Manufacturing method for medical tubular interior tube and manufacturing method for medical tubular delivery device

Abstract

To provide a method for manufacturing a medical tubular body inner packaging tube in which a medical tubular body is inserted into a tube having a reinforcing layer comprised of a wire rod, and thereby the tube where the medical tubular body is internally installed can be obtained efficiently.SOLUTION: A method for manufacturing a medical tubular body inner packaging tube has: a step of preparing a medical tubular body 11; a step of preparing a tube 12 having a first section 15 containing a first edge 13 without having a reinforcing layer 17, and a second section 16 positioned at the side of a second edge 14 from the first section 15 and having a reinforcing layer 17; a first insertion step of inserting the medical tubular body 11 in the tube 12 from the first edge 13 side, and arranging the medical tubular body 11 to the first section 15; a second insertion step of moving the medical tubular body 11 arranged to the first section 15 to the second edge 14 side in the tube 12, and arranging the medical tubular body 11 to the second section 16; and a cut step of cutting the tube 12 at the edge of the first edge 13 side of the medical tubular body 11 or at the first edge 13 side from it.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to a method for manufacturing a tube having a medical tubular body such as a stent inside, and a method for manufacturing a medical tubular body delivery device. [Background technology]

[0002] Medical tubular bodies, typified by stents, are medical devices used to treat various diseases caused by narrowing or obstruction of body lumens, such as the digestive tract, including the bile duct and pancreatic duct, and blood vessels, including the iliac artery. Medical tubular bodies include those that are placed in the lesion to expand the lesion, such as a narrowed or obstructed site, from the inside and maintain the inner diameter of the body lumen, and those that entangle and remove to the outside of the body thrombus or the like that has developed in or around the lesion, thereby restoring the inner diameter of the body lumen at the lesion.

[0003] As a medical tubular object delivery device, for example, Patent Document 1 discloses a catheter comprising an outer tube and an inner tube inserted inside the outer tube, with a stent housed in the outer tube, the outer tube being composed of a resin tube with a reinforcing layer embedded therein composed of a reinforcing wire. Patent Document 2 discloses a stent delivery device having an outer sheath, an inner shaft coaxially disposed inside the outer sheath, and a self-expanding stent housed in the outer sheath, the outer sheath being composed of an outer polymer layer, an inner polymer layer, and a wire reinforcement layer positioned therebetween. Patent Document 3 discloses a stent delivery system having a stent, an outer sheath covering the stent, and a pulling member attached to the outer sheath, the distal portion of the pulling member being captured between the outer sheath and a support member, the outer sheath comprising a first layer and a reinforcing layer formed of a polymer material, the captured portion of the pulling member being positioned between the first layer and the reinforcing layer, and a portion of the outer sheath being heat-shrunk onto the support member. Patent Document 3 also discloses a method for obtaining an outer sheath with a stent embedded therein by loading a stent into a sleeve of polymer material that forms an outer sheath and cold-drawing the sleeve of polymer material. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Japanese Patent Application Laid-Open No. 2012-75453 [Patent Document 2] Japanese Patent Application Publication No. 11-313893 [Patent Document 3] Special Publication No. 2013-512705 Summary of the Invention [Problem to be solved by the invention]

[0005] In the manufacture of a medical tubular body delivery device, for example, a tube containing a medical tubular body can be obtained by inserting the medical tubular body into the lumen of a tube. Inserting a medical tubular body into a typical resin tube is relatively easy. On the other hand, when inserting a medical tubular body into a tube having a reinforcing layer made of wire, the medical tubular body is likely to get caught on the inner surface of the tube, or the inner surface of the tube may peel off, causing the medical tubular body to become entangled with the wire that makes up the reinforcing layer. This can lead to a decrease in the manufacturing efficiency of the medical tubular body delivery device. On the other hand, using a tube having a reinforcing layer in which a medical tubular body is internally installed has the advantage of increasing the kink resistance of the tube, making it easier to slide the tube relative to the medical tubular body when placing the medical tubular body in the body.

[0006] The present invention has been made in consideration of the above circumstances, and its object is to provide a method for manufacturing a medical tubular body interior tube that can efficiently obtain a tube with a medical tubular body interior by inserting a medical tubular body into a tube having a reinforcing layer made of wire, and a method for manufacturing a medical tubular body transport device equipped with said medical tubular body interior tube. [Means for solving the problem]

[0007] The method for manufacturing an internal medical tubular tube of the present invention, which has solved the above-mentioned problems, is characterized by comprising the steps of: preparing a medical tubular body that extends in the axial direction and is expandable and contractable in the radial direction; preparing a tube having a first end and a second end in the longitudinal direction and a reinforcing layer made of wire, the tube having a first section that includes the first end and does not have the reinforcing layer, and a second section that is located closer to the second end than the first section and has the reinforcing layer; a first insertion step of inserting the medical tubular body in a reduced diameter state into the tube from the first end side and arranging the medical tubular body in the first section; a second insertion step of moving the medical tubular body arranged in the first section towards the second end within the tube and arranging the medical tubular body in the second section; and a cutting step of cutting the tube at the end of the medical tubular body on the first end side or closer to the first end side while the medical tubular body is arranged in the second section.

[0008] According to the manufacturing method of the medical tubular interior tube of the present invention, in the first insertion step, the medical tubular body is inserted into a first section of a tube that does not have a reinforcing layer, and then in the second insertion step, the medical tubular body is moved from the first section within the tube to a second section that has a reinforcing layer, making it easy to position the medical tubular body in the second section of the tube that has a reinforcing layer. For example, this makes it less likely that the medical tubular body will get caught on the inner surface of the tube or that the medical tubular body will become entangled with the wire that makes up the reinforcing layer. The medical tubular interior tube is then obtained by cutting the tube in the cutting step. Therefore, according to the manufacturing method of the present invention, it is possible to efficiently obtain a medical tubular interior tube in which the medical tubular body is internally inserted into a tube that has a reinforcing layer made of wire.

[0009] It is preferable to provide a step of visually inspecting the medical tubular body placed in the first section after the first insertion step, which makes it possible to check whether the medical tubular body has been damaged when it is inserted into the tube in the first insertion step.

[0010] In the second insertion step, the force used to move the medical tubular body toward the second end within the tube is preferably smaller than the force used to move the medical tubular body toward the second end within the tube in the first insertion step, which makes it less likely that the medical tubular body will get caught on the inner surface of the tube, the inner surface of the tube will be damaged, or the medical tubular body will be broken during the second insertion step.

[0011] In the first and second insertion steps, it is preferable to move the medical tubular body toward the second end within the tube by pushing the reduced-diameter medical tubular body with a rod-shaped member. In this case, for example, the rod-shaped member can be pushed mechanically in the first insertion step and manually in the second insertion step.

