WO2020196232A1

WO2020196232A1 - Balloon folding method, balloon folding device, and balloon catheter

Info

Publication number: WO2020196232A1
Application number: PCT/JP2020/012228
Authority: WO
Inventors: 後藤博; 黒崎靖夫
Original assignee: テルモ株式会社
Priority date: 2019-03-22
Filing date: 2020-03-19
Publication date: 2020-10-01
Also published as: JPWO2020196232A1; JP7394836B2

Abstract

[Problem] To provide a balloon folding method, a balloon folding device, and a balloon catheter, which are capable of uniformly folding, in the same direction, a plurality of wing sections protruding outward in a radial direction of a balloon. [Solution] This balloon folding method, for folding a balloon 30 of a balloon catheter 10 to the outer circumferential surface of an inner tube 22, has: a step for inserting the balloon 30 between a plurality of first moving members 122 arranged to surround a predetermined region, and for moving the first moving members 122 toward the balloon 30 to form, on the balloon 30, a plurality of wing sections 32 protruding outward in a radial direction; a step for applying a force to the wing sections 32 in the same direction as the circumferential direction of the inner tube 22 to cause the wing sections 32 to be bent in the same direction; and a step for inserting the balloon 30 having the bent wing sections 32 between a plurality of second moving members 132 arranged to surround a predetermined region, and for moving the second moving members 132 toward the inner tube 22 to fold the wing sections 32.

Description

Balloon folding method and balloon folding device and balloon catheter

The present invention relates to a balloon folding method, a balloon folding device, and a balloon catheter.

In recent years, balloon catheters have been used to improve lesions that have occurred in the lumen of the living body. Balloon catheters typically include an elongated shaft and a radially expandable balloon provided on the distal end side of the shaft. The lesion can be expanded by expanding the contracted balloon after reaching the destination in the body via a narrow biological lumen.

In the process of manufacturing a balloon catheter, in order to contract the balloon to a small diameter, the balloon is generally folded so as to be wound around the shaft of the catheter. For example, in Patent Document 1, a blade portion protruding in the radial direction of the balloon is formed in the balloon, and the blade portion is folded so as to be wound around the shaft of the catheter. In the step of forming the blade portion, the balloon is inserted into the center of a plurality of members arranged so as to surround a predetermined range, and the members are moved inward in the radial direction of the balloon to attach the blade portion to the balloon. Form.

Japanese Patent Publication No. 2004-525704

When folding the blades, it is necessary to suppress the occurrence of backfolds in which the blades are not folded in the same direction and part or all of the blades are folded or crushed in the opposite direction.

The present invention has been made to solve the above-mentioned problems, and is a balloon folding method, a balloon folding device, and a balloon catheter capable of uniformly folding a plurality of blades protruding outward in the radial direction of a balloon in the same direction. The purpose is to provide.

The balloon folding method according to the present invention that achieves the above object is a balloon folding method in which a balloon of a balloon catheter in which a balloon is extensiblely arranged on a long shaft is folded on an outer peripheral surface of the shaft. It is inserted between a plurality of first moving members arranged so as to surround a predetermined area, and the first moving member is moved toward the balloon to push the balloon, thereby projecting outward in the radial direction to the balloon. The step of forming a plurality of blades and a plurality of foundations located between the blades and the blades are bent in the same direction by applying a force to the blades in the same direction in the circumferential direction of the shaft. The step and the balloon having the bent blade portion are inserted between a plurality of second moving members arranged so as to surround a predetermined region, and the second moving member is moved toward the shaft to describe the above. It is characterized by having a step of folding the blade portion along the circumferential direction of the shaft.

In the balloon folding method configured as described above, a force is applied to the blades so as to bend all the blades in the same direction before folding the blades formed on the balloon. Therefore, when the blades are folded, backfolding is less likely to occur, and the plurality of blades can be uniformly folded in the same direction.

In the balloon folding method, in the step of bending the blade portion, the balloon is inserted into a hole formed in the inner wall surface of the pressing portion which is a spiral convex portion, and the blade portion is brought into contact with the pressing portion. You may bend it. As a result, by inserting the balloon into the hole, all the blades receive a force in the same direction from the spiral pressing portion. Therefore, all the blades can be satisfactorily bent in the same direction before the blades are folded.

In the balloon folding method, in the step of bending the blade portion, the balloon is arranged at a position surrounded by a plurality of columnar rotating bodies that can rotate around each axis, and the outer peripheral surface of the plurality of rotating bodies is arranged. The plurality of rotating bodies may be moved in the same direction in the circumferential direction of the shaft while the pressing portion is in contact with the outer surface of the balloon. As a result, by moving the rotating body while rotating it, the blade portion receives a force in the same direction from the pressing portion of the rotating body. Therefore, all the blades can be satisfactorily bent in the same direction before the blades are folded.

In the balloon folding method, in the step of bending the blade portion, the blade portion is pushed in the distal direction, and the blade portion is pushed by the pressing portion in which the distance to the shaft is arranged closer toward the distal direction. You may bend it. This facilitates pushing the balloon distally.

In the balloon folding method, the blade portion may be heated in the step of bending the blade portion. As a result, the shape of the bent blade portion can be well maintained.

In the step of forming the blade portion and the base portion, a flexible film is interposed between the first moving member and the balloon, and in the step of folding the blade portion, the flexible member is flexible between the second moving member and the balloon. Film may be interposed. Thereby, when the blade portion and the base portion are formed on the balloon and when the blade portion is folded, the surface of the balloon can be protected by a film to prevent the drug from peeling from the balloon.

One aspect of the balloon folding device according to the present invention that achieves the above object is a balloon folding device that folds the balloon of a balloon catheter provided with a balloon at the tip of a long shaft onto the outer peripheral surface of the shaft. A blade having a plurality of first moving members arranged so as to surround a region capable of accommodating a balloon, and moving the first moving member toward an area capable of accommodating the balloon so as to project radially outward to the balloon. It has a pleating portion capable of forming a portion and a bent portion provided with a pressing portion capable of applying a force to each of the blade portions in the same direction in the circumferential direction of the shaft, and the bent portion has the said portion. A hole into which the balloon can be inserted is formed, and the pressing portion is a spiral convex portion formed on the inner wall surface of the hole.

In the balloon folding device configured as described above, after forming the blade portion in the balloon at the pleating portion, the balloon is inserted into the hole portion, so that all the blade portions move in the same direction from the spiral pressing portion. Receive power. Therefore, all the blades can be satisfactorily bent in the same direction. Therefore, when the blades are folded, backfolding is less likely to occur, and the plurality of blades can be uniformly folded in the same direction.

The radius of the spiral of the pressing portion may gradually decrease toward the distal direction. This facilitates pushing the balloon into the hole in which the pressing portion is formed. Further, by moving the balloon in the distal direction, the bending of the blade portion can be gradually increased.

Another aspect of the balloon folding device according to the present invention that achieves the above object is a balloon folding device that folds the balloon of a balloon catheter provided with a balloon on a long shaft on the outer peripheral surface of the shaft. A plurality of first moving members arranged so as to surround the accommodating area are provided, and the first moving member is moved toward the accommodating area to provide a blade portion protruding outward in the radial direction of the balloon. It has a pleating portion that can be formed and a bending portion that is provided with a pressing portion that can apply a force to each of the blade portions in the same direction in the circumferential direction of the shaft, and the bending portion has an axial center. It has a rotary support portion that is rotatable at the center, and a plurality of columnar rotating bodies that are arranged so as to surround the axial center of the rotary support portion and are rotatably connected to the rotary support portion. However, the pressing portion is characterized in that it is located on the outer peripheral surface of the rotating body.

