JP5614508B1 - CATHETER AND METHOD FOR PRODUCING CATHETER - Google Patents

Abstract

The present invention provides a catheter with improved tip operability and a method for manufacturing the catheter. A catheter 100 includes a large-diameter resin tube forming a large-diameter lumen, a small-diameter operation line tubule disposed outside the lumen, and a distal end portion of the catheter that is inserted into the operation line tubule. An operation line connected to the distal end, and a reinforcing layer that is a coil that covers both the large diameter resin tube and the operation line thin tube, and the distal end of the large diameter resin tube and the distal end of the operation line thin tube The reinforcing layer and the operation line inserted through the reinforcing layer extend to the distal side of the terminal end including the end, and the curvature of the catheter due to the operation of the operating line is maximized near the distal side of the terminal end. Has the maximum curvature point. [Selection] Figure 1

Description

  The present invention relates to a catheter capable of bending a distal end and a method for manufacturing the catheter. In particular, the present invention relates to a so-called multi-lumen structure catheter in which an operation line is inserted into a communication hole different from a large-diameter lumen, and a method for manufacturing the catheter.

  In recent years, catheters have been provided that can manipulate the direction of entry into a body cavity by bending the distal end by manipulating the manipulation line. Among them, the multi-lumen structure catheter is excellent in functionality because an operation line can be arranged outside a large-diameter lumen for allowing a medical solution to flow or a long medical instrument to be inserted.

For example, Patent Document 1 discloses an invention of a catheter that is a multi-lumen structure including a large-diameter tube that forms a central lumen and a plurality of small-diameter tubes that form a sublumen disposed around the large-diameter tube ( Hereinafter, it is also referred to as Prior Art 1).
Prior art 1 includes the multi-lumen structure at least at the distal end flexible portion in the distal end region. Patent Document 1 describes that the distal end flexible portion bends (bends) when the operation wire in Prior Art 1 is pulled.

JP 2013-48711 A

However, as shown in the prior art 1, a catheter having a large diameter tube forming a central lumen and a small diameter tube forming a sublumen disposed around the large diameter tube has the following problems. there were.
That is, when the operation line is operated to bend the tip of the catheter, it is necessary to bend both the large diameter tube and the small diameter tube, so the bending force is large or it is difficult to bend sharply. The operability was not good, and improvements were demanded.

  The present invention has been made in view of the above problems. That is, the present invention provides a catheter and a catheter manufacturing method with improved tip bending operability.

The catheter of the present invention is a catheter having a lumen inside, a large-diameter resin tube forming the large-diameter lumen, a small-diameter operation line thin tube disposed outside the lumen, and the operation line An operation line inserted through a thin tube and having a distal end connected to the distal end of the catheter; a reinforcing layer that is a coil that covers both the large diameter resin tube and the operation line thin tube;
The reinforcing layer and the operation line inserted through the reinforcing layer to the distal side of the terminal portion including the distal end of the large-diameter resin tube and the distal end of the operation wire thin tube. It is extended and has the curvature maximum point in which the curvature of the said catheter by the operation of the said operation line becomes the maximum in the distal side vicinity of the said termination | terminus part.

  The catheter manufacturing method of the present invention is a catheter manufacturing method for forming the catheter of the present invention, and is disposed outside the lumen and a large-diameter resin tube forming the large-diameter lumen. A small-diameter operation line tubule, an operation line inserted through the operation line tubule and having a distal end connected to the distal end of the catheter, and a coil that covers both the large-diameter resin tube and the operation line tubule The reinforcing layer, and the reinforcing layer and the operation line inserted through the reinforcing layer to the distal side of the distal end of the large-diameter resin tube and the operating wire thin tube. It is made to extend.

The catheter of the present invention includes a reinforcing layer that is a coil that covers both the large-diameter resin tube and the manipulation wire tubule to the distal side of the distal end of the large-diameter resin tube and manipulation wire tubule, and a reinforcing layer. The inserted operation line extends. The catheter of the present invention has a maximum curvature point at which the curvature of the catheter due to manipulation of the manipulation line is maximum in the vicinity of the distal end of the distal end portion of the large-diameter resin tube and manipulation line tubule.
The catheter of this invention has the said curvature maximum point in the area | region where a large diameter resin tube and an operation wire tubule do not exist. Therefore, when the operation line is operated to bend the distal end of the catheter, it is not necessary to bend both the large diameter tube and the small diameter tube, and the bending operability is excellent.

  The method for producing a catheter of the present invention includes a reinforcing layer that is a coil that covers both the large-diameter resin tube and the manipulation wire tubule to the distal side of the distal end of the large-diameter resin tube and manipulation wire tubule; It is possible to manufacture a catheter in which an operation line inserted through the reinforcing layer extends.

1 is a side view of a catheter illustrating a first embodiment of the present invention. It is a longitudinal cross-sectional view in the front-end | tip area | region of the catheter shown in FIG. (3a) is a partially enlarged explanatory view showing an inner tip coil and an operation line provided at the tip of the catheter according to one embodiment of the present invention, and (3b) is a catheter according to one embodiment of the present invention. It is a partial expanded explanatory view which shows the inner side front end coil, outer side front end coil, and operation line which were provided in the front-end | tip part. It is a cross-sectional view in IV-IV of the catheter shown in FIG. 5a to 5f are process explanatory views illustrating the process of the catheter manufacturing method according to the second embodiment of the present invention.

Hereinafter, a first embodiment 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 redundant description will be appropriately omitted.
In the present embodiment, there are cases where the left and right directions are defined and illustrated as shown. However, this is provided for convenience in order to simply explain the relative relationship of the components, and does not limit the direction during the manufacture or use of the product implementing the present invention.
The various components of the catheter of the present invention do not have to be independent from each other, a plurality of components are formed as a single member, and a single 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.

In the context of the present invention, the proximal end of each elongate component constituting the catheter or the catheter refers to a predetermined length region including the proximal end of the catheter. Similarly, the distal end portion of each of the long components constituting the catheter or the catheter refers to a predetermined length region including the distal end of the catheter.
Moreover, the proximal end of each elongate structure which comprises a catheter or a catheter means the catheter in the operator side of the said catheter, or the edge part of each said structure. The distal end of each of the elongate components constituting the catheter or the catheter means the end opposite to the proximal end, and usually means the tip of the catheter or the operation side of the configuration. .
In describing the present invention, the term inside or outside may be used as appropriate. Unless otherwise specified, the inner side means the side facing the central axis of the catheter, and the outer side means the side not facing the central axis of the catheter.
In the description of the present invention, unless otherwise specified, the vertical section means a cut surface cut along the central axis of the catheter, and the horizontal section means a direction perpendicular to the central axis of the catheter. It means a cut surface obtained by cutting.
In the description of the present invention, unless otherwise specified, “axial direction” means the axial direction of the catheter.

