Method for manufacturing medical tubular body transport device

Abstract

A device (1) for delivering a medical tubular-body (10) into a living body includes an outside tube (20) having a lumen in which the medical tubular-body (10) is disposed; a guide wire tube (30) that is disposed in the lumen of the medical tubular-body (10) and that has a lumen into which a guide wire is inserted; a distal tip (40) provided on a distal end of the guide wire tube (30); and a tubular object (50) disposed inside the outside tube (20) and outside the guide wire tube (30), more to a proximal side than a distal end (10d) of the medical tubular-body (10). A proximal end (20p) of the outside tube (20) is positioned more to the distal side than a proximal end (50p) of the tubular object (50). A total distance obtained by totaling a first distance (D1) that is a distance from a proximal end (40p) of the distal tip (40) to the distal end (10d) of the medical tubular-body (10) and that satisfies the following condition, and a second distance (D2) that is a distance from a distal end (50d) of the tubular object (50) to the proximal end (10p) of the medical tubular-body (10) and that satisfies the following condition is 0.5 mm or less (including 0 mm).　Conditions: The first distance (D1) is a positive value when the proximal end (40p) of the distal tip (40) is positioned more to the distal side than the distal end (10d) of the medical tubular-body (10), and is a negative value when the proximal end (40p) of the distal tip (40) is positioned more to the proximal side than the distal end (10d) of the medical tubular-body (10); and the second distance (D2) is a positive value when the distal end (50d) of the tubular object (50) is positioned more to the proximal side than the proximal end (10p) of the medical tubular-body (10), and is a negative value when the distal end (50d) of the tubular object (50) is positioned more to the distal side than the proximal end (10p) of the medical tubular-body (10).

Description

[Technical Field]

[0001] The present invention relates to a medical tubular body delivery device, which is a device for delivering a medical tubular body into the body, and a method for manufacturing the same. [Background technology]

[0002] Medical tubular bodies, typified by stents, are medical devices used to treat various diseases caused by narrowing or obstruction of lumens in the body, such as the digestive tract, including the bile duct and pancreatic duct, and blood vessels, including the iliac artery. Examples of 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 lumen, and those that entangle thrombi and the like that have formed in or around the lesion and remove them from the body, thereby restoring the inner diameter of the lumen at the lesion.

[0003] As an example of treatment using a medical tubular body with an endoscope, a method of placing a medical tubular body in a biliary tract obstructed by bile duct cancer to drain bile from the bile duct to the duodenum is described below. First, an endoscope is inserted from the mouth to the entrance (papilla) of the bile duct in the duodenum. Next, a guidewire is delivered to the lesion through the endoscope. Further, a medical tubular body delivery device is delivered to the lesion along the guidewire. Then, the medical tubular body delivery device is operated to place the medical tubular body at the lesion.

[0004] An example of a medical tubular body transport device is an implantable medical endoprosthesis delivery system that includes a sheath that defines at least a portion of a first inner diameter, a catheter that is at least partially surrounded by the sheath, and a bumper that is positioned between the sheath and the catheter and defines a maximum outer diameter, wherein the bumper has at least some freedom of movement relative to the catheter, the outer diameter of the bumper is larger than the first inner diameter of the sheath, and the sheath, catheter, and bumper are configured so that the implantable medical endoprosthesis can be positioned distal to the bumper between the sheath and the catheter (see, for example, Patent Document 1). [Prior art documents] [Patent documents]

[0005] [Patent Document 1] Special Publication No. 2008-534169 Summary of the Invention [Problem to be solved by the invention]

[0006] In a typical medical tubular object delivery device such as that described in Patent Document 1, a medical tubular object such as a stent is disposed in the lumen of an outer tube, and a guidewire tube is disposed in the lumen of the medical tubular object. The medical tubular object is released from the medical tubular object delivery device by fixing the guidewire tube and pulling the outer tube toward the surgeon. At this time, a tubular object such as a bumper disposed inside the outer tube but outside the guidewire tube abuts against the medical tubular object, pushing it out.

[0007] In the medical tubular object delivery device described in Patent Document 1, there are gaps between the bumper and the stent, and between the stent and the distal tip. When there are gaps between the bumper and the stent, or between the stent and the distal tip, when the medical tubular object delivery device is placed in a curved intraluminal lumen, the outer tube has difficulty bending along the curved intraluminal lumen. As a result, the guidewire tube and the outer tube have different degrees of bending, making it difficult to pull the outer tube toward the surgeon, which has led to problems such as the inability to release a medical tubular object such as a stent from the medical tubular object delivery device, or the time required to release the medical tubular object.

[0008] The present invention has been made in consideration of the above circumstances, and its purpose is to provide a medical tubular body transport device and a method for manufacturing the same, which has no large gaps between the distal tip and the medical tubular body, and between the tubular object and the medical tubular body, and which makes it easy to smoothly release the medical tubular body. [Means for solving the problem]

[0009] The medical tubular body delivery device that can solve the above problem is a device for delivering a medical tubular body into the body, and comprises an outer tube in which the medical tubular body is disposed in the lumen, a guidewire tube that is disposed in the lumen of the medical tubular body and through which a guidewire is inserted, a distal tip provided at the distal end of the guidewire tube, and a tubular body that is disposed inside the outer tube and outside the guidewire tube, proximal to the distal end of the medical tubular body, wherein the proximal end of the outer tube is located distal to the proximal end of the tubular body, and the total distance obtained by adding together a first distance from the proximal end of the distal tip to the distal end of the medical tubular body that satisfies the following condition, and a second distance from the distal end of the tubular body to the proximal end of the medical tubular body that satisfies the following condition, is 0.5 mm or less (including 0 mm). [Condition] The first distance is a positive value when the proximal end of the tip is located distal to the distal end of the medical tubular body, and a negative value when the proximal end of the tip is located proximal to the distal end of the medical tubular body; the second distance is a positive value when the distal end of the tubular body is located proximal to the proximal end of the medical tubular body, and a negative value when the distal end of the tubular body is located distal to the proximal end of the medical tubular body.

[0010] In the medical tubular body delivery device of the present invention, a proximal tube is provided outside the guidewire tube and proximal to the medical tubular body, and it is preferable that the outer diameter of the proximal tube is smaller than the outer diameter of the outer tube.

[0011] In the medical tubular body delivery device of the present invention, the inner diameter of the proximal tube is preferably smaller than the maximum outer diameter of the tubular body.

[0012] In the medical tubular body delivery device of the present invention, the inner diameter of the proximal tube is preferably smaller than the maximum outer diameter of the distal tip.

[0013] In the medical tubular body delivery device of the present invention, the distal end of the proximal tube is preferably located inside the outer tube and distal to the proximal end of the outer tube.

[0014] In the medical tubular body delivery device of the present invention, the proximal end of the distal tip is preferably located more proximal than the distal end of the medical tubular body.

[0015] In the medical tubular body delivery device of the present invention, the proximal end of the distal tip preferably has an expanded diameter portion whose outer diameter increases distally.

[0016] In the medical tubular body delivery device of the present invention, the outer diameter of the proximal end of the distal tip is preferably smaller than the inner diameter of the distal end of the medical tubular body within the outer tube.

[0017] In the medical tubular body delivery device of the present invention, the total distance obtained by adding up the first distance and the second distance is preferably a negative value.

