catheter

Abstract

To enhance torque transmission property of a catheter, which has a reinforcement body formed outside an inner layer.SOLUTION: A catheter 1, which is a medical appliance to be inserted into a blood vessel or a digestive organ and used for a treatment or an examination, comprises a hollow shaft 10, a linear member 30 provided linearly on the outer periphery of the hollow shaft, and a metal film which is formed between the outer periphery of the hollow shaft and the linear member and joined with each of the outer periphery of the hollow shaft and the linear member.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present invention relates to a catheter. [Background technology]

[0002] Conventionally, a catheter has been disclosed that has an inner layer made of resin and a coil layer made of metal wire outside the inner layer (see, for example, Patent Document 1). Also disclosed is a catheter that has an inner tube made of resin and a braided body made of multiple metal wires outside the inner tube (see, for example, Patent Document 2). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 5075632 [Patent Document 2] Patent Publication No. 5-84303 Summary of the Invention [Problem to be solved by the invention]

[0004] However, even with the above-mentioned techniques, there is still room for improvement in torque transmission in a catheter having a reinforcing body formed on the outside of the inner layer.

[0005] The present invention has been made to solve at least part of the above-mentioned problems, and has an object to improve the torque transmission of a catheter. [Means for solving the problem]

[0006] The present invention has been made to solve the above-mentioned problems, and can be realized in the following forms.

[0007] (1) According to one aspect of the present invention, there is provided a catheter comprising a hollow shaft, a linear member provided linearly on the outer periphery of the hollow shaft, and a metal film formed between the outer periphery of the hollow shaft and the linear member, the metal film being joined to both the outer periphery of the hollow shaft and the linear member.

[0008] According to this configuration, the hollow shaft, the metal film, and the linear member are joined together, thereby making it possible to improve the torque transmission performance of the catheter.

[0009] (2) In the catheter of the above embodiment, the linear member may be wound in a spiral shape around the outer periphery of the hollow shaft. With this configuration, since the linear member is in a coil shape, it is possible to improve the flexibility and torque transmission of the catheter.

[0010] (3) In the catheter of the above embodiment, the linear member may have a height greater than a width in cross section. With this configuration, the pressure resistance of the catheter can be improved compared to a case in which the height of the linear member is smaller than the width in cross section of the linear member.

[0011] (4) In the catheter of the above embodiment, the width of the linear member may decrease from the inside where it is joined to the metal film toward the outside in cross section. With this configuration, the volume of the linear member near the surface of the hollow shaft can be reduced while maintaining the height of the linear member. This improves the flexibility of the hollow shaft near the surface while maintaining the pressure resistance of the hollow shaft, thereby reducing the possibility of the catheter damaging blood vessels or internal organs when the catheter is inserted into a patient's body.

[0012] (5) In the catheter of the above embodiment, the metal film may be made of stainless steel, and the linear member may be made of nickel-cobalt alloy. According to this configuration, the metal film made of stainless steel is used as a conductive film, and the linear member made of nickel-cobalt alloy can be formed on the outer peripheral surface of the metal film by electrolytic plating. By making the linear member out of nickel-cobalt alloy, the torque transmission of the catheter can be improved.

[0013] (6) In the catheter of the above embodiment, the hollow shaft may include a first hollow shaft made of PTFE (polytetrafluoroethylene) and a second hollow shaft arranged on the outer periphery of the first hollow shaft and made of PAE (polyamide thermoplastic elastomer). According to this configuration, for example, the first hollow shaft defines the lumen of the catheter, and the first hollow shaft is made of PTFE, thereby making it possible to reduce frictional resistance between the inner periphery of the catheter and a device inserted inside the catheter. In addition, the second hollow shaft has PAE, which makes it possible to improve the flexibility of the catheter and its restoring ability when the catheter is bent.

[0014] (7) In the catheter of the above embodiment, the linear member may be formed in a lattice pattern on the outer periphery of the hollow shaft. With this configuration, a catheter having a metallic reinforcing body can be produced without using metal wires. As a result, in the overlapping portions of the metal wires, the metal wires do not interfere with each other and inhibit the flexibility of the catheter, thereby improving the flexibility of the catheter.

