JPH1043313A - 二股ステントの作製方法 - Google Patents

二股ステントの作製方法

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Publication number
JPH1043313A
JPH1043313A JP11582297A JP11582297A JPH1043313A JP H1043313 A JPH1043313 A JP H1043313A JP 11582297 A JP11582297 A JP 11582297A JP 11582297 A JP11582297 A JP 11582297A JP H1043313 A JPH1043313 A JP H1043313A
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JP
Japan
Prior art keywords
edge
sheet
leg
stem
tubular member
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Granted
Application number
JP11582297A
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English (en)
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JP3532730B2 (ja
Inventor
Jacob Richter
リヒター ヤコブ
Gregory Pinchasik
ピンチャシク グレゴリー
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Medinol Ltd
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Medinol Ltd
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    • 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
    • A61F2/856—Single tubular stent with a side portal passage
    • 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
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    • A—HUMAN NECESSITIES
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    • 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
    • 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
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    • A61F2/852—Two or more distinct overlapping stents
    • 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
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    • 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
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    • 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
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • 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
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    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0041—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels or rivets, e.g. connecting screws
    • A—HUMAN NECESSITIES
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    • 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
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    • A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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    • A—HUMAN NECESSITIES
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    • A61F2240/00—Manufacturing or designing of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2240/001—Designing or manufacturing processes
    • 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
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    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
    • Y10S623/901—Method of manufacturing prosthetic device
    • 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
    • Y10T29/00—Metal working
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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Abstract

(57)【要約】 【課題】 茎部と2個の脚部とを備えた二股ステントの
作製を簡便にする。 【解決手段】 二股ステント5は、第1脚部10、第2
脚部15及び茎部20を備える。第1シートを巻き、そ
の対向2縁を溶接部14を介して接合することにより、
第1脚部10が形成される。第2シートを巻き、その対
向2縁を溶接部19を介して接合することにより、第2
脚部15が形成される。第3シートを巻き、その対向2
縁を溶接部24を介して接合することにより、茎部20
が形成される。第1脚部10は基端11、末端及び長手
方向ボア13を備える。第2脚部15は基端16、末端
及び長手方向ボア18を備える。茎部20は基端、末端
22及び長手方向ボア23を備える。第1脚部10の基
端11と第2脚部15の基端16とを茎部20の末端2
2に接合し、各長手方向ボア13、18、23を互いに
連通させることにより、二股ステント5が形成される。

Description

【発明の詳細な説明】
【0001】
【発明の属する技術分野】本発明はステント(stent) に
関し、特に、分岐管内に挿入される二股ステント(bifur
cated stent)の作製方法に関する。
【0002】
【従来の技術及び発明が解決しようとする課題】ステン
トは当該技術分野で良く知られている。一般にステント
は、内圧が加わったときに膨張可能な円筒形の金網から
形成される。或いは、ワイヤを円筒形に巻いたりシート
材を円筒形に形成したりすることによっても、ステント
を形成できる。
【0003】ステントは、脈管系を含む身体の導管内に
一般に植え込まれて、血管の崩壊、部分的閉塞、弱化又
は異常拡張した部分を補強する装置である。またステン
トは、例えば尿路や胆管等の他の領域に植え込まれてそ
のような身体導管を補強するためにも、首尾よく使用さ
れている。米国特許第4,994,071号(マクレガ
ー)は、連結形成された可撓性の主円筒格子を備えた膨
張可能な二股ステントを開示する。主格子よりも小径の
2個の補助円筒格子が同様に形成される。主格子は、主
格子を一方の補助格子に連結する可撓性ワイヤを備え
る。第2の可撓性ワイヤが、主格子を他方の補助格子に
連結する。これら可撓性ワイヤは、主格子及び各補助格
子に沿って軸方向へ延びる背骨部分を構成する。この二
股ステントの1つの課題は、背骨部分を構成する可撓性
ワイヤをループ状構造の各格子に連結する作業が複雑さ
を伴うことにある。
【0004】本発明の目的は、従来技術の上記又は他の
課題を解決すべく、茎部と2個の脚部とを備えた二股ス
テントを作製しかつ配備する方法を提供することにあ
