JP2012213627A - Catheter - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a catheter preferably preventing its distal end under torque rotation from being out of control.SOLUTION: The catheter 100 having an elongated tubular body 10, includes: an inner layer 11 having an inside main lumen 20; a reinforcement layer 30 for covering the inner layer 11; two sub lumens 80 and two rigidity adjusting wires 90 each having a diameter smaller than that of the main lumen 20 and alternately disposed around the main lumen 20 at 90 degree intervals; a marker 40; and an outer layer 12 for covering the reinforcement layer 30, the sub lumens 80, and the rigidity adjusting wires 90. Each of the rigidity adjusting wire 90 reduces angular dependence of torsional rigidity of the tubular body 10.

Description

  The present invention relates to a catheter.

  In recent years, there has been provided a catheter capable of manipulating the direction of entry into a body cavity by bending a tip (hereinafter referred to as a “distal end”). In this catheter, the distal end portion is required to be flexibly formed so as to be bent easily, and the intermediate portion and the rear end portion on the operation side (hereinafter referred to as “proximal end portion”) are formed in the body cavity. In order to require torque controllability and easy progress, it is required to have high rigidity. “Torque controllability” refers to the property that the angle direction of the catheter tip or the like can be oriented in a desired direction. With regard to this type of technology, as one aspect of bending the distal end portion of the catheter, an invention is disclosed in which a pair of operation lines fixed to the distal end portion at an interval of 180 degrees are operated on the proximal end side. (For example, refer to Patent Document 1). In Patent Document 1, a pair of operation lines are inserted through a sub-lumen having a smaller diameter than the main lumen, and the distal end of the catheter is bent toward the sub-lumen through which the operation line is inserted by pulling one of the operation lines. It is configured to

JP 2003-144554 A

  When the proximal end is torque-rotated without constraining the straight, straight catheter tip, the catheter rotates like a single bar. In this case, since a large twist does not occur between the distal end and the proximal end of the catheter, the catheter can be stably rotated by torque. On the other hand, it is difficult to torque-rotate a bent or curved catheter by being inserted into a curved blood vessel. In order to torque-rotate the catheter while maintaining the bent or curved shape of the catheter, while preventing the catheter from being pushed against the vessel wall and trying to swivel like a skipping rope, the rotation is restricted. This is because it is necessary to transmit the torque applied to the proximal end of the catheter to the distal end. In the following, bending and bending are not distinguished unless explicitly stated. While the curved catheter is rotated once, the resin on the catheter tube wall that has been compressed on the inside (inside) of the curve expands as it rotates halfway and moves to the outside (outside) of the curve. It is compressed as it rotates and moves back inside the original curve (inside). Such expansion / compression deformation of the resin on the catheter tube wall also occurs when the catheter is bent and deformed. That is, when a curved catheter is rotated by following the travel of a body cavity such as a blood vessel, the bending rigidity of the catheter acts as a rotational resistance.

  Furthermore, when there are two or less sub-lumens through which the operation lines are inserted, so-called “ramps” described below occur, and torque controllability is further reduced. In the related art including Patent Document 1, when the catheter is observed in the circumferential direction, a hard region and a soft region are alternately present. In the case of Patent Document 1, the area where the axial coupling element is disposed is hard and hardly stretched / compressed in the axial direction. Conversely, the area without the axial coupling element is soft and easily stretched / compressed in the axial direction. When attempting to torque-rotate a curved catheter, a large drag (rotational resistance) is generated when a hard region tends to stretch / compress greatly on the inside (inside) or outside (outside) of the curve. For this reason, when the hard region goes from the neutral position to the inside or outside of the curve, the rotational resistance against torque rotation is extremely large, and conversely, when the hard region goes from the inside or outside to the neutral position, the rotational resistance suddenly decreases. This is because, at the moment when the hard region passes inside the curve, the compressive force acting on the hard region changes discontinuously and instantaneously from compression to expansion. Conversely, at the moment of passing outside the curve, the extension force acting on the hard region changes discontinuously and instantly from extension to compression. As a result, the rotational resistance discontinuously increases or decreases while the catheter is rotated once. Therefore, it is difficult to stably rotate the curved catheter by torque, and it is difficult to accurately control the distal end of the catheter in a desired direction. Hereinafter, the fact that the rotational resistance significantly fluctuates and decreases the torque controllability during one rotation of the catheter may be expressed as “rambling” of the catheter.

The problem of this “rambling” of the catheter is not limited to the catheter of Patent Document 1, but also occurs in a catheter in which two sub-lumens through which an operation line is inserted are arranged opposite each other by 180 degrees, or in a single sub-lumen. . This is because the sub-lumen arrangement region is a hard region.

  The present inventor has found a new problem of occurrence of “rambling” in the case of torque-rotating a curved catheter. The present invention has been made in view of the above problems, and favorably prevents the occurrence of “rambling” in a curved state in a catheter having a sublumen.

The catheter of the present invention includes an elongate tubular body in which an inner layer having a main lumen therein and one or a plurality of sub-lumens having a smaller diameter than the main lumen and arranged around the main lumen are formed. A catheter,
One or a plurality of longitudinally long parallel ones of the sublumens, having a stiffness adjustment line for reducing the angular dependence of the torsional stiffness of the tubular body,
Three or more sub-lumens and rigidity adjustment lines are arranged around the main lumen at a fixed angular interval.

  In the catheter of the present invention, as a more specific embodiment, an operation line fixed to the distal end of the tubular body is slidably inserted into the sub-lumen, and the proximal end of the operation line is pulled. Thus, the distal end of the catheter may be bent.

  In the catheter of the present invention, as a more specific embodiment, the tubular main body further includes an outer layer on the outer periphery of the inner layer, and a sublumen and a stiffness adjusting line are formed inside the outer layer. It may be.

  In the catheter of the present invention, as a more specific embodiment, the sublumen may be formed as a lumen of a tube formed of a material harder than the material forming the outer layer.

  In the catheter of the present invention, as a more specific embodiment, the rigidity adjusting line and the outer layer are formed of a resin material, and the resin material forming the rigidity adjusting line is harder than the resin material forming the outer layer. It may be a thing. Furthermore, the rigidity adjustment line and the outer layer may be formed of the same kind of resin material.

  In the catheter of the present invention, as a more specific embodiment, the resin material of the stiffness adjusting line may contain a contrast agent.

  In the catheter of the present invention, as a more specific embodiment, the stiffness adjusting line and the sub-lumen may be arranged on the same circumference.

