WO2020235352A1 - Cathéter à ballonnet, méthode de pliage de ballonnet de cathéter à ballonnet, et dispositif de formation de ballonnet - Google Patents

Cathéter à ballonnet, méthode de pliage de ballonnet de cathéter à ballonnet, et dispositif de formation de ballonnet 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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WO
WIPO (PCT)
Prior art keywords
balloon
inner tube
concave
blades
balloon catheter
Prior art date
Application number
PCT/JP2020/018615
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English (en)
Japanese (ja)
Inventor
宏成 加藤
大暉 山根
史織 山岡
Original Assignee
株式会社東海メディカルプロダクツ
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Application filed by 株式会社東海メディカルプロダクツ filed Critical 株式会社東海メディカルプロダクツ
Publication of WO2020235352A1 publication Critical patent/WO2020235352A1/fr

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Classifications

    • 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
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  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Le problème décrit par la présente invention est de fournir une configuration pliée et une méthode de pliage pour le ballonnet d'un cathéter à ballonnet courbé, permettant un pliage facile du ballonnet tout en améliorant la fonction de gonflage du ballonnet lorsqu'il est gonflé. La solution selon la présente invention porte sur un cathéter à ballonnet 100 qui est pourvu d'une longue tige 10 comprenant un tube interne et un tube externe et un ballonnet 20 qui est formé sur une extrémité distale de la tige et façonné à l'avance pour avoir une forme courbée ou incurvée, l'extrémité distale du ballonnet est fixée de manière étanche au fluide au tube interne 11, l'extrémité proximale du ballonnet est fixée de manière étanche au fluide au tube externe 12, et le ballonnet se gonfle et se dégonfle en fonction de la pression du fluide fourni dans le ballonnet par l'intermédiaire d'un espace formé entre le tube interne et le tube externe. Le cathéter à ballonnet 100 est caractérisé en ce que le ballonnet est plié à l'intérieur du tube interne dans un état dégonflé de telle sorte qu'une pluralité d'ailettes est formée comprenant au moins une ailette latérale évidée 21 formée sur un côté évidé de la forme courbée ou incurvée.
PCT/JP2020/018615 2019-05-21 2020-05-08 Cathéter à ballonnet, méthode de pliage de ballonnet de cathéter à ballonnet, et dispositif de formation de ballonnet WO2020235352A1 (fr)

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JP2019-095402 2019-05-21
JP2019095402A JP7282364B2 (ja) 2019-05-21 2019-05-21 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

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11235386A (ja) * 1997-05-20 1999-08-31 Sumitomo Bakelite Co Ltd 拡張バルーンカテーテル
JP2007521878A (ja) * 2004-02-10 2007-08-09 アンジオスコア， インコーポレイテッド 螺旋状の折り目を有するバルーンカテーテル
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
JP2016013215A (ja) * 2014-07-01 2016-01-28 朝日インテック株式会社 バルーンカテーテル
JP2016521169A (ja) * 2013-05-02 2016-07-21 ヴェリヤン・メディカル・リミテッド 拡張可能なバルーン
JP2017012678A (ja) * 2015-07-06 2017-01-19 テルモ株式会社 バルーンカテーテル、およびバルーンの製造方法

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH11235386A (ja) * 1997-05-20 1999-08-31 Sumitomo Bakelite Co Ltd 拡張バルーンカテーテル
JP2007521878A (ja) * 2004-02-10 2007-08-09 アンジオスコア， インコーポレイテッド 螺旋状の折り目を有するバルーンカテーテル
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 (ja) * 2013-05-02 2016-07-21 ヴェリヤン・メディカル・リミテッド 拡張可能なバルーン
JP2016013215A (ja) * 2014-07-01 2016-01-28 朝日インテック株式会社 バルーンカテーテル
JP2017012678A (ja) * 2015-07-06 2017-01-19 テルモ株式会社 バルーンカテーテル、およびバルーンの製造方法

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