る。
【0005】
【課題を解決するための手段】上記目的を達成するため
に、請求項1に記載の本発明は、二股ステントの作製方
法であって、a)第1縁、第2縁、第3縁及び第4縁を
備えた第1シートを用意し、b)第1縁、第2縁、第3
縁及び第4縁を備えた第2シートを用意し、c)第1
縁、第2縁、第3縁及び第4縁を備えた第3シートを用
意し、d)第1シートの第2縁を第1シートの第3縁に
取付けて、基端及び末端を備える管状の第1脚部を形成
し、e)第2シートの第2縁を第2シートの第3縁に取
付けて、基端及び末端を備える管状の第2脚部を形成
し、f)第3シートの第2縁を第3シートの第3縁に取
付けて、基端及び末端を備える管状の茎部を形成し、
g)第1脚部の基端と第2脚部の基端とを茎部の末端に
取付ける、各ステップを有した方法を提供する。
【0006】また請求項2に記載の本発明は、二股ステ
ントの作製方法であって、a)基端及び末端を備えた第
1シートを用意し、b)第1シートの末端を変形して第
1脚部を形成するとともに、第1シートの基端を変形し
て茎部第1半体を形成し、c)基端及び末端を備えた第
2シートを用意し、d)第2シートの末端を変形して第
2脚部を形成するとともに、第2シートの基端を変形し
て茎部第2半体を形成し、e)茎部第1半体を茎部第2
半体に連結して茎部を形成する、各ステップを有した方
法を提供する。
【0007】また請求項3に記載の本発明は、二股ステ
ントの作製方法であって、a)基端、末端及び長手方向
ボアを備え、基端と末端との間に長手方向ボアに連通す
る枝穴が配置され、枝穴が第2の膨張可能な管状部材を
受容かつ固定するように寸法設定されてなる第1の膨張
可能な管状部材を用意し、b)第1の膨張可能な管状部
材を、第1管腔及び第2管腔を備えた分岐管に送給し
て、第1の膨張可能な管状部材を第1管腔内に配置する
とともに、枝穴を第2管腔に連通させ、c)第1の膨張
可能な管状部材を、第1の膨張可能な管状部材が第1管
腔内に固定されるに十分となるまで膨張させ、d)基
端、末端及び長手方向ボアを備えた第2の膨張可能な管
状部材を用意し、e)枝穴を拡張させ、f)第2の膨張
可能な管状部材を枝穴に送給して、第2の膨張可能な管
状部材の末端を第2管腔内に配置するとともに、第2の
膨張可能な管状部材の基端を第1の膨張可能な管状部材
の長手方向ボア内に配置し、g)第2の膨張可能な管状
部材を、第2の膨張可能な管状部材が第2管腔内及び枝
穴内に固定されるに十分となるまで膨張させる、各ステ
ップを有した方法を提供する。
【0008】本発明の第1の実施形態では、二股ステン
トは、所望の型に形成された3枚のシートを用意するこ
とにより作製される。3枚のシートは例えば、実質的同
一寸法の2枚のシートと、それら2枚のシートのいずれ
かより幅広の第3のシートとからなる。各シートは、長
手方向両縁を巻上げて溶接による接合部を形成すること
により管に形成される。大判の第3のシートは、二股ス
テントの茎部として機能する管を形成し、他のシートは
それぞれ、二股ステントの脚部として機能する管を形成
する。2つの脚部を茎部に連結することにより、二股ス
テントが作製される。
【0009】本発明の第2の実施形態では、二股ステン
トは2枚のシートを用意することにより作製される。各
シートに対し、シートの一部分の長手方向両縁を巻上げ
て互いに固定することにより、二股ステントの2つの脚
部の一方が形成される。2枚のシートの各々の残りの自
由縁を連結することにより、ステントの茎部が形成され
る。
【0010】本発明の第3の実施形態では、二股ステン
トは第1の管状部分と第2の管状部分とから構成され
る。第1の管状部分は、二股ステントの茎部を形成する
基端と、1つの脚部を形成する末端とを備える。第1の
管状部分の基端と末端との間には枝穴が配置される。第
2の管状部分は、第1の管状部分の茎部の長手方向ボア
に挿入され、枝穴を通して前進させられて枝穴から突出
し、第2の脚部を形成する。第2の管状部分を膨張させ
ると、第2の管状部分の基端が枝穴を画成する材料に係
合し、それにより第2の脚部が所望位置に固定される。
【0011】
【発明の実施の形態】図1は、本発明の第1実施形態に
従って作製された二股ステント5を示す。二股ステント
5は、第1脚部10、第2脚部15及び茎部20を備え
る。図2は、第1脚部10を形成するために使用される
第1シート25と、第2脚部15を形成するために使用
される第2シート30と、茎部20を形成するために使
用される第3シート35とを示す。第1シート25及び
第2シート30は、実質的に平坦で所定の長さ及び幅を
有する。多くの適用に対し、第1シート25及び第2シ
ート30は実質的同一寸法を有して、実質的同一寸法の
両脚部10、15を形成する。しかし両脚部10、1
