WO2020235352A1 - Balloon catheter, method for folding balloon of balloon catheter, and balloon forming device - Google Patents

Balloon catheter, method for folding balloon of balloon catheter, and balloon forming device Download PDF

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Publication number
WO2020235352A1
WO2020235352A1 PCT/JP2020/018615 JP2020018615W WO2020235352A1 WO 2020235352 A1 WO2020235352 A1 WO 2020235352A1 JP 2020018615 W JP2020018615 W JP 2020018615W WO 2020235352 A1 WO2020235352 A1 WO 2020235352A1
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WIPO (PCT)
Prior art keywords
balloon
inner tube
concave
blades
balloon catheter
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PCT/JP2020/018615
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French (fr)
Japanese (ja)
Inventor
宏成 加藤
大暉 山根
史織 山岡
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株式会社東海メディカルプロダクツ
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Publication of WO2020235352A1 publication Critical patent/WO2020235352A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates to a balloon catheter, a method for folding a balloon of a balloon catheter, and a balloon forming apparatus.
  • a balloon catheter having a bent part has been proposed as a catheter suitable for indwelling along a curved blood vessel or lumen.
  • the balloon catheter having such a bent portion includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft, and the distal end of the balloon is the inner tube and the liquid.
  • the proximal end of the balloon is tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube.
  • a balloon catheter in which the balloon expands and contracts due to the pressure of the fluid, and the balloon has a bent shape having a bent portion on the way from the proximal end side to the distal end side of the balloon. It is molded and expands with a pressure that does not stretch the membrane of the balloon to form the bent shape, and the balloon is folded and wrapped around the inner tube.
  • a balloon catheter has been proposed, which is characterized in that it has a spiral shape in a contracted state (Patent Document 1).
  • the present invention has been made to solve the above-mentioned problems, and in a balloon catheter having a bent balloon, a balloon that can be easily folded in a straight line while improving the expanding function at the time of expanding the balloon. And to provide a folding method.
  • the present invention has adopted the following means in order to achieve the above object.
  • the balloon catheter In the balloon catheter according to the present invention It is provided with a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube.
  • the proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube.
  • a balloon catheter in which the balloon expands and contracts due to the pressure of the fluid.
  • the balloon is characterized in that the balloon is folded into an inner tube in a contracted state so that a plurality of blades including a concave side blade formed on a concave side having at least a bent or curved shape are formed.
  • the gas inside the balloon should be evacuated to make it contracted before folding.
  • the balloon catheter of the present invention is contracted so as to form blades in this contracted state, so that at least one of the blades forms a concave side blade formed on the concave side in the bent or curved state of the balloon. It is folded after being shrunk to.
  • the concave side blades By forming the concave side blades in this way, wrinkles are likely to occur on the concave side blades when folded, and the balloon can be easily made straight. Therefore, the balloon can be made straight and easily folded.
  • the concave side blade may be characterized in that at least a part of the blades is contracted so as to be formed longer than the other blades. ..
  • the balloon By forming the concave side blade longer than the other blades, wrinkles are likely to occur on the concave side blade, the balloon can be easily straightened, and the balloon can be easily folded in a straight line state.
  • the concave side blade may be formed longer than the convex side blade formed on the convex side of a bent or curved shape. ..
  • the extension margin of the concave side blade becomes large when the balloon is made straight, so that it can be made straight and easy to fold.
  • it is suitable when a stretchable material is used as the material of the balloon.
  • the convex side blade formed on the convex side of the bent or curved shape may be formed longer than the concave side blade. ..
  • the convex side blade By forming the convex side blade longer than the concave side blade, when the balloon is made straight, it is possible to make the convex side blade more straight with wrinkles, and to make it straight and easy to fold. Can be done. In particular, it is suitable when a material having no elasticity is used as the material of the balloon.
  • the concave side blade is a concave side of the concave side having a bent or curved shape at a portion other than 10% of the distal end and the proximal end with respect to the total length of the balloon catheter. It may be characterized in that the blades are formed to be long.
  • the concave part of the balloon When the concave part of the balloon is made straight, it is most stretched near the center of the concave side blade, so by forming the concave side blade of this part to be long, the balloon is made straight. It is easy, and it is easy to secure a straight line in the folded state.
  • the blades may be characterized in that the blades other than the concave side blades are arranged on the convex side with respect to the inner tube.
  • the balloon catheter according to the present invention may be characterized in that the concave side blade of the blade is folded so as to be the outermost circumference.
  • the balloon By folding the concave side blades so that they are on the outermost circumference, when a liquid or gas for expansion is inserted, the balloon is expanded from the longest concave side blades, so that the balloons can be expanded smoothly without interfering with each other. can do.
  • the method for folding the balloon of the balloon catheter according to the present invention is as follows. It is provided with a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. The proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. It is a method of folding a balloon of a balloon catheter in which the balloon expands and contracts depending on the pressure of the fluid to be formed, and is characterized by the following steps.
  • the present invention also provides a balloon molding apparatus for a balloon catheter.
  • the balloon molding apparatus according to the present invention It includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube.
  • the proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube.
  • the balloon is formed to wind a balloon of a balloon catheter that expands and contracts due to the pressure of the fluid.
  • the molding apparatus includes a mold for molding the balloon into a predetermined shape before folding the balloon.
  • a concave groove formed in a concave shape in which an inner tube is arranged is formed over the entire length of the concave portion, and a middle claw type.
  • the curved balloon has a convex portion that is curved along the inner tube in the balloon when pressed from the lower direction on one side, and is formed in a concave shape at which the inner tube is arranged at the apex.
  • a back claw type in which a concave groove is formed over the entire length of the convex part,
  • the balloon is curved during molding, and when pressed from the lower direction on the other side, it has a convex portion that is curved along the inner tube inside the balloon, and is formed in a concave shape at the apex where the inner tube is arranged.
  • the front claw type in which the concave groove is formed over the entire length of the convex portion, It is characterized by having.
  • FIG. 1 is a side view of the balloon catheter 100 according to the embodiment.
  • FIG. 2 is a side view showing a folded state of the balloon catheter 100 according to the embodiment.
  • FIG. 3 is a cross-sectional view showing a contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 4 is a cross-sectional view showing another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 5 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 6 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 7 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 1 is a side view of the balloon catheter 100 according to the embodiment.
  • FIG. 2 is a side view showing a folded state of the balloon catheter 100 according to the embodiment.
  • FIG. 3 is a cross-
  • FIG. 8 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment.
  • FIG. 9 is a perspective view of the balloon molding apparatus 200 when the balloon catheter 100 according to the embodiment is contracted.
  • FIG. 10 is a perspective view showing a mold of the balloon molding apparatus 200 when the balloon catheter 100 according to the embodiment is contracted.
  • FIG. 11 is a diagram showing the shape of the wire 80 used for molding when the balloon catheter 100 according to the embodiment is contracted.
  • FIG. 1 is a side view of the balloon catheter 100 according to the embodiment.
  • FIG. 2 is a cross-sectional view of a portion AA of FIG. 1 showing a state in which gas is discharged into the balloon 20 before the balloon catheter 100 is folded and contracted.
  • the balloon catheter 100 mainly includes a long shaft 10 and a balloon 20 provided on the distal end side of the shaft 10.
  • the shaft 10 has a double pipe structure of an inner pipe 11 and an outer pipe 12, and the lumen 11a in the inner pipe 11 is mainly used for passing a guide wire, and is between the inner pipe 11 and the outer pipe 12.
  • Lumen 12a is used as a space for introducing a gas or liquid (hereinafter, also referred to as “expansion fluid”) for expanding the balloon 20.
  • the inner tube 11 extends to the distal end side of the balloon 20 and is liquid-tightly attached to the distal end of the balloon 20 at or near the distal end, and the inner tube 11 is placed within the balloon 20.
  • the outer tube 12 extends to the proximal end side of the balloon 20, and the distal end or the vicinity of the distal end of the outer tube 12 and the proximal end of the balloon 20 are liquid-tightly fixed.
  • the inner tube 11 is made of a tubular resin, and examples thereof include high-density polyethylene, polyamide, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane, polypropylene, and fluororesin.
  • the outer tube 12 is also made of a tubular resin, and examples thereof include polyamide, polyethylene, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane and polypropylene.
  • the balloon 20 is formed of a resin-made film-like hollow body, which is expanded by pressure by injecting a gas or liquid into the balloon 20 and contractible by suction.
  • the balloon according to the present invention is molded so as to have a bent or curved shape when expanded.
  • the bending rate and bending rate of the balloon are not limited, and can be appropriately selected depending on the intended use. Examples of the material constituting the balloon 20 include polyamide, polyamide elastomer, polyethylene terephthalate, polyester elastomer, and polyurethane.
  • the balloon 20 and the inner tube 11 are in a positional relationship so that the inner tube 11 does not come into contact with the inner surface of the balloon 20 when expanded. This is because when the balloon 20 and the inner tube 11 come into contact with each other, the inner tube 11 has a higher rigidity than the balloon 20, so that the expanded form of the balloon 20 may be deformed.
