JP2011125621A - Manufacturing method of balloon catheter and balloon catheter manufactured by the manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a manufacturing method of a balloon catheter capable of certainly mounting a stent on a balloon and further preventing generation of damage or the like of the balloon, and to provide the balloon catheter which is manufactured by the method. <P>SOLUTION: The method of manufacturing the balloon catheter 10 is the one for indwelling the stent 16 inside the body, and includes the processes of: casting the balloon 30 for mount for mounting the stent 16; folding an expanded part of the balloon 30 for mount to mount the stent 16 around the expanded part; inserting a folded balloon 28 for expansion into the inside of the balloon 30 for mount which mounts the stent 16 to join the tips and base ends of the balloon 28 for expansion and the balloon 30 for mount. <P>COPYRIGHT: (C)2011,JPO&INPIT

Description

  The present invention relates to a method for manufacturing a balloon catheter for placing a stent in the body, and a balloon catheter manufactured by the method.

  For example, in the treatment of myocardial infarction and angina pectoris, a method of expanding the lesion (stenosis) of the coronary artery with a balloon catheter is used, and other blood vessels, bile ducts, trachea, esophagus, urethra, other organs, etc. The improvement of the constriction formed in the living organ may be performed in the same manner. A balloon catheter is generally configured to include a long shaft main body and a balloon that is provided on the distal end side of the shaft main body and expands in the radial direction. Sent to the stenosis.

  Such a balloon catheter may be used as a balloon catheter for stent delivery for placing a stent for expanding a stenosis or the like in a living body (see, for example, Patent Document 1). A stent is usually a cylinder made of a metal wire or the like processed into a mesh shape. The stent is mounted around the balloon, and when the balloon is expanded at the desired stenosis, the stent is also expanded and adhered to the inner wall of the lumen. Is done.

JP 2009-82244 A

  By the way, when the stent is mounted around the balloon, if the stent is tightened too much, a pinhole may be formed in the balloon or damage causing balloon rupture (rupture) may occur. On the other hand, if the clamping force of the stent to the balloon is small, the stent may fall out in vivo.

  The present invention has been made in consideration of such conventional problems, and a balloon catheter manufacturing method capable of securely mounting a stent on a balloon and preventing the occurrence of balloon damage and the like. And it aims at providing the balloon catheter manufactured by this manufacturing method.

  The method for manufacturing a balloon catheter according to the present invention is a method for manufacturing a balloon catheter for placing a stent in the body, and includes a first step of molding a mounting balloon for mounting the stent, and the mounting balloon. A second step of folding the expansion portion of the device and mounting the stent around the expansion portion; and inserting the folded expansion balloon into the mounting balloon on which the stent is mounted; and the expansion balloon and the mount And a third step of joining the distal end portion and the proximal end portion of the balloon for use.

  According to such a method, a stent is mounted on a pre-folded mounting balloon, and an expansion balloon is inserted inside the mounting balloon to join the distal end side and the proximal end side to each other. As a result, even when a pinhole is created in the mounting balloon or damage that causes balloon rupture occurs when the stent is mounted, the pin is attached to the expansion balloon used for actual balloon expansion. There will be no holes or damage. Therefore, the stent can be securely mounted on the mounting balloon with a predetermined tightening force to prevent the stent from falling off, and the balloon can be expanded with the inner expansion balloon, resulting in poor expansion and balloon rupture. Can be prevented.

  When the shaft main body formed with the expansion lumen through which the expansion fluid for expanding the expansion balloon is preliminarily joined to the expansion balloon used in the third step, for example, other than for stent delivery The assembly of the shaft main body and the balloon for expansion used as a normal PTCA dilatation catheter can be easily diverted for stent delivery, and versatility can be improved.

  Further, a fourth shaft body is formed which has an expansion lumen through which an expansion fluid for expanding the expansion balloon circulates to the mounting balloon and the expansion balloon that are bonded to each other in the third step. When the process has a process, a balloon alone mounted with a stent is manufactured in advance, and then a shaft body having an outer diameter and a length corresponding to the use of the balloon catheter can be retrofitted, thereby improving versatility. be able to.

  The balloon catheter according to the present invention is a balloon catheter for placing a stent in the body, and is disposed on the outer surface side of the inner tube shaft and an inner tube shaft for inserting a guide wire. An outer tube shaft that forms an expansion lumen with the tube shaft, a distal end side is joined to the inner tube shaft, and a proximal end side is joined to the outer tube shaft, so that the expansion fluid from the expansion lumen An expandable balloon that can be expanded by the above, and a mounting balloon that is disposed around the expandable balloon and that is joined to the distal end portion and the proximal end portion of the expandable balloon and on which the stent is mounted. It is characterized by having.

