JP2004000791A - 二股ステントとその作製方法 - Google Patents

二股ステントとその作製方法 Download PDF

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JP2004000791A
JP2004000791A JP2003333781A JP2003333781A JP2004000791A JP 2004000791 A JP2004000791 A JP 2004000791A JP 2003333781 A JP2003333781 A JP 2003333781A JP 2003333781 A JP2003333781 A JP 2003333781A JP 2004000791 A JP2004000791 A JP 2004000791A
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tubular member
branch
lumen
proximal end
longitudinal bore
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JP4456842B2 (ja
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Jacob Richter
ヤコブ リヒター
Gregory Pinchasik
グレゴリー ピンチャシク
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Medinol Ltd
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Abstract

【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160は、第1の管状部材110と第2の管状部材140とから組立てられる。第1の管状部材110は、基端115、末端120及びそれらを貫通する長手方向ボア131を備え、基端115と末端120との間に長手方向ボア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を受容かつ固定するように寸法設定される。第2の管状部材140は、基端145、末端150及びそれらを貫通する長手方向ボア132を備え、基端145が第1の管状部材110の長手方向ボア131内に配置されるように枝穴135内に配置される。
【選択図】   図9

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とその作製方法に関する。
 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及びその作製方法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、二股ステントの作製方法であって、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な大きさに膨張させ、d)基端、末端及びそれらを貫通する長手方向ボアを備えた前記第2の膨張可能な管状部材を用意し、e)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、f)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な大きさに膨張させる、各ステップを有することを特徴とする二股ステント作製方法を提供する。
 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作製方法において、前記枝穴を拡張するステップをさらに有する二股ステント作製方法を提供する。
 請求項3に記載の発明は、請求項1に記載の二股ステント作製方法において、前記枝穴を、枝固定リップを形成するに十分な広さに拡張するステップをさらに有する二股ステント作製方法を提供する。
 請求項4に記載の発明は、請求項2又は3に記載の二股ステント作製方法において、前記枝穴を拡張する前記ステップを、前記第2の膨張可能な管状部材を前記枝穴に送給する前記ステップe)に関連して行う二股ステント作製方法を提供する。
 請求項5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内に配置されるように前記枝穴内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6に記載の発明は、請求項5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内に固定する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7に記載の発明は、請求項6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 (7)

  1.  二股ステントの作製方法であって、
     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な大きさに膨張させ、
     d)基端、末端及びそれらを貫通する長手方向ボアを備えた前記第2の膨張可能な管状部材を用意し、
     e)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、
     f)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な大きさに膨張させる、
    各ステップを有することを特徴とする二股ステント作製方法。
  2.  前記枝穴を拡張するステップをさらに有する請求項1に記載の二股ステント作製方法。
  3.  前記枝穴を、枝固定リップを形成するに十分な広さに拡張するステップをさらに有する請求項1に記載の二股ステント作製方法。
  4.  前記枝穴を拡張する前記ステップを、前記第2の膨張可能な管状部材を前記枝穴に送給する前記ステップe)に関連して行う請求項2又は3に記載の二股ステント作製方法。
  5.  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内に配置されるように前記枝穴内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。
  6.  前記枝穴に設置され、前記第2の管状部材を該枝穴内に固定する枝固定リップをさらに具備する請求項5に記載の二股ステント。
  7.  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6に記載の二股ステント。
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