JPH03205064A - カテーテル用膨脹部材及びその形成方法 - Google Patents

カテーテル用膨脹部材及びその形成方法

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Publication number
JPH03205064A
JPH03205064A JP2255027A JP25502790A JPH03205064A JP H03205064 A JPH03205064 A JP H03205064A JP 2255027 A JP2255027 A JP 2255027A JP 25502790 A JP25502790 A JP 25502790A JP H03205064 A JPH03205064 A JP H03205064A
Authority
JP
Japan
Prior art keywords
inflatable member
polymer
parison
layer
tubular
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
JP2255027A
Other languages
English (en)
Other versions
JPH0575432B2 (ja
Inventor
Robert N Hamlin
ロバート・エヌ・ハムリン
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Schneider USA Inc
Original Assignee
Schneider USA Inc
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Filing date
Publication date
Application filed by Schneider USA Inc filed Critical Schneider USA Inc
Publication of JPH03205064A publication Critical patent/JPH03205064A/ja
Publication of JPH0575432B2 publication Critical patent/JPH0575432B2/ja
Granted legal-status Critical Current

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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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/041—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/04—Macromolecular materials
    • A61L29/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L29/126—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/22—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor using multilayered preforms or parisons
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031—Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding
    • 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
    • A61M25/1027—Making of balloon catheters
    • A61M25/1034—Joining of shaft and balloon
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
    • B29C49/00—Blow-moulding, i.e. blowing a preform or parison to a desired shape within a mould; Apparatus therefor
    • B29C49/02—Combined blow-moulding and manufacture of the preform or the parison
    • B29C49/04—Extrusion blow-moulding
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04—Polymers of ethylene
    • B29K2023/06—PE, i.e. polyethylene
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2023/00—Use of polyalkenes or derivatives thereof as moulding material
    • B29K2023/04—Polymers of ethylene
    • B29K2023/08—Copolymers of ethylene
    • B29K2023/083—EVA, i.e. ethylene vinyl acetate copolymer
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
    • B29K2067/00—Use of polyesters or derivatives thereof, as moulding material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
    • B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
    • B29L2031/00—Other particular articles
    • B29L2031/753—Medical equipment; Accessories therefor
    • B29L2031/7542—Catheters
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/139—Open-ended, self-supporting conduit, cylinder, or tube-type article
    • Y10T428/1393—Multilayer [continuous layer]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
    • Y10T428/00—Stock material or miscellaneous articles
    • Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
    • Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
    • Y10T428/1397—Single layer [continuous layer]

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Biophysics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Manufacturing & Machinery (AREA)
  • Mechanical Engineering (AREA)
  • Child & Adolescent Psychology (AREA)
  • Composite Materials (AREA)
  • Materials Engineering (AREA)
  • Materials For Medical Uses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Blow-Moulding Or Thermoforming Of Plastics Or The Like (AREA)
  • Extrusion Moulding Of Plastics Or The Like (AREA)
  • Compositions Of Macromolecular Compounds (AREA)
  • Manufacturing Of Micro-Capsules (AREA)
  • Laminated Bodies (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。