[0012] In the cutting step, it is preferable to cut the tube at the end of the reinforcing layer on the first end side or further towards the first end side, which allows the tube to be cut in a portion where no reinforcing layer is present, making cutting the tube easier.

[0013] The present invention also provides a method for manufacturing a medical tubular body delivery device, which method comprises the step of obtaining a tube with a medical tubular body inside by the above-mentioned manufacturing method. The method for manufacturing a medical tubular body delivery device preferably further comprises the step of inserting an inner tube into the tube with the medical tubular body inside, and arranging the inner tube inside the medical tubular body and inside the tube. [Effects of the Invention]

[0014] The method for manufacturing a medical tubular interior tube of the present invention allows for efficient manufacturing of a medical tubular interior tube in which a medical tubular body is interiorly attached to a tube having a reinforcing layer made of wire. Furthermore, the method for manufacturing a medical tubular delivery device of the present invention allows for efficient manufacturing of a medical tubular delivery device equipped with a medical tubular interior tube in which a medical tubular body is interiorly attached to a tube having a reinforcing layer made of wire. [Brief explanation of the drawings]

[0015] [Figure 1] 1 is a schematic diagram showing the overall steps of a method for manufacturing an internal tube for medical use according to an embodiment of the present invention; [Figure 2] 2A and 2B are schematic diagrams illustrating a medical tubular body preparation step, a tube preparation step, and a first insertion step among the overall steps shown in FIG. [Figure 3] 2 shows a schematic diagram of the second insertion step among the overall steps shown in FIG. 1. [Figure 4] 2 shows a schematic diagram of a cutting process among the overall process steps shown in FIG. 1. [Figure 5] 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. [Figure 6] 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. [Figure 7] 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. [Figure 8] 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. [Figure 9] 6 shows an example of a method for manufacturing the shaft portion of the medical tubular body delivery device shown in FIG. 5. [Figure 10] 7 shows an example of a method for manufacturing the shaft portion of the medical tubular body delivery device shown in FIG. 6. [Figure 11] 9 shows an example of a method for manufacturing the shaft portion of the medical tubular body delivery device shown in FIGS. 7 and 8. [Figure 12] 9 shows another example of a method for manufacturing the shaft portion of the medical tubular body delivery device shown in FIGS. DETAILED DESCRIPTION OF THE INVENTION

[0016] The present invention relates to a method for manufacturing a tube equipped with a medical tubular body such as a stent, and a method for manufacturing a medical tubular body delivery device equipped with a tube equipped with a medical tubular body. The medical tubular body delivery device is a medical device that delivers a medical tubular body into the body. The medical tubular body can be used to treat various diseases caused by narrowing or obstruction of internal lumens such as the digestive tract (e.g., bile duct) or blood vessels.

[0017] The medical tubular body has a cylindrical shape and has an axial direction and a radial direction. The medical tubular body used in the present invention extends in the axial direction, is expandable and contractible in the radial direction, and is self-expandable. When the medical tubular body is loaded onto a medical tubular body delivery device and delivered to the lesion, the medical tubular body is placed in the lumen of the tube in a radially contracted state. Once the medical tubular body is delivered to the lesion, the tube is slid relative to the medical tubular body, causing the medical tubular body to be exposed from the tube and self-expand.

[0018] In the manufacture of a medical tubular body delivery device, a medical tubular body is inserted into the lumen of a tube to obtain a tube with an internal medical tubular body. Inserting a medical tubular body into a standard resin tube is relatively easy. For example, a reduced-diameter medical tubular body can be inserted into the tube by pushing it into the lumen of the tube with a rod-shaped member, thereby easily obtaining a tube with an internal medical tubular body. In contrast, when inserting a medical tubular body into a tube with a reinforcing layer made of wire, inserting the medical tubular body in the same manner as inserting a medical tubular body into a standard resin tube can easily cause the medical tubular body to get caught on the inner surface of the tube or peel off, causing the medical tubular body to become entangled with the wire constituting the reinforcing layer. This can reduce the manufacturing efficiency of medical tubular body delivery devices. On the other hand, when a medical tubular body is internally housed in a tube having a reinforcing layer and used in a medical tubular body delivery device, the kink resistance of the tube is increased, which has the advantage of making it easier to slide the tube relative to the medical tubular body when placing the medical tubular body inside the body.

[0019] The present invention provides a manufacturing method that allows for efficient placement of a medical tubular body in the lumen of a tube having a reinforcing layer, as described above, by inserting a medical tubular body into a tube having a reinforcing layer made of wire, thereby obtaining a tube with an internal medical tubular body. The present invention will be described in detail below based on the following embodiments. However, the present invention is not limited to these embodiments and may be modified within the scope of the spirit described above and below, and all such modifications are within the technical scope of the present invention. For convenience, hatching and component reference numbers may be omitted in the drawings. In such cases, reference should be made to the specification and other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as they are intended to facilitate understanding of the features of the present invention.

[0020] A method for producing an interior tubular medical tube according to an embodiment of the present invention will be described with reference to Figures 1 to 4. Figure 1 shows a schematic diagram of the overall steps of the method for producing an interior tubular medical tube according to an embodiment of the present invention, and Figures 2 to 4 show schematic diagrams of each step.

[0021] A method for manufacturing an internal medical tubular tube according to an embodiment of the present invention includes the steps of preparing a medical tubular body (hereinafter sometimes referred to as the "medical tubular body preparation step"), preparing a tube having a reinforcing layer made of wire (hereinafter sometimes referred to as the "tube preparation step"), inserting the medical tubular body into the tube (hereinafter sometimes referred to as the "insertion step"), and cutting the tube with the medical tubular body inserted (hereinafter sometimes referred to as the "cutting step"). The medical tubular body preparation step and the tube preparation step are shown in FIGS. 1(A) and 2, the insertion step is shown in FIGS. 1(A) to 1(C), 2, and 3, and the cutting step is shown in FIGS. 1(C) to 1(D) and 4. For ease of understanding, in FIGS. 1 to 4, the outer edge of the medical tubular body inserted into the tube is represented by a straight line rather than a dotted line.

[0022] In the medical tubular body preparation step, a medical tubular body 11 is prepared. A representative example of the medical tubular body 11 is a stent. Examples of the medical tubular body 11 include a coil-shaped medical tubular body formed from a single linear metal or polymer material, a medical tubular body cut out of a metal tube or a polymer material tube using a laser or the like, a medical tubular body assembled by welding linear members, and a medical tubular body made by weaving multiple linear metals. In addition to stents, other examples of the medical tubular body 11 include a stent graft, an occluder, an injection catheter, and a prosthetic valve.