  • the balloon catheter 100 is provided with one or more X-ray opaque markers 70 attached to the inner tube 11 in the balloon 20 so that the position of the balloon 20 and the bending or bending state can be grasped. Is also good.
  • a connector 50 for inserting a guide wire into the balloon catheter 100 or connecting with a fluid supply device for inserting an expansion fluid may be appropriately attached to the proximal end of the balloon catheter 100.
  • a known one can be appropriately selected and used.
  • the balloon catheter 100 thus produced is in a state in which the balloon 20 and the inner tube 11 are folded so as to be linear in the initial state before use such as surgery and housed in a sheath or the like. Used for use.
  • the balloon 20 of the balloon catheter 100 according to the present invention is manufactured in a state in which the balloon 20 is not completely contracted but expanded after production.
  • the balloon 20 is folded from this state, but as shown in FIG. 3, it is necessary to exhaust the air inside the balloon 20 to bring it into a contracted state before folding it.
  • the balloon 20 is pressed toward the inner tube 11, and the surplus balloon 20 has a plurality of blades (21, 22, 23) extending in the radial direction.
  • the portion (21, 22, 23) of the extended balloon 20 is referred to as a "blade" in the present specification and claims.
  • the blades are shown at intervals in FIG. 3 so as to be easy to understand, they are actually formed so as to overlap each other exactly.
  • the length of the blade refers to the distance from the central portion of the blade formed radially, as shown in FIG.
  • three blades (21, 22, 23) are shown, but the number of blades is not limited to three.
  • One of the blades (21, 22, 23) is formed with a concave side blade 21 arranged on the concave side (lower side in FIG. 3) of the curved balloon 20.
  • the concave side blade 21 refers to a blade on the concave side with respect to the temporary center line ( ⁇ in the figure) of the balloon 20 when viewed from the side with respect to the curved balloon 20.
  • the convex side blades 22 and 23 refer to the blades on the convex side with respect to the temporary center line ( ⁇ in the figure) of the balloon 20.
  • the concave side blade 21 has blades formed in the direction directly below, but it does not necessarily have to be in the direction directly below, and as shown in FIG. 4, an angle may be formed to some extent.
  • the length ⁇ from the center of the concave side blade 21 is made longer than the length ⁇ of the convex side blades 22 and 23 as shown in FIG.
  • the balloon 20 can be easily straightened in a contracted state, and the blades (21, 22, 23) can be easily folded.
  • the concave side blade 21 is formed to be long, the elongation margin becomes large and it becomes easy to make a straight line easily, and the blades 21 and 22 are easily formed. , 23 can be folded.
  • the concave side blade 21 is formed long at the time of folding, it is preferable to fold the concave side blade 21 so as to be on the outermost side. By folding in this way, when the balloon 20 is expanded, the largest concave side blade 21 can be expanded first, so that the other blades 22 and 23 can be expanded smoothly without interfering with each other.
  • all the blades 22 and 23 other than the concave side blade 21 are arranged on the convex side of the balloon 20 from the center of the inner tube 11.
  • the blades 22 and 23 other than the concave side blades 21 contract when the balloon 20 is straightened, so that it is possible to prevent an obstacle when the balloon 20 is straightened.
  • the range in which the concave side blade 21 is longer than the other blades 22 and 23 is preferably formed at a position other than the range of 10% with respect to the total length of the balloon 20 from the proximal end and the distal end of the balloon 20.
  • the blades may be habituated in the folding direction in advance so that the blades can be easily folded.
  • At least one of the blades (21, 22, 23) is a convex arranged on the convex side (upper side of FIG. 3) of the curved balloon 20.
  • Shaped side blades 22 and 23 are formed.
  • the length ⁇ from the center of some or all of the convex side blades 22 and 23 is formed to be longer than the length ⁇ of the concave side blade 21.
  • the blades (21, 22, 23) can be easily folded.
  • folding it is preferable to fold either of the convex side blades 22 and 23 so as to be on the outermost side.
  • the large convex side blades 22 and 23 can be expanded first, so that the other blades can be smoothly expanded without interfering with each other.
  • the convex side blades 22 and 23 are arranged with respect to the angle ⁇ formed by the concave side blades 21 and the convex side blades 22 and 23. It may be formed so that the angle ⁇ formed by is small.
  • the convex side blades 22 and 23 are arranged in a direction in which wrinkles are more likely to occur, so that the balloon 20 can be made more straight.
  • the range in which the convex side blades 22 and 23 are longer than the concave side blade 21 is formed at a position other than the range of 10% with respect to the total length of the balloon 20 from the proximal end and the distal end of the balloon 20. Is preferable as in the first contracted state.
  • the inner tube 11 does not necessarily have to be in the central portion of the contracted state, and may be arranged in the blade portion as shown in FIG.
  • FIG. 9 shows a perspective view of the device according to the embodiment of the balloon molding device 200 used when folding the balloon catheter 100 according to the present invention.
  • the balloon forming apparatus 200 mainly includes molds 211, 212, 213 for forming the balloon 20 into a predetermined shape before folding, and clamps arranged on the proximal end side and the distal end side for fixing the balloon catheter 100. It is equipped with 220.
  • the mold consists of a middle claw type 211, a back claw type 212, and a front claw type 213.
  • the middle claw mold 211 is a mold that is arranged on the convex side of the balloon 20 that is curved during molding, and as shown in FIG. 10A, the concave portion 211a is formed along the convex curvature of the inner tube 11 in the balloon 20.
  • the cross section of the concave portion 211a is formed in a chevron shape, and a concave groove 211b in which the inner pipe 11 is arranged is formed at the apex thereof over the entire length of the concave portion 211a. As shown in FIG.
  • the back claw type 212 follows the inner tube 11 in the balloon 20 when pressed from the lower side of the inner tube 11 on one side of the curved balloon 20 during molding. It has a curved convex portion 212a, and a concave groove 212b formed in a concave shape on which an inner tube 11 is arranged is formed over the entire length of the convex portion 212a at the apex thereof.
  • the front claw mold 213 has a convex portion 213a that is curved along the inner tube 11 of the balloon 20 when pressed from the lower side on the other side of the balloon 20 that is curved during molding.
  • a concave groove formed in a concave shape in which the inner tube 11 is arranged is formed over the entire length of the convex portion 213a. Since the front claw type 213 is manufactured symmetrically with respect to the back claw shape, the figure is omitted.
  • the middle claw mold 211 is arranged on the convex side of the curve of the balloon 20, and the back claw mold 212 and the front claw mold 213 are located laterally and downwardly. It is arranged so as to be movable in the radial direction with respect to the inner pipe 11.
  • the back claw type 212 and the front claw type 213 support the inner tube 11 and the inner tube 11 pushes the balloon 20 toward the middle claw type 211 inside the balloon 20. It is made to shrink.
  • the clamp 220 is a member that clamps and fixes the distal end side and the proximal end side of the balloon 20 when the balloon catheter 100 is attached to the mold. Any form may be used as long as the distal end side and the proximal end side of the balloon catheter 100 can be fixed.
  • the upper die 220a and the lower die 220b are sandwiched and fixed.
  • a method of molding the contracted state of the balloon 20 of the balloon catheter 100 will be described using the balloon molding device 200 configured in this way.
  • the gas is inserted into the balloon catheter 100 and is in the expanded state. From this state, the balloon catheter 100 is set in the balloon molding apparatus 200. At this time, as shown in FIG. 11, a wire 80 which is bent so as to match the curvature of the balloon and has a clamp support portion 81 sandwiched between the clamps at the tip is inserted into the inner tube 11 to fix the shape. Good.
  • the balloon 20 is pushed from three directions, and blades extending in three directions are formed between the molds.
  • the concave side blade 21 is formed long, and the middle claw type 211 is formed into the back claw type 212 and the front claw type 213.
  • the convex side blades 22 and 23 can be formed to be long.
  • blades are formed in three directions, and the balloon 20 in a contracted state is formed. From this state, the balloon 20 can be wound in a linear state by folding or winding the respective blades 21, 22, and 23 along the inner tube 11 in a linear state.
  • the balloon catheter 100 produced as described above is used as follows. While introducing the guide wire inserted and placed in the blood vessel in advance into the inner tube 11. The balloon catheter 100 is inserted to the desired position along the guide wire. The blood vessel or lumen at the target position of the balloon catheter 100 according to the present invention becomes a curved portion. At the time of this insertion, the balloon 20 is not curved but linear. When the balloon reaches the target position, the balloon expansion fluid is supplied to expand the balloon 20. When the fluid for balloon expansion is supplied to the inside of the balloon 20, the outermost blades are first melted, and when the outermost blades are melted to some extent, the balloons are expanded to the other blades. The fluid is supplied and the whole is gradually developed to expand into a bent or curved shape as shown in FIG.
  • the balloon catheter 100 since the expanded form of the balloon 20 is formed in a curved shape, the case where the blood vessel or lumen where the balloon 20 is placed is greatly curved. Even if there is, the balloon 20 can be placed according to the expanded shape of the balloon 20, and uniform pressure can be applied to the curved blood vessel or the wall surface of the lumen.
