JPH046377B2 - - Google Patents

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Publication number
JPH046377B2
JPH046377B2 JP61265419A JP26541986A JPH046377B2 JP H046377 B2 JPH046377 B2 JP H046377B2 JP 61265419 A JP61265419 A JP 61265419A JP 26541986 A JP26541986 A JP 26541986A JP H046377 B2 JPH046377 B2 JP H046377B2
Authority
JP
Japan
Prior art keywords
graft
body passageway
prosthesis
tubular member
catheter
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 - Lifetime
Application number
JP61265419A
Other languages
English (en)
Other versions
JPS62231657A (ja
Inventor
Shii Parumazu Jurio
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.)
Expandable Grafts Partnership
Original Assignee
Expandable Grafts Partnership
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
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=25167022&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JPH046377(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Expandable Grafts Partnership filed Critical Expandable Grafts Partnership
Publication of JPS62231657A publication Critical patent/JPS62231657A/ja
Publication of JPH046377B2 publication Critical patent/JPH046377B2/ja
Granted legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • A61F2002/91541—Adjacent bands are arranged out of phase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028—Shapes in the form of latin or greek characters
    • A61F2230/0054—V-shaped

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Vascular Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Optics & Photonics (AREA)
  • Physics & Mathematics (AREA)
  • Prostheses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Surgical Instruments (AREA)
  • Materials For Medical Uses (AREA)

