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
Links
- 238000000034 method Methods 0.000 claims abstract description 13
- 229920000642 polymer Polymers 0.000 claims abstract description 11
- 230000001747 exhibiting effect Effects 0.000 claims abstract description 5
- 229920000139 polyethylene terephthalate Polymers 0.000 claims description 16
- 239000005020 polyethylene terephthalate Substances 0.000 claims description 16
- 239000004033 plastic Substances 0.000 claims description 14
- 229920003023 plastic Polymers 0.000 claims description 14
- -1 polyethylene terephthalate Polymers 0.000 claims description 13
- 239000000463 material Substances 0.000 claims description 10
- 239000004698 Polyethylene Substances 0.000 claims description 8
- 229920000728 polyester Polymers 0.000 claims description 8
- 229920000573 polyethylene Polymers 0.000 claims description 8
- 239000011248 coating agent Substances 0.000 claims description 2
- 238000000576 coating method Methods 0.000 claims description 2
- 238000010438 heat treatment Methods 0.000 claims description 2
- 229920000098 polyolefin Polymers 0.000 claims description 2
- 239000002178 crystalline material Substances 0.000 claims 2
- 229920001477 hydrophilic polymer Polymers 0.000 claims 2
- 229920008790 Amorphous Polyethylene terephthalate Polymers 0.000 claims 1
- 229920001634 Copolyester Polymers 0.000 claims 1
- JOYRKODLDBILNP-UHFFFAOYSA-N Ethyl urethane Chemical compound CCOC(N)=O JOYRKODLDBILNP-UHFFFAOYSA-N 0.000 claims 1
- 239000004831 Hot glue Substances 0.000 claims 1
- 239000013078 crystal Substances 0.000 claims 1
- 229920006255 plastic film Polymers 0.000 claims 1
- 239000002985 plastic film Substances 0.000 claims 1
- 229920006254 polymer film Polymers 0.000 claims 1
- 238000000071 blow moulding Methods 0.000 abstract description 11
- 239000002131 composite material Substances 0.000 abstract description 8
- 238000002399 angioplasty Methods 0.000 abstract description 4
- 230000002708 enhancing effect Effects 0.000 abstract 1
- 239000010410 layer Substances 0.000 description 19
- 238000001125 extrusion Methods 0.000 description 7
- 239000012530 fluid Substances 0.000 description 4
- 239000004743 Polypropylene Substances 0.000 description 3
- 230000003902 lesion Effects 0.000 description 3
- 229920001155 polypropylene Polymers 0.000 description 3
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 2
- 229920002292 Nylon 6 Polymers 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000005485 electric heating Methods 0.000 description 2
- 239000000945 filler Substances 0.000 description 2
- 238000002844 melting Methods 0.000 description 2
- 230000008018 melting Effects 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 238000001356 surgical procedure Methods 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- OKTJSMMVPCPJKN-UHFFFAOYSA-N Carbon Chemical compound [C] OKTJSMMVPCPJKN-UHFFFAOYSA-N 0.000 description 1
- 230000009172 bursting Effects 0.000 description 1
- 229910000019 calcium carbonate Inorganic materials 0.000 description 1
- 229910052799 carbon Inorganic materials 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 230000010339 dilation Effects 0.000 description 1
- 239000006185 dispersion Substances 0.000 description 1
- 229920001971 elastomer Polymers 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000017 hydrogel Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 230000001050 lubricating effect Effects 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000002861 polymer material Substances 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 230000003014 reinforcing effect Effects 0.000 description 1
- 239000005060 rubber Substances 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 239000002356 single layer Substances 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 239000011343 solid material Substances 0.000 description 1
- 230000002966 stenotic effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
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
- B29C49/22—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]
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。
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。
(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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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。
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)
- 【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。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US41164989A | 1989-09-25 | 1989-09-25 | |
US411649 | 1989-09-25 |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP9117074A Division 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 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH03205064A JPH03205064A (ja) | 1991-09-06 |
JPH0575432B2 true JPH0575432B2 (ja) | 1993-10-20 |
Family
ID=23629775
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2255027A Granted JPH03205064A (ja) | 1989-09-25 | 1990-09-25 | カテーテル用膨脹部材及びその形成方法 |
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 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
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 |
Country Status (12)
Country | Link |
---|---|
US (4) | US5270086A (ja) |
EP (1) | EP0420488B1 (ja) |
JP (2) | JPH03205064A (ja) |
AT (1) | ATE91638T1 (ja) |
AU (1) | AU626103B2 (ja) |
CA (1) | CA2025962C (ja) |
DE (1) | DE69002295T2 (ja) |
DK (1) | DK0420488T3 (ja) |
ES (1) | ES2043289T3 (ja) |
FI (1) | FI904682A0 (ja) |
IE (1) | IE64203B1 (ja) |
NO (1) | NO178424C (ja) |
Cited By (1)
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JPH10506315A (ja) * | 1995-07-20 | 1998-06-23 | ナビアス コーポレイション | 膨張性ポリエチレン・テレフタレートバルーンおよびその製造方法 |
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- 1990-09-19 ES ES90310240T patent/ES2043289T3/es not_active Expired - Lifetime
- 1990-09-19 DK DK90310240.8T patent/DK0420488T3/da active
- 1990-09-19 DE DE90310240T patent/DE69002295T2/de not_active Expired - Fee Related
- 1990-09-21 CA CA002025962A patent/CA2025962C/en not_active Expired - Fee Related
- 1990-09-24 AU AU63172/90A patent/AU626103B2/en not_active Ceased
- 1990-09-24 NO NO904145A patent/NO178424C/no unknown
- 1990-09-24 IE IE343190A patent/IE64203B1/en not_active IP Right Cessation
- 1990-09-24 FI FI904682A patent/FI904682A0/fi not_active Application Discontinuation
- 1990-09-25 JP JP2255027A patent/JPH03205064A/ja active Granted
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1997
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- 1997-08-06 US US08/907,170 patent/US6132824A/en not_active Expired - Fee Related
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2004
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- 2004-05-05 US US10/839,687 patent/US20040207127A1/en not_active Abandoned
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Also Published As
Publication number | Publication date |
---|---|
NO178424B (no) | 1995-12-18 |
NO178424C (no) | 1996-03-27 |
NO904145L (no) | 1991-03-26 |
CA2025962C (en) | 1995-10-31 |
ES2043289T3 (es) | 1993-12-16 |
JPH1043287A (ja) | 1998-02-17 |
DE69002295D1 (de) | 1993-08-26 |
AU626103B2 (en) | 1992-07-23 |
IE64203B1 (en) | 1995-07-12 |
NO904145D0 (no) | 1990-09-24 |
EP0420488B1 (en) | 1993-07-21 |
EP0420488A1 (en) | 1991-04-03 |
DE69002295T2 (de) | 1993-11-04 |
AU6317290A (en) | 1991-03-28 |
ATE91638T1 (de) | 1993-08-15 |
CA2025962A1 (en) | 1991-03-26 |
US20040207127A1 (en) | 2004-10-21 |
JPH03205064A (ja) | 1991-09-06 |
US20040191443A1 (en) | 2004-09-30 |
US5270086A (en) | 1993-12-14 |
DK0420488T3 (da) | 1993-08-30 |
FI904682A0 (fi) | 1990-09-24 |
IE903431A1 (en) | 1991-04-24 |
US6132824A (en) | 2000-10-17 |
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