  • it can be used as a balloon catheter.

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Abstract

[Problem] To provide a folded configuration and a folded method for the balloon of a bent balloon catheter, allowing for easy folding of the balloon while improving the inflation function of the balloon when being inflated. [Solution] A balloon catheter 100 according to the present invention is provided with a long shaft 10 comprising an inner tube and an outer tube and a balloon 20 which is formed on a distal end of the shaft and shaped in advance to have a bent or curved shape, the distal end of the balloon is fluid-tightly fixed to the inner tube 11, the proximal end of the balloon is fluid-tightly fixed to the outer tube 12, and the balloon inflates and deflates depending on the pressure of fluid supplied into the balloon via a space formed between the inner tube and the outer tube. The balloon catheter 100 is characterized in that the balloon is folded inside the inner tube in a deflated state such that a plurality of fins is formed including at least a recessed side fin 21 formed on a recessed side of the bent or curved shape.

Description

バルーンカテーテル、バルーンカテーテルのバルーンの折り畳み方法及びバルーン成形装置Balloon catheter, balloon folding method and balloon molding device
　本発明は、バルーンカテーテル、バルーンカテーテルのバルーンの折り畳み方法及びバルーン成形装置に関する。 The present invention relates to a balloon catheter, a method for folding a balloon of a balloon catheter, and a balloon forming apparatus.
　湾曲した血管や管腔に沿うように留置するのに適したカテーテルとして、屈曲箇所を有するバルーンカテーテルが提案されている。 A balloon catheter having a bent part has been proposed as a catheter suitable for indwelling along a curved blood vessel or lumen.
　こうした屈曲箇所を有するバルーンカテーテルとしては、内管および外管よりなる長尺なシャフトと、該シャフトの遠位端側に設けられたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張および収縮するバルーンカテーテルであって、前記バルーンは、当該バルーンの近位端側から遠位端側に至る途中に屈曲箇所のある屈曲形状となるように、あらかじめ成型されたものであって、当該バルーンの膜を伸張させない程度の圧力で拡張させて前記屈曲形状となるものであり、かつ、前記バルーンは、折り畳まれて前記内管の周囲に巻きつけられていることによって、収縮した状態で螺旋状の形になっていることを特徴とするバルーンカテーテルが提案されている（特許文献１）。 The balloon catheter having such a bent portion includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft, and the distal end of the balloon is the inner tube and the liquid. The proximal end of the balloon is tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. A balloon catheter in which the balloon expands and contracts due to the pressure of the fluid, and the balloon has a bent shape having a bent portion on the way from the proximal end side to the distal end side of the balloon. It is molded and expands with a pressure that does not stretch the membrane of the balloon to form the bent shape, and the balloon is folded and wrapped around the inner tube. A balloon catheter has been proposed, which is characterized in that it has a spiral shape in a contracted state (Patent Document 1).
　しかし、このような屈曲箇所を有するバルーンカテーテルに対して、バルーンを直線にした状態で均等に螺旋状に折り畳むことは非常に困難であった。また、バルーンの拡張時においてスムーズに拡張しづらいという問題点があった。 However, it was very difficult to evenly spirally fold the balloon in a straight line with respect to the balloon catheter having such a bent portion. In addition, there is a problem that it is difficult to expand the balloon smoothly when the balloon is expanded.
特許第５０１５７７２号公報Japanese Patent No. 5015772
　そこで、本発明は、上述した問題点を解決するためになされたものであり、屈曲したバルーンを有するバルーンカテーテルにおいて、バルーンの拡張時の拡張機能を向上させつつ、直線にした状態で折り畳み易いバルーン及び折り畳み方法を提供することを目的とする。 Therefore, the present invention has been made to solve the above-mentioned problems, and in a balloon catheter having a bent balloon, a balloon that can be easily folded in a straight line while improving the expanding function at the time of expanding the balloon. And to provide a folding method.
　本発明は、上述の目的を達成するために以下の手段を採った。 The present invention has adopted the following means in order to achieve the above object.
　本発明にかかるバルーンカテーテルにおいて、
　内管及び外管よりなる長尺なシャフトと、前記シャフトの遠位端側に設けられ屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張及び収縮するバルーンカテーテルであって、
　前記バルーンは、少なくとも屈曲又は湾曲形状の凹状側に形成される凹状側羽根を含む複数の羽根が形成されるようにバルーンを収縮状態で内管に折り畳まれていることを特徴とする。 In the balloon catheter according to the present invention
It is provided with a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. Along with being liquid-tightly fixed, the proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. A balloon catheter in which the balloon expands and contracts due to the pressure of the fluid.
The balloon is characterized in that the balloon is folded into an inner tube in a contracted state so that a plurality of blades including a concave side blade formed on a concave side having at least a bent or curved shape are formed.
　バルーンを折り畳む場合には、バルーン内の気体を抜いて収縮した状態にしてから折り畳むことになる。本発明のバルーンカテーテルは、この収縮した状態において、羽根が形成されるように収縮させ、この羽根の少なくとも１つがバルーンの屈曲又は湾曲状態において凹状側に形成された凹状側羽根が形成されるように収縮させた後、折り畳んだものである。このように凹状側羽根が形成されることで折り畳む際に凹状側羽根にシワができやすくバルーンを直線状にしやすくなる。そのため、バルーンを直線状にして折り畳み易くすることができる。 When folding the balloon, the gas inside the balloon should be evacuated to make it contracted before folding. The balloon catheter of the present invention is contracted so as to form blades in this contracted state, so that at least one of the blades forms a concave side blade formed on the concave side in the bent or curved state of the balloon. It is folded after being shrunk to. By forming the concave side blades in this way, wrinkles are likely to occur on the concave side blades when folded, and the balloon can be easily made straight. Therefore, the balloon can be made straight and easily folded.
　さらに、本発明にかかるバルーンカテーテルにおいて、前記凹状側羽根は、少なくとも一部の羽根が他の羽根に対して長く形成されるように収縮した状態であることを特徴とするものであってもよい。 Further, in the balloon catheter according to the present invention, the concave side blade may be characterized in that at least a part of the blades is contracted so as to be formed longer than the other blades. ..
　凹状側羽根を他の羽根に対して長く形成することで凹状側羽根にシワができやすく、バルーンを直線状にしやすく、かつ直線にした状態で折り畳みやすくすることができる。 By forming the concave side blade longer than the other blades, wrinkles are likely to occur on the concave side blade, the balloon can be easily straightened, and the balloon can be easily folded in a straight line state.
　さらに、本発明にかかるバルーンカテーテルにおいて、前記凹状側羽根は、屈曲又は湾曲形状の凸状側に形成される凸状側羽根よりも長く形成されていることを特徴とするものであってもよい。 Further, in the balloon catheter according to the present invention, the concave side blade may be formed longer than the convex side blade formed on the convex side of a bent or curved shape. ..
　凹状側羽根を凸状側羽根よりも長く形成することによって、バルーンを直線にした際に凹状側羽根の伸びしろが大きくなるので、直線状にして折り畳みやすくすることができる。特に、バルーンの素材に伸縮性のある素材を使用した場合に好適である。 By forming the concave side blade longer than the convex side blade, the extension margin of the concave side blade becomes large when the balloon is made straight, so that it can be made straight and easy to fold. In particular, it is suitable when a stretchable material is used as the material of the balloon.
　さらに、本発明にかかるバルーンカテーテルにおいて、屈曲又は湾曲形状の凸状側に形成される凸状側羽根は、前記凹状側羽根よりも長く形成されていることを特徴とするものであってもよい。 Further, in the balloon catheter according to the present invention, the convex side blade formed on the convex side of the bent or curved shape may be formed longer than the concave side blade. ..
　凹状側羽根に対して凸状側羽根を長く形成することによって、バルーンを直線にした際に、凸状側羽根にしわがよりつつ直線状にしやすくすることができ、直線状にして折り畳みやすくすることができる。特に、バルーンの素材に伸縮性を有しない素材を使用した場合に好適である。 By forming the convex side blade longer than the concave side blade, when the balloon is made straight, it is possible to make the convex side blade more straight with wrinkles, and to make it straight and easy to fold. Can be done. In particular, it is suitable when a material having no elasticity is used as the material of the balloon.
　さらに、本発明にかかるバルーンカテーテルにおいて、前記凹状側羽根は、バルーンカテーテルの全長に対して、遠位端及び近位端の１０％の部位以外の部位で屈曲又は湾曲形状の凹状側の凹状側羽根が長くなるように形成されていることを特徴とするものであってもよい。 Further, in the balloon catheter according to the present invention, the concave side blade is a concave side of the concave side having a bent or curved shape at a portion other than 10% of the distal end and the proximal end with respect to the total length of the balloon catheter. It may be characterized in that the blades are formed to be long.
　バルーンの凹状部を直線状にする場合に、最も引き伸ばされるのは、凹状側羽根の中心付近であることから、この部位の凹状側羽根を長くするように形成することで、バルーンを直線状にしやすく、バルーンは折り畳まれた状態で直線状を確保しやすくなる。 When the concave part of the balloon is made straight, it is most stretched near the center of the concave side blade, so by forming the concave side blade of this part to be long, the balloon is made straight. It is easy, and it is easy to secure a straight line in the folded state.