<First embodiment>
Below, the main structure of the catheter 100 which is 1st embodiment of the catheter of this invention is demonstrated using FIGS. 1-4.
FIG. 1 is a side view of a catheter 100 illustrating a first embodiment of the present invention. In FIG. 1, the resin embedding unit 800 is not shown.
FIG. 2 is a longitudinal sectional view of the distal end region of the catheter 100 shown in FIG.
FIG. 3 a is a partially enlarged explanatory view showing the inner distal end coil 62 </ b> A and the operation line 18 provided at the distal end portion of the catheter 100 according to the first embodiment. FIG. 3 b is a partially enlarged explanatory view showing the inner tip coil 62 </ b> A, the outer tip coil 62 </ b> B, and the operation line 18 provided at the tip portion of the catheter 100 according to the first embodiment.
4 is a cross-sectional view taken along IV-IV of the catheter 100 shown in FIG.
In FIG. 1 and FIG. 2, the loop of the coil constituting the reinforcing layer 22 is not shown.

As shown in FIG. 1, the catheter 100 has a lumen 12, a large-diameter resin tube 14, an operation wire capillary 16, an operation wire 18, and a reinforcing layer 22 inside.
The large diameter resin tube 14 forms a large diameter lumen 12. The operation wire thin tube 16 is a small-diameter tube disposed outside the lumen 12. The operation line 18 is inserted through the operation line capillary 16 and has a distal end connected to the distal end of the catheter 100. The reinforcing layer 22 is a coil that covers both the large-diameter resin tube 14 and the operation wire thin tube 16.
The reinforcing layer 22 and the operating line 18 inserted through the reinforcing layer extend to the distal side of the terminal end X including the distal end of the large-diameter resin tube 14 and the distal end of the operating wire thin tube 16. Yes.
The catheter 100 has a curvature maximum point Y at which the curvature of the catheter 100 due to the operation of the operation line 18 is maximized near the distal side of the terminal end X.

  The catheter 100 has a rigid discontinuity point in the axial direction at the distal end of the large-diameter resin tube 14 and the distal end of the operation wire capillary 16. There is a maximum curvature point Y where the curvature is maximum on the distal side of the discontinuous point.

  As described above, the catheter 100 has the maximum curvature point Y on the distal side with respect to the terminal end X where the large-diameter resin tube 14 and the operation wire capillary 16 are terminated. In other words, the large-diameter resin tube 14 and the operation wire thin tube 16 do not pass through the maximum curvature point Y. Therefore, since the catheter 100 can be bent without bending the large-diameter resin tube 14 and the operation wire capillary 16 at the maximum curvature point Y, the bending operability is excellent.

As shown in FIG. 1, in the catheter 100 according to the present embodiment, the large-diameter resin tube 14 and the operation wire thin tube 16 terminate at a position substantially equal to the axial direction.
Therefore, the discontinuity point of rigidity in the axial direction of the catheter 100 is substantially one. Such a catheter 100 has a remarkable difference between a region having high rigidity and a region having low rigidity through the discontinuous point, and is particularly excellent in tip flexibility.

  For example, in the catheter 100, the distal end of the large-diameter resin tube 14 and the distal end of the manipulation wire tubule 16 are present at substantially the same position in the axial direction, and the terminal portion X substantially indicates one point. Here, the fact that the distal end of the large-diameter resin tube 14 and the distal end of the operation wire capillary 16 are substantially equal in the axial direction is not limited to the case where the two distal ends are completely in the same position in the axial direction. Including the case of slight deviation in the axial direction. The slight deviation means, for example, a distance corresponding to one outer diameter of the large diameter resin tube 14. However, as described above, the catheter 100 according to the present embodiment is configured such that the distal end of the large-diameter resin tube 14 and the distal end of the operation wire tubule 16 are separated by more than one outer diameter of the large-diameter resin tube 14. It is not excluded.

Next, the detailed structure of the distal end region of the catheter 100 will be described with reference to FIG.
The catheter 100 includes a reinforcing layer 22 that is a coil that covers both the large-diameter resin tube 14 and the operation wire tubule 16. In the distal end region of the catheter 100, the large-diameter resin tube 14 and the manipulation wire tubule 16 terminate on the proximal side from the distal end of the reinforcing layer 22.

  A distal end portion 752 that communicates from the distal end of the large-diameter resin tube 14 to the distal end of the catheter 100 and opens at the distal end is provided at the distal end portion of the reinforcing layer 22. The lumen 12 is extended by the large-diameter resin tube 14 and the tip hole 752 being continuous.

  When the large-diameter resin tube 14 having the lumen 12 inside terminates on the proximal side of the distal end of the catheter 100, the catheter 100 has the tip hole 752, so that the lumen 12 is extended to the tip of the catheter 100. Can be extended.

  In the catheter 100, an operation line 18 extends distal to the distal ends of the large-diameter resin tube 14 and the operation line capillary 16. The operation line 18 extends from the distal end of the operation line capillary 16 and is locked to the distal end portion of the catheter 100. Accordingly, the distal end of the catheter 100 can be bent together with the operation line 18 by operating the operation line 18.

For example, as shown in FIG. 2, in the catheter 100 according to this embodiment, the distal end portion of the operation line 18 is fixed to the distal end portion of the reinforcing layer 22.
As a result, the bending motion of the operation line 18 can be directly transmitted to the reinforcing layer 22, and the operation line 18 extending to the distal side from the distal ends of the large-diameter resin tube 14 and the operation line thin tube 16. The reinforcing layer 22 can be bent well on the distal side of the terminal end X.

The means for fixing the operation line 18 to the distal end portion of the reinforcing layer 22 is not particularly limited. For example, as shown in FIG. 2, the operation line 18 may have a folded portion 38 formed by folding the distal end portion, and the folded portion 38 may be locked to the distal end portion of the reinforcing layer 22.
More specifically, the distal end of the operation line 18 is provided with a surplus portion 38A (see FIG. 3a) extending more distally than the distal end of the reinforcing layer 22. A folded portion 38 is formed by folding the surplus portion 38A proximally.

  By providing the folded portion 38, the operation line 18 can be reliably locked to the distal end of the reinforcing layer 22, and the operation direction of the operation line can be satisfactorily transmitted to the distal end portion of the catheter 100.

  The folded portion 38 is disposed along the outer surface from the distal end of the reinforcing layer 22 over, for example, two or more loops of the coil forming the reinforcing layer 22.

As described above, the operation line 18 has the folded portion 38 formed by folding the distal end portion at the distal end of the reinforcing layer 22. For example, in the catheter 100, the tip of the folded portion 38 may enter from the outside to the inside of the one reinforcing layer 22.
That is, as shown in FIG. 3 b, the tip of the folded portion 38 has an intrusion portion 38 </ b> B that is inserted from the outside to the inside of the reinforcing layer 22.

  As a result, the operation line 18 can be securely locked to the reinforcing layer 22, and the bending operation of the operating line 18 can be transmitted to the distal end portion of the reinforcing layer 22 satisfactorily. Further, the distal end of the folded portion 38 disposed outside the reinforcing layer 22 is prevented from protruding outside the catheter 100 and damaging the body cavity.

