Catheter manufacturing method and catheter manufacturing apparatus

Abstract

[Problem] An objective of the present invention is to, in a case in which a first member and a second member such as tubes are fused to form a catheter, enable the performance of fusing a plurality of times while eliminating the need for removal work of members required for manufacturing from the product after the fusing the first member and the second member. [Solution] A manufacturing method for a catheter according to the present invention is a manufacturing method for a catheter 100 that includes a catheter main body 10 formed by fusing a first member 30 and a second member 40. The manufacturing method includes emitting laser light to an adjacent area P of the first member and the second member, in a proximal state and an external force applied state described below, thereby fusing the adjacent area. In the proximal state, an elastically deformable elastic body 220, that transmits the laser light and that includes a hollow section 221 through which the first member and the second member can, at a time of no load, be inserted with a gap, contacts the first member and the second member due to elastic deformation in the hollow section, thereby bringing the first member and the second member into proximity with each other. In the external force applied state, an external force is applied to the elastic body so that weakening of the force, caused by the elastic deformation that brings the first member and the second member into proximity with each other, is suppressed by a hard component 230 that transmits the laser light and that is harder than the elastic body.

Description

Technical Field

[0001] The present invention relates to a method for manufacturing a catheter and a manufacturing apparatus for a catheter.

Background Art

[0002] When performing various therapeutic acts within a living organ, a medical instrument having a tube body composed of a flexible tubular hollow member is often used. Among this type of medical instrument, a guiding catheter used when delivering a catheter device such as a balloon catheter to a desired position within a living body, a contrast catheter used when discharging a contrast agent into a living body, a micro catheter used for discharging a drug, etc. are generally known.

[0003] The above-described catheter may be manufactured through a process of joining hollow tubes to each other by means of a laser or the like. In a conventional technique for joining tubes at such a joining planned site, a heat-shrinkable tube may be used (see Patent Document 1).

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] The heat-shrinkable tubing described above is applied to the outside of the tubes to be joined, causing it to shrink and maintain contact between the tubes in the final product. However, with heat-shrinkable tubing, the tubes in the final product must be removed after the joining area is formed using a laser or the like. The inventors focused on the fact that heat-shrinkable tubing has a relatively large impact on costs and must be discarded after a single use. Furthermore, they noted that the removal of heat-shrinkable tubing from the product is performed by workers, and that failure to properly remove the tubing during this process can lead to increased costs due to the need to redo the work.

[0006] Therefore, the present invention has been made to solve the above-mentioned problems, and aims to enable multiple fusions when forming a catheter by fusing a first member and a second member, such as two tubes, together, while eliminating the need to remove the components necessary for manufacturing from the product after the fusion of the first and second members. [Means for solving the problem]

[0007] The above objective is achieved by the following (1) to (11), which are aspects of the present invention. (1) A method for manufacturing a catheter, which includes a catheter body formed by fusing a first member and a second member, A method for manufacturing a catheter, comprising: an elastically deformable elastic body having laser light transmittance and a hollow portion through which the first member and the second member can be inserted with a gap when unloaded, in a proximity state in which the first member and the second member are brought close together by elastic deformation in the hollow portion, and in an external force applied state in which an external force is applied to the elastic body so as to suppress the weakening of the force due to the elastic deformation that brings the first member and the second member close together by a hard component that has laser light transmittance and is harder than the elastic body, wherein laser light is irradiated onto the adjacent portions of the first member and the second member to fuse the adjacent portions. (2) The method for manufacturing a catheter according to (1), wherein at least one of the first member and the second member includes a material that absorbs laser light in the adjacent portion. (3) The first member and the second member have a cylindrical shape, The method for manufacturing a catheter according to (1) or (2), wherein the second member is positioned axially closer to the proximal end than the first member. (4) The first member is in close proximity to the second member at one end in the axial direction, The method for manufacturing a catheter according to (3), wherein the laser light is irradiated to an end of the first member that is different from the adjacent portion in the axial direction. (5) The first member and the second member have a cylindrical shape, The method for manufacturing a catheter according to (1), wherein the rigid component is positioned outside the elastic body in a radial direction intersecting the axial direction of the first member and the second member when the external force is applied, and the first rigid component applies the external force to the elastic body. (6) The rigid part is provided with an insertion portion through which the elastic body can be inserted, The method for manufacturing a catheter according to (1), wherein the outer surface of the elastic body in the insertion direction when unloaded is formed to have an overlap with the insertion portion of the rigid part. (7) The first member and the second member have a cylindrical shape, The method for manufacturing a catheter according to (6), wherein the elastic body is placed inside the insertion portion of the hard component by stretching the elastic body in the axial direction of the first member and the second member so that the outer diameter of the elastic body is smaller than the inner diameter of the hard component. (8) The hard part comprises a plurality of components arranged in a circumferential direction in the state in which the external force is applied, A method for manufacturing a catheter according to (1), wherein the plurality of components are elastically deformed by applying the external force to the elastic body toward the central axis of the first member and the second member in the state in which the external force is applied. (9) The method for manufacturing a catheter according to (5), wherein the rigid component is disposed outside the elastic body in the axial direction of the first member and the second member, and comprises a second rigid component that applies the external force to the elastic body. (10) The method for manufacturing a catheter according to (9), wherein the internal volume partitioned by the first rigid component and the second rigid component decreases, thereby transitioning from the unloaded state to the external force applied state. (11) An insertion member through which the first member and the second member can be inserted, A catheter manufacturing apparatus comprising the elastic body described in any one of (1) to (10) and the rigid component. [Effects of the Invention]

