JP6047596B2 - 素線末端を固定するための方法およびその結果得られる装置 - Google Patents
素線末端を固定するための方法およびその結果得られる装置 Download PDFInfo
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- JP6047596B2 JP6047596B2 JP2015018202A JP2015018202A JP6047596B2 JP 6047596 B2 JP6047596 B2 JP 6047596B2 JP 2015018202 A JP2015018202 A JP 2015018202A JP 2015018202 A JP2015018202 A JP 2015018202A JP 6047596 B2 JP6047596 B2 JP 6047596B2
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- Materials For Medical Uses (AREA)
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Description
本出願は、全体の内容が明確に参照により組み入れられる、2006年10月22日出願の米国特許仮出願第60/862,456号に対する優先権を主張する。
本発明は全体として、解剖学的構造体における配置に適した装置のワイヤーのような素線の末端を固定するための技術および構造、ならびにその結果得られる装置に関連する。そのような装置の例は、撚り合わせの自己拡張性ステントを含む。
一つまたは複数の素線から作成される、解剖学的構造体への挿入に適切な装置の例は、全てが参照により組み入れられる米国特許第6,007,574号(特許文献1);同第6,419,694号(特許文献2);および同第7,018,401号(特許文献3)、ならびに米国特許出願公開第2005/0049682号(特許文献4)および同第2006/0116752号(特許文献5)に見出される。
[本発明1001]
解剖学的構造体への挿入のために構成される装置の第一の素線末端部分へ結合構造を固定する段階、ならびに
装置の第二の素線部分へ結合構造を固定する段階
を含む、方法であって、
第一および第二素線末端部分が実質的に並列され、
結合構造が装置の素線ではなく、かつ
装置が、ニッケルおよびチタンを含む一つまたは複数の素線を含む、
方法。
[本発明1002]
装置が、撚り合わせの自己拡張性ステントである、本発明1001の方法。
[本発明1003]
第一および第二素線末端部分への結合構造の固定の前に存在する通路を結合構造が有する、本発明1001の方法。
[本発明1004]
装置が、二つまたはそれ以上の装置末端を含む撚り合わせの自己拡張性ステントであり、
各装置末端が素線屈曲によって規定され、かつ
全ての装置末端の素線屈曲が、実質的に類似の形態を有する、
本発明1001の方法。
[本発明1005]
結合構造が第一溶接領域を形成する溶接によって第一素線末端部分へ固定され、
結合構造が第二溶接領域を形成する溶接によって第二素線末端部分へ結合され、かつ
第一および第二溶接領域が別の溶接領域によって互いに直接連結されていない、
本発明1001の方法。
[本発明1006]
結合構造が第一素線末端部分および第二素線末端部分とは別の材料断片である、方法であって、
固定段階の前に、
固定構造を第一素線末端部分と直接接触させる段階、ならびに
固定構造を第二素線末端部分と直接接触させる段階
をさらに含む、
本発明1005の方法。
[本発明1007]
装置が多数の半素線を含み、かつ
各半素線が他の一つの素線のみへ固定される、
本発明1001の方法。
[本発明1008]
結合構造が、結合構造を横切る装置の素線の下方に配置される、本発明1001の方法。
[本発明1009]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置末端よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも一つの素線交差の分だけ間隔をあけられる、
本発明1001の方法。
[本発明1010]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも三つの素線交差によって規定される少なくとも一つの装置開口部の分だけ間隔をあけられる、
本発明1001の方法。
[本発明1011]
結合構造が、レーザー溶接によって第一素線末端部分へ固定される、本発明1001の方法。
[本発明1012]
結合構造が、レーザー溶接によって第二素線末端部分へ固定される、本発明1011の方法。
[本発明1013]
結合構造の第一および第二素線末端部分へのレーザー溶接が、部分的に自動化される、本発明1012の方法。
[本発明1014]
第二結合構造を装置の第三素線末端部分へ固定する段階、および
第二結合構造を装置の第四素線末端部分へ固定する段階
