JP2004041766A - 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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JP2004041766A
JP2004041766A JP2003333592A JP2003333592A JP2004041766A JP 2004041766 A JP2004041766 A JP 2004041766A JP 2003333592 A JP2003333592 A JP 2003333592A JP 2003333592 A JP2003333592 A JP 2003333592A JP 2004041766 A JP2004041766 A JP 2004041766A
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edge
sheet
leg
bifurcated stent
proximal end
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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22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。
【選択図】   図4

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)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2縁に対向する該第1シートの前記第4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縁に対向する該第2シートの前記第4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2縁に対向する該第3シートの前記第4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、前記第1シートと前記第2シートとが実質的同一の寸法を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、前記第1シートと前記第2シートとが異なる寸法を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1に記載の二股ステント作製方法において、前記取付けステップがねじ留めを利用して行われる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、請求項1に記載の二股ステント作製方法において、前記取付けステップがひだ付けを利用して行われる二股ステント作製方法を提供する。
 請求項6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、前記取付けステップがはんだ付けを利用して行われる二股ステント作製方法を提供する。
 請求項7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、前記取付けステップが溶接を利用して行われる二股ステント作製方法を提供する。
 請求項8に記載の発明は、請求項7に記載の二股ステント作製方法において、前記溶接がスポット溶接を利用して行われる二股ステント作製方法を提供する。
 請求項9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、前記ステントを食刻して、膨張時にその最終寸法を呈するように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10に記載の発明は、a)第1縁、第2縁、第3縁及び第4縁を備えた第1シートと、b)第1縁、第2縁、第3縁及び第4縁を備えた第2シートと、c)第1縁、第2縁、第3縁及び第4縁を備えた第3シートとを具備し、d)前記第1シートの前記第2縁が、該第2縁に対向する該第1シートの前記第4縁に取付けられて、基端及び末端を備える管状の第1脚部が形成され、e)前記第2シートの前記第2縁が、該第2縁に対向する該第2シートの前記第4縁に取付けられて、基端及び末端を備える管状の第2脚部が形成され、f)前記第3シートの前記第2縁が、該第2縁に対向する該第3シートの前記第4縁に取付けられて、基端及び末端を備える管状の茎部が形成され、g)前記第1脚部の前記基端と前記第2脚部の前記基端とが前記茎部の前記末端に取付けられてなること、を特徴とする二股ステントを提供する。
 請求項11に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1シートと前記第2シートとが実質的同一の寸法を有する二股ステントを提供する。
 請求項12に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1シートと前記第2シートとが異なる寸法を有する二股ステントを提供する。
 請求項13に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1、第2及び第3シートの取付けがねじを用いて行われる二股ステントを提供する。
 請求項14に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1、第2及び第3シートの取付けがひだを用いて行われる二股ステントを提供する。
 請求項15に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1、第2及び第3シートの取付けがはんだを用いて行われる二股ステントを提供する。
 請求項16に記載の発明は、請求項10に記載の二股ステントにおいて、前記第1、第2及び第3シートの取付けが溶接を用いて行われる二股ステントを提供する。
 請求項17に記載の発明は、請求項16に記載の二股ステントにおいて、前記溶接がスポット溶接である二股ステントを提供する。
 請求項18に記載の発明は、請求項10に記載の二股ステントにおいて、前記ステントが食刻され、膨張時にその最終寸法を呈するようになっ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、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、二股ステントが容易に作製される。
 図1は、本発明の一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、15、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31、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38及び第4縁39を備える。板金を切断して各シート25、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14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を画定する。第2脚部15は基端16及び末端17を備え、長手方向ボア18を画定する。茎部20は基端21及び末端22を備え、長手方向ボア23を画定する。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。
本発明の一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3の各管を組立前の状態で示す斜視図である。 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5に示す組立後のステントの頂面図である。
符号の説明
5…二股ステント
10…第1脚部
11、16、21…基端
12、17、22…末端
13、18、23…長手方向ボア
15…第2脚部
20…茎部
25…第1シート
26、31、36…第1縁
27、32、37…第2縁
28、33、38…第3縁
29、34、39…第4縁
30…第2シート
35…第3シート

Claims (18)

  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2縁に対向する該第1シートの前記第4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縁に対向する該第2シートの前記第4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2縁に対向する該第3シートの前記第4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、
    各ステップを有することを特徴とする二股ステント作製方法。
  2.  前記第1シートと前記第2シートとが実質的同一の寸法を有する請求項1に記載の二股ステント作製方法。
  3.  前記第1シートと前記第2シートとが異なる寸法を有する請求項1に記載の二股ステント作製方法。
  4.  前記取付けステップがねじ留めを利用して行われる請求項1に記載の二股ステント作製方法。
  5.  前記取付けステップがひだ付けを利用して行われる請求項1に記載の二股ステント作製方法。
  6.  前記取付けステップがはんだ付けを利用して行われる請求項1に記載の二股ステント作製方法。
  7.  前記取付けステップが溶接を利用して行われる請求項1に記載の二股ステント作製方法。
  8.  前記溶接がスポット溶接を利用して行われる請求項7に記載の二股ステント作製方法。
  9.  前記ステントを食刻して、膨張時にその最終寸法を呈するように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。
  10.  a)第1縁、第2縁、第3縁及び第4縁を備えた第1シートと、
     b)第1縁、第2縁、第3縁及び第4縁を備えた第2シートと、
     c)第1縁、第2縁、第3縁及び第4縁を備えた第3シートとを具備し、
     d)前記第1シートの前記第2縁が、該第2縁に対向する該第1シートの前記第4縁に取付けられて、基端及び末端を備える管状の第1脚部が形成され、
     e)前記第2シートの前記第2縁が、該第2縁に対向する該第2シートの前記第4縁に取付けられて、基端及び末端を備える管状の第2脚部が形成され、
     f)前記第3シートの前記第2縁が、該第2縁に対向する該第3シートの前記第4縁に取付けられて、基端及び末端を備える管状の茎部が形成され、
     g)前記第1脚部の前記基端と前記第2脚部の前記基端とが前記茎部の前記末端に取付けられてなること、
    を特徴とする二股ステント。
  11.  前記第1シートと前記第2シートとが実質的同一の寸法を有する請求項10に記載の二股ステント。
  12.  前記第1シートと前記第2シートとが異なる寸法を有する請求項10に記載の二股ステント。
  13.  前記第1、第2及び第3シートの取付けがねじを用いて行われる請求項10に記載の二股ステント。
  14.  前記第1、第2及び第3シートの取付けがひだを用いて行われる請求項10に記載の二股ステント。
  15.  前記第1、第2及び第3シートの取付けがはんだを用いて行われる請求項10に記載の二股ステント。
  16.  前記第1、第2及び第3シートの取付けが溶接を用いて行われる請求項10に記載の二股ステント。
  17.  前記溶接がスポット溶接である請求項16に記載の二股ステント。
  18.  前記ステントが食刻され、膨張時にその最終寸法を呈するようになっている請求項10に記載の二股ステント。
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