[0008] According to one aspect of the present invention, when forming a catheter by fusing a first member and a second member, multiple fusions can be performed while eliminating the need to remove the necessary components from the product after fusing the first member and the second member. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic diagram showing an example of a catheter manufactured by a catheter manufacturing method according to one embodiment of the present invention. [Figure 2] This is a schematic diagram showing a catheter manufacturing apparatus used in the catheter manufacturing method according to the first embodiment of the present invention. [Figure 3] This is a schematic diagram showing the outer and inner surfaces of the elastic body that makes up the catheter manufacturing apparatus. [Figure 4] This is a flowchart showing a method for manufacturing a catheter according to one embodiment of the present invention. [Figure 5] This diagram shows the state in which the first and second members are attached to the insertion member that constitutes the catheter manufacturing device. [Figure 6] This diagram shows the state in which the adjacent portions of the first and second components are positioned within the hollow portion of the elastic body that constitutes the catheter manufacturing apparatus. [Figure 7]It is a diagram showing a state in which a hard component constituting a catheter manufacturing apparatus is brought close to an elastic body and an external force is applied to the elastic body. [Figure 8] It is a diagram showing how a laser beam is irradiated on an adjacent portion between a first member and a second member. [Figure 9] It is a schematic diagram showing an irradiation site of a laser beam on a first member and a second member. [Figure 10] It is a schematic diagram showing a modified example of the first embodiment, where the axial length of the hard component is shorter than the axial length of the elastic body. [Figure 11] It is a schematic diagram showing a catheter manufacturing apparatus used in a catheter manufacturing method according to a second embodiment, showing a state before components constituting the hard component apply an external force to the elastic body. [Figure 12] It is a diagram showing a state in which an external force is applied to an elastic body by components in the catheter manufacturing apparatus shown in FIG. 11. [Figure 13] It is a flowchart showing a catheter manufacturing method according to a modified example of the second embodiment. [Figure 14] It is a diagram showing a state in which a second hard component is brought into contact with an elastic body in a catheter manufacturing method according to a modified example of the second embodiment. [Figure 15] It is a diagram showing a state in which an adjacent portion between a first member and a second member is arranged in a hollow portion of an elastic body in a catheter manufacturing method according to a modified example of the second embodiment. [Figure 16] It is a diagram showing a moment when a first hard component is brought into contact with an elastic body to apply an external force to the elastic body in a catheter manufacturing method according to a modified example of the second embodiment. [Figure 17] FIG. 17(a) is a diagram showing the internal volume surrounded by a first hard component and a second hard component at the time of FIG. 15 in a modified example of the second embodiment. FIG. 17(b) is a diagram showing the internal volume surrounded by a first hard component and a second hard component at the time of FIG. 16 in a modified example of the second embodiment. [Figure 18]This figure shows how laser light is irradiated onto adjacent portions of a first member and a second member in a catheter manufacturing method according to a modified example of the second embodiment. [Figure 19] This is a schematic diagram showing modified examples of the first and second members. [Figure 20] This is a schematic diagram showing a modified example of the outer surface of an elastic body. [Figure 21] This is a schematic diagram showing a modified example of the outer surface of an elastic body. [Figure 22] This is a schematic diagram showing a modified example of the inner surface of an elastic body. [Figure 23] This is a schematic diagram showing a modified example of the inner surface of an elastic body. [Modes for carrying out the invention]

[0010] Hereinafter, embodiments for carrying out the present invention will be described in detail with reference to the drawings. The embodiments shown herein are illustrative examples for embodying the technical idea of ​​the present invention and do not limit the present invention. Furthermore, all other implementable forms, examples, and operational techniques that can be conceived by those skilled in the art without departing from the spirit of the present invention are included in the scope and spirit of the present invention, as well as in the claims and their equivalents.

[0011] Furthermore, the drawings attached to this specification may be schematically represented with changes to scale, aspect ratio, shape, etc., from the actual object for the sake of illustration and ease of understanding, but these are merely examples and do not limit the interpretation of the present invention.

[0012] Furthermore, in the following explanations, ordinal numbers such as "1st" and "2nd" are used, but unless otherwise specified, they are used for convenience and do not prescribe any particular order.

[0013] The catheter 100 manufactured by the catheter manufacturing method according to this embodiment can be inserted into blood vessels, bile ducts, trachea, esophagus, urethra, or other biological tubular or body cavities for treatment, diagnosis, etc. The catheter 100 is a balloon catheter, microcatheter, contrast catheter, or guiding catheter used in PTCA (Percutaneous Transluminal Coronary Angioplasty) or PTA (Percutaneous Transluminal Angioplasty).

[0014] Figure 1 is a schematic diagram showing a catheter 100 manufactured by a catheter manufacturing method according to one embodiment. Referring to Figure 1, the catheter 100 comprises a long catheter body 10 that can be introduced into the body and a hub 20 connected to the proximal end of the catheter body 10. In this embodiment, the catheter body 10 is configured to have a kink-resistant protector 21 near the connection between the catheter body 10 and the hub 20, but the kink-resistant protector is not necessarily required.

[0015] In this specification, the side of the catheter body 10 on which the hub 20 is located is referred to as the proximal end, the side opposite to the proximal end and introduced into the body is referred to as the distal end, and the direction in which the tube body extends is referred to as the axial direction.

[0016] The catheter body 10 is configured as a flexible tubular member with a lumen extending in the axial direction. In this embodiment, the catheter body 10 is formed by fusing adjacent portions P of the first member 30 and the second member 40 with two cylindrical members, the first member 30 and the second member 40, while they are arranged in the axial direction (see Figure 9, etc.). The adjacent portion P is provided at one end of the first member 30 in the axial direction.

[0017] The first member 30 and the second member 40 have a cylindrical shape, and in this embodiment, the cylindrical shape is configured as a cylinder as an example. The second member 40 is configured to be positioned closer to the base end in the axial direction than the first member 30.

[0018] The constituent materials of the first member 30 and the second member 40 can include, for example, polyamide resin, polyester resin, polyolefin resin, polyurethane resin, as well as polyamide elastomer, polyester elastomer, polyurethane elastomer, or mixtures of two or more of these or mixtures of materials with different hardness. It is preferable that the constituent materials of the first member 30 and the second member 40 include the same type of constituent material. For example, the constituent material of the first member 30 is polyamide elastomer and the constituent material of the second member 40 is polyamide resin. Another example is that the constituent material of the first member 30 is polyester elastomer and the constituent material of the second member 40 is polyester resin.

[0019] These elastomers may be arranged with elastomers of different hardnesses so that they become more flexible from the base to the tip. Furthermore, the constituent materials of the first member 30 and the second member 40 may include polytetrafluoroethylene resin to enhance the sliding properties of the inner surface.

[0020] Furthermore, the first member 30 and the second member 40 may contain pigments or dyes that produce white, black, blue, red, or yellow colors, or mixtures thereof. Such pigments or dyes may be selected from materials that absorb laser light and generate heat. Examples of materials that absorb laser light and generate heat include carbon black.

[0021] Furthermore, the first member 30 and the second member 40 may be configured to contain a contrast agent in powder form. Specific materials include, for example, compounds of gold, titanium, bismuth, and tungsten. In addition, the first member 30 and the second member 40 may have reinforcing bodies made of tungsten, SUS, or the like placed within the aforementioned materials. The reinforcing bodies may take the form of coils or blades.

[0022] The hub 20 is liquid-tightly fixed to the catheter body 10 by adhesive or a fixing device (not shown). The hub 20 functions as an insertion point for the guidewire into the lumen of the catheter body 10, an injection point for drugs, embolic materials, contrast agents, etc. into the lumen, and also functions as a gripping part when manipulating the catheter 100. The material of the hub 20 can be a thermoplastic resin such as polycarbonate, polyamide, polysulfone, or polyarylate.

[0023] Furthermore, as shown in Figure 1, if the catheter 100 has a kink protector 21, the kink protector 21 can be made of an elastic material that surrounds a part of the proximal end of the catheter body 10. For example, natural rubber, silicone resin, etc., can be used as the material for the kink protector 21.

