JP4456842B2 - 二股ステント - Google Patents

二股ステント Download PDF

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JP4456842B2
JP4456842B2 JP2003333781A JP2003333781A JP4456842B2 JP 4456842 B2 JP4456842 B2 JP 4456842B2 JP 2003333781 A JP2003333781 A JP 2003333781A JP 2003333781 A JP2003333781 A JP 2003333781A JP 4456842 B2 JP4456842 B2 JP 4456842B2
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tubular member
branch
bifurcated stent
longitudinal bore
proximal end
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JP2004000791A (ja
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リヒター ヤコブ
ピンチャシク グレゴリー
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Medinol Ltd
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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
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    • A61F2/856—Single tubular stent with a side portal passage
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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
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    • 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 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
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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
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    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
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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
    • A61F2/95—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
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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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    • 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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    • 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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    • 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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    • Y10T29/00—Metal working
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    • Y10T29/494—Fluidic or fluid actuated device making

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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)

Description

本発明はステントに関し、特に、分岐管内に挿入される二股ステントに関する。
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。
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。
上記米国特許第４，９９４，０７１号に開示された二股ステントの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。
本発明の目的は、従来技術における上記課題を解決可能な、茎部と２個の脚部とを備えた二股ステントを提供することにある。
上記目的を達成するために、請求項１に記載の発明は、茎部に接続される２個の脚部を有する二股ステントであって、ａ）基端、末端及びそれらを貫通する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べく配置される枝穴が設けられ、該枝穴が第２の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の管状部材と、ｂ）基端、末端及びそれらを貫通する長手方向ボアを備え、該基端が前記第１の管状部材の前記長手方向ボアの内部に配置されるように、前記枝穴の内側に配置される前記第２の管状部材と、を具備することを特徴とする二股ステントを提供する。
請求項２に記載の発明は、請求項１に記載の二股ステントにおいて、前記枝穴に設置され、前記第２の管状部材を該枝穴の内側に固定するための枝固定リップをさらに具備する二股ステントを提供する。
請求項３に記載の発明は、請求項２に記載の二股ステントにおいて、前記枝固定リップが前記枝穴の拡張により形成されている二股ステントを提供する。
本発明によれば、二股ステントは第１の管状部材と第２の管状部材とから構成される。第１の管状部材は、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の管状部材の基端と末端との間には枝穴が配置される。第２の管状部材は、第１の管状部材の基端によって形成される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、それにより第２の脚部を形成する。この状態で、第２の管状部材を膨張させると、第２の管状部材の基端が、枝穴を画定する部分の材料に係合し、それにより第２の脚部が所望位置に容易に固定される。
