JP2009536082A5 - - Google Patents
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- JP2009536082A5 JP2009536082A5 JP2009510075A JP2009510075A JP2009536082A5 JP 2009536082 A5 JP2009536082 A5 JP 2009536082A5 JP 2009510075 A JP2009510075 A JP 2009510075A JP 2009510075 A JP2009510075 A JP 2009510075A JP 2009536082 A5 JP2009536082 A5 JP 2009536082A5
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- 210000001519 tissues Anatomy 0.000 claims description 201
- 238000007906 compression Methods 0.000 claims description 45
- 239000000789 fastener Substances 0.000 claims description 44
- 210000001847 Jaw Anatomy 0.000 claims description 32
- 239000000463 material Substances 0.000 claims description 14
- 230000000149 penetrating Effects 0.000 claims description 12
- 239000000523 sample Substances 0.000 claims description 10
- 238000006065 biodegradation reaction Methods 0.000 claims description 8
- 210000001008 Atrial Appendage Anatomy 0.000 claims description 6
- 210000001520 Comb Anatomy 0.000 claims description 6
- 229920002635 polyurethane Polymers 0.000 claims description 6
- 239000004814 polyurethane Substances 0.000 claims description 6
- 210000000088 Lip Anatomy 0.000 claims description 5
- 230000000087 stabilizing Effects 0.000 claims description 5
- 230000000875 corresponding Effects 0.000 claims description 4
- 229910052710 silicon Inorganic materials 0.000 claims description 4
- 239000010703 silicon Substances 0.000 claims description 4
- 238000001356 surgical procedure Methods 0.000 claims description 4
- 239000000126 substance Substances 0.000 claims description 3
- 239000003242 anti bacterial agent Substances 0.000 claims description 2
- 239000002260 anti-inflammatory agent Substances 0.000 claims description 2
- 230000003115 biocidal Effects 0.000 claims description 2
- 230000003287 optical Effects 0.000 claims description 2
- 229920001296 polysiloxane Polymers 0.000 claims description 2
- 230000002335 preservative Effects 0.000 claims 1