The balloon folding device configured as described above can rotate the rotating body with respect to the rotation support portion while rotating the rotation support portion. Therefore, when the blade portion is formed on the balloon by the pleating portion, the balloon is arranged in the area surrounded by the rotating body, and the rotation support portion is rotated, the rotating body rotates along the outer peripheral surface of the balloon. While moving around the balloon. Therefore, a force in the same direction can be applied to the blade portion by the pressing portion of the rotating body that rolls and moves on the outer surface of the balloon. Therefore, all the blades can be satisfactorily bent in the same direction. Therefore, when the blades are folded, backfolding is less likely to occur, and the plurality of blades can be uniformly folded in the same direction.

The outer diameter of the rotating body may gradually increase toward the distal direction. This facilitates pushing the balloon distally.

The bent portion may have a heating portion for heating the pressing portion. As a result, the shape of the bent blade portion can be well maintained.

The balloon folding device includes a plurality of second moving members arranged so as to surround an area capable of accommodating the balloon, and rotates the second moving member to fold the blade portion along the circumferential direction of the shaft. It may further have a folding section capable of being capable. As a result, after bending all the blades in the same direction at the bent portion, the blades can be folded at the folding portion. Therefore, when the blades are folded, backfolding is less likely to occur, and the plurality of blades can be uniformly folded in the same direction.

The balloon catheter configured as described above is a balloon catheter in which a balloon coated with a drug on the outer surface is placed inside a protective tube in a state of being folded on the outer peripheral surface of the shaft of the balloon catheter. , A plurality of blades folded along the circumferential direction of the shaft while projecting outward in the radial direction of the balloon, and a plurality of foundations in contact with the shaft, and each of the blades protrudes. The blade intermediate portion has a blade tip portion located on the side of the blade, a blade base end portion connected to the base portion, and a blade intermediate portion located between the blade tip portion and the blade base end portion. It has a blade intermediate outer portion facing the protective tube side and a blade intermediate inner portion facing the shaft side, and the inner surfaces of the balloons are formed in contact with each other over substantially the entire surface, and each blade tip portion is formed. The outer region is formed by the outer surface of the blade tip, the outer surface of the blade base that comes into contact with the blade tip, and the inner peripheral surface of the protective tube, which are in contact with the blade base end of another adjacent blade. Is defined, the inner region is defined by the inner surface of each of the blade base ends and the outer peripheral surface of the shaft, and substantially the entire outer surface of each of the blade intermediate outer portions is the inner peripheral surface of the protective tube. It is characterized in that substantially the entire outer surface of each of the blade intermediate inner portions is in contact with the outer surface of the base portion.

The balloon catheter configured as described above has a folded wing portion and a balloon coated with a drug is arranged between the shaft and the protective tube with almost no gap. Therefore, the drug-coated balloon can be held in the protective tube with a small diameter.

It is a front view which shows the balloon catheter. It is sectional drawing of the tip part of a balloon catheter. It is sectional drawing which is orthogonal to the long axis of a balloon in the tip part of a balloon catheter. It is a perspective view which shows the balloon folding apparatus. It is a front view which shows the pleating part. It is a front view which shows the 1st moving member of a pleating part. It is a front view which shows the folding part. It is a front view which shows the 2nd moving member of a folding part. It is a figure which shows the bent part, (A) is a front view, (B) is a sectional view. It is sectional drawing which shows the state which the balloon is inserted in the pleating part. It is sectional drawing which shows the state which the blade part was formed in the balloon by the pleating part. It is a perspective view which shows the state which the blade part was bent by the bent part. It is sectional drawing which shows the state which the blade part was folded by the folding part. It is a figure which shows the deformation example of a bent part, (A) is a side view, (B) is a perspective view which shows a part of a bent part. It is sectional drawing which shows the state which the blade part is bent by the deformation example of the bent part. It is sectional drawing which shows the modification of the balloon catheter.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensions of the drawings may be exaggerated and differ from the actual dimensions for convenience of explanation. Further, in the present specification and the drawings, components having substantially the same functional configuration are designated by the same reference numerals, so that duplicate description will be omitted. In the present specification, the side where the balloon catheter is inserted into the blood vessel is referred to as the "distal side", and the hand side to be operated is referred to as the "proximal side".

The balloon catheter 10 according to the embodiment of the present invention is a device for being inserted into a biological lumen such as a blood vessel and pushed to a narrowed lesion portion, and the lesion portion is expanded by an expandable balloon 30.

First, the structure of the balloon catheter 10 will be described. As shown in FIGS. 1 to 3, the balloon catheter 10 includes a long catheter body 20, a balloon 30 provided at the distal portion of the catheter body 20, a protective tube 15 covering the balloon 30, and the vicinity of the catheter body 20. It has a hub 26 fixed to a position. The balloon 30 has a balloon body 31 and a drug coating layer 40 that covers the outer surface of the balloon body 31. The balloon 30 having the drug coat layer 40 is covered and protected by the protective tube 15 until it is used.

The catheter body 20 includes an outer tube 21 which is a tubular body having an open distal end and a proximal end, and an inner tube 22 (shaft) which is a tubular body arranged inside the outer tube 21. ing. The inner tube 22 is housed inside the hollow of the outer tube 21, and the catheter body 20 has a double tube structure at the distal portion. The hollow inside of the inner pipe 22 is a guide wire lumen 24 through which a guide wire is inserted. Further, an expansion lumen 23 for circulating the expansion fluid of the balloon 30 is formed inside the hollow inside of the outer pipe 21 and outside the inner pipe 22. The inner pipe 22 is opened to the outside at an opening 25 that penetrates the wall surface of the outer pipe 21 sideways. The inner tube 22 projects further distal to the distal end of the outer tube 21.

The proximal end of the balloon 30 is fixed to the distal portion of the outer tube 21, and the distal end is fixed to the distal portion of the inner tube 22. As a result, the inside of the balloon 30 communicates with the expansion lumen 23. The balloon 30 can be expanded by injecting an expansion fluid into the balloon 30 via the expansion lumen 23. The expansion fluid may be a gas or a liquid, and for example, a gas such as helium gas, CO ₂ gas, or O ₂ gas, or a liquid such as physiological saline or a contrast medium can be used.

A cylindrical straight portion 34 having the same outer diameter when expanded is formed in the central portion of the balloon 30 in the semi-major axis direction, and a taper whose outer diameter gradually changes on both sides of the straight portion 34 in the semi-major axis direction. The portion 33 is formed. Then, the entire outer surface of the straight portion 34 is coated with the drug coating layer 40 containing the drug. The range of forming the drug coat layer 40 in the balloon 30 is not limited to the straight portion 34, and may include at least a part of the tapered portion 33 in addition to the straight portion 34, or the straight portion 34. It may be only a part.

The hub 26 has a proximal opening 27 that communicates with the expansion lumen 23 of the outer pipe 21 to allow the expansion fluid to flow in and out.

The length of the balloon 30 in the semimajor direction is not particularly limited, but is preferably 5 to 500 mm, more preferably 10 to 300 mm, and even more preferably 20 to 200 mm.

The outer diameter of the balloon 30 when expanded is not particularly limited, but is preferably 1 to 10 mm, more preferably 2 to 8 mm.

The constituent material of the balloon body 31 has a certain degree of flexibility and has a certain degree of hardness so that the drug can be expanded when it reaches a blood vessel, tissue, or the like and the drug can be released from the drug coat layer 40 on the surface thereof. Is preferable. Specifically, although it is made of resin or metal, it is preferable that at least the outer surface of the balloon body 31 on which the drug coating layer 40 is provided is made of resin. The constituent material of at least the outer surface of the balloon body 31 is, for example, a polyolefin such as polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more thereof, or a soft material. Thermoplastic resins such as polyvinyl chloride resin, polyamide, polyamide elastomer, nylon elastomer, polyester, polyester elastomer, polyurethane and fluororesin, silicone rubber, latex rubber and the like can be used. Among them, polyamides are preferable.