[0023] The medical tubular body 11 is a so-called self-expanding type that extends in the axial direction and can expand and contract radially. The self-expanding medical tubular body 11 is delivered to the lesion in a state in which expansion is suppressed, and can expand by itself at the lesion by removing the member that suppresses expansion. The tube 12, which will be described later, functions as a member that suppresses the expansion of the medical tubular body 11. When placed in the lumen of the tube 12, the medical tubular body 11 contracts radially and extends axially, thereby assuming a reduced-diameter state that is cylindrical and longer than the expanded state, and when not placed in the lumen of the tube 12, assumes an expanded state in which it expands radially.

[0024] In the tube preparation step, a tube 12 having a reinforcing layer 17 made of wire is prepared. The tube 12 extends in the longitudinal direction and has an inner lumen extending in the longitudinal direction. In the subsequent insertion step, the medical tubular body 11 is inserted into the inner lumen of the tube 12 prepared here.

[0025] The inner diameter of tube 12 is set appropriately depending on the outer diameter of medical tubular body 11 to be inserted (the outer diameter of medical tubular body 11 in a reduced diameter state), and may be, for example, approximately 0.3 mm to 3.5 mm. The longitudinal length of tube 12 is preferably at least 2.0 times, and more preferably 2.5 times, the axial length of medical tubular body 11 in a reduced diameter state. There is no particular upper limit to the longitudinal length of tube 12, and it may be, for example, 3000 mm or less, 2000 mm or less, 1000 mm or less, or 500 mm or less.

[0026] The tube 12 has a first end 13 and a second end 14 in the longitudinal direction, and has a reinforcing layer 17 made of wire rod along part of the longitudinal direction. The tube 12 has a first section 15 that includes the first end 13 and does not have the reinforcing layer 17, and a second section 16 that is located closer to the second end 14 than the first section 15 and has the reinforcing layer 17. The second section 16 is the section in which the medical tubular body 11 will ultimately be placed. The second section 16 is adjacent to the first section 15, and the end of the part of the second section 16 that has the reinforcing layer 17 on the first end 13 side forms the boundary between the first section 15 and the second section 16. The second section 16 may have a section that does not have the reinforcing layer 17.

[0027] The tube 12 is preferably made of resin. The tube 12 preferably has a resin layer in the first section 15 and the second section 16. Examples of resins that may be used to form the tube 12 include synthetic resins such as polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as polyethylene terephthalate, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, polyamide imide resins, fluorine-based resins such as PTFE, PFA, and ETFE, polyvinyl chloride resins, and silicone resins.

[0028] The tube 12 has a reinforcing layer 17 in the second section 16. The reinforcing layer 17 is made of wire material, and examples of the wire material that makes up the reinforcing layer 17 include metal wires and fibers. Examples of materials that make up the metal wire include stainless steel such as SUS304 and SUS316, carbon steel, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys, with stainless steel being preferred. The metal wire may be a solid wire or a twisted wire. Examples of fibers include polyarylate fibers, aramid fibers, ultra-high molecular weight polyethylene fibers, PBO fibers, and carbon fibers. The fibers may be monofilaments or multifilaments.

[0029] The arrangement pattern of the wires in the reinforcing layer 17 is not particularly limited, and examples thereof include a spiral, a mesh, a braid, etc. Among these, it is preferable that the wires in the reinforcing layer 17 be arranged in a braid because the reinforcing layer 17 can effectively increase the rigidity of the tube 12.

[0030] In the first section 15, the tube 12 may be made up of a single layer or multiple layers. For example, in the first section 15, the tube 12 may be made up of a single resin layer or multiple resin layers.

[0031] In the second section 16, the tube 12 is preferably composed of multiple layers, and preferably includes a reinforcing layer 17 and a resin layer. In the second section 16, the tube 12 preferably includes an inner layer and a reinforcing layer 17 disposed on the outer side thereof, and more preferably includes an outer layer on the outer side of the reinforcing layer 17. The inner and outer layers are preferably resin layers made of resin. By configuring the second section 16 in this manner, the slidability of the inner surface of the tube 12 can be improved in the second section 16, making it easier to place the medical tubular body 11 in the second section 16 in the subsequent insertion step. From the perspective of improving the slidability and rigidity of the inner surface of the tube 12 in the second section 16, it is more preferable that the tube 12 has an inner layer in the second section 16 made of a fluorine-based resin, a polyimide resin, or a polyamide-imide resin.

[0032] The tube 12 may be formed so that the inner diameter of the first end 13 is wider than that of the portion therebetween on the side of the second end 14. For example, the tube 12 may be formed so that the portion including the first end 13 expands toward the first end 13 by heating or the like. This makes it easier to insert the medical tubular body 11 into the tube 12 from the side of the first end 13 in the subsequent insertion step.

[0033] In the insertion step, medical tubular body 11 is inserted into the lumen of tube 12. In the present invention, this insertion step is divided into a first insertion step and a second insertion step. As shown in FIGS. 1(A)-(B) and 2, in the first insertion step, medical tubular body 11 in a reduced diameter state is inserted into tube 12 from first end 13, and medical tubular body 11 is positioned in first section 15. Next, as shown in FIGS. 1(B)-(C) and 3, in the second insertion step, medical tubular body 11 positioned in first section 15 is moved toward second end 14 within tube 12, and medical tubular body 11 is positioned in second section 16. Inserting medical tubular body 11 into tube 12 in this manner facilitates positioning medical tubular body 11 in second section 16 of tube 12, which has reinforcing layer 17. For example, the medical tubular body 11 is less likely to get caught on the inner surface of the tube 12 or to become entangled with the wire material that makes up the reinforcing layer 17 .

[0034] In the first insertion step, the medical tubular body 11 in a reduced diameter state is inserted into the tube 12 from the first end 13 side. In the first insertion step, the medical tubular body 11 in a reduced diameter state is inserted into the lumen of the tube 12 so that the axial direction of the medical tubular body 11 coincides with the longitudinal direction of the tube 12. Because the tube 12 does not have a reinforcing layer 17 in the first section 15 including the first end 13, the medical tubular body 11 can be easily inserted into the tube 12 in the same manner as conventional.

[0035] The longitudinal length of first section 15 of tube 12 is preferably longer than the axial length of medical tubular body 11 in the reduced diameter state. Furthermore, in the first insertion step, the entire medical tubular body 11 is preferably disposed in first section 15 of tube 12. The length of first section 15 of tube 12 is, for example, preferably 1.1 times or more, more preferably 1.2 times or more, and preferably 5.0 times or less, more preferably 4.0 times or less, and even more preferably 3.0 times or less, the axial length of medical tubular body 11 in the reduced diameter state.