5、及びそれらの形成に使用される両シート25、30
は、特定の適用に応じて異なる寸法を有することができ
る。本発明のステントは、組立てたときにその最終寸法
を呈するように寸法設定できるが、好適な実施形態で
は、ステントは膨張可能であって、膨張時にその最終寸
法を呈するように寸法設定される。ステント用の両シー
ト25、30は、特定の適用に応じて様々なパターンを
形成する孔群をそれらに模様付け又は食刻することによ
り、前述した所要の膨張可能性の特徴を得ることができ
る。第3シート35は、それを巻いて管を形成したとき
に、その内側断面形状が第1脚部10及び第2脚部15
の断面外径部分を収容できるように寸法設定される。第
1シート25は、第1縁26、第2縁27、第3縁28
及び第4縁29を備える。第2シート30は、第1縁3
1、第2縁32、第3縁33及び第4縁34を備える。
第3シート35は、第1縁36、第2縁37、第3縁3
8及び第4縁39を備える。板金を切断して各シート2
5、30、35を形成した後、各シートを変形して巻
き、対向2縁を合わせて円筒を形成する。図2及び図3
の実施形態では、第2縁27と第4縁29とが溶接部1
4を介して接合されて、第1脚部10が形成される。ま
た、第2縁32と第4縁34とが溶接部19を介して接
合されて、第2脚部15が形成される。さらに、第2縁
37と第4縁39とが溶接部24を介して接合されて、
茎部20が形成される。これら縁は、例えばねじ留め、
ひだ付け、はんだ付け等の、この目的に適した当業者に
周知の様々な方法で接合できるが、好適な実施形態では
溶接が採用される。特に好適な実施形態では、スポット
溶接が採用される。図3に示すように、第1脚部10は
基端11及び末端12を備え、長手方向ボア13を画成
する。第2脚部15は基端16及び末端17を備え、長
手方向ボア18を画成する。茎部20は基端21及び末
端22を備え、長手方向ボア23を画成する。図4は、
組立直前の第1脚部10、第2脚部15及び茎部20を
示す。二股ステント5を形成するために、第1脚部10
の基端11と第2脚部15の基端16とが茎部20の末
端22に接合され、各長手方向ボア13、18、23が
互いに連通される。図5は組立てられたステントの端面
図であり、図6は同側面図である。
【0012】図11(a)は、本発明の第2実施形態に
従って作製された二股ステント50を示す。二股ステン
ト50は、茎部65に付設される第1脚部55及び第2
脚部60を備える。二股ステント50は、図7(a)に
示す第1シート70と第2シート75とから形成され
る。ステント用の両シート70、75は、特定の適用に
応じて様々なパターンを形成する孔群をそれらに模様付
け又は食刻することにより、前述した所要の膨張可能性
の特徴を得ることができる。両シート70、75は実質
的に平坦で所定の長さ及び幅を有する。第1シート70
は、第1縁71、第2縁72、第3縁73及び第4縁7
4を備える。第2シート75は、第1縁76、第2縁7
7、第3縁78及び第4縁79を備える。ステントの両
脚部を形成するために、第2縁72の一部が第4縁74
の一部に向けて巻かれ、第2縁77の一部が第4縁79
の一部に向けて巻かれる。図8に示すように、両シート
70、75には境界画定点80、81、82、83が選
定される。これら境界画定点80、81、82、83
は、特定の適用の要求に適合すべく選定されるものであ
り、両脚部55、60に要求される長さ及び茎部65に
要求される長さに応じて調整できる。第1縁71及び第
3縁73から等距離に境界画定点80、81を選定し、
かつ第1縁76及び第3縁78から等距離に境界画定点
82、83を選定することにより、両脚部55、60が
茎部65に実質的に等しい長さを有するステントが形成
される。これら境界画定点を第1縁71、76よりも第
3縁73、78に近い位置に選定した場合は、茎部の長
さが各脚部の長さよりも長くなる。また、これら境界画
定点を第3縁73、78よりも第1縁71、76に近い
位置に選定した場合は、各脚部55、60の長さが茎部
65の長さよりも長くなる。しかし好適な実施形態で
は、各境界画定点80、81、82、83は、第2縁7
2、77及び第4縁74、79の長さの約1/3がそれ
ぞれ基端縁72″、77″、74″及び79″を形成す
る位置に選定される。図8に示すように、境界画定点8
0は第2縁72をそのほぼ中間で末端縁72′と基端縁
72″とに分割する。また境界画定点81は、第4縁7
4をそのほぼ中間で末端縁74′と基端縁74″とに分
割する。また境界画定点82は、第2縁77をそのほぼ
中間で末端縁77′と基端縁77″とに分割する。また
境界画定点83は、第4縁79をそのほぼ中間で末端縁
79′と基端縁79″とに分割する。