[0015] The present invention can be realized in various aspects, for example, in the form of a guidewire, a method for manufacturing a guidewire, an endoscope, a dilator, and the like. [Brief description of the drawings]

[0016] [Figure 1] FIG. 1 is an explanatory diagram illustrating the overall configuration of a catheter according to a first embodiment. [Diagram 2]FIG. 1 is an explanatory view illustrating the overall configuration of a catheter according to a first embodiment, with a portion of the catheter being see-through; [Diagram 3] FIG. 3 is an explanatory diagram showing an enlarged view of a region X1 in FIG. 2. [Figure 4] FIG. 3 is an explanatory diagram showing an enlarged view of a region Y1 in FIG. [Diagram 5] FIG. 2 is an explanatory diagram illustrating a cross-sectional configuration of the catheter of the first embodiment. [Figure 6] FIG. 6 is an explanatory diagram showing an enlarged view of a region Z in FIG. 5. [Figure 7] FIG. 2 is an explanatory diagram illustrating a first manufacturing method of the catheter of the first embodiment. [Figure 8] FIG. 11 is an explanatory diagram illustrating the overall configuration of a second embodiment with a portion thereof being see-through; [Figure 9] FIG. 9 is an explanatory diagram showing an enlarged view of region X2 in FIG. 8. [Figure 10] FIG. 9 is an explanatory diagram showing an enlarged view of region Y2 in FIG. 8. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] First Embodiment A catheter according to an embodiment of the disclosure will be described with reference to the drawings. The present disclosure is not limited to the embodiments described in the drawings.

[0018] Fig. 1 is an explanatory diagram illustrating the overall configuration of a catheter 1 of a first embodiment. Fig. 2 is an explanatory diagram illustrating the overall configuration by seeing through a portion of the catheter 1. Fig. 2 is a diagram illustrating the state of a linear member 30 in the entire catheter 1 by seeing through a portion of the catheter 1. In Fig. 2, region X1 indicates a portion of the tip portion of the hollow shaft 10, and region Y1 indicates a portion of the rear end portion of the hollow shaft 10.

[0019] In Fig. 1, the left side is the tip side of the catheter 1 and each of the components of the catheter 1, and the right side is the rear end side of the catheter 1 and each of the components of the catheter 1. The tip side of the catheter 1 is the side that is inserted into the body (distal side), and the base end side of the catheter 1 is the side that is operated by an operator such as a doctor (proximal side). The left-right direction in Fig. 1 is called the axial direction of the catheter 1 and each of the components. The direction perpendicular to the axial direction is called the radial direction of the catheter 1 and each of the components.

[0020] Additionally, the end portion located on the tip side of the catheter 1 and each component of the catheter 1 is described as the "tip", and the portion including the "tip" and extending from the tip to the middle toward the rear end is described as the "tip portion". Similarly, the end portion located on the rear end side of the catheter 1 and each component of the catheter 1 is described as the "rear end", and the portion including the "rear end" and extending from the rear end to the middle toward the tip side is described as the "rear portion".

[0021] For the sake of convenience, Fig. 1 includes some parts in which the relative proportions of the sizes of the components are depicted at different relative proportions from the actual proportions. The same applies to each of the explanatory views shown in Figs. 2 to 10.

[0022] The catheter 1 is a medical instrument that is inserted into blood vessels or digestive organs and used for treatment or examination. The catheter 1 includes a hollow shaft 10, a distal tip 40, and a grip portion 60. The hollow shaft 10 is a long tubular body extending in the axial direction of the catheter 1. The distal tip 40 is a tubular body joined to the distal end of the hollow shaft 10. The gripping portion 60 is a tubular body joined to the rear end of the hollow shaft 10 and gripped by an operator such as a doctor to operate the catheter 1.

[0023] The distal tip 40 is a tubular body that is joined to the distal end of the hollow shaft 10 and forms part of the distal end of the lumen 50 of the catheter 1. The distal tip 40 can be made of a flexible resin material. For example, TPU (thermoplastic polyurethane elastomer) can be selected. The distal tip 40 is not limited to a resin material and can be made of a metal material.

[0024] The gripping portion 60 is a tubular body that is joined to the rear end of the hollow shaft 10 and forms a part of the rear end of the lumen 50 of the catheter 1. The gripping portion 60 has a protector 61, a main body 62, and a connector 63. The protector 61 has a tapered shape in which the outer diameter increases toward the rear end side of the protector 61. The main body 62 has a protrusion on the outer periphery to make it easy for a surgeon such as a doctor to grasp it. The connector 63 is threaded on the inner periphery side and can be connected to other medical devices such as a syringe (not shown). The gripping portion 60 can be made of a material that is durable and suitable for sterilization. For example, it may be metal, injection-molded resin, or a combination thereof.