Description

【発明の詳細な説明】 産業上の利用分野 本発明は、一般にはいわゆるバルーンカテーテルに関し
、より詳細には個々の層の品質かもならず強化特性を提
する多層バルーンの成形方法に関する。
従来の技術及びその課題 心臓切開の代替として、冠状トランスルミナル（ｔｒａ
ｎｓｌｕｎｉｎａｌ　）血管形成術である冠状バイパス
外科学がグランツェック　ｆ　Ａ、Ｇｒｕｎｔｚｉｇ）
により該技術の導入に続いて開発された。この処決にお
いては外端に膨張可能な部材（バルーン）を有する拡張
カテーテルが脈管系を介して狭窄病巣を有する冠状動脈
内の位置へもたらされる。病巣を横切って該膨脹部材を
配置した後、流体をカテーテルの内端へ導入して所定の
かなりの高圧まで膨脹部材を膨脹させる。こうして病巣
を、閉塞した血管に対し開存を取戻している血管壁へ圧
縮する。
膨脹部材は、下記の特徴を提することか望ましい。
１、高破裂強度 ２、　高圧下での低半径方向膨服 ３、カテーテル本体へ対し容易に接合出来ること ４、　ピンポール破裂のないこと ５、　低摩擦係数 米国特許第４，４１３，９８９号は冠状トランスルミナ
ル血管形成術用カテーテルを開示している。このカテー
テルでは膨脹部材がポリエチレンテレフタレートにより
ドローインク及びブロー成形によって形成されており材
料に二軸配向か与えらノ１ている。このようなＰＥＴバ
ルーンは、７気圧又はそれ以上の圧力まで膨脹したとき
に高破裂強度とかなり低い半径方向膨張等の望ましい特
性を発揮することかわかっている。しかしカテーテル本
体は一般にシリコンゴム、ポリエチレン、ＰＥＴ又はポ
リウレタン等を含む構成物から形成されているので、膨
脹部材をカテーテル本体の外端部へ接合しまうとしたと
きに問題か発生する。　ＮＵちＰＥＴポリエステルバル
ーンはカテーテル本体に対し特に熱接合の場合には簡単
には接合しない傾向がある。
さらに経験によればポリエチレン、ＰＶＣ、ポリプロピ
レン製の膨脹部材は、かなりの高圧力時に、ピンホール
からの漏洩が、血管壁に高速度ジェットが衝突したとき
に血管に孔をあけるような膨張液の高速度ジェットを形
成する。このため、制御された方法での破壊即ち圧力か
短時間で大きい面積にわたって開放されるように迅速な
破裂を提するように膨脹部材か構成されうろことが望ま
しい。
課題を解決するための 上述の望ましい特徴は、個々の層が複合体に対する好ま
しい特性をもたらす多層バルーンを形成する本発明によ
って達成される。より詳細には、初めに管状パリソンが
同軸押出し工程にて形成され、これにより異なるポリマ
ー材料が同軸的に層をなして形成される。その後、パリ
ソンは、ブロー成形装置へ移し、複合フィルムが配向し
、膨脹部材の最大外径か画定され所望のフィルム厚みが
得られるまでパリソンを長手方向に引きかつ半径方向に
膨脹させる。例えば、パリソン形成時に、所定の粘度を
提するＰＥＴが同軸押出され、ポリエチレンでパリソン
を形成し、ポリエチレンがその管腔を裏打ちする。膨脹
部材がブロー成形作業によりパリソンから形成されると
き、ＰＥＴ層は所望の破裂強度と、限定された半径方向
膨脹特性とを提供し、一方ポリエチレン層はカテーテル
本体に対するバルーンの接合性を増化する。
高親水特性を提する適切なグラスチックでもって複合体
の外面をコートすることによって潤滑特性もまた増大す
る６例えばこの複合ＰＥＴ／ポリエチレンバルーンは、
ＰＥＴの外面をポリカプロラクタムでコートされる。
一つの層が公知の破壊特性を有するグラスチックから成