【0013】ステントを形成するために、末端縁72′
が溶接部90を介して末端縁74′に接続され、図9
(a)に示すように第1脚部55と茎部第1半体65′
とを備えた第1部材95が形成される。また、末端縁7
7′が溶接部91を介して末端縁79′に接続され、第
2脚部60と茎部第2半体65″とを備えた第2部材1
00が形成される。前述したように、これら縁は当業者
に周知の様々な方法で接続できる。図10(a)は、図
9(a)に示す第1部材95及び第2部材100を、組
立直前の相対位置合せ状態で示す。図11(a)及び図
12(a)に示す二股ステント50を作製するために、
基端縁72″が溶接部92を介して基端縁79″に接続
され、かつ基端縁74″が溶接部93を介して基端縁7
7″に接続されて、茎部第1半体65′と茎部第2半体
65″とにより茎部65を形成する。図12(a)は図
11(a)に示すステント50の横断面状の端面図であ
る。
【0014】図7(a)に示す実施形態では、各シート
70、75は正方形又は長方形のものである。しかし各
シート70、75はこのような形状に限定されるもので
なく、例えば図7(b)に示すような形状を採用でき
る。図11(b)は、図7(b)に示す第1シート27
0及び第2シート280を用いて作製された二股ステン
ト250を示す。二股ステント250は、茎部265に
付設される第1脚部255及び第2脚部260を備え
る。二股ステント250は、図7(b)に示す第1シー
ト270と第2シート280とから形成される。ステン
ト用の両シート270、280は、前述したようにして
寸法設定及び食刻を行うことができる。図7(b)に示
すように、第1シート270は、第1縁271、第2縁
272、第3縁273、第4縁274、第5縁275、
第6縁276、第7縁146及び第8縁147を備え
る。第2シート280は、第1縁281、第2縁28
2、第3縁283、第4縁284、第5縁285、第6
縁286、第7縁148及び第8縁149を備える。図
9(b)に示すように、第4縁274が溶接部290を
介して第6縁276に接続され、第1脚部255と茎部
第1半体265′とを備えた第1部材295が形成され
る。また、第4縁284が溶接部291を介して第6縁
286に接続され、第2脚部260と茎部第2半体26
5″とを備えた第2部材300が形成される。前述した
ように、これら縁は当業者に周知の様々な方法で接続で
きる。図10(b)は、図9(b)に示す第1部材29
5及び第2部材300を、組立直前の相対位置合せ状態
で示す。図11(b)及び図12(b)に示す二股ステ
ント250を作製するために、第2縁272が溶接部2
92を介して第8縁149に接続され、かつ第2縁28
2が溶接部293を介して第8縁147に接続されて、
茎部第1半体265′と茎部第2半体265″とにより
茎部265を形成する。図12(b)は図11(b)に
示すステント250の横断面状の端面図である。図12
(c)は図7(a)及び(b)に示す形状の代わりに使
用できる代替形状を示す。
【0015】本発明の第3実施形態では、2つの部分が
患部内に2ステップで順次に配置されて患部内で組立て
られることにより、二股ステントが作製される。図13
は、長手方向ボア131と、茎部125を構成する基端
115と、第1脚部130を構成する末端120とを備
えた茎及び第1脚部110を示す。第2脚部140は、
長手方向ボア132と基端145と末端150とを備え
る。茎及び第1脚部110と第2脚部140とは、前述
したように寸法設定でき、また模様付け又は刻設でき
る。茎及び第1脚部110の基端115と末端120と
の間に、枝穴135が配置される。枝穴135は、第2
脚部140を受容する寸法を有し、第2脚部140が枝
穴135内で膨張したときに第2脚部140を係合固定
するようになっている。第2脚部140は、膨張時に枝
穴135に係合して固定されるように寸法設定される。
図14〜図21は、二股ステントを分岐管腔内で組立て
る手順を示す。図14〜図21に示すように、処置すべ
き領域は第1すなわち本管腔190と第2すなわち枝管
腔195とを備えた分岐管腔である。図14に示すよう
に、第1ガイドワイヤ155が本管腔190内に導入さ
れ、第2ガイドワイヤ156が枝管腔195内に導入さ
れる。図15に示すように、バルーン式膨張可能な茎及
び第1脚部110は、バルーン175を長手方向ボア1
31内に配置するようにして、第1バルーンカテーテル
170の先端に配置される。次に第2バルーンカテーテ
ル171が、茎及び第1脚部110の長手方向ボア13
1内に導入され、バルーン176が枝穴135内に配置
されるように前進させられる。第1カテーテル170は
第1ガイドワイヤ155に装着され、第2カテーテル1