Description

【発明の詳細な説明】 本発明は身体通路（body passageway）又は
管（duct）内で使用するための伸張性のある管腔
内移植片（expandable intraluminal graft）又
はプロテーゼに関するものであり（以下、「移植
片」又は「プロテーゼ」は、本願発明の説明する
際に、或る程度交換可能に使用される。）更に特
定的には疾患により狭くなつた又は閉塞した血管
を修復するための特に有用な伸張性のある管腔内
脈管移植片（expandable vascular graft）移植
片及び伸張性のある管腔内又はプロテーゼに関す
るものである。管腔内脈管内移植（intraluminal
endovascular grafting）は慣用の脈管手術に替
わるものとして可能であることが実験により示さ
れた。管腔内脈管内移植には管状プロテーゼ移植
片の血管への経皮挿入及びその脈管系内の所望の
位置にカテーテルを介してそれを送り込むことが
含まれる。慣用の脈管手術に対するこの方法の利
点は欠陥のある血管を外科的に露出させ、切開
し、除去し、取り替え、又はバイパスを付ける必
要をなくすることを含む。
従来管腔内脈管移植片として使用されてきた構
造物には、ステンレス鋼コイルバネ；伸張性のあ
る感熱性材料から製造されたら旋状に巻かれたコ
イルバネ；及びジグザグパターンにステンレス鋼
ワイヤから形成された伸張性ステンレス鋼ステン
ト（stents）が包含されていた。一般に、上記の
構造は共通した１つの欠点を有している。身体通
路を通過するためには、これらの構造物はしぼん
だ（collapsed）状態で所定の身体通路内の所望
の位置に送られなければならなり限り、各構造物
の最終の伸張した形状にたいする有効な制御がで
きなかつた。例えば、特定のコイルバネ型移植片
の伸張はコイルバネ構造物を製造するのに使用さ
れた特定の材料のバネ定数及び弾性率によりによ
り予め決定される。これらの同じフアクターはス
テンレス鋼ワイヤからジグザグパターンに形成さ
れたしぼんだステントの伸張量を予め決定する。
加熱すると伸張する感熱性材料から形成された管
腔内移植片又はプロテーゼの場合には、伸張量は
管腔内移植片の製造に使用された特定の合金の熱
膨張特性により同様に予め決定される。
故に、前記した仮名の管腔内移植片が身体通路
内の、例えば動脈又は静脈内の所望の位置で伸張
させられると、移植片の伸張した寸法は変えるこ
とができない。所望の身体通路の直径を間違えて
計算すると、寸法が足りない移植片は身体通路の
内側表面にしつかりと取り付けられるように身体
通路の内側表面に接触するのに十分には伸張され
ないことがある。その場合にはそれは身体通路内
の所望の位置から移動して離れることがある。同
様に、寸法が大き過ぎる移植片は身体通路に対し
て移植片により及ぼされるバネ力又は伸張力が身
体通路の破壊を引き起こす程に伸張することがあ
る。
慣用の血管手術に替わる他の方法としては、カ
テーテルに取り付けられた血管形成術バルーンの
弾性脈管狭窄症（elastic vascular stenoses）又
は遮断障害（blockages）の経皮バルーン拡大
（percutaneous balloon dilation）であつた。こ
の方法においては、血管の壁成分に剪断力をかけ
てそれを砕いて（disrupt）拡大された内腔を得
るために、血管形成術バルーンは狭窄血管又は身
体通路内で膨らまされる。アテローム性動脈硬化
症に関しては、身体通路のより弾性の内側
（medial）及ば外膜（adventitial）層はプレーク
（plaque）の回りに伸びるが、比較的圧縮不能な
プレークは変化しないままである。この方法は動
脈又は身体通路の切り裂き（dissection）又は裂
け（splitting）及び引き裂き（tearing）を生じ、
動脈又は身体通路の脈管内膜（intima）又は内
側表面はき裂（fissuring）を生じる。この切り
裂きは下にある組織の“フラツプ”（flap）を形
成し、これは内腔を通る血流を減少させたり内腔
を閉塞することがある。典型的には、身体通路内
の拡張する（distending）管腔内圧力が砕かれた
層又はフラツプを所定の位置に保持することがで
きる。バルーン拡大過程により生じた脈管内膜フ
ラツプが伸張された脈管内膜に対して所定の位置
に保持されていないならば、脈管内膜フラツプは
内腔内に折れそして内腔をふさぐことがあり又は
離れたり身体通路に入つたりすることすらある。
脈管内膜フラツプが身体通路をふさぐ場合には、
この問題を直すために直ちに手術が必要である。
バルーン拡大法は典型的には病院のカテーテル
挿入室（catheterization lab）で行なわれるけれ
ども、前記の問題のため、脈管内膜フラツプが血
管又は身体通路をふさぐ場合に備えた外科医を待
機させることが常に必要である。更に、脈管内膜
フラツプが血管から引き裂けたり内腔をふさいだ
りする可能性があるため、バルーン拡大は或る極
めて重要な身体通路、例えば心臓に通じている左
主冠状動脈に対して行うことはできない。バルー
ン拡大法により形成された脈管内膜フラツプが球
に左主冠状動脈の如く重要身体通路に落ち込みそ
してそれをふさぐならば患者は手術を行う前に死
亡することがある。
弾性脈管狭窄症のバルーン拡大に関連した追加
の欠点は狭窄性病変（stenotic lesion）の弾性跳
ね返り（elastic recoil）のために多くが失敗す
るということである。これは通常病変における高
いフイブロコラーゲン含有率により起こり、そし
て時には拡大されるべき区域の或る機械的特性に
起因する。故に、身体通路は最初はバルーン拡大
法により都合良く伸張させられうるけれども、身
体通路の以前に伸張されられた内腔の寸法を減少