[0018] In the medical tubular body delivery device of the present invention, the length from the proximal end of the tip to the distal end of the tubular body is preferably shorter than the length from the distal end to the proximal end of the medical tubular body.

[0019] A method for manufacturing a medical tubular body delivery device that can solve the above-mentioned problems is a method for manufacturing a device for delivering a medical tubular body into the body, which includes an outer tube in which a medical tubular body is placed in its lumen, a guidewire tube in which a guidewire is inserted into its lumen, a tip provided at the distal end of the guidewire tube, and a tubular body placed outside the guidewire tube, and is characterized by having the following steps: a medical tubular body placement step for placing the medical tubular body in the lumen of the outer tube; a guidewire tube placement step for inserting the proximal end of the guidewire tube from the distal end of the outer tube and placing the guidewire tube in the lumen of the medical tubular body; a tubular body insertion step for inserting the proximal end of the guidewire tube from the distal end of the tubular body; and a tubular body placement step for inserting the distal end of the tubular body from the proximal end of the outer tube and placing the tubular body in the lumen of the outer tube.

[0020] The method for producing a medical tubular body delivery device of the present invention preferably includes a tip placement step of placing a tip at the distal end of the guidewire tube.

[0021] In the manufacturing method of the medical tubular body transport device of the present invention, after the tubular body placement step, there is a tubular body fixing step in which the tubular body is fixed to the guidewire tube proximal to the proximal end of the outer tube, and it is preferable that in the tubular body fixing step, the proximal end of the outer tube is located distal to the proximal end of the tubular body.

[0022] In the manufacturing method of the medical tubular body transport device of the present invention, it is preferable to have a proximal tube outside the guidewire tube and proximal to the medical tubular body, and to have a proximal tube fixing step after the tubular body fixing step in which the proximal tube is inserted from the proximal end of the guidewire tube and the proximal tube and outer tube are fixed together.

[0023] In the method of manufacturing a medical tubular body delivery device of the present invention, after the guidewire tube placement step, the proximal end of the distal tip is preferably located more proximal than the distal end of the medical tubular body.

[0024] In the method of manufacturing a medical tubular body delivery device of the present invention, after the tubular body placement step, the distal end of the tubular body preferably contacts the proximal end of the medical tubular body. [Effects of the Invention]

[0025] In the medical tubular body delivery device of the present invention, the total distance obtained by adding the first distance and the second distance is 0.5 mm or less (including 0 mm), so there are no large gaps between the distal tip and the medical tubular body, and between the tubular object and the medical tubular body. Therefore, when the medical tubular body delivery device is placed in a curved intraluminal cavity, the outer tube easily bends along the curved intraluminal cavity, making it easier for the surgeon to pull the outer tube toward him / her, and enabling the medical tubular body to be smoothly released.

[0026] Furthermore, the method for manufacturing a medical tubular body delivery device of the present invention includes a medical tubular body placement step of placing the medical tubular body in the lumen of an outer tube, a guidewire tube placement step of inserting the proximal end of a guidewire tube through the distal end of the outer tube and placing the guidewire tube in the lumen of the medical tubular body, a tubular body insertion step of inserting the proximal end of the guidewire tube through the distal end of the tubular body, and a tubular body placement step of inserting the distal end of the tubular body through the proximal end of the outer tube and placing the tubular body in the lumen of the outer tube. This reduces the likelihood of large gaps occurring between the distal tip and the medical tubular body, and between the tubular body and the medical tubular body, during the manufacture of the medical tubular body delivery device. As a result, the outer tube can be bent along a curved lumen in a living body, making it easier to pull the outer tube toward the surgeon. This makes it possible to manufacture a medical tubular body delivery device that facilitates the release of medical tubular bodies. [Brief explanation of the drawings]

[0027] [Figure 1] 1 is a plan view showing an entire medical tubular body transport device according to an embodiment of the present invention; [Figure 2] 2 is a cross-sectional view taken along the longitudinal direction of the medical tubular body delivery device shown in FIG. 1. [Figure 3] 1 is a longitudinal cross-sectional view of a medical tubular body delivery device in a medical tubular body placement step according to an embodiment of the present invention. [Figure 4] 1 is a longitudinal cross-sectional view of a medical tubular object delivery device in a guidewire tube placement step according to an embodiment of the present invention. FIG. [Figure 5] 1 is a longitudinal cross-sectional view of a medical tubular object transport device during a tubular object insertion step according to an embodiment of the present invention. [Figure 6] 1 is a longitudinal cross-sectional view of a medical tubular object transport device in a tubular object placement step according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0028] The present invention will be described in more detail below based on the following embodiments. However, the present invention is not limited to the following embodiments, and can be implemented with appropriate modifications within the scope of the above and below-described purposes, and all such modifications are included within the technical scope of the present invention. For convenience, hatching and component symbols 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 actual dimensions, as priority is given to helping understand the features of the present invention.

[0029] First, the medical tubular body transport device of the present invention will be described with reference to FIGS.

[0030] Fig. 1 is an overall plan view of a medical tubular body transport device 1 according to an embodiment of the present invention, and Fig. 2 is a longitudinal cross-sectional view of the medical tubular body transport device 1. Fig. 1 shows an example of the configuration of a so-called rapid exchange type medical tubular body transport device in which a wire is inserted partway from the distal side to the proximal side of the shaft. Note that the present invention can also be applied to a so-called over-the-wire type medical tubular body transport device in which a guide wire is inserted from the distal side to the proximal side of the shaft.

[0031] In the present invention, the proximal side refers to the side closer to the user in the direction of extension of the outer tube 20, and the distal side refers to the side opposite the proximal side, i.e., the side to be treated. The direction of extension of the outer tube 20 is referred to as the longitudinal direction. The longitudinal direction can also be referred to as the direction toward or away from the outer tube 20. The radial direction refers to the radial direction of the outer tube 20, and inward in the radial direction refers to the direction toward the axial center of the outer tube 20, while outward in the radial direction refers to the direction opposite to the inward. Note that in Figures 1 and 2, the right side of the figure is the proximal side, and the left side of the figure is the distal side.

[0032] The medical tubular body delivery device 1 of the present invention is a device for delivering a medical tubular body 10 into the body. Examples of medical tubular bodies 10 include stents, stent grafts, occluders, injection catheters, and prosthetic valves. Of these, stents are generally used to treat various diseases caused by narrowing or obstruction of internal lumens, such as the digestive tract (e.g., the bile duct) or blood vessels. Examples of stents include coil-shaped stents made from a single metal wire, stents cut out of a metal tube with a laser, stents assembled by welding linear members with a laser, stents made by weaving multiple metal wires, and stents of the same shape as these metal stents but made from a polymeric material.

[0033] As shown in Figures 1 and 2, the medical tubular body delivery device 1 comprises an outer tube 20 in whose lumen a medical tubular body 10 is disposed, a guidewire tube 30 disposed in the lumen of the outer tube 20 and through which a guidewire is inserted, a tip 40 provided at the distal end of the guidewire tube 30, and a tubular body 50 disposed inside the outer tube 20 and outside the guidewire tube 30, proximal to the distal end 10d of the medical tubular body 10.

[0034] The tubular member 50 is a member that restricts the position of the medical tubular member 10 within the lumen of the outer tube 20 and pushes the medical tubular member 10 distally. In particular, when the guidewire tube 30 is fixed and the outer tube 20 is pulled proximally to release the medical tubular member 10 from the medical tubular member delivery device 1, the tubular member 50 comes into direct or indirect contact with the medical tubular member 10, preventing the medical tubular member 10 from moving within the outer tube 20 and exposing the medical tubular member 10 from the outer tube 20.