For example, the intrusion portion 38B extends over two or more loops inside the coil forming the reinforcing layer 22 from the distal side toward the proximal side. Here, the inside of the coil includes the case where it is the inner surface of the reinforcing layer 22 and the case where the reinforcing layer 22 is a multiple coil and is the inner surface of one of the coils forming the multiple coil. .
The distal end of the catheter 100 shown in FIG. 3b is a multiple coil composed of an inner distal coil 62A and an outer distal coil 62B, and the intrusion portion 38B is located between the inner distal coil 62A and the outer distal coil 62B from the distal end to the proximal end. Extends towards.

  Next, the reinforcing layer 22 will be described. The catheter 100 has a reinforcing layer 22 that covers both the large-diameter resin tube 14 and the operation wire tubule 16. The reinforcing layer 22 is a layer for reinforcing the tubular main body 50 of the catheter 100 and is a layer for enclosing the large-diameter resin tube 14 and the operation wire thin tube 16 in one space.

  The coil forming the reinforcing layer 22 has a single cylindrical shape as a whole. For example, the coil forming the reinforcing layer 22 is formed by winding a linear member in a spiral shape in the axial direction. The coil is wound so that the edges of adjacent metal wires (that is, loops) abut or overlap each other, or the coil is wound so that the edges of adjacent metal wires are separated from each other. It can be any or a combination of windings. The coil has a tube shape, for example.

Examples of the linear member forming the coil that forms the reinforcing layer 22 include a metal wire. By selecting a metal wire as the constituent material of the reinforcing layer 22, it is possible to sufficiently maintain the force of loosening the coil wound in the axial direction.
As the metal material constituting the metal wire, in addition to fine metal wires such as stainless steel (SUS) and nickel titanium alloy, fine wires of polymer fibers such as polyimide (PI), polyamideimide (PAI) or polyethylene terephthalate (PET) are used. be able to. The cross-sectional shape of the metal wire is not particularly limited, and may be a circle, an ellipse, a square, a rectangle, a polygon, or the like. In this embodiment, a thin wire with a circular cross section or a flat plug wire with a flat cross section is preferably used. Can do.

  The reinforcing layer 22 may be a coil formed by winding a single linear member, or may be a multi-strand coil formed by multiple winding using two or more linear members. Specifically, the main body coil portion 60 constituting the reinforcing layer 22 in the present embodiment is a three-strand coil formed by winding three linear members with substantially the same diameter as shown in FIG. FIG. 4 shows a cross section of three linear members in the cross section of the reinforcing layer 22.

  The reinforcing layer 22 may be composed of a single coil composed of one coil, or may be composed of a multiple coil in which two or more coils overlap in the radial direction. As the main body coil portion 60 constituting the reinforcing layer 22 in the present embodiment, an example constituted by a single coil is shown in FIG. Moreover, the tip coil part 62 showed the example comprised from the double coil as shown in FIG.2 and FIG.3.

As shown in FIGS. 2 and 3, the reinforcing layer 22 in this embodiment includes a tip coil portion 62 provided on the distal side and a main body coil portion 60 provided on the proximal side of the tip coil portion 62. Have. The tip coil portion 62 is a multiple coil layer in which two or more coils overlap in the radial direction. In the multi-coil layer, an operation is performed between the inner tip coil 62A (FIG. 3a) located on the central axis side of the catheter 100 and the outer tip coil 62B (FIG. 3b) located outside the inner tip coil 62A. Line 18 is inserted.
The tip coil portion 62 is located on the distal side of the terminal portions of the large-diameter resin tube 14 and the operation wire thin tube 16.

  In the catheter 100 according to this embodiment, the reinforcing layer 22 having one cylindrical shape is configured by connecting the distal end portion of the main body coil portion 60 and the proximal end portion of the tip coil portion 62. However, the coil forming the reinforcing layer 22 can be appropriately changed to a coil that is one member continuous from the distal end to the proximal end. FIG. 2 shows a connection region 750 where the distal end portion of the main body coil portion 60 and the proximal end portion of the tip coil portion 62 are connected.

By providing the tip coil portion 62 described above, the operation wire 18 exposed from the operation wire tubule 16 can be extended toward the distal side inside the reinforcing layer 22 at the distal end portion of the catheter 100.
Thereby, it is possible to prevent the exposed operation line 18 from coming into contact with a medical instrument or the like that is inserted through the distal end hole 752 forming a part of the lumen. Further, according to this aspect, the bending operation of the catheter 100 is good because the bending operation of the operation line 18 is transmitted to the distal end coil portion 62 satisfactorily.

The linear members constituting the inner tip coil 62A and the outer tip coil 62B are wound in the same spiral direction.
The diameters of the linear members constituting the inner tip coil 62A and the outer tip coil 62B may be the same or different.
For example, the diameter of the linear member constituting the inner tip coil 62A is smaller than the diameter of the linear member constituting the outer tip coil 62B.

  The pitches of the coils constituting the inner tip coil 62A and the outer tip coil 62B may be the same or different. For example, as shown in FIGS. 3a and 3b, the pitch of the outer tip coil 62B can be made larger than the pitch of the inner tip coil 62A.

More specifically, for example, the inner tip coil 62A is formed in a substantially tube shape by winding a linear member in a state close to or close to the close winding, and a tip end and a base end are formed inside the inner tip coil 62A. It is advisable to clarify the outline of the tip hole 752 that passes between the two. The tip hole 752 communicates from the distal end of the lumen 12 provided inside the large-diameter resin tube 14 to the distal end opening 32, and substantially extends the lumen 12 to the distal end opening 32. As a result, the drug distribution in the lumen 12 and the insertion property of medical instruments such as a guide wire can be improved.
Alternatively, the outer tip coil 62B may be configured by pitch winding using a linear member having a relatively large diameter with respect to the inner tip coil 62A. As the thick line member, for example, a flat wire having a width dimension larger than the diameter of the inner tip coil 62A can be used. As a result, the outer tip coil 62B having a larger cross-sectional diameter than the inner tip coil 62A can be relatively flexible.

As shown in FIG. 2, a tip hole 752 that communicates from the distal end of the large diameter resin tube 14 to the distal end of the catheter 100 is provided inside the inner tip coil 62 </ b> A. The opening diameter 900 on the near end side of the tip hole 752 is substantially equal to the opening diameter 920 on the distal end side of the large diameter resin tube 14.
More specifically, the difference between the opening diameter 900 and the opening diameter 920 is substantially 0 to the sum of twice the thickness of the large diameter resin tube 14 and twice the thickness of the main body coil portion 60. The following range is preferable. More preferably, the difference is substantially from 0 to less than twice the thickness of the large diameter resin tube 14. When there is a slight difference between the opening diameter 900 and the opening diameter 920, it is preferable that the opening diameter 920 <the opening diameter 900.