  In the catheter of the present invention, as a more specific embodiment, sublumen is formed as a lumen of a tube made of a material harder than the material forming the outer layer, and the stiffness adjusting line is formed from the tube. Also, the bending rigidity may be low, and the rigidity adjustment line may be disposed on the outer peripheral side of the sub-lumen.

  In the catheter of the present invention, as a more specific embodiment, sublumen is formed as a lumen of a tube made of a material harder than the material forming the outer layer, and the stiffness adjusting line is formed from the tube. Also, the bending rigidity may be high, and the rigidity adjustment line may be arranged on the inner peripheral side with respect to the sub-lumen.

  In the catheter of the present invention, as a more specific embodiment, the stiffness adjusting line may be formed of the same type of tube as the tube on which the sublumen is formed.

  In the catheter of the present invention, as a more specific embodiment, the tube forming the rigidity adjusting line is such that the distal end side or the proximal end side rear end or middle is closed. There may be.

  In the catheter of the present invention, as a more specific embodiment, the rigidity adjustment line and the tube forming the sublumen have the same distal end position in the longitudinal direction. May be.

  In the catheter of the present invention, as a more specific embodiment, the sub-lumen may be provided with a coil formed by winding a wire material on the distal end side.

  Moreover, in the catheter of this invention, the pseudo operation line may be accommodated in the inside of the tube which forms a rigidity adjustment line as a more concrete embodiment.

  In the catheter of the present invention, as a more specific embodiment, the tubular main body has a reinforcing layer formed by winding a wire material around the main lumen, and the sub-lumen and the stiffness adjusting line are the reinforcing layer. It may be formed outside.

  Note that the various components of the present invention do not have to be individually independent, that a plurality of components are formed as one member, and one component is formed of a plurality of members. It may be 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.

  The catheter of the present invention can satisfactorily prevent so-called “ramping” when the catheter is torque-rotated in a bent state by sublumen. As a result, a catheter excellent in flexibility in a desired direction such as blood vessel selectivity can be provided.

It is a longitudinal cross-sectional schematic diagram of the front-end | tip part of the catheter concerning 1st embodiment of this invention. FIG. 2 is a cross-sectional perspective view (cross-sectional perspective view) taken along the line AA ′ of FIG. 1. It is a side view which shows the whole catheter which concerns on 1st embodiment, and a side view which shows the bending example of a front-end | tip part, Comprising: (a) is a side view which shows the whole before a catheter is bent, (b) FIG. 4 is a side view showing a state in which the tip is bent upward by operating the slider, and (c) is a side view showing a state in which the tip is bent upward with a larger curvature than in (b) by operating the slider. (D) is a side view showing a state where the slider is operated to bend the tip downward, and (e) is a slider operated to bend the tip downward with a larger curvature than (d). It is a side view which shows the state made to do. (A)-(c) is a schematic diagram which shows the state which advances the catheter of 1st embodiment toward the blood vessel branch from the main tube | vessel of the curved blood vessel. It is explanatory drawing for demonstrating that the torsion angle dependency by the rotation resistance at the time of bending (at the time of bending) of a long catheter is large, that is, "rambling", (a) is a sublumen part containing a hard tube And (b) is a schematic view showing a state where the catheter is bent with a portion without sublumen being inside and outside, and (c). FIG. 3 is a transverse cross-sectional view of a catheter for showing a bending direction.

  Hereinafter, embodiments of the present invention will be described with reference to the drawings. In all the drawings, the same reference numerals are given to the same components, and the description will be omitted as appropriate.

[Configuration example]
First, the outline | summary of a structure of the catheter of this embodiment is demonstrated. As shown in FIGS. 1 and 2, the catheter 100 of the present embodiment includes an inner layer 11 having a main lumen 20 therein, and a diameter smaller than that of the main lumen 20 around the main lumen 20 through an angular interval of 180 degrees. A pair of arranged sublumens 80 (first sublumen 80a, second sublumen 80b) and the distal end DE of the sheath 10 (DE also serves as the distal end of the catheter 100) are fixed, and the sublumen 80 ( 80a, 80b) and the operation line 70 (first operation line 70a, second operation line 70b) slidably inserted through the sub-lumen 80 (80a, 80b) through an angular interval of 90 degrees. , The rigidity adjustment line 90 (the first rigidity adjustment line 90a and the second rigidity adjustment line 90b) disposed around the main lumen 20, the sub-lumen 80 and the rigidity adjustment line 90 are The outer layer 12 that covers the outer periphery of the inner layer 11, the reinforcing layer 30 that is formed by winding the wire material 31 around the outer periphery of the inner layer, the marker 40 that is arranged in a ring shape, and the outer layer 12 is covered. As an outermost layer of the catheter 100, a long tubular body 10 having a hydrophilic coat layer 50 having a lubrication treatment applied to the outer surface is provided. The catheter 100 of the present embodiment optionally has a marker 40, a reinforcing layer 30, and a coat layer 50.

  The tubular body 10 of the catheter 100 is hereinafter referred to as a sheath 10. The distal ends of the sheath 10 and the catheter 100 are referred to as a distal end DE, the rear end of the sheath 10 is referred to as a proximal end PE, and the rear end of the catheter 100 is referred to as a proximal end CE. The sublumen 80 is provided along the longitudinal direction (vertical direction in FIG. 1) of the catheter 100, and although not shown, at least the proximal end PE side of the sheath 10 is open.

  Further, in the present embodiment, as shown in FIG. 1, the distal end portion 71 (71a, 71b) of the operation line 70 (70a, 70b) is formed in a spherical shape at the distal end DE of the sheath 10, and the outer layer The tip 71 (71a, 71b) of the operation line 70 (70a, 70b) is fixed to the distal end DE by being embedded in the terminal 12. Therefore, each of the operation lines 70 (70a, 70b) is slidably inserted into the sub-lumens 80 (80a, 80b), and the distal end of the catheter 100 is pulled by pulling the proximal end 72 (72a, 72b). 15 bends (see FIGS. 3B to 3D). Further, in the catheter 100 of the present embodiment, the curvature and direction of the bent distal end portion 15 change in a plurality of ways depending on selection of the operation line 70 (70a, 70b) to be pulled.

  Here, by providing a sub-lumen 80 (80a, 80b) through which the operation line 70 (70a, 70b) is inserted away from the main lumen 20, a medicine or the like is supplied through the main lumen 20 or an optical system is inserted. In doing so, they do not leak into the sublumen 80 (80a, 80b). The sub-lumen 80 (80a, 80b) and the stiffness adjusting line 90 are provided outside the reinforcing layer 30. By providing the sub-lumen 80 (80a, 80b) outside the reinforcing layer 30 as in the present embodiment, the inside of the reinforcing layer 30 with respect to the operation line 70 (70a, 70b) sliding in the sheath 10; That is, the main lumen 20 is protected. For this reason, even if the operation line 70 (70a, 70b) is detached from the distal end portion 15 of the catheter 100, the operation line 70 (70a, 70b) does not cleave the peripheral wall of the main lumen 20.