71は第2ガイドワイヤ156に装着される。図16に
示すように、非膨張状態の茎及び第1脚部110が処置
領域に案内され、それにより第1脚部130が本管腔1
90内に配置されるとともに、枝穴135が枝管腔19
5に連通させられる。第2ガイドワイヤ156は、枝穴
135を枝管腔195に向けるように作用する。従来一
般的なカテーテル及びバルーンの寸法は規定しないし、
当業者に周知の詳細事項は明瞭化のために省略する。バ
ルーン175の膨張により茎及び第1脚部110が膨張
し、図17に示すように茎及び第1脚部110が所望位
置に固定される。茎及び第1脚部110の外壁は膨張後
に本管腔190の内壁に接触するが、図では明瞭化のた
めに隙間を故意に残して示す。第1カテーテル170の
バルーン175は膨張状態に保持され、次に第2カテー
テル171のバルーン176が膨張して図18に示すよ
うに枝穴135を拡張させる。枝穴135が拡張するに
従い、枝穴135を画成するステントの一部分が外側に
押されて枝固定リップ180を形成する。
【0016】両バルーン175、176を抜気し、第2
カテーテル171を引抜く一方で、第2ガイドワイヤ1
56を枝管腔195内の適所に残す。次に、バルーン1
76を長手方向ボア132内に配置するようにして第2
脚部140を第2カテーテル171に取付け、次いで第
2カテーテル171を第2ガイドワイヤ156に取付け
る。そして図19に示すように、第2脚部140を、茎
及び第1脚部110の長手方向ボア131内に案内しつ
つ導入し、かつ枝穴135を通して前進させ、それによ
り第2脚部140の末端150を枝管腔195内に突出
させるとともに、基端145を長手方向ボア131に連
通させる。そこで第2カテーテル171のバルーン17
6を不完全に膨張させ、次いで第1カテーテル170の
バルーン175を、バルーン176内の圧力と実質的同
一の圧力まで不完全に膨張させる。その後、両バルーン
175、176を実質的同一圧力まで同時に膨張させ
る。図20に示すように、第2カテーテル171のバル
ーン176の膨張により第2脚部140が膨張し、第2
脚部の外壁が枝穴135の周辺領域に係合して固定され
る。第1カテーテル170のバルーン175の膨張は、
バルーン176の膨張時に茎及び第1脚部110を折曲
させないように作用する。膨張後に、第2脚部140の
外壁は枝管腔195の内壁に接触するが、図では明瞭化
のために隙間を故意に残して示す。両バルーン175、
176を抜気し、両ガイドワイヤ155、156を引抜
く一方で、組立てられた二股ステント160を図21に
示すように適所に残す。
【図面の簡単な説明】
【図1】本発明の第1実施形態に従って作製された二股
ステントを示す斜視図である。
【図2】図1の二股ステントの脚部及び茎部の形成に使
用される各シートを示す平面図である。
【図3】図2の各シートを管状に巻いた状態で示す斜視
図である。
【図4】図3の各管を組立前の状態で示す斜視図であ
る。
【図5】図3及び図4に示す各管を組立てて形成したス
テントの端面図である。
【図6】図5に示す組立後のステントの頂面図である。
【図7】(a)本発明の第2実施形態に従って作製され
る二股ステントに使用される各シートを示す平面図、及
び(b)本発明の第2実施形態に従って作製される他の
二股ステントに使用される各シートを示す平面図、であ
る。
【図8】図7(a)の各シートを境界画定点と共に示す
平面図である。
【図9】(a)図8の各シートを管状に巻いた状態で示
す斜視図、及び(b)図7(b)の各シートを管状に巻
いた状態で示す斜視図、である。
【図10】(a)図9(a)の各管を組立直前の状態で
示す斜視図、及び(b)図9(b)の各管を組立直前の
状態で示す斜視図、である。
【図11】(a)図9(a)及び図10(a)の各管を
組立後の状態で示す側面図、並びに(b)図9(b)及
び図10(b)の各管を組立後の状態で示す側面図、で
ある。
【図12】(a)図11(a)に示す組立後のステント
の端面図、(b)図11(b)に示す組立後のステント
の端面図、並びに(c)図7(a)及び(b)に示す各
シート形状の代わりに使用できるシート形状を示す平面
図、である。
【図13】本発明の第3実施形態に従って作製される二
股ステントに使用される茎及び第1脚部と第2脚部とを
示す斜視図である。
【図14】処置対象の本管腔及び枝管腔内に配置された
両ガイドワイヤを示す図である。
【図15】カテーテルに配置された図13に示す茎及び
第1脚部と、両ガイドワイヤとを、処置対象の管腔内に
挿入される前段階で示す図である。
【図16】図13に示す茎及び第1脚部を、処置対象の
分岐部分に送給した後でかつ膨張前の状態で示す図であ
る。
【図17】図16に示す第2脚部を膨張後の状態で示す
図である。
【図18】枝穴の膨張を示す図である。