[0036] In the second insertion step, the medical tubular body 11 disposed in the first section 15 is moved toward the second end 14 within the tube 12, and the medical tubular body 11 is disposed in the second section 16. The medical tubular body 11 is disposed in the section of the tube 12 where the reinforcing layer 17 is provided. By disposing the medical tubular body 11 in a reduced diameter state in the first section 15 of the tube 12 in the first insertion step, the medical tubular body 11 is stably held in the lumen of the tube 12 in a reduced diameter state. Therefore, by moving the medical tubular body 11 in this state toward the second end 14 within the tube 12, the medical tubular body 11 (particularly the end portion of the medical tubular body 11 on the side of the second end 14) is less likely to get caught on the inner surface of the tube 12 in the second section 16, making it easier to move the medical tubular body 11 from the first section 15 to the second section 16.

[0037] The longitudinal length of the section of the second section 16 of the tube 12 where the reinforcing layer 17 is provided is preferably longer than the axial length of the medical tubular body 11 in the contracted state. Furthermore, in the second insertion step, the entire medical tubular body 11 is preferably disposed in the section of the second section 16 of the tube 12 where the reinforcing layer 17 is provided. The length of the section of the second section 16 of the tube 12 where the reinforcing layer 17 is provided is, for example, preferably 1.1 times or more, more preferably 1.2 times or more, and preferably 5.0 times or less, more preferably 4.0 times or less, and even more preferably 3.0 times or less, the axial length of the medical tubular body 11 in the contracted state. There is no particular upper limit to the length of the second section 16 of the tube 12.

[0038] In the first and second insertion steps, it is preferable to use a rod-shaped member to move medical tubular body 11 toward second end 14 within tube 12. This makes it easier to move medical tubular body 11 toward second end 14 within tube 12. The rod-shaped member may be solid or hollow.

[0039] For example, the rod-shaped member can be inserted into tube 12 from first end 13 of tube 12, and medical tubular body 11 can be pushed from first end 13 to move medical tubular body 11 toward second end 14 within tube 12. In this case, the rod-shaped member can have an outer diameter on the second end 14 side that is equal to or smaller than the inner diameter of tube 12 and equal to or larger than the inner diameter of medical tubular body 11 in a contracted state.

[0040] The rod-shaped member may have an outer diameter on the second end 14 side that is equal to or smaller than the inner diameter of the medical tubular body 11 in the contracted state, and an outer diameter on the first end 13 side that is equal to or smaller than the inner diameter of the tube 12 but equal to or larger than the inner diameter of the medical tubular body 11 in the contracted state. In this case, the rod-shaped member has a small-diameter portion on the second end 14 side and a large-diameter portion on the first end 13 side. The rod-shaped member is inserted into the tube 12 from the first end 13 side of the tube 12 with the small-diameter portion leading, and the small-diameter portion of the rod-shaped member passes through the lumen of the medical tubular body 11 and extends out from the second end 14 of the tube 12. The large-diameter portion of the rod-shaped member is in contact with the end of the medical tubular body 11 on the first end 13 side. In this state, by pulling the rod-shaped member extending outward from the second end 14 of the tube 12, the medical tubular body 11 is pushed from the first end 13 side by the large diameter portion of the rod-shaped member, and the medical tubular body 11 can be moved toward the second end 14 side within the tube 12.

[0041] The rod-shaped member used may have an outer diameter approximately the same as the inner diameter of the reduced-diameter medical tubular body 11. In this case, the outer surface of the rod-shaped member preferably has tackiness, and by inserting the rod-shaped member into the reduced-diameter medical tubular body 11, causing the tacky portion of the outer surface of the rod-shaped member to adhere to the inner surface of the medical tubular body 11, and then moving the rod-shaped member toward the second end 14, the medical tubular body 11 can be moved toward the second end 14 within the tube 12 together with the rod-shaped member.

[0042] In the first and second insertion steps, it is preferable to move medical tubular body 11 toward second end 14 within tube 12 by pushing medical tubular body 11 in a reduced diameter state with a rod-shaped member. This makes it easier to move medical tubular body 11 toward second end 14 within tube 12.

[0043] In the second insertion step, the force that moves medical tubular body 11 toward second end 14 within tube 12 is preferably smaller than the force that moves medical tubular body 11 toward second end 14 within tube 12 in the first insertion step. By moving medical tubular body 11 toward second end 14 within tube 12 in this manner, it is less likely that medical tubular body 11 will get caught on the inner surface of tube 12, which could damage the inner surface of tube 12 or break medical tubular body 11. On the other hand, in the first insertion step, even if medical tubular body 11 is pushed in with a relatively strong force, medical tubular body 11 can be moved smoothly toward second end 14 without getting caught on the inner surface of tube 12. Rather, in the first insertion step, when medical tubular body 11 is inserted into tube 12, medical tubular body 11 tends to expand, which tends to create a large resistance between medical tubular body 11 and first end 13 of tube 12. Therefore, by pushing medical tubular body 11 with a relatively strong force, it becomes easier to insert medical tubular body 11 into tube 12. The force that moves medical tubular body 11 toward second end 14 within tube 12 in the second insertion step is, for example, preferably 0.8 times or less, more preferably 0.7 times or less, and even more preferably 0.6 times or less, the force that moves medical tubular body 11 toward second end 14 within tube 12 in the first insertion step.

[0044] In the first and second insertion steps, when the rod-shaped member is used to push the reduced-diameter medical tubular body 11, the rod-shaped member may be pushed mechanically or manually. In the first insertion step, pushing the rod-shaped member mechanically is preferred, as this facilitates inserting the medical tubular body 11 into the tube 12. In the second insertion step, the rod-shaped member may be pushed mechanically or manually. Pushing the rod-shaped member manually in the second insertion step is preferred because it allows the user to sense when the medical tubular body 11 gets caught on the inner surface of the tube 12 by touch. In this case, pushing the medical tubular body 11 more carefully with the rod-shaped member can prevent damage to the inner surface of the tube 12 or breakage of the medical tubular body 11. This reduces the occurrence of defective products and increases yield during the production of the medical tubular interior tube 20.

[0045] 1(C) to 1(D) and 4, in the cutting step, with medical tubular body 11 disposed in second section 16, tube 12 is cut at the end of medical tubular body 11 on the side of first end 13 or closer to first end 13. This makes it possible to obtain tube 12 with medical tubular body 11 inside, in which medical tubular body 11 is disposed in the section of tube 12 where reinforcing layer 17 is provided.

[0046] In the cutting step, the tube 12 can be cut by cutting means 18 such as a cutter, laser light, or heat wire. In the cutting step, the tube 12 is preferably cut approximately perpendicular to the longitudinal direction.

[0047] The cutting position of tube 12 is preferably within 50 mm, more preferably within 30 mm, and even more preferably within 20 mm from the end on the first end 13 side of medical tubular body 11 arranged in second section 16. This allows medical tubular body 11 to be easily exposed from tube 12 by pulling tube 12 toward second end 14 relative to medical tubular body 11 when performing treatment using a medical tubular body delivery device assembled from medical tubular body internal tube 20.