させる身体通路の跳ね返り（recoil）によりその
後の早期の再発狭窄症（restenosis）が起こるこ
とがある。例えば、入り口（ostium）における
腎臓動脈の狭窄症は、前記拡大力が腎臓動脈自体
にかかるよりはむしろ大動脈壁にかかるため、バ
ルーン拡大にたいして治療抵抗性であることが知
られている。新生内膜線維症（neointimal
fibrosis）により引き起こされる脈管狭窄症、例
えば、透析路フイステル（dialysis−access
fistulas）においてみられる如きこれらは、高い
拡大圧力及びより大きいバルーン直径を必要とす
るので拡大するのが困難であることが証明され
た。同様な困難が移植動脈物合狭窄症（graft−
artery anastomotic strictures）及び動脈内膜切
除後の再発狭窄症（postendarterectomy
recurrent stenoses）の血管形成術において観察
された。高安動脈炎（Takayasu arteritis）及び
神経線維腫症動脈狭窄症（neurofibromatosis
arterial stenoses）の経皮血管形成術は不十分な
初期応答及びこれらの症状の線維症の性質
（fibrotic nature）によると考えられる再発を示
すことがある。
従つて、本発明の開発以前には、身体通路にお
ける狭窄症の再発を防止し；患者の心臓の左主冠
状動脈の如き極めて重要な身体通路に使用するこ
とができ；身体通路壁の跳ね返りを防止し；そし
て管腔内移植片が可変寸法に伸張させられて移植
片が所望の位置から離れるように移動するのを防
止することを可能としそして伸張させられた移植
片による身体通路の破壊を防止することを可能と
する、伸張性のある管腔内脈管移植片及び身体通
路内の内腔を伸張させるための方法及び装置はな
かつた。故に、当業者では、身体通路における狭
窄症の再発を防止し；心臓の左主冠状動脈の如き
極めて重要な身体通路に使用することができると
考えられ；身体通路の跳ね返りを防止し；身体通
路内で可変寸法に伸張させられて移植片が所望の
位置から離れるように移動するのを防止しそして
伸張させられた移植片による身体通路の破壊を防
止することができる、伸張性のある管腔内脈管移
植片及び身体通路の内腔を伸張させるための方法
及び装置が探し求められてきた。
本発明に従えば、前記利点は本発明の伸張性の
ある管腔内脈管移植片により達成される。本発明
は、第１端部及び第２端部と該第１端部と該第２
端部との間に配置されている壁表面とを有する管
状部材を含み、該壁表面は複数の交差する細長い
部材によつて形成されており、該細長い部材の少
なくとも幾つかは該管状部材の第１端部と第２端
部との中間で相互に交差しており、該管状部材は
内腔を有する身体通路内への該管状部材の管腔内
送り込みを可能とする第１の直径を有しており、
そして、該管状部材は該管状部材の内側から半径
方向外方に伸び広げる力をかけられるとき第２の
伸張した直径を有し、該第２の直径は可変であり
且つ該管状部材に加えられた力の量に依存してお
り、それにより、該管状部材は該身体通路の内腔
を伸張させるように伸張させることができるよう
になつている。
本発明の更なる特徴は複数の細長い部材が複数
のワイヤであることができ、そして該ワイヤは該
ワイヤが相互に交差するところで相互に固定され
る（fixedly secured）ことができるということ
である。本発明の追加の特徴は複数の細長い部材
が複数の薄いバーであることができ、該複数の細
長いバーが該バーが相互に交差しているところで
相互に固定されていることである。本発明の更な
る特徴は、第５図及び第６図に示されているよう
に、管状部材がその壁表面に生物学的に不活性な
コーテイングを有することができ、このコーテイ
ングは管状部材を身体通路に固着させるための手
段を含むことができることである。
本発明に従えば、前記利点は身体通路の内腔を
伸張させるための方法によつても達成される。該
方法は、カテーテル上に配置された管腔内移植片
を、それが該身体通路内の所望の位置に隣接して
配置されるまで、該身体通路内に挿入すること
と、該身体通路の所望の位置における該身体通路
の内腔が伸張させられるまで、該カテーテルの部
分を伸張させて該管腔内移植片を半径方向外方に
伸張させて該身体通路と接触させ、それにより、
該管腔内移植片は該身体通路がしぼんだり該伸張
した内腔の寸法が減少するのを防止することを含
む。
該方法の更なる特徴は管腔内移植片と接触して
いる該カテーテルの部分をしぼませそして該カテ
ーテルを該身体通路から除去することができるこ
とである。該方法更なる特徴はそれと関連した伸
張性のある膨張可能な部分を有するカテーテルを
使用することができ、そして該管腔内移植片及び
該カテーテルの部分の伸張は該カテーテルの伸張
性のある膨張可能な部分を膨らますことにより達
成されることである。
本発明の更なる特徴は管腔内移植片として金網
管（wire mesh tube）を使用することができ、
この金網管は、該管が所望の位置で身体通路内に
挿入されそして所望の位置に送り込まれることを
可能とする第１の所定のしぼんだ直径を有するこ
とである。本発明の他の特徴は、金網管を該身体
通路内で第の直径に伸張させることができ；該第
２の伸張した直径は可変でありそして、該身体通
路の所望の伸張された内径により決定され、それ
により、該伸張した金網管は該身体通路内で所望
の位置から移動せず且該管腔内移植片の伸張は該
身体通路の破壊を引き起こさないことである。
本発明に従えば、前記利点は移植片又はプロテ
ーゼを保持し、身体通路内へ挿入するための装置
によつても達成される。該装置は、第１端部及び
第２端部と該第１端部と該第２端部との間に配置
されている壁表面とを有する伸張性のある管状プ