　さらに、本発明にかかるバルーンカテーテルにおいて、前記羽根は、凹状側羽根以外の羽根は、内管に対して凸状側に配置されていることを特徴とするものであってもよい。 Further, in the balloon catheter according to the present invention, the blades may be characterized in that the blades other than the concave side blades are arranged on the convex side with respect to the inner tube.
　かかる構成を採用することによって、他の羽根は、バルーンを直線状にした場合でも縮む方向となるので、バルーンを直線状にする際に他の羽根が妨げとなることを防止することができる。 By adopting such a configuration, the other blades tend to contract even when the balloon is straightened, so that it is possible to prevent the other blades from interfering with the straightening of the balloon.
　さらに、本発明にかかるバルーンカテーテルにおいて、羽根のうち凹状側羽根が最外周になるように折り畳まれていることを特徴とするものであってもよい。 Further, the balloon catheter according to the present invention may be characterized in that the concave side blade of the blade is folded so as to be the outermost circumference.
　凹状側羽根が最外周になるように折り畳むことによって、拡張用の液体又は気体を挿入した際に、最も長い凹状側羽根から拡張されるため、互いの羽根が干渉することなくスムーズにバルーンを拡張することができる。 By folding the concave side blades so that they are on the outermost circumference, when a liquid or gas for expansion is inserted, the balloon is expanded from the longest concave side blades, so that the balloons can be expanded smoothly without interfering with each other. can do.
　また、本発明にかかるバルーンカテーテルのバルーンの折り畳み方法は、
　内管および外管よりなる長尺なシャフトと、前記シャフトの遠位端側に設けられ、屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張および収縮するバルーンカテーテルのバルーンの折り畳み方法であって、以下の工程からなることを特徴とする。
　（１）前記バルーンカテーテルのバルーンの屈曲又は湾曲形状の凸状側及び屈曲又は湾曲形状の凹状側かつ両方側の三方向から押圧し、凹状側の羽根が最も長くなるように三つの羽根を形成する工程。
　（２）前記バルーンカテーテルのバルーンの屈曲又は湾曲形状を直線にする工程。
　（３）三羽根の凹状側の羽根が最外周となるように内管に折り畳む工程。 Further, the method for folding the balloon of the balloon catheter according to the present invention is as follows.
It is provided with a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. The proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. It is a method of folding a balloon of a balloon catheter in which the balloon expands and contracts depending on the pressure of the fluid to be formed, and is characterized by the following steps.
(1) Press from three directions, the convex side of the bent or curved shape of the balloon of the balloon catheter and the concave side and both sides of the bent or curved shape, and form three blades so that the blade on the concave side is the longest. Process to do.
(2) A step of straightening the bent or curved shape of the balloon of the balloon catheter.
(3) A step of folding into an inner pipe so that the concave side blades of the three blades are on the outermost circumference.
　このような折り畳み方法を採用することによって、前述した折り畳み方を有するバルーンカテーテルを提供することができる。 By adopting such a folding method, it is possible to provide a balloon catheter having the above-mentioned folding method.
　また、本発明は、バルーンカテーテルのバルーン成形装置についても提供する。本発明にかかるバルーン成形装置は、
　内管および外管よりなる長尺なシャフトと、前記シャフトの遠位端側に設けられ、屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張および収縮するバルーンカテーテルのバルーンを巻回するために成形するバルーン成形装置において、
　前記成形装置は、バルーンを折り畳む前に所定の形態に成形する型を備え、
　成形時に湾曲したバルーンの凸状側に配置される型であり、バルーン内の内管の凸状の湾曲に沿うように凹状部を有しており、凹状部の断面は、山形に形成され、その頂点には内管が配置される凹状に形成された凹状溝が凹状部の全長に渡って形成されている中爪型と、
　湾曲したバルーンに対して、一方側下方の方向から押圧した場合にバルーン内の内管に沿うように湾曲した凸状部を有し、その頂点には内管が配置される凹状に形成された凹状溝が凸状部の全長に渡って形成されている奥爪型と、
　成形時に湾曲したバルーンに対して、他方側下方の方向から押圧した場合にバルーン内の内管に沿うように湾曲した凸状部を有し、その頂点には内管が配置される凹状に形成された凹状溝が凸状部の全長に渡って形成されている手前爪型と、
　を備えていることを特徴とする。 The present invention also provides a balloon molding apparatus for a balloon catheter. The balloon molding apparatus according to the present invention
It includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. The proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. In a balloon forming apparatus, the balloon is formed to wind a balloon of a balloon catheter that expands and contracts due to the pressure of the fluid.
The molding apparatus includes a mold for molding the balloon into a predetermined shape before folding the balloon.
It is a mold that is placed on the convex side of a curved balloon during molding, and has a concave portion along the convex curvature of the inner tube in the balloon, and the cross section of the concave portion is formed in a chevron shape. At the apex, a concave groove formed in a concave shape in which an inner tube is arranged is formed over the entire length of the concave portion, and a middle claw type.
The curved balloon has a convex portion that is curved along the inner tube in the balloon when pressed from the lower direction on one side, and is formed in a concave shape at which the inner tube is arranged at the apex. A back claw type in which a concave groove is formed over the entire length of the convex part,
The balloon is curved during molding, and when pressed from the lower direction on the other side, it has a convex portion that is curved along the inner tube inside the balloon, and is formed in a concave shape at the apex where the inner tube is arranged. The front claw type, in which the concave groove is formed over the entire length of the convex portion,
It is characterized by having.
　かかるバルーン成形装置を使用することによって、容易に前述したバルーンカテーテルのバルーンの形態に折り畳むことができる。 By using such a balloon molding device, it can be easily folded into the balloon form of the balloon catheter described above.
　本発明にかかるバルーンカテーテルによれば、湾曲したバルーンであっても容易に直線状に折り畳むことができる。 According to the balloon catheter according to the present invention, even a curved balloon can be easily folded in a straight line.
図１は、実施形態にかかるバルーンカテーテル１００の側面図である。FIG. 1 is a side view of the balloon catheter 100 according to the embodiment. 図２は、実施形態にかかるバルーンカテーテル１００を折り畳んだ状態を示す側面図である。FIG. 2 is a side view showing a folded state of the balloon catheter 100 according to the embodiment. 図３は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態を示す断面図である。FIG. 3 is a cross-sectional view showing a contracted state before folding the balloon catheter 100 according to the embodiment. 図４は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態の別実施形態を示す断面図である。FIG. 4 is a cross-sectional view showing another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment. 図５は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態のさらなる別実施形態を示す断面図である。FIG. 5 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment. 図６は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態のさらなる別実施形態を示す断面図である。FIG. 6 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment. 図７は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態のさらなる別実施形態を示す断面図である。FIG. 7 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment. 図８は、実施形態にかかるバルーンカテーテル１００を折り畳む前の収縮状態のさらなる別実施形態を示す断面図である。FIG. 8 is a cross-sectional view showing still another embodiment of the contracted state before folding the balloon catheter 100 according to the embodiment. 図９は、実施形態にかかるバルーンカテーテル１００を収縮させる際のバルーン成形装置２００の斜視図である。FIG. 9 is a perspective view of the balloon molding apparatus 200 when the balloon catheter 100 according to the embodiment is contracted. 図１０は、実施形態にかかるバルーンカテーテル１００を収縮させる際のバルーン成形装置２００の型を示す斜視図である。FIG. 10 is a perspective view showing a mold of the balloon molding apparatus 200 when the balloon catheter 100 according to the embodiment is contracted. 図１１は、実施形態にかかるバルーンカテーテル１００を収縮させる際の成形に使用する針金８０の形状を示す図である。FIG. 11 is a diagram showing the shape of the wire 80 used for molding when the balloon catheter 100 according to the embodiment is contracted.
　次に、本発明にかかるバルーンカテーテル１００の実施形態について、図を参照しつつ詳細に説明する。なお、以下に説明する実施の形態及び図面は、本発明の実施形態の一部を例示するものであり、これらの構成に限定する目的に使用されるものではなく、本発明の要旨を逸脱しない範囲において適宜変更することができる。 Next, an embodiment of the balloon catheter 100 according to the present invention will be described in detail with reference to the drawings. It should be noted that the embodiments and drawings described below exemplify a part of the embodiments of the present invention, are not used for the purpose of limiting to these configurations, and do not deviate from the gist of the present invention. It can be changed as appropriate within the range.
　図１は、実施形態にかかるバルーンカテーテル１００の側面図である。図２は、バルーンカテーテル１００を折り畳む前のバルーン２０内に気体を排出して収縮した状態を示す図１のＡ－Ａ部の断面図である。 FIG. 1 is a side view of the balloon catheter 100 according to the embodiment. FIG. 2 is a cross-sectional view of a portion AA of FIG. 1 showing a state in which gas is discharged into the balloon 20 before the balloon catheter 100 is folded and contracted.
