JP6026741B2 - 組織層を固定するための組織アンカ及び組織を接近させるシステム - Google Patents
組織層を固定するための組織アンカ及び組織を接近させるシステム Download PDFInfo
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- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
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Description
(発明の分野)
本発明は、概して、医療方法および医療デバイスに関する。特に、本発明は、組織アンカと、医療手順において複数の隣接する組織層を締結する際に組織アンカを使用する方法とに関する。
特許文献3は、十二指腸から胆嚢に前進する針を有する経口的に前進するカテーテルによってなされた貫通を介して導入された、内視鏡で十二指腸による胆汁ドレナージシステムを記載する。特許文献2は、針および内視鏡を用いて胃から偽嚢胞まで自己拡張ステントを配置するシステムを記載する。本願と同一人に譲渡された特許文献1は、内視鏡手順または超音波内視鏡検査ガイド(超音波)手順のための組織貫通デバイスを記載し、ここではアンカが、複数の体腔(腸、胃および胆嚢を含む)の間の吻合を形成するように配置され得る。同様に、米国特許第5,458,131号、米国特許第5,495,851号、米国特許第5,944,738号、米国特許第6,007,522号、米国特許第6,231,587号、米国特許第6,655,386号、米国特許第7,273,451号、米国特許第7,309,341号、米国出願公開特許第2004/0243122号、米国出願公開特許第2004/0249985号、米国出願公開特許第2007/0123917号、国際公開第2006/062996号、欧州特許第1314404号、非特許文献1および非特許文献2も参照されたい。
本発明にしたがう組織アンカは、織物フィラメント組物から形成された本体を備えている。フィラメントは、典型的には、金属ワイヤであり、より典型的には、ニッケル−チタンあるいは他の超弾性または形状記憶金属ワイヤである。代替的には、弾性が、それほど重要でない場合には、フィラメントは、ポリマー材料(ポリプロピレン、ポリエチレン、ポリエステル、ナイロン、PTFE、など)から形成され得る。いくつかの場合において、生体吸収可能または生体分解可能材料(典型的には、生体分解可能ポリマー、例えば、ポリ−L−乳酸(PLLA)が使用を見出され得る。
本発明は、例えば、以下も提供する。
(項目1)
織物フィラメント編組で形成された本体を備えている組織アンカであって、該本体は、細長い管状構成と、短縮された構成とを有し、該短縮された構成において、該本体の近位端部と遠位端部とが、二重壁フランジ構成に拡張され、該二重壁フランジ構成の間に円筒形のサドル領域が存在する、組織アンカ。
(項目2)
前記管状本体は、前記細長い管状構成内の中心軸に沿った開放性通路を規定する、項目1に記載の組織アンカ。
(項目3)
前記管状本体は、前記細長い管状構成内の中心軸に沿って閉鎖されている、項目1に記載の組織アンカ。
(項目4)
前記本体の少なくとも一部分の上に膜をさらに備えている、項目1に記載の組織アンカ。
(項目5)
シースが前記細長い構成と前記短縮された構成の両方とにおいて、前記本体に適合するエラストマー膜を備えている、項目4に記載の組織アンカ。
(項目6)
前記二重壁フランジ構造は、1g/mm〜100g/mmの範囲の所定の曲げ剛性を有する、項目1に記載の組織アンカ。
(項目7)
前記細長い管状本体は、7mm〜100mmの範囲の直径を有する、項目1に記載の組織アンカ。
(項目8)
前記二重壁フランジ構造は、3mm〜70mmの範囲の直径を有し、前記サドル領域は、前記短縮された構成において1mm〜40mmの範囲の直径を有する、項目7に記載の組織アンカ。
(項目9)
前記本体上の前記フランジは、該本体が拘束から解放されるとき、自己拡張する、項目1に記載の組織アンカ。
(項目10)