  In addition, the catheter 100 of the present embodiment is harder than the material forming the outer layer 12 in the long cylindrical space portion 81 (the first space portion 81a and the second space portion 81b) formed in the outer layer 12. It is formed by embedding a tube 82 (82a, 82b) made of a resin material. Hereinafter, the tubes 82a and 82b may be referred to as a first tube and a second tube, respectively. The magnitude of the hardness of the resin material can be compared with the Shore D hardness. The sublumen 80 (80a, 80b) is formed as a lumen of these tubes 82 (82a, 82b). Furthermore, the tube 82 (82a, 82b) is not embedded up to the distal end DE of the sheath 10 in the space 81 (81a, 81b), and the space 81 (81a, 81b) on the distal end DE side. Inside, coils 84 (first coil 84a, second coil 84b) formed by winding wire material 83 are embedded, and the lumens of these coils 84 (84a, 84b) are inside the tubes 82 (82a, 82b). A sub-lumen 80 (80a, 80b) which is flush with the cavity is formed. The sublumen 80 formed by the lumen of the tube 82 is the first region 80A (first region 80Aa, first region 80Ab), and the sublumen 80 formed by the lumen of the coil 84 is the second region 80B (first region). Two regions 80Ba and a second region 80Bb).

  Note that the stiffness adjustment lines 90 (90a, 90b) are functional members for reducing the angular dependence of the rotational resistance when the catheter 100 is bent and suppressing “rambling” during torque rotation. By having the rigidity adjustment line 90 inside the sheath 10, the torque control performance of the catheter 100 is improved. As a result, it is possible to satisfactorily prevent “rambling” and improve the effect of preventing the influence on the inner wall of the body cavity. As described above, in order to prevent the “rambling” well, it is preferable that the total number of the sub-lumens 80 and the stiffness adjusting lines 90 is three or more, and is preferably arranged at a constant angular interval. In this book, the “rabbit” prevention effect is low.

  The reason why the number is three or more will be described in detail with reference to FIGS. First, a long body (catheter 100) in which a pair of hard tubes 82 (82a, 82b) (that is, two) are arranged at an angular interval of 180 degrees is assumed. The internal space of the tube 82 (82a, 82b) corresponds to the sub-lumen 80 (80a, 80b). Next, the angle dependency when the catheter 100 formed with two sub-lumens 80 is bent will be described. When the catheter 100 is bent so that the X-ray direction in which the pair of sublumens 80 in FIG. 5C are arranged is on the inside and the outside, as shown in FIG. There will be tubes 82a and 82b which are hard and have poor stretchability. Therefore, a strong resistance force acts on the catheter 100 against bending in the X-ray direction. This resistance force becomes a rotational resistance when the catheter 100 bent in the X-ray direction is torque-rotated. On the other hand, when the catheter 100 is bent so that the Y-line direction in FIG. 5C, which is the direction in which the sub-lumen 80 does not exist, becomes the inside and the outside, as shown in FIG. Since the tube 82a and the tube 82b (not shown) are positioned on the bending neutral line, the tubes 82a and 82b do not substantially cause the rotation resistance against the torque rotation without inhibiting the bending of the catheter 100. When the bent catheter 100 is rotated by torque, the compressive force acting on the tube 82b is instantaneously eliminated at the moment when the state shown in FIG. 5A changes to the state shown in FIG. 5B. Further, the stretching force acting on the tube 82a is instantly eliminated. At this moment, the catheter 100 tries to rotate torque rapidly, and the “fluctuation” of the bent portion occurs. The occurrence of the “rambling” is not limited to the case where the pair of tubes 82a and 82b are arranged to face each other by 180 degrees, and a total of two of the one sub-lumen 80 and one stiffness adjusting line 90 is 180 degrees. This also occurs in the case where they are arranged to face each other. The same phenomenon occurs when only one tube 82 or rigidity adjustment line 90 is provided.

  As described above, when the number of the sub-lumens 80 and the rigidity adjusting lines 90 is two or less, the flexibility and the twistability are varied depending on the bending position, that is, the bending angle. The variation due to the difference in the bending position is the “angle dependency” of the torsional rigidity. On the other hand, in this embodiment, since a total of three or more sub-lumens 80 and the rigidity adjustment lines 90 are arranged at a constant angular interval, the flexibility and torsional ease can be achieved by bending at any position. There is no variation. When three or more are arranged at equiangular intervals, at the moment when any one sub-lumen 80 or stiffness adjusting line 90 passes inside or outside of the curve when the torque of the catheter 100 is rotated (in FIG. 5A). In the corresponding state), the other sub-lumen 80 or the rigidity adjustment line 90 is present at or near the neutral position of the curve (the state corresponding to FIG. 5B). The rotation resistance during bending of the catheter 100 is constant when there are a total of three or more sub-lumens 80 and the stiffness adjusting line 90 at any rotational position. Therefore, the internal and external rotational resistances are uniform over the entire circumference of the catheter 100, the angle dependency is eliminated, and torque transmission is performed smoothly. As a result, it is possible to satisfactorily prevent “rambling” due to torsional rigidity during rotation of the catheter 100. In addition, although it demonstrates in detail by the below-mentioned modification, even when the radial direction position of the sub-lumen 80 and the rigidity adjustment line 90 does not completely correspond, these rigidity and radial position are adjusted suitably. Thereby, the angle dependence of the rotation resistance at the time of bending of the catheter 100 can be eliminated.

  Further, the stiffness adjusting line 90 (90a, 90b) and the outer layer 12 are formed of a resin material to be described later. The resin material that forms the stiffness adjusting line 90 (90a, 90b) is a harder resin material than the resin material that forms the outer layer 12. In a long cylindrical hollow portion 91 (the first hollow portion 91a and the second hollow portion 91b) formed in the outer layer 12, a pseudo operation line 92 (the first operation line 92 formed of a resin material harder than the outer layer 12 is formed. By storing the pseudo operation line 92a and the second pseudo operation line 92b), the rigidity adjustment lines 90 (90a, 90b) are formed. That is, the pseudo operation line 92 of the present embodiment corresponds to the rigidity adjustment line 90. The pseudo operation line is a linear body arranged inside the catheter 100 along the operation line 70 and is an element that does not have a function of bending the distal end of the catheter 100 even if the operation unit 60 is operated.

