JP4307725B2 - 自己拡張性部分を有するバルーン拡張型ステント - Google Patents

自己拡張性部分を有するバルーン拡張型ステント Download PDF

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JP4307725B2
JP4307725B2 JP2000550419A JP2000550419A JP4307725B2 JP 4307725 B2 JP4307725 B2 JP 4307725B2 JP 2000550419 A JP2000550419 A JP 2000550419A JP 2000550419 A JP2000550419 A JP 2000550419A JP 4307725 B2 JP4307725 B2 JP 4307725B2
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stent
self
balloon
expandable
expanding
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JP2002516143A (ja
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シー. バーバ、アントニー
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Boston Scientific Limited
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958Inflatable balloons for placing stents or stent-grafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2002/065Y-shaped blood vessels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/821Ostial stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents 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 sheet material 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents 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
    • A61F2/91Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0048Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

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  • 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)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Description

【0001】
(発明の分野)
本発明は、新型の経管移植用ステントに関し、特に新規な血管ステントに関する。
【0002】
(発明の背景)
経管移植用ステントは広く知られている。それらは一般に、金属製の支持部材からなり、この支持部材が、胆管、尿路系、消化管あるいは血管内経皮経路などの人体の各部に挿入されるものであるが、通常は動脈が前記血管内経皮経路として知られており、この場合は特に血管ステントと称される。通常、ステントは概ね円筒形であり、体内の所定位置に配置されると放射状に拡張するように設計及び構成される。通常それらは、比較的小さな第一の径を持つ状態で挿入され、血管内などの所望の領域に移植され、続いて、第一の径よりも大きな第二の径に達するまでそので拡張せしめられる。通常は、カテーテルに付随するバルーンを使用して、必要な内部半径方向の力をステントに与え、ステントを半径方向に拡張する。バルーンのような内部半径方向の力を与える手段を使用せず、第一の径からそれより大きな第二の径へ拡張可能な自己拡張型ステントも知られている。そのような自己拡張型ステントの一つに、体温に晒されるとその第二の径まで拡張する形状記憶金属で作られたステントがある。そのようなステントもまた知られている。
米国特許第5366504号は体腔内で機能するために弛緩した状態で互いに絡み合った模様(織りループ)を有する管状壁部を備えた管状プロテーゼを開示している。プロテーゼは自己拡張性の固定端と、バルーン拡張性の壁部により形成されてもよい。
米国特許第5741325号は管内合成プロテーゼを開示している。プロテーゼは二叉状であってもよい。
【0003】
(発明の要旨)
本発明は、拡張のために内部半径方向の力を必要とする要素又は部分と、自己拡張要素又は部分とを併せ持つ新型のステントを提唱するものである。より詳細には、本発明による経管移植用ステントは複数の円筒形部分を好ましくは並設してなり、少なくとも一部分が自己拡張性であり、他の部分がバルーンカテーテルなどのように、その拡張に内部半径方向の力を必要とするものである。基本的に、ステントは、少なくとも二つの前記部分により構成されるが、二以上の部分により構成されてもよい。上記構成は、搬送カテーテルからステントを放出する際に、一部を即座に拡張させることにより、ステント設置を改善するものである。
【0004】
(好適な態様の詳細な説明)
図1は、自己拡張性と、バルーン拡張性とを併せ持つ、すなわち内部半径方向の力を利用して拡張することが必要なステントを示している。好ましくは、該ステントは、一端がバルーン拡張性ステント14の近位端と隣接して結合された自己拡張性部分12を有してなる。ステントの各部分は、隣り合う帯に跨る要素によって相互に連結された複数の波形帯で形成されたステントを含む従来技術による任意の公知ステントに準拠して形成することができる。ステント10の自己拡張性部分12は一の波形帯13で構成され、バルーン拡張型ステント14は結合要素17により相互に連結された複数の波形帯15で構成される。自己拡張性部分12は、相互結合要素19によってバルーン拡張性部分14と結合される。しかしながら自己拡張性部分12は、ステントをその搬送カテーテル(非図示)から放出する際に体温において自己拡張しうるように、ニチノールのような形状記憶金属で形成することが好ましい。部分12が即座に拡張することにより、放出中のステント配置が容易になり、この操作に続いてバルーン又は類似のものを使用して部分14を拡張させることができる。
【0005】
