WO2016190009A1 - Cathéter à ballonnet - Google Patents

Cathéter à ballonnet Download PDF

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Publication number
WO2016190009A1
WO2016190009A1 PCT/JP2016/062444 JP2016062444W WO2016190009A1 WO 2016190009 A1 WO2016190009 A1 WO 2016190009A1 JP 2016062444 W JP2016062444 W JP 2016062444W WO 2016190009 A1 WO2016190009 A1 WO 2016190009A1
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
guide wire
wire insertion
insertion tube
balloon catheter
Prior art date
Application number
PCT/JP2016/062444
Other languages
English (en)
Japanese (ja)
Inventor
靖洋 大川
和都 遠藤
Original Assignee
日本ライフライン株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 日本ライフライン株式会社 filed Critical 日本ライフライン株式会社
Publication of WO2016190009A1 publication Critical patent/WO2016190009A1/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
    • 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 balloon catheter for effectively expanding a stenosis
  • a balloon catheter cutting balloon catheter formed by mounting a plurality of incisors provided with cutting blades on the outer surface of the balloon
  • Patent Document a balloon catheter formed by mounting a plurality of incisors provided with cutting blades on the outer surface of the balloon.
  • the stenosis portion is cut by the cutting blade when the balloon is expanded, so that the stress of the blood vessel being expanded can be relaxed and the stenosis portion can be effectively expanded.
  • Patent Document 1 is disadvantageous in that a special mounting portion (cutting device) must be provided to fix the cutting blade to the balloon.
  • a special mounting portion cutting device
  • such a cutting blade falls off the balloon.
  • a balloon catheter for angiogenesis As a balloon catheter for angiogenesis that can solve such problems and prevent the balloon from slipping, it is a flexible catheter that extends from the rear end of the balloon to the tip while being separated from the outer surface of the balloon.
  • An element in which a plurality of elongated elements (anti-slip elements) are provided at a plurality of (three locations) at equal angular intervals along the circumferential direction of the balloon is disclosed (Patent Document 2).
  • the anti-slip element bonded to both ends of the balloon is moved in the radial direction of the balloon and meshed with the lesion, thereby longitudinally moving the lesion.
  • An axial channel is formed, which can prevent the balloon from moving (sliding) in the axial direction when the balloon is expanded.
  • the anti-slip element before the balloon catheter is used (before the balloon is expanded) is covered with the balloon in a folded state.
  • the anti-slip element which is glued only at the end (not glued to the outer surface of the balloon other than the tip and rear ends), is loosened away from the outer surface of the balloon, expanding the balloon It is difficult to return to the previous state.
  • another device can be inserted into the front end of the balloon while the anti-slip element is spaced from the outer surface of the balloon, or the balloon catheter can be pulled back with another device on the rear end of the balloon.
  • the anti-slip element that is loosened away from the outer surface of the balloon is caught on the other device (the other device enters between the outer surface of the balloon and the anti-slip element), May cause damage to the device or balloon catheter (including slipping of the anti-slip element).
  • the anti-slip element may be caught in the opening of the guiding catheter, which may cause the anti-slip element to fall off.
  • the diameter of the adhesion portion of the anti-slip element at the front end portion and the rear end portion of the balloon becomes considerably large, this also significantly impairs the insertion property of the balloon catheter, in particular, the insertion property to a thin blood vessel.
  • the present invention has been made based on the above situation.
  • the object of the present invention is to effectively expand the constriction while preventing the balloon from sliding, and the elements for preventing the balloon from interfering with the bent part of the blood vessel or other devices. Therefore, it is an object of the present invention to provide a balloon catheter excellent in penetrability and safety in a blood vessel in which the element does not fall off.
  • the balloon catheter of the present invention includes an outer shaft, A guide wire insertion tube that is inserted through the lumen of the outer shaft and extends from the tip of the outer shaft; Connected to the tip of the outer shaft and arranged to extend in the axial direction while contacting the outer periphery of the guide wire insertion tube extending from the tip of the outer shaft (while making contact with its outer periphery) With balloons,
  • the guide wire insertion tube is fixed to the outer periphery of the guide wire insertion tube or integrally formed with the guide wire insertion tube at a position opposite to the circumferential direction with respect to the position on the outer periphery where the balloon contacts. And an anti-slip element protruding outward in the radial direction of the common tube.
  • a channel can be formed in the diseased tissue by causing the anti-slip element to bite into the stenosis by the expansion force.
  • the balloon at the time of expansion moves (slides) to an axial direction.
  • the anti-slip element is fixed to the outer periphery of the guide wire insertion tube or integrally formed with the guide wire insertion tube. It does not interfere with other devices, and the anti-slip element does not fall away from the balloon.
  • the anti-slip element and the portion of the guide wire insertion tube in which the anti-slip element is fixed or integrally formed with the anti-slip element (the length at which the anti-slip element is located)
  • the direction portion is preferably made of a resin material containing a contrast agent.
  • the position of the anti-slip element and the balloon can be easily grasped on the X-ray image.
  • the balloon is composed of a cylindrical portion and reduced diameter portions located at both ends thereof.
  • the anti-slip element is fixed to the outer periphery of the guide wire insertion tube or at the guide wire insertion tube at a position opposite to the circumferential direction with respect to the position on the outer periphery where the cylindrical portion of the balloon is in contact. It is preferable that they are integrally formed.