る三層管状パリソンを成形することによって、ポリエチ
レン層はＰＥＴに対する接合性、限定された半径方向膨
張特性及び／又は制御された破壊特性を提供し、一方、
ポリカプロラクタムは潤滑性をもたらず。
本発明の種々の特性、特徴、利点等は好ましい実施例に
ついて記述している下記記載から明白となろう。
作　　用 本発明は血管形成術用カテーテルのような脈管内力デー
チルに使用するに適した複合特性を有する限定された膨
張可能な実質的に伸びない膨脹部材の成形方法を開示す
る。異なる特性の種々のポリマー合成物か同軸押出しさ
れ多層パリソンを形成している。このパリソンは実質的
にブロー成形作業によってドローされがっ膨張され、潤
滑性、破壊強度、限定された半径方向膨張、接合性、破
裂特性を含む強化特性を提する膨脹部材を生産する。
Ｋ」Ｌ」 第１図において、本発明による多層膨脹部材を構成する
第１の工程はパリソンを形成することである。このパリ
ソンは加熱し、次いでドロー成形しかつブロー成形する
ことにより脈管内カテーテルに使用するバルーン即ち膨
脹部材を発現する。
この押出機は第２図において番号１ｏで概括的に示して
あり、歯車装置１４へ駆動関係に連結されたモータ１２
を有している。該装置１４の出方軸は加熱創部Ｉ８内を
回動する粗なピッチを有するスクリュー１６を有してい
る。公知の用法によれば一般にはこのスクリューは３つ
の区域を有している。供給ホッパ２２のすぐ下部にある
供給区域２０においてはねじ湧深さは比較的大きい一定
値を有し、ホッパからの固形ポリマ材料を搬送する機能
を有する。圧縮区域２４における湧の深さは均一のテー
パを有し、がっグラスチックを圧縮しかつ溶融を強化す
るため胴部１８へ強制的に接するような構造となってい
る。この溶融は主に胴部内に設けられたｔ熱要素２６か
らもたらされる熱と、胴部と固形材料との間に形成され
る溶融層内の激しい剪断によって生じる熱と、の組合せ
によって得られる０番号２８はスクリューの計量区域を
示す、ここでは溝の深さは一定で比較的小さい。
この区域は、押出機から出る被押出物の定量性、定流動
性、定量性を制御する。スクリュー１６の端部には押出
タイ３０か配置されている。このダイ３０は、本発明の
場合には、少なくとも２つの異なるプラスチックの同軸
押出を可能とするものである。押出８１１０を通る第１
のグラスチックが番号３２で略図的に示す実質的に同一
の押出機から出る第２のプラスチックと組合され、同軸
をなす層を構成した、第４図に示すような断面を有する
、管状パリソンを形成する。
第３図は２開口を有する同軸押出ダイの横断面図である
６例えば押出ａｉｉｏの計量区域２８からの樹脂は第３
図のダイ開口Ａ内へ供給され、一方押出機３２のスクリ
ューの計量区域からの樹脂は開口Ｂ内へ供給される。こ
れらの溶融プラスチックはプラスチック入口開口Ｂがプ
ラスチック入口開口Ａを取囲む層を形成するように流動
する。プラスチックかタイを介して流れるときにダイ３
゜の中心孔３４に空気を同時に導入して管状押出体の変
形を防止する。
本発明によれば例えば開口Ａへ送り込、ｔｈるプラスチ
ックはポリオレフィン又はＰＶｃから成り、一方開口Ｂ
内へ送り込まれるグラスチックは所定の粘性を有するホ
モポリエステル、望ましくはＰＥＴである。これらの２
つの構成物により構成される管状パリソンは内側管状層
にＰＶｃを外側管状層にＰＥＴを有することとなろう、
各層の厚みは各押出機によって提供される質量流れ比率
によって決定される。パリソンの最終直径はダイ出口開