The drug coat layer 40 contains a drug. The drug coating layer 40 may contain an additive (excipient). The agent may be crystalline, non-crystalline (amorphous), or a mixture thereof. When the drug is crystalline, for example, homogeneous (white) crystals are formed all around the balloon 30 (substantially free of amorphous).

The drug may be a water-soluble drug, but is preferably a water-insoluble drug. The water-insoluble drug means a drug that is insoluble or sparingly soluble in water, and specifically, the solubility in water is less than 1 mg / mL at pH 5 to 8. Its solubility may be less than 0.1 mg / mL. Water-insoluble agents include fat-soluble agents.

Examples of some preferred water-insoluble agents include immunosuppressive agents, such as cyclosporines containing cyclosporin, immunoactive agents such as rapamycin, anticancer agents such as paclitaxel, antiviral or antibacterial agents, antineoplastic agents, Paclitaxel and anti-inflammatory agents, antibiotics, antiepileptic agents, anxiety-relieving agents, anti-paralytic agents, antagonists, neuroblock agents, anticholinergic and cholinergic agents, antimuscarinic and muscarinic agents, antiadrenaline agonists Includes antiarrhythmic agents, antihypertensive agents, hormonal agents and nutritional agents.

The water-insoluble drug is preferably at least one selected from the group consisting of rapamycin, paclitaxel, docetaxel, and everolimus. As used herein, rapamycin, paclitaxel, docetaxel, and everolimus include analogs thereof and / or derivatives thereof as long as they have similar efficacy. For example, paclitaxel and docetaxel are analogs. Rapamycin and everolimus are derivatives. Of these, paclitaxel is even more preferred.

The additive is not particularly limited, but includes, for example, a water-soluble low molecular weight compound. The molecular weight of the water-soluble low molecular weight compound is 50 to 2000, preferably 50 to 1000, more preferably 50 to 500, and even more preferably 50 to 200. The water-soluble low molecular weight compound is preferably 10 to 5000 parts by mass, more preferably 50 to 3000 parts by mass, and further preferably 100 to 1000 parts by mass with respect to 100 parts by mass of the water-insoluble drug. The constituent materials of water-soluble low-molecular-weight compounds are serine ethyl ester, sugar such as glucose, sugar alcohol such as sorbitol, citric acid ester, polysorbate, polyethylene glycol, urea, water-soluble polymer, contrast agent, amino acid ester, short-chain mono. A glycerol ester of a carboxylic acid, a pharmaceutically acceptable salt and a surfactant, or a mixture of two or more thereof can be used.

The method of coating the balloon body 31 with the drug coat layer 40 is not particularly limited. For example, the balloon body 31 may be moved in the semimajor direction while rotating about its axis, and a coating liquid containing a drug, an additive, and a solvent may be applied to the surface of the balloon in a spiral manner. .. The coating liquid applied to the surface of the balloon forms the drug coating layer 40 by evaporating the solvent. Alternatively, the drug coating layer 40 may be formed by dipping the balloon body 31 into the coating liquid or spraying the coating liquid on the balloon body 31.

The protective tube 15 is a member that covers and protects the balloon 30 and suppresses the drug from falling out of the balloon 30. The protective tube 15 is removed before using the balloon catheter 10. The protective tube 15 is made of a flexible material, for example, a polyolefin such as polyethylene, polypropylene, polybutene, an ethylene-propylene copolymer, an ethylene-vinyl acetate copolymer, an ionomer, or a mixture of two or more thereof, or a soft material. Thermoplastic resins such as polyvinyl chloride resin, polyamide, polyamide elastomer, polyester, polyester elastomer, polyurethane and fluororesin, silicone rubber, latex rubber and the like can be used.

As shown in FIG. 3, the balloon 30 has a plurality of blades 32 (pleats in the case of one, pleats in the case of a plurality of pleats) protruding outward in the radial direction of the balloon 30 by the balloon folding device 100 described later. )) Is formed and folded. The blade portion 32 is a fold, which is an elongated crease formed in a thin material. The plurality of blade portions 32 are formed substantially evenly in the circumferential direction of the balloon 30. Each blade portion 32 is arranged inside the protective tube 15 in a state of being folded in the same direction in the circumferential direction of the balloon 30 so as to be wrapped around the inner tube 22. In the example shown in FIG. 3, four blade portions 32 are formed.

The balloon 30 has a plurality of blade portions 32 and a plurality of base portions 35 located between adjacent blade portions 32. Each base portion 35 is in contact with the outer peripheral surface of the inner pipe 22. The blade portions 32 and the foundation portion 35 are alternately arranged along the circumferential direction of the inner pipe 22. The blade portion 32 is formed by a crease extending in the substantially semi-major axis direction of the balloon 30. The length of the blade portion 32 in the long axis direction does not exceed the length of the balloon 30. The length in the direction in which the blade portion 32 projects radially outward from the catheter main body 20 is not particularly limited, but is about 1 to 8 mm. The number of blades 32 is not particularly limited, but is, for example, about 2 to 12. When the balloon 30 is expanded, the base portion 35 is separated from the inner tube 22 (not in contact with each other), and the inner surfaces of the balloons 30 in contact with or facing each other in the blade portion 32 are separated (not in contact with each other). It can have a substantially cylindrical shape (see FIG. 10). The inner surface of the balloon 30 is a surface located on the inner space side into which the fluid of the balloon 30 flows.

The blade portion 32 includes a blade tip portion 51 located on the protruding side, a blade base end portion 53 close to the inner tube 22, and a blade intermediate portion 52 located between the blade tip portion 51 and the blade base end portion 53. ,have.

Each blade tip 51 is formed by folding back the balloon 30. At each blade tip 51, the inner surfaces of the balloons 30 are in contact with each other. In the blade tip portion 51, it is possible that minute ranges on the inner surface of the balloon 30 are separated (not in contact with each other).

Each blade intermediate portion 52 has a blade intermediate outer portion 52A facing the protective tube 15 side and a blade intermediate inner portion 52B facing the inner tube 22 side. The blade intermediate portion 52 is formed thinly by contacting the inner surfaces of the balloons 30 with each other. In the blade intermediate portion 52, the inner surfaces of the balloons 30 may be separated (not in contact with each other) within a minute range. The outer surface of the blade intermediate outer portion 52A is substantially entirely in contact with the inner peripheral surface of the protective tube 15. It is possible that a minute range of the blade intermediate outer portion 52A is separated (not in contact with) the inner peripheral surface of the protective tube 15. In the cross section orthogonal to the long axis of the inner tube 22, the range of contact with the inner peripheral surface of the protective tube 15 in the outer surface of the blade intermediate outer portion 52A is preferably 50% or more, more preferably 60%. Above, more preferably 70% or more. Almost the entire outer surface of the blade intermediate inner portion 52B is in contact with the foundation portion 35. It is possible that the minute range of the blade intermediate inner portion 52B is separated from the foundation portion 35. In the cross section orthogonal to the long axis of the inner pipe 22, the range of contact with the outer surface of the base portion 35 of the outer surface of the blade intermediate inner portion 52B is preferably 50% or more, more preferably 60% or more. , More preferably 70% or more.