本発明においては、２つの部材を患部内に順次に配置して患部内で組立てることにより、二股ステントが作製される。図１は、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、それらを貫通する長手方向ボア１３１とを備えた第１の管状部材１１０を示す。第２脚部１４０は、基端１４５と末端１５０とそれらを貫通する長手方向ボア１３２とを備えた第２の管状部材１４０から構成される。第１の管状部材１１０と第２の管状部材１４０とは、いずれも膨張可能であって、後述するように膨張段階を経て組立てたときに、その最終寸法を呈するように寸法設定される。また、第１及び第２の管状部材１１０、１４０はいずれも、用途に応じて、様々なパターンを有する孔群を食刻等により形成することにより、所要の膨張容易性を得ることができる。
第１の管状部材１１０の基端１１５と末端１２０との間には、長手方向ボア１３１に連通すべく配置される枝穴１３５が設けられる。枝穴１３５は、第２の管状部材１４０を受容する寸法を有し、第２の管状部材１４０が枝穴１３５内で膨張したときに、第２の管状部材１４０を係合固定するようになっている。第２の管状部材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２〜図９は、二股ステントを分岐管内で組立てる手順を示す。図２〜図９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とを備えた分岐管である。図２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３に示すように、バルーン方式で膨張可能な第１の管状部材１１０は、バルーン１７５を長手方向ボア１３１内に配置するようにして、第１バルーンカテーテル１７０（以下、第１カテーテル１７０と称する）の先端に配置される。また、第２バルーンカテーテル１７１（以下、第２カテーテル１７１と称する）が、第１の管状部材１１０の長手方向ボア１３１内に導入され、バルーン１７６が枝穴１３５内に位置す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１７１は第２ガイドワイヤ１５６に装着される。
非膨張状態の第１の管状部材１１０は、図４に示すように、第１脚部１３０が本管腔１９０内に配置されるとともに、枝穴１３５が枝管腔１９５に連通するようにして、処置領域に案内される。このとき第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。なお、カテーテル及びバルーンの寸法は従来一般的なもので良く、当業者に周知の他の詳細事項も省略する。次に、図５に示すように、バルーン１７５の膨張により第１の管状部材１１０を膨張させ、それにより第１の管状部材１１０を本管腔１９０内の所望位置に固定する。第１の管状部材１１０の外壁は、膨張後に本管腔１９０の内壁に接触するが、図では理解を助けるために隙間を故意に残して示す。続いて、第１カテーテル１７０のバルーン１７５を膨張状態に保持した状態で、図６に示すように、第２カテーテル１７１のバルーン１７６の膨張により枝穴１３５を拡張する。枝穴１３５が拡張するに従い、枝穴１３５を画定するステントの一部分が外側に押され、それにより枝固定リップ１８０が形成される。
次に、両バルーン１７５、１７６を抜気し、第２カテーテル１７１を第１の管状部材から引抜く一方で、第２ガイドワイヤ１５６を枝管腔１９５内の適所に残す。続いて、バルーン１７６を長手方向ボア１３２内に配置するようにして第２の管状部材１４０を第２カテーテル１７１に取付け、この第２カテーテル１７１を第２ガイドワイヤ１５６に装着する。そして図７に示すように、第２の管状部材１４０を、第１の管状部材１１０の長手方向ボア１３１内に案内しつつ導入し、かつ枝穴１３５を通して前進させる。それにより、第２の管状部材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に配置する。
図示の状態で、第２カテーテル１７１のバルーン１７６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。そして図８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の管状部材１４０が膨張し、第２の管状部材１４０の外壁が枝穴１３５の周辺領域（すなわち枝固定リップ１８０）に係合して固定される。このようにして、第１の管状部材１１０からなる茎部１２５及び第１脚部１３０と、第２の管状部材１４０からなる第２脚部１４０とから、二股ステント１６０が分岐管内で組立てられる。なお、第１カテーテル１７０のバルーン１７５の膨張は、第２カテーテル１７１のバルーン１７６の膨張時に第１の管状部材１１０を折曲させないように作用する。また膨張後に、第２の管状部材１４０の外壁は枝管腔１９５の内壁に接触するが、図では理解を助けるために隙間を故意に残して示す。最後に、両バルーン１７５、１７６を抜気し、両ガイドワイヤ１５５、１５６を分岐管から引抜く一方で、組立てられた二股ステント１６０を図９に示すように分岐管内の適所に残す。
本発明の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第１の管状部材と第２の管状部材とを示す斜視図である。 処置対象の本管腔及び枝管腔内に配置された一対のガイドワイヤを示す図である。 カテーテル上に配置された図１の第１の管状部材と、図２の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１に示す第１の管状部材を、処置対象の管腔の分岐部分に送給した後の、膨張前の状態で示す図である。 図４の第１の管状部材を膨張した後の状態で示す図である。 枝穴の膨張を示す図である。 非膨張状態の第２の管状部材を枝穴内に配置した状態を示す図である。 図７の第２の管状部材を膨張した後の状態で示す図である。 処置対象の分岐管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
１１０…第１の管状部材
１１５…基端
１２０…末端
１２５…茎部
１３０…第１脚部
１３１…長手方向ボア
１３２…長手方向ボア
１３５…枝穴
１４０…第２の管状部材（第２脚部）
１４５…基端
１５０…末端
１６０…二股ステント
１８０…枝固定リップ
１９０…第１（本）管腔
１９５…第２（枝）管腔

Claims (3)

  1. 茎部に接続される２個の脚部を有する二股ステントであって、
    ａ）基端、末端及びそれらを貫通する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べく配置される枝穴が設けられ、該枝穴が第２の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の管状部材と、
    ｂ）基端、末端及びそれらを貫通する長手方向ボアを備え、該基端が前記第１の管状部材の前記長手方向ボアの内部に配置されるように、前記枝穴の内側に配置される前記第２の管状部材と、
    を具備することを特徴とする二股ステント。
  2. 前記枝穴に設置され、前記第２の管状部材を該枝穴の内側に固定するための枝固定リップをさらに具備する請求項１に記載の二股ステント。
  3. 前記枝固定リップが前記枝穴の拡張により形成されている請求項２に記載の二股ステント。
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