[0025] Fig. 3 is an explanatory diagram showing an enlargement of region X1 in Fig. 2. Fig. 3 is an explanatory diagram showing an enlargement of a part of the tip end of the hollow shaft 10, with a partial see-through view to explain the aspects of the metal film 20 and the linear member 30. Fig. 4 is an explanatory diagram showing an enlargement of region Y1 in Fig. 2. Fig. 4 is an explanatory diagram showing an enlargement of a part of the rear end of the hollow shaft 10, with a partial see-through view to explain the aspects of the metal film 20 and the linear member 30.

[0026] The hollow shaft 10 has an inner layer 11 , an intermediate layer 12 , an outer layer 13 , a metal film 20 , and a linear member 30 .

[0027] The inner layer 11 is a long tubular body provided on the inside of the hollow shaft 10. The inner layer 11 defines the lumen 50 of the catheter 1. The intermediate layer 12 is a long tubular body that covers the outer periphery of the inner layer 11. The outer layer 13 is a long tubular body that is provided on the outside of the hollow shaft 10 and covers the outer periphery of the intermediate layer 12. The distal end portions of the inner layer 11, intermediate layer 12, and outer layer 13 are joined to the distal tip 40. The rear end portions of the inner layer 11, intermediate layer 12, and outer layer 13 are joined to the grip portion 60.

[0028] The inner layer 11 can be made of a resin material with excellent slip properties because a medical device such as a guidewire (not shown) is inserted inside the inner layer 11. For example, a fluorine-based resin such as PTFE (polytetrafluoroethylene), PFA (tetrafluoroethylene-perfluoroalkylvinylether copolymer), or FEP (tetrafluoroethylene-hexafluoropropylene copolymer), or polyethylene, etc. can be selected. The inner layer 11 may be made of a known material other than those mentioned above.

[0029] The intermediate layer 12 and the outer layer 13 may be formed of, but are not limited to, an elastomer-based resin material. For example, they may be formed of PAE (polyamide thermoplastic elastomer), TPU (polyurethane thermoplastic elastomer), TPEE (polyester elastomer), etc. The intermediate layer 12 and the outer layer 13 may be formed of a known material other than those mentioned above.

[0030] Fig. 5 is an explanatory diagram illustrating the cross-sectional configuration of the catheter of the first embodiment. Fig. 5 is a cross-sectional view of the catheter 1 in a longitudinal section. In Fig. 5, region Z indicates a part of the hollow shaft 10. Fig. 6 is an explanatory diagram in which region Z in Fig. 5 is enlarged. Fig. 6 is an enlarged view of a part of the hollow shaft in a longitudinal section of the catheter 1, illustrating the aspects of the metal film 20 and the linear member 30.

[0031] The metal film 20 will be described with reference to Figs. 2 to 6. The metal film 20 is a metallic film-like member formed in a spiral shape on the surface of the intermediate layer 12 along the axial direction of the catheter 1. The metal film 20 is bonded to the intermediate layer 12 and does not move relative to the intermediate layer 12 in the axial direction of the catheter 1. The size of the metal film 20 in the axial direction of the catheter 1 is defined as the width Wm of the metal film 20. As shown in Fig. 3, the width Wm of the metal film 20 located in the region X1 is defined as Wm1, and as shown in Fig. 4, the width Wm of the metal film 20 located in the region Y1 is defined as Wm2. As shown in Fig. 5, the width Wm of the metal film 20 becomes smaller toward the tip direction of the catheter 1. In other words, the width Wm1 of the metal film 20 located on the tip side is smaller than the width Wm2 of the metal film 20 located at the rear end of the catheter 1. The height of the metal film 20 is defined as Hm. The height Hm of the metal film 20 can be set, for example, from 1 Å to 100 Å. The metal film 20 can be made of, for example, stainless steel or the like. It can also be made of silver, copper, or the like. Since silver and copper have high electrical conductivity, it is relatively easy to consider various pattern conditions. In particular, silver has high electrical conductivity and has a proven track record in terms of biocompatibility, making it effective as a coating for areas that require blood contact.