[0024] (Catheter manufacturing equipment) Next, the catheter manufacturing apparatus 200 according to the first embodiment will be described. Figure 2 is a schematic diagram showing the catheter manufacturing apparatus 200 used in the method for manufacturing the catheter 100 according to the first embodiment. Referring to Figure 2, the catheter manufacturing apparatus 200 includes an insertion member 210, an elastic body 220, a rigid part 230 (corresponding to the first rigid part), and a laser irradiation unit 240.

[0025] In the following diagrams showing the catheter manufacturing apparatus, the coordinate system is indicated. In the Cartesian coordinate system, X is the axial direction of the first member 30 and the second member 40 that constitute the catheter 100, and is referred to as axial X. Y and Z are planes that intersect with axial X, and are referred to as planar directions YZ. Further details are provided below.

[0026] (Insertion member) The insertion member 210, also called a core, is configured to allow insertion of the cylindrical first member 30 and the second member 40, which are to be fused together. In this embodiment, the insertion member 210 has a circular cross-sectional shape that intersects the axial direction X.

[0027] However, the cross-sectional shape of the insertion member 210 is not limited to a circular shape, but may be a polygon or the like, as long as it can be inserted and attached to the first member 30 and the second member 40. The insertion member 210 may also be tubular. The insertion member 210 can be made of a metal material or the like. The insertion member 210 is supported by a motor, gear, bearing, etc., at both ends or near both ends of the insertion member 210 so as to be rotatable with respect to the axial direction X as the axis of rotation, so as to be able to form fused portions in the circumferential direction intersecting the axial direction X of the first member 30 and the second member 40.

[0028] (Elastic body) The elastic body 220 is configured to be elastically deformable so that the first member 30 and the second member 40 to be fused can be brought into close proximity. The elastic body 220 is configured to be elastically deformable so as to apply a force to the objects to be fused, such as the first member 30 and the second member 40, radially inward. The elastic body 220 maintains a predetermined shape when unloaded, but can deform toward the unrestrained portion when an external force is applied. The elastic body 220 includes a hollow portion 221 (see Figure 6). The hollow portion 221 is configured so that the first member 30 and the second member 40 attached to the insertion member 210 can be inserted through it with a gap when unloaded.

[0029] Furthermore, the elastic body 220 is configured to have an overlap with the hard part 230, which will be described later. In this embodiment, in order to facilitate assembly of the elastic body 220 to the hard part 230, jigs (not shown) that extend the elastic body 220 in the axial direction X are attached to both ends of the elastic body 220 in the axial direction X. As a result, the outer diameter D of the elastic body 220 is as shown in Figure 2. after The inner diameter D' of the hard part 230 can be made smaller, as shown above.

[0030] The elastic body 220 is configured to be elastically deformable so as to bring the first member 30 and the second member 40 into close proximity when an external force is applied to them by a hard part 230, which will be described later. In this specification, the state in which the first member 30 and the second member 40 are in close proximity due to the hard part is referred to as the proximity state. In this specification, the state in which the hard part applies an external force to the elastic body so that the elastic body is displaced toward the object to be fused is referred to as the external force application state. The external force application state includes cases in which hard parts are arranged outward in multiple directions of the elastic body, one hard part pressurizes the elastic body, and other hard parts are arranged to suppress or limit the deformation of the elastic body so that the elastic body is not displaced in directions other than the object to be fused.

[0031] The elastic body 220 includes a material that is laser light transparent so that when laser light is irradiated onto it while it is located outside the first member 30 and the second member 40, the adjacent portions P of the first member 30 and the second member 40 are fused together. In this specification, laser light transparent means that the elastic body is made of a material with a transmittance to laser light of 80% or more per 1 mm of radial thickness.

[0032] Furthermore, the elastic body 220 includes a material that has higher heat resistance than the workpieces, the first member 30 and the second member 40, when the first member 30 and the second member 40 are fused together. Examples of materials for the elastic body 220 include silicone rubber and fluororubber.

[0033] Figure 3 shows the outer surface 222 and inner surface 223 of the elastic body 220. The elastic body 220 has an outer surface 222 that contacts the hard part 230 when an external force is applied and an inner surface 223 that contacts the first member 30 and the second member 40 in proximity. In this embodiment, both the outer surface 222 and the inner surface 223 are configured to include a cylindrical side shape, as shown in Figure 3.

[0034] As shown in Figure 3, when the cross-section of the hollow portion 221 perpendicular to the axial direction X is a circle, the diameter of the hollow portion 221 in the state where no external force is applied is larger than the diameters of the first member 30 and the second member 40. Furthermore, the elastic body 220 is supported so as to be rotatable with the axial direction X as the axis of rotation, similar to the insertion member 210.

[0035] (Hard parts) The rigid component 230 is made of a material harder than the elastic body 220. The rigid component 230 is made of a material that does not substantially deform even when an external force is applied to the elastic body 220 to impose a radially inward force on the object to be fused. The rigid component 230 is configured so that an external force can be applied to the elastic body 220 from outside the elastic body 220 so that the first member 30 and the second member 40 are brought into close proximity by the elastic body 220. The rigid component 230 is configured so that an external force can be applied to the elastic body 220 to impose a radially inward force on the object to be fused, such as the first member 30 and the second member 40 by the elastic body 220.

[0036] The rigid component 230 suppresses the weakening of the force due to the elastic deformation of the elastic body 220 that brings the first member 30 and the second member 40 closer together when an external force is applied. In this embodiment, the rigid component 230 is positioned outside the elastic body 220 in the radial direction intersecting the axial direction X when an external force is applied, and applies an external force to the elastic body 220 in the radial direction.

[0037] In this embodiment, the rigid component 230 is configured to include a hollow cylindrical member. As shown in Figure 2, the rigid component 230 has an insertion portion N as a cavity through which the elastic body 220 can be inserted. The elastic body 220 is configured such that its outer surface in the insertion direction under no load has an overlap with the insertion portion N in the rigid component 230 as described above. In other words, the outer diameter D of the outer surface of the elastic body 220 (see the dashed line in Figure 2) is configured to be larger than the inner diameter D' of the rigid component 230, as shown in Figure 2.

[0038] As described above, the elastic body 220 is stretched in the axial direction X, thereby increasing its outer diameter D. afterAs shown above, the rigid part 230 can be placed inside the insertion portion N of the rigid part 230 with a diameter smaller than the inner diameter D' of the rigid part 230. In this embodiment, the length of the rigid part 230 in the axial direction X is set to be the same as the length of the elastic body 220 in the axial direction X, as shown in Figure 2, etc.

[0039] Although the rigid component 230 is described as including a cylindrical member, the specific shape of the rigid component is not limited to a hollow cylindrical member, as long as an external force can be applied to the elastic body 220 so that the first member 30 and the second member 40 are in close proximity at the fusion joint.