前記フランジは、事前形成された本体構成に拡張する、項目9に記載の組織アンカ。
(項目11)
前記本体の前記複数の端部を接合する弾性テザーをさらに備え、該弾性テザーは、該本体を短縮し、前記フランジを拡張する軸方向の引っ張りを加える、項目9に記載の組織アンカ。
(項目12)
前記本体を前記短縮された構成に維持するロックをさらに備えている、項目9に記載の組織アンカ。
(項目13)
前記ロックは、前記本体内にロッドまたはシリンダを備えており、該ロッドまたはシリンダは、該本体が短縮されているとき、該本体の両方の端部をラッチする、項目12に記載の組織アンカ。
(項目14)
前記円筒形サドル領域の上部に配置されたスリーブをさらに備えている、項目9に記載の組織アンカ。
(項目15)
前記本体上の前記フランジは、該本体の前記複数の端部に軸方向の引っ張りを加えることによって拡張される、項目1に記載の組織アンカ。
(項目16)
前記本体の一端部に取り付けられた少なくとも1つの軸方向部材をさらに備え、該軸方向部材は、該本体を短縮するように引かれることが可能である、項目15に記載の組織アンカ。
(項目17)
前記軸方向部材は、複数のテザーを含む、項目16に記載の組織アンカ。
(項目18)
前記テザーは、前記本体の前記サドル領域の上部と、該本体の前記フランジ領域の前記管腔内とに位置する、項目17に記載の組織アンカ。
(項目19)
前記軸方向部材は、前記本体の管腔内にロッドまたはシリンダを備えている、項目16に記載の組織アンカ。
(項目20)
前記軸方向部材は、前記短縮された構成において前記本体をロックする、項目16に記載の組織アンカ。
(項目21)
組織アンカを送達するシステムであって、該システムは、
項目9に記載の組織アンカと、
シースを備えている送達カテーテルであって、該シースは、該組織アンカの本体を該組織アンカの細長い管状構成にし、該本体を解放し、前記フランジが容易に拡張することを可能にするように該アンカに対して後退させられる、送達カテーテルと
を備えている、システム。
(項目22)
組織アンカを送達するシステムであって、該システムは、
項目16に記載の組織アンカと、
組織アンカを解放可能に保持するアクチュエータを備えている送達カテーテルであって、該送達カテーテルは、前記フランジを拡張し、該アンカを展開するように前記軸方向部材を係合し、引くためのアクチュエータを含む、送達カテーテルと
を備えている、システム。
(項目23)
組織を接近させる方法であって、該方法は、
2つの隣接する層に整列した貫通を形成することと、
該整列した貫通を通して、織物フィラメント編組で形成された本体を備えている組織アンカを前進させることであって、該本体は、前進している間、細長い管状構成である、ことと、
該本体の遠位端部と近位端部とを、それぞれ二重壁フランジ構造に変形させて、該遠位端部と該近位端部との間に円筒形のサドル領域を残すように該本体を短縮することであって、該フランジ構造は、該貫通内に配置された該サドル領域を伴う該組織層を押し付ける、ことと
を包含する、方法。
(項目24)
前記本体は、有意な組織壊死または癒着を引き起こすことなしに、前記組織を一緒に保持するように、該組織に十分な圧力を加えるように短縮される、項目23に記載の方法。
(項目25)
前記加えられる圧力は、0.025psi〜2.5psiの範囲にある、項目24に記載の方法。
(項目26)
前記隣接する層は、食道、胃、十二指腸、小腸、大腸、胆管、膵管、胆嚢、膵臓、膵仮性嚢胞、肝臓、横隔膜、および下腿(curs)の組織から選択される、項目23に記載の方法。
(項目27)
前記形成することと前記前進させることとは、
体腔内の組織壁上の標的位置近くにカテーテルを配置することと、
該貫通を形成するように、該カテーテルから貫通要素を前進させることと、
前記短縮することの前に、該カテーテルを通して前記組織アンカを配置するように該貫通を通して該カテーテルを前進させることと
を包含する、項目23に記載の方法。
(項目28)
前記短縮することは、前記フランジが自己拡張するように、拘束から前記細長い管状本体を解放することを包含する、項目23に記載の方法。
(項目29)