  As a means for making the resin material of the rigidity adjustment line 90 (90a, 90b) harder than the resin material of the outer layer 12 in this way, for example, a contrast agent may be mixed with the same or the same kind of resin material as the outer layer 12. Thereby, not only the rigidity adjustment line 90 (90a, 90b) becomes hard, but the catheter 100 can be operated while observing the rigidity adjustment line 90 with an X-ray or the like. Therefore, the position and orientation of the catheter 100 can be grasped well. Therefore, as in the prior art, the contrast agent is included in the entire outer layer, thereby impairing the flexibility of the catheter. After the contrast agent is injected into the main lumen 20 and the position is confirmed, treatment is performed. Can be saved.

  The rigidity adjusting line 90 and the outer layer 12 may be formed of the same kind of resin material. That is, the resin material of the rigidity adjustment line 90 may be a resin material that is the same type as the resin material of the outer layer 12 and has a higher hardness. The same kind of resin material is a resin material having the same chemical structure form, regardless of the product number (brand). As an example, when the rigidity adjustment line 90 and the outer layer 12 are both made of a polyether block amide copolymer (nylon elastomer), a resin material with a product number having a Shore D hardness higher than that of the outer layer 12 is selected for the rigidity adjustment line 90. Good. As a result, it is possible to obtain good adhesion between the outer layer 12 and the stiffness adjusting line 90 while giving the desired stiffness to the stiffness adjusting line 90. Further, since the stiffness adjusting line 90 and the outer layer 12 are the same kind of resin material, the linear expansion coefficients of both are substantially equal. For this reason, since the rigidity adjusting line 90 follows the outer layer 12 and is thermally deformed during thermoforming of the catheter 100 and at room temperature cooling, the interface between the two does not peel off.

  The rigidity adjusting line 90 of the present embodiment is disposed inside the outer layer 12 over substantially the entire length of the catheter 100. However, for the purpose of the rigidity adjustment line 90 to reduce the angle dependency of the rotational resistance of the catheter 100 during bending, the rigidity adjustment line 90 is bent from the length region of the catheter 100, specifically from the distal end portion 15. It may be disposed only in the intermediate portion 16.

  The sublumen 80 (80a, 80b) is formed up to the vicinity of the marker 40 arranged at the distal end portion of the sheath 10. On the other hand, the hollow portions 91 (91a, 91b) in which the rigidity adjusting lines 90 (90a, 90b) are embedded are parallel to the sub-lumen 80 (80a, 80b), but the distal end DE side from the sub-lumen 80. Is shorter than sublumen 80.

  The bending rigidity of the reinforcing layer 30 increases stepwise or continuously from the distal end 15 to the proximal end 17 of the catheter 100. You may provide the location where the bending rigidity of the reinforcement layer 30 changes discontinuously in the distal end 15 about 5 to 20 mm from the distal end DE. By making the bending rigidity of the reinforcing layer 30 on the proximal end side of the discontinuous portion significantly larger than the bending rigidity on the distal end side, the bending position of the catheter 100 when the operation line 70 is pulled is set to the discontinuous portion. Can be identified.

  The tip of the stiffness adjusting line 90 may be positioned slightly distal to the discontinuous portion of the bending rigidity of the reinforcing layer 30. Alternatively, the tip of the stiffness adjusting line 90 may be positioned slightly distal to the tip of the reinforcing layer 30. The distal end of the operation line 70 is fixed to the sheath 10 further on the distal side than the distal end of the rigidity adjustment line 90. Thereby, when the operating line 70 is pulled, the discontinuity of the bending rigidity of the reinforcing layer 30 and the kink of the catheter 100 at the distal end of the reinforcing layer 30 can be prevented. Since the rigidity adjustment line 90 having higher bending rigidity than the outer layer 12 protrudes more distally than the discontinuous portion or tip of the reinforcing layer 30, the catheter 100 concentrated on the discontinuous portion or tip of the reinforcing layer 30. This is because the bending stress is dispersed by the stiffness adjustment line 90.

  That is, in the catheter 100 described above, the stiffness adjusting line 90 is made of an elastic body having higher rigidity than the sheath 10, and is embedded in the tube wall portion at the distal end portion of the sheath 10 and extends in the longitudinal direction of the sheath 10. The catheter 100 has a high-rigidity region having a higher bending rigidity than the region where the rigidity adjustment line 90 is disposed in the sheath 10 on the proximal end side relative to the region where the rigidity adjustment line 90 is disposed. A low-rigidity region having a bending rigidity smaller than the region where the stiffness adjusting line 90 is disposed is provided between the tip of the stiffness adjusting line 90 and the tip of the operation line 70. Accordingly, the catheter 100 can be bent without being kinked in the high-rigidity region (discontinuous portion or distal end of the reinforcing layer 30) having a high bending rigidity.

  The distal end DE side of the hollow portion 91 is closed with the resin material 121 of the outer layer 12. That is, the position of the tip of the closed portion is the same as the tip of the tube 82 (82a, 82b) of the sub-lumen 80 (80a, 80b) in the longitudinal direction. Since the rigidity adjustment line 90 (90a, 90b) is embedded over the entire length in the hollow portion 91 (91a, 91b), not only the distal end DE side of the sheath 10 but also the entire length of the hollow portion 91 is blocked. ing. However, instead of this, the proximal end PE side (rear end) or the middle (any portion between the front end and the rear end) of the sheath 10 may be closed and the front end of the hollow portion 91 may be opened. . Since at least a part of the hollow portion 91 is closed in this way, even when the rigidity adjustment line 90 is formed of a hollow tube, foreign matter such as body fluid is prevented from entering the hollow portion 91. .

  In the present embodiment, the stiffness adjusting line 90 and the tube 82 of the sub-lumen 80 are arranged on the same circumference. Such an arrangement is preferable when the rigidity adjustment line 90 and the tube 82 have substantially the same bending rigidity. Note that “on the same circumference” is most preferably that the centers of the stiffness adjustment line 90 and the sub-lumen 80 are arranged on the same circumference, but the center is not necessarily coincident, but the stiffness adjustment line 90 90 or the center of the sub-lumen 80 should just exist in the outer periphery of the other rigidity adjustment line 90 or the sub-lumen 80. Moreover, it may include that at least a part of the outer periphery of the stiffness adjusting line 90 and the outer periphery of the sub-lumen 80 overlap in the circumferential direction on substantially the same circumference. In any case, it is only necessary that the torsional rigidity is well balanced and the angle dependency is eliminated. With this configuration, the sub-lumen 80 (80a, 80b) and the stiffness adjustment line 90 (90a, 90b) are alternately arranged on the same circumference at the same angular interval (90 degrees). With such an arrangement, the “rambling” of the distal end of the catheter 100 can be well prevented. Details of the principle of preventing such “rambling” will be described later.