[0040] The rigid component 230 is positioned outside the first member 30 and the second member 40 and the elastic body 220, and laser light is shone onto the adjacent portion P of the first member 30 and the second member 40. Therefore, the rigid component 230 is configured to have laser light transmittance, similar to the elastic body 220. The laser light transmittance of the rigid component 230 means that the rigid component is configured such that the transmittance is 80% for every 1 mm of radial thickness of the elastic body, similar to the elastic body 220.

[0041] The rigid component 230 can deform the elastic body 220 into a desired shape, and is harder than the elastic body 220 (has high hardness) to the extent that it does not deform significantly in response to the reaction force from the elastic body 220, and the specific material is not particularly limited as long as it can transmit laser light. Specific examples of materials for the rigid component 230 include glass, quartz, sapphire, or materials mentioned for the elastic body 220 that have higher hardness than the elastic body 220 as described above. The rigid component 230 can be rephrased as an external force applying member. Furthermore, the rigid component 230, like the insertion member 210 and the elastic body 220, is configured to be rotatably supported with the axial direction X as the axis of rotation.

[0042] (Laser irradiation area) The laser irradiation unit 240 is used when fusing adjacent portions P of the first member 30 and the second member 40. The laser irradiation unit 240 includes a light source (not shown) that emits a laser, and a galvanoscan (scanner), prism, etc., that changes the direction of the laser emitted from the light source in a predetermined direction using a motor, mirror, etc.

[0043] The laser irradiation unit 240 irradiates the fused portion with laser light of a wavelength that generates heat through radiant heating. The spot diameter of the laser light can be configured from φ0.1 to φ10 mm, and the wavelength of the laser light can be configured from 800 to 10000 nm. This allows the laser light from the laser irradiation unit 240 to pass through the hard part 230 and the elastic body 220 and irradiate the adjacent portion P of the first member 30 and the second member 40 to form the fused portion. The adjacent portion irradiated with laser light refers to the end faces and surrounding portions of both members when the two members are arranged axially. Also, the adjacent portion irradiated with laser light refers to the overlapping portion and surrounding portion when the two members are stacked on top of each other.

[0044] (Catheter manufacturing method) Next, a method for manufacturing the catheter 100 according to this embodiment will be described. Figure 4 is a flowchart showing the method for manufacturing the catheter 100 according to this embodiment, and Figures 5 to 9 are diagrams used to explain the method for manufacturing the catheter 100 according to this embodiment.

[0045] Referring to Figure 4, the manufacturing method of the catheter 100 according to this embodiment is outlined as follows: the first member 30 and the second member 40 are attached to the insertion member 210 (S1), and the first member 30 and the second member 40 are placed in the hollow portion 221 of the elastic body 220 (S2). The method also involves applying an external force to the elastic body 220 with a hard part 230 (S3), irradiating with laser light (S4), separating the hard part 230 from the elastic body 220 (S5), and removing the first member 30 and the second member 40 (S6). The details are described below.

[0046] First, the first member 30 and the second member 40 are inserted into the insertion member 210 as shown in Figure 5 (S1). In this state, the first member 30 and the second member 40 become movable and rotatable integrally with the insertion member 210. Note that in Figure 5, the first member 30 and the second member 40 are shown with their opposing end faces in contact. However, as will be described later, this may also include a state in which the first member 30 overlaps with a part of the second member 40 (Figure 19) or a state in which there is a gap between the first member 30 and the second member 40.

[0047] Next, with the rotation axes of the insertion member 210 and the elastic body 220 aligned, either the insertion member 210 or the elastic body 220 is moved axially X to position the adjacent portions P of the first member 30 and the second member 40 inside the hollow portion 221 of the elastic body 220 (S2). In this state, as shown in Figure 6, the first member 30 and the second member 40 are not in contact with the hollow portion 221 of the elastic body 220 in the radial direction, and a gap is created.

[0048] Next, as shown in Figure 7, the hard part 230 is brought close to the elastic body 220 to apply an external force to the elastic body 220. In this embodiment, both ends (or near both ends) of the elastic body 220 in the axial direction X are grasped and stretched in the axial direction X, and as shown in Figure 2, the outer diameter D of the elastic body 220 is extended to the outer diameter D after With the elastic body 220 in this state, it is placed inside the insertion portion N of the hard part 230. By temporarily reducing the outer diameter of the elastic body 220 in this way, it becomes easier to insert the elastic body 220 into the hard part 230.

[0049] After positioning the elastic body 220 inside the insertion portion N of the hard part 230, the outward extension of the elastic body 220 in the axial direction X is released. This releases the outer diameter D of the elastic body 220. afterThe elastic body 220 is displaced radially outward, and the inner surface of the rigid part 230 comes into contact with the outer surface of the elastic body 220, and an external force is applied to the elastic body 220 radially inward by the rigid part 230 (S3). The outer surface 222 of the elastic body 220 is in close contact with the inner surface of the rigid part 230, and the elastic body 220 is subjected to a force that causes it to contract radially inward by the rigid part 230. Then, the inner surface 223 of the elastic body 220, which is the wall surface of the hollow portion 221, moves radially inward due to the external force applied from the rigid part 230. Since the deformation of the outer circumferential surface of the elastic body 220 is restricted by the inner circumferential surface of the rigid part 230, it deforms toward the hollow portion 221 of the elastic body 220, which is not restricted by the rigid part 230.

[0050] As a result, the first member 30 and the second member 40 are pressed inward in the radial direction r by the elastic body 220. The inner surface 223, which is the wall surface of the hollow portion 221, comes into contact with the first member 30 and the second member 40, causing the first member 30 and the second member 40 to press against each other in the axial direction X. At this point, the first member 30 and the second member 40 are in close proximity, and the hard component 230 is subjected to an external force.

[0051] Next, the laser irradiation unit 240 determines the irradiation position of the laser beam to the adjacent portion P between the first member 30 and the second member 40 as shown in Figure 8 by galvanoscanning or the like, and the laser beam L is irradiated onto the adjacent portion P (S4). In this embodiment, the insertion member 210, the elastic body 220, and the rigid part 230 rotate about the axial direction X as the axis of rotation, causing the first member 30 and the second member 40 to rotate about the axial direction X as the axis of rotation. As a result, the first member 30 and the second member 40 generate heat themselves, and / or heat is transferred from the insertion member 210 to the first member 30 and the second member 40, forming a fused portion from the outer circumference to the interior of the adjacent portion P between the first member 30 and the second member 40.