[0032] The linear member 30 will be described with reference to Figs. 2 to 6. As shown in Fig. 2, the linear member 30 is a metal linear member formed in a spiral shape on the surface of the metal film 20 along the axial direction of the catheter 1. The linear member 30 is joined to the metal film 20 and does not move relative to the metal film 20 in the axial direction of the catheter 1. When the catheter 1 is observed from a plane (longitudinal section) parallel to the axial direction of the catheter 1, the linear member 30 appears repeatedly so as to cross the axis of the catheter 1. In the linear members 30 that appear repeatedly, the interval between adjacent linear members 30 is defined as the pitch P of the linear members 30, and the angle of each linear member 30 with respect to the virtual axis 51 of the catheter 1 is defined as the inclination angle α. The pitch P of the linear members 30 becomes smaller toward the tip direction of the catheter 1. The inclination angle α of the linear members 30 becomes smaller toward the tip direction of the catheter 1.

[0033] As shown in FIG. 3, the pitch P of the linear member 30 located in the region X1 is P1, and as shown in FIG. 4, the pitch P of the linear member 30 located in the region Y1 is P2. The pitch P1 of the linear member 30 located on the tip side is smaller than the pitch P2 of the linear member 30 located at the rear end of the catheter 1. The linear member 30 is bonded to the metal film 20, which is bonded to the intermediate layer 12, so the pitch P will not change unless the intermediate layer 12 is deformed by bending or the like. The inclination angle α of the linear member 30 located in the region X1 is α1, and the inclination angle α of the linear member 30 located in the region Y1 is α2. The inclination angle α1 of the linear member 30 located on the tip side is smaller than the inclination angle α2 of the linear member 30 located at the rear end of the catheter 1.

[0034] As shown in FIG. 5 and FIG. 6, the linear member 30 has a trapezoidal shape in the longitudinal section of the catheter 1. The linear member 30 has a width Wi at a portion in contact with the metal film 20 and a width Wo at a portion close to the outer peripheral surface of the catheter 1. The width Wi is larger than the width Wo. The widths Wi and Wo become smaller toward the tip of the catheter 1. As shown in FIG. 3, the width Wi of the linear member 30 located in the region X1 is Wi1, and the width Wo is Wo1. As shown in FIG. 4, the width Wi of the linear member 30 located in the region Y1 is Wi2, and the width Wo is Wo2. The linear member 30 has a height H. The height H is larger than the width Wi, and can be set so that the ratio of the height H to the width Wi is 3:1, for example. The height H of the linear member 30 can be set to, for example, 10 μm to 100 μm. The height H is approximately constant in the axial direction of the catheter 1. The wire member 30 may be made of, for example, a nickel-cobalt alloy.

[0035] <Examples of effects> According to this configuration, the hollow shaft 10, the metal film 20, and the linear member 30 are joined together, so that the torque transmission, pressure resistance, stretch resistance, and the like of the catheter 1 can be improved. The rate at which the torque generated in the catheter 1 by an operator such as a doctor rotating the gripping part 60 is attenuated from the rear end to the tip of the catheter 1 can be reduced. In addition, if the linear member 30 is only wound spirally around the hollow shaft 10 and the multiple linear members 30 and the hollow shaft 10 are not joined together, the end of the linear member 30 tends to expand in the radial direction due to its own elasticity. According to this configuration, the metal film 20 and the linear member 30 are joined to the hollow shaft 10, so that the possibility that the end of the linear member 30 will expand in the radial direction can be reduced.

[0036] In addition, the hollow shaft of the catheter may be provided with a side hole that communicates the inside and outside of the hollow shaft and injects a medicinal liquid such as a contrast agent. In this case, if a coil body formed by winding a metal wire in a spiral shape around the hollow shaft or a braided body formed by braiding multiple metal wires is used as the reinforcing body, a restoring force that causes the metal wire of the coil body or braided body to return to a straight shape is applied to the hollow shaft. This may cause the hollow shaft to break around the side hole. This configuration does not have a metal wire, and the linear body 30 is joined to the intermediate layer 12 via the metal film 20, so that pressure is not applied from the linear member 30 to the hollow shaft 10. This reduces the possibility that the hollow shaft 10 will break around the side hole, even if the catheter 1 is provided with a side hole.

[0037] Furthermore, the width Wm of the metal film 20 and the widths Wi and Wo of the linear members 30 become smaller toward the tip of the catheter 1, so that the catheter 1 has a structure in which flexibility increases toward the tip. When the catheter 1 is inserted into a patient's body and comes into contact with the patient's blood vessels, internal organs, etc., the possibility of damaging the patient's blood vessels or internal organs is reduced. Furthermore, when the catheter 1 is inserted into a curved blood vessel, etc., the catheter 1 deforms according to the curved shape of the blood vessel, allowing the catheter 1 to advance within the blood vessel.