部分12は、例えば血管など、部分12が挿入される人体部分と真っ先に接触するように、より大きな直径を持つか、フレア状に広がってなる。この構成は、図2及び3に明瞭に示されており、これら図面は搬送カテーテルに装着された図1のステントと同様のステント10を示している。図2は、二つの部分12及び14を有してなるステントを示している。部分12は、自己拡張性部分であり、一方、部分14は、ステント内側に総括的に符号18で示される搬送カテーテルのバルーン16のように、拡張のために別の力を必要とするものである。図2においては、放出又は配置前のステントが示されており、自己拡張性部分が引込み式シース20により包囲されている。図3においては、前記シースが引き戻され、自己拡張性部分12が外側に開いている。続いて、バルーン16を公知の方法で使用して、部分14を拡張することができる。
【0006】
殆どのステント搬送カテーテルが、移植及びカテーテルからの放出に際してステントを剥き出しにする引込み式シースを含んでなるので、図示の如く自己拡張性部分12がステントの近位端に設けられる場合は、ステントの残りの部分がバルーン拡張によって拡張するまで、最も確実にステントを所定位置に固定することができる。この配置は好ましいものであるが、ステント本体における他の部分への配置も可能である。
【0007】
自己拡張性部分がステントの近位端に設けられる場合、ステントは、血管が二叉又は分岐型である場合の血管内ステント配置において特に有用となる。このようなステントが図4及び5に、符号10として模式的に示されている。図4は、近位端部分12を有してなるステントを示しており、該近位端部分は自己拡張性であり、一方、ステント本体の残りの部分14は、カテーテル18に装備されたバルーン16によりバルーン拡張可能なものである。図4においては、引込み式シースが既に引き戻され、大動脈のような主要血管から分岐する血管24の入口22において自己拡張性部分が拡張しており、その結果、より正確なステント配置が容易になる。図5は、バルーンカテーテルにより部分14が拡張し、カテーテルが引き戻された後のステントを示している。本発明によるステントは、分岐口近傍での確実なステント配置を可能にするものである。
【0008】
また本発明によるステントは、複数の自己拡張性部分と、複数のバルーン拡張性部分とからなるものであってもよい。これら部分のどのような組み合わせも、本発明の範囲内にあるものと思われる。例えば、図6を参照すると、バルーン膨張性部分114の両端にそれぞれ自己拡張性部分112を有してなるステント110が示されている。
ステント110の自己拡張性部分112は波形帯113で構成されてなり、バルーン拡張型ステント114は、結合要素117によって相互に連結された複数の波形帯115で構成されてなる。自己拡張性部分112は、相互結合要素119によってバルーン拡張性部分114に結合されてなる。
【0009】
ここで図7乃至10を参照して、本発明を利用する二叉ステントを説明する。一般に、二叉ステントは、三つの部分又は部材、すなわち一つの主幹と二つの分岐とで構成される。本発明を利用するにあたって、三つの部分いずれも、必要に応じてバルーン拡張性又は自己拡張性とすることができる。例えば、図7は、主幹30、第一分岐32及び第二分岐34を有し、まだ拡張していない状態にある二叉ステント10の一形態を模式的に示している。図示の如く、主幹30は前出図面における部分12と同様に自己拡張性であり、分岐32及び34は、前出図面における部分14と同様にバルーン拡張性である。
【0010】
図8は、分岐血管36内の移植位置にある図7のステントを示している。
図9は、主幹30及び分岐32、34からなり、まだ拡張していない状態にある二叉ステント10の他の形態を模式的に示している。この場合、主幹30及び分岐23は共に自己拡張性であり、分岐34はバルーン拡張性である。
【0011】
図10は、分岐血管36内の移植位置にある図9のステントを示している。
別の態様においては、主幹30をバルーン拡張性にし、分岐32、34を自己拡張性とすることも可能である。
以上の実施例及び開示は、例示的なものであって網羅的なものではない。これら実施例及び説明は、当該分野の通常の知識を有する者に多くの変形及び代替を暗示すると思われる。そのような代替及び変形の全ては、添付の請求項の範囲内に含まれるものと思われる。また当該分野に精通した者であれば、ここで記載された具体的態様と等価なものを認識することが可能であり、そのような等価なものもここに添付の請求項に包含されるものと思われる。
【図面の簡単な説明】
【図1】 本発明によるステントの一態様を示す図である。
【図2】 搬送カテーテルに装着された図1のステントと同様のステントを示す模式図である。
【図3】 移植のために放出されたステントと、図2の搬送カテーテルを示す模式図である。
【図4】 血管分岐形成状況下において使用される本発明ステントを示す模式図である。
【図5】 血管分岐形成状況下において使用される本発明ステントを示す模式図である。
【図6】 本発明によるステントの他の一態様を示す図である。
【図7】 本発明を利用する二叉ステントを示す模式図である。
【図8】 本発明を利用する二叉ステントを示す模式図である。
【図9】 本発明を利用する二叉ステントを示す模式図である。
【図10】 本発明を利用する二叉ステントを示す模式図である。

Claims (3)

  1. 主幹部と、同主幹部から延びる一方の分岐部と他方の分岐部とを含むステントにおいて、
    自己拡張可能な部分と、
    バルーン拡張型部分とからなり、
    前記自己拡張可能な部分は主幹部、一方の分岐部及び他方の分岐部のうちの1つ又は2つよりなり、バルーン拡張型部分は自己拡張可能な部分を構成する主幹部及び分岐部を除く部位からなることを特徴とするステント。
  2. 前記自己拡張可能な部分はニチノールから形成されることを特徴とする請求項1に記載のステント。
  3. 前記自己拡張可能な部分はステントの基端部を構成する請求項1または2に記載のステント。
JP2000550419A 1998-05-29 1999-05-26 自己拡張性部分を有するバルーン拡張型ステント Expired - Fee Related JP4307725B2 (ja)

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US09/087,526 US6168621B1 (en) 1998-05-29 1998-05-29 Balloon expandable stent with a self-expanding portion
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US6168621B1 (en) 2001-01-02
CA2326882C (en) 2009-01-20
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JP2002516143A (ja) 2002-06-04
EP1079768A1 (en) 2001-03-07
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