前記短縮することは、前記複数の端部をより近くに引くために前記本体に軸方向の引っ張りを加えることを包含する、項目23に記載の方法。
図1に示されるように、本発明の原理にしたがって構築される組織アンカ10は、本体12を備え、本体12はその各端部にキャップ14を有する。本体12は、織物フィラメント編組を備え、その細長い管状構成において示されている。この特定の実施形態において、本体12は、超弾性材料(典型的にはニチノールまたはeligiloy)から形成され得,熱設定され、その結果、放射方向の拘束力または軸方向の伸張力がない場合に、本体は、各端部において形成された二重壁フランジを有するその記憶構成に戻る。複数のフランジ16のうちの1つが図1に破線で示され、一方、図3A〜図3Fは、フランジ16の様々な構成を示す。
Claims (26)
- 織物フィラメント編組で形成された本体を備えている組織アンカであって、該本体は、細長い管状構成と、短縮された構成とを有し、該短縮された構成において、該本体の近位端部と遠位端部とが、二重壁フランジ構造に放射方向に拡張され、該遠位端部と該近位端部との間に円筒形の接続領域を残し、該円筒形の接続領域は、長手方向軸を有し、該本体は、該細長い管状構成内に中心軸に沿った開放性通路を規定し、各二重壁フランジ構造は、一対の壁を有し、該一対の壁のそれぞれは、該短縮された構成において、該円筒形の接続領域の長手方向軸に対して垂直に整列され、該組織アンカは、該組織アンカの外部全体にわたって形成されたシリコーン膜をさらに含み、該膜は、該細長い管状構成および該短縮された構成の両方において、該膜と該組織アンカとの間に隙間が存在しないように該組織アンカに適合する、組織アンカ。
- 前記二重壁フランジ構造は、1g/mm〜100g/mmの範囲の所定の曲げ剛性を有する、請求項1に記載の組織アンカ。
- 前記本体は、前記細長い管状構成において7mm〜100mmの範囲の長さを有する、請求項1に記載の組織アンカ。
- 前記二重壁フランジ構造は、3mm〜70mmの範囲の直径を有し、前記接続領域は、前記短縮された構成において1mm〜40mmの範囲の直径を有する、請求項3に記載の組織アンカ。
- 前記本体上の前記フランジは、該本体が拘束から解放されるとき、自己拡張する、請求項1に記載の組織アンカ。
- 前記フランジは、事前形成された本体構成に拡張する、請求項5に記載の組織アンカ。
- 前記本体の前記複数の端部を接合する弾性テザーをさらに備え、該弾性テザーは、該本体を短縮し、前記フランジを拡張する軸方向の引っ張りを加える、請求項1に記載の組織アンカ。
- 前記本体を前記短縮された構成に維持するロックをさらに備えている、請求項5に記載の組織アンカ。
- 前記ロックは、前記本体内にロッドまたはシリンダを備えており、該ロッドまたはシリンダは、第1のロッキング端部と第2のロッキング端部とを備え、該本体が短縮されているとき、該第1のロッキング端部は、該本体の第1の端部を係合し、該第2のロッキング端部は、該本体の第2の端部を係合する、請求項8に記載の組織アンカ。
- 前記円筒形の接続領域は、前記本体の中心部分のみを覆うように配置されたスリーブによって規定される、請求項5に記載の組織アンカ。
- 前記本体上の前記フランジは、該本体の前記複数の端部に軸方向の引っ張りを加えることによって拡張される、請求項1に記載の組織アンカ。
- 前記本体の一端部に取り付けられた少なくとも1つの軸方向部材をさらに備え、該軸方向部材は、該本体を短縮するように引かれることが可能である、請求項11に記載の組織アンカ。
- 前記軸方向部材は、複数のテザーを含む、請求項12に記載の組織アンカ。
- 前記テザーは、前記本体の前記接続領域に位置し、かつ、該本体の前記フランジ領域の管腔内に位置する、請求項13に記載の組織アンカ。
- 前記軸方向部材は、前記本体の管腔内にロッドまたはシリンダを備えている、請求項12に記載の組織アンカ。
- 前記軸方向部材は、前記短縮された構成において前記本体をロックする、請求項12に記載の組織アンカ。
- 組織アンカを送達するシステムであって、該システムは、
請求項5に記載の組織アンカと、