[0038] In the cross section of the linear member 30, the height H is greater than the width Wi, so that the durability against pressure applied in the radial direction of the hollow shaft 10 is improved compared to when the height H is smaller than the width Wi. In addition, the width Wi is smaller than the height H, so that the gap between the linear members 30 in the axial direction of the catheter 1 is relatively large. As a result, the volume of the resin layers such as the inner layer 11, the intermediate layer 12, and the outer layer 13 provided in the gap is relatively large. Therefore, when the catheter 1 is curved, the compressive force or tensile force in the axial direction of the catheter 1 applied to the outer circumferential surface of the catheter 1 can be relaxed by the resin layer. In addition, since the height H of the linear member 30 is large, the resistance against the force applied in the radial direction of the catheter 1 is large, so that deformation is suppressed. As a result, the roundness of the catheter 1 during operation can be maintained. In addition, since the width Wi is greater than the width Wo in the cross section of the linear member 30, the volume of the linear member on the surface of the hollow shaft 10 can be reduced. This makes it possible to improve the flexibility near the surface of the hollow shaft 10 while maintaining the pressure resistance of the hollow shaft 10. This reduces the possibility that the catheter 1 will damage the patient's blood vessels or internal organs when the catheter 1 comes into contact with the patient's blood vessels or internal organs.

[0039] By using stainless steel for the metal film 20 and a nickel-cobalt alloy for the linear member 30, the metal film 20 can be made a conductive film and the linear member 30 can be formed on the outer peripheral surface of the metal film 20 by electrolytic plating. By using a nickel-cobalt alloy for the linear member 30, a catheter 1 with excellent torque transmission properties can be produced. Furthermore, by using PTFE for the inner layer 11, the frictional resistance between the inner peripheral surface of the catheter 1 and a device inserted inside the catheter 1 can be reduced. By using PAE for the intermediate layer 12 or the outer layer 13, the flexibility of the catheter 1 and its restorability when curved can be improved.

[0040] By decreasing the inclination angle α of the linear member 30 toward the tip of the catheter 1 and decreasing the pitch P toward the tip of the catheter 1, the linear member 30 can be formed densely toward the tip of the catheter 1. This improves torque transmission to the tip of the catheter 1.

[0041] <Manufacturing method> FIG. 7 is an explanatory diagram illustrating a first manufacturing method for the catheter 1 of the first embodiment.

[0042] First, as shown in FIG. 7A, the core material 120 is coated with the inner layer 11 and the intermediate layer 12 by extrusion molding or the like to produce a hollow shaft 200. Next, the outer periphery of the intermediate layer 12 is coated with the metal film 20 by electroless plating or sputtering, and the outer periphery of the metal film 20 is coated with the metal layer 100 by electrolytic plating or the like. Next, an etching resist 110 made of an etching-resistant resin is applied to the outer periphery of the metal layer 100. Through the above steps, a base material 300 is produced. Next, for example, while rotating the base material 300 around the axial direction of the base material 300 and moving it in the axial direction, a laser 130 is irradiated to the outer periphery of the base material 300. This removes the etching resist 110 in a spiral shape. Next, as shown in FIG. 7B, the metal layer 100 exposed in a spiral shape to the outside due to the removal of the etching resist 110 and the metal film 20 inside it are melted by an etching solution 140. At this time, the metal layer 100 starts to melt from the portion located on the radial outside of the metal layer 100. Therefore, the portion located on the radial outside of the metal layer 100 melts more, and the portion located on the radial inside of the metal layer 100 melts less. As a result, the molten metal layer 100 becomes a trapezoidal shape whose width increases from the radial outside to the radial inside in the longitudinal section of the catheter 1. Next, as shown in (C) of FIG. 7, the etching resist 110 that was not removed by the laser 130 in the previous process and remains on the outer periphery of the spirally formed metal layer 100 is removed. Through the above steps, the outer periphery of the core material 120 is coated with the inner layer 11 and the intermediate layer 12, and the base material 300 having the metal film 20 and the metal layer 100 formed on the outer periphery of the intermediate layer 12 in a spiral shape can be produced. The base material 300 may be coated with an outer layer 13 (see FIGS. 1 to 6).

[0043] <Examples of effects> According to this configuration, the catheter 1 having a reinforcing body made of metal can be manufactured without using a metal wire. The metal film 20 is formed on the outer surface of the hollow shaft by electroless plating, sputtering, or the like, and the metal layer 100 is formed on the outer surface of the metal film 20 by electrolytic plating or the like. As a result, the metal layer 100 is joined to the first hollow shaft 201 via the metal film 20. Therefore, for example, when a resin tube for forming the outer layer 13 is coated on the outer periphery of the metal layer 100, the position of the metal layer 100 does not move relative to the hollow shaft 200. This improves the manufacturing efficiency of the catheter 1.