  In addition, as shown in FIG. 3, the catheter 100 has an operation portion 60 that pulls the first operation line 70 a and the second operation line 70 b individually to bend the distal end portion 15 of the catheter 100. The upper end portion 17 is provided. A portion between the distal end portion 15 and the proximal end portion 17 is referred to as an intermediate portion 16.

  The operation unit 60 includes a shaft portion 61 extending in the longitudinal direction of the catheter 100, a slider 64 (64a, 64b) that moves forward and backward in the longitudinal direction of the catheter 100 with respect to the shaft portion 61, and a handle portion that rotates the shaft portion 61 about its axis. 62 and a gripping portion 63 through which the sheath 10 is rotatably inserted. Further, the proximal end portion 17 of the sheath 10 is fixed to the shaft portion 61. Moreover, the handle | steering-wheel part 62 and the axial part 61 are comprised integrally. Then, the entire sheath 10 including the operation line 70 is torque-rotated together with the shaft portion 61 by rotating the grip portion 63 and the handle portion 62 relative to each other.

  Therefore, the operation unit 60 of the present embodiment rotates the distal end portion 15 of the tubular main body (sheath 10). In the present embodiment, a handle portion 62 as a rotation operation portion for torque-rotating the sheath 10 and a slider 64 as a bending operation portion for bending the sheath 10 are integrally provided. However, the present invention is not limited to this, and the handle portion 62 and the slider 64 may be provided separately.

  A proximal end 72 (72 a) of the first operation line 70 a protrudes from the proximal end portion 17 of the sheath 10 to the proximal end side, and is connected to the slider 64 a of the operation portion 60. Similarly, the proximal end 72 (72b) of the second operation line 70b is also connected to the slider 64b of the operation unit 60. Then, by sliding the slider 64a and the slider 64b individually to the proximal end side with respect to the shaft portion 61, the first operation line 70a or the second operation line 70b connected thereto is pulled and the distal end of the sheath 10 is pulled. A tensile force is applied to the end portion 15. As a result, the distal end portion 15 bends toward the pulled operation line 70.

  The distal end DE of the sheath 10 of the catheter 100 is provided with a ring-shaped marker 40 made of a material that does not transmit radiation such as X-rays. Specifically, a metal material such as platinum can be used for the marker 40. The marker 40 of this embodiment is provided around the main lumen 20 and inside the outer layer 12.

  As described above, the tip of the operation line 70 (70a, 70b) (the distal end 71 (71a, 71b)) is spherical and embedded in the outer layer 12, so that the tip of the operation line 70 (70a, 70b). Is fixed to the distal end DE of the sheath 10. However, the mode of fixing the tip of the operation line 70 (70a, 70b) to the distal end DE is not particularly limited. For example, the tip of the operation line 70 (70a, 70b) may be fastened to the marker 40, welded to the distal end DE of the sheath 10, or the marker 40 or the distal end DE of the sheath 10 with an adhesive. It may be adhered and fixed to.

  For example, a fluorine-based thermoplastic polymer material (resin material 111) can be used for the inner layer 11. More specifically, polytetrafluoroethylene (PTFE), polyvinylidene fluoride (PVDF), perfluoroalkoxy fluororesin (PFA), or the like can be used. By using a fluorine-based resin for the inner layer 11, the delivery property when supplying a contrast medium or a drug solution to the affected area through the main lumen 20 of the catheter 100 is improved.

  For the outer layer 12, a thermoplastic polymer (resin material 121) is widely used. Examples include polyimide (PI), polyamideimide (PAI), polyethylene terephthalate (PET), polyethylene (PE), polyamide (PA), nylon elastomer, polyurethane (PU), ethylene-vinyl acetate resin (EVA), poly Vinyl chloride (PVC) or polypropylene (PP) can be used.

  The wire material 31 constituting the reinforcing layer 30 and the wire material 83 constituting the second region 80B (second region 80Ba, second region 80Bb) of the sublumen 80 are made of stainless steel (SUS), nickel titanium alloy, or the like. In addition to fine metal wires, fine fiber wires such as PI, PAI, or PET can be used. Moreover, the cross-sectional shape of the wire materials 31 and 83 is not specifically limited, A round wire or a flat wire may be sufficient.

  There are various methods for inserting the operation lines 70 (the first operation line 70a and the second operation line 70b) into the sub-lumen 80 (80a, 80b). The operation line 70 may be inserted from one end side of the sheath 10 of the catheter 100 formed in advance through the sub-lumen 80 (80a, 80b). Alternatively, when the sheath 10 is extruded, the operation lines 70 (70a, 70b) are extruded together with the coils 84 (84a, 84b) and the tubes 82 (82a, 82b) for the sub-lumens 80 (80a, 80b). (80a, 80b) may be inserted inside.

  When the operation line 70 (70a, 70b) is pushed out together with the coil 84 (84a, 84b) and the tube 82 (82a, 82b) and inserted through the sub-lumen 80 (80a, 80b), the operation line 70 (70a, 70b) Further, heat resistance equal to or higher than the melting temperature of the resin material constituting the sheath 10 is required. In the case of the operation line 70, specific materials include, for example, polyether ether ketone (PEEK), polyphenylene sulfide (PPS), polybutylene terephthalate (PBT), polymer fiber such as PI or PTFE, or SUS, Corrosion-resistant coated steel wires, metal wires such as titanium or titanium alloys can be used. On the other hand, in the case where the operation line 70 is not required to have heat resistance, such as when the operation line 70 is inserted through the sub-lumen 80 of the preformed sheath 10, in addition to the above materials, PVDF, high-density polyethylene ( HDPE) or polyester can also be used.

  The tube 82 (82a, 82b) and the stiffness adjusting line 90 (90a, 90b) of the first region 80A (80Aa, 80Ab) of the sub-lumen 80 (80a, 80b) may be made of the same resin material as that of the outer layer 12. Although it is good, it is preferably formed of a resin material harder than the outer layer 12. In the present embodiment, the tube 82 (82a, 82b) is formed of PTFE or PEEK as a resin material harder than the outer layer 12. Further, as described above, the stiffness adjusting lines 90 (90a, 90b) are formed by the pseudo operation lines 92 (92a, 92b) formed by adding a contrast agent to the same resin material as that of the outer layer 12 and forming a harder material than the outer layer 12. Forming.

