 42, and the distal end is connected to the first marker 14 and pulled toward the proximal end so that the distal end can be bent. Line 60 is provided.
The sub-lumen tube 40 extends in contact with the edge of at least a part of the concave groove 24a formed between the first marker 14 and the second marker 16. Thus, when the sub-lumen tube 40 is extended, when the outer layer 50 is thermoformed, the sub-lumen tube 40 comes into contact with the edge of the concave groove 24a, so that a frictional effect can be generated. . Thereby, the sub-lumen tube 40 can be made difficult to slide with respect to the inner layer 24. Details of the concave groove 24a will be described later.

  In addition, although the catheter 1 which concerns on this embodiment is provided with the 1st marker 14, the 2nd marker 16, the wire reinforcement layer 30, the sub-lumen tube 40, and the operation line 60, it is not an essential component in this invention. The catheter 1 may not include these.

<Detailed description of the overall configuration and tip of the catheter>
Hereinafter, this embodiment will be described in detail. The catheter 1 of this embodiment is an intravascular catheter that is used by inserting the tubular body 10 into a blood vessel.

The tubular body 10 is also called a sheath, and is a hollow tubular and long member in which a main lumen 20 is formed.
The tubular body 10 has a laminated structure. An inner layer (main tube) 24 and an outer layer 50 are laminated in order from the inner diameter side with the main lumen 20 as the center, and the tubular body 10 is configured. A hydrophilic layer (not shown) is formed on the surface of the outer layer 50. The inner layer 24 and the outer layer 50 are made of a flexible resin material, and each has a tubular shape and a substantially uniform thickness.

  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 thereof may be uniform over the longitudinal direction of the tubular body 10 or may be different 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 main lumen 20 may have a tapered shape in which the diameter of the main lumen 20 continuously increases from the distal end toward the proximal end.

  Examples of the material of the inner layer 24 include a fluorine-based thermoplastic polymer resin. 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 chemical solution or the like through the main lumen 20 is improved. Further, sliding resistance when a guide wire or the like is inserted through the main lumen 20 is reduced.

A concave groove 24 a is formed on the outer peripheral surface of the inner layer 24.
In FIG. 3, the concave groove 24a is shown by a broken line for distinction from the reinforcing wire 32. In the present embodiment, the concave groove 24a has a shape including a plurality of line segments intersecting each other. Since the groove 24a has such a shape, the edges of the groove 24a extend in a direction intersecting with each other. Therefore, the groove 24a is disposed around the inner layer 24 where the groove 24a is formed. The deviation of the outer layer 50 can be prevented.
The concave groove 24a preferably has a shape including a plurality of intersecting line segments, but the present invention is not limited to such a configuration. For example, the concave groove 24a may be formed in a spiral shape, may be formed along the axial direction of the tubular body 10, or may be formed intermittently. Good.
The concave groove 24a is impregnated with an outer layer 50 formed of a resin material having a lower bending rigidity (specifically, a lower Young's modulus) than the material of the inner layer 24, or a reinforcing wire 32 is disposed. .
Further, as described above, the concave groove 24a is impregnated with a material having lower bending rigidity than the material forming the inner layer 24, so that the concave groove 24a is not formed and is formed flat. Even in comparison, the bending rigidity can be kept low. For this reason, the distal end portion of the catheter 1 (tubular body 10) can be flexibly deformed.
The material impregnated in the concave groove 24a is not limited to the outer layer 50 as long as it is impregnated with a material having lower bending rigidity than the material forming the inner layer 24, and is impregnated with an intervening material such as an adhesive. It may be.
In particular, if the outer layer 50 is impregnated in the concave groove 24a, the material can be impregnated simultaneously in the concave groove 24a when the outer layer 50 is formed, so that the catheter 1 can be easily manufactured.

It is preferable that a bank portion 24c protruding toward the outer layer 50 is formed on the edge of the concave groove 24a in the inner layer 24 as compared with the periphery (outer surface 24b). Since the bank portion 24c is formed in this manner, the contact area between the inner layer 24 and the outer layer 50 can be increased, so that the degree of coupling between the inner layer 24 and the outer layer 50 can be further increased.
In addition, the holding wire 70 compresses the bank portion 24c via the sub-lumen tube 40, thereby bringing the sub-lumen tube 40 and the bank portion 24c into close contact with each other, so that the frictional effect between the sub-lumen tube 40 and the inner layer 24 is achieved. Will increase. For this reason, the shift | offset | difference with respect to the inner layer 24 (bank part 24c) of the sub-lumen tube 40 can be suppressed.