  • the anti-slip element can apply a pressing force that does not vary in the longitudinal direction to the stenosis, and the anti-slip element is bitten into the stenosis over the entire length thereof.
  • Channels can be formed in the diseased tissue.
  • the stenosis can be effectively expanded while reliably preventing the balloon from slipping, and the anti-slip element may interfere with the bent part of the blood vessel or other devices.
  • the anti-slip element does not fall off. Therefore, the balloon catheter of the present invention is excellent in penetration and safety in blood vessels.
  • FIG. 4A is a cross-sectional view taken along the line AA in FIG. 1
  • FIG. 4B is a cross-sectional view taken along the line BB in FIG. 1
  • FIG. 4C is a cross-sectional view taken along the line C in FIG. FIG.
  • FIG. 1 It is sectional drawing which shows the further another example of the folding method of the balloon which comprises the balloon catheter shown in FIG. It is a perspective view which shows the front-end
  • the balloon catheter 100 of this embodiment shown in FIGS. 1 to 4 is used for percutaneous coronary angioplasty (PTCA) and the like.
  • the balloon catheter 100 is inserted through a distal end side shaft 10 (outer shaft) made of a resin tube, a rear end side shaft 20 made of a tube connected to the rear end of the distal end side shaft 10, and a lumen of the distal end side shaft 10.
  • the guide wire insertion tube 30 extending from the distal end of the distal shaft 10 and the guide wire insertion tube 30 connected to the distal end of the distal shaft 10 and extending from the distal end of the distal shaft 10.
  • the balloon 40 arranged so as to extend in the axial direction while contacting its outer periphery with the outer periphery of the distal end portion thereof, and the position on the outer periphery of the guide wire insertion tube 30 with which the outer periphery of the balloon 40 is in contact
  • the guide wire insertion channel An anti-slip element 50 integrally formed with the guide wire insertion tube 30 so as to protrude radially outward of the tube 30, a hub 60 connected to the rear end of the rear end side shaft 20, and a rear A strain relief 70 provided at a connection portion between the rear end of the end-side shaft 20 and the hub 60 and a core wire (not shown) inserted through the lumen of the tip-side shaft 10 are provided.
  • the distal shaft 10 constituting the balloon catheter 100 is an outer shaft made of a resin tube.
  • a lumen (expansion lumen) through which a fluid for expanding the balloon 40 is circulated is formed on the distal end side shaft 10 (outer shaft).
  • the outer diameter of the resin tube constituting the distal shaft 10 is usually 0.7 to 1.0 mm, and the inner diameter of this resin tube is usually 0.65 to 0.95 mm.
  • the length of the distal shaft 10 is usually 150 to 450 mm.
  • Examples of the material of the resin tube constituting the distal end side shaft 10 include thermoplastic resins such as polyamide, polyether polyamide, polyurethane, polyether block amide (PEBAX) (registered trademark), and nylon. Among these, PEBAX Is preferred.
  • the hardness of the resin tube constituting the distal shaft 10 is preferably 63 to 80 as measured by a D-type hardness meter.
  • a rear end side shaft 20 is connected to the rear end of the front end side shaft 10.
  • the rear end side shaft 20 constituting the balloon catheter 100 is formed with a lumen (expansion lumen) communicating with the lumen of the front end side shaft 10.
  • the rear end side shaft 20 is composed of, for example, a metal tube (hypotube) such as stainless steel, Ni—Ti alloy, Cu—Mn—Al alloy, and a spiral slit is formed at the tip of the metal tube. May be formed.
  • the rear end side shaft 20 may be comprised from the resin tube.
  • the material of the resin tube constituting the rear end side shaft 20 the same material as that of the resin tube constituting the front end side shaft 10 can be exemplified.
  • the metal tube constituting the rear end side shaft 20 is inserted at the front end portion thereof into the rear end portion of the resin tube constituting the front end side shaft 10, and the rear end portion thereof is inserted into the hub 60.
  • the outer diameter of the metal tube constituting the rear end side shaft 20 is usually 0.5 to 0.8 mm, and the inner diameter of this metal tube is usually 0.4 to 0.7 mm.
  • the length of the rear end side shaft 20 is usually 900 to 1500 mm.
  • the guide wire insertion tube 30 constituting the balloon catheter 100 is a resin tube forming a lumen (guide wire lumen) for inserting a guide wire.
  • the guide wire insertion tube 30 is inserted through the lumen of the distal end side shaft 10, and the distal end portion of the guide wire insertion tube 30 extends from the distal end 15 of the distal end side shaft 10.
  • the rear end of the guide wire insertion tube 30 is opened on the side surface of the distal shaft 10, and the opening 31 is a guide wire port.
  • An opening 32 is formed at the tip of the guide wire insertion tube 30.
  • the outer diameter of the guide wire insertion tube 30 is usually 0.48 to 0.60 mm, and the inner diameter is usually 0.35 to 0.45 mm.
  • the axial distance from the formation position of the opening 31 of the guide wire insertion tube 30 to the tip of the rear end side shaft 20 is usually 50 mm or less, preferably 5 to 50 mm.
  • the constituent material of the guide wire insertion tube 30 include synthetic resins such as PEBAX, nylon, and PEEK.
  • the bending elastic modulus (the bending elastic modulus measured in accordance with JIS K 7171) of the resin constituting the guide wire insertion tube 30 is usually 50 to 10,000 MPa, preferably 150 to 5,000 MPa, more preferably Is set to 3,500 to 4,200 MPa.
  • the hardness of the resin constituting the guide wire insertion tube 30 is preferably 55 or more as measured by a D-type hardness meter.
  • the bending elastic modulus and hardness of the resin constituting the guide wire insertion tube 30 may be different in the axial direction.
  • the rear end of the balloon 40 is fixed (fixed) to the distal end 15 of the distal shaft 10.
  • the balloon 40 constituting the balloon catheter 100 is arranged so as to extend in the axial direction while contacting its outer periphery with the outer periphery of the distal end portion of the guide wire insertion tube 30, and the distal end of the balloon 40 is the guide wire insertion tube It is fixed (fixed) to the outer periphery of the tip portion of 30. That is, the distal end portion of the guide wire insertion tube 30 and the balloon 40 are circumscribed (the outer circumferences of both are in contact with each other) (see FIG. 4A).
