JP7803755B2 - Manufacturing method for medical tubular interior tube and manufacturing method for medical tubular delivery device - Google Patents

Description

The present invention relates to a method for manufacturing a tube equipped with a medical tubular object such as a stent, and a method for manufacturing a medical tubular object delivery device.

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 left in place at the lesion to expand the lesion, such as a narrowed or obstructed area, from the inside and maintain the inner diameter of the body lumen, and those that entangle and remove thrombus that has developed at or around the lesion, restoring the inner diameter of the body lumen at the lesion.

As an example of a medical tubular body delivery device, Patent Document 1 discloses a catheter comprising an outer tube and an inner tube inserted therein, the outer tube containing a stent, 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 within the outer sheath, and a self-expanding stent housed within the outer sheath, the outer sheath being composed of an outer polymer layer, an inner polymer layer, and a wire reinforcing 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 from 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-stretching the sleeve of polymer material.

JP 2012-75453 A Japanese Patent Application Publication No. 11-313893 Special Publication No. 2013-512705

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 regular resin tube is relatively easy. On the other hand, when inserting a medical tubular body into a tube with 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 reduce the manufacturing efficiency of medical tubular body delivery devices. On the other hand, using a tube with a reinforcing layer containing a medical tubular body for a medical tubular body delivery device 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 inside the body.

The present invention was made in consideration of the above circumstances, and its purpose is to provide a method for manufacturing a medical tubular body interior tube that can efficiently obtain a tube with a medical tubular body inside 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 delivery device equipped with such a medical tubular body interior tube.

The manufacturing method for an internal medical tubular body of the present invention, which solves the above-mentioned problems, is characterized by 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 contracted state into the tube from the first end side and positioning the medical tubular body in the first section; a second insertion step of moving the medical tubular body positioned in the first section toward the second end within the tube and positioning 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.

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. 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 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 a medical tubular body is internally inserted into a tube that has a reinforcing layer made of wire.

It is preferable to include a step of visually inspecting the medical tubular body placed in the first section after the first insertion step. This makes it possible to check whether the medical tubular body was damaged when it was inserted into the tube in the first insertion step.

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. This 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.

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.

In the cutting process, 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. This allows the tube to be cut in a portion where no reinforcing layer is present, making cutting the tube easier.

The present invention also provides a method for manufacturing a medical tubular body delivery device, which includes the step of obtaining a tube with a medical tubular body inside using the above-mentioned manufacturing method. Preferably, the method for manufacturing a medical tubular body delivery device further includes the step of inserting an inner tube into the tube with a medical tubular body inside, and arranging the inner tube inside the medical tubular body and inside the tube.

The manufacturing method for a medical tubular interior tube of the present invention allows for the efficient production of a medical tubular interior tube in which a medical tubular body is internally disposed within a tube having a reinforcing layer made of wire. Furthermore, the manufacturing method for a medical tubular delivery device of the present invention allows for the efficient production of a medical tubular body delivery device equipped with a medical tubular interior tube in which a medical tubular body is internally disposed within a tube having a reinforcing layer made of wire.

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; 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. 1. 2 is a schematic diagram of a second insertion step among the overall steps shown in FIG. 1 . 2 is a schematic diagram of a cutting step among the overall steps shown in FIG. 1 . 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. 1 shows an example of the configuration of a shaft portion of a medical tubular body transport device. 6 shows an example of a method for manufacturing the shaft portion of the medical tubular body transport device shown in FIG. 5 . 7 shows an example of a method for manufacturing the shaft portion of the medical tubular body transport device shown in FIG. 6 . 9 shows an example of a method for manufacturing the shaft portion of the medical tubular body transport device shown in FIGS. 7 and 8. 9 shows another example of a method for manufacturing the shaft portion of the medical tubular body transport device shown in FIGS. 7 and 8.

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 medical tubular bodies into the body. By using medical tubular bodies, it is possible to treat various diseases caused by narrowing or obstruction of internal lumens such as the digestive tract, including the bile duct, or blood vessels.

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, it is placed in the lumen of the tube in a radially contracted state. Once the medical tubular body has been 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.