In addition, at least a part of the concave groove 24a is disposed closer to the proximal end than the distal end of the operation line 60 (in other words, the first marker 14).
As described above, the concave groove 24a that can reduce the bending rigidity by thinning the inner layer 24 is disposed on the base end side with respect to the distal end of the operation line 60. Ten distal portions DE can be easily bent. This is because the distal end of the operation line 60 is included in the distal portion DE.

The wire reinforcing layer 30 reinforces the catheter 1 and 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 can prevent the operation line 60 from penetrating from the outer layer 50 to the inner layer 24 and being exposed to the main lumen 20.
Moreover, the wire reinforcement layer 30 is formed in the front end side and the base end side rather than the area | region in which the ditch | groove 24a was formed. Strictly speaking, the concave groove 24a is also formed in a portion of the inner layer 24 that contacts the reinforcing wire 32. Here, the “region where the concave groove 24a is formed” is a region that is not covered by the reinforcing wire 32. This is a region where the wire reinforcing layer 30 is not formed.
As described above, since the wire reinforcing layer 30 is formed, the shape of the tubular main body 10 is locally retained by the wire reinforcing layer 30 while making the tubular main body 10 easy to bend in the region where the concave groove 24a is formed. It becomes possible. Further, after the reinforcing wire 32 is pressed against the inner layer 24, the concave groove 24a can be easily formed by removing a part of the wire reinforcing layer 30.

  The wire reinforcing layer 30 is constituted by a reinforcing wire 32 formed by winding. 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, and is sheared more than the inner layer 24 and the outer layer 50. A resin material such as polyimide (PI), polyamideimide (PAI), or polyethylene terephthalate (PET) having high strength can be used. In the present embodiment, a fine stainless steel wire is used as the reinforcing wire 32.

  The wire reinforcing layer 30 is a mesh layer. Since the lower layer of the first marker 14 and the second marker 16 is the wire reinforcing layer 30 formed as a mesh layer that hardly causes mechanical deformation, the first marker 14 and the second marker 16 can be caulked and fixed. It becomes possible.

  The number of strips and the number of meshes of the reinforcing wire 32 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.

  As shown in FIG. 3, the reinforcing wires 32 are wound around the inner layer 24 in a lattice shape so as to cross each other obliquely. 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 recessed groove 24 a is formed to extend on the extension of the reinforcing wire 32. Since the concave groove 24a is formed so as to extend on the extension of the reinforcing wire 32, the portion having a large contact area between the reinforcing wire 32 and the outer layer 50, and the concave groove 24a and the material impregnated therein are used. A site | part with a large contact area will be formed continuously.
For this reason, when a torque is applied to the catheter 1 for directing the catheter 1, the torsional torque is smoothly transmitted from the proximal end to the distal end of the catheter 1. For this reason, the user can easily bend the distal portion DE in a predetermined direction, and the operability of the catheter 1 is improved.

  The number of reinforcing wires 32 constituting the wire reinforcing layer 30 is not particularly limited, but in this embodiment, the wire reinforcing layer 30 formed by 16 reinforcing wires 32 is illustrated.

  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 including a metal 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 1 can be easily determined.

The first marker 14 and the second marker 16 are members having the same shape including the same material in the present embodiment.
The outer diameter of the first marker 14 and the outer diameter of the second marker 16 are the same, and the first marker 14 and the second marker 16 are disposed at the same height in the radial direction of the catheter 1.

Since the first marker 14 and the second marker 16 are arranged at the same height, the sub-lumen tube 40 can be arranged linearly on the upper layer. Therefore, when the catheter 1 is manufactured, a corner portion due to bending of the sublumen tube 40 is not formed in the sublumen 42 of the distal portion DE of the sublumen tube 40. Thereby, it is possible to effectively prevent the sub-lumen tube 40 from being worn and damaged by rubbing the operation line 60 against the corner portion when the operation unit 90 is operated.
In this way, the first marker 14 and the second marker 16 can be made by using a common mold by making them the same member, and are manufactured in comparison with the case of making them as members having different shapes. The cost required for this can be reduced.

  The wire reinforcing layer 30 described above is formed below the first marker 14 and the second marker 16 and is not formed in a region between the first marker 14 and the second marker 16. This is a region where the wire reinforcing layer 30 is not formed.