  • the balloon 40 is expanded by the liquid flowing through the lumens of the front end side shaft 10 and the rear end side shaft 20.
  • the liquid include physiological saline and a contrast medium.
  • the balloon 40 includes a cylindrical portion 41 and reduced diameter portions 42 located at both ends thereof.
  • the diameter of the balloon 40 (cylindrical part 41) at the time of expansion is usually 1.0 to 5.0 mm, preferably 2.0 to 4.0 mm.
  • the length of the balloon 40 is usually 5 to 40 mm, preferably 10 to 30 mm.
  • the axial distance from the formation position of the opening 31 of the guide wire insertion tube 30 to the rear end position of the balloon 40 is normally 150 to 300 mm.
  • a constituent material of the balloon 40 the same material as that of a balloon constituting a conventionally known balloon catheter can be used, and a suitable material is PEBAX.
  • the balloon catheter 100 of the present embodiment is configured so that the distal end of the guide wire insertion tube 30 is located at a position opposite to the circumferential direction with respect to the position on the outer periphery of the guide wire insertion tube 30 with which the outer periphery of the balloon 40 is in contact.
  • the anti-slip element 50 is formed integrally with the portion and protrudes outward in the radial direction of the guide wire insertion tube 30.
  • the anti-slip element 50 constituting the balloon catheter 100 has a substantially triangular cross section as shown in FIG. 4A.
  • the apex angle ( ⁇ ) of the triangle is preferably 30 to 100 °, and more preferably 40 to 60 °.
  • the tip of the anti-slip element may be deformed (particularly when the hardness of the anti-slip element is low) during the expansion of the balloon, and may not be able to bite into the stenosis. .
  • the angle ( ⁇ ) is too wide, the anti-slip element may not be able to bite into the constriction when the balloon is expanded.
  • the anti-slip element 50 is formed integrally with the distal end portion of the guide wire insertion tube 30 (the portion 30A where the cylindrical portion 41 of the balloon 40 is in contact). According to such an anti-slip element 50, it is possible to apply a pressing force without variation in the longitudinal direction to the narrowed portion of the blood vessel, and to reliably prevent the anti-slip element 50 from falling off. .
  • a contrast agent is contained in the resin material (resin material constituting the portion indicated by halftone dots in the drawing) constituting the anti-slip element 50 and the portion 30A of the guide wire insertion tube 30 formed integrally therewith.
  • the resin material resin material constituting the portion indicated by halftone dots in the drawing
  • the bending elastic modulus (the bending elastic modulus measured in accordance with JIS K 7171) of the resin constituting the anti-slip element 50 is usually 50 to 10,000 MPa, preferably 150 to 5,000 MPa, more preferably 3 , 500-4,200 MPa.
  • the hardness of the resin constituting the anti-slip element 50 is preferably 55 or more as measured by a D-type hardness meter.
  • the tip of the anti-slip element cannot be deformed and bite into the stenosis when the balloon is expanded.
  • the flexural modulus of the resin constituting the anti-slip element is too high, the balloon wall interposed between the stenosis and the stenosis may be damaged when the balloon is expanded.
  • the balloon portion where such an anti-slip element is located is difficult to bend and it is difficult to follow the bent blood vessel and curve the portion, the blood vessel penetrability as a balloon catheter is impaired. Sometimes.
  • the anti-slip element 50 bites into the stenosis portion and forms a channel in the diseased tissue. Thereby, while being able to expand a stenosis part effectively, it can prevent that the balloon at the time of expansion moves (slides) to an axial direction.
  • the deflated balloon 40 can be folded so as to wind around the distal end portion of the guide wire insertion tube 30 and the anti-slip element 50.
  • a plurality of anti-slip elements arranged outside the balloon interfere with the folding of the balloon and cannot be folded cleanly, but it is integrated with the distal end portion of the guide wire insertion tube 30.
  • the balloon catheter 100 including the anti-slip element 50 formed in a typical manner the balloon 40 can be folded easily and cleanly.
  • the balloon catheter 100 of this embodiment is also excellent in rewrapability.
  • the stenosis can be effectively expanded and the balloon 40 during expansion can be effectively prevented from slipping. That is, the anti-slip element 50 formed integrally with the distal end portion of the guide wire insertion tube 30 is excellent in strength, and is inserted into the guide wire insertion tube 30 when the balloon catheter 100 is used. Since the anti-slip element 50 is supported (reinforced) by the guide wire, the balloon 40 is expanded to ensure that the anti-slip element 50 bites into the stenosis of the blood vessel and forms a channel in the diseased tissue. Thus, the stress of the blood vessel is relieved to effectively expand the stenosis, and the frictional resistance with the diseased tissue is increased to prevent the balloon 40 from moving (sliding) in the axial direction. be able to.
  • the anti-slip element 50 is formed integrally with the distal end portion of the guide wire insertion tube 30, so that the anti-slip element 50 can be used as a bent portion of a blood vessel or the like.
  • the anti-slip element 50 is not separated from the balloon 40 and does not fall off.
  • the balloon catheter of this invention is not limited to these, A various change is possible.
  • the shape and number of the anti-slip element are not particularly limited as long as the anti-slip element can bite into the narrowed portion via the balloon wall.
  • the anti-slip elements 51, 52, 53) shown in FIG. 6A may be arranged on a straight line. Further, as shown in FIG. 6B, the anti-slip elements 51 ′, 52 ′, and 53 ′ may be arranged at intervals.
  • an anti-slip element formed separately from the guide wire insertion tube is fixed to the outer periphery of the guide wire insertion tube at a position opposite to the circumferential direction with respect to the position where the balloon is in contact by bonding or the like. You may comprise the balloon catheter of invention.
  • the rapid exchange type balloon catheter 100 has been described.
  • the balloon catheter of the present invention is, for example, an over-the-wire type balloon catheter in which a guide wire is inserted from the proximal end (hand side) to the distal end. There may be.