口寸法、開口Ａ、Ｂへの材料の合計流、及び引出し速度
等によって決定される。
バルーン自体はブロー成形作業により構成される。この
作業におい′ζは、パリソン４ｏが第４図に示すように
ブロー成形金型４２内に導入され、かつ空気又はその他
の適当な流体が所定の圧力で開口４４を介して導入され
る。金型４２は成形されるバルーンの所定の寸法に対応
する凹部４６を有している。
管状パリソンが金型内に配置された後、該金型は加熱し
パリソンの温度をポリエステルポリマーの第２オーダ遷
移温度と第１オーダ遷移温度との間の温度まで上昇する
。
この管状パリソンを初めにドローし次にこれをブロー成
形することによって、二軸配向が発生し、こうして可撓
性を存置したままＰＥＴ層は、材料か破壊する膨脹圧力
を強化する。第５図に示すようにカテーテル本体へ仕上
ったバルーンを接合したい場合にはＰＶＣの内層が外方
のＰＶＣ管状本体５０及び内方管状本体５２へ容易に接
合されうる６回転上に配置した管状体間の間隔はバルー
ン膨脹流体の注入を可能としている０本発明により構成
されたバルーンは破裂圧力が７気圧以上で半径方向膨張
率が約３−１０％以下である。ｐｖｃ層４８はこの複合
体破裂強度にほとんど寄与していないか、管状カテーテ
ル本体の外部へ対するバルーンの取付けを容易にする役
目を有している。
もしこの複合バルーンの平滑さを増したい場合にはポリ
ビニリドール（Ｐｏ１ｙｖｉｎｙｌｉｄｏｌ　）　、Ｎ
　−ビニルピロロトン、ハイドロゲール等のような適当
な親水性材料につけたり又はコーテングしたりすればよ
い。
強化特性を有するバルーンは、ＰＶＣとの組合にてＰＥ
Ｔを使用するよりは、ボリソン成形に際し、低分子量の
無定形ポリエステルと共に高分子量の結晶質のポリエス
テルを同軸押出しすることにより得られる。その後、ブ
ロー成形作業によりドロー及び半径方向膨張によって、
バルーンは公知のＰＥＴ単独層バルーンに比較して、高
い破裂強度、低い半径方向膨張及び勝れた結合性を提供
することがわかっている。
ポリマー層の破壊特性は充填材を付加することによって
破壊速度を増大するように変えることができる。この充
填材は、一般に粉末状の炭酸カルシウム、繊維状のカー
ボン、相客性のない第二ポリマーなどのような不活性タ
イプのものである。
相容性のない相ポリマーシステムは多くの有利な特徴を
６たらしており、２つの相間の分散の関数をなしている
。このための候補となる材料はポリフ゛ロビレン及び選
択されたゴム、ポリエステル及びボリグロピレンなどで
ある。
本発明を詳細に述べたが、本発明はこれ以外の異なる手
法等によっても実施できるものであり、上述実施例は単
なる一例であり、添付の請求の範囲によってのみ制限さ
れるものである。
【図面の簡単な説明】
第１図は本発明の工程を示したフローチャートである。 第２図は同軸工程にてパリソンを製造するための装置の
部分概略図、第３図は２層パリソンを形成するのに有用
な２つの要素から成る同軸押出ダイの断面図、第４図は
二軸配向した多層押出部材内にてパリソンをブロー成形
する装置の概略図、第５図はカテーテルの外端に接合し
た膨脹部材を示す図である。 符号の説明 １０；押出機 １４：歯車装置 １８；胴部 ２２；ホッパ ２６：電熱要素 ３０：ダイ ３４：中心孔 ４２ニブロー成形金型 ４６：凹部 ５０：外方本体 １２：モータ １６：スクリュー ２０：供給区域 ２４：圧縮区域 ２８：計量区域 ３２：押出機 ４０：パリソン ４４：開口 ４８：内層 ５２：内方本体 （外４名）