- 239000003755 preservative agent Substances 0.000 claims 1
- 230000035515 penetration Effects 0.000 description 3
- 230000002421 anti-septic Effects 0.000 description 1
- 230000003601 intercostal Effects 0.000 description 1
Description
本発明は、例えば、以下を提供する：
（項目１）
２つの対向する順応性のある組織係合表面を有する圧縮体と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位における組織を通り該組織係合表面のうちの第２の組織係合表面に延在するように配置され、その間の組織構造を閉鎖する１つ以上の組織貫通ファスナと
を備える、組織閉鎖装置。
（項目２）
上記組織係合表面の一方は安定化リップを含み、他方の組織係合表面よりも面積が大きい、項目１に記載の組織閉鎖装置。
（項目３）
上記穿刺部位に隣接し、上記組織係合表面の１つに配置された開放ウェルをさらに含む、項目１に記載の組織閉鎖装置。
（項目４）
上記組織貫通ファスナは、上記対向する組織係合表面上に整列した雄コネクタと雌コネクタを含む、項目１に記載の組織閉鎖装置。
（項目５）
上記第１の組織係合表面の中へ延在する上記雄コネクタのバーブの周囲に配置された開放ウェルをさらに含み、該開放ウェルは該バーブよりも直径が大きい、項目４に記載の組織閉鎖装置。
（項目６）
上記第２の組織係合表面の中へ延在する上記雌コネクタに隣接して配置された開放ウェルをさらに含む、項目４に記載の組織閉鎖装置。
（項目７）
上記雄コネクタおよび雌コネクタは、それぞれ後ろ向きの凹部を含む、項目４に記載の組織閉鎖装置。
（項目８）
上記圧縮体は、各凹部に対応するウェルを含む、項目７に記載の組織閉鎖装置。
（項目９）
上記圧縮体は、全体が順応性のある材料で形成される、項目１に記載の組織閉鎖装置。
（項目１０）
上記雄コネクタと雌コネクタは、互いにしっかりと係合し、上記組織係合表面の間に規定の距離を形成するように構成される、項目４に記載の組織閉鎖装置。
（項目１１）
上記圧縮体の上記順応性のある表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目１に記載の組織閉鎖装置。
（項目１２）
上記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目１に記載の組織閉鎖装置。
（項目１３）
上記順応性のある圧縮体は、一対の平行に対向する脚を含み、各脚は組織係合表面を担持する、項目１に記載の組織閉鎖装置。
（項目１４）
各脚は、雄コネクタまたは雌コネクタのいずれかを担持する、項目１に記載の組織閉鎖装置。
（項目１５）
上記平行に対向する脚が、連続した環状構造を形成するように接続される、項目１３に記載の組織閉鎖装置。
（項目１６）
上記脚は、一端のみにおいて結合される、項目１３に記載の組織閉鎖装置。
（項目１７）
上記脚は、いずれの端においても結合されない、項目１３に記載の組織閉鎖装置。
（項目１８）
上記圧縮体は、該順応性のある圧縮体の各脚とともに真空プレナムをさらに備える、項目１３に記載の組織閉鎖装置。
（項目１９）
上記真空プレナムは、上記圧縮体の上記脚の少なくとも１つの表面に沿う複数のポートに対して開き、該ポートは、上記組織貫通ファスナとは異なる方向に配向される、項目１８に記載の組織閉鎖装置。
（項目２０）
上記ポートは、上記ファスナに対して略垂直な角度で配向される、項目１９に記載の組織閉鎖装置。
（項目２１）
上記プレナムは、真空プローブを受容する少なくとも１つのポートを有する、項目１８に記載の組織閉鎖装置。
（項目２２）
上記圧縮体は、生分解性材料で形成される、項目１に記載の組織閉鎖装置。
（項目２３）
上記ファスナは、生分解性材料を備えている、項目１に記載の組織閉鎖装置。
（項目２４）
上記ファスナは、展開前は上記圧縮体内に完全に含まれ、展開後は該圧縮体を越えて延在しない、項目１に記載の組織閉鎖装置。
（項目２５）
左心耳の基部を閉鎖するシステムであって、
対向する組織係合表面を有する順応性のある圧縮体を含む閉鎖装置と、
該閉鎖装置を取り外し可能に固定し、該装置を該組織構造の周囲または上に配置するために開く、閉鎖装置アプリケータと、