  A method of arranging the pseudo operation line 92 inside the sheath 10 is not particularly limited. The pseudo operation line 92 may be formed in advance into a solid long rod shape, and the hollow portion 91 may be formed so as to penetrate the outer layer 12, and the pseudo operation line 92 may be inserted from one end of the hollow portion 91. Alternatively, the pseudo operation line 92 and the outer layer 12 may be coextruded.

  However, the material of the pseudo operation line 92 is not necessarily limited thereto, and the pseudo operation line 92 is embedded using a resin material whose hardness itself is harder than that of the outer layer 12 without including a contrast agent in the resin material. The rigidity adjustment line 90 may be formed, or other means such as containing a filler may be used. If necessary, it may be formed of a resin material softer than the tube 82 of the sub-lumen 80 or the like, a hard resin material, the same kind of tube, or the like. Details thereof will be described in a modification.

  For the resin material 51 of the coat layer 50, a hydrophilic material such as polyvinyl alcohol (PVA) or polyvinyl pyrrolidone can be used.

  The typical dimension of the catheter 100 of this embodiment is demonstrated. The radius of the main lumen 20 can be about 200 to 300 μm, the thickness of the inner layer 11 can be about 10 to 30 μm, the thickness of the outer layer 12 can be about 50 to 150 μm, and the thickness of the reinforcing layer 30 can be 20 to 30 μm. The radius from the axial center of the catheter 100 to the center of the sublumen 80 is about 300 to 450 μm, the diameter of the sublumen 80 (the inner diameter of the tube 82) is about 40 to 100 μm, and the thickness of the operation line 70 is 30 to 60 μm. Can be about. And the outermost diameter of the catheter 100 is about 350-490 micrometers.

  That is, the outer diameter of the catheter 100 of this embodiment is less than 1 mm in diameter, and can be inserted into blood vessels such as the celiac artery. Further, the catheter 100 according to the present embodiment is operated freely by pulling the operation line 70 (70a, 70b), so that the catheter 100 can be advanced in a desired direction even in a branching blood vessel, for example. Is possible.

[Operation example]
Next, an operation example of the catheter 100 of the present embodiment will be described in detail. First, in the catheter 100 of the present embodiment, when the proximal end 72 (72a or 72b) of the operation line 70 (the first operation line 70a or the second operation line 70b) is pulled, the distal end 15 of the catheter 100 is pulled. The distal end portion 15 of the distal end 15 is directed toward the sub-lumen 80 (sub-lumen 80a or sub-lumen 80b) through which the operation line 70 (the first operation line 70a or the second operation line 70b) is inserted. Some or all bend. On the other hand, when the proximal end 72 of the operation line 70 is pushed into the catheter 100, a pushing force is not substantially applied from the operation line 70 to the distal end portion 15 of the catheter 100.

  The distal end portion 15 of the catheter 100 refers to a predetermined length region including the distal end DE of the catheter 100. Similarly, the proximal end portion 17 of the catheter 100 refers to a predetermined length region including the proximal end CE of the catheter 100. The intermediate portion 16 refers to a predetermined length region between the distal end portion 15 and the proximal end portion 17. The bending of the catheter 100 means that a part or all of the catheter 100 is bent or bent.

  In the catheter 100 of the present embodiment, as shown in FIG. 2, a pair (two) of sub-lumens 80 (80a, 80b) through which the operation lines 70 (70a, 70b) are respectively inserted, and a pair (two) of Rigidity adjustment lines 90 (90a, 90b) are alternately arranged in the circumferential direction of the main lumen 20 with an angular interval of 90 degrees.

  In the catheter 100 of this embodiment, the operation line 70 to be pulled is only the first operation line 70a, only the second operation line 70b, or whether the two operation lines 70a and 70b are pulled simultaneously. The curvature of the bent distal end portion 15 changes in a plurality of ways. Thereby, the catheter 100 can be freely entered into a body cavity that branches at various angles.

  The catheter 100 of the present embodiment can individually pull the proximal ends 72 of the plurality of operation lines 70 (the first operation line 70a or the second operation line 70b). The bending direction can be changed by the operating line 70 to be pulled. Specifically, when the first operation line 70a is pulled as shown in FIGS. 3B and 3C, it bends to the side where the first operation line 70a is provided, as shown in FIGS. 3D and 3E. When the second operation line 70b is pulled, the second operation line 70b is bent. Further, the curvature of curvature (the radius of curvature) can be changed by adjusting the pulling amount of each operation line 70 (70a, 70b). Specifically, as shown in FIGS. 3B and 3D, when the first or second operation lines 70a and 70b are slightly pulled, the distal end portion 15 has a small curvature (a large radius of curvature). Bend. On the other hand, as shown in FIGS. 3C and 3E, when the first or second operation line 70a or 70b is pulled longer, the distal end portion 15 bends with a large curvature (the curvature radius is small). .

  Here, in the catheter 100 of this embodiment, it is preferable that the flexibility of the sheath 10 is formed so as to increase from the proximal end PE side toward the distal end DE side. That is, the catheter 100 is partitioned along the longitudinal direction into a distal end portion 15, an intermediate portion 16, and a proximal end portion 17, and the sheath 10 portion and the intermediate portion 16 of the proximal end portion 17 are rigid. The distal end 15 is highly flexible. Here, the flexibility of the catheter 100 refers to the ease of bending when a unit load is applied in the radial direction.

  Various methods can be used to change the flexibility of the catheter 100. For example, the diameter of the sheath 10 may be narrowed in the order of the proximal end portion 17, the intermediate portion 16, and the distal end portion 15. Alternatively, the winding of the wire material 31 of the reinforcing layer 30 is a close winding at the proximal end portion 17, a narrow pitch winding at the intermediate portion 16, and the distal end portion 15 is increased in flexibility, so that a wide pitch winding is possible. Good.

  Further, by increasing the bending rigidity of the sheath 10 from the proximal end portion 17 to the intermediate portion 16 of the catheter 100, it is possible to improve torque transmission. According to this embodiment, the intermediate portion 16 can be sufficiently bent and deformed while maintaining the moment resistance in the vicinity of the proximal end portion 17 of the catheter 100.

  Then, by making the catheter 100 the most flexible at the distal end portion 15, the followability of the distal end portion 15 by pulling of the operation line 70 becomes good, and the tip including the distal end portion 15 is moved to the operation line 70. It can be easily bent to the side. On the other hand, by increasing the rigidity of the proximal end portion 17 to which the bending moment caused by the own weight of the catheter 100 is most applied, the stiffness of the catheter 100 can be strengthened and the shape stability can be maintained. However, due to such a difference in rigidity, the torque control performance during the rotation of the catheter 100 is lowered, and the “rambling” of the distal end portion is likely to occur. Therefore, in the present embodiment, by arranging the rigidity adjustment line 90 on the outer layer 12, the torque control performance is improved, the torque can be smoothly transmitted, and the "rambling" can be prevented well.