[0048] In the cutting step, with medical tubular body 11 positioned in second section 16, tube 12 is preferably cut at the end of reinforcing layer 17 on the first end 13 side or closer to first end 13. That is, tube 12 is preferably cut in a portion where reinforcing layer 17 is not present. This makes it easier to cut tube 12. Furthermore, when tube 12 is cut, there is no risk that the wire constituting reinforcing layer 17 will protrude from the end of tube 12 on the first end 13 side. Therefore, when a medical tubular body delivery device assembled from medical tubular body interior tube 20 is used for treatment, it is possible to prevent the wire of reinforcing layer 17 from damaging the body lumen. In this case, the cutting position of tube 12 is preferably within 30 mm, more preferably within 20 mm, and even more preferably within 10 mm from the end of reinforcing layer 17 on the first end 13 side.

[0049] In the manufacturing method of the medical tubular interior tube of the present invention, it is preferable to perform a visual inspection to confirm that the medical tubular body 11 is not damaged when the medical tubular body 11 is inserted into the tube 12 in the first insertion step. The medical tubular body 11 is ultimately placed in the second section 16 of the tube 12, but because the second section 16 has a reinforcing layer 17, it is difficult to perform a visual inspection of the medical tubular body 11 placed in the second section 16 from outside the tube 12. For this reason, it is preferable to perform the visual inspection on the medical tubular body 11 placed in the first section 15. Therefore, the manufacturing method of the medical tubular interior tube 20 of the present invention preferably includes a step of performing a visual inspection of the medical tubular body 11 placed in the first section 15 after the first insertion step (hereinafter, sometimes referred to as the "visual inspection step"). It is preferable to perform the visual inspection of the medical tubular body 11 in the visual inspection step to confirm that the medical tubular body 11 is not damaged, before performing the second insertion step.

[0050] In the visual inspection step, the medical tubular body 11 placed in the first section 15 is visually inspected from outside the tube 12. The visual inspection may be performed visually, or may be performed using a microscope. Alternatively, the visual inspection may be performed by taking a photograph with a camera and then performing image diagnosis. If no damage is found in the medical tubular body 11 placed in the first section 15 through the visual inspection, the second insertion step is preferably performed.

[0051] Next, a method for manufacturing a medical tubular body delivery device according to an embodiment of the present invention will be described. The method for manufacturing a medical tubular body delivery device according to an embodiment of the present invention includes the step of obtaining a tube with an internal medical tubular body by the above-described method for manufacturing an internal medical tubular body tube.

[0052] The medical tubular body delivery device has a shaft portion equipped with an internal tube for a medical tubular body. The shaft portion is an elongated member extending in the longitudinal direction, and a proximal side and a distal side are defined in the longitudinal direction. In the medical tubular body delivery device, the proximal side refers to the side closer to the user's hand, and the distal side refers to the opposite side of the proximal side, i.e., the side toward the treatment target. For example, in the case of endoscopic treatment, the shaft portion is inserted into the forceps channel through the forceps port of the endoscope and delivered to the lesion. A control unit is preferably provided on the proximal side of the shaft portion, and by operating the control unit, the tube can be slid relative to the medical tubular body inside the patient's body. This allows the medical tubular body to be exposed from the tube and placed inside the body. In the following description, the medical tubular body delivery device may be simply referred to as the "delivery device." Furthermore, the tube of the internal tube for a medical tubular body described above will be referred to as the "outer tube."

[0053] The shaft portion preferably has an outer tube and an inner tube disposed in the lumen of the outer tube, with the medical tubular body being disposed between the outer tube and the inner tube. This allows the medical tubular body to be stably held in the lumen of the outer tube. Furthermore, when placing the medical tubular body in the body, the outer tube can be pulled proximally to easily and stably expose the medical tubular body. The longitudinal length of the shaft portion may be, for example, approximately 800 mm to 3000 mm.

[0054] The outer tube may be disposed at least in the distal portion of the shaft and extend to the proximal portion of the shaft. For example, when the shaft is divided into thirds in the longitudinal direction, the outer tube may be disposed so as to extend from at least a portion of the distal one-third of the shaft to at least a portion of the proximal one-third of the shaft, or may be disposed in at least a portion of the distal one-third of the shaft but not in the proximal two-thirds of the shaft. In the latter embodiment, the outer tube is preferably capable of being pulled proximally via another member.

[0055] The inner tube may be disposed at least at the distal portion of the shaft and extend to the proximal portion of the shaft. The lumen of the inner tube may serve as a passageway for a guidewire. In over-the-wire delivery devices, the inner tube preferably extends from the distal portion of the shaft to the proximal portion of the shaft, and in rapid exchange delivery devices, the inner tube preferably extends from the distal portion of the shaft to partway to the proximal portion of the shaft.

[0056] The inner tube is preferably provided with a stopper on the proximal side of the medical tubular body. The stopper is attached to the outer surface of the inner tube. The stopper is positioned so that it abuts against the proximal end of the medical tubular body or is positioned near the proximal end of the medical tubular body. For example, it is preferable that the portion of the stopper that abuts against the proximal end of the medical tubular body is positioned within 10 mm proximally of the proximal end of the medical tubular body. By providing a stopper on the proximal side of the medical tubular body, when the outer tube is pulled proximally, the medical tubular body is prevented from being pulled proximally together with the outer tube, making it easier to expose the medical tubular body to the outside of the shaft portion.

[0057] A distal tip is preferably provided at the distal end of the inner tube. The distal tip preferably has an inner lumen that communicates with the inner lumen of the inner tube. The distal tip constitutes the distal end of the shaft, which prevents the tip of the shaft from damaging the body lumen when the shaft is inserted into the forceps channel of the endoscope and delivered to the lesion. This also improves the ability of the shaft to follow the preceding guidewire and forceps channel and the ability of the tip of the shaft to be delivered to the lesion, thereby improving the operability of the delivery device.

[0058] The shaft portion may have a tubular member other than the outer tube and the inner tube. For example, a traction tube may be provided connected to the proximal end of the outer tube, a protective tube may be provided on the outside of the outer tube or the traction tube, or an intermediate tube may be provided between the outer tube and the inner tube and proximal to the medical tubular body.

[0059] When the outer tube does not extend to the proximal end of the shaft, the traction tube is connected to the proximal end of the outer tube. In this case, the outer surface of the distal end of the traction tube is preferably joined to the inner surface of the proximal end of the outer tube, thereby reducing the outer diameter of the traction tube. By pulling the traction tube proximally, the outer tube can be moved proximally and the medical tubular body can be exposed outside the shaft.