  According to such a configuration, the mounting balloon on which the stent is mounted is provided around the expansion balloon that can be expanded by the expansion fluid from the expansion lumen, thereby directly contributing to the balloon expansion. As a result, it is possible to effectively prevent the occurrence of poor expansion and balloon rupture because the expansion balloon is prevented from causing pinholes or damage. Moreover, since the stent is mounted on the mounting balloon, the stent can be securely mounted on the mounting balloon with a predetermined tightening force at the time of mounting, and the stent can be prevented from falling off.

  In this case, when the inner surface side of the mounting balloon is arranged on the outer surface side of the wing formed by folding the expansion balloon, the expansion balloon on the inner side is expanded by the expansion fluid that circulates the expansion lumen when the balloon is expanded. The mounting balloon and the stent can be reliably expanded by the expansion force of the expansion balloon.

  According to the present invention, a stent is mounted on a pre-folded mounting balloon, and an expansion balloon is inserted inside the mounting balloon to join the distal end side and the proximal end side to each other. As a result, even when a pinhole is created in the mounting balloon or damage that causes balloon rupture occurs when the stent is mounted, the pin is attached to the expansion balloon used for actual balloon expansion. There will be no holes or damage. Therefore, the stent can be securely mounted on the mounting balloon with a predetermined tightening force to prevent the stent from falling off, and the balloon can be expanded with the inner expansion balloon, resulting in poor expansion and balloon rupture. Can be prevented.

1 is an overall configuration diagram of a balloon catheter according to an embodiment of the present invention. 2A is a partially sectional side view in which the distal end side of the balloon catheter shown in FIG. 1 is enlarged, and FIG. 2B is a partially sectional side view in a state where the balloon is expanded from the state shown in FIG. 2A. It is a schematic cross section which follows the III-III line in FIG. 2A. It is a flowchart which shows the procedure of the manufacturing method of the balloon catheter which concerns on one Embodiment of this invention. It is a partial cross section side view of the balloon for mounting. FIG. 6 is a partial cross-sectional side view in a state where a core material is inserted into the mounting balloon shown in FIG. 5. FIG. 7 is a partial cross-sectional side view in a state where a stent is mounted after the mounting balloon shown in FIG. 6 is folded. It is a partial cross section side view which shows the state which inserts the balloon for expansion | swelling joined to the front-end | tip of a shaft main body with respect to the balloon for mounting shown in FIG. It is a flowchart which shows another procedure of the manufacturing method of the balloon catheter which concerns on one Embodiment of this invention. FIG. 10 is a partial cross-sectional side view showing a state in which a shaft body is inserted into a balloon of the balloon catheter manufactured by the procedure shown in FIG. 9.

  DESCRIPTION OF EMBODIMENTS Hereinafter, a balloon catheter according to the present invention will be described with reference to the accompanying drawings by giving preferred embodiments in relation to the manufacturing method thereof.

  FIG. 1 is an overall configuration diagram of a balloon catheter 10 according to an embodiment of the present invention. 2A is a partially sectional side view in which the distal end side of the balloon catheter 10 shown in FIG. 1 is enlarged, and FIG. 2B is a partially sectional side view in a state where the balloon 14 is expanded from the state shown in FIG. 2A. is there.

  In the balloon catheter 10 according to the present embodiment, the long shaft body 12 is inserted into a living organ, for example, a coronary artery, and the balloon 14 provided on the distal end side thereof is expanded at the stenosis part (lesion part), thereby the stenosis part. Is a so-called PTCA (Percutaneous Transluminal Coronary Angioplasty) dilatation catheter, which is a stent delivery for placing the stent 16 mounted around the balloon 14 in a desired stenosis ( Used for stent systems). Of course, the present invention is other than such PTCA dilatation catheters, for example, catheters for improving lesions formed in living organs such as other blood vessels, bile ducts, trachea, esophagus, urethra, and other organs. It is also applicable to.