ロテーゼとカテーテルを具備し、該壁表面は複数
の交差する細長い部材によつて形成されており；
該カテーテルはプロテーゼに関連した伸張性のあ
る膨張可能な部分を有しそして該伸張性のある膨
張可能な部分に前記伸張性のある管状プロテーゼ
を取り付け且つ保持するための手段を含み、それ
により該カテーテルの伸張性のある膨張可能な部
分が膨らまされると、該プロテーゼは半径方向外
方に強制されて該身体通路と接触するようになつ
ている。該装置の更なる特徴は上記取り付け及び
保持手段が該伸張性のある膨張可能な部分に隣接
して且つ該伸張性のある管状プロテーゼの各端部
に隣接して該カテーテル上に配置されている保持
器リング部材を具備することができることであ
る。
本発明の、伸張性のある管腔内脈管移植片、そ
して、該移植片により身体通路の内腔を伸張させ
る方法及び身体通路を管腔内で強化する装置を、
これまでに提唱された先行技術の管腔内移植片、
それらを移植する方法及びバルーン拡大法と比較
したとき、狭窄症の再発を防止する；心臓の左主
冠状動脈における如き極めて重要な身体通路にお
ける移植片の移植を可能とすると考えられる；身
体通路の跳ね返りを防止する；身体通路内の条件
に依存して変動可能な寸法に移植片を伸張させる
ことを可能とする；という利点を有している。
本発明を好ましい態様に関して説明するが、こ
れは本発明をその態様に限定することを意図する
ものではないことを理解されたい。反対に、特許
請求の範囲に記載された本発明の精神及び範囲内
に包含されうるようなすべての代替、修正及び均
等物及び均等手段を包含することを意図する。
第１Ａ図及び第２Ａ図において、伸張性のある
管腔内脈管移植片又は身体通路のための伸張性の
あるプロテーゼ７０が例示されている。用語“伸
張性のある管腔内脈管移植片”及び伸張性のある
プロテーゼとは、方法、装置及び構造が血管又は
身体通路の部分的に閉塞されたセグメントを伸張
させるための伸張性のある管腔内脈管移植片に関
連してのみならず、他の多くの型の身体通路のた
めの伸張性のあるプロテーゼとして多くの他の目
的にも使用することが出来る限りにおいて、本発
明を説明する際に或る程度交換可能に使用される
ことは理解されるべきである。例えば、伸張性の
あるプロテーゼ７０は(1)トランスルミナル再疎通
（transluminal recanalizstion）により開かれて
いるがしかし内部支持体の不存在不ではつぶれそ
うな閉塞された動脈内の支持移植片配置、(2)手術
不能のガンにより閉塞された縦隔静脈
（mediastinal vein）及び他の静脈を通るカテー
テル通路に従う同様な使用；(3)門脈高圧症
（portal hypertension）にかかつている患者の門
脈と肝臓静脈間のカテーテルで作られた肝内の連
通の強化：(4)食道、腸、尿管、尿道の狭窄化の支
持移植片配置（supportive graft placement）；
及び(5)再開された及び以前に閉塞された胆管の支
持移植片強化；の如き目的にも使用することが出
来る。従つて、用語“プロテーゼ”の使用は種々
のタイプの身体通路内の使用法を包含しそして用
語“管腔内脈管移植片”の使用は身体通路の内腔
を伸張させるための使用を包含する。更に、この
点について、用語“身体通路”は前記した如き人
間の身体内の管及び人間の脈管系（vascular
system）内の静脈、動脈又は血管を包含する。
更に第１Ａ図を参照すると、伸張性のある管腔
内脈管移植片又はプロテーゼ７０は、第１端部７
２及び第２端部７３と該第１端部７２と該第２端
部７３の間に配置された壁表面７４を有する管状
部材７１を具備する。好ましくは、壁表面７４は
複数の交差する細長い部材７５，７６により形成
され、細長い部材７５，７６の少なくとも幾つか
は交差点７７で示された如き管状部材７１の第１
及び第２端部７２，７３の中間で相互に交差して
いる。管状部材７１は、後に詳細に説明する如
く、内腔８１を有する身体通路８０への管状部材
７１の管腔内送り込みを可能とする第１直径ｄを
有する。第１Ｂ図を参照すると、後に更に詳細に
説明する如く、半径方向外方に伸び広げる力が管
状部材７１の内側から加えられると管状部材７１
は第２の伸張した直径d′を有し、該第２直径d′は
寸法が可変でありそして管状部材７１に加えられ
た力の量に依存する。
第１Ａ図及び第１Ｂ図を参照すると、管状部材
７１の壁表面74を形成する細長い部材７５，７６
の人間の身体及び脈管移植片又はプロテーゼ７０
が接触しうる体液（示されていない）と適合性で
あるいかなる適当な材料であつてもよい。細長い
部材７５，７６は又、管状部材７１が第１Ａ図に
示された形状から第１Ｂ図に示された形状に伸張
させられることを許容するとともに更に管状部材
７１を第１Ｂ図に示された拡大された直径d′を有
するその伸張された形状を保持することを許容す
るのに必要な強度及び弾性特性を有する材料から
作られなければならない。管状部材７１を製造す
るのに適当な材料には銀、タンタル、ステンレス
鋼、金、チタン又は前記した必要な特性を有する
適当なプラスチツク材料が包含される。好ましく
は、細長い部材７５，７６はステンレス鋼から作
られる。好ましくは、第１Ａ図及び第１Ｂ図に示
された細長い部材７５，７６はシリンダ状断面を
有する小さな直径のステンレス鋼ワイヤである。
各細長い部材７５，７６は三角形、四角形、長方
形、六角形等の如き他の断面形状を有することも
できることはもちろん理解されるべきである。更
に、複数の細長い部材７５，７６は、該細長い部
材７５，７６が例えば交差点７７における如き、
相互に交差するところで相互に固定して取り付け
られる（fixedly secured）ことが好ましい。細
長い部材７５，７６は慣用の方法で、例えば、溶