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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)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un cathéter à ballonnet conçu pour permettre l'élargissement efficace d'une section resserrée tout en empêchant le glissement du ballonnet ; pour éviter qu'un élément empêchant le glissement du ballonnet n'interfère avec une partie courbée dans un vaisseau sanguin, un autre dispositif, etc.; et pour éviter la chute de l'élément. Le cathéter à ballonnet selon l'invention comprend : un axe extérieur (10) ; un tube d'insertion de fil guide (30) qui est inséré à travers une lumière de l'axe extérieur (10) et qui s'étend vers l'extérieur à partir d'une extrémité de l'axe extérieur (10) ; un ballonnet (40) qui est relié à l'extrémité de l'axe extérieur (10) et qui s'étend dans la direction axiale tout en étant maintenu en contact avec la périphérie extérieure du tube d'insertion de fil guide (30) ; et un élément anti-glissement (50) qui est formé d'un seul tenant avec le tube d'insertion de fil guide (30) à une position opposée, dans la direction circonférentielle, à une position sur la périphérie externe avec laquelle le ballonnet (40) est en contact.
PCT/JP2016/062444 2015-05-28 2016-04-19 Cathéter à ballonnet WO2016190009A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2015109220A JP6316238B2 (ja) 2015-05-28 2015-05-28 バルーンカテーテル
JP2015-109220 2015-05-28