Claims (1)

  1. 【特許請求の範囲】 １、医療用カテーテルに取付ける膨脹部材であって、 （ａ）かなりの高ポリマー結晶構造を提する二軸配向し
    た外方管状ポリマーフィルム層と、（ｂ）該外方の層に
    接合されかつかなりの低ポリマー結晶構造を提する内方
    ポリマープラスチックフィルム層と、 から成る膨脹部材。 ２、外方フィルム層がポリエチレン・テレフタレート・
    コポリエステル又は、７気圧以上の破裂圧力を提するホ
    モポリエステルから成る請求項１の膨脹部材。 ３、内方フィルム層が無定形ポリエステルから成る請求
    項２の膨脹部材。 ４、内方フィルム層がポリオレフィンから成る請求項２
    の膨脹部材。 ５、さらに外方層と内方層との間に配置されたホットメ
    ルト接着剤を含む請求項４の膨脹部材。 ６、外方層が親水性ポリマーでコートされている請求項
    １の膨脹部材。 ７、親水性ポリマーがポリカプロレタム（Ｐｏｌｙ−ｃ
    ａｐｒｏｌａｔｏｍ）である請求項６の膨脹部材。 ８、脈管内カテーテル本体部分へ取付ける膨脹部材を形
    成する方法であつて、 （ａ）内部に低ポリマー結晶質を提するポリマー材料を
    有する層状の管状パリソンを形成するため該低ポリマー
    結晶質を提するポリマー材料と共に高ポリマー結晶質を
    提するポリエステルプラスチックを共軸押出しすること
    、 （ｂ）該パリソンを型内にて所定温度まで加熱すること
    、 （ｃ）該パリソンを長手方向にドローし膨脹部材が約７
    気圧以上の破裂強度を提するように高ポリマー結晶質を
    提する前記ポリエステルを二軸配向するよう該パリソン
    を半径方向に膨脹すること、 を含む膨脹部材の形成方法。 ９、前記ポリエステルプラスチックがポリエチレンテレ
    フタレートであり、前記ポリマー材料がポリエチレン、
    ウレタン、無定形ポリエチレンテレフタレートを含む群
    から選択される請求項８の形成方法。 １０、さらに膨脹部材を親水性プラスチックでコートす
    ることを含む請求項８の形成方法。
JP2255027A 1989-09-25 1990-09-25 カテーテル用膨脹部材及びその形成方法 Granted JPH03205064A (ja)

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US41164989A 1989-09-25 1989-09-25
US411649 1989-09-25

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JPH03205064A true JPH03205064A (ja) 1991-09-06
JPH0575432B2 JPH0575432B2 (ja) 1993-10-20

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AU (1) AU626103B2 (ja)
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DE (1) DE69002295T2 (ja)
DK (1) DK0420488T3 (ja)
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JP4885737B2 (ja) * 2003-12-31 2012-02-29 ボストン サイエンティフィック リミテッド 変化する物理特性を備えた医療装置
JP2009519810A (ja) * 2005-12-20 2009-05-21 アボット、カーディオバスキュラー、システムズ、インコーポレーテッド カテーテルのための非伸張性の多層バルーン
US9205232B2 (en) 2011-09-29 2015-12-08 Terumo Kabushiki Kaisha Balloon for catheter and balloon catheter
JP2015512695A (ja) * 2012-03-09 2015-04-30 クリアストリーム・テクノロジーズ・リミテッド 共押出されたｘ線不透過性の部分を備える医療用バルーン
CN104785184A (zh) * 2015-03-28 2015-07-22 佛山市顺德区良朋材料制造有限公司 一种能级分子材料细胞撕裂设备的出料机构及出料方法

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DE69002295T2 (de) 1993-11-04
EP0420488B1 (en) 1993-07-21
DE69002295D1 (de) 1993-08-26
ATE91638T1 (de) 1993-08-15
NO178424C (no) 1996-03-27
AU6317290A (en) 1991-03-28
IE64203B1 (en) 1995-07-12
NO904145L (no) 1991-03-26
AU626103B2 (en) 1992-07-23
NO904145D0 (no) 1990-09-24
US20040191443A1 (en) 2004-09-30
JPH1043287A (ja) 1998-02-17
IE903431A1 (en) 1991-04-24
US20040207127A1 (en) 2004-10-21
FI904682A0 (fi) 1990-09-24
CA2025962A1 (en) 1991-03-26
ES2043289T3 (es) 1993-12-16
US5270086A (en) 1993-12-14
JPH0575432B2 (ja) 1993-10-20
US6132824A (en) 2000-10-17
NO178424B (no) 1995-12-18
DK0420488T3 (da) 1993-08-30
EP0420488A1 (en) 1991-04-03

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