[0052] Furthermore, in this embodiment, the laser beam L is irradiated not only to the adjacent portion P of the first member 30 and the second member 40 as shown at position Pt1 in Figure 9, but also to the tip portion of the first member 30 that is different from the adjacent portion P, as shown at position Pt2 in Figure 9. As a result, the tip portion of the first member 30 deforms, and the corner portion of the tip portion of the first member 30 is smoothly formed like a curved surface. Note that the irradiation of the laser beam L to positions Pt1 and Pt2 may be performed intermittently or continuously.

[0053] Next, the rigid component 230 is separated from the elastic body 220 (S5). In this embodiment, the rigid component 230 is moved relative to the elastic body 220 in the axial direction X to release the external force applied to the elastic body 220 by the rigid component 230. As a result, the wall surface of the hollow portion 221 of the elastic body 220 changes from a state in which it was in contact with the first member 30 and the second member 40 as shown in Figure 7 to a state in which it is separated again with a gap, as shown in Figure 6.

[0054] Furthermore, the stretching of the elastic body 220 in the axial direction X may be performed not only in step S3, but also when separating the elastic body 220 from the hard part 230 (S5).

[0055] Next, the insertion member 210, to which the first member 30 and the second member 40 are attached, is moved relative to the elastic body 220 to remove the joined first member 30 and second member 40 from the insertion member 210 (S6). After that, the kink-resistant protector 21 and the hub 20 are attached to the catheter body 10, thereby completing the manufacturing of the catheter 100 shown in Figure 1.

[0056] As described above, the method for manufacturing a catheter 100 including a cylindrical first member 30 and a second member 40 according to this embodiment involves irradiating adjacent portions P of the first member 30 and the second member 40 with laser light L in proximity and under external force application conditions to fuse the adjacent portions P together.

[0057] In close proximity, the elastic body 220 is transparent to laser light, and in the hollow portion 221, it elastically deforms to come into contact with the first member 30 and the second member 40, bringing them closer together. The elastic body 220 has a hollow portion 221 through which the first member 30 and the second member 40 can be inserted with a gap when unloaded, and is configured to be elastically deformable.

[0058] In the state where an external force is applied, the system is configured to apply an external force to the elastic body 220 in such a way that the force caused by elastic deformation that brings the first member 30 and the second member 40 closer together by the hard part 230, which has laser light transmittance and is harder than the elastic body 220, is suppressed.

[0059] Furthermore, the catheter manufacturing apparatus 200 includes an insertion member 210 through which the first member 30 and the second member 40 can be inserted, the elastic body 220 described above, and a rigid part 230.

[0060] With this configuration, if the application of external force to the elastic body 220 by the hard part 230 is stopped after irradiation with laser light L, the elastic body 220 will move from a state of contact with the first member 30 and the second member 40 to a state of separation with a gap between them. Therefore, while fusion using heat shrink tubing would require the removal of the heat shrink tubing from the first member and the second member after fusion, the method according to this embodiment eliminates the need for such removal work.

[0061] This eliminates or reduces the need for rework due to failed tube removal, as is the case with heat-shrink tubing. Furthermore, since the elastic body 220 returns to a state with a gap between the first member 30 and the second member 40 (the state before use) through elastic deformation without cutting the elastic body itself, the elastic body 220 can be used for multiple fusions of the first member 30 and the second member 40. Therefore, it is possible to reduce labor costs and material costs.

[0062] Furthermore, since a molten portion of the first member 30 and the second member 40 is formed near the laser beam L irradiation area, the shape of the molten portion can be broadly selected by controlling the laser beam irradiation area. In addition, if the cross-sections of the elastic body 220 and the hard part 230 intersecting the axial direction X are circular in shape, the quality of the fused portion can be improved by the hard part 230 uniformly pressing the outer circumference of the adjacent portion P of the first member 30 and the second member 40 with the elastic body 220.

[0063] Furthermore, at least one of the first member 30 and the second member 40 is configured to include a material that absorbs laser light L in the adjacent portion P. Therefore, the first member 30 and the second member 40 can be effectively fused together by the heat generated by laser light absorption in the adjacent portion P of the first member 30 and the second member 40.

[0064] Furthermore, the first member 30 and the second member 40 have a cylindrical shape, and according to the manufacturing method of this embodiment, it is possible to manufacture a catheter 100 in which the second member 40 is positioned closer to the proximal end in the axial direction X than the first member 30.

[0065] Furthermore, in the manufacturing method according to this embodiment, by irradiating the tip portion or the like, which is different from the adjacent portion P in the axial direction X of the first member 30, with laser light L, the portion in question can be formed into a curved shape or the like.

[0066] Furthermore, the rigid component 230 is positioned outside the elastic body 220 in a radial direction intersecting the axial direction X of the first member 30 and the second member 40 when an external force is applied, thereby applying an external force to the elastic body 220. This configuration suppresses separation between the first member 30 and the second member 40, and allows the adjacent portions P of the first member 30 and the second member 40 to be fused together.

[0067] Furthermore, the rigid component 230 is provided with an insertion portion N through which the elastic body 220 can be inserted. The outer surface of the elastic body 220 in the unloaded state is formed to have an overlap with the insertion portion N of the rigid component. By arranging the rigid component 230 to fit onto the outer diameter portion of the elastic body 220 in this way, an external force can be applied to the elastic body 220 that brings the first member 30 and the second member 40 closer together.

[0068] Furthermore, the elastic body 220 is stretched in the axial direction X, so that its outer diameter is smaller than the inner diameter of the hard part 230, and it is positioned inside the insertion portion N of the hard part 230. With this configuration, the elastic body 220 can be easily positioned inside the insertion portion N of the hard part 230.

[0069] In this embodiment, the elastic body 220 maintains a predetermined shape when unloaded, and deforms toward the hollow portion 221 of the elastic body 220, which is not restricted by the hard portion 230, when an external force is applied by the hard portion 230. This allows for stable pressure to be applied to the workpiece, such as the first member 30 and the second member 40. Furthermore, the method of this embodiment allows for the workpiece to be processed into any shape by imparting an arbitrary shape to the hollow portion 221 of the elastic body 220.

[0070] (Modified version of the first embodiment) Figure 10 shows a catheter manufacturing apparatus 200a according to a modified example of the first embodiment. In the first embodiment, it was explained that the length of the rigid part 230 in the axial direction X is the same as the length of the elastic body 220 in the axial direction X. However, the length of the rigid part in the axial direction X is not limited to the above, as long as an external force can be applied by the rigid part to bring the first member and the second member of the elastic body closer together in the axial direction X.

[0071] In addition to the above, the length of the rigid component 230a in the axial direction X may be shorter than the length of the elastic body 220 in the axial direction X, as shown in Figure 10. Note that the configuration of the catheter manufacturing apparatus other than the rigid component and the catheter manufacturing method are the same as in the first embodiment, so the common explanations are omitted.