該アプリケータおよび閉鎖装置を通る真空パスであって、該装置を該組織構造に接着させるために、該装置が該組織構造上にある場合に、該閉鎖装置と該組織構造との間に真空を適用する、真空パスと、
一方の組織係合表面から該組織構造を通って他方の組織係合表面に展開可能であり、その間の該組織構造を閉鎖する複数のファスナと
を備える、システム。
（項目２６）
上記順応性のある圧縮体の上記表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目２５に記載のシステム。
（項目２７）
上記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目２５に記載のシステム。
（項目２８）
上記順応性のある圧縮体は、一対の脚を含み、各脚は対向する組織係合表面を担持する、項目２５に記載のシステム。
（項目２９）
上記対向する脚は、連続した環状構造を形成するように接続される、項目２８に記載のシステム。
（項目３０）
上記脚は、一端のみにおいて結合される、項目２８に記載のシステム。
（項目３１）
上記脚は、いずれの端においても結合されない、項目２８に記載のシステム。
（項目３２）
上記閉鎖装置アプリケータは、２つのプローブを担持する顎機構を備え、各プローブは、上記順応性のある圧縮体の一方の脚を取り外し可能に係合する、項目２８に記載のシステム。
（項目３３）
上記プローブの少なくとも１つは、上記真空パスの一部を提供する管腔を有する、項目３２に記載のシステム。
（項目３４）
上記少なくとも１つのプローブは、上記閉鎖装置の順応性のある圧縮体の少なくとも一方の脚における真空プレナムに受容される、項目３３に記載のシステム。
（項目３５）
上記真空プレナムは、上記少なくとも２つの組織係合表面の少なくとも一部の上で開く、項目３４に記載の組織閉鎖装置。
（項目３６）
上記プレナムは、上記組織係合表面上に分散した複数のポートを通じて開く、項目３５に記載の組織閉鎖装置。
（項目３７）
上記プレナムは、上記プローブを受容するポートを有する、項目３４に記載の組織閉鎖装置。
（項目３８）
上記顎機構の上記プローブは、機械的に広がる機構により結合される、項目３２に記載のシステム。
（項目３９）
上記機械的に広がる機構は、上記脚を平行に開くラックアンドピニオン機構を備える、項目３８に記載のシステム。
（項目４０）
上記機械的に広がる機構は、上記脚を旋回的に開く旋回機構を備える、項目３８に記載のシステム。
（項目４１）
組織構造を閉鎖する方法であって、
該組織構造上に圧縮体を配置するステップであって、少なくとも２つの順応性のある組織係合表面が該構造の両側を係合する、ステップと、
該圧縮体を通じて真空を適用し、該表面を該組織構造に接着させるステップと、
該真空の適用を継続しながら、該表面の少なくとも１つから該組織を通して他方の表面にファスナを展開し、該組織構造を閉鎖するステップと
を含む、方法。
（項目４２）
上記組織構造は左心耳である、項目４１に記載の方法。
（項目４３）
上記配置するステップは、上記圧縮材を肋間部に進めるステップを含む、項目４２に記載の方法。
（項目４４）
上記配置するステップは、アプリケータ上で上記順応性のある圧縮体を担持するステップと、該アプリケータを使用して上記組織係合表面を広げるステップと、上記真空を適用する前に該広げた脚を上記組織構造上で閉鎖するステップと
を含む、項目４２に記載の方法。
（項目４５）
上記ファスナを展開するステップは、雄要素を、上記組織係合表面のいずれか一方または両方から対向する組織係合表面における雌要素に進めるステップを含む、項目４１に記載の方法。
（項目４６）
上記ファスナを展開するステップは、バーブ針を一方の組織係合表面から他方の組織係合表面に進めるステップを含む、項目４１に記載の方法。
（項目４７）
手術の少なくとも一部の間、光学スコープを通して上記組織構造を見るステップをさらに含む、項目４１に記載の方法。
（項目４８）
手術の少なくとも一部の間、経皮的開口を通して上記組織構造を直接見るステップをさらに含む、項目４１に記載の方法。
（項目４９）
上記圧縮体を通じて物質を上記組織構造に導入するステップをさらに含む、項目４１に記載の方法。
（項目５０）
上記物質は、抗生物質、防腐剤、または抗炎症薬である、項目４９に記載の方法。
（項目５１）
上記ファスナを展開した後に、上記圧縮体より上の位置において上記組織構造を切除するステップをさらに含む、項目４１に記載の方法。
（項目５２）