をさらに含む、本発明1001の方法。
[本発明1015]
一つの結合構造を装置の素線末端部分の他の5対の各々へ固定する段階をさらに含む、本発明1001の方法。
[本発明1016]
結合構造を軸方向に並列する、本発明1015の方法。
[本発明1017]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1015の方法。
[本発明1018]
一つの結合構造を装置の素線末端の他の5対の各々へレーザー溶接する段階をさらに含む、方法であって、
各結合構造がニッケルおよびチタンを含み、かつ各素線末端部分がニッケルおよびチタンを含む、本発明1001の方法。
[本発明1019]
他の5対の一つが装置の二つの異なる素線の末端部分を含む、本発明1018の方法。
[本発明1020]
他の5対の一つが装置の同一素線の末端部分を含む、本発明1018の方法。
[本発明1021]
結合構造を軸方向に並列する、本発明1018の方法。
[本発明1022]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1018の方法。
[本発明1023]
装置が、各々がニッケルおよびチタンを含む4つの異なる素線を含む、本発明1001の方法。
[本発明1025]
装置が、各々がニッケルおよびチタンを含む5つの異なる素線を含む、本発明1001の方法。
[本発明1026]
装置が、各々がニッケルおよびチタンを含む6つの異なる素線を含む、本発明1001の方法。
[本発明1027]
解剖学的構造体への挿入のために構成される装置の第一素線末端部分へ結合構造を溶接する段階、ならびに
装置の第二素線末端部分へ結合構造を溶接する段階
を含む、方法であって、
結合構造が装置の素線ではなく、かつ
装置が、一つまたは複数のニッケルおよびチタンを含む素線を含む、
方法。
[本発明1028]
第一素線末端部分を第二素線末端部分と実質的に並列する、本発明1027の方法。
[本発明1029]
装置が、撚り合わせの自己拡張性ステントである、本発明1027の方法。
[本発明1030]
第一および第二素線末端部分への結合構造の溶接の前に存在する通路を結合構造が有する、本発明1027の方法。
[本発明1031]
装置が、二つまたはそれ以上の装置末端を含む撚り合わせの自己拡張性ステントであり、
各々の装置末端が素線屈曲によって定義され、かつ
全ての装置末端の素線屈曲が実質的に類似の形態を有する、
本発明1027の方法。
[本発明1032]
第一溶接領域が結合構造を第一素線末端部分へ溶接することによって形成され、
第二溶接領域が結合構造を第二素線末端部分へ溶接することによって形成され、かつ
第一および第二溶接領域が別の溶接領域によって互いに直接連結されていない、
本発明1027の方法。
[本発明1033]
結合構造が第一素線末端部分および第二素線末端部分とは別の材料断片である、方法であって、
溶接段階の前に、
固定構造を第一素線末端部分と直接接触させる段階、ならびに
固定構造を第二素線末端部分と直接接触させる段階
をさらに含む、
本発明1032の方法。
[本発明1034]
装置が多数の半素線を含み、かつ
いかなる半素線も複数の他の半素線へは溶接されない、
本発明1027の方法。
[本発明1035]
結合構造が、結合構造を横切る装置の素線の下方に配置される、本発明1027の方法。
[本発明1036]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置末端よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも一つの素線交差の分だけ間隔をあけられる、
本発明1027の方法。
[本発明1037]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも三つの素線交差によって規定される少なくとも一つの装置開口部の分だけ間隔をあけられる、
本発明1027の方法。
[本発明1038]
結合構造が、レーザー溶接によって第一素線末端部分へ溶接される、本発明1027の方法。
[本発明1039]
結合構造が、レーザー溶接によって第二素線末端部分へ溶接される、本発明1038の方法。
[本発明1040]
結合構造の第一および第二素線末端部分へのレーザー溶接が、部分的に自動化される、本発明1039の方法。
[本発明1041]
第二結合構造を装置の第三素線末端部分へ溶接する段階、および
第二結合構造を装置の第四素線末端部分へ溶接する段階
をさらに含む、本発明1027の方法。
[本発明1042]
一つの結合構造を装置の素線末端部分の他の5対の各々へ溶接する段階をさらに含む、本発明1027の方法。
[本発明1043]
結合構造を軸方向に並列する、本発明1042の方法。
[本発明1044]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1042の方法。
[本発明1045]
一つの結合構造を装置の素線末端部分の他の5対の各々へレーザー溶接する段階をさらに含む、方法であって、