[0060] The protective tube is provided on the outside of the outer tube so as to cover a portion of the outer tube in the longitudinal direction, or on the outside of the traction tube so as to cover a portion of the traction tube in the longitudinal direction. When the outer tube is pulled proximally to place the medical tubular object in the body, it is preferable that the portion of the outer tube or traction tube not covered by the protective tube is retracted into the lumen of the protective tube. This reduces the generation of frictional resistance caused by contact between the outer tube or traction tube and the forceps channel or forceps port of the endoscope when the outer tube is pulled proximally. This reduces the operating load when pulling the outer tube proximally, allowing the medical tubular object to be deployed stably. Furthermore, when pulling the outer tube proximally, the entire shaft portion can be prevented from moving proximally, allowing the medical tubular object to be placed accurately at the desired position.

[0061] When a protective tube is provided as described above, a linear traction member may be attached to the proximal end of the outer tube or the proximal end of the traction tube. The linear traction member preferably extends to the proximal end of the shaft portion, and by pulling the linear traction member proximally, the outer tube can be moved proximally and the medical tubular body can be exposed outside the shaft portion.

[0062] The intermediate tube can be provided to function as the stopper described above. In this case, instead of providing a stopper on the inner tube, the intermediate tube is provided so as to extend proximally from or near the proximal end of the medical tubular body. The distal end of the intermediate tube preferably abuts the proximal end of the medical tubular body or is located within 10 mm proximally of the proximal end of the medical tubular body, and the intermediate tube preferably extends to the proximal portion of the shaft portion.

[0063] Examples of the configuration of the shaft portion of the delivery device are shown in Figures 5 to 8. Note that the configuration of the shaft portion is not limited to the embodiments shown in the drawings. In Figures 5 to 8, the right side of the drawing corresponds to the proximal side of the delivery device and shaft portion, and the left side of the drawing corresponds to the distal side of the delivery device and shaft portion.

[0064] The shaft portion 21 shown in Fig. 5 has an outer tube 22 and an inner tube 23 disposed in the lumen of the outer tube 22. At the distal portion of the shaft portion 21, a medical tubular body 11 in a reduced diameter state is disposed between the outer tube 22 and the inner tube 23. The outer tube 22 is an inner tube 20 for a medical tubular body.

[0065] The inner tube 23 extends from the distal to the proximal portion of the shaft portion 21, providing an over-the-wire type delivery device. The outer tube 22 extends from the distal to the proximal portion of the shaft portion 21, with the inner tube 23 extending proximally beyond the proximal end of the outer tube 22. A tip 25 is provided at the distal end of the inner tube 23, and a stopper 24 is provided on the outer surface of the inner tube 23 on the proximal side of the medical tubular body 11. The outer tube 22 is slidable longitudinally relative to the inner tube 23. In the delivery device including the shaft portion 21 shown in FIG. 5, by pulling the outer tube 22 proximally, the medical tubular body 11 is exposed outside the shaft portion 21, allowing the medical tubular body 11 to be placed in the body.

[0066] The shaft portion 21 shown in Figure 6 has an outer tube 22, an inner tube 23 disposed in the lumen of the outer tube 22, and an intermediate tube 26 disposed between the outer tube 22 and the inner tube 23. A medical tubular body 11 in a reduced diameter state is disposed between the outer tube 22 and the inner tube 23 at the distal portion of the shaft portion 21. The outer tube 22 serves as an inner tube 20 for a medical tubular body. A stopper 24 is provided at the distal end of the intermediate tube 26.

[0067] The inner tube 23 extends from the distal end to the proximal end of the shaft 21, providing an over-the-wire delivery device. The outer tube 22 extends from the distal end to the proximal end of the shaft 21, with the inner tube 23 extending proximally beyond the proximal end of the outer tube 22. A distal tip 25 is provided at the distal end of the inner tube 23. The intermediate tube 26 is positioned proximal to the medical tubular body 11 and preferably extends proximally beyond the proximal end of the outer tube 22. The distal end of the intermediate tube 26 preferably abuts the proximal end of the medical tubular body 11 or is positioned within 10 mm proximal of the proximal end of the medical tubular body 11. The intermediate tube 26 is fixed relative to the inner tube 23, and the outer tube 22 is longitudinally slidable relative to the inner tube 23 and intermediate tube 26. In the delivery device equipped with the shaft portion 21 shown in Figure 6, by pulling the outer tube 22 proximally, the medical tubular body 11 is exposed to the outside of the shaft portion 21, and the medical tubular body 11 can be placed inside the body.

[0068] 7 has an outer tube 22, a traction tube 27 connected to the proximal portion of the outer tube 22, an inner tube 23 disposed in the lumen of the outer tube 22 and the lumen of the traction tube 27, and a protective tube 28 disposed on the outside of the traction tube 27. At the distal portion of the shaft 21, a medical tubular body 11 in a reduced diameter state is disposed between the outer tube 22 and the inner tube 23. The outer tube 22 serves as an inner tube 20 for a medical tubular body.

[0069] The inner tube 23 extends from the distal portion to the proximal portion of the shaft portion 21, providing an over-the-wire type delivery device. The outer tube 22 is disposed only on the distal portion of the shaft portion 21. The traction tube 27, connected to the proximal portion of the outer tube 22, extends proximally from the proximal end of the outer tube 22 to the proximal portion of the shaft portion 21. The inner tube 23 extends proximally beyond the proximal end of the traction tube 27. The protective tube 28 is disposed so as to cover only a portion of the traction tube 27, and the traction tube 27 extends distally beyond the distal end of the protective tube 28 and proximally beyond the proximal end of the protective tube 28. A tip 25 is disposed at the distal end of the inner tube 23, and a stopper 24 is disposed on the outer surface of the inner tube 23 on the proximal side of the medical tubular body 11. The outer tube 22 and the pulling tube 27 are slidable in the longitudinal direction relative to the protective tube 28 and the inner tube 23. In the delivery device equipped with the shaft portion 21 shown in Figure 7, by pulling the pulling tube 27 proximally, the outer tube 22 moves proximally, exposing the medical tubular body 11 to the outside of the shaft portion 21, and the medical tubular body 11 can be placed in the body.

[0070] The shaft portion 21 shown in Figure 8 comprises an outer tube 22, a traction tube 27 connected to a proximal portion of the outer tube 22, a protective tube 28 disposed outside the traction tube 27 and extending proximally beyond the proximal end of the traction tube 27, an inner tube 23 disposed in the lumen of the outer tube 22, the lumen of the traction tube 27, and the lumen of the protective tube 28, and a linear traction member 29 attached to the proximal portion of the traction tube 27 and disposed in the lumen of the protective tube 28. A medical tubular body 11 in a reduced diameter state is disposed between the outer tube 22 and the inner tube 23 at the distal portion of the shaft portion 21. The outer tube 22 serves as an inner tube 20 for a medical tubular body.