In the manufacture of medical tubular body delivery devices, 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, 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 way 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 the inner surface of the tube can peel off, causing the medical tubular body to become entangled with the wire that makes up the reinforcing layer. This can easily reduce the manufacturing efficiency of medical tubular body delivery devices. On the other hand, when a medical tubular body is housed inside a tube with 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.

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 to obtain 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 the following embodiments, and appropriate modifications can be made within the scope of the spirit described above and below, all of which 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 or other drawings. The dimensions of various components in the drawings may differ from their actual dimensions, as priority is given to aiding understanding of the features of the present invention.

A method for manufacturing an internal medical tubular body 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 in the method for manufacturing an internal medical tubular body tube according to an embodiment of the present invention, and Figures 2 to 4 show schematic diagrams of each step.

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 composed of wire (hereinafter sometimes referred to as the "tube preparation step"), inserting a 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 tube preparation step are shown in Figures 1(A) and 2, the insertion step is shown in Figures 1(A)-(C), 2, and 3, and the cutting step is shown in Figures 1(C)-(D) and 4. For ease of understanding, in Figures 1-4, the outer edge of the medical tubular body is represented by a straight line rather than a dotted line, even when inserted into the tube.

In the medical tubular body preparation step, a medical tubular body 11 is prepared. A typical 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 tube made of a polymer material 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 stent grafts, occluders, injection catheters, prosthetic valves, etc.

The medical tubular body 11 is a so-called self-expanding type that extends axially and can expand and contract radially. The self-expanding medical tubular body 11 is delivered to the lesion in a state where expansion is suppressed, and can expand on its own by removing the member that suppresses expansion at the lesion. The tube 12, described below, 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 contracted state that is cylindrical and longer than the expanded state. When not placed in the lumen of the tube 12, the medical tubular body 11 assumes an expanded state in which it expands radially.

In the tube preparation process, a tube 12 is prepared, which has a reinforcing layer 17 made of wire. The tube 12 extends in the longitudinal direction and has an inner lumen that also extends in the longitudinal direction. In the subsequent insertion process, the medical tubular body 11 is inserted into the inner lumen of the tube 12 prepared here.

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

The tube 12 has a first end 13 and a second end 14 in the longitudinal direction, and a reinforcing layer 17 made of wire material 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.

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 make the tube 12 include 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 synthetic resins such as silicone resins.

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 wire and fiber. Examples of materials that can be used to make 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 can be solid or twisted. Examples of fibers include polyarylate fiber, aramid fiber, ultra-high molecular weight polyethylene fiber, PBO fiber, and carbon fiber. The fiber can be monofilament or multifilament.

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

In the first section 15, the tube 12 may be composed of a single layer or multiple layers. For example, in the first section 15, the tube 12 may be composed of a single resin layer or multiple resin layers.

In the second section 16, the tube 12 is preferably composed of multiple layers, and preferably has a reinforcing layer 17 and a resin layer. In the second section 16, the tube 12 preferably has an inner layer and a reinforcing layer 17 disposed on the outer side thereof, and more preferably has 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 process. 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, polyimide resin, or polyamide-imide resin.

The tube 12 may be formed so that the inner diameter of the first end 13 is wider than that of the portion thereof toward 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, for example. This makes it easier to insert the medical tubular body 11 into the tube 12 from the first end 13 side in the subsequent insertion step.

In the insertion step, the medical tubular body 11 is inserted into the lumen of the tube 12. In this case, the present invention provides a first insertion step and a second insertion step. As shown in FIGS. 1(A)-(B) and 2, 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, and the medical tubular body 11 is positioned in the first section 15. Next, as shown in FIGS. 1(B)-(C) and 3, in the second insertion step, the medical tubular body 11 positioned in the first section 15 is moved toward the second end 14 within the tube 12, and the medical tubular body 11 is positioned in the second section 16. By inserting the medical tubular body 11 into the tube 12 in this manner, it becomes easy to position the medical tubular body 11 in the second section 16 of the tube 12, which has the 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 that makes up the reinforcing layer 17.

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 methods.