上記ファスナは、展開後に上記圧縮体の外側に延在しない、項目４１に記載の方法。
（項目５３）
上記ファスナを展開し、０．２５ｐｓｉ〜２０ｐｓｉの範囲の圧力で上記組織に対して上記組織係合表面を閉鎖する、項目４１に記載の方法。
（項目５４）
上記圧力は０．２５ｐｓｉ〜１．５ｐｓｉの範囲である、項目５３に記載の方法。
（項目５５）
左心耳の基部を閉鎖するシステムであって、
対向する順応性のある組織係合表面を有する圧縮体を含む閉鎖装置と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位の組織を通って該組織係合表面のうちの第２の組織係合表面に延在し、その間の該組織構造を閉鎖するように配置された１つ以上の組織貫通ファスナであって、該ファスナのそれぞれは、後ろ向きの凹部を含む、ファスナと、
該閉鎖装置を設置するための、一対の顎を含む閉鎖装置アプリケータと、
一対の整列コームであって、それぞれのコームは該アプリケータの顎に連結され、該ファスナの凹部を解放可能に係合するように構成された１つ以上のスタッドを含み、該アプリケータの該顎は、該ファスナを展開させるために、該一対のコームを動かし、より近づけるように構成される、コームと
を備える、システム。
（項目５６）
上記一対の顎は、上記一対の整列コームおよび一対の外部顎に連結された一対の内部顎を備え、上記アプリケータは、該内部顎を独立に動かして該外部顎から離し、上記スタッドを上記凹部から解放するように構成される、項目５５に記載のシステム。
（項目５７）
上記顎は、平行に開くように構成される、項目５５に記載のシステム。
（項目５８）
上記顎は、ピボットを中心に開くように構成される、項目５５に記載のシステム。
（項目５９）
上記組織閉鎖装置は、上記穿刺部位に隣接する、上記組織係合表面の１つに配置された開放ウェルをさらに備えている、項目５５に記載のシステム。
（項目６０）
上記組織貫通ファスナは、上記対向する組織係合表面に整列した雄コネクタおよび雌コネクタを備えている、項目５９に記載のシステム。
（項目６１）
上記雄コネクタは、組織を穿通するように構成された鋭利な端部を有するバーブを含む、項目６０に記載のシステム。
（項目６２）
上記開放ウェルは、上記バーブの周囲に配置され、上記第１の組織係合表面の中に延在し、該開放ウェルは該バーブの直径より大きい、項目６１に記載のシステム。
（項目６３）
上記開放ウェルは、上記雌コネクタに隣接して配置され、上記第２の組織係合表面の中に延在する、項目６１に記載のシステム。
（項目６４）
上記圧縮体は、全体が順応性のある材料で形成される、項目５５に記載のシステム。
（項目６５）
上記圧縮体はウェルを含み、該ウェルは、上記スタッドが上記凹部に係合するのを可能にするように構成された、該凹部のそれぞれに対応する、項目５５に記載のシステム。
（項目６６）
上記雄コネクタおよび雌コネクタは、互いにしっかりと係合し、上記組織係合表面の間に規定の距離を形成するように構成される、項目６０に記載のシステム。
（項目６７）
上記組織係合表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目５５に記載のシステム。
（項目６８）
上記組織係合表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目６７に記載のシステム。
（項目６９）
上記圧縮体は、一対の平行に対向する脚を備え、各脚は、組織係合表面と、上記雄コネクタまたは上記雌コネクタのいずれかとを担持する、項目６０に記載のシステム。
（項目７０）
上記組織係合表面の一方は、安定化リップを含み、他方の組織係合表面よりも面積が大きい、項目５５に記載のシステム。
（項目７１）
上記圧縮体は、生分解性材料で形成される、項目５５に記載のシステム。
（項目７２）
上記ファスナは、生分解性材料を備えている、項目５５に記載のシステム。
（項目７３）
上記顎は、アプリケータシャフトの平面からオフセットした平面に配置される、項目５５に記載のシステム。
（項目７４）
上記オフセットは１０〜４５°である、項目７３に記載のシステム。
（項目７５）
上記オフセットは１０〜２５°である、項目７３に記載のシステム。
（項目７６）
上記顎のうちの一方の遠位から展開するように構成されたラッソワイヤをさらに備え、該ワイヤは、該顎間のスペースを封鎖するように他方の顎の遠位端に固定される、項目５５に記載のシステム。