接、はんだ付け又は接着（gluing）、例えば適当
なエポキシ接着材（epoxy glue）による接着に
よつて相互に固定的に取り付けることができる。
しかしながら、交差点７７は銀ではんだ付けされ
ていることが好ましい。細長い部材７５，７６を
相互に固定的に取り付けることによつて、管状部
材７１は半径方向押しつぶしに対する比較的高い
抵抗を与えられ、そして管状部材７１は第１Ｂ図
に示された如きその拡大された直径d′を保持する
能力を有する。好ましくは、管状部材７１は、一
般に金網管（wire mesh tube）として示すこと
ができるものを形成するように、十分形管状パタ
ーンで織られた連続的なステンレス鋼ワイヤで作
られる。
管状部材又は金網管７１を製造する場合に、そ
れは第１Ａ図に示された直径ｄを有する形状に最
初作ることができる。あるいは、それは最初の直
径ｄより大きい直径に作り、作つた後第１Ａ図に
示された直径ｄを有するように注意深くしぼませ
ることができる。管状部材又は金網管７１をしぼ
ませる期間中隣接した細長い部材７５，７６の重
なりが回避されるように注意しなければならな
い。管状部材又は金網管７１が第１Ｂ図に示され
た形状に伸張される第１及び第２端部７２及び７
３間の距離はもちろん減少することは理解される
べきである。
第２Ａ図及び第２Ｂ図を参照すると、伸張性の
ある管腔内脈管移植片又はプロテーゼ７０の他の
態様が示される。同じ参照番号が使用されそして
第１Ａ図及び第１Ｂ図に前記した要素に適用可能
である。第２Ａ図及び第２Ｂ図の管腔内脈管移植
片又はプロテーゼ７０は、複数の細長い部材７
５，７６が複数の薄いバー７８，７９であり、こ
れらのバーはバー７８，７９が相互に交差すると
ころで好ましくは相互に固定的に取り付けられて
いるという点で、第１Ａ図及び第２Ａ図に関連し
て前記したそれとは異なる。バー７８，７９は好
ましくは薄い長方形断面形状を有しており、そし
て例えば、溶接、ろう付け、はんだ付けの如き慣
用の方法によつて相互に接合されていてもよく、
又は相互に一体的に形成されていてもよい。好ま
しくは、管状部材７１は最初肉薄の（thin−
walled）ステンレス鋼管であり、そして交差す
るバー７８と７９間の開口８２は慣用のエツチン
グプロセス、例えば電気機械的又はレーザーエツ
チングにより形成され、その際得られる構造は複
数の交差する細長い部材７８，７９を有する管状
部材７１である。第２Ａ図の移植片又はプロテー
ゼ７０の態様は半径方向外方に伸び広げる力が管
状部材７１の内側から加えられると、第２Ｂ図に
示されそして第１Ｂ図に関連して前記した如き伸
張された形状を同様にとることができる。更に第
２Ａ図及び第２Ｂ図の脈管移植片又はプロテーゼ
７０の態様は一般に金網管として示すこともでき
ることは理解されるべきである。
本発明の移植片又はプロテーゼを保持し、身体
通路内へ挿入する方法及び装置を、主として、第
３図及び第４図を参照しながら、更に詳細に説明
する。再び、該方法及び装置は人間の脈管系の動
脈、静脈又は血管の如き身体通路の内腔を伸張さ
せるためのみならず、前記した方法を行つて前記
した如き他の身体通路又は管を管腔内で強化する
（intraluminally reinforce）のにも有用であるこ
とが理解されるべきである。第１Ａ図又は第２Ａ
図に関して前記した型のものであつてもよい伸張
性のある管腔内脈管移植片又はプロテーゼ７０は
カテーテル８３上に配置され又は取り付けられ
る。カテーテル８３はそれに関連した伸張性のあ
る膨張可能な部分８４を有している。カテーテル
８３は伸張性のある管腔内脈管移植片又はプロテ
ーゼをカテーテル８３の伸張性のある膨張可能な
部分８４に取り付け及び保持するための手段８５
を含む。好ましくは、取り付け及び保持手段８５
はカテーテル８３の伸張性のある膨張可能な部分
８４に隣接してカテーテル８３上に配置された保
持器リング部材８６を具備し、そして保持器リン
グ部材８６は伸張性のある管腔内脈管移植片又は
プロテーゼ７０の各端部７２，７３に隣接して配
置されている。保持器リング部材はカテーテル８
３と一体的に形成されるが、後に詳細に説明する
如く、移植片又はプロテーゼ７０が身体通路８０
の内腔８１に挿入されるときそれを保護及び保持
するために、カテーテル８３の先導チツプ８７に
隣接した保持器リング部材８６はカテーテルチツ
プ87から遠ざかる方向に登りこう配を持つている
ことが好ましい。残りの保持器リング部材８６は
身体通路８０からのカテーテル８３の容易な除去
を確実にするためにカテーテル８３のチツプ８７
から遠ざかる方向に下りこう配を持つている。伸
張性のある管腔内脈管移植片又はプロテーゼ７０
が前記した如くカテーテル８３上に配置された
後、移植片又はプロテーゼ７０及びカテーテル８
３は慣用の方法で身体通路８０のカテーテル挿入
（cathe terization）により身体通路８０内に挿
入される。
慣用の方法においては、カテーテル８３及び移
植片又はプロテーゼ７０は身体通路８０内の所望
の位置に送り込まれ、そこで管腔内移植片７０を
経由して身体通路８０の内腔８１を伸張させるこ
とが望まれ又はそこでプロテーゼ７０を移植する
ことが望まれる。カテーテル８３及び移植片又は
プロテーゼ７０が身体通路内の所望の位置に送り
込まれることを確実にするために、Ｘ線透視検査
（fluoroscopy）及び／又は他の慣用の方法を使用
することが出来る。次いでプロテーゼ又は移植片
７０はカテーテル８３の伸張性のある膨張可能な
部分８４を伸張させることにより伸張せしめら
れ、それによりプロテーゼ又は移植片７０は身体
通路８０と接触するように半径方向外方に強制さ
れる。この点について、カテーテル８３の伸張性
のある膨張可能な部分は慣用の血管形成術バルー
ン８８であることが出来る。プロテーゼ又は移植