The longitudinal length of the first section 15 of the tube 12 is preferably longer than the axial length of the medical tubular body 11 in the contracted state. Furthermore, in the first insertion step, the entire medical tubular body 11 is preferably disposed in the first section 15 of the tube 12. The length of the first section 15 of the 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 the medical tubular body 11 in the contracted state.

In the second insertion step, the medical tubular body 11 positioned in the first section 15 is moved toward the second end 14 within the tube 12, and the medical tubular body 11 is positioned in the second section 16. The medical tubular body 11 is positioned in the section of the tube 12 where the reinforcing layer 17 is provided. By placing 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 toward the second end 14 within the tube 12 in this state, the medical tubular body 11 (particularly the end portion of the medical tubular body 11 closer to 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.

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 positioned 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.

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

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

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 to the outside 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 within the tube 12 toward the second end 14 side.

The rod-shaped member may have an outer diameter approximately the same as the inner diameter of the medical tubular body 11 in the contracted state. In this case, the outer surface of the rod-shaped member preferably has tackiness. By inserting the rod-shaped member into the medical tubular body 11 in the contracted state, adhering the tacky portion of the outer surface of the rod-shaped member 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.

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

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

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, it is preferable to push the rod-shaped member mechanically, 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 preferable, as 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 and 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.

As shown in Figures 1(C)-(D) and 4, in the cutting process, with the medical tubular body 11 positioned in the second section 16, the tube 12 is cut at the end of the medical tubular body 11 on the first end 13 side or closer to the first end 13. This makes it possible to obtain a tube 12 in which the medical tubular body 11 is internally installed, with the medical tubular body 11 positioned in the section where the reinforcing layer 17 of the tube 12 is provided.

In the cutting process, the tube 12 can be cut using cutting means 18 such as a cutter, laser light, or heat wire. In the cutting process, it is preferable to cut the tube 12 approximately perpendicular to the longitudinal direction.

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

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

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. However, 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. Therefore, it is preferable to perform a visual inspection of 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 a 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.

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, using a microscope, or by photographing the medical tubular body 11 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 during the visual inspection, the second insertion step is preferably performed.

Next, a method for manufacturing a medical tubular body delivery device 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 a step of obtaining a tube with an internal medical tubular body by the method for manufacturing an internal medical tubular body tube described above.

The medical tubular body delivery device has a shaft portion equipped with an internal tube for the medical tubular body. The shaft portion is an elongated member extending longitudinally, and a proximal side and a distal side are defined longitudinally. In the medical tubular body delivery device, the proximal side refers to the side closest to the user, and the distal side refers to the opposite side of the proximal side, i.e., the side toward the treatment target. For example, in 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 internal tube for the medical tubular body described above will be referred to as the "outer tube."

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

The outer tube may be positioned 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 longitudinally, the outer tube may be positioned to extend from at least part of the distal one-third of the shaft to at least part of the proximal one-third, or it may be positioned in at least part of the distal one-third of the shaft but not in the proximal two-thirds of the shaft. In the latter case, it is preferable that the outer tube be able to be pulled proximally via another member.

The inner tube is positioned at least at the distal portion of the shaft and may extend to the proximal portion of the shaft. The lumen of the inner tube can function as a passageway for a guidewire. In the case of an over-the-wire type delivery device, the inner tube preferably extends from the distal portion of the shaft to the proximal portion of the shaft, and in the case of a rapid exchange type delivery device, the inner tube preferably extends from the distal portion of the shaft to partway to the proximal portion of the shaft.

A stopper is preferably provided on the inner tube proximal to the medical tubular body. The stopper is attached to the outer surface of the inner tube. The stopper is positioned in contact with or near the proximal end of the medical tubular body. For example, it is preferable that the portion of the stopper that abuts 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 along with the outer tube, making it easier to expose the medical tubular body to the outside of the shaft portion.

A tip is preferably provided at the distal end of the inner tube. The tip preferably has an inner lumen that communicates with the inner lumen of the inner tube. The tip forms 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 shaft's ability to follow the preceding guidewire and forceps channel, and the delivery of the shaft's tip to the lesion, improving the operability of the delivery device.

The shaft portion may have tubular members other than the outer tube and inner tube. For example, a traction tube may be 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 inner tube and proximal to the medical tubular body.