[0044] <Second embodiment> FIG. 8 is an explanatory diagram illustrating the overall configuration of the catheter 2 of the second embodiment, with a portion of the catheter 2 seen through. FIG. 8 is a diagram illustrating the state of the linear member 31 in the entire catheter 2, with a portion of the catheter 2 seen through. The catheter 2 of the second embodiment has a hollow shaft 70 instead of the hollow shaft 10 of the catheter 1 of the first embodiment. The hollow shaft 70 has a metal film 21 instead of the metal film 20 in the catheter 1, and a linear member 31 instead of the linear member 30. The catheter 2 is the same as the catheter 1, except for the hollow shaft 70. Therefore, the description of the members other than the hollow shaft 70 will be omitted. Region X2 indicates a portion of the tip of the hollow shaft 70, and region Y2 indicates a portion of the rear end of the hollow shaft 70.

[0045] Fig. 9 is an explanatory diagram showing an enlargement of region X2 in Fig. 8. Fig. 9 is an explanatory diagram showing an enlargement of a part of the tip end of the hollow shaft 70, with a partial see-through view to explain the aspects of the metal film 21 and the linear member 31. Fig. 10 is an explanatory diagram showing an enlargement of region Y2 in Fig. 8. Fig. 10 is an explanatory diagram showing an enlargement of a part of the rear end of the hollow shaft 70, with a partial see-through view to explain the aspects of the metal film 21 and the linear member 31.

[0046] As shown in Fig. 8, the metal film 21 is a metal film-like member formed in a lattice shape around the outer periphery of the intermediate layer 12 along the axial direction of the catheter 2. The metal film 21 is bonded to the intermediate layer 12 and does not move relative to the intermediate layer 12 in the axial direction of the catheter 2. As shown in Fig. 9, the width Wm of the metal film 21 located in the region X2 is set to Wm3, and as shown in Fig. 10, the width Wm of the metal film 21 located in the region Y2 is set to Wm4. In this case, the relationship between Wm3 and Wm4 is the same as the relationship between Wm1 and Wm2 in the first embodiment.

[0047] As shown in FIG. 8, the linear member 31 is a metal linear member formed in a lattice shape around the outer periphery of the metal film 21 along the axial direction of the catheter 2. The linear member 31 is joined to the metal film 21 and does not move relative to the metal film 21 in the axial direction of the catheter 2. When the catheter 2 is observed from a plane (longitudinal section) parallel to the axial direction of the catheter 2, X-shaped linear members 31 that cross the axis of the catheter 2 appear repeatedly. In the longitudinal section of the catheter 2, the part of the linear member 31 that is inclined toward the tip end side with respect to the axis of the catheter 2 is called element 31a of the linear member 31, and the part that is inclined toward the rear end side is called element 31b. The elements 31a and 31b are not separate members, and the linear member 31 is integrally manufactured over its entire length. Therefore, when the catheter 2 is operated by a technician such as a doctor, the elements 31a and 31b do not move independently of each other, and the X-shape formed by the elements 31a and 31b is maintained even during the operation of the catheter 2.

[0048] As shown in FIG. 9, the inclination angle αa of the element 31a of the linear member 31 located in the region X2 with respect to the imaginary axis 51 of the catheter 2 is α3a, and the inclination angle αb of the element 31b of the linear member 31 located in the region X2 with respect to the imaginary axis 51 of the catheter 2 is α3b. As shown in FIG. 10, the inclination angle αa of the element 31a of the linear member 31 located in the region Y2 with respect to the imaginary axis 51 of the catheter 2 is α4a, and the inclination angle αb of the element 31b of the linear member 31 located in the region Y2 with respect to the imaginary axis 51 of the catheter 2 is α4b. In each linear member 31, the inclination angle αa and the inclination angle αb are approximately the same. In FIG. 9, the inclination angle α3a and the inclination angle α3b are approximately the same. In FIG. 10, the inclination angle α4a and the inclination angle α4b are approximately the same.