本発明は、組織構造を閉鎖する代替および改良型装置、システム、および方法を提供する。本発明の実施形態は、組織構造の両側に係合する２つの対向する順応性のある表面を有する圧縮体を含む組織閉鎖装置を提供する。順応性のある表面は、組織構造の表面に一致する柔軟性を有することが望ましい。閉鎖装置は、組織構造と同様の柔軟性および動的性能を有することが望ましい。ファスナは、対向する順応性のある表面に隣接して圧縮体内に配置され、少なくとも１つの組織貫通ファスナは、第１の順応性のある表面から現れ、穿通部位における介在組織を通過して第２の順応性のある表面に至り、第２ファスナをしっかりと係合して２つの表面間の組織を圧縮するように構成される。開放ウェルは、穿通部位周囲の順応性のある表面のいずれか一方または両方に配置されてもよい。ここで、組織貫通ファスナは、介在組織を通過し、穿通部位の周囲にガスケット密閉を形成する。安定化リップを一方の順応性のある表面上に提供し、一方の表面が他方の表面より大きくなるようにしてもよい。また真空ポートを順応性のある表面内に提供し、組織構造の表面を係合するようにしてもよい。閉鎖装置のファスナは、閉鎖装置の設置に使用される装置アプリケータと相互作用する開いた管腔または凹部を含んでもよい。
（項目１）
２つの対向する順応性のある組織係合表面を有する圧縮体と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位における組織を通り該組織係合表面のうちの第２の組織係合表面に延在するように配置され、その間の組織構造を閉鎖する１つ以上の組織貫通ファスナと
を備える、組織閉鎖装置。
（項目２）
上記組織係合表面の一方は安定化リップを含み、他方の組織係合表面よりも面積が大きい、項目１に記載の組織閉鎖装置。
（項目３）
上記穿刺部位に隣接し、上記組織係合表面の１つに配置された開放ウェルをさらに含む、項目１に記載の組織閉鎖装置。
（項目４）
上記組織貫通ファスナは、上記対向する組織係合表面上に整列した雄コネクタと雌コネクタを含む、項目１に記載の組織閉鎖装置。
（項目５）
上記第１の組織係合表面の中へ延在する上記雄コネクタのバーブの周囲に配置された開放ウェルをさらに含み、該開放ウェルは該バーブよりも直径が大きい、項目４に記載の組織閉鎖装置。
（項目６）
上記第２の組織係合表面の中へ延在する上記雌コネクタに隣接して配置された開放ウェルをさらに含む、項目４に記載の組織閉鎖装置。
（項目７）
上記雄コネクタおよび雌コネクタは、それぞれ後ろ向きの凹部を含む、項目４に記載の組織閉鎖装置。
（項目８）
上記圧縮体は、各凹部に対応するウェルを含む、項目７に記載の組織閉鎖装置。
（項目９）
上記圧縮体は、全体が順応性のある材料で形成される、項目１に記載の組織閉鎖装置。
（項目１０）
上記雄コネクタと雌コネクタは、互いにしっかりと係合し、上記組織係合表面の間に規定の距離を形成するように構成される、項目４に記載の組織閉鎖装置。
（項目１１）
上記圧縮体の上記順応性のある表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目１に記載の組織閉鎖装置。
（項目１２）
上記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目１に記載の組織閉鎖装置。
（項目１３）
上記順応性のある圧縮体は、一対の平行に対向する脚を含み、各脚は組織係合表面を担持する、項目１に記載の組織閉鎖装置。
（項目１４）
各脚は、雄コネクタまたは雌コネクタのいずれかを担持する、項目１に記載の組織閉鎖装置。
（項目１５）
上記平行に対向する脚が、連続した環状構造を形成するように接続される、項目１３に記載の組織閉鎖装置。
（項目１６）
上記脚は、一端のみにおいて結合される、項目１３に記載の組織閉鎖装置。
（項目１７）
上記脚は、いずれの端においても結合されない、項目１３に記載の組織閉鎖装置。
（項目１８）
上記圧縮体は、該順応性のある圧縮体の各脚とともに真空プレナムをさらに備える、項目１３に記載の組織閉鎖装置。
（項目１９）
上記真空プレナムは、上記圧縮体の上記脚の少なくとも１つの表面に沿う複数のポートに対して開き、該ポートは、上記組織貫通ファスナとは異なる方向に配向される、項目１８に記載の組織閉鎖装置。
（項目２０）
上記ポートは、上記ファスナに対して略垂直な角度で配向される、項目１９に記載の組織閉鎖装置。
（項目２１）
上記プレナムは、真空プローブを受容する少なくとも１つのポートを有する、項目１８に記載の組織閉鎖装置。
（項目２２）
上記圧縮体は、生分解性材料で形成される、項目１に記載の組織閉鎖装置。