The blade base end portion 53 is located between the base portion 35 and the blade intermediate portion 52, and the inner surfaces of the balloon 30 are formed apart from each other. Inside the blade base end portion 53, a minute inner region 53C is defined by the inner surface of the balloon 30 and the outer peripheral surface of the inner tube 22. A part of the blade base end portion 53 is in contact with the blade tip portion 51 of another adjacent blade portion 32. A minute outer region 53D is defined outside the blade base end portion 53 by the outer surface of the blade base end portion 53, the outer surface of the blade tip portion 51, and the inner peripheral surface of the protective tube 15.

Next, the balloon folding device 100 will be described. The balloon folding device 100 is a device that can fold the balloon 30 so as to be wound around the inner tube 22.

As shown in FIG. 4, the balloon folding device 100 includes a base 110, a pleating portion 120, a folding portion 130, a support base 140, a pressurizing / depressurizing device 160, and a bending portion 170. The pleating portion 120, the folding portion 130, the support base 140, and the bent portion 170 are arranged on the base 110 formed in a trapezoidal shape.

As shown in FIG. 11, the pleating portion 120 can form a blade portion 32 protruding in the radial direction from the balloon 30. As shown in FIG. 13, the folding portion 130 can be folded by laying the blade portion 32 formed on the balloon 30 in the circumferential direction. As shown in FIG. 3, the support base 140 can hold the balloon catheter 10 while forming the blade portion 32 on the balloon 30 and folding it. The pressurizing / depressurizing device 160 can supply fluid to the inside of the balloon 30 to pressurize it, and can suck the fluid from the inside of the balloon 30 to reduce the pressure.

On the base 110, a film supply unit 150 that supplies the first film 155 and the second film 156 to the pleating unit 120 is arranged adjacent to the pleating unit 120. Further, on the base 110, a film supply unit 180 that supplies the first film 181 and the second film 182 to the folding unit 130 is arranged adjacent to the folding unit 130.

The pleating portion 120 has a front plate 121 perpendicular to the base 110, and the front plate 121 has an insertion hole 121a into which the distal portion of the balloon catheter 10 can be inserted. Further, the folding portion 130 has a front plate 131 perpendicular to the base 110, and the front plate 131 has an insertion hole 131a into which a distal portion of the balloon catheter 10 can be inserted. The front plate 131 of the folding portion 130 faces in a direction different from the direction in which the front plate 121 of the pleating portion 120 faces.

It is rotatable so as to face both the pleating portion 120 of the support base 140 and the folding portion 130. The support base 140 has a base portion 141 that is rotatably mounted on the base base 110, and a holding base 142 that is horizontally movable on the base portion 141. The holding table 142 can hold the balloon catheter 10 on the upper surface. The holding base 142 slides on the upper surface of the base 141 and can move forward or backward toward the pleating portion 120 or the folding portion 130. The holding table 142 holding the balloon catheter 10 moves forward or backward toward the pleating portion 120, so that the balloon 30 is inserted into or pulled out from the insertion hole 121a of the pleating portion 120. Further, the holding table 142 holding the balloon catheter 10 moves forward or backward toward the folding portion 130, so that the balloon 30 is inserted into or pulled out from the insertion hole 131a of the folding portion 130.

The bent portion 170 is arranged in front of the front plate 131 of the folding portion 130. The bent portion 170 has a hole portion 171 through which the balloon 30 inserted into the insertion hole 131a of the folding portion 130 passes before reaching the insertion hole 131a. Therefore, the bending of the blade portion 32 in the bending portion 170 and the folding of the blade portion 32 in the folding portion 130 can be performed by a series of operations. The bent portion 170 may be fixed to the folding portion 130. Further, the bent portion 170 does not have to be arranged in front of the front plate 131.

The pressurizing / depressurizing device 160 is, for example, a pump. The pressurizing / depressurizing device 160 may be a syringe, an indeflator, or the like. The pressurizing / depressurizing device 160 has a pressurizing / depressurizing tube 161 that can be connected to the proximal opening 27 of the balloon catheter 10. The pressurizing / depressurizing tube 161 supplies the fluid to the proximal opening 27 and sucks the fluid from the proximal opening 27. The pressurizing / depressurizing tube 161 may be provided with a stopcock 162 that can be manually opened and closed. The stopcock 162 is, for example, a three-way stopcock.

Next, the structure of the pleating unit 120 will be described in detail. As shown in FIGS. 5 and 6, the pleating unit 120 has a plurality of first moving members 122 inside. The number of the first moving members 122 matches the number of the blade portions 32 formed on the balloon 30. Here, a case where three first moving members 122 are provided will be described. Each first moving member 122 is a plate-shaped member having the same cross-sectional shape at each position along the long axis direction of the balloon catheter 10 to be inserted. The first moving member 122 is arranged so as to surround the central region so that each of the first moving members 122 forms an angle of 120 degrees with respect to the center of the central region through which the balloon 30 is inserted. That is, each of the first moving members 122 is arranged at equal angles in the circumferential direction. The first moving member 122 has a rotation center portion 122a near the outer peripheral end portion, and can rotate around the rotation center portion 122a. Further, the first moving member 122 has a moving pin 122d extending in the long axis direction on the inner peripheral side of the rotation center portion 122a. The moving pin 122d is fitted in the fitting groove 124a formed in the rotating member 124 that can rotate in the pleating portion 120. The rotating member 124 is connected to a beam portion 126 extending in a substantially horizontal direction. The rotating member 124 can rotate by receiving a rotational force from a beam portion 126 that tilts by receiving a force from a drive source 125 such as a hydraulic cylinder or a motor. When the rotating member 124 rotates, the moving pin 122d fitted in the fitting groove 124a moves in the circumferential direction, whereby each of the first moving members 122 rotates about the rotation center portion 122a. By rotating the three first moving members 122, the central region surrounded by the first moving members 122 can be narrowed. The number of the first moving members 122 is not particularly limited as long as it is two or more.

The first moving member 122 has a substantially arc-shaped first shape forming portion 122b and a second shape forming portion 122c at an inner peripheral end portion opposite to the rotation center portion 122a. The first shape forming portion 122b abuts on the surface of the balloon 30 inserted into the pleating portion 120 as the first moving member 122 rotates, and the blade portion 32 protruding radially into the balloon 30. Can be formed. The second shape forming portion 122c can abut on the blade portion formed on the balloon 30 as the first moving member 122 rotates, and the blade portion 32 can be curved in a predetermined direction. Further, the pleating unit 120 has a heater (not shown) for heating the first moving member 122. The pleating unit 120 does not have to have a heater for heating the first moving member 122. The length of the first moving member 122 along the long axis direction of the balloon catheter 10 is longer than the length of the balloon 30. Further, the lengths of the first shape forming portion 122b and the second shape forming portion 122c of the first moving member 122 may or may not extend over the entire length of the first moving member 122.

The first film 155 and the second film 156 made of resin are supplied to the first moving member 122 from the film supply unit 150. A plurality of rotation shaft portions 123 are provided in the pleating portion 120 in order to guide each film. The first film 155 is engaged with the surface of the first moving member 122 arranged above the first film holding portion 151 via the rotation shaft portion 123. Further, the first film 155 reaches the film winding portion 153 which is rotationally driven by a drive source such as a motor (not shown) via the rotation shaft portion 123 from the first moving member 122. The second film 156 is engaged with two first moving members 122 arranged at the lower part from the second film holding portion 152 via the rotation shaft portion 123. Further, the second film 156 reaches the film winding portion 153 via the rotating shaft portion 123. As a result, the central position of the pleating portion 120 through which the balloon 30 is inserted is surrounded by the first film 155 and the second film 156. Films are supplied from each of the first film holding section 151 and the second film holding section 152, and the two films are overlapped and collected at the film winding section 153.