[0035] 2, the proximal end 20p of the outer tube 20 is located distal to the proximal end 50p of the tubular body 50. Because the proximal end 20p of the outer tube 20 is located distal to the proximal end 50p of the tubular body 50, the proximal end 50p of the tubular body 50 is exposed from the outer tube 20 during the manufacture of the medical tubular body delivery device 1. This has the effect of facilitating the joining of the tubular body 50 and the guidewire tube 30, and also makes it easy to adjust the position at which the tubular body 50 is fixed so as not to create a large gap between the distal end 50d of the tubular body 50 and the proximal end 10p of the medical tubular body 10.

[0036] As shown in Figure 2, the total distance obtained by adding together a first distance D1, which is the distance from the proximal end 40p of the tip 40 to the distal end 10d of the medical tubular body 10 and satisfies the following condition, and a second distance D2, which is the distance from the distal end 50d of the tubular object 50 to the proximal end 10p of the medical tubular body 10 and satisfies the following condition, is 0.5 mm or less (including 0 mm). [Conditions] The first distance D1 is a positive value when the proximal end 40p of the tip 40 is located distal to the distal end 10d of the medical tubular body 10, and is a negative value when the proximal end 40p of the tip 40 is located proximal to the distal end 10d of the medical tubular body 10. The second distance D2 is a positive value when the distal end 50d of the tubular body 50 is located proximal to the proximal end 10p of the medical tubular body 10, and is a negative value when the distal end 50d of the tubular body 50 is located distal to the proximal end 10p of the medical tubular body 10.

[0037] By setting the total distance of the first distance D1 and the second distance D2 to 0.5 mm or less (including 0 mm), there is no large gap between the proximal end 40p of the tip 40 and the distal end 10d of the medical tubular body 10, and between the distal end 50d of the tubular body 50 and the proximal end 10p of the medical tubular body 10. The elimination of excess play between the medical tubular body 10, such as a stent, and the tubular body 50 improves the accuracy of stent deployment. Furthermore, the lack of a large gap between the medical tubular body 10 and the tubular body 50 ensures continuous rigidity from the tip 40 to the tubular body 50. As a result, kinking is less likely to occur in the medical tubular body delivery device 1, facilitating stent deployment and delivery operations.

[0038] In conventional medical tubular body delivery devices, for convenience in manufacturing and to improve manufacturing efficiency, there is generally a gap between the medical tubular body 10 and the distal tip 40, and between the medical tubular body 10 and the tubular body 50. In other words, a large gap exists in one or both of the following locations: between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10; and between the distal end 50d of the tubular body 50 and the proximal end 10p of the medical tubular body 10; and the total distance obtained by adding up the first distance D1 and the second distance D2 exceeds 0.5 mm.

[0039] The outer tube 20 has a longitudinal direction and a lumen extending in the longitudinal direction, and the medical tubular body 10 is disposed in the lumen. Examples of materials constituting the outer tube 20 include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, fluororesins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. Among these, the material constituting the outer tube 20 is preferably a fluororesin, and more preferably PTFE. Using a fluororesin as the material constituting the outer tube 20 ensures that the outer tube 20 has good slidability. Improving the slidability of the outer tube 20 enhances the slipperiness between the outer tube 20 and the medical tubular body 10, facilitating the procedure of placing the medical tubular body 10 in a lumen within a living body.

[0040] The outer tube 20 may have a single-layer structure or a multi-layer structure. When the outer tube 20 has a multi-layer structure, for example, the outer tube 20 may have a structure in which a metal braid such as stainless steel, carbon steel, or nickel-titanium alloy is used as an intermediate layer of a resin tube constituting the outer tube 20. Alternatively, the outer tube 20 may have a two-layer structure in which a fluororesin is used as an inner layer and a polyamide resin is used as an outer layer.

[0041] The longitudinal length of the outer tube 20 can be selected appropriately depending on the longitudinal length of the medical tubular body 10 to be placed in the lumen. For example, the longitudinal length of the outer tube 20 can be 50 mm or more and 800 mm or less.

[0042] The outer diameter of the outer tube 20 is preferably 0.5 mm or more, more preferably 0.7 mm or more, and even more preferably 1 mm or more. By setting the lower limit of the outer diameter of the outer tube 20 within the above range, the rigidity of the distal side of the medical tubular body delivery device 1 in which the outer tube 20 is disposed can be increased. As a result, the insertability of the medical tubular body delivery device 1 is improved, resulting in a medical tubular body delivery device 1 with good pushability. Furthermore, the outer diameter of the outer tube 20 is preferably 3.5 mm or less, more preferably 3.3 mm or less, and even more preferably 3.0 mm or less. By setting the upper limit of the outer diameter of the outer tube 20 within the above range, the distal side outer diameter of the medical tubular body delivery device 1 can be prevented from becoming too large, thereby improving the minimally invasive nature of the medical tubular body delivery device 1. Furthermore, the rigidity of the distal side of the medical tubular body delivery device 1 can be prevented from becoming too large, thereby improving operability during delivery into the body.

[0043] The wall thickness of the outer tube 20 is preferably 10 μm or more, more preferably 30 μm or more, and even more preferably 50 μm or more. By setting the lower limit of the wall thickness of the outer tube 20 within the above range, the rigidity of the outer tube 20 can be increased, and the insertability of the medical tubular body transport device 1 can be improved. Furthermore, the wall thickness of the outer tube 20 is preferably 350 μm or less, more preferably 300 μm or less, and even more preferably 250 μm or less. By setting the upper limit of the wall thickness of the outer tube 20 within the above range, the lumen of the outer tube 20 can be widened, and the variety of diameters of medical tubular bodies 10 that can be housed in the lumen of the outer tube 20 can be increased. This makes it possible to transport various types of medical tubular bodies 10 using the medical tubular body transport device 1.

[0044] The guidewire tube 30 has a longitudinal direction and a lumen extending in the longitudinal direction, through which a guidewire is inserted. The guidewire tube 30 is also disposed in the lumen of the outer tube 20. Since the medical tubular body delivery device 1 has the guidewire tube 30, it becomes easy to insert a guidewire into the medical tubular body delivery device 1, and the medical tubular body delivery device 1 can be delivered into the body along the guidewire. Furthermore, by inserting the guidewire into the guidewire tube 30, it is possible to prevent the guidewire from damaging the outer tube 20, etc.

[0045] Examples of materials constituting the guidewire tube 30 include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyetherketone resins such as PEEK, polyetherpolyamide resins, polyurethane resins, polyimide resins, fluorine-based resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. Among these, polyimide resins are preferred. Using polyimide resin as the material for the guidewire tube 30 improves the lubricity of the guidewire tube 30. This facilitates inserting a guidewire through the lumen of the guidewire tube 30 and feeding the medical tubular body delivery device 1 into the body along the guidewire. The guidewire tube 30 may also have a multilayer structure including a braided layer such as a metal braid. The multilayer structure of the guidewire tube 30 enhances the tensile strength, lubricity relative to the guidewire, and kink resistance of the guidewire tube 30.