When the difference between the opening diameter 900 and the opening diameter 920 is in the above-described relationship, the inside of the lumen 12 is circulated from the proximal side to the distal side via the terminal end X where the large-diameter resin tube 14 terminates. The operation of the medicine to be performed or the medical instrument inserted into the inside is smooth.
When the opening diameter 920 is smaller than the opening diameter 900, the diameter is increased from the proximal side to the distal side, but the medical device or the like inserted from the proximal side is opened with the opening diameter 920. It is possible to avoid catching a step with the aperture 900.

  As described above, the reinforcing layer 22 includes the tip coil portion 62 provided on the distal side and the main body coil portion 60 provided on the proximal side of the tip coil portion 62, and constitutes the tip coil portion 62. The coil to be used is a coil different from the coil constituting the main body coil unit 60. The catheter 100 according to the present embodiment includes a proximal end portion of the tip coil portion 62 and a distal end portion of the main body coil portion 60 at a position substantially equal to a position where the large-diameter resin tube 14 or the operation wire capillary 16 ends. A connection region 750 is provided in which are connected.

In the connection region 750, the proximal end portion of the tip coil portion 62 is located between the distal end portion of the main body coil portion 60 and the large diameter resin tube 14.
More specifically, for example, as shown in FIG. 2, the proximal end portion of the inner tip coil 62A is inserted between the large-diameter resin tube 14 and the manipulation wire tubule 16, and the proximal end of the outer tip coil 62B. A portion may be inserted between the reinforcing layer 22 and the operation wire tubule 16.

Below, the other structure of the catheter 100 is demonstrated in detail.
The catheter 100 includes a long and tubular tubular body 50, a tip portion 52 provided on the distal side of the tubular body 50, an operation line operation unit 810 provided on the proximal side of the tubular body 50, and the proximal side of the catheter 100. A syringe 812 provided on the end side is provided. The tip 52 can be displaced between a bent state and a straight state as indicated by double-ended arrows shown in FIG. 1 by operating the operation line 18 (FIG. 2). The distal end portion 52 includes a curvature maximum point Y portion at which the bending rate in the catheter 100 is maximized.
The tubular body 50 has a lumen 12 therein, and is a flexible tubular body that is inserted through a body cavity such as a blood vessel through an endoscope or directly.

  In the intermediate region of the main body coil unit 60, for example, as shown in FIG. 4, the large-diameter resin tube 14 and the operation wire thin tube 16 may be disposed in a state of being separated inside the reinforcing layer 22. In other words, the reinforcing layer 22 and the large-diameter resin tube 14 are separated from each other so that they can be separated from each other, and the operation wire thin tube 16 may be loosely inserted between the reinforcing layer 22 and the large-diameter resin tube 14. . According to such an arrangement, the operation wire tubule 16 can move in the circumferential direction of the large-diameter resin tube 14. That the reinforcing layer 22 and the large-diameter resin tube 14 are separated means that they are disposed so as to be substantially separated from each other. Further, the operation wire tubule 16 is loosely inserted between the reinforcing layer 22 and the large diameter resin tube 14. The operation wire tubule 16 is inserted without being coupled to the large diameter resin tube 14 and the reinforcement layer 22. Means that Such bonding includes chemical bonding or adhesion and physical fixation.

The operation line operation unit 810 is an operation part for operating the operation line 18. The catheter 100 according to this embodiment includes a dial-type operation line operation unit 810 including a disk-shaped dial 816. The dial type operation line operation unit 810 has a connection part 818 near an arbitrary periphery of the dial 816, and the proximal end of the operation line 18 is fixed to the connection part 818. The pulling length of the operation line 18 is adjusted by rotating the dial 816 with respect to the central axis of the disk, whereby the operation line 18 can be operated. However, in the present invention, instead of the dial method, an operation line operation unit of another operation method can be appropriately selected and provided.
In the operation line operation unit 810, the distal end region of the catheter 100 including the maximum curvature point Y can be bent by performing an operation such as pushing the operation line 18 distally or pulling the operation line 18 proximally.

  The syringe 812 is an injection site for processing a chemical solution or the like through the lumen 12 to a desired location in the body cavity. Inside the operation line operation unit 810, there is a lumen (not shown) extending in the extending direction of the catheter 100. The lumen 12 and the syringe 812 communicate with each other through the lumen, and the medicine introduced from the syringe 812 flows through the lumen and the lumen 12 to the distal end opening 32 of the catheter 100 and can be released into the body cavity. . As a modification of the present embodiment, a medical instrument such as a microcatheter including a guide wire may be inserted into the lumen 12 instead of the syringe 812.

  The large-diameter resin pipe 14 is a resin tubular member having a lumen 12 communicating with the inside. The material of the large diameter resin tube 14 is not particularly limited, and for example, a fluorine-based thermoplastic polymer can be used. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used. As described above, by using a fluorine-based resin for the large-diameter resin tube 14, the delivery property when supplying a contrast medium or a drug solution to the affected area through the lumen 12 of the catheter 100 is improved.

  The small-diameter operation line thin tube 16 is a resin tubular member through which the operation line 18 is inserted. In the present invention, the “large diameter” in the large-diameter resin tube 14 and the “small diameter” in the small-diameter operation line capillary 16 compare the inner diameter of the large-diameter resin tube 14 and the inner diameter of the operation line capillary 16, and Represents a magnitude relationship. That is, the inner diameter of the large-diameter resin tube 14 is larger than the inner diameter of the operation wire thin tube 16. In general, the outer diameter of the large-diameter resin tube 14 is larger than the outer diameter of the operation wire thin tube 16.

The material of the operation wire tubule 16 is, for example, polyether ether ketone (PEEK), polysulfone (PSF), polytetrafluoroethylene (PTFE) from the viewpoint of slidability in the sliding direction of the operation wire tubule 16 inserted inside. , Fluorine polymer materials such as polyvinylidene fluoride (PVDF) can be suitably used.
From the viewpoint of smooth movement of the operation line thin tube 16 with respect to the outer peripheral direction of the large-diameter resin tube 14, a material capable of reducing friction with the large-diameter resin tube 14 can be selected. From this point of view, for example, the material of the operation wire tubule 16 and the material of the large diameter resin tube 14 may be different. More specifically, one preferable combination is to select a fluorine-based resin such as PTFE as the material of the large-diameter resin tube 14 and to select PEEK as the material of the operation wire capillary 16. However, the above description does not exclude that the material of the operation wire thin tube 16 and the material of the large diameter resin tube 14 are the same.

The operation line 18 is a member for performing an operation for bending the distal end of the catheter 100. The distal end portion of the operation line 18 is fixed to the distal end portion of the catheter 100, and the proximal end portion is fixed to the connection portion 818 in the dial 816. The operation line 18 is inserted into a communication hole formed inside the operation line capillary 16 so as to be slidable. Therefore, when the operation line thin tube 16 moves in the outer peripheral direction of the large diameter resin tube 14, the operation line 18 also moves in the outer peripheral direction of the large diameter resin tube 14 together with the operation line thin tube 16.
The distal end portion and the proximal end portion of the operation line 18 may protrude from the end portion of the operation line capillary 16, respectively.