In the first film 155 and the second film 156, when the balloon 30 is inserted into the pleating portion 120 and the first moving member 122 rotates to form the blade portion 32 on the balloon 30, the balloon 30 moves first. Protects the member 122 from direct contact with the surface. After forming the blade portion 32 of the balloon 30, the first film 155 and the second film 156 are wound around the film winding portion 153 to a predetermined length. That is, the portion of the first film 155 and the second film 156 that once contacted the balloon 30 does not contact the balloon 30 again, and a new portion is supplied to the center position of the pleating portion 120 each time the balloon 30 is inserted. To.

As shown in FIG. 5, in the state before the insertion of the balloon 30, the first shape forming portion 122b and the second shape forming portion 122c of the three first moving members 122 are separated from each other. The region surrounded by the plurality of first moving members 122 is surrounded by the substantially arc-shaped first shape forming portion 122b, and the expanded balloon 30 can be inserted.

Next, the structure of the folding portion 130 will be described in detail. As shown in FIGS. 7 and 8, the folding portion 130 has 10 second moving members 132 inside. Each second moving member 132 is a plate-shaped member having the same cross-sectional shape at each position along the long axis direction of the balloon catheter 10 to be inserted. The second moving members 132 are arranged so as to form an angle of 36 degrees with respect to the central position through which the balloon is inserted. That is, each of the second moving members 132 is arranged at equal angles in the circumferential direction. The second moving member 132 has a rotation center portion 132a near the substantially center, and can rotate around the rotation center portion 132a. Further, each of the second moving members 132 has a moving pin 132c extending in the axial direction in the vicinity of the substantially outer peripheral end portion. The moving pin 132c is fitted in the fitting groove 133a formed in the rotating member 133 that can rotate in the folding portion 130. The rotating member 133 is connected to a beam 135 extending in a substantially horizontal direction. The rotating member 133 can rotate by receiving a rotational force from a beam 135 that tilts by receiving a force from a drive source 134 such as a hydraulic cylinder or a motor. When the rotating member 133 rotates, the moving pin 132c fitted in the fitting groove 133a moves in the circumferential direction, whereby each of the second moving members 132 rotates about the rotation center portion 132a. By rotating the 10 second moving members 132, the space area of the central portion surrounded by the second moving members 132 can be narrowed. The number of the second moving members 132 is not limited to 10.

The tip side of the second moving member 132 is bent, and the tip 132b has a sharp shape. The tip portion 132b abuts on the surface of the balloon 30 inserted into the folding portion 130 as the second moving member 132 rotates, so that the blade portion 32 formed in the balloon 30 is laid down in the circumferential direction. Can be folded. Further, the folding unit 130 has a heater (not shown) for heating the second moving member 132. The folding portion 130 does not have to have a heater for heating the second moving member 132.

The first film 181 and the second film 182 made of resin are supplied to the second moving member 132 from the film supply unit 180. The supply structure of each film is the same as that of the pleating unit 120. The first film 181 and the second film 182 are arranged to face each other so as to sandwich a central space region surrounded by the second moving member 132. With the first film 181 and the second film 182, the balloon 30 inserted into the folding portion 130 can be prevented from directly contacting the surface of the second moving member 132. The first film 181 and the second film 182 pass through the second moving member 132 and reach the film winding unit 183 which is rotationally driven by a drive source such as a motor (not shown).

As shown in FIG. 8, in the state before the insertion of the balloon 30, the tip portions 132b of each of the second moving members 132 are separated from each other in the circumferential direction. A balloon 30 having a blade portion 32 formed can be inserted between the first film 181 and the second film 182 in the central region surrounded by the second moving member 132.

Next, the structure of the bent portion 170 will be described in detail. As shown in FIG. 9, the bent portion 170 includes a tubular portion 172 in which the hole portion 171 is formed and a tubular support portion 173 that supports the tubular portion 172. The center line of the hole portion 171 coincides with the center line of the insertion hole 131a of the folding portion 130, and also coincides with the center line of the spatial region surrounded by the second moving member 132 of the folding portion 130. The inner diameter of the hole 171 is tapered toward the folding portion 130. The inner diameter of the hole 171 does not have to decrease toward the folding portion 130. A pressing portion 174, which is a spiral convex portion, is formed on the inner wall surface of the hole portion 171. The pressing portion 174 comes into contact with the blade portion 32 when the balloon 30 passes through the hole portion 171 toward the folding portion 130. At this time, the pressing portion 174 can apply a force to all the blade portions 32 in the same direction in the circumferential direction of the inner pipe 22 to bend all the blade portions 32 in the same direction. The direction of the spiral is the direction in which the blade portion 32 is desired to be bent when the balloon 30 moves toward the direction in which the inner diameter of the hole portion 171 becomes smaller. The number of pressing portions 174 is not particularly limited, but is preferably a plurality. That is, the pressing portion 174 is formed in the form of a multi-row spiral in which a plurality of spirals are arranged. The number of pressing portions 174 may match the number of blade portions 32. Further, the number of pressing portions 174 may be one. The opening 176 on the distal side of the hole 171 has a shape corresponding to the shape of the balloon 30 to be folded. Therefore, it does not have to be formed in the opening 176. A spiral pressing portion 174 may be formed in the opening 176. The angle of the protrusion 174 with respect to the center line of the hole 171 is not particularly limited, but is preferably about 5 ° to 45 °.

The tubular portion 172 preferably has a heating portion 175 for heating. The heating unit 175 is, for example, a heat ray. The heating unit 175 may not be provided.

Next, a method of folding the balloon 30 and arranging it on the protective tube 15 using the balloon folding device 100 will be described.

First, as shown in FIG. 4, the catheter main body 20 is placed on the holding base 142 of the support base 140 in order to form the blade portion 32 on the balloon 30. A core material 101 (see FIG. 2) is inserted into the guide wire lumen 24. The distal end of the core material 101 is located distal to the distal end of the balloon 30. The proximal end of the core 101 may be located inside the balloon 30, distal to the proximal opening 25 of the guidewire lumen 24, or of the guidewire lumen 24. It may be located proximal to the proximal opening 25. If the distal end of the core material 101 is located distal to the distal end of the balloon 30, the length of the core material 101 may be shorter than the first moving member 122 and the second moving member 132. .. The core material 101 may have a length that overlaps the entire first moving member 122 and the second moving member 132 in the long axis direction. Further, the first moving member 122 and the second moving member 132 do not have to overlap with the opening 25 on the proximal side of the guide wire lumen 24 in the long axis direction. The core material 101 does not have to be inserted. A pressurizing / depressurizing tube 161 of the pressurizing / depressurizing device 160 is connected to the proximal opening 27 of the balloon catheter 10. The balloon 30 is in a state of being expanded by its own shape in a natural state where it is not pressurized or depressurized by the pressurizing / depressurizing device 160.

Next, the holding base 142 is slid and moved on the base 141, and the balloon catheter 10 is inserted into the pleating portion 120 through the insertion hole 121a. The first moving member 122 of the pleating portion 120 is preferably heated, but may not be heated. As shown in FIG. 9, the balloon 30 is arranged in a central region surrounded by a plurality of first moving members 122.