  FIGS. 4A to 4C are schematic views for explaining the usage state of the catheter 100 of the present embodiment. FIG. 4A shows a state in which the distal end portion 15 of the catheter 100 inserted through the curved blood vessel 200 reaches the branching portion 201 of the blood vessel 200. Here, an attempt is made to advance the catheter 100 from the main tube 204 toward the blood vessel branch 203 at the branch portion 201. Therefore, as shown by a rotation arrow in FIG. 4A, the entire catheter 100 is torque-rotated so that one of the operation lines 70 (the first operation line 70a) extends in the direction to bend, that is, the blood vessel branch 203 extends. Rotate to the current direction. For convenience, the operation line 70 (first operation line 70a) is shown by a solid line. Such a state is shown in FIG. In the state of FIG. 4B, the operation unit 60 (see each drawing in FIG. 3) is operated to pull the first operation line 70a to the proximal end side as indicated by a straight arrow. As a result, the distal end portion 71 of the catheter 100 is bent toward the blood vessel branch 203 as shown in FIG. By pushing the entire catheter 100 from this state, the catheter 100 enters the blood vessel branch 203 from the main tube 204.

  Here, when the catheter 100 is torque-rotated from the state shown in FIG. 4A to the state shown in FIG. 4B, a stiffness adjustment line 90 (see FIG. 2) is embedded in the outer layer 12, and the torsional rigidity of the sheath 10 depends on the angle. As a result, the catheter 100 can be stably torqued by a desired rotation angle. Thereby, the 1st operation line 70a can be accurately rotationally moved to the inner side of the planned bending direction quickly.

  In the present embodiment, the coil 84 (84a, 84b) is provided on the distal end 15 side of the space 81 (81a, 81b) for forming the sub-lumen 80 (80a, 80b), and the tube 82 is otherwise provided. (82a, 82b) are inserted. By comprising in this way, in the distal end part 15, 2nd area | region 80B (2nd area | region 80Ba, 2nd area | region 80Bb) which comprised the coil 84 is excellent in a softness | flexibility, and it becomes easy to bend. Then, the sheath 10 bends with the boundary with the first region 80A (second region 80Aa, second region 80Ab) where the tube 82 is disposed as a base point. The distal end 15 of the catheter 100 can be more freely adjusted to a desired curvature by the flexibility of the second region 80B and fine adjustment of the pulling amount of the operation line 70 (70a, 70b). It becomes.

  As described above, in the present embodiment, the catheter 100 can be rapidly and surely entered into a blood vessel branch that branches from a curved blood vessel. In addition, when the catheter 100 is rotated in various directions in various blood vessels, the angle dependency of the bending rigidity and torsional rigidity of the catheter 100 can be preferably eliminated by the rigidity adjustment line 90. As a result, the torque control performance of the catheter 100 is stable, and torque transmission from the proximal end portion 17 to the distal end portion 15 can be performed smoothly. In addition, it is possible to satisfactorily prevent so-called “rambling” such that the tip is rapidly rotated, and it is possible to provide the catheter 100 with excellent operability and little influence on the inner wall of the body cavity.

<Modification>
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.

  For example, in the above embodiment, one of the two operation lines and the two sub-lumens 80 (80a, 8b) is selected as one operation line 70 (the first operation line 70a or the second operation line 70b). However, the present invention is not limited to this. That is, as described above, three or more operation lines 70 may be inserted into the sheath 10 and then one or two or more of them may be pulled. Further, the distal end portions 71 (71a, 71b) of the two operation lines 70 (70a, 70b) are separately fixed to the distal end DE of the sheath 10, but one continuous operation line is used. Then, both ends may be wound around a dial type operation unit, and the towing direction and the amount of towing may be adjusted by operating the dial.

  In the above embodiment, two sub-lumens 80 and two stiffness adjusting lines 90 are formed, for a total of four. However, if the total number is three or more and they are arranged at equal angular intervals in the circumferential direction, The number is not limited to four. For example, three sub-lumens 80 may be provided in the sheath 10 at intervals of 120 degrees, and the operation line 70 may be inserted through each. A stiffness adjustment line 90 may be disposed between each sub-lumen 80. In such a configuration, the sheath 10 is bent in the direction of the operation line 70 or the intermediate direction of the two operation lines 70 by selecting and pulling any one or two operation lines 70. be able to.

  Further, four or more sub-lumens 80 may be arranged, and the distal end DE may be directed to a desired curvature or a desired direction by finely adjusting the pulling amount of each operation line 70. Also in this case, the rigidity adjustment lines 90 are provided according to the position and the number of the sub-lumens 80, and the respective sub-lumens 80 and the rigidity adjustment lines 90 are adjusted so as to be arranged in the circumferential direction at regular angular intervals.

  In the above embodiment, the rigidity adjustment line 90 is arranged on the same circumference as the sub-lumen 80. That is, by making the stiffness adjustment line 90 and the tube 82 the same hardness and arranging them on the same circumference, the “rampage” caused by the bending stiffness due to angle dependency can be reduced well by the stiffness adjustment line 90. This is because smooth rotation is possible. However, when the rigidity adjustment line 90 has a lower bending rigidity than the tube 82, it is desirable to dispose the rigidity adjustment line 90 on the outer peripheral side of the sub-lumen 80. On the other hand, when the rigidity adjustment line 90 is higher in bending rigidity than the tube 82, it is desirable to dispose the rigidity adjustment line 90 on the inner peripheral side of the sub-lumen 80. By adjusting the position of the rigidity adjustment line 90 in this manner, even if there is a slight difference in bending rigidity between the tube 82 and the rigidity adjustment line 90, fine adjustment is performed by changing the radial arrangement position. Thus, the function of the stiffness adjusting line 90 can be satisfactorily exhibited, and the angle dependency of the bending stiffness of the catheter can be preferably eliminated. In addition, since it is not necessary to strictly match the bending rigidity between the tube 82 and the rigidity adjusting line 90 and it is only necessary to adjust the radial position, the catheter 100 can be manufactured efficiently.

  Further, the stiffness adjusting line 90 may be formed of the same type of tube as the tube 82 for forming the sub-lumen 80. The tube of the same type has the same dimensions and material, and the torsional rigidity is almost the same regardless of the material, etc., and the sub-lumen 80 and the rigidity adjustment line 90 preferably eliminate the angle dependency of the torsion. Including what can be done. By forming in this way, the manufacturing procedure of the stiffness adjusting line 90 and the sub-lumen 80 can be reduced, and the bending stiffness of the stiffness adjusting line 90 and the tube 82 can be easily formed to be the same. Can be manufactured efficiently.