[0071] The inner tube 23 extends partway from the distal portion to the proximal portion of the shaft 21, providing a rapid exchange type delivery device. Alternatively, the inner tube 23 can be configured to extend from the distal portion to the proximal portion of the shaft 21 to provide an over-the-wire type delivery device. The outer tube 22 is disposed only in the distal portion of the shaft 21, and the traction tube 27 connected to the proximal portion of the outer tube 22 extends proximally from the proximal end of the outer tube 22 to partway to the proximal portion of the shaft 21. The linear traction member 29 attached to the proximal portion of the traction tube 27 extends proximally from the proximal end of the traction tube 27 to the proximal portion of the shaft 21. The protective tube 28 is provided to cover a portion of the traction tube 27 and a portion of the linear traction member 29, and the linear traction member 29 extends proximally from the proximal end of the protective tube 28. A tip 25 is provided at the distal end of inner tube 23, and a stopper 24 is provided on the outer surface of inner tube 23 on the proximal side of medical tubular body 11. Outer tube 22 and traction tube 27 are slidable in the longitudinal direction relative to protective tube 28 and inner tube 23. Furthermore, linear traction member 29 is not fixed relative to protective tube 28. In the delivery device equipped with shaft portion 21 shown in FIG. 8, by pulling linear traction member 29 proximally, outer tube 22 moves proximally and medical tubular body 11 is exposed outside shaft portion 21, allowing medical tubular body 11 to be placed in the body.

[0072] 5 to 8, the medical tubular body 11 is disposed between the outer tube 22 and the inner tube 23. In this case, the method of manufacturing the delivery device may first involve performing the above-described step of obtaining the medical tubular body interior tube 20 to obtain the outer tube 22 with the medical tubular body 11 inside, and then inserting the inner tube 23 into the outer tube 22 with the medical tubular body 11 inside, and disposing the inner tube 23 inside the medical tubular body 11 and the outer tube 22; alternatively, the inner tube 23 may first be inserted into the outer tube 22, and then performing the above-described step of obtaining the medical tubular body interior tube 20 to dispose the medical tubular body 11 inside the outer tube 22 and outside the inner tube 23. Note that the former method of manufacturing the delivery device is preferred because it is easier to dispose the medical tubular body 11 in the lumen of the outer tube 22. That is, after performing the step of obtaining the outer tube 22 having the medical tubular body 11 inside, it is preferable to perform the step of inserting the inner tube 23 into the outer tube 22 having the medical tubular body 11 inside, and arranging the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22.

[0073] Specific examples of methods for producing the above-described medical tubular body will be described with reference to Figures 9 to 12. Figures 9 to 12 show examples of methods for producing the shaft portion shown in Figures 5 to 8. Note that the method for producing the medical tubular body of the present invention is not limited to the embodiments shown in the drawings. In Figures 9 to 12, the right side of the drawing corresponds to the proximal side of the shaft portion, and the left side of the drawing corresponds to the distal side of the shaft portion.

[0074] 9 shows an example of a method for manufacturing the shaft portion 21 shown in FIG. 5. When the shaft portion 21 has an outer tube 22 and an inner tube 23, as shown in FIG. 9, it is preferable to prepare the outer tube 22 in which the medical tubular body 11 is housed, and then insert the inner tube 23 into the outer tube 22 in which the medical tubular body 11 is housed, so that the inner tube 23 is disposed inside the medical tubular body 11 and inside the outer tube 22. When a stopper 24 is provided on the outer surface of the inner tube 23, it is preferable to insert the inner tube 23 with the stopper 24 from the proximal side of the outer tube 22 in which the medical tubular body 11 is housed. It is also preferable to attach a tip 25 to the distal end of the inner tube 23 after disposing the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22.

[0075] 10 shows an example of a method for manufacturing the shaft portion 21 shown in FIG. 6. When the shaft portion 21 has an outer tube 22, an inner tube 23, and an intermediate tube 26, as shown in FIG. 10, it is preferable to insert the inner tube 23 into the outer tube 22 in which the medical tubular body 11 is disposed, and then position the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22. Then, the intermediate tube 26 is inserted from the proximal side of the outer tube 22, and positioned inside the outer tube 22 and outside the inner tube 23. It is preferable to insert the intermediate tube 26 up to or near the proximal end of the medical tubular body 11 disposed inside the outer tube 22. It is also preferable to position the intermediate tube 26 inside the outer tube 22 and outside the inner tube 23, and then fix the intermediate tube 26 to the inner tube 23 directly or via another member.

[0076] 10 , the inner tube 23 with a distal tip 25 attached to its distal end is inserted into the outer tube 22 housing the medical tubular body 11, in which case it is preferable to insert the inner tube 23 from the distal side of the outer tube 22. On the other hand, although not shown in the drawing, the inner tube 23 without the distal tip 25 attached may also be inserted into the outer tube 22 housing the medical tubular body 11, in which case the inner tube 23 may be inserted from either the distal side or the proximal side of the outer tube 22. It is preferable to attach the distal tip 25 to the distal end of the inner tube 23 after inserting the inner tube 23 into the outer tube 22.

[0077] Figures 11 and 12 show an example of a method for manufacturing the shaft portion 21 shown in Figures 7 and 8. When the shaft portion 21 has an outer tube 22, an inner tube 23, and a pulling tube 27, the shaft portion 21 can be manufactured by inserting the inner tube 23 into the outer tube 22 in which the medical tubular body 11 is installed, and arranging the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22, as shown in Figures 11 and 12.

[0078] 11 , the inner tube 23 provided with the stopper 24 is inserted from the proximal side of the outer tube 22 in which the medical tubular body 11 is housed, and the inner tube 23 is then positioned inside the medical tubular body 11 and inside the outer tube 22, and a tip 25 is attached to the distal end of the inner tube 23. On the other hand, in FIG. 12 , a stopper 24 with a long length in the longitudinal direction is used. In such a case, the inner tube 23 can be positioned inside the medical tubular body 11 and inside the outer tube 22, and then the stopper 24 can be inserted from the proximal side of the outer tube 22, and the stopper 24 can be positioned inside the outer tube 22 and outside the inner tube 23, and then the stopper 24 can be attached to the inner tube 23.

[0079] 12, the inner tube 23 with a distal tip 25 attached to its distal end is inserted into the outer tube 22 housing the medical tubular body 11, in which case it is preferable to insert the inner tube 23 from the distal side of the outer tube 22. On the other hand, in FIG. 12, the inner tube 23 without the distal tip 25 attached can also be inserted into the outer tube 22 housing the medical tubular body 11, in which case it may be inserted from either the distal side or the proximal side of the outer tube 22. It is preferable to attach the distal tip 25 to the distal end of the inner tube 23 after inserting the inner tube 23 into the outer tube 22.