[0049] As shown in Fig. 9, the pitch Pa between adjacent elements 31a of the linear member 31 located in region X2 is defined as P3a, and the pitch Pb between adjacent elements 31b of the linear member 31 located in region X2 is defined as P3b. As shown in Fig. 10, the pitch P between adjacent elements 31a of the linear member 31 located in region Y2 is defined as P4a, and the pitch Pb between adjacent elements 31b of the linear member 31 located in region Y2 is defined as P4b. In each linear member 31, the pitch Pa and the pitch Pb are approximately the same. In Fig. 9, the pitch P3a and the pitch P3b are approximately the same. In Fig. 10, the pitch P4a and the pitch P4b are approximately the same.

[0050] As shown in Fig. 9, the width Wi of the linear member 31 located in region X2 is Wi3, and the width Wo is Wo3. As shown in Fig. 10, the width Wi of the linear member 31 located in region Y2 is Wi4, and the width Wo is Wo4. In this case, the relationship between Wi3 and Wi4 is similar to the relationship between Wi1 and Wi2 in the first embodiment. Also, the relationship between Wo3 and Wo4 is similar to the relationship between Wo1 and Wo2 in the first embodiment.

[0051] <Examples of effects> When the catheter has a braided body formed by braiding a plurality of metal wires, when the catheter is bent, the metal wires interfere with each other at the intersections of the plurality of metal wires. This causes the braided body to deform into an elliptical shape, which reduces torque transmission, push-pull operability, and flexibility. However, the linear member 31 is an integrally manufactured lattice-like member and does not have a plurality of metal wires. Therefore, the metal wires do not interfere with each other, and even when the catheter 2 is bent, the linear member 31 can maintain a shape close to a perfect circle. This improves torque transmission, push-pull operability, and flexibility. In addition, the outer diameter of the catheter can be made smaller than when a plurality of metal wires are used. This makes it easier to insert the catheter 2 into peripheral blood vessels with small inner diameters. In addition, when the plurality of linear members 31 are simply wound around the hollow shaft 70 in a braided manner and the plurality of linear members 31 and the hollow shaft 70 are not joined, the end of the linear member 31 tends to expand radially due to its own elastic force. According to this configuration, since the metal film 21 and the linear member 31 are joined to the hollow shaft 70, the possibility that the end of the linear member 31 will expand in the radial direction can be reduced.

[0052] By making the inclination angle αa of element 31a of linear member 31 approximately equal to the inclination angle αb of element 31b, and by making the pitch Pa of element 31a approximately equal to the pitch Pb of element 31b, torque transmittance can be improved regardless of the rotation direction of catheter 2.

[0053] <Modifications of this embodiment> The present invention is not limited to the above-described embodiment, and may be modified without departing from the spirit and scope of the present invention. The present invention can be embodied in various ways, and the following modifications are also possible.

[0054] [Variation 1] In the catheter 1 of the first embodiment, the metal film 20 is bonded to the surface of the intermediate layer 12. However, the catheter 1 may not have the intermediate layer 12, but may have only the inner layer 11 and the outer layer 13, with the metal film 20 bonded to the surface of the inner layer 11. Also, the width Wm of the metal film 20 is smaller toward the tip of the catheter 1. However, the width Wm of the metal film 20 may be larger toward the tip of the catheter 1. In this case, the rigidity of the tip of the catheter 1 can be increased.

[0055] [Variation 2] In the catheter 1 of the first embodiment, the pitch P of the linear member 30 is smaller toward the tip of the catheter 1. However, the pitch P of the linear member 30 may be larger toward the tip of the catheter 1. This can further improve the flexibility of the tip of the catheter 1. In addition, the inclination angle α of the linear member 30 is smaller toward the tip of the catheter 1. However, the inclination angle α of the linear member 30 may be larger toward the tip of the catheter 1.

[0056] [Variation 3] In the catheter 1 of the first embodiment, the linear member 30 has a trapezoidal shape in the longitudinal section of the catheter 1. However, the linear member 30 may have a square or rectangular shape, or a semicircular shape convex toward the radially outward direction, instead of a trapezoidal shape in the longitudinal section of the catheter 1, and may be formed in various shapes. In addition, although the lateral width Wi is larger than the lateral width Wo, the lateral width Wi may be smaller than the lateral width Wo.

[0057] [Variation 4] In the catheter 1 of the first embodiment, the widths Wi and Wo of the linear member 30 are smaller toward the tip of the catheter 1. However, the widths Wi and Wo of the linear member 30 may be larger toward the tip of the catheter 1. This can increase the rigidity of the tip of the catheter 1. In addition, the height H of the linear member 30 is larger than the width Wi. However, the height H of the linear member 30 may be smaller than the width Wi. In this case, the outer diameter of the catheter 1 can be smaller than when the height H is larger than the width Wi. In addition, the height H of the linear member 30 is approximately constant in the axial direction of the catheter 1. However, the height H of the linear member 30 does not have to be approximately constant in the axial direction of the catheter 1. For example, the height H may be smaller toward the tip of the catheter 1. In this case, the flexibility of the tip of the catheter 1 can be further improved.