　本実施形態にかかるバルーンカテーテル１００は、図１に示すように、主として、長尺なシャフト１０と、シャフト１０の遠位端側に設けられたバルーン２０と、を備えている。 As shown in FIG. 1, the balloon catheter 100 according to the present embodiment mainly includes a long shaft 10 and a balloon 20 provided on the distal end side of the shaft 10.
　シャフト１０は、内管１１及び外管１２の二重管構造となっており、内管１１内のルーメン１１ａは、主としてガイドワイヤを通すために使用され、内管１１と外管１２との間のルーメン１２ａは、バルーン２０を拡張するための気体又は液体（以下「拡張用流体」ともいう。）を導入するための空間として使用される。内管１１は、バルーン２０の遠位端側まで延びており、遠位端又は遠位端近傍でバルーン２０の遠位端と液密に固着され、内管１１はバルーン２０内に配置されている。外管１２は、バルーン２０の近位端側まで延びており、外管１２の遠位端又は遠位端近傍とバルーン２０の近位端が液密に固着されている。 The shaft 10 has a double pipe structure of an inner pipe 11 and an outer pipe 12, and the lumen 11a in the inner pipe 11 is mainly used for passing a guide wire, and is between the inner pipe 11 and the outer pipe 12. Lumen 12a is used as a space for introducing a gas or liquid (hereinafter, also referred to as “expansion fluid”) for expanding the balloon 20. The inner tube 11 extends to the distal end side of the balloon 20 and is liquid-tightly attached to the distal end of the balloon 20 at or near the distal end, and the inner tube 11 is placed within the balloon 20. There is. The outer tube 12 extends to the proximal end side of the balloon 20, and the distal end or the vicinity of the distal end of the outer tube 12 and the proximal end of the balloon 20 are liquid-tightly fixed.
　内管１１は、チューブ状の樹脂で作製されており、例えば、高密度ポリエチレン、ポリアミド、ポリイミド、ポリエーテルエーテルケトン、ポリエチレンテレフタレート、ポリウレタン、ポリプロピレン、またフッ素樹脂等が挙げられる。 The inner tube 11 is made of a tubular resin, and examples thereof include high-density polyethylene, polyamide, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane, polypropylene, and fluororesin.
　外管１２も、チューブ状の樹脂で作製されており、例えば、ポリアミド、ポリエチレン、ポリイミド、ポリエーテルエーテルケトン、ポリエチレンテレフタレート、ポリウレタン又はポリプロピレン等を挙げることができる。 The outer tube 12 is also made of a tubular resin, and examples thereof include polyamide, polyethylene, polyimide, polyetheretherketone, polyethylene terephthalate, polyurethane and polypropylene.
　バルーン２０は、樹脂製のフィルム状の中空体で形成されており、内部に気体又は液体を注入することにより、圧力により拡張し、吸引することにより収縮可能に形成されている。本発明にかかるバルーンは、拡張した際に屈曲又は湾曲した形状を有するように成型されている。バルーンの屈曲率や湾曲率は限定するものではなく、使用用途に応じて適宜選択することができる。バルーン２０を構成する材料としては、例えば、ポリアミド、ポリアミドエラストマー、ポリエチレンテレフタレート、ポリエステルエラストマー又はポリウレタン等を挙げることができる。 The balloon 20 is formed of a resin-made film-like hollow body, which is expanded by pressure by injecting a gas or liquid into the balloon 20 and contractible by suction. The balloon according to the present invention is molded so as to have a bent or curved shape when expanded. The bending rate and bending rate of the balloon are not limited, and can be appropriately selected depending on the intended use. Examples of the material constituting the balloon 20 include polyamide, polyamide elastomer, polyethylene terephthalate, polyester elastomer, and polyurethane.
　バルーン２０と内管１１は、図１に示すように拡張時において、バルーン２０の内面に内管１１が接触しないような位置関係にすることが好ましい。バルーン２０と内管１１が接触すると、内管１１の方がバルーン２０よりも剛性が高いため、バルーン２０の拡張形態が変形する可能性があるからである。 As shown in FIG. 1, it is preferable that the balloon 20 and the inner tube 11 are in a positional relationship so that the inner tube 11 does not come into contact with the inner surface of the balloon 20 when expanded. This is because when the balloon 20 and the inner tube 11 come into contact with each other, the inner tube 11 has a higher rigidity than the balloon 20, so that the expanded form of the balloon 20 may be deformed.
　さらに、任意に、バルーンカテーテル１００には、バルーン２０の位置及び、屈曲又は湾曲状態が把握可能なように、１つ又は複数のＸ線不透過マーカー７０をバルーン２０内の内管１１に取り付けても良い。 Further, optionally, the balloon catheter 100 is provided with one or more X-ray opaque markers 70 attached to the inner tube 11 in the balloon 20 so that the position of the balloon 20 and the bending or bending state can be grasped. Is also good.
　また、バルーンカテーテル１００の近位端には、適宜、バルーンカテーテル１００にガイドワイヤを挿入したり、拡張用流体を挿入するための流体供給装置と接続するためのコネクタ５０を取り付けてもよい。コネクタ５０の形態は既知のものを適宜選択して使用することができる。 Further, a connector 50 for inserting a guide wire into the balloon catheter 100 or connecting with a fluid supply device for inserting an expansion fluid may be appropriately attached to the proximal end of the balloon catheter 100. As the form of the connector 50, a known one can be appropriately selected and used.
　こうして作製されたバルーンカテーテル１００は、図２に示すように、手術等の使用前の初期状態ではバルーン２０及び内管１１が直線状になるように折り畳まれて、シース等に収容された状態で使用に供される。 As shown in FIG. 2, the balloon catheter 100 thus produced is in a state in which the balloon 20 and the inner tube 11 are folded so as to be linear in the initial state before use such as surgery and housed in a sheath or the like. Used for use.
　ここで、バルーンカテーテル１００の折り畳み方法について説明する。 Here, a method of folding the balloon catheter 100 will be described.
　（第１収縮状態による折り畳み方法）
　本発明にかかるバルーンカテーテル１００のバルーン２０は、作製後はバルーン２０が完全に収縮した状態ではなく拡張した状態で作製される。この状態からバルーン２０を折り畳むのであるが、図３に示すように折り畳む前にバルーン２０の内の空気を排出し、収縮した状態にする必要がある。収縮状態は、バルーン２０が内管１１側に押し付けられ、余ったバルーン２０が放射方向へ複数延びた羽根（２１，２２，２３）を有する状態にされる。なお、この延びたバルーン２０の部分（２１，２２，２３）を本明細書及び特許請求の範囲では「羽根」をいう。なお、図３においては羽根の部分が理解容易となるように間隔が空いて図示されているが、実際には互いがぴったりと重なりあうように形成される。また羽根の長さとは、図３に示すように、放射状に形成された羽根の中心部分からの距離を指す。本実施形態においては、３つの羽根（２１，２２，２３）が形成されたものが示されているが、羽根の数は３つの限定するものではない。羽根（２１，２２，２３）のうちの１つは、湾曲されたバルーン２０の凹状側（図３の下方側）に配置される凹状側羽根２１が形成される。凹状側羽根２１とは、図１に示すように、湾曲したバルーン２０に対して側方から観た場合にバルーン２０の仮中心線（図のθ）に対して凹状側にある羽根をいい、凸状側羽根２２，２３とは、バルーン２０の仮中心線（図のθ）に対して凸状側にある羽根をという。凹状側羽根２１は、図３においては、直下の方向に羽根が形成されているが、必ずしも直下方向である必要はなく、図４に示すように、ある程度角度が形成されていても構わない。この際に、第１収縮状態では、凹状側羽根２１の中心からの長さαが図３に示すように、凸状側羽根２２，２３の長さβよりも長くなるように作製される。このように凹状側羽根２１を形成することによって、バルーン２０の素材に比較的柔らかい素材を使用した場合は、シワがよって形成されることになる。そのため、バルーン２０を収縮した状態で容易に直線状にすることができ、容易に羽根（２１，２２，２３）を折り畳むことができる。また、バルーン２０の素材に伸縮性を有する素材を使用した場合には、凹状側羽根２１が長く形成されているため、伸びしろが大きくなり容易に直線状にしやすくなり、容易に羽根２１，２２，２３を折り畳むことができる。なお、折り畳む際に、凹状側羽根２１を長く形成した場合には、凹状側羽根２１を最も外周側となるように折り畳むことが好ましい。このように折り畳むことで、バルーン２０を拡張する際に最も大きな凹状側羽根２１を最初に拡張させることができるので、その他の羽根２２，２３が干渉することなくスムーズに拡張することができる。さらに、凹状側羽根２１以外の羽根２２，２３すべてを内管１１の中心より、バルーン２０の凸状側に配置されるようにすることが好ましい。このように形成することで、バルーン２０を直線状にするときに凹状側羽根２１以外の羽根２２，２３は縮むことになるため、直線にする際の障害になることを防止することができる。この凹状側羽根２１を他の羽根２２，２３より長くする範囲は、バルーン２０の近位端及び遠位端からバルーン２０の全長に対して１０％の範囲以外の位置に形成することが好ましい。バルーン２０を直線状にする際に、バルーン２０の遠位端及び近位端近傍は、それほど湾曲を矯正されないので凹状側羽根２１が障害になることは少ないからである。なお、羽根を折り畳みやすいように、図５に示すように、予め折り畳む方向へクセ付けをしておいてもよい。 (Folding method according to the first contracted state)