各結合構造がニッケルおよびチタンを含み、各素線末端部分がニッケルおよびチタンを含む、
本発明1027の方法。
[本発明1046]
他の5対の一つが、装置の二つの異なる素線の末端部分を含む、本発明1045の方法。
[本発明1047]
他の5対の一つが、装置の同一素線の末端部分を含む、本発明1045の方法。
[本発明1048]
結合構造を軸方向に並列する、本発明1045の方法。
[本発明1049]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1045の方法。
[本発明1050]
装置が、各々がニッケルおよびチタンを含む4つの異なる素線を含む、本発明1027の方法。
[本発明1051]
装置が、各々がニッケルおよびチタンを含む5つの異なる素線を含む、本発明1027の方法。
[本発明1052]
装置が、各々がニッケルおよびチタンを含む6つの異なる素線を含む、本発明1027の方法。
[本発明1053]
二つの異なる素線末端部分がニッケルおよびチタンを含み、かつ
結合構造が装置の素線ではない、
互いに実質的に並列された二つの異なる素線末端部分へ固定された結合構造
を含む、一つまたは複数の素線を有しかつ解剖学的構造体への挿入のために構成される装置。
[本発明1054]
撚り合わせの自己拡張性ステントとして構成される、本発明1053の装置。
[本発明1055]
結合構造が、二つの素線末端部分が配置される通路を有する、本発明1053の装置。
[本発明1056]
各々の装置末端が素線屈曲によって規定され、かつ
全ての装置末端の素線屈曲が実質的に類似の形態を有する、
二つまたはそれ以上の装置末端を含み、
撚り合わせの自己拡張性ステントとして構成される、
本発明1053の装置。
[本発明1057]
結合構造が、第一溶接領域を形成する溶接によって第一素線末端部分へ固定され、
結合構造が、第二溶接領域を形成する溶接によって第二素線末端部分へ固定され、かつ
第一および第二溶接領域が別の溶接領域によって互いに直接連結されていない、
本発明1053の装置。
[本発明1058]
装置が多数の半素線を含み、かつ
各半素線が他の一つの半素線のみへ固定される、
本発明1053の装置。
[本発明1059]
結合構造が、結合構造を横切る装置の素線の下方に配置される、本発明1053の装置。
[本発明1060]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置末端よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも一つの素線交差の分だけ間隔をあけられる、
本発明1053の装置。
[本発明1061]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも三つの素線交差によって規定される少なくとも一つの装置開口部の分だけ間隔をあけられる、
本発明1053の装置。
[本発明1062]
結合構造が、第一素線末端部分へレーザー溶接される、本発明1053の装置。
[本発明1063]
結合構造が、第二素線末端部分へレーザー溶接される、本発明1062の装置。
[本発明1064]
別の対の素線末端部分へ固定された第二結合構造をさらに含む、本発明1053の装置。
[本発明1065]
素線末端部分の他の5対の各々へ固定された一つの結合構造をさらに含む、本発明1053の装置。
[本発明1066]
結合構造を軸方向に並列する、本発明1065の装置。
[本発明1067]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1065の装置。
[本発明1068]
各結合構造がニッケルおよびチタンを含み、かつ
各素線末端部分がニッケルおよびチタンを含む、
装置の素線末端部分の他の5対の各々へレーザー溶接された一つの結合構造
をさらに含む、本発明1032の装置。
[本発明1069]
他の5対の一つが、装置の二つの異なる素線の末端部分を含む、本発明1068の装置。
[本発明1070]
他の5対の一つが、装置の同一素線の末端部分を含む、本発明1068の装置。
[本発明1071]
結合構造を軸方向に並列する、本発明1068の装置。
[本発明1072]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1068の装置。
[本発明1073]
二つの異なる素線末端部分がニッケルおよびチタンを含み、かつ
結合構造が装置の素線ではない、
二つの異なる素線末端部分へ溶接された結合構造
を含む、一つまたは複数の素線を有しかつ解剖学的構造体への挿入のために構成される装置。
[本発明1074]
撚り合わせの自己拡張性ステントとして構成される、本発明1073の装置。
[本発明1075]
結合構造が、二つの素線末端部分が配置される通路を有する、本発明1073の装置。
[本発明1076]
各々の装置末端が素線屈曲によって規定され、かつ
全ての装置末端の素線屈曲が実質的に類似の形態を有する、