  As shown in FIGS. 1, 2A and 2B, the balloon catheter 10 is mounted on the periphery of the balloon 14 with a thin and long shaft body 12, a balloon 14 provided on the distal end side of the shaft body 12, and the balloon 14. And a hub 18 provided on the proximal end side of the shaft body 12. In the present embodiment, a balloon catheter 10 called a rapid exchange type in which an opening 22 through which the guide wire 20 is led out is provided slightly near the middle of the shaft body 12 will be described as an example. Is applicable to other types, for example, an over-the-wire type in which an opening for a guide wire is provided in the hub 18 on the proximal end side of the shaft body 12. 1, 2 </ b> A, and 2 </ b> B, the right side (hub 18 side) of the shaft body 12 is referred to as the “base end (rear end)” side, and the left side of the shaft body 12 (balloon 14 side) is referred to as the “front end” side. The same applies to the other drawings.

  As shown in FIGS. 2A and 2B, the shaft main body 12 has an inner tube (inner tube shaft, guide wire tube) 24 that forms a wire lumen 24 a through which the guide wire 20 is inserted, and an expansion fluid for the balloon 14. This is a concentric double tube composed of an outer tube (outer tube shaft) 26 formed between an expansion lumen 26a for supply and an outer peripheral surface of the inner tube 24.

  The inner tube 24 extends through the balloon 14 and the outer tube 26, and the vicinity of the distal end thereof is liquid-tightly joined to the distal end side of the balloon 14, and the base end thereof is an opening formed at the intermediate portion of the outer tube 26. 22 is liquid-tightly joined. Therefore, the guide wire 20 inserted with the distal end opening of the inner tube 24 as the inlet is inserted through the wire lumen 24a of the inner tube 24 from the distal end side to the proximal end side and led out from the opening 22 which is the outlet. .

  The outer tube 26 extends from the rear end of the balloon 14 to the tip of the hub 18, and a portion from the tip to the opening 22 constitutes a double tube that forms an expansion lumen 26 a between the inner tube 24 and the outer tube 26. A portion from the opening 22 to the hub 18 is a single tube. The outer tube 26 is capable of delivering an expansion fluid pumped from a pressure application device such as an indeflator (not shown) to the balloon 14 by a luer taper 18 a provided on the hub 18.

  The inner tube 24 has, for example, an outer diameter of about 0.1 to 1.0 mm, preferably about 0.3 to 0.7 mm, a wall thickness of about 10 to 150 μm, preferably about 20 to 100 μm, and a long length. The tube has a length of about 100 to 2000 mm, preferably about 150 to 1500 mm, and may have different outer diameters and inner diameters on the distal end side and the proximal end side. The outer tube 26 has, for example, an outer diameter of about 0.3 to 3.0 mm, preferably about 0.5 to 1.5 mm, a thickness of about 10 to 150 μm, preferably about 20 to 100 μm, and a length. Is about 300 to 2000 mm, preferably about 700 to 1600 mm, and may have different outer diameters and inner diameters on the distal end side and the proximal end side.

  These inner tube 24 and outer tube 26 allow the operator to smoothly insert the long shaft body 12 into a living organ such as a blood vessel while grasping and operating the proximal end side. A structure having flexibility and moderate strength (stiffness, rigidity) is preferable. Therefore, the inner tube 24 and the outer tube 26 are made of, for example, polyolefin (for example, polyethylene, polypropylene, polybutene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ionomer, or a mixture of two or more of these). It may be formed of a polymer material such as polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or a multilayer tube of the above two or more polymer materials.

  As shown in FIGS. 2A, 2B and 3, the balloon 14 includes an expansion balloon (inner balloon) 28 disposed on the outer peripheral side of the inner tube 24, and a mounting balloon disposed on the outer peripheral side of the expansion balloon 28. It has a radial concentric double structure having a balloon (outer balloon) 30 and can be folded and expanded by a change in internal pressure based on the expansion lumen 26a.

  The expansion balloon 28 has a cylindrical portion (straight portion) 28a that expands into a cylindrical shape (cylindrical shape) by an expansion fluid injected into the inside through the expansion lumen 26a, and a gradually reduced diameter at the distal end side of the cylindrical portion 28a. A distal end taper portion 28b, and a proximal end taper portion 28c that gradually decreases in diameter on the proximal end side of the cylindrical portion 28a.

  The expansion balloon 28 is provided on the proximal end side of the proximal end taper portion 28c, with a cylindrical portion which is a non-expanded portion provided on the distal end side of the distal end tapered portion 28b being joined to the outer peripheral surface of the inner tube 24 in a liquid-tight manner. Further, the cylindrical portion which is a non-expanded portion is fixed to the shaft body 12 by being liquid-tightly joined to the distal end portion of the outer tube 26. That is, the inner diameter of the cylindrical portion on the distal end side of the balloon for expansion 28 is substantially the same as the outer diameter of the inner tube 24, and the outer diameter of the cylindrical portion on the proximal end side is substantially the same as the outer diameter of the outer tube 26. ing. The expansion balloon 28 and the inner tube 24 (outer tube 26) may be fixed in a liquid-tight manner, and may be joined by, for example, adhesion or heat fusion.