  In the above embodiment, the rigidity adjustment lines 90 are formed in the same number as the sub-lumens 80 having the operation lines 70. However, the number of the rigidity adjustment lines 90 is not necessarily the same as that of the sub-lumens 80. . For example, the number of sublumens 80 may be smaller or larger depending on the purpose of use, bending rigidity, and torsional rigidity of the catheter 100. Specifically, in the case of a total of four, there may be one sub-lumen 80 and three stiffness adjustment lines 90, or three sub-lumens 80 and one stiffness adjustment line 90. Further, in the case where the number is the smallest, the number of sublumens 80 may be one and the rigidity adjustment lines 90 may be two, or the number of sublumens 80 may be two and the rigidity adjustment lines 90 may be one. Further, the total number of combinations of the sub-lumen 80 and the rigidity adjustment line 90 may be five or more, and bending in a finer direction and curvature can be performed, and the effect of preventing “rambling” can be maintained. However, the bending rigidity of the tubular local region containing the sublumen is the bending rigidity of the outer layer 12 (the outer layer 12 is formed, for example, the hardness of the tube wall defining the sublumen is equal to or less than the hardness of the outer layer 12. When the resin material is lower than the bending rigidity (when the resin material is molded in the same shape as the tubular local region), the number of sublumens is excluded from the number. For example, the number of sublumens simply formed through holes in the outer layer 12 such as sublumens for injecting air or hollow portions for reducing the weight is excluded from the above numbers.

  The rigidity adjustment line 90 is at the same position in the length direction as the distal end of the tube 82 (first region 80A) of the sub-lumen 80. By forming in this way, the positions of the tube 82 and the stiffness adjusting line 90 that are harder than the outer layer 12 are matched, and the stiffness balance is maintained. However, the present invention is not limited to this, and may be in the same position as the tip of the sub-lumen 80, that is, the tip of the coil 84 (second region 80B). Also in this case, it is preferable that the length region that coincides with the second region 80B of the stiffness adjusting line 90 is formed so as to have the same flexibility as the coil 84 so as not to impair the flexibility of the coil 84. As described above, the rigidity of the rigidity adjustment line 90 may be discontinuous depending on the position.

10 Tubular body (sheath)
DESCRIPTION OF SYMBOLS 11 Inner layer 12 Outer layer 15 Distal end part 16 Intermediate | middle part 17 Proximal end part 20 Main lumen 30 Reinforcing layer 31, 83 Wire material (reinforcing layer)
40 Marker 50 Coat layer 51 Resin material 60 Operation part 61 Shaft part 62 Handle part 63 Grasping part 64 Slider 70 Operation line 70a First operation line 70b Second operation line 71 Distal end (tip part)
71a Distal end (first operation line)
71b Distal end (second operation line)
72 Proximal end 72a Proximal end (first operation line)
72b Proximal end (second operation line)
80 Sublumen 80a First sublumen 80b Second sublumen 80A, 80Aa, 80Ab First region 80B, 80Ba, 80Bb Second region 81 Space part 82 Tube 84 Coil 84a First coil 84b Second coil 90 Stiffness adjustment wire 90a First One rigidity adjustment line 90b Second rigidity adjustment line 91 Hollow portion 92 Pseudo operation line 92a First pseudo operation line 92b Second pseudo operation line 100 Catheter 111 Resin material (inner layer)
121 Resin material (outer layer)
200 Blood vessel 201 Branching portion 203 Blood vessel branch 204 Main tube DE Distal end PE Proximal end CE Proximal end

Claims (16)

A catheter comprising an elongate tubular body formed with an inner layer having a main lumen therein and one or more sub-lumens arranged around the main lumen with a smaller diameter than the main lumen. ,
One or more parallel to the sub-lumen and elongated in the longitudinal direction, having a stiffness adjustment line for reducing the angular dependence of the torsional stiffness of the tubular body,
3. The catheter according to claim 1, wherein the sub-lumen and the rigidity adjusting line are arranged around the main lumen at a fixed angular interval in total of three or more.   The operation line fixed to the distal end of the tubular body is slidably inserted into the sub-lumen, and the distal end of the catheter is bent by pulling the proximal end of the operation line. The catheter according to 1. The tubular body further has an outer layer on the outer periphery of the inner layer,
The catheter according to claim 1 or 2, wherein the sublumen and the stiffness adjusting line are formed inside the outer layer.   The catheter according to claim 3, wherein the sublumen is formed as a lumen of a tube formed of a material harder than a material forming the outer layer.   The catheter according to claim 3, wherein the rigidity adjustment line and the outer layer are formed of a resin material, and the resin material forming the rigidity adjustment line is harder than the resin material forming the outer layer.   The catheter according to claim 5, wherein the rigidity adjusting line and the outer layer are formed of the same kind of resin material.   The catheter according to claim 5 or 6, wherein the resin material of the rigidity adjusting line contains a contrast agent.   The catheter according to any one of claims 1 to 7, wherein the rigidity adjustment line and the sub-lumen are arranged on the same circumference. The sublumen is formed as a lumen of a tube formed of a material harder than the material forming the outer layer;
The catheter according to any one of claims 1 to 7, wherein the rigidity adjustment line has a lower bending rigidity than the tube, and the rigidity adjustment line is disposed on an outer peripheral side of the sub-lumen. The sublumen is formed as a lumen of a tube formed of a material harder than the material forming the outer layer;
The catheter according to any one of claims 1 to 7, wherein the rigidity adjustment line has higher bending rigidity than the tube, and the rigidity adjustment line is disposed on an inner peripheral side of the sub-lumen.   The catheter according to claim 4, wherein the rigidity adjustment line is formed of a tube of the same type as the tube in which the sublumen is formed.   The catheter according to claim 11, wherein the tube forming the stiffness adjusting line is closed at a distal end side distal end or a proximal end side rear end or middle.   The catheter according to claim 11 or 12, wherein the rigidity adjustment line and the tube forming the sublumen have the same distal end tip position in the longitudinal direction.   The catheter according to any one of claims 1 to 13, wherein the sublumen is provided with a coil formed by winding a wire material on a distal end side.   The catheter according to any one of claims 11 to 13, wherein a pseudo operation line is accommodated in the tube forming the rigidity adjustment line.   The tubular body has a reinforcing layer formed by winding a wire material around the main lumen, and the sub-lumen and the rigidity adjusting line are formed outside the reinforcing layer. The catheter according to any one of the above.

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