  The material of the operation line 18 is not particularly limited. For example, PEEK, polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or SUS, corrosion-resistant coated steel wire. A metal wire such as titanium or a titanium alloy can be used.

  As shown in FIG. 4, the cross-sectional inner diameter of the operation wire capillary 16 in the present embodiment has a major axis and a minor axis. For example, the shape including the cross-sectional inner diameter of the operation wire capillary 16 is an ellipse, an ellipse, a rectangle, or the like.

  Further, the outer diameter of the cross section of the operation wire capillary 16 in this embodiment has a major axis and a minor axis. The major axis of the sectional inner diameter and the major axis of the sectional outer diameter, and the minor axis of the sectional inner diameter and the minor axis of the sectional outer diameter extend in substantially the same direction.

The shape of the operation line 18 used in the present invention is not particularly limited as long as it is inserted into the operation line capillary 16 and the distal end of the catheter 100 can be operated to be bendable, and is arbitrarily determined. The operation line 18 in the present embodiment is a flat wire (see FIG. 4). A flat wire is a long member having a cross-sectional shape including a major axis and a minor axis. The cross-sectional shape may be a rectangle as shown in FIG. 4, or may be an ellipse or an ellipse.
When the operation line 18 is a flat wire, and the cross-sectional inner diameter of the operation line capillary 16 has a major axis and a minor axis, the state of the inserted operation line 18 is stable, and the operation line 18 is operated. Operation is stable at times.

In the catheter 100 according to the present embodiment, for example, it is desirable that the reinforcing layer 22 extending distally from the end portion X is embedded with a resin member together with the exposed operation line 18.
In the resin embedding unit 800, the resin member is impregnated from the outer periphery to at least an intermediate position in the thickness direction of the reinforcing layer 22. More specifically, in the catheter 100, the distal end coil portion 62 is embedded with a resin member impregnated from the outer peripheral surface of the reinforcing layer 22 to at least the operation line 18 with a resin member. The resin member may be impregnated from the outer peripheral surface of the reinforcing layer 22 to the outer periphery of the tip hole 752. A region of the tip coil portion 62 embedded by the resin member is referred to as a resin embedded portion 800.

  While protecting the bending area | region in a front-end | tip part, the bending operation | movement of the operating line 18 is sharply transmitted to the front-end | tip of the catheter 100 by fixing the operating line 18 integrally with the reinforcement layer 22 in the distal end part of the catheter 100. be able to.

In the tip coil portion 62 forming a part of the reinforcing layer 22, for example, a resin member may be impregnated so as to reach the inner tip coil 62A from the outer surface of the outer tip coil 62B. Thus, the outer tip coil 62B and the operation wire 18 can be embedded by the resin member, and the outer tip coil 62B, the operation wire 18 and the inner tip coil 62A can be integrally held by the resin member. By providing the resin embedding part 800, the rigidity of the distal end of the catheter 100 can be increased moderately, and the safety can be improved by embedding the metal member at the distal end of the catheter 100 entering the body cavity with the resin. it can.
From the viewpoint of improving safety, a resin tip cap 820 may be attached to the tip of the catheter 100 further on the distal side than the resin embedding portion 800.

  The resin material for forming the resin embedding part 800 is not particularly limited. For example, in addition to polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA ), Nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), polyvinyl chloride (PVC), polypropylene (PP), and the like.

  The catheter 100 according to the present embodiment can be appropriately provided with an outer layer 42 that covers the reinforcing layer 22. The outer layer 42 is a film-like layer composed of a resin member attached so as to cover the outer surface of the reinforcing layer 22. The outer layer 42 in this embodiment constitutes the outermost layer of the catheter 100. By providing the outer layer 42, the coil forming the reinforcing layer 22 is prevented from coming into direct contact with the body cavity, so that the body cavity is protected.

The outer layer 42 is preferably provided from the proximal end of the catheter 100 to the vicinity of the terminal end X. For example, the distal end of the outer layer 42 is preferably positioned substantially at the same position as the terminal end X in the axial direction or on the distal side of the terminal end X.
Further, the distal end of the outer layer 42 may be provided on the proximal end of the resin embedding part 800.

The method for forming the outer layer 42 is not particularly limited. For example, the outer layer 42 can be formed by disposing a heat-shrinkable material such as a tube or sheet around the reinforcing layer 22 and heat-shrinking the heat-shrinkable material by heating from the outer periphery. .
For example, the heat-shrinkable member is disposed in contact with the circumferential direction of the reinforcing layer 22 and is heated in this state, whereby the heat-shrinkable member is contracted so that the reinforcing layer 22 is tightened inward in the radial direction. It is good to form. As a result, the coil which is the reinforcing layer 22 holding the unwinding force biases the outer layer 42 outward. The outer layer 42 is provided on the catheter 100 while being stretched outward.
The outer layer 42 is made of a resin material. As the resin material constituting the outer layer 42, the same resin as the constituent resin of the resin embedding portion 800 described above can be used.

<Second embodiment>
Next, a second embodiment which is an example of a method for manufacturing a catheter of the present invention (hereinafter also referred to as the present manufacturing method) will be described with reference to FIGS. 5a to 5f. 5a to 5f are process explanatory views for explaining each process related to the manufacturing method of the present invention. FIGS. 5a to 5f show essential steps and optional steps in the manufacturing method.
In this manufacturing method, as shown in FIG. 5 f, the large-diameter resin tube 14 forming the large-diameter lumen 12, the small-diameter operation wire tubule 16 disposed outside the lumen 12, and the operation-wire tubule 16 are inserted. An operation line 18 whose distal end is connected to the distal end of the catheter 100 and a reinforcing layer 22 that is a coil that covers both the large-diameter resin tube 14 and the operation line thin tube 16 are provided. In this manufacturing method, the reinforcement layer 22 and the operation line 18 inserted through the reinforcement layer 22 are extended to the distal side of the distal end portion X of the large-diameter resin tube 14 and the operation wire thin tube 16. It is characterized by making it.

  According to this manufacturing method, the reinforcing layer 22 and the operation line 18 extend farther to the distal side than the distal end portion X of the large-diameter resin tube 14 and the operation wire tubule 16 and excellent in bending operability. A catheter 100 can be provided.