片７０の所望の伸張が終了した後、血管形成術バ
ルーン８８はしぼまされ、又は収縮させられ、そ
してカテーテル８３は慣用の方法で身体通路８０
から除去することができる。所望により、それに
移植片又はプロテーゼ７０が配置されているカテ
ーテル８３は最初慣用のテフロンさや８９に包ま
れていてもよく、さや８９はプロテーゼ又は移植
片７０の伸張の前にプロテーゼ又は移植片７０か
ら引つ張り離される。
プロテーゼ又は移植片７０の管状部材７１は、
金網管又は管状部材７１が前記した如く身体通路
８０内に挿入されるのを可能とするために、最初
は、第１Ａ図及び第２Ａ図に関連して記載された
如き第１の所定のしぼまされた直径ｄを有するこ
とに留意するべきである。前記した目的でプロテ
ーゼ７０を身体通路８０内に移植することを望む
場合には、金網管又はプロテーゼ７０は第２直径
d′に伸張させられ、そして第２直径d′は可変であ
りそして身体通路８０の内径により決定される。
従つて、伸張させられたプロテーゼ７０は血管形
成術バルーン８８が収縮させられると身体通路８
０内の所望の位置から移動することが出来ず、プ
ロテーゼ７０の伸張は多分身体通路８０の破断
（rupture）を引き起こさないであろう。
狭窄症の区域を有する身体通路８０の内腔８１
を伸張するのに伸張性のある管腔内移植片７０を
使用することが所望される場合には、血管形成術
バルーン８８により管腔内脈管移植片の伸張は狭
窄症区域の制御された拡大を可能とし、同時に、
脈管移植片７０の制御された伸張を可能とし、そ
れにより脈管移植片７０は身体通路８０がしぼん
だり、先に伸張させられた内腔８１の寸法が減少
したりするのを防止する。この場合も、管腔内脈
管移植片７０の第２の伸張させられた直径d′は可
変であり、そして身体通路８０の所望の伸張させ
られた内径により決定される。かくして、伸張性
のある管腔内移植片７０は血管形成術バルーン８
８が収縮しても身体通路８０内の所望の位置から
離れるように移動せず、管腔内移植片７０の伸張
は身体通路８０の破断を引き起こさないようであ
る。内膜フラツプ又は裂溝（fissure）が身体通
路８０内で移植片７０の位置に形成されているな
らば、移植片７０はこのような内膜フラツプが身
体通路８０へと内方に折り込まれ得ないこと及び
ゆるく引き裂けたり身体通路８０を通つて流れた
りしないことを確実にする。左主動脈の部分の内
腔を伸張させるために前記した方法で移植片７０
を使用する情況においては、内膜フラツプは心臓
にはいることができずそして患者の死を引き起こ
すことはできないと考えられる。
移植片７０を伸張させるために血管形成術バル
ーン８８を１回しか膨らます必要はないので、ト
ランスルミナル血管形成術（transluminal
angiop lasty）期間中内皮の表皮はく落
（endothelial denudation）の程度がバルーン膨
らまし時間に比例している限りは、より多くの量
の内皮、又は内膜の内側層又は身体通路の内側表
面が保存されると考えられる。更に、理論上に
は、移植片７０の伸張させられた形状においては
可能性として内皮の80％が移植片７０の開口８２
をとおして露出されるので、保存される内皮
（preserve endothelium）の量は大きいであろ
う。更に、移植片７０の細長い部材７５，７６，
７８，７９間の内皮の損なわれていないパツチが
実験的研究により示された如く迅速な多中心内皮
化パターン（multicentric endothelialization
pattern）をもたらしうると考えられる。
本発明は例示されそして説明された構造、操作
の詳細そのもの、材料そのもの又は態様に限定さ
れるものではなく、修正及び均等物又は均等手段
が当業者には明らかであることは理解されるべき
である。例えば、プロテーゼ又は移植片を伸張さ
せるための手段はカテーテル上に配置された複数
の流体圧作動式硬質部材であることができ、又は
複数の血管形成術バルーンはがプロテーゼ又は移
植片を伸張させるのに使用されうる。従つて、本
発明は特許請求の範囲のみによつて限定されるべ
きである。
【図面の簡単な説明】
第１Ａ図は身体通路内への移植片又はプロテー
ゼの送り込みを可能とする第１の直径を有する身
体通路のための伸張性のある管腔内脈管移植片又
はプロテーゼの斜視図である。第１Ｂ図は身体通
路内に配置されたときその伸張された形状にある
第１Ａ図の移植片又はプロテーゼの斜視図であ
る。第２Ａ図は身体通路内への移植片又はプロテ
ーゼの管腔内送り込みを可能とする第１の直径を
有する、身体通路のための伸張性のある管腔内脈
管移植片又はプロテーゼの他の態様の斜視図であ
る。第２Ｂ図は身体通路内に配置されたときその
伸張された形状において示された第２Ａ図の移植
片又はプロテーゼの斜視図である。第３図は、第
１Ａ図及び第２Ａ図に示された形状にある移植片
又はプロテーゼを保持し、身体通路内へ挿入する
ための装置の断面図である。第４図は、第１Ｂ図
及び第２Ｂ図に示された形状にある移植片又はプ
ロテーゼを保持している上記装置の断面図であ
る。第５図及び第６図は移植片又はプロテーゼが
その上にコーテイングを有している、身体通路の
ための移植片又はプロテーゼの斜視図である。 図において、７０……伸張性のある管腔内脈管
移植片又はプロテーゼ、７１……管状部材、７２
……第１端部、７３……第２端部、７４……壁表
面、７５，７６……交差している細長い部材、７
７……交差点、７８，７９……バー、８０……身
体通路、８１……内腔、８２……開口、８３……
カテーテル、８４……伸張性のある膨張可能な部
分、８５……取り付け及び保持手段、８６……保
持器リング部材、８７……先導チツプ、８８……
慣用の血管形成術バルーン、８９……慣用のテフ
ロンさや、である。