【図19】枝穴内に配置された非膨張状態の第2脚部を
示す図である。
【図20】図19の第2脚部を膨張状態で示す図であ
る。
【図21】処置対象の分岐管腔内に配置された組立後の
二股ステントを示す図である。
【符号の説明】
5、50…二股ステント 10、55、130…第1脚部 15、60、140…第2脚部 20、65…茎部 25、70…第1シート 30、75…第2シート 35…第3シート 110…茎及び第1脚部 135…枝穴

Claims (3)

    【特許請求の範囲】
  1. 【請求項1】 二股ステントの作製方法であって、 a)第1縁、第2縁、第3縁及び第4縁を備えた第1シ
    ートを用意し、 b)第1縁、第2縁、第3縁及び第4縁を備えた第2シ
    ートを用意し、 c)第1縁、第2縁、第3縁及び第4縁を備えた第3シ
    ートを用意し、 d)前記第1シートの前記第2縁を該第1シートの前記
    第3縁に取付けて、基端及び末端を備える管状の第1脚
    部を形成し、 e)前記第2シートの前記第2縁を該第2シートの前記
    第3縁に取付けて、基端及び末端を備える管状の第2脚
    部を形成し、 f)前記第3シートの前記第2縁を該第3シートの前記
    第3縁に取付けて、基端及び末端を備える管状の茎部を
    形成し、 g)前記第1脚部の前記基端と前記第2脚部の前記基端
    とを前記茎部の前記末端に取付ける、各ステップを有し
    た方法。
  2. 【請求項2】 二股ステントの作製方法であって、 a)基端及び末端を備えた第1シートを用意し、 b)前記第1シートの前記末端を変形して第1脚部を形
    成するとともに、該第1シートの前記基端を変形して茎
    部第1半体を形成し、 c)基端及び末端を備えた第2シートを用意し、 d)前記第2シートの前記末端を変形して第2脚部を形
    成するとともに、該第2シートの前記基端を変形して茎
    部第2半体を形成し、 e)前記茎部第1半体を前記茎部第2半体に連結して茎
    部を形成する、各ステップを有した方法。
  3. 【請求項3】 二股ステントの作製方法であって、 a)基端、末端及び長手方向ボアを備え、該基端と該末
    端との間に該長手方向ボアに連通する枝穴が配置され、
    該枝穴が第2の膨張可能な管状部材を受容かつ固定する
    ように寸法設定されてなる第1の膨張可能な管状部材を
    用意し、 b)前記第1の膨張可能な管状部材を、第1管腔及び第
    2管腔を備えた分岐管に送給して、該第1の膨張可能な
    管状部材を該第1管腔内に配置するとともに、前記枝穴
    を該第2管腔に連通させ、 c)前記第1の膨張可能な管状部材を、該第1の膨張可
    能な管状部材が前記第1管腔内に固定されるに十分とな
    るまで膨張させ、 d)基端、末端及び長手方向ボアを備えた第2の膨張可
    能な管状部材を用意し、 e)前記枝穴を拡張させ、 f)前記第2の膨張可能な管状部材を前記枝穴に送給し
    て、該第2の膨張可能な管状部材の前記末端を前記第2
    管腔内に配置するとともに、該第2の膨張可能な管状部
    材の前記基端を前記第1の膨張可能な管状部材の前記長
    手方向ボア内に配置し、 g)前記第2の膨張可能な管状部材を、該第2の膨張可
    能な管状部材が前記第2管腔内及び前記枝穴内に固定さ
    れるに十分となるまで膨張させる、各ステップを有した
    方法。
JP11582297A 1996-05-03 1997-05-06 二股ステントとその作製方法 Expired - Lifetime JP3532730B2 (ja)

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NO972030L (no) 1997-11-04
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NO20012907L (no) 1997-11-04
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US6406489B1 (en) 2002-06-18
US6117156A (en) 2000-09-12
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US5755734A (en) 1998-05-26
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US5755735A (en) 1998-05-26
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