[0046] The wall thickness of the guidewire tube 30 is preferably smaller than the wall thickness of the outer tube 20. Having the guidewire tube 30 thinner than the outer tube 20 increases the flexibility of the medical tubular body delivery device 1. This makes it easier to insert the medical tubular body delivery device 1 through even curved intravital lumens.

[0047] The wall thickness of the guidewire tube 30 is preferably 99% or less, more preferably 98% or less, and even more preferably 97% or less of the wall thickness of the outer tube 20. By setting the upper limit of the ratio of the wall thickness of the guidewire tube 30 to the wall thickness of the outer tube 20 within the above range, the flexibility of the guidewire tube 30 can be sufficiently increased. Furthermore, the wall thickness of the guidewire tube 30 is preferably 50% or more, more preferably 60% or more, and even more preferably 70% or more of the wall thickness of the outer tube 20. By setting the lower limit of the ratio of the wall thickness of the guidewire tube 30 to the wall thickness of the outer tube 20 in this range, the rigidity of the guidewire tube 30 can be increased, resulting in a medical tubular object delivery device 1 with good pushability.

[0048] The rigidity of the distal side of the guidewire tube 30 is preferably higher than the rigidity of the proximal side of the guidewire tube 30. By making the rigidity of the distal side of the guidewire tube 30 higher than the rigidity of the proximal side of the guidewire tube 30, the pushability of the medical tubular object delivery device 1 can be improved.

[0049] Although not shown, one way to increase the rigidity of the distal side of the guidewire tube 30 compared to the rigidity of the proximal side is to configure the guidewire tube 30 to include a distal guidewire tube and a proximal guidewire tube, with the rigidity of the distal guidewire tube being increased compared to the rigidity of the proximal guidewire tube. Specifically, it is preferable that the proximal guidewire tube has a single-layer synthetic resin structure and the distal guidewire tube has a multi-layer synthetic resin structure with a metal braid as an intermediate layer. Examples of metal braids used for the distal guidewire tube include stainless steel, carbon steel, and nickel-titanium alloy. Of these, it is preferable that the distal guidewire tube has a stainless steel metal braid. The multi-layer structure of the distal guidewire tube allows the rigidity of the distal guidewire tube to be sufficiently increased compared to the rigidity of the proximal guidewire tube.

[0050] The distal tip 40 is provided at the distal end of the guidewire tube 30. The distal tip 40 may be a separate member from the guidewire tube 30, and a member constituting the distal tip 40 may be attached to the guidewire tube 30, or the distal tip 40 and the guidewire tube 30 may be integrally configured.

[0051] When the distal tip 40 is a separate member from the guidewire tube 30, it is preferable that the distal tip 40 is fixed to the guidewire tube 30. Methods for fixing the distal tip 40, which is a separate member, to the guidewire tube 30 include, for example, adhesive bonding, welding, fitting, screwing, etc. The distal tip 40 and the guidewire tube 30 may be fixed directly or indirectly via another member.

[0052] Examples of materials constituting the distal tip 40 include synthetic resins such as polyolefin resins (e.g., polyethylene, polypropylene, etc.), polyamide resins (e.g., nylon, etc.), polyester resins (e.g., PET, etc.), aromatic polyetherketone resins (e.g., PEEK, etc.), polyetherpolyamide resins, polyurethane resins, polyimide resins, fluorine-based resins (e.g., PTFE, PFA, ETFE, etc.), and polyvinyl chloride resins. Among these, the material constituting the distal tip 40 is preferably polyamide resin, and more preferably polyamide elastomer. Using a polyamide resin as the material for the distal tip 40 improves the followability of the distal tip 40 to the guidewire. Furthermore, using a polyamide resin as the material for the distal tip 40 prevents excessive rigidity of the distal tip 40, making it less likely to damage the walls of the digestive tract, blood vessels, etc., thereby improving safety.

[0053] The outer diameter of the distal end 40d of the tip 40 may be the same as or larger than the outer diameter of the distal end 20d of the outer tube 20, but is preferably smaller than the outer diameter of the distal end 20d of the outer tube 20. By making the outer diameter of the distal end 40d of the tip 40 smaller than the outer diameter of the distal end 20d of the outer tube 20, it is possible to improve the ability to follow bends, the ability to follow the preceding guidewire, and the ability to reach the periphery when delivering the medical tubular body delivery device 1 into the body, thereby improving operability during delivery.

[0054] The tubular member 50 has a longitudinal direction and a lumen extending in the longitudinal direction. The tubular member 50 is disposed inside the outer tube 20 and outside the guidewire tube 30, proximal to the distal end 10d of the medical tubular member 10. The material constituting the tubular member 50 is preferably an elastic resin material, examples of which include polyolefin resins such as polyethylene, fluorine-based resins such as PTFE and PFA, polyamide-based resins, polyurethane-based resins, polyester-based resins, silicone-based resins, and polyimide-based resins. In particular, the material constituting the tubular member 50 preferably contains a polyimide-based resin. By including a polyimide-based resin in the material constituting the tubular member 50, the rigidity of the tubular member 50 is increased, the rear end of the medical tubular member 10 is supported, and the medical tubular member 10, such as a stent, can be efficiently deployed.

[0055] The tubular object 50 is preferably fixed to the guidewire tube 30. Methods for fixing the tubular object 50 to the guidewire tube 30 include, for example, bonding, welding, fitting, or screwing the tubular object 50 and the guidewire tube 30 together, inserting the tubular object 50 into a heat-shrinkable resin tube to heat-shrink the resin tube, or inserting the tubular object 50 into a metal tube and crimping the same.

[0056] The maximum outer diameter of the tubular article 50 is preferably the same as or smaller than the outer diameter of the medical tubular body 10 when housed in the lumen of the outer tube 20, and smaller than the inner diameter of the outer tube 20. By having the maximum outer diameter of the tubular article 50 be the same as or smaller than the outer diameter of the medical tubular body 10 and smaller than the inner diameter of the outer tube 20, the tubular article 50 is less likely to interfere with the movement of the outer tube 20 in the longitudinal direction, and the tubular article 50 can sufficiently push out the medical tubular body 10.

[0057] The thickness of the distal end of the tubular body 50 is preferably greater than the thickness of the proximal end of the tubular body 50. By making the thickness of the distal end of the tubular body 50 greater than the thickness of the proximal end, the rigidity of the distal end of the tubular body 50, which is in direct or indirect contact with the medical tubular body 10, is increased compared to the rigidity of the proximal end. This makes it easier to prevent movement of the medical tubular body 10 within the outer tube 20, facilitating release of the medical tubular body 10.

[0058] The thickness of the distal end of the tubular object 50 is preferably at least 1.05 times, more preferably at least 1.1 times, and even more preferably at least 1.15 times the thickness of the proximal end of the tubular object 50. By setting the lower limit of the thickness ratio of the distal end to the proximal end of the tubular object 50 within the above range, the rigidity of the distal end of the tubular object 50 can be made sufficiently higher than the rigidity of the proximal end. Furthermore, the thickness of the distal end of the tubular object 50 is preferably at most 5 times, more preferably at most 4 times, and even more preferably at most 3 times the thickness of the proximal end of the tubular object 50. By setting the upper limit of the thickness ratio of the distal end to the proximal end of the tubular object 50 within the above range, contact between the inner surface of the outer tube 20 and the outer surface of the distal end of the tubular object 50 is reduced. As a result, the force required to pull the outer tube 20 toward the surgeon's hand can be reduced, resulting in a medical tubular object delivery device 1 that easily releases the medical tubular object 10.