Claims (1)

  1. 【特許請求の範囲】 １ 第１端部及び第２端部と該第１端部と該第２
    端部との間に配置されている壁表面とを有する管
    状部材を具備し、該壁表面は複数の交差する細長
    い部材によつて形成されており、該細長い部材の
    少なくとも幾つかは該管状部材の第１端部と第２
    端部との中間で相互に交差していることと、 該交差している細長い部材は複数の薄いバーで
    あり、各バーは均一な薄い長方形の断面形状を有
    することと、 該管状部材は内腔を有する身体通路内への該管
    状部材の管腔内送り込みを可能とする第１の直径
    を有していることと、 該管状部材は該管状部材の内側から半径方向外
    方に伸び広げる力をかけられるとき第２の伸張し
    た直径を有し、該第２の直径は可変であり且つ該
    管状部材に加えられた力の量に依存していること
    を特徴とする伸張性のある管腔内脈管移植片又は
    プロテーゼ。 ２ 該複数の薄いバーは、該バーが相互に交差し
    ているところで相互に固定されている特許請求の
    範囲第１項記載の伸張性のある管腔内脈管移植片
    又はプロテーゼ。
JP61265419A 1985-11-07 1986-11-07 伸張性のある管腔内脈管移植片又はプロテーゼ Granted JPS62231657A (ja)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US796009 1985-11-07
US06796009 US4733665C2 (en) 1985-11-07 1985-11-07 Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP3225376A Division JP2731642B2 (ja) 1985-11-07 1991-08-12 伸張性のある管腔内脈管移植片又はプロテーゼ