[0072] In this embodiment, when the elastic body 220 is stretched, it is configured to be longer in the axial direction X than the hard part 230 when unloaded. Therefore, because the elastic body 220 is positioned inside the hard part 230, a gripping area is provided on the elastic body 220, making it easier to insert and remove the elastic body 220.

[0073] (Second Embodiment) Figure 11 shows the state of the rigid component 230b (corresponding to the first rigid component) constituting the catheter manufacturing apparatus 200b according to the second embodiment before an external force is applied to the elastic body 220, and Figure 12 shows the state after an external force is applied to the elastic body 220 by the rigid component 230b.

[0074] In the first embodiment, the rigid component 230 was configured in a cylindrical shape similar to the elastic body 220, and the rigid component 230 was attached to the elastic body 220 so as to fit against the elastic body 220. However, the rigid component can also be configured as follows. In this embodiment, the insertion member 210, the elastic body 220, and the laser irradiation unit 240 are the same as in the first embodiment, so their description is omitted.

[0075] Note that cylindrical coordinates are shown in Figures 11 and 12. In the cylindrical coordinate system, r is the direction extending radially or radially from the centers of the first member 30 and the second member 40 constituting the catheter 100, along the planar direction YZ, and is referred to as the radial direction r. θ is the direction along the circumferential or angular direction of the first member 30 and the second member 40, etc., in the planar direction YZ that intersects the axial direction X of the first member 30 and the second member 40, and is referred to as the circumferential direction θ.

[0076] The rigid component 230b is positioned outside the elastic body 220 in the radial direction r intersecting the axial direction X of the first member 30 and the second member 40 when an external force is applied, and applies the external force to the elastic body 220. As shown in Figure 11, the rigid component 230b comprises a plurality of components divided into a predetermined number in the circumferential direction θ intersecting the axial direction X of the first member 30 and the second member 40. In this embodiment, the rigid component 230b is configured to include component 231, component 232, and component 233.

[0077] Components 231, 232, and 233 are configured to elastically deform the elastic body 220 by applying an external force to the elastic body 220 toward the central axis of the first member 30 and the second member 40 when an external force is applied. Components 231, 232, and 233 are configured to move toward and toward the elastic body 220 in the radial direction r. Components 231, 232, and 233 each have inner surfaces 231a, 232a, and 233a, respectively, as inner surfaces facing the elastic body 220. Components 231, 232, and 233 each have outer surfaces 231b, 232b, and 233b, respectively, as outer surfaces with respect to the central axis.

[0078] By configuring it in this way, the elastic body 220 can be in a state where there is a gap between it and the first member 30 and the second member 40, or in a state where it is in contact with the first member 30 and the second member 40.

[0079] Components 231, 232, and 233 contact the elastic body 220 in a manner that surrounds its outer circumference when they come into contact with it. The radii of curvature of the inner surfaces 231a, 232a, and 233a are smaller than the radii of curvature of the outer surface of the elastic body 220 in an unloaded state. The inner surfaces 231a, 232a, and 233a form a circle in the plane direction YZ when an external force is applied. The cross-sectional area of ​​the formed circle is smaller than the cross-sectional area of ​​the elastic body 220 in the plane direction YZ in an unloaded state. The areas of the inner surfaces 231a, 232a, and 233a of each component 231, 232, and 233a are smaller than the areas of their corresponding outer surfaces 231b, 232b, and 233b, respectively. In this embodiment, components 231, 232, and 233 are configured to each surround the outer circumference of the elastic body 220 in the circumferential direction θ, which is divided into three equal angles.

[0080] However, the number of components is not limited to three, and the angles of the components do not need to be equal, as long as a force is generated at the adjacent portion P that causes the first member 30 and the second member 40 to press against each other so that they do not separate during fusion.

[0081] The rigid component 230b can be made movable by synchronizing each of its components 231, 232, and 233 in the radial direction r using a hydraulic cylinder (not shown) or the like. Furthermore, the components 231, 232, and 233 of the rigid component 230b are configured to be rotatable with respect to the axial direction X as the axis of rotation, similar to the insertion member 210 of the first embodiment, when their position in the radial direction r is not moving.

[0082] Next, the method for manufacturing a catheter according to this embodiment will be described. Steps S1, S2, and S6 are the same as in the first embodiment, so their description will be omitted.

[0083] After positioning the adjacent portions P of the first member 30 and the second member 40 in the hollow portion 221 of the elastic body 220, components 231, 232, and 233 of the rigid component 230b are moved radially r toward the elastic body 220 and brought into contact, as shown in Figure 12. Components 231, 232, and 233 of the rigid component 230b press the elastic body 220 radially r. As a result, an external force is applied to the elastic body 220 radially r by the rigid component 230b (S3), and the elastic deformation of the elastic body 220 causes the first member 30 and the second member 40 to press against each other at the adjacent portion P. The elastic body 220 changes from its unloaded outer diameter, as shown by the dashed line in Figure 12, to its contracted outer diameter. Since the deformation of the elastic body 220 toward its outer surface is restricted by the rigid part 230b, it deforms toward the unrestricted hollow portion 221. As a result, the first member 30 and the second member 40 are pressed inward in the radial direction r by the elastic body 220. Note that the deformation of the hollow portion of the elastic body 220 is omitted in Figure 12.

[0084] In this state, the laser irradiation unit 240 aligns the irradiation position of the laser beam L with the adjacent portion P and irradiates with the laser beam L. As the insertion member 210, the elastic body 220, and the rigid part 230b whose position in the radial direction r is determined rotate about the axial direction X as the axis of rotation, the first member 30 and the second member 40 rotate, and when the laser beam L is irradiated in this state, a fusion area is formed on the outer circumference of the adjacent portion P (S4). The laser beam L is irradiated from the outer surfaces 231b, 232b, and 233b of the components 231, 232a, and 233 of the rigid part 230b, passing through the inner surfaces 231a, 232a, 233a and the elastic body 220 respectively, to the outer circumference of the adjacent portion P of the first member 30 and the second member 40.

[0085] After the fusion is complete, components 231, 232, and 233 of the hard part 230b are moved outward in the radial direction r to separate components 231, 232, and 233 from the elastic body 220 (S5). As a result, the elastic body 220 moves from a state in which it was in contact with the first member 30 and the second member 40, as in the first embodiment, to a state in which there is a gap between them.

[0086] As described above, in the second embodiment, the rigid component 230b comprises a plurality of components 231, 232, and 233 arranged in a divided manner in the circumferential direction θ when an external force is applied. The plurality of components 231, 232, and 233 are configured to cause elastic deformation of the elastic body 220 by applying an external force to the elastic body 220 toward the central axis of the first member 30 and the second member 40.

[0087] In this way, the rigid part 230b allows the elastic body 220 to be elastically deformed in the same manner as in the first embodiment, and fusion can be performed at adjacent portions P while applying a pressing force so that the first member 30 and the second member 40 do not separate.