二つまたはそれ以上の装置末端を含み、
撚り合わせの自己拡張性ステントとして構成される、
本発明1073の装置。
[本発明1077]
装置が、第一素線末端部分を結合構造へ固定する溶接によって形成される第一溶接領域、および第二素線末端部分を結合構造へ固定する溶接によって形成される第二溶接領域を含み、かつ
第一および第二溶接領域が、別の溶接領域によって互いに直接連結されていない、
本発明1073の装置。
[本発明1078]
装置が多数の半素線を含み、かつ
各半素線が他の一つの半素線のみへ固定される、
本発明1073の装置。
[本発明1079]
結合構造が、結合構造を横切る装置の素線の下方に配置される、本発明1073の装置。
[本発明1080]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置末端よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも一つの素線交差の分だけ間隔をあけられる、
本発明1073の装置。
[本発明1081]
装置が、少なくとも二つの装置末端および縦軸を含み、
結合構造が、該装置末端の一つに任意の他の装置よりも近接し、かつ
結合構造が、縦軸に対して実質的に平行な線に沿った最も近接した装置末端から離れて、少なくとも3つの素線交差によって規定される少なくとも一つの装置開口部の分だけ間隔をあけられる、
本発明1073の装置。
[本発明1082]
結合構造が、第一素線末端部分へレーザー溶接される、本発明1073の装置。
[本発明1083]
結合構造が、第二素線末端部分へレーザー溶接される、本発明1082の装置。
[本発明1084]
別の対の素線末端部分へ溶接された第二結合構造をさらに含む、本発明1073の装置。
[本発明1085]
素線末端部分の他の5対の各々へ溶接された一つの結合構造をさらに含む、本発明1073の装置。
[本発明1086]
結合構造を軸方向に並列する、本発明1085の装置。
[本発明1087]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1085の装置。
[本発明1088]
各結合構造がニッケルおよびチタンを含み、かつ
各素線末端部分がニッケルおよびチタンを含む、
装置の素線末端部分の他の5対の各々へレーザー溶接された一つの結合構造
をさらに含む、本発明1032の装置。
[本発明1089]
他の5対の一つが、装置の二つの異なる素線の末端部分を含む、本発明1088の装置。
[本発明1090]
他の5対の一つが、装置の同一素線の末端部分を含む、本発明1088の装置。
[本発明1091]
結合構造を軸方向に並列する、本発明1088の装置。
[本発明1092]
二つまたはそれ以上の結合構造が、装置の周縁で互いに軸からはずれる、本発明1088の装置。
「含む(comprise)」(ならびに「含む(comprises)」および「含んでいる(comprising)」のような、含む(comprise)の任意の形態)、「有する(have)」(ならびに「有する(has)」および「有している(having)」のような、有する(have)の任意の形態)、「含む(contain)」(ならびに「含む(contains)」および「含んでいる(containing)」のような、含む(contain)の任意の形態)、ならびに「含む(include)」(ならびに「含む(includes)」および「含んでいる(including)」のような、含む(include)の任意の形態)という語は、開放型の連結動詞である。結果として、一つもしくは複数の要素を「含む(comprises)」、「有する(has)」、「含む(contains)」もしくは「含む(includes)」装置または方法は、それらの一つもしくは複数の要素を所有するが、一つもしくは複数のそれらの要素または段階のみを所有することに限定されない。同様に、一つもしくは複数の特徴を「含む(comprises)」、「有する(has)」、「含む(contains)」もしくは「含む(includes)」装置の要素または方法の段階は、それらの一つもしくは複数の特徴を所有するが、一つもしくは複数のそれらの特徴のみを所有することに限定されない。さらに、特定の様式で構成される構造体は、少なくともその様式で構成されねばならないが、特定されない様式で構成されてもよい。
ステントを部分的に逆方向に編み込み(例えば、手作業によって)、これは12個のうちのワイヤー末端の6個をステント中へ編みこむことを意味する。
任意の適切なワイヤー交差部位から開始して(例えば、逆方向に編み込まれた末端から第四または第五ワイヤー交差)、上に記載されるようなワイヤー末端が交差ワイヤー下で接触するように、ワイヤー末端を切断する。
結合構造をワイヤー末端に搭載し、かつステントの内径が正確に設定されるようにマンドレル上での間、結合構造を交差ワイヤーの中心に置く。