  The mounting balloon 30 can be passively expanded by the expansion force of the expansion balloon 28 disposed on the inside thereof, and is substantially the same as the expansion balloon 28, and is a cylindrical portion (straight) that expands into a cylindrical shape (cylindrical shape). Portion) 30a, a distal end taper portion 30b that gradually decreases in diameter on the distal end side of the cylindrical portion 30a, and a proximal end tapered portion 30c that gradually decreases in diameter on the proximal end side of the cylindrical portion 30a, and the outer peripheral surface of the cylindrical portion 30a The stent 16 is mounted on the surface.

  The mounting balloon 30 has a cylindrical portion that is a non-expanded portion provided on the distal end side of the distal tapered portion 30b and is joined to a cylindrical portion on the distal end side of the expanding balloon 28, and is provided on the proximal end side of the proximal tapered portion 30c. The cylindrical portion which is the non-expanded portion is bonded to the cylindrical portion on the proximal end side of the expansion balloon 28, thereby being fixed to the expansion balloon 28. In other words, in the mounting balloon 30, the inner diameter of the cylindrical portion on the distal end side substantially matches the outer diameter of the cylindrical portion on the distal end side of the balloon for expansion 28, and the outer diameter of the cylindrical portion on the proximal end side is It substantially matches the outer diameter of the cylindrical portion on the proximal end side of the balloon 28. It should be noted that the distal end side and the proximal end side of the mounting balloon 30 may be directly fixed to the inner tube 24 and the outer tube 26 instead of the expansion balloon 28. The mounting balloon 30 and the expansion balloon 28 (or the inner tube 24 and the outer tube 26) may be firmly fixed to such an extent that at least peeling does not occur. For example, the mounting balloon 30 and the expansion balloon 28 may be bonded by adhesion or heat fusion.

  The size of the mounting balloon 30 when expanded is, for example, that the outer diameter of the cylindrical portion 30a is about 1 to 6 mm, preferably about 1 to 5 mm, and the length is about 5 to 50 mm, preferably about 5 to 40 mm. is there. Further, the outer diameter of the cylindrical portion which is the non-expanded portion on the distal end side is about 0.5 to 1.5 mm, preferably about 0.6 to 1.3 mm, and the length is about 1 to 5 mm, preferably 1. About 2.0 mm. The outer diameter of the cylindrical portion of the non-expanded portion on the proximal side is about 0.5 to 1.6 mm, preferably about 0.7 to 1.5 mm, and the length is about 1 to 5 mm, preferably about 2 to 4 mm. It is. Furthermore, the length of the distal end taper portion 30b and the proximal end taper portion 30c is about 1 to 10 mm, preferably about 3 to 7 mm. Since the expansion balloon 28 is disposed between the mounting balloon 30 and the inner tube 24 and the outer tube 26, the dimensions may be appropriately set in relation to these.

The expansion balloon 28 and the mounting balloon 30 constituting such a balloon 14 are required to have an appropriate flexibility like the inner tube 24 and the outer tube 26, and can surely expand the stenosis. A certain degree of strength is required, and the material thereof may be, for example, the same as that of the inner tube 24 and the outer tube 26 exemplified above, and other materials may be used.

  The stent 16 is a so-called balloon expandable stent that expands (plastically deforms) by the expansion force of the balloon 14 and is mounted on the mounting balloon 30 so as to encapsulate the balloon 14. The stent 16 has a cylindrical shape in which a predetermined metal wire is formed in a mesh shape, and a plurality of metal wires are formed as a wavy annular body, and a metal wire is appropriately connected between them. Well-known structures such as those formed into a spiral shape or a metal wire wound in a cylindrical shape can be applied. The material of the metal wire forming the stent 16 is preferably a biocompatible metal, such as stainless steel, tantalum (tantalum alloy), platinum (platinum alloy), gold (gold alloy), cobalt base alloy, cobalt chrome. An alloy, a titanium alloy, a niobium alloy, etc. are mentioned.

  Next, a method for manufacturing the balloon catheter 10 according to the present embodiment will be described with reference to the flowchart of FIG.