Next, the pressurizing / depressurizing device 160 is adjusted to further rotate the rotating member 124 (see FIG. 5) by the drive source 125 while gradually sucking and discharging the fluid from the balloon 30. As a result, as shown in FIG. 10, the first moving member 122 rotates. Therefore, the first shape forming portions 122b of each first moving member 122 approach each other, and the central region between the first moving members 122 is narrowed to about the outer diameter of the inner pipe 22. Along with this, the balloon 30 inserted in the central region between the first moving members 122 is pressed against the inner pipe 22 by the first shape forming portion 122b to form the base portion 35. The portion of the balloon 30 that is not pressed by the first shape forming portion 122b is between the tip portion of the first moving member 122 and the second shape forming portion 122c of the first moving member 122 adjacent to the first moving member 122. The blade portion 32 is extruded into the gap between the two and curved on one side. The balloon 30 is heated to about 50-60 degrees by the first moving member 122. Therefore, the formed blade portion 32 can maintain its original shape. In this way, a plurality of blade portions 32 and a base portion 35 are formed on the balloon 30. The balloon 30 does not have to be heated. Inside the balloon 30, decompression by the pressurizing / depressurizing device 160 and pressurization by being pushed by the first moving member 122 act. The decompression by the pressurizing / depressurizing device 160 and the pressurization by the first moving member 122 driven by the drive source 125 are adjusted so that the internal pressure of the balloon 30 is maintained at a level slightly higher than the atmospheric pressure. As a result, it is possible to prevent the balloon 30 from being suddenly contracted by the pressurizing / depressurizing device 160 before being pushed by the first moving member 122 to form the blade portion 32 on the balloon 30. Therefore, the balloon 30 is appropriately pushed by the first moving member 122 to form the blade portion 32. When forming the blade portion 32 on the balloon 30, the proximal opening 27 may be opened to the atmosphere instead of being sucked by the pressurizing / depressurizing device 160. The opening of the proximal opening 27 can be easily performed by a stopcock 162, which is a three-way stopcock. After the step of forming the blade portion 32 on the balloon 30 is completed, the inside of the balloon 30 is maintained in a decompressed state. Therefore, the pressure may be continuously reduced by the pressurizing / depressurizing device 160, but the stopcock 62 may be closed. In the process of forming the blade portion 32 of the balloon 30, most of the fluid inside the balloon 30 is discharged.

In the step of forming the blade portion 32, the surface of each first moving member 122 in contact with the balloon 30 is covered with the first film 155 and the second film 156. Therefore, the balloon 30 does not come into direct contact with the surface of the first moving member 122. After forming the blade portion 32 on the balloon 30, the first moving member 122 is rotated so as to return to the original position. After this, the balloon 30 is pulled out from the pleating portion 120.

Next, as shown in FIG. 4, the holding table 142 is moved on the upper surface of the base portion 141 to be separated from the pleating portion 120, and the balloon catheter 10 is pulled out from the pleating portion 120. Next, the support base 140 is slid and moved on the upper surface of the base 110, and the support base 140 is positioned at a position facing the hole 171 of the bent portion 170. After that, the holding table 142 is moved on the upper surface of the base portion 141, and the balloon 30 is inserted into the hole portion 171 while maintaining the decompressed state inside the balloon 30.

The blade portion 32 inserted into the hole portion 171 contacts the spiral pressing portion 174 and receives a force from the pressing portion 174 in the same direction in the circumferential direction of the inner pipe 22. As a result, all the blades 32 are bent in the same direction. At this time, even if the number of pressing portions 174 does not match the number of blade portions 32, the spiral pressing portion 174 can bend all the blade portions 32 in the same direction. Therefore, the bent portion 170 having the same structure can handle a wide variety of blades. Further, the inner diameter of the hole portion 171 is tapered toward the folding portion 130. Therefore, when the balloon 30 is pushed to the distal side, the blade portion 32 is reduced in diameter while bending, and the crease of the blade portion 32 is strongly bent. Therefore, the blade portion 32 is satisfactorily bent by the taper of the hole portion 171. The blade portion 32 may rise to some extent from the state of being pushed by the bent portion 170 and bent. When the tubular portion 172 is heated by the heating portion 175, the blade portion 32 is held in a bent state by the pressing portion 174. At this time, the pressing portion 174 is heated to about 50 to 60 degrees. The tubular portion 172 does not have to be heated.

After that, when the balloon catheter 10 is further moved in the distal direction, the balloon 30 passes through the hole 171 and is inserted into the folding part 130 through the insertion hole 131a. The balloon 30 may be cooled before being inserted into the folding portion 130. For example, a gas (for example, nitrogen, air, etc.) may be blown onto the balloon 30 that has passed through the hole 171 and has not yet entered the insertion hole 131a. The temperature of the gas is preferably equal to or lower than the ambient temperature. As a result, the balloon 30 is cooled and hardened, and the shape of the blade portion 32 is easily maintained.

The second moving member 132 of the folding portion 130 has already been heated to about 50 to 60 degrees. The second moving member 132 does not have to be heated. After the balloon 30 on which the blade portion 32 is formed is inserted into the folding portion 130, the drive source 134 is operated to rotate the rotating member 133 as shown in FIG. 7. As a result, as shown in FIG. 13, the second moving member 132 rotates, and the tip portions 132b of each second moving member 132 approach each other. Therefore, the central region between the second moving members 132 is narrowed. Along with this, the balloon 30 inserted in the central region between the second moving members 132 is in a state in which the blade portion 32 is laid down in the circumferential direction by the tip portion 132b of each second moving member 132. The blade portion 32 is bent in one direction by the bent portion 170 before the balloon 30 is inserted into the folding portion 130. Therefore, when the blade portions are folded at the folding portion 130, backfolding is less likely to occur, and the plurality of blade portions 32 can be uniformly folded in the same direction. The blade portion 32 is folded while maintaining the decompressed state inside the balloon 30. The second moving member 132 is preheated before the insertion of the balloon 30, and the balloon 30 is heated by the second moving member 132. Therefore, the blade portion 32 laid down in the circumferential direction by the second moving member 132 is , Can maintain its original shape. At this time, the surface of each second moving member 132 in contact with the balloon 30 is covered with the first film 181 and the second film 182. Therefore, the balloon 30 does not come into direct contact with the surface of the second moving member 132.

After folding the blade portion 32 of the balloon 30, the second moving member 132 is rotated so as to return to the original position. The blade portion 32 may rise to some extent from the state of being pushed and folded by the second moving member 132. Next, the balloon 30 is pulled out from the folding portion 130 and the bending portion 170 while maintaining the decompressed state inside the balloon 30. Next, the balloon catheter 10 is removed from the support base 140, and the balloon 30 is inserted into the tubular protective tube 15 as shown in FIGS. 2 and 3 while maintaining the decompressed state inside the balloon 30. As a result, the folding of the balloon 30 is completed. The balloon 30 is inserted into the protective tube 15 after forming the blade portion 32 and the base portion 35 in a state where most of the fluid inside is discharged.

As described above, the balloon folding method is a balloon folding method in which the balloon 30 of the balloon catheter 10 in which the balloon 30 is expandably arranged in the long inner tube 22 is folded on the outer peripheral surface of the inner tube 22 (shaft). , The balloon 30 is inserted between a plurality of first moving members 122 arranged so as to surround a predetermined area, and the first moving member 122 is moved toward the balloon 30 to push the balloon 30 into the balloon 30. A step of forming a plurality of base portions 35 located between the plurality of blade portions 32 protruding outward in the radial direction and a plurality of base portions 35 located between the blade portions 32, and applying a force to the blade portions 32 in the same direction in the circumferential direction of the inner tube 22. , A step of bending the blade portion 32 in the same direction and a balloon 30 having the bent blade portion 32 are inserted between a plurality of second moving members 132 arranged so as to surround a predetermined region, and the second moving member 132 is inserted. Is characterized by having a step of moving the blade portion 22 toward the inner pipe 22 and folding the blade portion 32 along the circumferential direction of the inner pipe 22.

In the balloon folding method configured as described above, a force is applied to the blades 32 so as to bend all the blades 32 in the same direction before folding the blades 32 formed on the balloon 30. Therefore, when the blade portions 32 are folded, backfolding is less likely to occur, and the plurality of blade portions 32 can be uniformly folded in the same direction.