The manufacturing method according to the second embodiment includes, for example, a main body coil portion forming step, a tip coil portion forming step, a reinforcing layer forming step, and an embedding step.
In the main body coil portion forming step, the linear member is spiraled so as to cover both the large-diameter resin tube 14 and the operation wire thin tube 16 in which the core member 700 is inserted and the core member 700 is exposed and extended from at least one end. The main body coil part 60 is formed by winding in a shape. Although not shown in the drawing, the coil is temporarily fixed with a clamp or the like while holding the loosened winding until the coil formed by winding the linear member in each manufacturing process is finally fixed. Good.
In the tip coil portion forming step, the operation wire 18 is exposed from the tip of the operation wire tubule 16, and the linear member is covered so as to cover both the core material 700 exposed from the end portion of the large diameter resin tube 14 and the exposed operation wire 18. Is wound spirally to form the tip coil portion 62.
In the reinforcing layer forming step, the reinforcing layer 22 is formed by connecting the distal end portion of the main body coil portion 60 and the proximal end portion of the tip coil portion 62 to form the connecting region 750.
A resin member is impregnated from the outer surface of the tip coil portion 62 to at least the operation line 18 to form a resin embedding portion 800 for embedding the tip coil portion 62 with the resin member.

The tip coil portion forming step may include an inner tip coil forming step and an outer tip coil forming step.
In the inner tip coil forming step, a linear member is wound around the core member 700 to form the inner tip coil 62A. Next, in the outer tip coil forming process, the outer tip coil 62B is formed by winding a linear member so as to cover both the inner tip coil 62A and the exposed operation wire 18. A tip coil portion 62 is formed by the inner tip coil 62A and the outer tip coil 62B.
For example, the main body coil portion forming step may be performed between the inner wire tip coil forming step and the outer tip coil forming step.
In addition, when forming a coil with a linear member in this manufacturing method, when forming a single strip coil with one linear member, and forming a multi-strand coil using a plurality of linear members. Including cases.

  By performing the tip coil portion forming step having the inner tip coil forming step and the outer tip coil forming step, the tip coil portion 62 that is a multiple coil is formed, and the distal side is formed inside the multiple coil toward the distal side. An extended operation line 18 can be arranged.

Details of this production method will be described below, including the steps that are optionally carried out.
First, as shown in FIG. 5 a, a large-diameter resin tube 14 is prepared in which a core material 700 is inserted and the core material 700 is exposed and extended from at least one end. As the tip coil portion forming step, a linear member is wound around the core member 700 exposed from the large diameter resin tube 14 to form the inner tip coil 62A. At this time, as shown in FIG. 5 a, the linear member is wound between the exposed core member 700 and the distal end portion of the large-diameter resin tube 14, and is wound around the distal end portion of the large-diameter resin tube 14. The inner tip coil 62A that rides may be formed.

  In the core material 700 used in the present embodiment, the exposed end portion is gradually reduced in diameter toward the tip end. Therefore, the diameter of the distal end portion of the tip coil portion 62 is reduced toward the distal end by winding the linear member along the inclined surface of the end portion. As a modification, a cylindrical core member having a uniform outer diameter may be used, and the diameter of the lumen 12 communicating with the inside of the catheter 100 to be formed may be substantially constant.

The main body coil part forming step will be described with reference to FIG. The core member 700 is inserted so that the core member 700 is exposed from at least one end (the end on the left side of the drawing), and the large-diameter resin tube 14 and the operation wire thin tube 16 are covered together to spiral the linear member. A main body coil forming step is performed in which the main body coil portion 60 is formed.
In the present embodiment, the winding direction of the inner tip coil 62A and the winding direction of the main body coil portion 60 are made different by winding the linear member in a direction different from the winding direction of the inner tip coil 62A. The distal end of the body coil portion 60 rides on the proximal end portion of the inner tip coil 62A and is terminated. As a result, the main body coil unit 60 and the inner tip coil 62A are connected (first series connection step). Note that the coil winding directions are different from each other when the coil loop of one coil in the multi-coil layer is tilted in the range of more than 0 ° and less than 90 ° with respect to the axial center of the catheter 100 in a side view. Means that the loop is inclined in the range of more than 90 ° and less than 180 °. The understanding of the difference in coil winding direction described above is common throughout the description of the present invention unless otherwise specified.
In FIG. 5 b, an example in which a single coil is formed as the main body coil unit 60 is shown, but a different linear member is wound around one coil formed along the core material 700 to form a coil as appropriate. And the main body coil part 60 which is a multiple coil may be formed.

  In the present embodiment, the operation wire 18 is inserted into the operation wire capillary 16 before the main body coil portion forming step, during the main body coil portion forming step, or after the main body coil portion forming step.

Next, the outer tip coil forming process will be described with reference to FIG.
The outer tip coil forming step is performed after the inner tip coil forming step. In the outer tip coil forming step, a second linear member that is a second coil is spirally wound so as to cover both the inner tip coil 62A and the exposed operation wire 18 to form the outer tip coil 62B. A tip coil portion 62 is formed by the inner tip coil 62A and the outer tip coil 62B.

In the execution of the outer tip coil forming step, the outer tip coil 62B is formed so as to cover both the operation line 18 exposed from the tip of the manipulation wire tubule 16 and the inner tip coil 62A. Accordingly, the operation line 18 can be disposed between the inner tip coil 62A and the outer tip coil 62B. Further, the surplus portion 38A is secured by extending the operation line 18 sandwiched between the inner tip coil 62A and the outer tip coil 62B from the tip side of the inner tip coil 62A and the outer tip coil 62B.
The tip coil portion 62 is formed by performing the tip coil portion forming step including the inner tip coil forming step and the outer tip coil forming step described above.

The reinforcing layer forming step of forming the reinforcing layer 22 is completed by connecting the distal end portion of the main body coil portion 60 and the proximal end portion of the tip coil portion 62 to form the connecting region 750.
Specifically, in addition to the above-described first connecting step, the proximal end portion of the outer tip coil 62B is connected to the distal end portion of the main body coil portion 60 (second connecting step). The tip coil portion 62 is connected.
The second connecting step can be performed, for example, by inserting the proximal end portion of the outer tip coil 62B between the main body coil portion 60 and the operation wire capillary 16. Alternatively, the second connecting step may be performed by entwining the end of the coil at the proximal end of the outer tip coil 62 </ b> B with the end of the coil at the distal end of the main body coil 60.
As described above, the reinforcing layer forming step in the present embodiment includes the tip coil portion forming step and the main body coil portion forming step. By carrying out the reinforcing layer forming step, the reinforcing layer 22 and the reinforcing layer 22 are disposed farther to the distal side than the distal end portions (the end portion on the left side of the drawing) of the large-diameter resin tube 14 and the operation wire thin tube 16. The operation line 18 inserted through is extended.

Next, the operation line locking step will be described with reference to FIG.
In the operation line locking step, as described above, the operation line 18 extending between the inner tip coil 62A and the outer tip coil 62B extends further to the distal side than the distal end of the tip coil portion 62, thereby surplus portions. 38A is provided. Then, the surplus portion 38 </ b> A is folded back to the proximal end side of the catheter 100 to form the folded portion 38. The intrusion portion 38B is formed by intruding the tip of the folded portion 38 from the outside to the inside of the outer tip coil 62B.
Accordingly, the operation line 18 is locked to the distal end portion of the catheter 100.