  First, in step S1 of FIG. 4, the mounting balloon 30 is molded by a known molding method using a predetermined mold (see FIG. 5). Next, in step S 2, as shown in FIG. 6, a rod-shaped core member 34 is inserted into the inside of the mounting balloon 30 molded in an expanded state, and the mounting balloon 30 of the mounting balloon 30 is used with reference to the core member 34. The cylinder part 30a, the distal end taper part 30b, and the proximal end taper part 30c, which are expansion parts, are folded. As can be seen from FIG. 3, the number of wings 36 when the mounting balloon 30 is folded may be set to, for example, about 2 to 5 (3 in FIG. 3).

  Subsequently, as shown in FIG. 7, after the stent 16 is mounted and tightened on the outer periphery of the cylindrical portion 30a that is the expanded portion of the mounting balloon 30 (step S3), the core material inserted inside 34 is removed (step S4). As a result, the expanded portion is folded, and an assembly of the mounting balloon 30 in which the stent 16 is mounted on the outer periphery thereof is formed.

  In step S3, when the stent 16 is mounted, a pressurizing device (not shown) capable of pumping air, nitrogen, or the like is connected to both opening portions of the mounting balloon 30 to pressurize the mounting balloon 30 from the inside. Good. As a result, the stent 16 can be tightened while appropriately pressurizing the expanded portion of the mounting balloon 30, so that the stent 16 can be mounted more stably.

  Next, in step S5, as shown in FIG. 8, the expansion balloon 28 joined and folded to the tip of the shaft body 12 is inserted inside the mounting balloon 30 on which the stent 16 is mounted. At this time, in steps S2 and S3, the core member 34 is disposed inside the mounting balloon 30 when the mounting balloon 30 is folded and when the stent 16 is mounted. Therefore, a cylindrical space to the extent that the expansion balloon 28 can be smoothly inserted can be more reliably secured inside the folded mounting balloon 30, and the insertion operation of the expansion balloon 28 can be further performed. It can be done easily.

  In step S6, the expansion balloon 28 (or the shaft body 12) and the mounting balloon 30 are joined. That is, as shown in FIG. 2A, the distal end side of the mounting balloon 30 and the cylindrical portion that is the non-expanded portion on the distal end side are joined to the cylindrical portion that is the distal end side of the expansion balloon 28 and the non-expanded portion on the distal end side. Thus, the manufacture of the balloon catheter 10 is completed.

  The joining method of the expansion balloon 28 and the mounting balloon 30 in step S6 is not particularly limited, and examples thereof include a joining method by fusion or adhesion. In the case of the joining method by fusion, a heat shrinkable tube (not shown) is placed on the outer peripheral surfaces of the cylindrical portion of the mounting balloon 30 and the cylindrical portion of the expansion balloon 28, and then heated by a predetermined heating device to fuse them together.・ After joining, the heat-shrinkable tube may be removed. Further, in the case of the bonding method by bonding, the cylindrical portion of the mounting balloon 30 and the cylindrical portion of the expansion balloon 28 may be bonded and bonded with a predetermined adhesive.

  As described above, according to the balloon catheter 10 of the present embodiment, the stent 16 is mounted on the pre-folded mounting balloon 30, and the dilatation balloon 28 is inserted inside the mounting balloon 30, so The side and the base end side are joined. As a result, when the stent 16 is mounted, even if a pinhole is generated in the mounting balloon 30 or damage that causes balloon rupture occurs, the expansion is provided for the actual expansion of the balloon 14. There is no pinhole or damage to the balloon 28 for use. That is, according to the present embodiment, the expansion balloon 28 is not given a compressive force when the stent 16 is tightened, and even if a pinhole or the like is generated in the mounting balloon 30, the balloon 14 itself Therefore, the stent 16 can be securely mounted on the mounting balloon 30 with a predetermined tightening force to prevent the stent 16 from falling off, and the balloon 14 can be expanded on the inner side. It is possible to prevent the balloon 14 from being poorly expanded or causing balloon rupture by being performed with the balloon 28 for use.

  Further, in the balloon catheter 10, since the stent 16 is mounted on the folded mounting balloon 30, and the expansion balloon 28 is inserted inside the mounting balloon 30, as shown in FIG. At least in the unused folded state, the inner peripheral surface of the mounting balloon 30 around the wing 38 formed by folding the expansion portions (the cylindrical portion 28a, the distal end tapered portion 28b, and the proximal end tapered portion 28c) of the expansion balloon 28. The structure is arranged. Therefore, when the balloon 14 is expanded, the inner expansion balloon 28 can be reliably expanded by the expansion fluid that is pumped from the hub 18 side and circulated through the expansion lumen 26a, and the expansion force of the expansion balloon 28 is increased. Thus, the mounting balloon 30 and the stent 16 can be reliably expanded.