  There is a discontinuity in bending rigidity between the region where the wire reinforcement layer 30 is not formed and the region where the wire reinforcement layer 30 is formed, and the region where the wire reinforcement layer 30 is not formed is reinforced in the concave groove 24a. Since the wire 32 is not provided, the bending rigidity is small. For this reason, when the operation line 60 is pulled, the tubular body 10 can be bent sharply in the region where the wire reinforcing layer 30 is not formed.

The wire reinforcement layer 30 is the same mesh layer before and after the non-formation region of the wire reinforcement layer 30.
As will be described later in detail, the wire reinforcing layer 30 is initially formed by winding the reinforcing wire 32 around the entire inner layer 24 in a mesh shape as shown in FIG. The first marker 14 and the second marker 16 are formed by caulking and fixing. Then, a portion of the reinforcing wire 32 corresponding to the non-formation region is removed to form a non-formation region. Therefore, the wire reinforcing layer 30 is the same mesh layer before and after the region where the wire reinforcing layer 30 is not formed. Thus, the wire reinforcement layer 30 which becomes the same mesh layer before and after the non-formation region can be easily formed, and the manufacturability of the catheter 1 can be improved.

  The first marker 14 and the second marker 16 are fixed by caulking. However, if the wire reinforcing layer 30 is not provided, the first marker 14 and the second marker 16 are directly caulked and fixed to the inner layer 24. However, it is difficult to caulk and fix the first marker 14 and the second marker 16 directly to the inner layer 24. Even if the first marker 14 and the second marker 16 are fixed, it may be easily detached due to deformation of the inner layer 24.

  On the other hand, in the present embodiment, the first marker 14 and the second marker 16 are provided with the wire reinforcing layer 30 that is a mesh layer that is less likely to be mechanically deformed than the inner layer 24 below the first marker 14 and the second marker 16. The second marker 16 can be fixed by caulking. Furthermore, it is possible to prevent the first marker 14 and the second marker 16 from being detached after being fixed.

  The sub-lumen tube 40 is a hollow tubular member that defines the sub-lumen 42. The sublumen tube 40 is embedded in the outer layer 50 in a state of being constrained to the inner layer 24 side by a linear restraining member (holding wire 70) that presses the sublumen tube 40 against the inner layer 24. The sublumen tube 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 sub-lumen tube 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 sublumen tube 40 is subjected to etching treatment such as metal sodium treatment or plasma treatment. This improves the adhesion between the sub-lumen tube 40 and the outer layer 50.

  As shown in FIGS. 3 to 6, two sub-lumen tubes 40 are arranged around the wire reinforcing layer 30 so as to face each other by 180 degrees, and an operation line 60 is inserted into each of the two sub-lumen tubes 40. Has been. The two sublumen tubes 40 are parallel to the axial direction of the tubular body 10.

  As shown in FIGS. 3 to 6, the two sub-lumen tubes 40 are arranged on the same circumference so as to surround the main lumen 20. Instead of this embodiment, three or four sub-lumen tubes 40 may be arranged around the main lumen 20 at equal intervals. In this case, the operation lines 60 may be arranged on all the sub-lumen tubes 40, or the operation lines 60 may be arranged on some of the sub-lumen tubes 40.

  The operation line 60 is loosely inserted into the sub-lumen 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. The operation line 60 of this embodiment is a stranded wire in which seven strands are twisted together. More specifically, seven strands are twisted together by spirally winding six strands (peripheral strands) around a single strand (center strand). It is. The six peripheral strands are arranged at the vertices of a hexagon centered on the central strand.

  As the operation wire 60, low carbon steel (piano wire), stainless steel (SUS), a steel wire coated with corrosion resistance, titanium or a titanium alloy, or a 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 distal end portion of the operation line 60 is fixed to the outer peripheral portion of 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. . In the present embodiment, the operation line 60 is fixed to the outer peripheral portion of the first marker 14 using solder bonding.

  The holding wire 70 winds the sub-lumen tube 40, the first marker 14, the second marker 16, and the wire reinforcing layer 30 together. The holding wire 70 is formed around the sub-lumen tube 40 by coil winding or braiding in a mesh shape.

  The holding wire 70 of the present embodiment is a coil, and more specifically, a coil (multiple coil) in which a plurality of strands are wound in multiple lines.