（項目２３）
上記ファスナは、生分解性材料を備えている、項目１に記載の組織閉鎖装置。
（項目２４）
上記ファスナは、展開前は上記圧縮体内に完全に含まれ、展開後は該圧縮体を越えて延在しない、項目１に記載の組織閉鎖装置。
（項目２５）
左心耳の基部を閉鎖するシステムであって、
対向する組織係合表面を有する順応性のある圧縮体を含む閉鎖装置と、
該閉鎖装置を取り外し可能に固定し、該装置を該組織構造の周囲または上に配置するために開く、閉鎖装置アプリケータと、
該アプリケータおよび閉鎖装置を通る真空パスであって、該装置を該組織構造に接着させるために、該装置が該組織構造上にある場合に、該閉鎖装置と該組織構造との間に真空を適用する、真空パスと、
一方の組織係合表面から該組織構造を通って他方の組織係合表面に展開可能であり、その間の該組織構造を閉鎖する複数のファスナと
を備える、システム。
（項目２６）
上記順応性のある圧縮体の上記表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目２５に記載のシステム。
（項目２７）
上記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目２５に記載のシステム。
（項目２８）
上記順応性のある圧縮体は、一対の脚を含み、各脚は対向する組織係合表面を担持する、項目２５に記載のシステム。
（項目２９）
上記対向する脚は、連続した環状構造を形成するように接続される、項目２８に記載のシステム。
（項目３０）
上記脚は、一端のみにおいて結合される、項目２８に記載のシステム。
（項目３１）
上記脚は、いずれの端においても結合されない、項目２８に記載のシステム。
（項目３２）
上記閉鎖装置アプリケータは、２つのプローブを担持する顎機構を備え、各プローブは、上記順応性のある圧縮体の一方の脚を取り外し可能に係合する、項目２８に記載のシステム。
（項目３３）
上記プローブの少なくとも１つは、上記真空パスの一部を提供する管腔を有する、項目３２に記載のシステム。
（項目３４）
上記少なくとも１つのプローブは、上記閉鎖装置の順応性のある圧縮体の少なくとも一方の脚における真空プレナムに受容される、項目３３に記載のシステム。
（項目３５）
上記真空プレナムは、上記少なくとも２つの組織係合表面の少なくとも一部の上で開く、項目３４に記載の組織閉鎖装置。
（項目３６）
上記プレナムは、上記組織係合表面上に分散した複数のポートを通じて開く、項目３５に記載の組織閉鎖装置。
（項目３７）
上記プレナムは、上記プローブを受容するポートを有する、項目３４に記載の組織閉鎖装置。
（項目３８）
上記顎機構の上記プローブは、機械的に広がる機構により結合される、項目３２に記載のシステム。
（項目３９）
上記機械的に広がる機構は、上記脚を平行に開くラックアンドピニオン機構を備える、項目３８に記載のシステム。
（項目４０）
上記機械的に広がる機構は、上記脚を旋回的に開く旋回機構を備える、項目３８に記載のシステム。
（項目４１）
組織構造を閉鎖する方法であって、
該組織構造上に圧縮体を配置するステップであって、少なくとも２つの順応性のある組織係合表面が該構造の両側を係合する、ステップと、
該圧縮体を通じて真空を適用し、該表面を該組織構造に接着させるステップと、
該真空の適用を継続しながら、該表面の少なくとも１つから該組織を通して他方の表面にファスナを展開し、該組織構造を閉鎖するステップと
を含む、方法。
（項目４２）
上記組織構造は左心耳である、項目４１に記載の方法。
（項目４３）
上記配置するステップは、上記圧縮材を肋間部に進めるステップを含む、項目４２に記載の方法。
（項目４４）
上記配置するステップは、アプリケータ上で上記順応性のある圧縮体を担持するステップと、該アプリケータを使用して上記組織係合表面を広げるステップと、上記真空を適用する前に該広げた脚を上記組織構造上で閉鎖するステップと
を含む、項目４２に記載の方法。
（項目４５）
上記ファスナを展開するステップは、雄要素を、上記組織係合表面のいずれか一方または両方から対向する組織係合表面における雌要素に進めるステップを含む、項目４１に記載の方法。
（項目４６）
上記ファスナを展開するステップは、バーブ針を一方の組織係合表面から他方の組織係合表面に進めるステップを含む、項目４１に記載の方法。
（項目４７）
手術の少なくとも一部の間、光学スコープを通して上記組織構造を見るステップをさらに含む、項目４１に記載の方法。
（項目４８）