When the outer tube does not extend to the proximal portion of the shaft portion, 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, exposing the medical tubular body to the outside of the shaft portion.

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 placing the medical tubular object inside the body, it is preferable that when the outer tube is pulled proximally, the portion of the outer tube or traction tube not covered by the protective tube is retracted into the inner cavity 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 in the desired position.

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 portion of the shaft portion, and by pulling the linear traction member proximally, the outer tube can be moved proximally, exposing the medical tubular body outside the shaft portion.

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.

Example configurations 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 forms 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.

The shaft portion 21 shown in Figure 5 has an outer tube 22 and an inner tube 23 disposed within 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 serves as an inner tube 20 for the medical tubular body.

The inner tube 23 extends from the distal to the proximal portion of the shaft portion 21, providing an over-the-wire 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 proximal to the medical tubular body 11. The outer tube 22 is slidable longitudinally relative to the inner tube 23. In the delivery device equipped with the shaft portion 21 shown in Figure 5, the medical tubular body 11 is exposed outside the shaft portion 21 by pulling the outer tube 22 proximally, allowing the medical tubular body 11 to be placed within the body.

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

The inner tube 23 extends from the distal to the proximal portion of the shaft 21, providing an over-the-wire delivery device. The outer tube 22 extends from the distal to the proximal portion 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 preferably positioned proximal to the medical tubular body 11 and 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, the medical tubular body 11 is exposed to the outside of the shaft portion 21 by pulling the outer tube 22 proximally, allowing the medical tubular body 11 to be placed inside the body.

The shaft portion 21 shown in Figure 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 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 serves as an inner tube 20 for the medical tubular body.

The inner tube 23 extends from the distal to the proximal portion of the shaft portion 21, providing an over-the-wire 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 from the proximal end of the traction tube 27. The protective tube 28 is disposed to cover only a portion of the traction tube 27, and the traction tube 27 extends distally from the distal end of the protective tube 28 and proximally from the proximal end of the protective tube 28. 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 and the traction 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 traction tube 27 proximally, the outer tube 22 moves proximally, exposing the medical tubular body 11 to the outside of the shaft portion 21, allowing the medical tubular body 11 to be placed inside the body.

The shaft portion 21 shown in Figure 8 comprises an outer tube 22, a traction tube 27 connected to the 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 within the lumen of the outer tube 22, the traction tube 27, and the protective tube 28, and a linear traction member 29 attached to the proximal portion of the traction tube 27 and disposed within the lumen of the protective tube 28. 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 serves as an inner tube 20 for the medical tubular body.

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

In all of the shaft portions 21 shown in Figures 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 involve first performing the process of obtaining the medical tubular body inner tube 20 described above 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 be inserted into the outer tube 22, and then performing the process of obtaining the medical tubular body inner tube 20 described above 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 incorporating the medical tubular body 11, it is preferable to perform the step of inserting the inner tube 23 into the outer tube 22 incorporating the medical tubular body 11, and positioning the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22.

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

Figure 9 shows an example of a method for manufacturing the shaft portion 21 shown in Figure 5. When the shaft portion 21 has an outer tube 22 and an inner tube 23, as shown in Figure 9, it is preferable to prepare the outer tube 22 housing the medical tubular body 11, and then insert the inner tube 23 into the outer tube 22 housing the medical tubular body 11, so that the inner tube 23 is positioned 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 housing the medical tubular body 11. Furthermore, it is preferable to attach a tip 25 to the distal end of the inner tube 23 after positioning the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22.

Figure 10 shows an example of a method for manufacturing the shaft portion 21 shown in Figure 6. When the shaft portion 21 has an outer tube 22, an inner tube 23, and an intermediate tube 26, as shown in Figure 10, it is preferable to insert the inner tube 23 into the outer tube 22 in which the medical tubular body 11 is housed, and then position the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22. After that, 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 housed inside the outer tube 22. Furthermore, it is 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.

In Figure 10, an inner tube 23 with a distal tip 25 attached to its distal end is inserted into an outer tube 22 housing a medical tubular body 11. In this 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, an inner tube 23 without a distal tip 25 attached may also be inserted into an outer tube 22 housing a medical tubular body 11. In this case, the inner tube 23 may be inserted from either the distal side or the proximal side of the outer tube 22. After inserting the inner tube 23 into the outer tube 22, it is preferable to attach a distal tip 25 to the distal end of the inner tube 23.