The holding wires 70 as the restraining members extend two by two along the outer peripheral surface of the inner layer 24, and spirally surround the outside of the pair of sublumen tubes 40 arranged to face the periphery of the main lumen 20. It is wound. The winding shape of the holding wire 70 of the present embodiment is a substantially elliptical shape or a substantially rhomboid shape with the arrangement direction of the sub-lumen tubes 40 as the major axis direction when viewed in the axial direction of the tubular body 10.
As shown in FIG. 3, the extending portion of the restraining member (holding wire 70) extends at an angle intersecting the concave groove 24 a on the outer peripheral surface of the inner layer 24. By extending the holding wire 70 in this way, the position of the sub-lumen tube 40 can be constrained by the holding wire 70, and the holding wire 70 is made of a material having a low bending rigidity (the outer layer 50 or the adhesive). ) Can be prevented from impeding impregnation into the concave groove 24a. In other words, the concave groove 24a extends at an angle intersecting the holding wire 70, so that when the outer layer 50 is formed, a part of the outer layer 50 flows from a portion that does not overlap the holding wire 70, Part of the outer layer 50 can be impregnated into the concave groove 24a.

  4 to 6, the holding wire 70 whose winding shape forms a substantially rhombus is illustrated by a broken line. The holding wire 70 is in contact with the peripheral surface of the sub-lumen 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 mentioned here includes a rhombus, a flat polygon such as a kite shape, a flat hexagon, and a flat octagon. The substantially elliptical shape includes an elliptical shape such as an oval shape as well as an elliptical shape or an oval shape.

  In the present embodiment, the main lumen 20 is circular and disposed at the center of the tubular main body 10, and two sub-lumen tubes 40 are disposed 180 degrees opposite to each other around the main lumen 20. However, three or more (N) sub-lumen tubes 40 may be evenly distributed around the main lumen 20. In this case, the winding shape of the holding wire 70 may be a rounded N-square shape with each sub-lumen tube 40 as a corner.

  In the region where the wire reinforcement layer 30 is formed, the holding wire 70 is in contact with the outer surface of the wire reinforcement layer 30 on both sides or one side in the minor axis direction orthogonal to the major axis direction.

  The inner surface of the sublumen tube 40 is the outer surface of the first marker 14, the outer surface of the second marker 16, and the outer surface between the first marker 14 and the second marker 16 and in which the groove 24a of the inner layer 24 is formed. (Refer to FIG. 2). The holding wire 70 is spirally wound in contact with the outer surfaces of the pair of sub-lumen tubes 40. As viewed in the longitudinal direction of the tubular body 10, the holding wire 70 is wound over substantially the entire length of the sub-lumen tube 40.

  As a result, the holding wire 70 co-winds the sub-lumen tube 40, the first marker 14 and the second marker 16, and the wire reinforcing layer 30 under the first marker 14 and the second marker 16 in close contact with each other. ing. For this reason, even after the molding process of the outer layer 50, the sub-lumen tube 40 can be kept in parallel with the first marker 14, the second marker 16 and the wire reinforcing layer 30 with high accuracy. Misalignment can be prevented. Further, the displacement of the sub-lumen tube 40 can be more effectively prevented because the holding wire 70 is a multi-strand coil and the tightening force is increased.

  As the material of the holding wire 70, any of the above metal materials or resin materials that can be used as the reinforcing wire 32 can be used. In the present embodiment, the holding wire 70 is formed to include a material different from 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 a 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 plastic when the holding wire 70 is wound around the sub-lumen tube 40 or is braided into a mesh shape (coil winding in this embodiment). Accordingly, the holding wire 70 can be prevented from being loosened by being elongated and deformed. In this way, the sub-lumen tube 40 is stably fixed by the holding wire 70.

The proximal end of the wire reinforcing layer 30 is 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.

  The outer layer 50 is a tubular portion that constitutes the main wall thickness of the tubular body 10. Inside the outer layer 50, a wire reinforcing layer 30, a first marker 14, a second marker 16, a sub-lumen tube 40, and a holding wire 70 are provided in this order from the inner diameter side. The wire reinforcing layer 30, the first marker 14 and the second marker 16, and the holding wire 70 are disposed coaxially with the tubular 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.

<About catheter operation>
Next, the operation of the catheter 1 will be described with reference mainly to FIGS. 8 and 9 in addition to FIG. FIG. 8 is an overall side view of the catheter 1 showing a state where the wheel operation unit 92 is operated in one direction, and FIG. 9 is an overall side view of the catheter 1 showing a state where the wheel operation unit 92 is operated in the other direction.

As shown in FIG. 1, the catheter 1 has an operation portion 90 provided at the proximal end portion of the tubular main body 10. The operation unit 90 and the operation line 60 constitute an operation mechanism for performing a bending operation of the distal portion DE of the tubular main body 10.
The operation unit 90 of the present embodiment includes a main body case 94 that is gripped by a 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.