[0088] Furthermore, in this embodiment, the elastic body 220 maintains a predetermined shape when unloaded, and when an external force is applied by the hard part 230, it deforms toward the hollow portion 221 of the elastic body 220, which is not restricted by the deformation of the hard part 230. This allows for stable pressurization of the workpiece, such as the first member 30 and the second member 40. In addition, the method of this embodiment allows for fine control of pressurization. Moreover, the method of this embodiment allows for the processing of the workpiece into any shape by imparting an arbitrary shape to the hollow portion 221 of the elastic body 220.

[0089] (Modified version of the second embodiment) Figure 13 is a flowchart showing a catheter manufacturing method according to a modified example of the second embodiment, and Figures 14 to 18 are diagrams illustrating the catheter manufacturing apparatus 200c. In the second embodiment, it was explained that components 231, 232, and 233 of the rigid component 230b apply an external force to the elastic body 220 from the outside in the radial direction r of the first member 30 and the second member 40 toward the inside.

[0090] However, the rigid components can be configured as follows. Note that the insertion member 210, the elastic body 220, and the laser irradiation unit 240 are the same as in the first embodiment, so their description is omitted.

[0091] The rigid component 230c comprises a first rigid component 231c and a second rigid component 232c, as shown in Figure 14, etc. The first rigid component 231c is positioned outside the elastic body 220 in a radial direction intersecting the axial direction X of the first member 30 and the second member 40 when an external force is applied. The first rigid component 231c applies an external force to the elastic body 220. Since the first rigid component 231c comprises components 231, 232, and 233 described in the second embodiment, the description of components 231, 232, and 233 is omitted.

[0092] The second rigid component 232c applies an external force to the elastic body 220 from a direction different from that of the first rigid component 231c. In this modified example, the second rigid component 232c is positioned outside the elastic body 220 in an axial direction X different from the radial direction r in which the first rigid component 231c applies the external force. The second rigid component 232c applies an external force to the elastic body 220.

[0093] The second rigid component 232c comprises components 234 and 235, which are configured in a substantially cylindrical shape to surround the elastic body 220 from the outside in the axial direction X. Components 234 and 235 of the second rigid component 232c are positioned so that their faces facing the elastic body 220 are in contact with the side surface of the elastic body 220. With this configuration, the second rigid component 232c, together with the first rigid component 231c, can cover the outer surface of the elastic body 220. Furthermore, the second rigid component 232c is supported so as to be rotatable with the axial direction X as the axis of rotation, similar to the insertion member 210 of the first embodiment. In addition, components 234 and 235 are configured to be movable in the axial direction X so that the elastic body 220 can be positioned.

[0094] Next, a method for manufacturing the catheter 100 according to this modified example will be described with reference to Figure 13. Note that in this modified example, step S1 in the flowchart of Figure 13 is the same as step S1 in the flowchart of Figure 4, so its explanation will be omitted.

[0095] After attaching the first member 30 and the second member 40 to the insertion member 210, the elastic body 220 is positioned in the apparatus at the location where the fusion joint will be formed (S2). Here, the elastic body 220 is positioned at the location where the fusion joint will be formed with the second hard part 232c in axial direction X in contact with the elastic body 220 as shown in Figure 14. Next, the adjacent portions P of the first member 30 and the second member 40 are placed in the hollow portion 221 of the elastic body 220, similar to step S2 in Figure 4 (S3, see Figure 15).

[0096] Next, as shown in Figure 16, components 231, 232, and 233 of the first rigid component 231c are moved radially r toward the elastic body 220 and brought into contact with it. That is, the first rigid component 231c and the second rigid component 232c are moved so that one outer surface is along the other inner surface. As explained in Figure 15, one outer surface 231c1 and the other outer surface 231c2 of the first rigid component 231c are moved along one inner surface 232c1 and the other inner surface 232c2 of the second rigid component 232c, respectively. Then, the first rigid component 231c and the second rigid component 232c apply an external force to the elastic body 220. As a result, the elastic body 220 is subjected to external forces in the radial direction r and the axial direction X by the first rigid component 231c and the second rigid component 232c.

[0097] As shown in Figures 17(a) and 17(b), the internal volume partitioned by the first hard component 231c and the second hard component 232c decreases. Specifically, as shown by the dashed line in Figure 17(a), the internal volume partitioned by the first hard component 231c and the second hard component 232c in the unloaded state is defined as internal volume V1. On the other hand, as shown by the dashed line in Figure 17(b), the internal volume partitioned by the first hard component 231c and the second hard component 232c in the external force applied state is defined as internal volume V2. The internal volume partitioned by the first hard component 231c and the second hard component 232c decreases from internal volume V1 to internal volume V2. As a result, the elastic body 220 transitions from the unloaded state to the external force applied state. The volume of the elastic body 220 decreases as its surface is surrounded (see D in Figure 14 and D' in Figure 16, D>D'). In this way, the volume of the elastic body 220 decreases due to the reduction in the internal volume partitioned by the first rigid part 231c and the second rigid part 232c. As a result, the elastic body 220 transitions from an unloaded state to a state with an external force applied (S4). In addition, the application of an external force to the elastic body 220 by the rigid part 230c brings the first member 30 and the second member 40 into close proximity.

[0098] In this state, as shown in Figure 18, the laser beam L is transmitted through the hard part 230c and the elastic body 220 and irradiated onto the adjacent portion P of the first member 30 and the second member 40. As the insertion member 210, the elastic body 220, and the hard part 230c rotate, the first member 30 and the second member 40 rotate about the axial direction X as the axis of rotation, and a fusion portion is formed on the outer circumference of the adjacent portion P (S5).

[0099] Once the fusion is complete, the first hard part 231c and the second hard part 232c are separated from the elastic body 220. That is, components 231, 232, and 233 constituting the first hard part 231c are moved outward in the radial direction r, and components 234 and 235 constituting the second hard part 232c are moved outward in the axial direction X. The order in which the first hard part 231c and the second hard part 232c are separated is not particularly limited. As a result, the hard part 230c is separated from the elastic body 220 (S6).

[0100] Then, similar to step S6 in Figure 4, the first member 30 and the second member 40, which have been fused together, are removed from the hollow portion 221 of the elastic body 220 (S7). Then, the hub 20 and the kink protector 21 are attached to form the catheter.

[0101] As described above, in this modified example, the rigid part 230c comprises a first rigid part 231c and a second rigid part 232c. The first rigid part 231c is positioned outside the elastic body 220 in the radial direction r and applies an external force to the elastic body 220 in the radial direction r. The second rigid part 232c is positioned outside the elastic body 220 in the axial direction X of the first member 30 and the second member 40 and applies an external force to the elastic body 220 in the axial direction X.