[0080] In Figures 11 and 12, the inner tube 23 is placed inside the medical tubular body 11 and inside the outer tube 22, and then the traction tube 27 is joined to the proximal portion of the outer tube 22. However, it is also possible to first join the traction tube 27 to the proximal portion of the outer tube 22, and then insert the inner tube 23 into the outer tube 22 in which the medical tubular body 11 is housed.

[0081] 11 and 12 , the traction tube 27 may be joined to the proximal portion of the outer tube 22, and then the linear traction member 29 may be attached to the traction tube 27, or the traction tube 27 to which the linear traction member 29 is attached may be joined to the proximal portion of the outer tube 22. The traction tube 27 may be joined to the proximal portion of the outer tube 22 with a portion of it disposed in the lumen of the protective tube 28, or the traction tube 27 may be joined to the proximal portion of the outer tube 22, and then a portion of the traction tube 27 may be disposed in the lumen of the protective tube 28. Note that, in terms of ease of joining the traction tube 27 to the proximal portion of the outer tube 22, it is preferable to join the traction tube 27 to the proximal portion of the outer tube 22, and then dispose a portion of the traction tube 27 in the lumen of the protective tube 28.

[0082] The components that make up the shaft portion will now be described. Each component that makes up the shaft portion can be made of resin, metal, or a composite material of these. It is also preferable that each of these materials is biocompatible. The components can be joined by known joining methods such as bonding with an adhesive, welding, or fitting.

[0083] Examples of resin materials include synthetic resins such as polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as polyethylene terephthalate, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, polyamide imide resins, fluorine-based resins such as PTFE, PFA, and ETFE, polyvinyl chloride resins, and silicone resins. Examples of metal materials include stainless steels such as SUS304 and SUS316, carbon steel, platinum, nickel, cobalt, chromium, titanium, tungsten, gold, nickel-titanium alloys, cobalt-chromium alloys, and tungsten alloys.

[0084] The inner tube, traction tube, protective tube, and intermediate tube may be formed into a tubular shape and may be composed of a single layer or multiple layers. Each of these tubes may be composed of different materials in one longitudinal portion and the other longitudinal portion, or may have a single layer and multiple layers in the other longitudinal portion. The inner tube, traction tube, protective tube, and intermediate tube may have the reinforcing layer described above. For details of the outer tube, see the description of the medical tubular body interior tube described above.

[0085] The linear traction member is preferably made of a thread formed from a metal wire or a synthetic resin. The linear traction member may be a composite made of multiple materials, for example, a composite of metal and synthetic resin. The linear traction member may be made of a metal wire coated with resin.

[0086] The distal tip is preferably made of an elastomer resin. Preferred examples of elastomer resins include polyurethane resin, polyester resin, and polyamide resin, and polyamide resin is particularly preferred. By configuring the distal tip in this manner, the followability of the distal tip to the guidewire and the safety of the distal end of the shaft portion can be improved.

[0087] The shape of the stopper can be, for example, a ring shape. The outer diameter of the stopper is preferably equal to or smaller than the inner diameter of the outer tube and equal to or larger than the inner diameter of the medical tubular body in the contracted state. The stopper can be made of resin, metal, or a composite material thereof. For specific examples of each of these materials, see the explanation of the constituent materials of the shaft portion above. In particular, the stopper is preferably made of an elastomer resin, which can prevent deformation or damage to the medical tubular body when the stopper comes into contact with the medical tubular body. Polyamide resin is preferably used as the elastomer resin, which increases the rigidity of the stopper and allows the stopper to support the proximal end of the medical tubular body and effectively deploy the medical tubular body.

[0088] The shaft portion may be provided with a radiopaque marker. By providing the radiopaque marker on the shaft portion, the position of the shaft portion within the body can be confirmed under X-ray fluoroscopy using the radiopaque marker as a guide. The radiopaque marker is preferably provided near the location on the shaft portion where the medical tubular body is placed, and is preferably provided on the distal tip, stopper, or outer tube. By providing the radiopaque marker on the distal tip, the position of the distal end of the shaft portion can be confirmed under X-ray fluoroscopy. Furthermore, by providing the radiopaque marker on the stopper, the position and extrusion state of the medical tubular body can be confirmed under X-ray fluoroscopy. When the radiopaque marker is provided on the outer tube, the timing when the medical tubular body is exposed from the outer tube can be determined under X-ray fluoroscopy. The number of radiopaque markers provided may be one or more. [Explanation of symbols]

[0089] 11: Medical tubular body 12: Tube 13: 1st end 14:Second end 15: First Section 16: Second Section 17: Reinforcement layer 18: Cutting means 20: Medical tubular body inner tube 21: Shaft section 22: Outer tube 23: Inner tube 24: Stopper 25: Tip 26: Intermediate tube 27: Towing tube 28: Protective tube 29: Linear traction member

Claims

1. providing an axially extending, radially expandable and contractible medical tubular body; a step of preparing a tube having a first end and a second end in a longitudinal direction and a reinforcing layer made of wire material, the tube having a first section including the first end and not having the reinforcing layer, and a second section located closer to the second end than the first section and having the reinforcing layer; a first insertion step of inserting the reduced-diameter medical tubular body into the tube from the first end side and arranging the medical tubular body in a first section; a second insertion step of moving the medical tubular body disposed in the first section toward the second end within the tube and disposing the medical tubular body in the second section; a cutting step of cutting the tube at the end of the medical tubular body on the first end side or further toward the first end side while the medical tubular body is disposed in the second section; A method for manufacturing an internal tube for medical use.

2. 2. The method for manufacturing an internal tube for medical use according to claim 1, further comprising a step of visually inspecting the medical tubular body disposed in the first section after the first insertion step.

3. 3. A method for manufacturing a medical tubular interior tube according to claim 1, wherein the force that moves the medical tubular body toward the second end within the tube in the second insertion step is smaller than the force that moves the medical tubular body toward the second end within the tube in the first insertion step.

4. In the first insertion step and the second insertion step, the medical tubular body in a reduced diameter state is pushed by a rod-shaped member to move the medical tubular body toward the second end within the tube; In the first insertion step, the rod-shaped member is pushed by a machine; 4. The method for manufacturing an interior tube for medical tubular bodies according to claim 1, wherein the rod-shaped member is pushed by human force in the second insertion step.

5. A method for manufacturing a medical tubular interior tube according to any one of claims 1 to 4, wherein in the cutting step, the tube is cut at the end of the reinforcing layer on the first end side or closer to the first end.

6. A method for producing a medical tubular body delivery device, comprising the step of obtaining a tube having a medical tubular body inside by the method according to any one of claims 1 to 5.

7. 7. The method for manufacturing a medical tubular body delivery device according to claim 6, further comprising the step of inserting an inner tube into a tube in which the medical tubular body is housed, and positioning the inner tube inside the medical tubular body and inside the tube.

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