The balloon 20 of the balloon catheter 100 according to the present invention is manufactured in a state in which the balloon 20 is not completely contracted but expanded after production. The balloon 20 is folded from this state, but as shown in FIG. 3, it is necessary to exhaust the air inside the balloon 20 to bring it into a contracted state before folding it. In the contracted state, the balloon 20 is pressed toward the inner tube 11, and the surplus balloon 20 has a plurality of blades (21, 22, 23) extending in the radial direction. The portion (21, 22, 23) of the extended balloon 20 is referred to as a "blade" in the present specification and claims. Although the blades are shown at intervals in FIG. 3 so as to be easy to understand, they are actually formed so as to overlap each other exactly. Further, the length of the blade refers to the distance from the central portion of the blade formed radially, as shown in FIG. In the present embodiment, three blades (21, 22, 23) are shown, but the number of blades is not limited to three. One of the blades (21, 22, 23) is formed with a concave side blade 21 arranged on the concave side (lower side in FIG. 3) of the curved balloon 20. As shown in FIG. 1, the concave side blade 21 refers to a blade on the concave side with respect to the temporary center line (θ in the figure) of the balloon 20 when viewed from the side with respect to the curved balloon 20. The convex side blades 22 and 23 refer to the blades on the convex side with respect to the temporary center line (θ in the figure) of the balloon 20. In FIG. 3, the concave side blade 21 has blades formed in the direction directly below, but it does not necessarily have to be in the direction directly below, and as shown in FIG. 4, an angle may be formed to some extent. At this time, in the first contracted state, the length α from the center of the concave side blade 21 is made longer than the length β of the convex side blades 22 and 23 as shown in FIG. By forming the concave side blade 21 in this way, when a relatively soft material is used for the material of the balloon 20, wrinkles are formed. Therefore, the balloon 20 can be easily straightened in a contracted state, and the blades (21, 22, 23) can be easily folded. Further, when a stretchable material is used as the material of the balloon 20, since the concave side blade 21 is formed to be long, the elongation margin becomes large and it becomes easy to make a straight line easily, and the blades 21 and 22 are easily formed. , 23 can be folded. In addition, when the concave side blade 21 is formed long at the time of folding, it is preferable to fold the concave side blade 21 so as to be on the outermost side. By folding in this way, when the balloon 20 is expanded, the largest concave side blade 21 can be expanded first, so that the other blades 22 and 23 can be expanded smoothly without interfering with each other. Further, it is preferable that all the blades 22 and 23 other than the concave side blade 21 are arranged on the convex side of the balloon 20 from the center of the inner tube 11. By forming the balloon 20 in this way, the blades 22 and 23 other than the concave side blades 21 contract when the balloon 20 is straightened, so that it is possible to prevent an obstacle when the balloon 20 is straightened. The range in which the concave side blade 21 is longer than the other blades 22 and 23 is preferably formed at a position other than the range of 10% with respect to the total length of the balloon 20 from the proximal end and the distal end of the balloon 20. This is because when the balloon 20 is straightened, the curvature of the distal end and the vicinity of the proximal end of the balloon 20 is not corrected so much, so that the concave side blade 21 is less likely to be an obstacle. As shown in FIG. 5, the blades may be habituated in the folding direction in advance so that the blades can be easily folded.
　（第２収縮状態による折り畳み方法）
　第２収縮状態では、図６に示すように、羽根（２１，２２，２３）のうちの少なくとも１つは、湾曲されたバルーン２０の凸状側（図３の上方側）に配置される凸状側羽根２２、２３が形成される。この際に、一部又はすべての凸状側羽根２２，２３の中心からの長さβが凹状側羽根２１の長さαと比較して長くなるように形成される。このように凸状側羽根２２，２３を長く形成することによって、バルーン２０を直線状にした際に凸状側羽根２２，２３にシワがよりやすくなり、比較的剛性がある素材をバルーン２０にした場合であっても直線にしやすくすることができる。そのため、容易に羽根（２１，２２，２３）を折り畳むことができる。なお、折り畳む際には、凸状側羽根２２，２３のいずれかを最も外周側となるように折り畳むことが好ましい。このように折り畳むことで、バルーン２０を拡張する際に大きな凸状側羽根２２，２３を最初に拡張させることができるので、その他の羽根が干渉することなくスムーズに拡張することができる。なお、３枚の羽根を形成する場合においては、図７に示すように、凹状側羽根２１と凸状側羽根２２，２３とがなす角度δに対して、凸状側羽根同士２２，２３とがなす角度γが小さくなるように形成してもよい。このように形成することによって、凸状側羽根２２，２３がよりシワがより易い方向に配置されるので、よりバルーン２０を直線にしやすくすることができる。なお、この凸状側羽根２２，２３を凹状側羽根２１より長くする範囲は、バルーン２０の近位端及び遠位端からバルーン２０の全長に対して１０％の範囲以外の位置に形成することが好ましいことは第１収縮状態と同様である。 (Folding method in the second contracted state)
In the second contracted state, as shown in FIG. 6, at least one of the blades (21, 22, 23) is a convex arranged on the convex side (upper side of FIG. 3) of the curved balloon 20. Shaped side blades 22 and 23 are formed. At this time, the length β from the center of some or all of the convex side blades 22 and 23 is formed to be longer than the length α of the concave side blade 21. By forming the convex side blades 22 and 23 long in this way, wrinkles are more likely to occur on the convex side blades 22 and 23 when the balloon 20 is straightened, and a relatively rigid material is used as the balloon 20. Even if it is done, it can be easily made into a straight line. Therefore, the blades (21, 22, 23) can be easily folded. When folding, it is preferable to fold either of the convex side blades 22 and 23 so as to be on the outermost side. By folding in this way, when the balloon 20 is expanded, the large convex side blades 22 and 23 can be expanded first, so that the other blades can be smoothly expanded without interfering with each other. In the case of forming three blades, as shown in FIG. 7, the convex side blades 22 and 23 are arranged with respect to the angle δ formed by the concave side blades 21 and the convex side blades 22 and 23. It may be formed so that the angle γ formed by is small. By forming in this way, the convex side blades 22 and 23 are arranged in a direction in which wrinkles are more likely to occur, so that the balloon 20 can be made more straight. The range in which the convex side blades 22 and 23 are longer than the concave side blade 21 is formed at a position other than the range of 10% with respect to the total length of the balloon 20 from the proximal end and the distal end of the balloon 20. Is preferable as in the first contracted state.
　第１収縮状態及び第２収縮状態ともに、内管１１が必ずしも収縮状態の中心部分にある必要はなく、図８に示すように、羽根の部分に配置されていてもよい。 In both the first contracted state and the second contracted state, the inner tube 11 does not necessarily have to be in the central portion of the contracted state, and may be arranged in the blade portion as shown in FIG.
　次に、バルーンカテーテル１００のバルーン２０の収縮状態を成形する成形方法を説明する。はじめに折り畳み前のバルーン２０の形態を形成するためのバルーン成形装置２００について説明する。本発明にかかるバルーンカテーテル１００を折り畳む際に使用されるバルーン成形装置２００の実施形態に係る装置の斜視図が図９に示されている。バルーン成形装置２００は、主として、バルーン２０を折り畳む前に所定の形態に成形する型２１１，２１２，２１３と、バルーンカテーテル１００を固定するため、近位端側と遠位端側に配置されるクランプ２２０とを備えている。 Next, a molding method for molding the contracted state of the balloon 20 of the balloon catheter 100 will be described. First, the balloon forming apparatus 200 for forming the form of the balloon 20 before folding will be described. FIG. 9 shows a perspective view of the device according to the embodiment of the balloon molding device 200 used when folding the balloon catheter 100 according to the present invention. The balloon forming apparatus 200 mainly includes molds 211, 212, 213 for forming the balloon 20 into a predetermined shape before folding, and clamps arranged on the proximal end side and the distal end side for fixing the balloon catheter 100. It is equipped with 220.