Further, in the balloon folding method, in the step of bending the blade portion 32, the balloon 30 is inserted into the hole portion 171 formed in the inner wall surface of the pressing portion 174 which is a spiral convex portion, and the blade portion 32 is inserted into the pressing portion 174. Make contact and bend. As a result, by inserting the balloon 30 into the hole portion 171 all the blade portions 32 receive a force in the same direction from the spiral pressing portion 174. Therefore, all the blades 32 can be satisfactorily bent in the same direction before the blades 32 are folded.

Further, in the balloon folding method, in the step of bending the blade portion 32, the blade portion is pushed by the pressing portion 174, which pushes the balloon 30 in the distal direction and arranges the distance to the inner tube 22 closer toward the distal direction. Bend 32. This facilitates pushing the balloon 30 in the distal direction.

Further, in the balloon folding method, the blade portion 32 may be heated in the step of bending the blade portion 32. As a result, the shape of the bent blade portion 32 can be well maintained, and the balloon 30 can be moved to the folding step.

Further, in the balloon folding method, in the step of forming the blade portion 32 and the base portion 35 on the balloon 30, the

flexible film

155 and 156 are interposed between the first moving member 122 and the balloon 30, and the blade portion 32 is folded. In the step,

flexible films

181 and 182 may be interposed between the second moving member 132 and the balloon 30. Thereby, when the blade portion 32 and the base portion 35 are formed on the balloon 30, and when the blade portion 32 is folded, the surface of the balloon 30 can be protected by a film to prevent the drug from peeling from the balloon 30. The form of the film is not limited to the above-mentioned form.

Further, the balloon folding device 100 is a balloon folding device 100 that folds the balloon 30 of the balloon catheter 10 in which the balloon 30 is provided on the long inner tube 22 on the outer peripheral surface of the inner tube 22, and is an area capable of accommodating the balloon 30. A plurality of first moving members 122 arranged so as to surround the balloon 30 are provided, and the first moving member 122 is moved toward a region capable of accommodating the balloon 30 to form a blade portion 32 protruding outward in the radial direction of the balloon 30. It has a pleating portion 120 capable of being formed, and a bending portion 170 having a pressing portion 174 capable of applying a force to each of the blade portions 32 in the same direction in the circumferential direction of the inner tube 22, and the bending portion 170 is provided. A hole 171 into which the balloon 30 can be inserted is formed, and the pressing portion 174 is a spiral convex portion formed on the inner wall surface of the hole 171.

In the balloon folding device 100 configured as described above, after the blade portion 32 is formed in the balloon 30 by the pleating portion 120, the balloon 30 is inserted into the hole portion 171 so that all the blade portions 32 are spiral. Receives a force in the same direction from the pressing portion 174 of. Therefore, all the blade portions 32 can be satisfactorily bent in the same direction. Therefore, when the blade portions 32 are folded, backfolding is less likely to occur, and the plurality of blade portions 32 can be uniformly folded in the same direction.

Further, the radius of the spiral of the pressing portion 174 may gradually decrease toward the distal direction of the balloon 30. As a result, the balloon 30 is easily pushed into the hole 171 when the pressing portion 174 is formed. Further, by moving the balloon 30 in the distal direction, the bending of the blade portion 32 can be gradually increased.

Further, the bent portion 170 may have a heating portion 175 that heats the pressing portion 174. As a result, the shape of the bent blade portion 32 can be well maintained. Therefore, when the blade portions 32 are folded, backfolding is less likely to occur, and the plurality of blade portions 32 can be uniformly folded in the same direction.

Further, the balloon folding device 100 includes a plurality of second moving members 132 arranged so as to surround the area capable of accommodating the balloon 30, and the second moving member 132 is rotated to rotate the blade portion 32 around the inner pipe 22. It has a folding portion 130 that can be folded along the direction. As a result, after all the blade portions 32 are bent in the same direction by the bent portion 170, the blade portions 32 can be folded by the folding portion 150. Therefore, when the blade portions 32 are folded, backfolding is less likely to occur, and the plurality of blade portions 32 can be uniformly folded in the same direction.

Further, the balloon catheter 10 according to the present embodiment is a balloon catheter in which the balloon 30 whose outer surface is coated with the drug is arranged inside the protective tube 15 in a state of being folded on the outer peripheral surface of the inner tube 22 of the balloon catheter 10. No. 10, the balloon 30 includes a plurality of blade portions 32 that are folded along the circumferential direction of the inner pipe 22 while projecting outward in the radial direction of the balloon 30, and a plurality of base portions 35 that are in contact with the inner pipe 22. Each blade portion 32 is located between the blade tip portion 51 located on the protruding side, the blade base end portion 53 connected to the base portion 35, and the blade tip portion 51 and the blade base end portion 53. The blade intermediate portion 52 has a blade intermediate portion 52, and the blade intermediate portion 52 has a blade intermediate outer portion 52A facing the protective tube 15 side and a blade intermediate inner portion 52B facing the inner tube 22 side, and inside the balloon 30. The surfaces are in contact with each other over substantially the entire surface, and each blade tip 51 is in contact with the blade base end 53 of another adjacent blade 32, and is in contact with the outer surface of the blade tip 51 and the blade tip 51. The outer region 35D is defined by the outer surface of the blade base end 53 and the inner peripheral surface of the protective tube 15, and the inner region 35C is defined by the inner surface of each blade base 53 and the outer peripheral surface of the inner tube 22. Approximately the entire outer surface of each blade intermediate outer portion 52A contacts the inner peripheral surface of the protective tube 15, and substantially the entire outer surface of each blade intermediate inner portion 52B contacts the outer surface of the foundation portion 35. It is characterized by that.

The balloon catheter 10 configured as described above has a folded blade portion 32 and a balloon 30 coated with a drug is arranged between the inner tube 22 and the protective tube 15 with substantially no gap. Therefore, the balloon 30 coated with the drug can be held in the protective tube 15 with a small diameter. The balloon 30 coated with the drug is usually arranged inside the protective tube 15 while forming a gap in order to prevent the drug from peeling off due to friction, contact, or the like. However, if the peeling of the drug can be suppressed, the balloon 30 can be folded without a gap to have a small diameter, thereby improving the insertability to a target position. Further, when the balloon 30 is folded without a gap, it becomes difficult for the drug on the outer surface that is folded and overlapped to come into contact with blood or the like, and the drop of the drug can be suppressed.

The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the balloon catheter 10 according to the above-described embodiment is a rapid exchange type (Rapid exchange type), but may be an over-the-wire type (Over-the-wire type). Further, the balloon folding device 100 does not have to be provided with the folding portion 130. In this case, the folding portion 170 completes the folding of the blade portion 32.

Further, as in the modified example shown in FIG. 14, the bent portion 190 is arranged so as to surround the rotational support portion 191 that can rotate about the axial center and the axial center of the rotational support portion 191. It may have a plurality of columnar rotating bodies 192 rotatably connected to 191. The pressing portion 193 is located on the outer peripheral surface of each rotating body 192.

The rotary support portion 191 is rotatably supported by the cylinder support portion 194. For example, three rotating bodies 192 are provided, but four or more rotating bodies 192 may be provided. It is preferable that the axis of each rotating body 192 and the axis of the rotation support portion 191 are substantially parallel. The three rotating bodies 192 are arranged evenly arranged in the circumferential direction so as to surround the area in which the balloon 30 can be accommodated. The rotation support portion 191 can be manually rotated. Alternatively, the rotation support portion 191 may be rotationally driven by a drive source such as a motor.