Publications (2)

Publication Number Publication Date
JPS62231657A JPS62231657A (ja) 1987-10-12
JPH046377B2 true JPH046377B2 (ja) 1992-02-05

Family

ID=25167022

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Application Number Title Priority Date Filing Date
JP61265419A Granted JPS62231657A (ja) 1985-11-07 1986-11-07 伸張性のある管腔内脈管移植片又はプロテーゼ
JP3225376A Expired - Lifetime JP2731642B2 (ja) 1985-11-07 1991-08-12 伸張性のある管腔内脈管移植片又はプロテーゼ
JP34646396A Expired - Lifetime JP2999731B2 (ja) 1985-11-07 1996-12-11 移植片又はプロテーゼとカテーテルとを具備する装置

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JP3225376A Expired - Lifetime JP2731642B2 (ja) 1985-11-07 1991-08-12 伸張性のある管腔内脈管移植片又はプロテーゼ
JP34646396A Expired - Lifetime JP2999731B2 (ja) 1985-11-07 1996-12-11 移植片又はプロテーゼとカテーテルとを具備する装置

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US (3) US4733665C2 (ja)
EP (1) EP0221570B2 (ja)
JP (3) JPS62231657A (ja)
AT (1) ATE60500T1 (ja)
BR (1) BR8605658A (ja)
CA (2) CA1281504C (ja)
DE (2) DE3677321D1 (ja)
ES (1) ES2020502T5 (ja)
GR (2) GR3001410T3 (ja)
ZA (1) ZA868414B (ja)

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EP0221570A3 (en) 1987-12-23
US4776337B1 (en) 2000-12-05
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ATE60500T1 (de) 1991-02-15
US4733665C2 (en) 2002-01-29
AU591942B2 (en) 1989-12-21
ES2020502B3 (es) 1991-08-16
JPH04357949A (ja) 1992-12-10
EP0221570A2 (en) 1987-05-13
US4733665B1 (en) 1994-01-11
BR8605658A (pt) 1987-12-15
AU6488286A (en) 1987-05-14
EP0221570B2 (en) 2000-10-04
US4739762A (en) 1988-04-26
JP2731642B2 (ja) 1998-03-25
JP2999731B2 (ja) 2000-01-17
US4733665A (en) 1988-03-29
JPS62231657A (ja) 1987-10-12
GR3035143T3 (en) 2001-04-30
ZA868414B (en) 1987-09-30
GR3001410T3 (en) 1992-09-25
US4739762B1 (en) 1998-10-27
JPH09276302A (ja) 1997-10-28
ES2020502T5 (es) 2001-03-16
CA1281504C (en) 1991-03-19
DE3677321D1 (de) 1991-03-07
EP0221570B1 (en) 1991-01-30
US4776337A (en) 1988-10-11
DE221570T1 (de) 1987-12-17

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