　型は、中爪型２１１、奥爪型２１２及び手前爪型２１３からなる。中爪型２１１は、成形時に湾曲したバルーン２０の凸側に配置される型であり、図１０Ａに示すように、バルーン２０内の内管１１の凸状の湾曲に沿うように凹状部２１１ａを有しており、凹状部２１１ａの断面は、山形に形成され、その頂点には内管１１が配置される凹状溝２１１ｂが凹状部２１１ａの全長に渡って形成されている。奥爪型２１２は、図１０Ｂに示すように成形時に湾曲したバルーン２０に対して、一方側面であって内管１１の下方側方向から押圧した場合にバルーン２０内の内管１１に沿うように湾曲した凸状部２１２ａを有し、その頂点には内管１１が配置される凹状に形成された凹状溝２１２ｂが凸状部２１２ａの全長に渡って形成されている。手前爪型２１３は、成形時に湾曲したバルーン２０に対して、他方側側面であって下方側方向から押圧した場合にバルーン２０の内管１１に沿うように湾曲した凸状部２１３ａを有し、その頂点には内管１１が配置される凹状に形成された凹状溝が凸状部２１３ａの全長に渡って形成されている。手前爪型２１３は、奥爪形に対して対称に作製されるので、図は省略する。このように作製された型は、図９に示すように、中爪型２１１がバルーン２０の湾曲の凸状側に配置され、奥爪型２１２及び手前爪型２１３が側方かつ下方の位置となるように配置され、内管１１に対して放射方向に移動可能に形成されている。バルーン２０が配置された状態で型締めした場合に、奥爪型２１２及び手前爪型２１３が内管１１を支持してバルーン２０内で内管１１が中爪型２１１側に押し込みつつバルーン２０を収縮するように作製されている。 The mold consists of a middle claw type 211, a back claw type 212, and a front claw type 213. The middle claw mold 211 is a mold that is arranged on the convex side of the balloon 20 that is curved during molding, and as shown in FIG. 10A, the concave portion 211a is formed along the convex curvature of the inner tube 11 in the balloon 20. The cross section of the concave portion 211a is formed in a chevron shape, and a concave groove 211b in which the inner pipe 11 is arranged is formed at the apex thereof over the entire length of the concave portion 211a. As shown in FIG. 10B, the back claw type 212 follows the inner tube 11 in the balloon 20 when pressed from the lower side of the inner tube 11 on one side of the curved balloon 20 during molding. It has a curved convex portion 212a, and a concave groove 212b formed in a concave shape on which an inner tube 11 is arranged is formed over the entire length of the convex portion 212a at the apex thereof. The front claw mold 213 has a convex portion 213a that is curved along the inner tube 11 of the balloon 20 when pressed from the lower side on the other side of the balloon 20 that is curved during molding. At the apex, a concave groove formed in a concave shape in which the inner tube 11 is arranged is formed over the entire length of the convex portion 213a. Since the front claw type 213 is manufactured symmetrically with respect to the back claw shape, the figure is omitted. In the mold thus produced, as shown in FIG. 9, the middle claw mold 211 is arranged on the convex side of the curve of the balloon 20, and the back claw mold 212 and the front claw mold 213 are located laterally and downwardly. It is arranged so as to be movable in the radial direction with respect to the inner pipe 11. When the balloon 20 is placed and the mold is clamped, the back claw type 212 and the front claw type 213 support the inner tube 11 and the inner tube 11 pushes the balloon 20 toward the middle claw type 211 inside the balloon 20. It is made to shrink.
　クランプ２２０は、バルーンカテーテル１００を型に取り付けた場合に、バルーン２０の遠位端側及び近位端側を挟持して固定する部材である。バルーンカテーテル１００の遠位端側及び近位端側を固定することができれば、どのような形態のものであっても構わない。本実施形態においては、上型２２０ａと下型２２０ｂで挟むようにして固定している。 The clamp 220 is a member that clamps and fixes the distal end side and the proximal end side of the balloon 20 when the balloon catheter 100 is attached to the mold. Any form may be used as long as the distal end side and the proximal end side of the balloon catheter 100 can be fixed. In the present embodiment, the upper die 220a and the lower die 220b are sandwiched and fixed.
　こうして構成されたバルーン成形装置２００を使用してバルーンカテーテル１００のバルーン２０の収縮状態の成形方法について説明する。 A method of molding the contracted state of the balloon 20 of the balloon catheter 100 will be described using the balloon molding device 200 configured in this way.
　バルーンカテーテル１００が作製された状態では、バルーンカテーテル１００内に気体が挿入された状態であり、拡張された状態にある。この状態からバルーン成形装置２００にバルーンカテーテル１００をセットする。この際に、図１１に示すようにバルーンの曲率に合うように折り曲げられ、先端にクランプに挟まれるクランプ用支持部８１が設けられた針金８０を内管１１内に挿入して形状を固定するとよい。この状態から型を締めることによって、三方向からバルーン２０が押されて、型と型の間に三方向に延びた羽根が形成される。この際に、中爪型２１１を奥爪型２１２及び手前爪型２１３に対して早く押し付けることによって、凹状側羽根２１が長く形成され、中爪型２１１を奥爪型２１２及び手前爪型２１３に対して遅く押し付けることによって、凸状側羽根２２、２３が長くなるように形成することができる。この状態で内部の気体を排出することで３方向に羽根が形成され、収縮された状態のバルーン２０が成形される。この状態からバルーン２０を直線状にした状態でそれぞれの羽根２１，２２，２３を内管１１に沿って折り畳む又は巻回することで直線状に保った状態で巻きつけることができる。 In the state where the balloon catheter 100 is manufactured, the gas is inserted into the balloon catheter 100 and is in the expanded state. From this state, the balloon catheter 100 is set in the balloon molding apparatus 200. At this time, as shown in FIG. 11, a wire 80 which is bent so as to match the curvature of the balloon and has a clamp support portion 81 sandwiched between the clamps at the tip is inserted into the inner tube 11 to fix the shape. Good. By tightening the mold from this state, the balloon 20 is pushed from three directions, and blades extending in three directions are formed between the molds. At this time, by pressing the middle claw type 211 against the back claw type 212 and the front claw type 213 quickly, the concave side blade 21 is formed long, and the middle claw type 211 is formed into the back claw type 212 and the front claw type 213. By pressing it slowly, the convex side blades 22 and 23 can be formed to be long. By discharging the gas inside in this state, blades are formed in three directions, and the balloon 20 in a contracted state is formed. From this state, the balloon 20 can be wound in a linear state by folding or winding the respective blades 21, 22, and 23 along the inner tube 11 in a linear state.
　以上のようにして作製されたバルーンカテーテル１００は以下のようにして使用される。あらかじめ、血管内に挿入・留置されたガイドワイヤを内管１１内へ導入しつつ。ガイドワイヤに沿ってバルーンカテーテル１００を目的の位置まで挿入する。本発明にかかるバルーンカテーテル１００の目的の位置の血管又は管腔は、湾曲している部分になる。この挿入の際にはバルーン２０は湾曲しておらず、直線状である。バルーンが目的の位置まで到達したら、バルーン拡張用流体を供給し、バルーン２０を拡張する。バルーン２０内部にバルーン拡張用の流体が供給されると、まず、最も外側に配置された羽根が解けていくことになり、ある程度、最も外側の羽根が解けていくと、その他の羽根にバルーン拡張用流体が供給されて全体が徐々に展開されて、図１に示すように、屈曲又は湾曲した形状に拡張することになる。 The balloon catheter 100 produced as described above is used as follows. While introducing the guide wire inserted and placed in the blood vessel in advance into the inner tube 11. The balloon catheter 100 is inserted to the desired position along the guide wire. The blood vessel or lumen at the target position of the balloon catheter 100 according to the present invention becomes a curved portion. At the time of this insertion, the balloon 20 is not curved but linear. When the balloon reaches the target position, the balloon expansion fluid is supplied to expand the balloon 20. When the fluid for balloon expansion is supplied to the inside of the balloon 20, the outermost blades are first melted, and when the outermost blades are melted to some extent, the balloons are expanded to the other blades. The fluid is supplied and the whole is gradually developed to expand into a bent or curved shape as shown in FIG.
　このように本発明にかかるバルーンカテーテル１００によれば、バルーン２０の拡張時の形態が湾曲して形成されているので、バルーン２０の留置場所である血管又は管腔が大きく湾曲している場合であっても、バルーン２０の拡張形状に合わせてバルーン２０を留置することができ、湾曲している血管や管腔の壁面に対して均一の圧力をかけることができる。 As described above, according to the balloon catheter 100 according to the present invention, since the expanded form of the balloon 20 is formed in a curved shape, the case where the blood vessel or lumen where the balloon 20 is placed is greatly curved. Even if there is, the balloon 20 can be placed according to the expanded shape of the balloon 20, and uniform pressure can be applied to the curved blood vessel or the wall surface of the lumen.
　なお、本発明は上述した各実施形態に何ら限定されることはなく、本発明の技術的範囲に属する限り種々の態様で実施し得ることはいうまでもない。 It goes without saying that the present invention is not limited to the above-described embodiments, and can be implemented in various embodiments as long as it belongs to the technical scope of the present invention.
　上述した実施の形態で示すように、バルーンカテーテルとして利用することができる。 As shown in the above-described embodiment, it can be used as a balloon catheter.