シースを備えている送達カテーテルであって、該シースは、該組織アンカの本体を該組織アンカの細長い管状構成にし、該本体を解放し、前記フランジが放射方向に拡張することを可能にするように該アンカに対して後退させられる、送達カテーテルと
を備えている、システム。 - 組織アンカを送達するシステムであって、該システムは、
請求項12に記載の組織アンカと、
該組織アンカを解放可能に保持するアクチュエータを備えている送達カテーテルであって、該アクチュエータは、前記フランジを拡張し、該アンカを展開するように前記軸方向部材を係合し、引くためのアクチュエータを含む、送達カテーテルと
を備えている、システム。 - 組織を接近させるシステムであって、該システムは、
2つの隣接する組織層に整列した貫通を形成する手段と、
該整列した貫通を通して、織物フィラメント編組で形成された本体を備えている組織アンカを前進させる手段であって、該本体は、前進している間、細長い管状構成である、手段と
を備え、
該本体は、該本体の遠位端部および近位端部のそれぞれを二重壁フランジ構造に変形させて、該遠位端部と該近位端部との間に円筒形の接続領域を残すように短縮されるように構成され、該円筒形の接続領域は、長手方向軸を有し、該本体は、該細長い管状構成内に中心軸に沿った開放性通路を規定し、各二重壁フランジ構造は、一対の壁を有し、該一対の壁のそれぞれは、該短縮された構成において、該円筒形の接続領域の長手方向軸に対して垂直に整列され、該組織アンカは、該組織アンカの外部全体にわたって形成されたシリコーン膜をさらに含み、該膜は、該細長い管状構成および該短縮された構成の両方において、該膜と該組織アンカとの間に隙間が存在しないように該組織アンカに適合し、
該二重壁フランジ構造は、該貫通内に配置された該接続領域を伴う該組織層を押し付ける、システム。 - 前記本体は、有意な組織壊死または癒着を引き起こすことなしに、前記組織を一緒に保持するように、該組織に十分な圧力を加えるように短縮される、請求項19に記載のシステム。
- 前記加えられる圧力は、0.172kPa〜17.2kPaの範囲にある、請求項20に記載のシステム。
- 前記隣接する組織層は、食道、胃、十二指腸、小腸、大腸、胆管、膵管、胆嚢、膵臓、膵仮性嚢胞、肝臓、横隔膜、および下腿の組織から選択される、請求項19に記載のシステム。
- 前記形成する手段と前記前進させる手段とは、
体腔内の組織壁上の標的位置近くに配置されるカテーテルと、
該貫通を形成するように、該カテーテルから前進させられるように構成された貫通要素と
を備え、
該カテーテルは、前記本体が短縮される前に、該カテーテルを通して前記組織アンカを配置するように該貫通を通して前進させられるように構成される、請求項19に記載のシステム。 - 前記細長い管状本体は、前記本体が短縮されるときに前記フランジが自己拡張するように、拘束から解放されるように構成される、請求項19に記載のシステム。
- 前記本体は、さらに、前記複数の端部をより近くに引くために前記本体に軸方向の引っ張りを加えるように、短縮されるように構成される、請求項19に記載のシステム。
- 前記組織アンカは、移植の後に取り外し可能である、請求項1に記載の組織アンカ。
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EP2273942A4 (en) | 2012-08-15 |
EP2273942B1 (en) | 2016-04-20 |
JP2015142790A (ja) | 2015-08-06 |
US20130253546A1 (en) | 2013-09-26 |
US20090281557A1 (en) | 2009-11-12 |
JP2011519709A (ja) | 2011-07-14 |
EP2273942A1 (en) | 2011-01-19 |
US10076330B2 (en) | 2018-09-18 |
WO2009140195A1 (en) | 2009-11-19 |
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