手術の少なくとも一部の間、経皮的開口を通して上記組織構造を直接見るステップをさらに含む、項目４１に記載の方法。
（項目４９）
上記圧縮体を通じて物質を上記組織構造に導入するステップをさらに含む、項目４１に記載の方法。
（項目５０）
上記物質は、抗生物質、防腐剤、または抗炎症薬である、項目４９に記載の方法。
（項目５１）
上記ファスナを展開した後に、上記圧縮体より上の位置において上記組織構造を切除するステップをさらに含む、項目４１に記載の方法。
（項目５２）
上記ファスナは、展開後に上記圧縮体の外側に延在しない、項目４１に記載の方法。
（項目５３）
上記ファスナを展開し、０．２５ｐｓｉ〜２０ｐｓｉの範囲の圧力で上記組織に対して上記組織係合表面を閉鎖する、項目４１に記載の方法。
（項目５４）
上記圧力は０．２５ｐｓｉ〜１．５ｐｓｉの範囲である、項目５３に記載の方法。
（項目５５）
左心耳の基部を閉鎖するシステムであって、
対向する順応性のある組織係合表面を有する圧縮体を含む閉鎖装置と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位の組織を通って該組織係合表面のうちの第２の組織係合表面に延在し、その間の該組織構造を閉鎖するように配置された１つ以上の組織貫通ファスナであって、該ファスナのそれぞれは、後ろ向きの凹部を含む、ファスナと、
該閉鎖装置を設置するための、一対の顎を含む閉鎖装置アプリケータと、
一対の整列コームであって、それぞれのコームは該アプリケータの顎に連結され、該ファスナの凹部を解放可能に係合するように構成された１つ以上のスタッドを含み、該アプリケータの該顎は、該ファスナを展開させるために、該一対のコームを動かし、より近づけるように構成される、コームと
を備える、システム。
（項目５６）
上記一対の顎は、上記一対の整列コームおよび一対の外部顎に連結された一対の内部顎を備え、上記アプリケータは、該内部顎を独立に動かして該外部顎から離し、上記スタッドを上記凹部から解放するように構成される、項目５５に記載のシステム。
（項目５７）
上記顎は、平行に開くように構成される、項目５５に記載のシステム。
（項目５８）
上記顎は、ピボットを中心に開くように構成される、項目５５に記載のシステム。
（項目５９）
上記組織閉鎖装置は、上記穿刺部位に隣接する、上記組織係合表面の１つに配置された開放ウェルをさらに備えている、項目５５に記載のシステム。
（項目６０）
上記組織貫通ファスナは、上記対向する組織係合表面に整列した雄コネクタおよび雌コネクタを備えている、項目５９に記載のシステム。
（項目６１）
上記雄コネクタは、組織を穿通するように構成された鋭利な端部を有するバーブを含む、項目６０に記載のシステム。
（項目６２）
上記開放ウェルは、上記バーブの周囲に配置され、上記第１の組織係合表面の中に延在し、該開放ウェルは該バーブの直径より大きい、項目６１に記載のシステム。
（項目６３）
上記開放ウェルは、上記雌コネクタに隣接して配置され、上記第２の組織係合表面の中に延在する、項目６１に記載のシステム。
（項目６４）
上記圧縮体は、全体が順応性のある材料で形成される、項目５５に記載のシステム。
（項目６５）
上記圧縮体はウェルを含み、該ウェルは、上記スタッドが上記凹部に係合するのを可能にするように構成された、該凹部のそれぞれに対応する、項目５５に記載のシステム。
（項目６６）
上記雄コネクタおよび雌コネクタは、互いにしっかりと係合し、上記組織係合表面の間に規定の距離を形成するように構成される、項目６０に記載のシステム。
（項目６７）
上記組織係合表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、項目５５に記載のシステム。
（項目６８）
上記組織係合表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、項目６７に記載のシステム。
（項目６９）
上記圧縮体は、一対の平行に対向する脚を備え、各脚は、組織係合表面と、上記雄コネクタまたは上記雌コネクタのいずれかとを担持する、項目６０に記載のシステム。
（項目７０）
上記組織係合表面の一方は、安定化リップを含み、他方の組織係合表面よりも面積が大きい、項目５５に記載のシステム。
（項目７１）
上記圧縮体は、生分解性材料で形成される、項目５５に記載のシステム。
（項目７２）
上記ファスナは、生分解性材料を備えている、項目５５に記載のシステム。
（項目７３）
上記顎は、アプリケータシャフトの平面からオフセットした平面に配置される、項目５５に記載のシステム。