  The operation unit 90 includes a hub 96 provided in communication with the main lumen 20 of the tubular main 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 attached from the rear of the hub 96. By injecting the 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 subject via the main lumen 20. Examples of the chemical solution include a contrast agent, a liquid anticancer agent, physiological saline, a chemical solution such as NBCA (n-butyl-2-cyanoacrylate) used as an instantaneous adhesive, a detachable coil, a bead (emboli globular substance), and the like. Mention may be made of medical devices.

  The operation line 60 and the sub-lumen tube 40 are branched from the tubular main body 10 inside the front end portion of the main body case 94. The proximal end portions of the operation lines 60 drawn from the two sub-lumen tubes 40 are connected directly or indirectly to the wheel operation portion 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 tubular body 10.

  Specifically, as shown in FIG. 8, when the wheel operation unit 92 is rotated in one direction (clockwise), one operation line 60 is pulled to the proximal end side. Then, a tensile force is applied to the distal portion DE of the tubular body 10 via the one operation line 60. Thereby, the distal part DE of the tubular body 10 bends toward the sub-lumen tube 40 side through which the one operation line 60 is inserted, with the axis of the tubular body 10 as a reference.

  As shown in FIG. 9, when the wheel operation unit 92 is rotated in the other direction (counterclockwise) around the rotation axis, the other operation line 60 is pulled to the base end side. Then, a tensile force is applied to the distal portion DE of the tubular main body 10 via the other operation line 60. As a result, the distal portion DE of the tubular body 10 is bent toward the sub-lumen tube 40 through which the other operation line 60 is inserted, with the axis of the tubular body 10 as a reference.

  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 tubular body 10 are first or second included in the same plane. It can be selectively bent in the second direction.

An uneven engagement portion 921 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 (not shown) is formed at the tip of the slider 98 below (the back side in FIG. 1) and facing the wheel operation unit 92.

  The protrusion is smaller than the opening width of the uneven engagement portion (vertical knurling) 921 provided on the peripheral surface of the wheel operation portion 92. Therefore, when the slider 98 is slid toward the wheel operation unit 92, the protrusion is hooked on the peripheral surface of the wheel operation unit 92 to restrict the rotation of the wheel operation unit 92. Thereby, rotation of the wheel operation part 92 can be controlled in a state where the distal portion DE of the tubular main body 10 is bent, and the bent state of the catheter 1 can be maintained.

  Further, by rotating the operation unit 90 itself around the axis of the tubular main body 10, the distal portion DE of the tubular main body 10 can be torque-rotated at a predetermined angle. Therefore, the direction of the distal portion DE of the catheter 1 can be freely controlled by combining the operation of the wheel operation unit 92 and the entire axial rotation of the operation unit 90. Further, by adjusting the rotation angle of the wheel operation unit 92 to be larger or smaller, the pulling length of the operation line 60 is adjusted to a predetermined length, and the bending angle of the distal portion DE of the catheter 1 can be controlled. For this reason, it is possible to push the catheter 1 into a body cavity such as a blood vessel that branches at various angles.

  In the conventional catheter, the flexibility of the distal portion of the tubular main body is imparted by utilizing the difference in rigidity between the portion where the single wire reinforcing layer is provided and the portion where the two layers are provided. On the other hand, in the present invention, a non-formed region of the wire reinforcing layer 30 (particularly, a region where the reinforcing wire 32 is not provided and only the concave groove 24a is formed) is provided, and the peripheral region where the wire reinforcing layer 30 is formed. Flexibility is imparted to the tubular body 10 by utilizing the difference in rigidity.

  Thus, in the present invention, the flexibility is provided by changing the rigidity by providing the non-formation region of the wire reinforcing layer 30, so that the number of layers constituting the tubular body 10 can be reduced. Therefore, the diameter of the catheter 1 can be reduced while ensuring good flexibility.

  In addition, since the wire reinforcing layer 30 is formed below the first marker 14 and the second marker 16, it is possible to fix by caulking as described above, and to ensure good assembly of the catheter 1. However, the diameter can be reduced.