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 traction tube 27, as shown in Figures 11 and 12, 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, positioning the inner tube 23 inside the medical tubular body 11 and inside the outer tube 22, and then joining the traction tube 27 to the proximal portion of the outer tube 22.

In Figure 11, the inner tube 23 equipped with a stopper 24 is inserted from the proximal side of the outer tube 22 in which the medical tubular body 11 is housed. After the inner tube 23 is positioned inside the medical tubular body 11 and inside the outer tube 22, a tip 25 is attached to the distal end of the inner tube 23. On the other hand, in Figure 12, a stopper 24 with a long longitudinal length 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, after which 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 attached to the inner tube 23.

In Figure 12, an inner tube 23 with a distal tip 25 attached to its distal end is inserted into an outer tube 22 housing a medical tubular body 11. In this case, it is preferable to insert the inner tube 23 from the distal side of the outer tube 22. On the other hand, in Figure 12, an inner tube 23 without a distal tip 25 attached can also be inserted into an outer tube 22 housing a medical tubular body 11. In this case, the inner tube 23 may be inserted from either the distal side or the proximal side of the outer tube 22. After inserting the inner tube 23 into the outer tube 22, it is preferable to attach a distal tip 25 to the distal end of the inner tube 23.

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 with the medical tubular body 11 inside.

Although not shown in Figures 11 and 12, after joining the traction tube 27 to the proximal portion of the outer tube 22, a linear traction member 29 may be attached to the traction tube 27, or the traction tube 27 with the linear traction member 29 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, because it is easier to join 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.

The components that make up the shaft portion will now be described. Each component that makes up the shaft portion can be made from 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 adhesive bonding, welding, or fitting.

Examples of resin materials include 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 synthetic resins such as 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.

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 in one longitudinal portion and multiple layers in the other longitudinal portion. The inner tube, traction tube, protective tube, and intermediate tube may have a reinforcing layer as described above. For details about the outer tube, see the description of the medical tubular body interior tube above.

The linear traction member is preferably composed of a thread formed from a metal wire or synthetic resin. The linear traction member may also be a composite made of multiple materials, such as a composite of metal and synthetic resin. The linear traction member may also be composed of a metal wire coated with resin.

The distal tip is preferably made of an elastomer resin. Preferred examples of elastomer resins include polyurethane resin, polyester resin, and polyamide resin, with polyamide resin being particularly preferred. Constructing the distal tip in this manner improves the distal tip's ability to follow the guidewire and the safety of the distal end of the shaft.

The shape of the stopper can be, for example, ring-shaped. 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 its contracted state. The stopper can be made of resin, metal, or a composite material of these. For specific examples of these materials, see the explanation of the materials constituting the shaft portion above. In particular, the stopper is preferably made of an elastomer resin, which prevents 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, effectively deploying the medical tubular body.

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 of the medical tubular body on the shaft portion, 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. If 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.

11: Medical tubular body 12: Tube 13: First end 14: Second end 15: First section 16: Second section 17: Reinforcing layer 18: Cutting means 20: Medical tubular body inner tube 21: Shaft portion 22: Outer tube 23: Inner tube 24: Stopper 25: Distal tip 26: Intermediate tube 27: Pulling tube 28: Protective tube 29: Linear pulling member

Claims (7)

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 closer to the first end side while the medical tubular body is positioned in the second section. The method for manufacturing an internal medical tubular tube according to claim 1, further comprising a step of visually inspecting the medical tubular body placed in the first section after the first insertion step. The method for manufacturing an internal medical tubular tube according to claim 1 or 2, wherein the force used to move the medical tubular body toward the second end within the tube in the second insertion step is smaller than the force used to move the medical tubular body toward the second end within the tube in the first insertion step. 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. A method for manufacturing an interior medical tubular 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. A method for manufacturing a medical tubular body delivery device, comprising the step of obtaining a tube with a medical tubular body inside by the manufacturing method described in any one of claims 1 to 5. 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.