[0059] 2, the outer diameter of the distal end of the tubular member 50 is preferably larger than the outer diameter of the proximal end of the tubular member 50. By making the outer diameter of the distal end of the tubular member 50 larger than the outer diameter of the proximal end, the area of ​​direct or indirect contact between the distal end of the tubular member 50 and the medical tubular member 10 can be increased. This makes it easier to restrict the position of the tubular member 50 within the outer tube 20 of the medical tubular member 10.

[0060] The outer diameter of the distal end of the tubular member 50 is preferably at least 1.05 times, more preferably at least 1.1 times, and even more preferably at least 1.15 times the outer diameter of the proximal end of the tubular member 50. By setting the lower limit of the ratio of the outer diameters of the distal and proximal ends of the tubular member 50 within the above range, the rigidity of the distal end of the tubular member 50 can be increased relative to the proximal end, making it easier to restrict the position of the medical tubular member 10 within the outer tube 20. Furthermore, the outer diameter of the distal end of the tubular member 50 is preferably no more than 5 times, more preferably no more than 4 times, and even more preferably no more than 3 times the outer diameter of the proximal end of the tubular member 50. By setting the upper limit of the ratio of the outer diameters of the distal and proximal ends of the tubular member 50 within the above range, the outer diameter of the tubular member 50 is less likely to become excessively large relative to the inner diameter of the outer tube 20, making it possible to reduce the force required to pull the outer tube 20 toward the surgeon's hand.

[0061] The rigidity of the distal end of the tubular body 50 is preferably higher than the rigidity of the proximal end of the tubular body 50. By making the rigidity of the distal end of the tubular body 50 higher than the rigidity of the proximal end, the rigidity of the distal end of the tubular body 50, which comes into direct or indirect contact with the medical tubular body 10, can be made higher than the proximal end of the tubular body 50. As a result, the tubular body 50 can sufficiently prevent the medical tubular body 10 from moving within the outer tube 20, making it easier to release the medical tubular body 10. In order to increase the rigidity of the distal end of the tubular object 50 more than the rigidity of the proximal end, in addition to making the thickness of the distal end of the tubular object 50 greater than the thickness of the proximal end and making the outer diameter of the distal end of the tubular object 50 greater than the outer diameter of the proximal end, as mentioned above, it is also possible to increase the hardness of the material constituting the distal end of the tubular object 50 more than the hardness of the material constituting the proximal end, or to place a reinforcing material at the distal end of the tubular object 50.

[0062] It is also preferable that the distal end of the tubular body 50 contains a radiopaque material. By including a radiopaque material in the distal end of the tubular body 50, the position of the distal end of the tubular body 50 can be confirmed under X-ray fluoroscopy, and the position of the medical tubular body 10 can be determined.

[0063] Examples of radiopaque materials include lead, barium, iodine, tungsten, gold, platinum, iridium, stainless steel, tantalum, titanium, and cobalt-chromium alloys. Of these, platinum is preferred as the radiopaque material. By using platinum as the radiopaque material, X-ray contrast can be improved.

[0064] The proximal end 20p of the outer tube 20 is located distal to the proximal end 50p of the tubular member 50, but is preferably located distal to the proximal end 50p of the tubular member 50 and proximal to the distal end 50d of the tubular member 50. By positioning the proximal end 20p of the outer tube 20 distal to the proximal end 50p of the tubular member 50 and proximal to the distal end 50d of the tubular member 50, the position of the proximal end 20p of the outer tube 20 does not overlap with the proximal end 50p and the distal end 50d of the tubular member 50. Therefore, even if a separate member is joined to the proximal end 20p of the outer tube 20, the rigidity of this joined portion is unlikely to be excessively high, and the outer tube 20 can be made to be easily bendable along a lumen in a living body.

[0065] 2, the proximal end 40p of the distal tip 40 is preferably located more proximal than the distal end 20d of the outer tube 20. By positioning the proximal end 40p of the distal tip 40 more proximal than the distal end 20d of the outer tube 20, the outer tube 20 can more easily follow the bending of the distal tip 40 when inserting the medical tubular body delivery device 1 into a curved intravital lumen. Therefore, even when the medical tubular body delivery device 1 is bent, the operator can easily pull the outer tube 20 toward his or her hand, making it easier to place the medical tubular body 10.

[0066] As shown in FIG. 2 , the medical tubular body delivery device 1 includes a proximal tube 60 outside the guidewire tube 30 and proximal to the medical tubular body 10, and the outer diameter of the proximal tube 60 is preferably smaller than the outer diameter of the outer tube 20. By including the proximal tube 60 in the medical tubular body delivery device 1, the length of the outer tube 20 in the longitudinal direction can be shortened. As a result, when manufacturing the medical tubular body delivery device 1, it is easy to adjust the positions of the guidewire tube 30 and the tubular body 50 disposed in the lumen of the outer tube 20 relative to the medical tubular body 10, facilitating joining of the guidewire tube 30 and the tubular body 50. Furthermore, because the outer diameter of the proximal tube 60 is smaller than the outer diameter of the outer tube 20, the rigidity of the medical tubular body delivery device 1 on the proximal side relative to the outer tube 20 is increased. This improves the pushability of the medical tubular body delivery device 1.

[0067] Examples of materials that can be used to form the proximal tube 60 include polyolefin resins such as polyethylene and polypropylene, polyamide resins such as nylon, polyester resins such as PET, aromatic polyether ketone resins such as PEEK, polyether polyamide resins, polyurethane resins, polyimide resins, fluorine-containing resins such as PTFE, PFA, and ETFE, and synthetic resins such as polyvinyl chloride resins. Among these, the material that forms the proximal tube 60 is preferably the same as the material that forms the outer tube 20. By using the same material for the proximal tube 60 as the outer tube 20, the slipperiness of the distal surface of the medical tubular body delivery device 1 is improved, thereby improving insertability.

[0068] The inner diameter of the proximal tube 60 is preferably smaller than the maximum outer diameter of the tubular body 50. The tubular body 50 receives the retraction pressure of the medical tubular body 10 at the portion with the largest outer diameter of the tubular body 50, and concentrates the force on the proximal side of the tubular body 50 before transmitting it to the guidewire tube 30. At this time, because the inner diameter of the proximal tube 60 is smaller than the maximum outer diameter of the tubular body 50, deflection on the proximal side of the tubular body 50 is suppressed, making it difficult for the concentrated force to escape, and preventing displacement of the medical tubular body 10 at the start of deployment. It also has the effect of preventing retraction when the pushing load of the medical tubular body 10 during delivery is applied to the distal tip 40 and causes the guidewire tube 30 to retract, the effect of preventing a decrease in the placement accuracy of the medical tubular body 10 by maintaining contact between the tubular body 50 and the medical tubular body 10, and the effect of preventing detachment by the tubular body 50 and the distal tip 40 in the unlikely event that the proximal tube 60 breaks. Furthermore, during the manufacture of the medical tubular body delivery device 1, when inserting the proximal tube 60 from the proximal side of the outer tube 20, it is possible to prevent the proximal tube 60 from being accidentally inserted too far into the distal side. This also has the effect of making it easier to control the positional relationship and facilitating assembly.