Publications (1)

Publication Number Publication Date
WO2016190009A1 true WO2016190009A1 (fr) 2016-12-01

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PCT/JP2016/062444 WO2016190009A1 (fr) 2015-05-28 2016-04-19 Cathéter à ballonnet

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WO (1) WO2016190009A1 (fr)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7410706B2 (ja) * 2019-12-20 2024-01-10 株式会社カネカ バルーンカテーテル

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09501852A (ja) * 1993-08-24 1997-02-25 ソーラー、ロナルド、ジェイ． 偏心状のバルーンを備えた拡張カテーテル
FR2738489A1 (fr) * 1995-09-12 1997-03-14 Balt Extrusion Catheter a ballonnet d'occlusion et son procede de fabrication
JPH11514891A (ja) * 1995-07-26 1999-12-21 インテラ インターヴェンショナル システムズ インコーポレイテッド 低断面形状バルーンカテーテル及び方法
JP2001518808A (ja) * 1995-06-07 2001-10-16 ハートポート インコーポレイテッド 心臓を停止させるための血管内システム
US20020072706A1 (en) * 2000-12-11 2002-06-13 Thomas Hiblar Transluminal drug delivery catheter
JP2005040599A (ja) * 2003-07-09 2005-02-17 Sumitomo Bakelite Co Ltd 医療用カテーテルおよびカテーテル収納体
WO2013064132A2 (fr) * 2011-11-05 2013-05-10 Peter Osypka Cathéter à ballonnet

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5669880A (en) * 1993-08-24 1997-09-23 Cordis Corporation Stent delivery system
CA2399439C (fr) * 2000-02-18 2010-02-23 E.V.R. Endovascular Researches S.A. Dispositif endoluminal destine a la mise en place et au deploiement d'une prothese endoluminale extensible
JP6103878B2 (ja) * 2012-10-24 2017-03-29 日本ライフライン株式会社 バルーンカテーテル
JP6304711B2 (ja) * 2014-11-18 2018-04-04 日本ライフライン株式会社 バルーンカテーテル

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH09501852A (ja) * 1993-08-24 1997-02-25 ソーラー、ロナルド、ジェイ． 偏心状のバルーンを備えた拡張カテーテル
JP2001518808A (ja) * 1995-06-07 2001-10-16 ハートポート インコーポレイテッド 心臓を停止させるための血管内システム
JPH11514891A (ja) * 1995-07-26 1999-12-21 インテラ インターヴェンショナル システムズ インコーポレイテッド 低断面形状バルーンカテーテル及び方法
FR2738489A1 (fr) * 1995-09-12 1997-03-14 Balt Extrusion Catheter a ballonnet d'occlusion et son procede de fabrication
US20020072706A1 (en) * 2000-12-11 2002-06-13 Thomas Hiblar Transluminal drug delivery catheter
JP2005040599A (ja) * 2003-07-09 2005-02-17 Sumitomo Bakelite Co Ltd 医療用カテーテルおよびカテーテル収納体
WO2013064132A2 (fr) * 2011-11-05 2013-05-10 Peter Osypka Cathéter à ballonnet

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JP2016220861A (ja) 2016-12-28

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