Next, an embedding process for forming the resin embedding part 800 and an outer layer forming process for forming the outer layer 42 are performed using FIG. 5E.
The resin embedding step is a step of embedding with a resin member from the outer side surface to the inner side surface of the tip coil portion 62.
More specifically, the resin member is impregnated from the outer surface of the outer tip coil 62B constituting the tip coil portion 62 to the inner tip coil 62A. As a result, a resin embedding portion 800 for fixing the outer tip coil 62B, the operation wire 18 and the inner tip coil 62A to a certain level is formed.
Since the explanation regarding the formation of the resin embedding part 800 in the first embodiment is appropriately applied to the resin embedding part forming step, the detailed explanation is omitted here.

The outer layer forming step is a step of forming the outer layer 42 made of a resin member that is attached so as to cover the outer surface of the reinforcing layer 22. The outer layer 42 can be formed by disposing the heat-shrinkable member around the reinforcing layer 22 and heating the heat-shrinkable member to heat-shrink the heat-shrinkable member and attach it to the outer surface of the reinforcing layer 22. .
In the outer layer forming step, the description related to the formation of the outer layer 42 in the first embodiment is referred to as appropriate, and thus the detailed description is omitted here.

As shown in FIG. 5 f, the core material 700 is removed from the large-diameter resin tube 14 to form the lumen 12 that is a hole communicating with the inside of the reinforcing layer 22. At the same time, the tip hole 752 described in the first embodiment is formed inside the tip coil portion 62. By providing the tip hole 752, the lumen 12 provided inside the large diameter resin tube 14 can be communicated to the distal end of the catheter 100.
By the manufacturing method described above, the catheter 100 in which the reinforcing layer 22 and the operation line 18 extend to the distal side of the terminal portion X between the large-diameter resin tube 14 and the operation line thin tube 16 is manufactured. Can do. The catheter 100 is provided with a curvature maximum point Y at which the curvature of the catheter 100 by the operation of the operation line 18 is maximized in the vicinity of the distal side of the terminal end X.

The first embodiment and the second embodiment of the present invention have been described above. The present invention is not limited to the above-described embodiment, and includes various modifications and improvements as long as the object of the present invention is achieved. The matters described in each embodiment can be applied to other embodiments as appropriate.
Moreover, the order of description of each process in 2nd embodiment does not limit this manufacturing method. As long as the desired catheter can be manufactured, the order of the steps can be appropriately changed. Moreover, you may further add arbitrary processes suitably before or after each process demonstrated, or between one process and another process.

The above embodiment includes the following technical idea.
(1) A catheter having a lumen inside,
A large diameter resin pipe forming the large diameter lumen;
A small-diameter operating line tubule disposed outside the lumen;
An operating line inserted through the operating line capillary and having a distal end connected to the distal end of the catheter;
A reinforcing layer that is a coil that covers both the large-diameter resin tube and the operation wire tubule;
Have
The reinforcement layer and the operation line inserted through the reinforcement layer extend to the distal side of the terminal portion including the distal end of the large-diameter resin tube and the distal end of the operation line thin tube. And
A catheter having a maximum curvature point at which the curvature of the catheter by the operation of the operation line is maximized in the vicinity of the distal side of the terminal portion.
(2) The distal end portion of the reinforcing layer is provided with a tip hole that communicates from the distal end of the large-diameter resin tube to the tip of the catheter and opens at the tip.
The catheter according to (1), wherein the lumen is extended by the large-diameter resin tube and the tip hole being continuous.
(3) The catheter according to (1) or (2), wherein the large-diameter resin tube and the manipulation line tubule are terminated at substantially the same position in the axial direction.
(4) The catheter according to any one of (1) to (3), wherein a distal end portion of the operation line is fixed to a distal end portion of the reinforcing layer.
(5) The operation line has a folded portion formed by folding a distal end portion,
The catheter according to (4), wherein the folded portion is locked to a distal end portion of the reinforcing layer.
(6) The operation line has a folded portion formed by folding a distal end portion at a distal end of the reinforcing layer,
The catheter according to (4) or (5), wherein a tip of the folded portion enters from the outside to the inside of the reinforcing layer.
(7) The reinforcing layer has a tip coil portion provided on the distal side and a main body coil portion provided on the proximal side of the tip coil portion,
The distal coil portion is a multiple coil layer in which two or more coils overlap in the radial direction, and is located outside the inner distal coil and the inner distal coil located on the central axis side of the catheter. The catheter according to any one of (1) to (6), wherein the operation line is inserted between the outer tip coil and the outer tip coil.
(8) A tip hole communicating from the distal end of the large-diameter resin tube to the distal end of the catheter is provided inside the inner tip coil, and the opening diameter on the near end side of the tip hole is The catheter according to (7), wherein the opening diameter on the distal end side of the large-diameter resin tube is substantially equal.
(9) The catheter according to (7) or (8), wherein a diameter of the linear member constituting the inner tip coil is smaller than a diameter of the linear member constituting the outer tip coil.
(10) The catheter according to (8), wherein the tip coil portion is embedded with a resin member from an outer peripheral surface of the reinforcing layer to an outer periphery of the tip hole.
(11) The reinforcing layer has a tip coil portion provided on the distal side, and a main body coil portion provided proximal to the tip coil portion,
The coil constituting the tip coil part is a coil different from the coil constituting the main body coil part,
A connecting region where the proximal end portion of the tip coil portion and the distal end portion of the main body coil portion are connected to each other is provided at a position substantially equal to a position where the large-diameter resin tube or the operation wire thin tube ends. The catheter according to any one of (1) to (10) above.
(12) The catheter according to (11), wherein a proximal end portion of the tip coil portion is located between a distal end portion of the main body coil portion and the large diameter resin tube in the connection region. .
(13) A method for producing a catheter for forming the catheter according to any one of (1) to (12) above,
A large diameter resin tube forming a large diameter lumen;
A small-diameter operating line tubule disposed outside the lumen;
An operating line inserted through the operating line capillary and having a distal end connected to the distal end of the catheter;
A reinforcing layer that is a coil that covers both the large-diameter resin tube and the operation wire tubule;
Provided,
A catheter characterized by extending the reinforcing layer and the operating line inserted through the reinforcing layer to a distal side of a distal end portion of the large-diameter resin tube and the operating line thin tube. Manufacturing method.
(14) A linear member is spirally wound so as to cover both the large-diameter resin tube and the operation wire thin tube extending through the core material being exposed and extending from at least one end through which the core material is inserted. A main body coil part forming step for forming the main body coil part;
The operation line is exposed from the tip of the operation line thin tube, and a linear member is spirally wound so as to cover both the core material exposed from the end of the large-diameter resin tube and the exposed operation line. A tip coil portion forming step for forming the tip coil portion;
A reinforcing layer forming step of forming a reinforcing layer by connecting a distal end portion of the main body coil portion and a proximal end portion of the tip coil portion to form a connecting region;
An embedding step of impregnating a resin member from the outer surface of the tip coil portion to at least the operation line to form a resin embedding portion for embedding the tip coil portion with the resin member;
The method for producing a catheter according to (13) above, comprising:
(15) In the tip coil portion forming step, an inner tip coil forming step for forming an inner tip coil by winding a linear member around the core material is performed, and then the operation wire exposed to the inner tip coil. (14) wherein the outer end coil forming step of forming an outer end coil by winding a linear member so as to cover the outer end coil is performed, and the end coil portion is formed by the inner end coil and the outer end coil. A method for producing the catheter according to 1.
(16) A surplus portion is provided by extending the operation line extending between the inner tip coil and the outer tip coil further to the distal side than the distal end of the tip coil portion,
While folding the surplus portion to the proximal end side of the catheter to form a folded portion,
The method for producing a catheter according to (15) above, further comprising an operation portion locking step of allowing the distal end of the folded portion to enter the inside from the outside of the outer tip coil.