[0069] The inner diameter of the proximal tube 60 is preferably smaller than the maximum outer diameter of the distal tip 40. By making the inner diameter of the proximal tube 60 smaller than the maximum outer diameter of the distal tip 40, the distal tip 40 cannot pass through the proximal tube 60, making it easier to control the relative positions of the medical tubular body 10, the guidewire tube 30, the distal tip 40, the tubular object 50, and the proximal tube 60, and facilitating the manufacture of the medical tubular body delivery device 1. Furthermore, by making the inner diameter of the proximal tube 60 smaller than the maximum outer diameter of the distal tip 40, the cross-sectional areas of the distal tip 40, the portion of the proximal tube 60 that houses the medical tubular body 10 inside the outer tube 20 and outside the guidewire tube 30, and the proximal tube 60 can be made closer together, thereby improving the transfer of pushing force from the hand to the distal tip 40 and the operability of the medical tubular body delivery device 1. Furthermore, by making the outer diameter of the proximal tube 60 and the maximum outer diameter of the outer tube 20 approximately the same, the cross-sectional areas of the proximal tube 60 and the outer tube 20 become closer, thereby further improving the transmission of pushing force.

[0070] 2, the distal end 60d of the proximal tube 60 is preferably located inside the outer tube 20 and distal to the proximal end 20p of the outer tube 20. By having the distal end 60d of the proximal tube 60 located inside the outer tube 20 and distal to the proximal end 20p of the outer tube 20, the boundary between the outer tube 20 and the proximal tube 60 is less likely to get caught on the inner wall of the intraluminal cavity when the medical tubular body delivery device 1 is fed to a target site in the intraluminal cavity. This improves the insertability of the medical tubular body delivery device 1.

[0071] Although not shown, the proximal end 40p of the distal tip 40 is preferably located more proximal than the distal end 10d of the medical tubular body 10. To locate the proximal end 40p of the distal tip 40 more proximal than the distal end 10d of the medical tubular body 10, for example, the proximal end 40p of the distal tip 40 may be disposed in the lumen of the medical tubular body 10. By locating the proximal end 40p of the distal tip 40 more proximal than the distal end 10d of the medical tubular body 10, it is possible to eliminate a gap between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10. As a result, continuity of rigidity can be imparted to the distal end of the outer tube 20, which makes it easier for the outer tube 20 to bend along a curved lumen in a living body and to pull the outer tube 20 toward the surgeon's hand.

[0072] As shown in FIG. 2 , the proximal end of the distal tip 40 preferably has an expanded diameter section 41 whose outer diameter increases distally. The expanded diameter section 41 at the proximal end of the distal tip 40 allows the proximal end of the distal tip 40 to smoothly expand in diameter. Although not shown, the distal tip 40 can be shaped to engage with the distal end 20d of the outer tube 20 while also contacting the distal end 10d of the medical tubular body 10. This shape enhances the unity between the distal tip 40 and the distal end 20d of the outer tube 20, allowing the outer tube 20 to move in accordance with the distal tip 40 during bending, etc. Furthermore, the proximal end of the distal tip 40 may be engaged with the distal end 10d of the medical tubular body 10 to prevent the distal end 10d of the medical tubular body 10 from shifting position.

[0073] The outer diameter of the expanded diameter section 41 may change entirely or partially in a tapered, stepped, uneven, or wavy manner from the proximal end to the distal end of the expanded diameter section 41. In particular, it is preferable that the expanded diameter section 41 expands in a tapered manner entirely from the proximal end to the distal end of the expanded diameter section 41. When the expanded diameter section 41 expands in a tapered manner entirely from the proximal end to the distal end, the surface of the proximal end of the distal tip 40 becomes smooth, making the distal tip 40 more easily bendable when the medical tubular body delivery device 1 is placed in a curved intravital lumen, and also making it easier for the outer tube 20 to follow the bending of the distal tip 40.

[0074] 2, the outer diameter of the proximal end 40p of the distal tip 40 is preferably smaller than the inner diameter of the distal end 10d of the medical tubular body 10 within the outer tube 20. Because the outer diameter of the proximal end 40p of the distal tip 40 is smaller than the inner diameter of the distal end 10d of the medical tubular body 10 within the outer tube 20, the proximal end 40p of the distal tip 40 can enter the lumen of the medical tubular body 10 within the outer tube 20. This eliminates any gap that may occur between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10, making it easier for the outer tube 20 to bend along the curved lumen of the body when the medical tubular body delivery device 1 is placed in a curved lumen of the body, and allowing the medical tubular body 10 to be released smoothly.

[0075] The total distance obtained by adding up the first distance D1 and the second distance D2 is preferably a negative value. The total distance is negative when at least one of the first distance D1 and the second distance D2 is a negative value. The first distance D1 is negative when the distance from the proximal end 40p of the tip 40 to the distal end 10d of the medical tubular body 10 is a negative value, i.e., when the proximal end 40p of the tip 40 is located more proximal than the distal end 10d of the medical tubular body 10. The second distance D2 is negative when the distance from the distal end 50d of the tubular body 50 to the proximal end 10p of the medical tubular body 10 is a negative value, i.e., when the distal end 50d of the tubular body 50 is located more distal than the proximal end 10p of the medical tubular body 10. Because the total distance is a negative value, there is a small gap or no gap between the proximal end 40p of the tip 40 and the distal end 10d of the medical tubular body 10, or between the distal end 50d of the tubular object 50 and the proximal end 10p of the medical tubular body 10. Therefore, when the medical tubular body delivery device 1 is inserted into a curved lumen in a living body, the outer tube 20 is easily bent along the lumen in the living body, allowing for smooth release of the medical tubular body 10.

[0076] It is more preferable that the first distance D1 and the second distance D2 are both negative values. When both the first distance D1 and the second distance D2 are negative values, no gaps are formed between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10, and between the distal end 50d of the tubular object 50 and the proximal end 10p of the medical tubular body 10. As a result, when the medical tubular body delivery device 1 is placed in a curved intravital lumen, the outer tube 20 is more likely to bend along the intravital lumen. This makes it possible to easily pull the outer tube 20 toward the surgeon, facilitating placement of the medical tubular body 10.

[0077] The length from the proximal end 40p of the tip 40 to the distal end 50d of the tubular body 50 is preferably shorter than the length from the distal end 10d to the proximal end 10p of the medical tubular body 10. Because the length from the proximal end 40p of the tip 40 to the distal end 50d of the tubular body 50 is shorter than the length from the distal end 10d to the proximal end 10p of the medical tubular body 10, there is little or no gap between the proximal end 40p of the tip 40 and the distal end 10d of the medical tubular body 10, and between the distal end 50d of the tubular body 50 and the proximal end 10p of the medical tubular body 10. Therefore, when the medical tubular body delivery device 1 is placed in a curved intraluminal lumen, the outer tube 20 is more likely to bend along the intraluminal lumen, allowing the medical tubular body 10 to be released smoothly. In addition, in order to make the length from the proximal end 40p of the tip 40 to the distal end 50d of the tubular body 50 shorter than the length from the distal end 10d to the proximal end 10p of the medical tubular body 10, for example, at least one of the proximal end 40p of the tip 40 and the distal end 50d of the tubular body 50 may be located in the lumen of the medical tubular body 10.

[0078] 1, the medical tubular body delivery device 1 may have a controller 2 on the proximal side. It is preferable that the outer tube 20 can be moved in the longitudinal direction by operating the controller 2. By having the medical tubular body delivery device 1 have the controller 2, it becomes easier to move the outer tube 20 in the longitudinal direction, making it easier to release the medical tubular body 10.