　１０…シャフト、１１…内管、１１ａ…ルーメン、１２…外管、１２ａ…ルーメン、２０…バルーン、２１…凹状側羽根、２２…凸状側羽根、５０…コネクタ、７０…Ｘ線不透過マーカー、８０…針金、８１…クランプ用支持部、１００…バルーンカテーテル、２００…バルーン成形装置、２１１…中爪型、２１１ａ…凹状部、２１１ｂ…凹状溝、２１２…奥爪型、２１２ａ…凸状部、２１２ｂ…凹状溝、２１３…手前爪型、２１３ａ…凸状部、２２０…クランプ、２２０ａ…上型、２２０ｂ…下型
  10 ... Shaft, 11 ... Inner tube, 11a ... Lumen, 12 ... Outer tube, 12a ... Lumen, 20 ... Balloon, 21 ... Concave side blade, 22 ... Convex side blade, 50 ... Connector, 70 ... X-ray opaque marker , 80 ... Wire, 81 ... Clamp support, 100 ... Balloon catheter, 200 ... Balloon molding device, 211 ... Middle claw type, 211a ... Concave part, 211b ... Concave groove, 212 ... Back claw type, 212a ... Convex part , 212b ... Concave groove, 213 ... Front claw type, 213a ... Convex part, 220 ... Clamp, 220a ... Upper mold, 220b ... Lower mold

Claims (9)

  1. 　内管及び外管よりなる長尺なシャフトと、前記シャフトの遠位端側に設けられ屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張及び収縮するバルーンカテーテルであって、
    　前記バルーンは、少なくとも屈曲又は湾曲形状の凹状側に形成される凹状側羽根を含む複数の羽根が形成されるように前記バルーンを収縮状態で内管に折り畳まれていることを特徴とするバルーンカテーテル。     It includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. Along with being liquid-tightly fixed, the proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. A balloon catheter in which the balloon expands and contracts due to the pressure of the fluid.
    The balloon catheter is characterized in that the balloon is folded into an inner tube in a contracted state so that a plurality of blades including a concave side blade formed on a concave side having at least a bent or curved shape are formed. ..
  2. 　前記凹状側羽根は、少なくとも一部の羽根が他の羽根に対して長く形成されるように収縮した状態であることを特徴とする請求項１に記載のバルーンカテーテル。 The balloon catheter according to claim 1, wherein the concave side blade is in a state of being contracted so that at least a part of the blades is formed longer than the other blades.
  3. 　前記凹状側羽根は、屈曲又は湾曲形状の凸状側に形成される凸状側羽根よりも長く形成されていることを特徴とする請求項１又は２に記載のバルーンカテーテル。 The balloon catheter according to claim 1 or 2, wherein the concave side blade is formed longer than the convex side blade formed on the convex side of a bent or curved shape.
  4. 　屈曲又は湾曲形状の凸状側に形成される凸状側羽根は、前記凹状側羽根よりも長く形成されていることを特徴とする請求項１又は２に記載のバルーンカテーテル。 The balloon catheter according to claim 1 or 2, wherein the convex side blade formed on the convex side of the bent or curved shape is formed longer than the concave side blade.
  5. 　前記凹状側羽根は、バルーンカテーテルの全長に対して、遠位端及び近位端の１０％の部位以外の部位で屈曲又は湾曲形状の凹状側の前記凹状側羽根が長くなるように形成されていることを特徴とする請求項１から４のいずれか１項に記載のバルーンカテーテル。 The concave side blade is formed so that the concave side blade on the concave side having a bent or curved shape is longer than the total length of the balloon catheter at a site other than 10% of the distal end and the proximal end. The balloon catheter according to any one of claims 1 to 4, wherein the balloon catheter is provided.
  6. 　前記羽根は、前記凹状側羽根以外の羽根は、内管に対して凸状側に配置されていることを特徴とする請求項１から５のいずれか１項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 5, wherein the blades other than the concave side blades are arranged on the convex side with respect to the inner tube.
  7. 　羽根のうち前記凹状側羽根が最外周になるように折り畳まれていることを特徴とする請求項１から６のいずれか１項に記載のバルーンカテーテル。 The balloon catheter according to any one of claims 1 to 6, wherein the concave side blade of the blade is folded so as to be the outermost circumference.
  8. 　内管および外管からなる長尺なシャフトと、前記シャフトの遠位端側に設けられ、屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張および収縮するバルーンカテーテルのバルーンの折り畳み方法であって、以下の工程からなることを特徴とする。
    　（１）前記バルーンカテーテルのバルーンの屈曲又は湾曲形状の凸状側及び屈曲又は湾曲形状の凹状側かつ両方側の三方向から押圧し、凹状側の羽根が最も長くなるように三つの羽根を形成する工程。
    　（２）前記バルーンカテーテルのバルーンの屈曲又は湾曲形状を直線にする工程。
    　（３）三つの羽根の凹状側の羽根が最外周となるように内管に折り畳む工程。     It is provided with a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. The proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. It is a method of folding a balloon of a balloon catheter in which the balloon expands and contracts depending on the pressure of the fluid to be formed, and is characterized by the following steps.
    (1) Press from three directions, the convex side of the bent or curved shape of the balloon of the balloon catheter and the concave side and both sides of the bent or curved shape, and form three blades so that the blade on the concave side is the longest. Process to do.
    (2) A step of straightening the bent or curved shape of the balloon of the balloon catheter.
    (3) A step of folding the three blades into an inner pipe so that the concave side blades are on the outermost circumference.
  9. 　内管および外管よりなる長尺なシャフトと、前記シャフトの遠位端側に設けられ、屈曲又は湾曲形状となるようにあらかじめ成型されたバルーンを備え、前記バルーンの遠位端が前記内管と液密に固着されるとともに、前記バルーンの近位端が前記外管と液密に固着され、前記内管と前記外管との間に形成される空間を介して前記バルーンの内部に供給される流体の圧力によって、前記バルーンが拡張および収縮するバルーンカテーテルの前記バルーンを巻回するために成形するバルーン成形装置において、
    　前記バルーン成形装置は、前記バルーンを折り畳む前に所定の形態に成形する型を備え、
    　成形時に湾曲した前記バルーンの凸状側に配置される型であり、前記バルーン内の内管の凸状の湾曲に沿うように凹状部を有しており、凹状部の断面は、山形に形成され、その頂点には内管が配置される凹状に形成された凹状溝が凹状部の全長に渡って形成されている中爪型と、
    　湾曲した前記バルーンに対して、一方側下方の方向から押圧した場合に前記バルーン内の内管に沿うように湾曲した凸状部を有し、その頂点には内管が配置される凹状に形成された凹状溝が凸状部の全長に渡って形成されている奥爪型と、
    　成形時に湾曲した前記バルーンに対して、他方側下方の方向から押圧した場合に前記バルーン内の内管に沿うように湾曲した凸状部を有し、その頂点には内管が配置される凹状に形成された凹状溝が凸状部の全長に渡って形成されている手前爪型と、
    　を備えていることを特徴とするバルーン成形装置。
          It includes a long shaft composed of an inner tube and an outer tube, and a balloon provided on the distal end side of the shaft and preformed so as to have a bent or curved shape, and the distal end of the balloon is the inner tube. The proximal end of the balloon is liquid-tightly fixed to the outer tube and supplied to the inside of the balloon through a space formed between the inner tube and the outer tube. In a balloon forming apparatus, the balloon is formed to wind the balloon of a balloon catheter in which the balloon expands and contracts due to the pressure of the fluid.
    The balloon molding apparatus includes a mold for molding the balloon into a predetermined shape before folding the balloon.
    It is a mold that is arranged on the convex side of the balloon that is curved at the time of molding, and has a concave portion along the convex curvature of the inner tube in the balloon, and the cross section of the concave portion is formed in a chevron shape. In the middle claw type, a concave groove formed in a concave shape on which an inner tube is arranged is formed over the entire length of the concave portion.
    The curved balloon has a convex portion curved along the inner tube in the balloon when pressed from the lower direction on one side, and the inner tube is arranged in a concave shape at the apex. The back claw type, in which the concave groove is formed over the entire length of the convex part,
    A concave portion having a convex portion curved along the inner tube in the balloon when pressed from the lower direction on the other side of the balloon curved at the time of molding, and an inner tube is arranged at the apex thereof. The front claw type, in which the concave groove formed in the above is formed over the entire length of the convex portion,
    A balloon molding apparatus characterized by the above.
PCT/JP2020/018615 2019-05-21 2020-05-08 Balloon catheter, method for folding balloon of balloon catheter, and balloon forming device WO2020235352A1 (en)

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JP2016013215A (en) * 2014-07-01 2016-01-28 朝日インテック株式会社 Balloon catheter
JP2016521169A (en) * 2013-05-02 2016-07-21 ヴェリヤン・メディカル・リミテッド Expandable balloon
JP2017012678A (en) * 2015-07-06 2017-01-19 テルモ株式会社 Balloon catheter and manufacturing method of balloon

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11235386A (en) * 1997-05-20 1999-08-31 Sumitomo Bakelite Co Ltd Dilating balloon catheter
JP2007521878A (en) * 2004-02-10 2007-08-09 アンジオスコア， インコーポレイテッド Balloon catheter with spiral fold
US20130303982A1 (en) * 2010-12-21 2013-11-14 Invatec Technology Center Gmbh Drug eluting balloon for the treatment of stenosis and method of manufacturing the balloon
JP2016521169A (en) * 2013-05-02 2016-07-21 ヴェリヤン・メディカル・リミテッド Expandable balloon
JP2016013215A (en) * 2014-07-01 2016-01-28 朝日インテック株式会社 Balloon catheter
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