ステントとマンドレルとの間の相対運動を防止するために、ステントの内径を正確に設定するために、かつ結合構造内部でのワイヤー末端部分の適切な設置を保持するために、バネに搭載されたクリップを用いてステントの結合領域をマンドレルへ固定する。
マンドレルが取り付けられ、その後、固定されたステントをレーザー溶接システム中に置き、かつシステムの閲覧スクリーン上で第一結合構造を水平方向の十字線と並列させる。
溶接されるステントのサイズに関する、溶接プログラム(以下に提供される例)を起動する。かつ、
操作者は、結合の上部左隅と十字線を合わせるよう促される。合わせられると、操作者は開始ボタンを押し、かつ左側溶接ビードが作成される。その後、システムは、移動し、かつ操作者に上部右隅へ十字線を合わせるよう促す。合わせられると、操作者は開始ボタンを押し、かつ右側溶接ビードが作成される。その後、システムが第二結合の上部左隅に移動し、かつ工程を繰り返す。これは、全ての12回の溶接が完了するまで継続する。
4 mm ID ステント
5 mm ID ステント
6 mm ID ステント
7 mm ID ステント
8 mm ID ステント
9 mm ID ステント
10 mm ID ステント
Claims (15)
- 以下の段階を含む、自己拡張性ステントを形成する方法:
第一の素線屈曲および各第一の素線屈曲の両側における素線部分をもたらすために複数の素線のそれぞれを屈曲させることによって、該ステントの第一の末端を形成する段階であって、該素線部分のそれぞれが末端を有する、段階;
該素線部分を撚り合わせる段階であって、第二の素線屈曲をもたらすために該素線部分の一部を屈曲させることを含み、第二の素線屈曲が該ステントの第二の末端を画定する、段階;ならびに
複数の結合構造のそれぞれを一対の該素線部分末端へ固定する段階であって、該素線部分末端の該対が、2本の異なる素線または同一の素線の2つの素線部分末端を含み、結合構造の数が素線の数と等しく、結合構造が素線とは異なっており、固定する段階が、素線部分末端の該対を末端同士並列させることを含み、かつ固定する段階が、少なくとも1本の交差素線を、該結合構造から半径方向外側の位置において結合構造のそれぞれを超えて交差させることをさらに含む、段階。 - 素線部分を撚り合わせる段階の後に複数の素線を熱処置する段階をさらに含む、請求項1記載の方法。
- 撚り合わせる段階が、素線部分末端をステントの第二の末端に近接して配置することを含む、請求項1または2記載の方法。
- 固定する段階が、素線部分末端を結合構造へ溶接することを含む、請求項1〜3のいずれか一項記載の方法。
- 溶接することが、第一の溶接領域および第二の溶接領域を形成することを含み、第一の溶接領域が、結合構造の長さに沿って第二の溶接領域から空間的に離れている、請求項4記載の方法。
- 素線部分を撚り合わせる段階が機械で撚り合わせることを含む、請求項1〜5のいずれか一項記載の方法。
- 第一の素線屈曲の両側における素線部分をそれぞれ含む複数の素線であって、該素線部分のそれぞれが末端を有し、第一のステント本体末端と第二のステント本体末端の間に複数の素線交差部を含むステント本体を形成するために該素線部分が撚り合わされ、1つの該素線部分が、該素線交差部のそれぞれにおいて他の1つの該素線部分と交差し、第一の素線屈曲が第一のステント本体末端を画定し、該素線部分のいくつかが第二の素線屈曲を含み、第二の素線屈曲が第二のステント本体末端を画定し、該素線部分末端の対が末端同士並列しており、該素線部分末端の該対のそれぞれが2本の異なる素線または同一の素線の2つの素線部分末端を含む、複数の素線;ならびに
複数の結合構造であって、該結合構造の数が該素線の数と等しく、該結合構造が該素線とは異なっており、該結合構造のそれぞれが該素線部分末端の対のうち1つへ固定されており、少なくとも1本の交差素線が該結合構造から半径方向外側の位置において該結合構造のそれぞれを超えて交差している、複数の結合構造
を含む、自己拡張性ステント。 - 素線部分末端が第二のステント本体末端に近接して配置されている、請求項7記載のステント。
- 結合構造のそれぞれが、溶接部分を形成するために、素線部分末端の対における素線部分末端のそれぞれへ溶接されている、請求項7または8記載のステント。
- 溶接部分が第一の溶接領域および第二の溶接領域を含み、第一の溶接領域が、結合構造の長さに沿って第二の溶接領域から空間的に離れている、請求項9記載のステント。
- 結合構造のそれぞれが、1本の素線を収容するよう寸法付けされた直径を有する通路を含む、請求項7〜10のいずれか一項記載のステント。
- 素線部分末端の各対における素線部分末端が互いに空間的に離れている、請求項7〜11のいずれか一項記載のステント。
- 素線がニチノールを含む、請求項7〜12のいずれか一項記載のステント。
- 結合構造がニチノールを含む、請求項7〜13のいずれか一項記載のステント。
- 複数の素線が6本の素線である、請求項7〜14のいずれか一項記載のステント。
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