[0079] Next, a method for manufacturing a medical tubular body delivery device of the present invention will be described with reference to Figures 3 to 6. In the following description, parts that overlap with the above description will be omitted.

[0080] Figure 3 is a longitudinal cross-sectional view of a medical tubular body transport device during the medical tubular body placement process in an embodiment of the present invention, Figure 4 is a longitudinal cross-sectional view of a medical tubular body transport device during the guidewire tube placement process, Figure 5 is a longitudinal cross-sectional view of a medical tubular body transport device during the tubular body insertion process, and Figure 6 is a longitudinal cross-sectional view of a medical tubular body transport device during the tubular body placement process.

[0081] As shown in FIGS. 3 to 6, the manufacturing method of the present invention is a method for manufacturing a medical tubular body delivery device 1 that delivers a medical tubular body 10 into a body, the medical tubular body delivery device 1 having an outer tube 20 in the lumen of which a medical tubular body 10 is disposed, a guidewire tube 30 in the lumen of which a guidewire is inserted, a distal tip 40 provided at the distal end of the guidewire tube 30, and a tubular body 50 disposed outside the guidewire tube 30, the manufacturing method of the medical tubular body delivery device 1 includes a guidewire tube placement step of inserting the proximal end 30p of the guidewire tube 30 from the distal end 20d of the outer tube 20 and placing the guidewire tube 30 in the lumen of the medical tubular body 10, a tubular body insertion step of inserting the proximal end 30p of the guidewire tube 30 from the distal end 50d of the tubular body 50, and a tubular body placement step of inserting the distal end 50d of the tubular body 50 from the proximal end 20p of the outer tube 20 and placing the tubular body 50 in the lumen of the outer tube 20. Each step in the manufacturing method of the medical tubular body delivery device 1 will be described in detail below.

[0082] 3 , the medical tubular body positioning step involves positioning the medical tubular body 10 in the lumen of the outer tube 20. In the medical tubular body positioning step, the distal end 10d of the medical tubular body 10 is located proximal to the distal end 20d of the outer tube 20, and the proximal end 10p of the medical tubular body 10 is located distal to the proximal end 20p of the outer tube 20. In other words, the medical tubular body 10 is not exposed from the outer tube 20.

[0083] In the medical tubular body positioning step, it is preferable to insert the proximal end 10p of the medical tubular body 10 first into the distal end 20d of the outer tube 20. By inserting the proximal end 10p of the medical tubular body 10 first into the distal end 20d of the outer tube 20, it becomes easier to position the medical tubular body 10 closer to the distal side of the outer tube 20. This makes it less likely that a gap will form between the medical tubular body 10 and the distal tip 40 located at the distal end of the outer tube 20.

[0084] 4, in the guidewire tube placement step, the proximal end 30p of the guidewire tube 30 is inserted from the distal end 20d of the outer tube 20, and the guidewire tube 30 is placed in the lumen of the medical tubular body 10. In the guidewire tube placement step, by inserting the proximal end 30p of the guidewire tube 30 from the distal end 20d of the outer tube 20, the guidewire tube 30 can be placed in the lumen of the medical tubular body 10 while adjusting the position of the guidewire tube 30 so that no large gap is created between the proximal end 40p of the tip 40 and the distal end 10d of the medical tubular body 10. As a result, a medical tubular body delivery device 1 can be manufactured in which the outer tube 20 is easily bent along a curved lumen in a living body, and the outer tube 20 can be easily pulled toward the surgeon's hand, facilitating the release of the medical tubular body 10.

[0085] After the guidewire tube placement step, it is preferable that the proximal end 30p of the guidewire tube 30 is more proximal than the proximal end 20p of the outer tube 20. In other words, after the guidewire tube placement step, it is preferable that the proximal end 30p of the guidewire tube 30 is exposed from the outer tube 20. Having the proximal end 30p of the guidewire tube 30 more proximal than the proximal end 20p of the outer tube 20 makes it easier to perform the tubular object insertion step, which will be described later, and makes it possible to improve the efficiency of manufacturing the medical tubular object delivery device 1.

[0086] 5, in the tubular object insertion step, the proximal end 30p of the guidewire tube 30 is inserted into the distal end 50d of the tubular object 50. The tubular object insertion step is a step of inserting the tubular object 50 into the guidewire tube 30, or in other words, inserting the distal end 50d of the tubular object 50 into the proximal end 30p of the guidewire tube 30. In the tubular object insertion step, inserting the proximal end 30p of the guidewire tube 30 from the distal end 50d of the tubular object 50 makes it easier to adjust the position at which the tubular object 50 is placed, and makes it easier to perform the tubular object placement step, which will be described later.

[0087] As shown in Figure 6, in the tubular object placement step, the distal end 50d of the tubular object 50 is inserted into the proximal end 20p of the outer tube 20, and the tubular object 50 is placed in the lumen of the outer tube 20. In the tubular object placement step, by inserting the distal end 50d of the tubular object 50 into the proximal end 20p of the outer tube 20 in the tubular object placement step, the tubular object 50 can be placed without a large gap between the proximal end 10p of the medical tubular object 10 and the distal end 50d of the tubular object 50. Eliminating excess play between the proximal end 10p of the medical tubular object 10 and the distal end 50d of the tubular object 50 has the effect of improving the accuracy of deployment of the medical tubular object 10, and providing continuous rigidity from the distal tip 40 to the tubular object 50, making kinking less likely to occur in the medical tubular object delivery device 1 and facilitating deployment and delivery of the medical tubular object 10.

[0088] When the distal tip 40 is a separate member from the guidewire tube 30, the manufacturing method of the present invention preferably includes a distal tip positioning step of positioning the distal tip 40 at the distal end 30d of the guidewire tube 30. By including the distal tip positioning step in the manufacturing method of the present invention, it becomes possible to smoothly manufacture the medical tubular body delivery device 1 even if the distal tip 40 and the guidewire tube 30 are separate members.

[0089] The distal tip positioning step may be performed before or after the medical tubular body positioning step. The guidewire tube positioning step is preferably performed after the medical tubular body positioning step. By performing the guidewire tube positioning step after the medical tubular body positioning step, it becomes easier to adjust the position of the guidewire tube 30 when placing the guidewire tube 30 in the lumen of the medical tubular body 10 in the guidewire tube positioning step. This makes it easier to adjust the position of the guidewire tube 30 so that no gap occurs between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10.

[0090] The tubular object positioning step is followed by a tubular object fixing step of fixing the tubular object 50 to the guidewire tube 30 proximal to the proximal end 20p of the outer tube 20. In the tubular object fixing step, the proximal end 20p of the outer tube 20 is preferably located distal to the proximal end 50p of the tubular object 50. Since the manufacturing method of the present invention includes a tubular object fixing step of fixing the tubular object 50 to the guidewire tube 30 so that the proximal end 20p of the outer tube 20 is located distal to the proximal end 50p of the tubular object 50, the proximal end 50p of the tubular object 50 is exposed from the outer tube 20. Since the proximal end 50p of the tubular object 50 is exposed from the outer tube 20, the step of fixing the proximal end of the tubular object 50 to the guidewire tube 30 can be easily and reliably performed. This improves the efficiency of manufacturing the medical tubular object delivery device 1.

