JPH0575432B2 - - Google Patents

Info

Publication number
JPH0575432B2
JPH0575432B2 JP2255027A JP25502790A JPH0575432B2 JP H0575432 B2 JPH0575432 B2 JP H0575432B2 JP 2255027 A JP2255027 A JP 2255027A JP 25502790 A JP25502790 A JP 25502790A JP H0575432 B2 JPH0575432 B2 JP H0575432B2
Authority
JP
Japan
Prior art keywords
inflatable member
parison
film layer
polymer
layer
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.)
Expired - Fee Related
Application number
JP2255027A
Other languages
English (en)
Other versions
JPH03205064A (ja
Inventor
Enu Hamurin Robaato
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
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 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

Links

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
    • A61M25/0043—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
    • B29C49/02—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
    • 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
    • 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]

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Manufacturing & Machinery (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Mechanical Engineering (AREA)
  • Child & Adolescent Psychology (AREA)
  • Materials Engineering (AREA)
  • Composite Materials (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 Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)

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がもたら
す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
（transluminal）血管形成術である冠状バイパス
外科学がグランツエツク（A.Gruntzig）により
該技術の導入に続いて開発された。この処法にお
いては外端に膨脹可能な部材（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
切つ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が望まし
い。
１ 高破裂強度 ２ 高圧下での低半径方向膨脹 ３ カテーテル本体へ対し容易に接合出来ること ４ ピンホール破裂のないこと ５ 低摩擦係数 米国特許第4413989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グ及びブロー成形によつて
形成されており材料に二軸配向が与えられてい
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脹等の望ましい特性を発揮す
ることがわかつている。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構成されている
ので、膨脹部材をカテーテル本体の外端部へ接合
しようとしたときに問題が発生する。即ち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
エツトが衝突したときに血管に孔をあけるような
膨脹液の高速度ジエツトを形成する。このため、
制御された方法での破壊即ち圧力が短時間で大き
い面積にわたつ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が構成されうることが望ま
しい。
課題を解決するための手段 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
する本発明によつて達成される。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、複合フイルムが配向し、膨脹
部材の最大外径が画定され所望のフイルム厚みが
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。
高親水性を提する適切なプラスチツクでもつて
複合体の外面をコートすることによつて潤滑特性
もまた増大する。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プラスチツ
クから成る三層管状パリソンを成形することによ
つて、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脹特性及び／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
は潤滑性をもたらす。
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
内カテーテルに使用するに適した複合特性を有す
る限定された膨脹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
リマー合成物が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
作業によつてドローされかつ膨脹され、潤滑性、
破壊強度、限定された半径方向膨脹、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。
実施例 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１０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の出力軸
は加熱胴部１８内を回動する粗なピツチを有する
スクリユー１６を有している。公知の用法によれ
ば一般にこのスクリユーは３つの区域を有してい
る。供給ホツパ２２のすぐ下部にある供給区域２
０においてねじ溝深さは比較的大きい一定値を有
し、ホツ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における溝の深さは均一
のテーパを有し、かつプラスチツクを圧縮しかつ
溶融を強化するため胴部１８へ強制的に接するよ
うな構造となつている。この溶融は主に胴部内に
接けられた電熱要素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
しい剪断によつて生じる熱と、の組合せによつて
得られる。番号２８はスクリユーの計量区域を示
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、定質性を制御する、スクリユー１６の端
部には押出ダイ３０が配置されている。このダイ
３０は、本発明の場合には、少なくとも２つの異
なるプラスチツクの同軸押出を可能とするもので
ある。押出機１０を通る第１のプラスチツクが番
号32で略図的に実質的に同一の押出機から出る第
２のプラスチツクと組合され、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。例えば押出機１０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のスクリユ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ツ
クはプラスチツク入口開口Ｂがプラスチツク入口
開口Ａを取囲む層を形成するように流動する。プ
ラスチツクがダイを介して流れるときにダイ３０
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へ送り込まれるプ
ラスチツクはポリオレフイン又はPVCから成り、
一方開口Ｂ内へ送り込まれるプラスチツクは所定
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
みは各押出機によつて提供される質量流れ比率に
よつて決定される。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
引出し速度等によつて決定される。
バルーン自体はブロー成形作業により構成され
る。この作業においては、パリソン４０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つて、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、
材料が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つたバルーンを接
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。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。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
半径方向膨脹率が約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
いないが、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（Polyvinylidol）、Ｎ−ビ
ニルピロロドン、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PETを使用するよりは、ポリソン成形に際
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脹によつて、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、低い半径方向膨脹及び勝れた結合性を提供
することがわかつている。
ポリマー層の破壊特性は充填材を付加すること
によつ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、遷移状のカーボン、相容性のない第二ポ
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
特徴をもたらしており、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
プロピレン及び選択されたゴム、ポリエステル及
びポリプ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
異なる手法等によつ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
囲によつ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ヤート
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、１２：モータ、１
４：歯車装置、１６：スクリユー、１８：胴部、
２０：供給区域、２２：ホツパ、２４：圧縮区
域、２６：電熱要素、２８：計量区域、３０：ダ
イ、３２：押出機、３４：中心孔、４０：パリソ
ン、４２：ブロー成形金型、４４：開口、４６：
凹部、４８：内層、５０：外方本体、５２：内方
本体。

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つ
    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イルム層と、 (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ツク
    フイルム層と、 から成る膨脹部材。 ２ 外方フイ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 内方フイ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 内方フイルム層がポリオレフインから成る請
    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
    ツ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
    −caprolatom）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
    スチツ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ツクがポリエチレ
    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ツクでコ
    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 JPH03205064A (ja) 1991-09-06
JPH0575432B2 true JPH0575432B2 (ja) 1993-10-20

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JP9117074A Pending JPH1043287A (ja) 1989-09-25 1997-05-07 カテーテル用膨脹部材及びその形成方法

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JP (2) JPH03205064A (ja)
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AU (1) AU626103B2 (ja)
CA (1) CA2025962C (ja)
DE (1) DE69002295T2 (ja)
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AU6317290A (en) 1991-03-28
CA2025962A1 (en) 1991-03-26
JPH03205064A (ja) 1991-09-06
US20040191443A1 (en) 2004-09-30
EP0420488B1 (en) 1993-07-21
ES2043289T3 (es) 1993-12-16
EP0420488A1 (en) 1991-04-03
ATE91638T1 (de) 1993-08-15
NO178424C (no) 1996-03-27
FI904682A0 (fi) 1990-09-24
CA2025962C (en) 1995-10-31
IE64203B1 (en) 1995-07-12
FI904682A7 (fi) 1991-03-26
US5270086A (en) 1993-12-14
NO904145L (no) 1991-03-26
NO178424B (no) 1995-12-18
IE903431A1 (en) 1991-04-24
DE69002295D1 (de) 1993-08-26
DK0420488T3 (da) 1993-08-30
DE69002295T2 (de) 1993-11-04
JPH1043287A (ja) 1998-02-17
AU626103B2 (en) 1992-07-23
US6132824A (en) 2000-10-17
US20040207127A1 (en) 2004-10-21
NO904145D0 (no) 1990-09-24

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