<About the catheter manufacturing method>
Next, with reference to FIGS. 10-17, the manufacturing method of the catheter 1 of this embodiment is demonstrated. FIG. 10 is a longitudinal sectional view showing a state in which the wire reinforcing layer 30 is wound around the inner layer 24.
FIG. 11 is a longitudinal sectional view showing a state in which the first marker 14 and the second marker 16 are fixed to the upper layer of the wire reinforcing layer 30.
FIG. 12 is a longitudinal sectional view showing a state in which the wire reinforcing layer 30 in the region between the first marker 14 and the second marker 16 is removed from the configuration of FIG.
FIG. 13 is a longitudinal sectional view showing a state in which the sub-lumen tube 40 is arranged in the configuration of FIG.
14 is a longitudinal sectional view showing a state in which the holding wire 70 is wound around the configuration of FIG.
FIG. 15 is a longitudinal sectional view showing a state in which the outer layer 50 is formed in the configuration of FIG.
16, the distal outer layer 50 is removed in the configuration of FIG. 15, the sub-core wire 44 is removed from the sub-lumen tube 40, the operation line 60 is inserted into the sub-lumen tube 40, and the end of the operation line 60 is inserted. It is a longitudinal cross-sectional view which shows the state fixed to the 1st marker.
FIG. 17 is a longitudinal sectional view showing a state in which the outer layer 50 is re-formed in the removed portion of the outer layer 50 on the distal side in the configuration of FIG.
First, an outline of a method for manufacturing the catheter 1 according to the present embodiment will be described.

This manufacturing method includes a wire reinforcing layer forming step, a marker fixing step, a wire reinforcing layer removing step, and an outer layer forming step.
The wire reinforcing layer forming step is a step of forming the wire reinforcing layer 30 by winding the reinforcing wire 32 around the inner layer 24 that defines the main lumen 20.
In the marker fixing step, the ring-shaped first marker 14 and the second marker 16 each including a metal material that does not transmit radiation are arranged around the wire reinforcing layer 30, and the second marker 16 is proximal to the first marker 14. It is a process of caulking and fixing to be on the side.
The wire reinforcing layer removing step is a step of removing the wire reinforcing layer 30 between the first marker 14 and the second marker 16.
The outer layer forming step is a step of forming the outer layer 50 including the wire reinforcing layer 30, the first marker 14, and the second marker 16.
In addition, the manufacturing method includes a co-winding step of co-winding the wire reinforcing layer 30, the first marker 14, and the second marker 16 with the holding wire 70.

  Furthermore, this manufacturing method has a sub-lumen tube arrangement | positioning process, an operation line insertion process, and an operation line connection process. The sub-lumen tube placement step is a step of placing a sub-lumen tube 40 that defines a sub-lumen 42 having a smaller diameter than the main lumen 20 outside the first marker 14 and the second marker 16 after the wire reinforcing layer removal step. The operation line insertion step is a step of movably inserting the operation line 60 into the sub-lumen 42 after the sub-lumen tube placement step. The operation line connection step is a step of connecting the tip of the operation line 60 to the first marker 14 after the operation line insertion step.

Hereinafter, this production method will be described in detail.
In the wire reinforcing layer forming 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, as shown in FIG. 10, a multi-strand reinforcing wire 32 is braided into a mesh shape on the outer surface of the inner layer 24 to form a wire reinforcing layer 30. The reinforcing wire 32 has a higher hardness than the inner layer 24. For this reason, by braiding the reinforcing wire 32 so that a force is applied to the radially central side of the inner layer 24, a groove 24a is formed in a portion of the outer surface of the inner layer 24 that is pressed by the reinforcing wire 32. That is, the reinforcing wire 32 is made to have a hardness higher than that of the inner layer 24, and the reinforcing wire 32 is braided on the inner layer 24 so that a pressing force of a predetermined level or more is applied to the center side in the radial direction of the inner layer 24. Can be easily formed.

  Next, in the marker fixing step, as shown in FIG. 11, the first marker 14 and the second marker 16 are disposed around the wire reinforcing layer 30, and the second marker 16 is closer to the proximal side than the first marker 14. Fix it by caulking.

  Next, in the wire protective layer removing step, as shown in FIG. 12, the wire reinforcing layer 30 between the first marker 14 and the second marker 16 is removed. The removal of the wire reinforcing layer 30 can be performed using any means such as a laser or a cutting blade. By removing the wire reinforcing layer 30 between the first marker 14 and the second marker 16, the groove 24 a is exposed on the surface of the inner layer 24. In addition, as shown in FIG. 12, you may make it remove the wire reinforcement layer 30 of the front end side rather than the 1st marker 14. FIG.