The bent portion 190 can rotate the rotating body 192 with respect to the rotary support portion 191 while rotating the rotary support portion 191. Therefore, as shown in FIG. 11, when the balloon 30 is arranged in the region surrounded by the rotating body 192 and the rotating support portion 191 is rotated, the rotating body 192 rubs the outer surface of the balloon 30 from the balloon 30. It moves around the balloon 30 while rolling under the force. Therefore, a force in the same direction can be applied to the blade portion 32 by the pressing portion 193 of the rotating body 192 that rolls and moves on the outer surface of the balloon 30. Therefore, before the blade portion 32 is folded, the blade portion 32 is strongly bent at the crease, and all the blade portions 32 are satisfactorily bent in the same direction. The rotating body 192 may not be rotated by the frictional force received from the balloon 30, but may be rotationally driven by a drive source such as a motor.

The outer diameter of the rotating body 192 gradually increases toward the distal direction of the balloon 32. This makes it easy to insert the balloon 30 into the region surrounded by the rotating body 192. The outer diameter of the rotating body 192 may be constant. The rotation support portion 191 may be formed with a hole for inserting the balloon 30 into the folding portion 130 by a series of operations.

Further, the balloon 30 does not have to have the drug coat layer 40. The balloon catheter 10 according to the present embodiment can suppress the occurrence of backfold even without the drug-coated layer 40, and makes it easier to expand the folded balloon 30.

Further, as in the modified example shown in FIG. 16, the balloon catheter 10 may have a flexible protective film 16 sandwiched between the protective tube 15 and the balloon 30. As a result, the drug on the outer surface of the balloon 30 comes into contact with the protective tube 15 via the flexible protective film 16, so that peeling of the drug can be suppressed. Further, by providing the protective tube 15, the balloon 30 can be inserted into the protective tube 15 or taken out from the protective tube 15 while the balloon 30 is covered with the protective film 16. Therefore, when the balloon 30 is inserted into the protective tube 15 and / or when the balloon 30 is taken out from the protective tube 15, the peeling of the drug caused by the blade portion 32 rubbing against the protective tube 15 can be suppressed.

Further, the pleating unit and the folding unit may be provided in different devices.

10 Balloon catheter 15 Protective tube 22 Inner tube (shaft)
30 Balloon 32 Blade 35 Base 40 Chemical coat layer 51 Blade tip 52 Blade intermediate 52A Blade intermediate outer 52B Blade intermediate inner 53 Blade base end

53C Inner area

53D Outer area 100 Balloon folding device 120 Pleating part 130

Folding part

170, 190 Bending part 171

Hole part

174, 193 Pressing part 175 Heating part 191 Rotating support part 192 Rotating body

Claims

A balloon folding method in which a balloon of a balloon catheter having a balloon provided at the tip of a long shaft is folded on the outer peripheral surface of the shaft.
The balloon is inserted between a plurality of first moving members arranged so as to surround a predetermined area, and the first moving member is moved toward the balloon to push the balloon in the radial direction. A step of forming a plurality of blades protruding outward and a plurality of foundations located between the blades,
A step of applying a force to all the blades in the same direction in the circumferential direction of the shaft to bend the blades in the same direction.
The balloon having the bent blade portion is inserted between a plurality of second moving members arranged so as to surround a predetermined region, and the second moving member is moved toward the shaft to move the blade portion. A balloon folding method comprising: a step of folding along the circumferential direction of the shaft.
In the step of bending the blade portion, the balloon is inserted into a hole formed in the inner wall surface of the pressing portion which is a spiral convex portion, and the blade portion is brought into contact with the pressing portion to be bent. The balloon folding method according to claim 1.
In the step of bending the blade portion,
The balloon is arranged at a position surrounded by a plurality of columnar rotating bodies that can rotate around each axis, and the pressing portion, which is the outer peripheral surface of the plurality of rotating bodies, is brought into contact with the outer surface of the balloon. The balloon folding method according to claim 1, wherein the plurality of rotating bodies are moved in the same direction in the circumferential direction of the shaft.
In the step of bending the blade portion, the blade portion is bent by the pressing portion, which is arranged so that the distance to the shaft is closer toward the distal direction while pushing the balloon in the distal direction. The balloon folding method according to claim 2 or 3.
The balloon folding method according to any one of claims 1 to 4, wherein the blade portion is heated in the step of bending the blade portion.
In the step of forming the blade portion and the base portion, a flexible film is interposed between the first moving member and the balloon.
The balloon folding method according to any one of claims 1 to 5, wherein a film is interposed between the second moving member and the balloon in the step of folding the blade portion.
A balloon folding device that folds a balloon of a balloon catheter provided with a balloon on a long shaft on the outer peripheral surface of the shaft.
A plurality of first moving members arranged so as to surround the area in which the balloon can be accommodated are provided, and the first moving member is moved toward the area in which the balloon can be accommodated and protrudes radially outward to the balloon. A pleating part that can form a blade part and
Each of the blades has a bent portion provided with a pressing portion capable of applying a force in the same direction in the circumferential direction of the shaft.
The bent portion is formed with a hole into which the balloon can be inserted.
The balloon folding device, wherein the pressing portion is a spiral convex portion formed on the inner wall surface of the hole portion.
The balloon folding device according to claim 7, wherein the radius of the spiral of the pressing portion gradually decreases toward the distal direction.
A balloon folding device that folds a balloon of a balloon catheter provided with a balloon at the tip of a long shaft onto the outer peripheral surface of the shaft.
A plurality of first moving members arranged so as to surround the area in which the balloon can be accommodated are provided, and the first moving member is moved toward the area in which the balloon can be accommodated and protrudes radially outward to the balloon. A pleating part that can form a blade part and
Each of the blades has a bent portion provided with a pressing portion capable of applying a force in the same direction in the circumferential direction of the shaft.
The bent portion is
A rotary support portion that is rotatable around an axial center, and a plurality of columnar rotating bodies that are arranged so as to surround the axial center of the rotary support portion and are rotatably connected to the rotary support portion. Have,
The pressing portion is a balloon folding device characterized in that it is located on the outer peripheral surface of the rotating body.
The balloon folding device according to claim 9, wherein the outer diameter of the rotating body gradually increases toward the distal direction.
The balloon folding device according to any one of claims 7 to 10, wherein the bent portion has a heating portion that heats the pressing portion.
A folding portion provided with a plurality of second moving members arranged so as to surround the area capable of accommodating the balloon, and the blade portion can be folded along the circumferential direction of the shaft by rotating the second moving member. The balloon folding device according to any one of claims 7 to 11, further comprising.
A balloon catheter in which a balloon coated with a drug on the outer surface is placed inside a protective tube in a state of being folded on the outer peripheral surface of the shaft of the balloon catheter.
The balloon has a plurality of blade portions that are folded along the circumferential direction of the shaft while projecting outward in the radial direction of the balloon, and a plurality of foundation portions that are in contact with the shaft.
Each of the blade portions has a blade tip portion located on a protruding side, a blade base end portion connected to the base portion, and a blade intermediate portion located between the blade tip portion and the blade base end portion. And
The blade intermediate portion has a blade intermediate outer portion facing the protective tube side and a blade intermediate inner portion facing the shaft side, and the inner surfaces of the balloons are formed in contact with each other over substantially the entire surface.
Each of the blade tips comes into contact with the blade base end of another adjacent blade,
The outer region is defined by the outer surface of the blade tip, the outer surface of the blade base end in contact with the blade tip, and the inner peripheral surface of the protective tube.
The inner region is defined by the inner surface of each of the blade base ends and the outer peripheral surface of the shaft.
Approximately the entire outer surface of each of the blade intermediate outer portions is in contact with the inner peripheral surface of the protective tube.
A balloon catheter characterized in that substantially the entire outer surface of each of the inner inner portions of the blade is in contact with the outer surface of the base portion.