[0058] The above-described modified examples of the catheter 1 of the first embodiment can also be applied to the second embodiment to the extent that they are applicable.

[0059] [Variation 5] In the catheter 2 of the second embodiment, the inclination angles αa and αb of the respective linear members 31 are substantially the same. However, the inclination angles αa and αb do not have to be substantially the same. In this case, when the catheter 2 is observed from a plane (longitudinal cross section) parallel to the axial direction of the catheter 2, the linear members 31 have an X-shape that is not line-symmetric.

[0060] [Variation 6] In the catheter 2 of the second embodiment, the pitch Pa and the pitch Pb of each linear member 31 are approximately the same. However, the pitch Pa and the pitch Pb do not have to be approximately the same. In this case, when the catheter 2 is observed from a plane (longitudinal cross section) parallel to the axial direction of the catheter 2, the linear members 31 have an X-shape that is not line-symmetric.

[0061] The present embodiment has been described above based on the embodiment and the modified examples. The form of is for facilitating understanding of this embodiment and is not intended to limit this embodiment. This embodiment may be modified or improved without departing from the spirit and scope of the claims. In addition, the present embodiment includes equivalents thereof. If not explained as such, it may be deleted as appropriate. [Explanation of symbols]

[0062] 1...Catheter of the first embodiment 2...Catheter of the second embodiment 10... Hollow shaft of the first embodiment 11…Inner layer 12. Middle class 13…outer layer 20...metal film of the first embodiment 21...metal film of the second embodiment 30...Linear member of the first embodiment 31...Linear member of the second embodiment 31a: A portion inclined toward the tip side of the linear member in the second embodiment 31b: A portion of the linear member inclined toward the rear end of the second embodiment 40…Tip 50…lumens 51...Virtual axis of catheter 60...Gripping part 61…Protector 62…Main body 63…Connector 70...hollow shaft of the second embodiment 100...metal layer 120…Core material 130…Laser 140…Etching solution 200…Hollow shaft 300…Base material Wm: Width of metal film Hm: Height of metal film Wi: Width of the part of the linear member that contacts the metal film 20 Wo: Outer width of linear member H: Height of linear member P: Pitch of linear members Pa: Pitch of the inclined portion toward the tip of the linear member of the second embodiment Pb: Pitch of the portion of the linear member inclined toward the rear end of the second embodiment α: Incline angle of linear member αa: inclination angle of the portion inclined toward the tip side of the linear member in the second embodiment αb: inclination angle of the portion inclined toward the rear end of the linear member of the second embodiment

Claims

1. A catheter comprising: A hollow shaft; A linear member provided linearly on the outer periphery of the hollow shaft; a metal film formed between an outer periphery of the hollow shaft and the linear member, the metal film being joined to the outer periphery of the hollow shaft and the linear member, The linear member is a first linear member that is wound helically around the outer periphery of the hollow shaft along the axial direction of the catheter and is inclined to one side with respect to the axis of the catheter; a second linear member different from the first linear member, the second linear member being wound spirally around the outer periphery of the hollow shaft along the axial direction of the catheter and inclined to the other side with respect to the axial direction of the catheter, the first linear member and the second linear member intersect with each other at a plurality of points and are integrally formed at the intersecting portions; The pitch of the linear members becomes smaller toward the distal end of the catheter. catheter.

2. 2. The catheter of claim 1, The linear member has a height greater than a width in cross section. catheter.

3. The catheter according to claim 1 or 2, In a cross section, the width of the linear member decreases from the inside where the linear member is joined to the metal film toward the outside. catheter.

4. A catheter according to any one of claims 1 to 3, The metal film is made of stainless steel, and the linear member is made of a nickel-cobalt alloy. catheter.

5. A catheter according to any one of claims 1 to 4, The hollow shaft includes a first hollow shaft formed of PTFE (polytetrafluoroethylene), and a second hollow shaft disposed on the outer periphery of the first hollow shaft and formed of PAE (polyamide thermoplastic elastomer). catheter.

6. 2. The catheter of claim 1, The linear members are formed in a lattice pattern on the outer periphery of the hollow shaft. catheter.

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