Next, in the sub-lumen tube arranging step, as shown in FIG. 13, a sub-lumen tube 40 that defines a sub-lumen 42 having a smaller diameter than the main lumen 20 is arranged outside the first marker 14 and the second marker 16.
The sub-lumen tube 40 is formed in advance around the sub-core wire 44. The sub-core wire 44 is a wire having a circular cross section that defines the sub-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 thickness of the sublumen tube 40 is preferably thinner than the inner layer 24. When the sub-lumen tube 40 is made of a fluorine-based polymer such as polytetrafluoroethylene (PTFE), the sub-core wire 44 is dipped in a coating liquid in which the polymer is dispersed in a solvent and then dried. .

  In addition, the sub-lumen tube 40 is drawn into a tube shape so that the inner diameter of the sub-lumen tube 40 is larger than the outer diameter of the sub-core wire 44, and this is then coated around the sub-core wire 44 to create a cored tube. May be.

Next, as shown in FIG. 14, in the co-winding step, the wire reinforcing layer 30, the first marker 14, the second marker 16, and the sub-lumen tube 40 are co-wound by the holding wire 70.
Due to the load applied by the winding of the holding wire 70, the sub-lumen tube 40 is brought into close contact with the outer peripheral surface of the inner layer 24 so as to touch at least some of the edges of the plurality of concave grooves 24a.
In this manufacturing method, the arrangement of the sublumen tube 40 on the first marker 14 and the second marker 16 is performed before the co-winding by the holding wire 70. However, the present invention is not limited to this, and the arrangement of the sub-lumen tube 40 and the co-winding by the holding wire 70 may be performed simultaneously.

  Next, as shown in FIG. 15, an outer layer 50 is formed around the inner layer 24, the wire reinforcing layer 30, the first marker 14, the second marker 16, the sub-core wire 44 and the sub-lumen tube 40. The outer layer 50 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.

  Next, in the operation line insertion step shown in FIG. 16, first, the tip portion of the outer layer 50 at the distal portion DE of the tubular body 10 is removed. Then, the sub core wire 44 is stretched to be reduced in diameter and peeled from the sub-lumen tube 40, and the sub-core wire 44 having a reduced diameter is removed from the sub-bloom tube 40. Thus, the sub-lumen 42 is formed in the sub-lumen tube 40, and the operation line 60 is movably inserted into the sub-lumen 42.

  In the operation line connection step, the tip of the operation line 60 is connected to the outer peripheral portion of the first marker 14. The operation line 60 is connected to the first marker 14 using solder bonding. The formation of the removed portion 50a of the outer layer 50 in the distal portion DE described above is performed in order to expose the outer peripheral portion of the first marker 14 to the outside in order to perform this soldering.

  Next, as shown in FIG. 17, the removed portion 50a of the outer layer 50 is back-filled. The backfill portion 500 may be formed by coating extrusion in which a molten resin material is applied to the surface of the structure in the same manner as when the outer layer 50 is initially formed. 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.

Next, the main core wire 22 is removed from the tubular body 10 to form the main lumen 20.
In this manufacturing method, the distal end portion of the tubular body 10 is further processed to be rounded by a method such as polishing or plastic deformation by heating (see FIG. 2). Further, a hydrophilic layer (not shown) is formed on the surface of the outer layer 50, and the operation unit 90 is attached to the proximal end portion of the tubular main body 10. Thus, the completed catheter 1 can be obtained.

  It should be noted that the various components of the present invention need not be individually independent. A plurality of components are formed as one member, a component is formed of a plurality of members, one component is a part of another component, and one component is And a part of other components are allowed to overlap.

  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.

Moreover, in the said embodiment, although the ditch | groove 24a was formed in the outer surface of the inner layer 24 by pressing the reinforcement wire 32 to the inner layer 24, this invention is not limited to such a manufacturing method.
For example, the groove 24 a may be formed on the outer surface of the inner layer 24 with a laser without using the reinforcing wire 32. In this way, the rigidity of the inner layer 24 does not need to be lower than the rigidity of the reinforcing wire 32, and it is not necessary to apply a predetermined pressing force to the inner layer 24 via the reinforcing wire 32. In this case, the concave groove 24 a may not be formed in a portion of the outer surface of the inner layer 24 that is covered with the reinforcing wire 32.

  The present invention only needs to solve the problem that the inner layer is formed with a concave groove to reduce the rigidity of the inner layer and make it easier to bend, and can be bent only passively without an operation line or a sub-lumen tube. It can also be applied to possible catheters.