  In the balloon catheter 10, as shown in the above step S 5, a process sequence for inserting and joining the expansion balloon 28 previously joined to the tip of the shaft body 12 and folded inside the mounting balloon 30 on which the stent 16 is mounted is performed. Thus, the assembly of the shaft body 12 and the expansion balloon 28 (ordinary balloon catheter) used as a normal PTCA dilatation catheter other than for stent delivery can be easily diverted for stent delivery. , Versatility can be improved.

  In the balloon catheter 10, as shown in FIGS. 9 and 10, for example, an expansion balloon 28 that is not joined to the shaft body 12 is inserted and mounted inside the mounting balloon 30 on which the stent 16 is mounted. After joining, it is also possible to manufacture in the order of the process of joining the shaft body 12.

  In this case, first, in steps S11 to S14 in FIG. 9, the same steps as in steps S1 to S4 in FIG. 4 are performed. Next, as shown in FIG. 10, the expansion balloon 28 folded in advance is inserted into the inside of the mounting balloon 30 on which the stent 16 is mounted (step S15), and the expansion balloon 28, the mounting balloon 30, After joining (step S16), the distal end side of the shaft body 12 is inserted into the inside of the expansion balloon 28 (step S17). Finally, the manufacture of the balloon catheter 10 can be completed by joining the inner tube 24 of the shaft body 12 and the distal end side of the expansion balloon 28 and the outer tube 26 and the proximal end side of the expansion balloon 28. (Step S18). Note that the joining method in step S16 and step S18 may be the same as the joining method in step S6 of FIG. 4 described above, and may be performed by fusion, adhesion, or other joining methods.

  In this way, after inserting and joining the expansion balloon 28 not joined to the shaft body 12 inside the mounting balloon 30 on which the stent 16 is mounted, the order of the process of joining the shaft body 12 (see steps S15 to S18). ), The assembly of the balloon 14 on which the stent 16 is mounted is manufactured in advance, and then the shaft body 12 having an outer diameter and length corresponding to the use of the balloon catheter 10 is attached to the balloon. 14 can be retrofitted, so versatility can be improved.

  The present invention is not limited to the above-described embodiment, and it is needless to say that various configurations and processes can be adopted without departing from the gist of the present invention.

DESCRIPTION OF SYMBOLS 10 ... Balloon catheter 12 ... Shaft body 14 ... Balloon 16 ... Stent 24 ... Inner tube 24a ... Wire lumen 26 ... Outer tube 26a ... Expansion lumen 28 ... Expansion balloon 30 ... Mount balloon 34 ... Core material 36, 38 ... wing

Claims (5)

A method of manufacturing a balloon catheter for placing a stent in a body,
A first step of molding a mounting balloon for mounting the stent;
A second step of folding an expansion site of the mounting balloon and mounting the stent around the expansion site;
A third step of inserting a folded expansion balloon into the mounting balloon mounted with the stent, and joining the expansion balloon and the distal end portion and the proximal end portion of the mounting balloon;
A method for producing a balloon catheter, comprising: In the manufacturing method of the balloon catheter of Claim 1,
The balloon balloon for expansion used in the third step is preliminarily joined with a shaft body formed with an expansion lumen through which an expansion fluid for expanding the expansion balloon flows. Production method. In the manufacturing method of the balloon catheter of Claim 1,
A fourth step of joining a shaft main body formed with an expansion lumen through which an expansion fluid for expanding the expansion balloon flows to the mounting balloon and the expansion balloon that are bonded to each other in the third step; A method for producing a balloon catheter, comprising: A balloon catheter for placing a stent in the body,
An inner tube shaft for inserting a guide wire;
An outer tube shaft disposed on the outer surface side of the inner tube shaft and forming an expansion lumen with the inner tube shaft;
An expansion balloon that can be expanded by an expansion fluid from the expansion lumen by joining a distal end side to the inner tube shaft and a proximal end side to the outer tube shaft;
A mounting balloon disposed around the dilatation balloon, joined to a distal end portion and a proximal end portion of the dilatation balloon, and the stent is mounted therearound;
A balloon catheter characterized by comprising: The balloon catheter according to claim 4,
A balloon catheter, wherein an inner surface side of the mounting balloon is disposed on an outer surface side of a wing formed by folding the expansion balloon.

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