12 ... Lumen 14 ... Large diameter resin tube 16 ... Operation line thin tube 18 ... Operation line 22 ... Reinforcement layer 32 ... Distal end opening 38 ... Folded part 38A ... Excess part 38B ... Intrusion part 42 ... Outer layer 50 ... Tubular body 52 ... Tip part 60 ... Body coil part 62 ... Tip coil part 62A ... Inner tip coil 62B ... Outer tip coil 100 ... catheter 700 ... core material 750 ... articulation region 752 ... tip hole 800 ... resin embedding part 810 ... operation line operation part 812 ... syringe 816 ... Dial 818 ... connecting part 820 ... tip cap 900 ... opening diameter 920 ... opening diameter X ... end part Y ... maximum curvature point

Claims (16)

A catheter having a lumen therein,
A large diameter resin pipe forming the large diameter lumen;
A small-diameter operating line tubule disposed outside the lumen;
An operating line inserted through the operating line capillary and having a distal end connected to the distal end of the catheter;
A reinforcing layer that is a coil that covers both the large-diameter resin tube and the operation wire tubule;
Have
The reinforcement layer and the operation line inserted through the reinforcement layer extend to the distal side of the terminal portion including the distal end of the large-diameter resin tube and the distal end of the operation line thin tube. And
A catheter having a maximum curvature point at which the curvature of the catheter by the operation of the operation line is maximized in the vicinity of the distal side of the terminal portion. The distal end of the reinforcing layer is provided with a tip hole that communicates from the distal end of the large-diameter resin tube to the tip of the catheter and opens at the tip.
The catheter according to claim 1, wherein the lumen is extended by the large-diameter resin tube and the tip hole being continuous.   The catheter according to claim 1 or 2, wherein the large-diameter resin tube and the operation wire tubule are terminated at substantially the same position in the axial direction.   The catheter according to any one of claims 1 to 3, wherein a distal end portion of the operation line is fixed to a distal end portion of the reinforcing layer. The operation line has a folded portion formed by folding a distal end portion,
The catheter according to claim 4, wherein the folded portion is locked to a distal end portion of the reinforcing layer. The operation line has a folded portion formed by folding a distal end portion at a distal end of the reinforcing layer,
The catheter according to claim 4 or 5, wherein a distal end of the folded portion enters from the outside to the inside of the reinforcing layer. The reinforcing layer has a tip coil portion provided on the distal side, and a main body coil portion provided proximal to the tip coil portion,
The distal coil portion is a multiple coil layer in which two or more coils overlap in the radial direction, and is located outside the inner distal coil and the inner distal coil located on the central axis side of the catheter. The catheter according to any one of claims 1 to 6, wherein the operation line is inserted between the outer tip coil and the outer tip coil.   A tip hole communicating from the distal end of the large-diameter resin tube to the distal end of the catheter is provided inside the inner tip coil, and the opening diameter on the near end side of the tip hole is the large-diameter resin. The catheter according to claim 7, which is substantially equal to the opening diameter on the distal end side of the tube.   The catheter according to claim 7 or 8, wherein a diameter of the linear member constituting the inner tip coil is smaller than a diameter of the linear member constituting the outer tip coil.   The catheter according to claim 8, wherein the distal coil portion is embedded with a resin member from an outer peripheral surface of the reinforcing layer to an outer periphery of the distal end hole. The reinforcing layer has a tip coil portion provided on the distal side, and a main body coil portion provided proximal to the tip coil portion,
The coil constituting the tip coil part is a coil different from the coil constituting the main body coil part,
A connecting region where the proximal end portion of the tip coil portion and the distal end portion of the main body coil portion are connected to each other is provided at a position substantially equal to a position where the large-diameter resin tube or the operation wire thin tube ends. The catheter according to any one of claims 1 to 10.   The catheter according to claim 11, wherein a proximal end portion of the tip coil portion is located between the distal end portion of the main body coil portion and the large-diameter resin tube in the connection region. A method for manufacturing a catheter for forming the catheter according to any one of claims 1 to 12,
A large diameter resin tube forming a large diameter lumen;
A small-diameter operating line tubule disposed outside the lumen;
An operating line inserted through the operating line capillary and having a distal end connected to the distal end of the catheter;
A reinforcing layer that is a coil that covers both the large-diameter resin tube and the operation wire tubule;
Provided,
A catheter characterized by extending the reinforcing layer and the operating line inserted through the reinforcing layer to a distal side of a distal end portion of the large-diameter resin tube and the operating line thin tube. Manufacturing method. A main body coil portion is formed by spirally winding a linear member so as to cover both the large-diameter resin tube and the operation wire thin tube extending through at least one end portion through which the core material is inserted. Forming a main body coil part;
The operation line is exposed from the tip of the operation line thin tube, and a linear member is spirally wound so as to cover both the core material exposed from the end of the large-diameter resin tube and the exposed operation line. A tip coil portion forming step for forming the tip coil portion;
A reinforcing layer forming step of forming a reinforcing layer by connecting a distal end portion of the main body coil portion and a proximal end portion of the tip coil portion to form a connecting region;
An embedding step of impregnating a resin member from the outer surface of the tip coil portion to at least the operation line to form a resin embedding portion for embedding the tip coil portion with the resin member;
The method for producing a catheter according to claim 13.   The tip coil portion forming step performs an inner tip coil forming step of forming an inner tip coil by winding a linear member around the core material, and then the inner tip coil and the exposed operation line are both The catheter according to claim 14, wherein an outer tip coil forming step of forming an outer tip coil by winding a linear member so as to cover is performed, and the tip coil portion is formed by the inner tip coil and the outer tip coil. Manufacturing method. Extending the operation line extending between the inner tip coil and the outer tip coil further to the distal side than the distal end of the tip coil portion to provide a surplus portion;
While folding the surplus portion to the proximal end side of the catheter to form a folded portion,
The catheter manufacturing method according to claim 15, further comprising an operation portion locking step of causing the distal end of the folded portion to enter the inside from the outside of the outer tip coil.

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