The above embodiment includes the following technical idea.
(1) A catheter comprising an inner layer formed through the main lumen, and an outer layer disposed around the inner layer, wherein a concave groove is formed on the outer peripheral surface of the inner layer at the distal end of the catheter. The catheter is characterized in that the concave groove is impregnated with a material having a lower bending rigidity than the material of the inner layer.
(2) The catheter according to (1), wherein the concave groove has a shape including a plurality of line segments intersecting each other.
(3) A distal end is connected to the distal end of the catheter, and an operation line that allows the distal end to be bent by being pulled toward the proximal end side is further provided, and at least a part of the concave groove includes the manipulation line The catheter according to (1) or (2), wherein the catheter is disposed closer to the proximal end side than the distal end of the wire.
(4) It further includes a sub-lumen tube that is disposed radially outward from the inner layer along the outer peripheral surface of the inner layer, and through which the operation line is inserted, and the sub-lumen tube is provided at an edge of the concave groove. The catheter according to (3), which extends in contact with the catheter.
(5) The sub-lumen tube is constrained to the inner layer side by a linear constraining member that presses the sub-lumen tube against the inner layer, and the constraining member extends along the outer peripheral surface of the inner layer. And the extension site | part of the said restraint member is a catheter as described in (4) extended in the angle which cross | intersects the said ditch | groove in the outer peripheral surface of the said inner layer.
(6) The outer layer is formed of a resin material, and the material impregnated in the concave groove is the resin material constituting the outer layer (1) to (5). The catheter according to 1.
(7) It further includes a wire reinforcement layer constituted by a wire that reinforces the catheter, and the wire reinforcement layer is formed on the distal end side and the proximal end side with respect to the region where the concave groove is formed (1). The catheter according to any one of (6) to (6).
(8) The catheter according to (7), wherein the concave groove is formed to extend on an extension of the wire.
(9) The catheter according to any one of (1) to (8), wherein a bank portion protruding toward the outer layer side is formed at an edge of the concave groove as compared with the periphery thereof.

DESCRIPTION OF SYMBOLS 1 Catheter 10 Tubular main body 14 1st marker 16 2nd marker 20 Main lumen 22 Main core wire 24 Inner layer 24a Concave groove 24b Outer surface (periphery)
24c Bank portion 30 Wire reinforcing layer 32 Reinforcing wire 40 Sub-lumen tube 42 Sub-lumen 44 Sub-core wire 50 Outer layer 50a Removal portion 60 Operation line 70 Holding wire (restraint member)
90 Operation part 92 Wheel operation part 94 Main body case 95 Concave part 96 Hub 98 Slider 500 Backfill part 921 Concave and convex engagement part DE Distal part

Claims (9)

An inner layer formed through the main lumen;
An outer layer disposed around the inner layer, the catheter comprising:
A concave groove is formed in the outer peripheral surface of the inner layer at the distal end of the catheter,
The catheter, wherein the concave groove is impregnated with a material having lower bending rigidity than the material of the inner layer.   The catheter according to claim 1, wherein the concave groove has a shape including a plurality of line segments intersecting each other. The distal end of the catheter is further connected to the distal end, and further includes an operation line that can be bent by being pulled toward the proximal end,
The catheter according to claim 1 or 2, wherein at least a part of the concave groove is disposed on a proximal end side with respect to the distal end of the operation line. Further comprising a sub-lumen tube disposed along the outer peripheral surface of the inner layer on the radially outer side of the inner layer and through which the operation line is inserted;
The catheter according to claim 3, wherein the sublumen tube extends in contact with an edge of the concave groove. The sublumen tube is constrained to the inner layer side by a linear restraining member that presses the sublumen tube against the inner layer,
The restraining member extends along the outer peripheral surface of the inner layer,
The catheter according to claim 4, wherein the extending portion of the restraining member extends at an angle intersecting the concave groove on the outer peripheral surface of the inner layer. The outer layer is formed of a resin material,
The catheter according to any one of claims 1 to 5, wherein the material impregnated in the concave groove is the resin material constituting the outer layer. A wire reinforcing layer constituted by a wire for reinforcing the catheter;
The catheter according to any one of claims 1 to 6, wherein the wire reinforcing layer is formed on a distal end side and a proximal end side with respect to a region where the concave groove is formed.   The catheter according to claim 7, wherein the concave groove is formed to extend on an extension of the wire.   The catheter according to any one of claims 1 to 8, wherein a bank portion protruding toward the outer layer side is formed at an edge of the concave groove as compared with the periphery thereof.

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