[0091] As shown in FIG. 2 , the medical tubular body delivery device 1 preferably includes a proximal tube 60 outside the guidewire tube 30 and proximal to the medical tubular body 10, and after the tubular body fixing step, includes a proximal tube fixing step in which the proximal tube 60 is inserted through the proximal end 30p of the guidewire tube 30 and fixed to the outer tube 20. Because the medical tubular body delivery device 1 includes the proximal tube 60 and the manufacturing method of the present invention includes the proximal tube fixing step, the length of the outer tube 20 can be shortened in the longitudinal direction, making it easier to adjust the relative positions of the medical tubular body 10, the guidewire tube 30, the distal tip 40, and the tubular body 50. As a result, it is easy to arrange each component so as not to create large gaps between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10, and between the proximal end 10p of the medical tubular body 10 and the distal end 50d of the tubular body 50. Therefore, the outer tube 20 can be easily bent along a curved lumen in the body, making it easier to manufacture a medical tubular body delivery device 1 that can easily release the medical tubular body 10 .

[0092] Although not shown, after the guidewire tube placement step, the proximal end 40p of the distal tip 40 is preferably located more proximal than the distal end 10d of the medical tubular body 10. By locating the proximal end 40p of the distal tip 40 more proximal than the distal end 10d of the medical tubular body 10, it is possible to eliminate a gap between the proximal end 40p of the distal tip 40 and the distal end 10d of the medical tubular body 10. As a result, it is possible to manufacture a medical tubular body delivery device 1 in which the rigidity of the distal end of the outer tube 20 is continuous, which makes it easier for the outer tube 20 to bend along a curved lumen in a living body and easier for the surgeon to pull the outer tube 20 toward his or her hand.

[0093] Although not shown, after the tubular object placement step, the distal end of the tubular object 50 preferably contacts the proximal end of the medical tubular body 10. By having the distal end of the tubular object 50 contact the proximal end of the medical tubular body 10, the tubular object 50 can prevent the medical tubular body 10 from moving distally when the outer tube 20 is pulled toward the surgeon, allowing the medical tubular body 10 to be released smoothly.

[0094] As described above, the medical tubular body delivery device of the present invention is a device for delivering a medical tubular body into the body, and comprises an outer tube in which the medical tubular body is disposed in a lumen, a guidewire tube disposed in the lumen of the medical tubular body and through which a guidewire is inserted, a distal tip provided at the distal end of the guidewire tube, and a tubular body disposed inside the outer tube and outside the guidewire tube, proximal to the distal end of the medical tubular body, wherein the proximal end of the outer tube is located distal to the proximal end of the tubular body, and the total distance obtained by adding together a first distance from the proximal end of the distal tip to the distal end of the medical tubular body, which satisfies the following condition, and a second distance from the distal end of the tubular body to the proximal end of the medical tubular body, which satisfies the following condition, is 0.5 mm or less (including 0 mm). [Condition] The first distance is a positive value when the proximal end of the tip is located distal to the distal end of the medical tubular body, and a negative value when the proximal end of the tip is located proximal to the distal end of the medical tubular body; the second distance is a positive value when the distal end of the tubular body is located proximal to the proximal end of the medical tubular body, and a negative value when the distal end of the tubular body is located distal to the proximal end of the medical tubular body. Because the medical tubular body transport device has this configuration, there are no large gaps between the distal tip and the medical tubular body, and between the tubular object and the medical tubular body.When the medical tubular body transport device is placed in a curved intravital lumen, the outer tube is more likely to bend along the curved intravital lumen, making it easier to pull the outer tube toward the surgeon, and allowing the medical tubular body to be released smoothly.

[0095] Furthermore, the method for manufacturing a medical tubular body delivery device of the present invention is a method for manufacturing a device for delivering a medical tubular body into a body, the device having an outer tube in which a medical tubular body is placed in its lumen, a guidewire tube in which a guidewire is inserted into its lumen, a distal tip provided at the distal end of the guidewire tube, and a tubular body placed outside the guidewire tube, and includes the following steps: a medical tubular body placement step of placing the medical tubular body in the lumen of the outer tube; a guidewire tube placement step of inserting the proximal end of the guidewire tube from the distal end of the outer tube and placing the guidewire tube in the lumen of the medical tubular body; a tubular body insertion step of inserting the proximal end of the guidewire tube from the distal end of the tubular body; and a tubular body placement step of inserting the distal end of the tubular body from the proximal end of the outer tube and placing the tubular body in the lumen of the outer tube. By having the manufacturing method include these steps, large gaps are less likely to occur between the distal tip and the medical tubular body, and between the tubular object and the medical tubular body, during the manufacture of the medical tubular body transport device, the outer tube can be bent along a curved intravital lumen, making it easier to pull the outer tube toward the surgeon, and a medical tubular body transport device can be manufactured that makes it easier to release the medical tubular body.

[0096] This application claims the benefit of priority to Japanese Patent Application No. 2021-058328, filed on March 30, 2021. The entire contents of the specification of Japanese Patent Application No. 2021-058328, filed on March 30, 2021, are incorporated herein by reference. [Explanation of symbols]

[0097] 1: Medical tubular body transport device 2: Controller 10: Medical tubular body 10d: Distal end of medical tubular body 10p: Proximal end of medical tubular body 20: Outer tube 20d: Distal end of outer tube 20p: Proximal end of outer tube 30: Guidewire tube 30d: Distal end of guidewire tube 30p: Proximal end of guidewire tube 40: Tip 40d: Distal end of tip 40p: Proximal end of tip 41: Expanded diameter part 50: Tube 50d: Distal end of tubular object 50p: Proximal end of tubular object 60: Proximal tube 60d: Distal end of proximal tube D1: First distance D2: 2nd distance

Claims

1. an outer tube disposed within the lumen of the medical tubular body; a guidewire tube through which a guidewire is inserted; a tip provided at the distal end of the guidewire tube; a tubular object disposed outside the guidewire tube, the method comprising: a medical tubular body placement step of placing the medical tubular body in the lumen of the outer tube; a guidewire tube placement step of inserting the proximal end of the guidewire tube through the distal end of the outer tube and placing the guidewire tube in the lumen of the medical tubular body; a tubular object insertion step of inserting the proximal end of the guidewire tube into the distal end of the tubular object; a tubular object placement step of inserting the distal end of the tubular object from the proximal end of the outer tube and placing the tubular object in the lumen of the outer tube.

2. The method of claim 1 further comprising the step of placing the tip on the distal end of the guidewire tube.

3. a tubular object fixing step of fixing the tubular object to the guidewire tube on a side proximal to the proximal end of the outer tube after the tubular object placing step, 3. The manufacturing method according to claim 1, wherein in the tubular object fixing step, the proximal end of the outer tube is located distal to the proximal end of the tubular object.

4. a proximal tube located outside the guidewire tube and proximal to the medical tubular body; 4. The manufacturing method according to claim 3, further comprising, after the tubular object fixing step, a proximal tube fixing step of inserting the proximal tube from the proximal end of the guidewire tube and fixing the proximal tube and the outer tube together.

5. 5. The manufacturing method according to claim 1, wherein after the guidewire tube placement step, the proximal end of the distal tip is located proximal to the distal end of the medical tubular body.

6. The manufacturing method according to any one of claims 1 to 5, wherein after the tubular object placement step, the distal end of the tubular object is in contact with the proximal end of the medical tubular body.

Images