[0102] As described above, by using the first rigid part 231c and the second rigid part 232c, it is possible to suppress unnecessary deformation of the elastic body 220 that is not related to the fusion of the first member 30 and the second member 40.

[0103] This reduces the amount of compression of the elastic body 220, making it easier to control the compression of the elastic body. In addition, it prevents or suppresses misalignment of the first member 30 and the second member 40, thereby improving the dimensional accuracy of the finished catheter 100.

[0104] Furthermore, the internal volume partitioned by the first rigid component 231c and the second rigid component 232c decreases, causing the elastic body 220 to transition from an unloaded state to a state where an external force is applied. This prevents or suppresses unintended deformation of the elastic body 220 that may occur if an external force is applied from one direction, thereby preventing or suppressing a decrease in the dimensional accuracy of the finished catheter.

[0105] It should be noted that the present invention is not limited to the embodiments described above, and various modifications are possible within the scope of the claims. Figure 19 shows a modified example of the first member and the second member. The above describes a method for fusing the first member 30 and the second member 40, which are adjacent in the axial direction X.

[0106] However, the direction in which the first and second members are aligned is not limited to the axial direction X. For example, in addition to the above, as shown in Figure 19, the first member 30 and the second member 40a may be aligned radially, and they may be fused together by a manufacturing apparatus including an insertion member, an elastic body, a hard part, and a laser irradiation unit.

[0107] Furthermore, even when the members to be fused, such as the first member 30 and the second member 40a, are aligned radially, the laser irradiation unit irradiates laser light from the radially outward direction, intersecting the axial direction of the first member 30 and the second member 40a, toward the adjacent portion that is the fusion site, similar to the laser irradiation unit 240.

[0108] In this embodiment, the elastic body 220 maintains a predetermined shape when unloaded, and deforms toward the hollow portion 221 of the elastic body 220, which is not restricted by the first hard part 231c and the second hard part 232c, when an external force is applied, thus enabling stable pressurization of the workpiece, such as the first member 30 and the second member 40. Furthermore, the method of this embodiment allows for fine control of pressurization and also has a fast pressurization response. Moreover, the method of this embodiment allows for the processing of the workpiece into any shape by imparting an arbitrary shape to the hollow portion 221 of the elastic body 220.

[0109] Figures 20 and 21 show modified examples of the outer surface of the elastic body, and Figures 22 and 23 show modified examples of the inner surface of the elastic body. In the first embodiment, the outer surface 222 and inner surface 223 of the elastic body 220 were described as cylindrical sides in Figure 3, but the invention is not limited to this. In addition to the above, the outer surface 222a of the elastic body 220a may be made up of a hexagonal prism side, which is an example of a polygonal prism, as shown in Figure 20, or the outer surface 222b of the elastic body 220b may be made up of a frustoconical side, as shown in Figure 21.

[0110] Furthermore, as shown in Figure 22, the inner surface 223c of the elastic body 220c may be formed by the side surface of a frustocone, or as shown in Figure 23, the inner surface 223d of the elastic body 220d may be formed by the side surface of a rectangular prism, which is an example of a polygonal prism. When the cross-sections of the hard component and the elastic body intersecting (orthogonal to) the axial direction X consist only of circles, the entire circumference of each position in the circumferential direction of the first member and the second member can be uniformly pressurized.

[0111] Furthermore, in the first embodiment, as shown in Figure 9, the laser light L is irradiated not only at position Pt1, which corresponds to the adjacent portion P between the first member 30 and the second member 40, but also at position Pt2, which corresponds to the tip of the first member 30. However, one embodiment of the present invention also includes a case in which the laser light L is irradiated at position Pt1 but not at position Pt2.

[0112] Furthermore, as explained above, the first and second members are rotated around the axial direction X by rotating the insertion member, elastic body, and hard part, thereby forming a fused portion on the outer circumference of the adjacent portion P. However, the invention is not limited to this, and a fused portion may also be formed on the outer circumference of the adjacent portion P of the first and second members by changing the position and direction of laser light irradiation by the laser irradiation unit without rotating the insertion member, elastic body, and hard part.

[0113] Furthermore, in a modified example of the second embodiment, it was explained that in step S2 of Figure 13, when the elastic body 220 is positioned at the fusion site, the second hard component 232c is in prior contact with the elastic body 220. However, the invention is not limited to this, and the second hard component 232c may be configured to approach the elastic body 220 after the elastic body 220 has been positioned at the fusion site.

[0114] This application is based on Japanese Patent Application No. 2021-127512, filed on 3 August 2021, the disclosures of which are cited in their entirety by reference. [Explanation of Symbols]

[0115] 10 Catheter body, 30 First member, 40, 40a Second member, 100 catheters, 200, 200a, 200b, 200c manufacturing equipment, 210 Insertion member, 220, 220a, 220b, 220c, 220d elastic bodies, 222 Exterior, 221 Hollow part, 230, 230b Hardened parts (first hardened part), 230c hard parts, 231c First hard component, 232c Second hard component, 231, 232, 233 Components, 240 laser irradiation section, N insertion part, P adjacent part, r radial direction, X-axis direction θ represents the circumferential direction.

Claims

1. A method for manufacturing a catheter, which includes a catheter body formed by fusing a first member and a second member, In a catheter manufacturing method, a laser beam is irradiated onto the adjacent portions of a first member and a second member to fuse them together, in a state in which an elastically deformable elastic body having laser light transmittance and a hollow portion through which the first member and the second member can be inserted with a gap when unloaded comes into contact with the first member and the second member by elastic deformation in the hollow portion, bringing the first member and the second member into close proximity, and in a state in which an external force is applied to the elastic body by a hard component that has laser light transmittance and is harder than the elastic body, in order to suppress the weakening of the force caused by the elastic deformation that brings the first member and the second member into close proximity, The first member and the second member have a cylindrical shape, The hard component is positioned outside the elastic body in a radial direction intersecting the axial directions of the first member and the second member when the external force is applied, and comprises a first hard component that applies the external force to the elastic body. A method for manufacturing a catheter comprising a second rigid component which is positioned outside the elastic body in the axial direction of the first member and the second member and applies the external force to the elastic body.

2. The method for manufacturing a catheter according to Claim 1, wherein the internal volume partitioned by the first rigid component and the second rigid component decreases, thereby transitioning from the unloaded state to the external force applied state.

3. The method for manufacturing a catheter according to claim 1, wherein the laser light is irradiated onto the adjacent portion by passing through the hard component and the elastic body.

4. The method for manufacturing a catheter according to claim 1, wherein the first rigid component and the second rigid component are moved so that one outer surface is moved along the other inner surface.

5. An insertion member having a cylindrical shape through which the first member and the second member can be inserted, A catheter manufacturing apparatus comprising the elastic body described in claim 1, and the hard component described in claim 1, comprising the first hard component and the second hard component.

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