（項目７４）
上記オフセットは１０〜４５°である、項目７３に記載のシステム。
（項目７５）
上記オフセットは１０〜２５°である、項目７３に記載のシステム。
（項目７６）
上記顎のうちの一方の遠位から展開するように構成されたラッソワイヤをさらに備え、該ワイヤは、該顎間のスペースを封鎖するように他方の顎の遠位端に固定される、項目５５に記載のシステム。
本発明は、組織構造を閉鎖する代替および改良型装置、システム、および方法を提供する。本発明の実施形態は、組織構造の両側に係合する２つの対向する順応性のある表面を有する圧縮体を含む組織閉鎖装置を提供する。順応性のある表面は、組織構造の表面に一致する柔軟性を有することが望ましい。閉鎖装置は、組織構造と同様の柔軟性および動的性能を有することが望ましい。ファスナは、対向する順応性のある表面に隣接して圧縮体内に配置され、少なくとも１つの組織貫通ファスナは、第１の順応性のある表面から現れ、穿通部位における介在組織を通過して第２の順応性のある表面に至り、第２ファスナをしっかりと係合して２つの表面間の組織を圧縮するように構成される。開放ウェルは、穿通部位周囲の順応性のある表面のいずれか一方または両方に配置されてもよい。ここで、組織貫通ファスナは、介在組織を通過し、穿通部位の周囲にガスケット密閉を形成する。安定化リップを一方の順応性のある表面上に提供し、一方の表面が他方の表面より大きくなるようにしてもよい。また真空ポートを順応性のある表面内に提供し、組織構造の表面を係合するようにしてもよい。閉鎖装置のファスナは、閉鎖装置の設置に使用される装置アプリケータと相互作用する開いた管腔または凹部を含んでもよい。
Claims (76)
- ２つの対向する順応性のある組織係合表面を有する圧縮体と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位における組織を通り該組織係合表面のうちの第２の組織係合表面に延在するように配置され、その間の組織構造を閉鎖する１つ以上の組織貫通ファスナと
を備える、組織閉鎖装置。 - 前記組織係合表面の一方は安定化リップを含み、他方の組織係合表面よりも面積が大きい、請求項１に記載の組織閉鎖装置。
- 前記穿刺部位に隣接し、前記組織係合表面の１つに配置された開放ウェルをさらに含む、請求項１に記載の組織閉鎖装置。
- 前記組織貫通ファスナは、前記対向する組織係合表面上に整列した雄コネクタと雌コネクタを含む、請求項１に記載の組織閉鎖装置。
- 前記第１の組織係合表面の中へ延在する前記雄コネクタのバーブの周囲に配置された開放ウェルをさらに含み、該開放ウェルは該バーブよりも直径が大きい、請求項４に記載の組織閉鎖装置。
- 前記第２の組織係合表面の中へ延在する前記雌コネクタに隣接して配置された開放ウェルをさらに含む、請求項４に記載の組織閉鎖装置。
- 前記雄コネクタおよび雌コネクタは、それぞれ後ろ向きの凹部を含む、請求項４に記載の組織閉鎖装置。
- 前記圧縮体は、各凹部に対応するウェルを含む、請求項７に記載の組織閉鎖装置。
- 前記圧縮体は、全体が順応性のある材料で形成される、請求項１に記載の組織閉鎖装置。
- 前記雄コネクタと雌コネクタは、互いにしっかりと係合し、前記組織係合表面の間に規定の距離を形成するように構成される、請求項４に記載の組織閉鎖装置。
- 前記圧縮体の前記順応性のある表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、請求項１に記載の組織閉鎖装置。
- 前記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、請求項１に記載の組織閉鎖装置。
- 前記順応性のある圧縮体は、一対の平行に対向する脚を含み、各脚は組織係合表面を担持する、請求項１に記載の組織閉鎖装置。
- 各脚は、雄コネクタまたは雌コネクタのいずれかを担持する、請求項１に記載の組織閉鎖装置。
- 前記平行に対向する脚が、連続した環状構造を形成するように接続される、請求項１３に記載の組織閉鎖装置。
- 前記脚は、一端のみにおいて結合される、請求項１３に記載の組織閉鎖装置。
- 前記脚は、いずれの端においても結合されない、請求項１３に記載の組織閉鎖装置。
- 前記圧縮体は、該順応性のある圧縮体の各脚とともに真空プレナムをさらに備える、請求項１３に記載の組織閉鎖装置。
- 前記真空プレナムは、前記圧縮体の前記脚の少なくとも１つの表面に沿う複数のポートに対して開き、該ポートは、前記組織貫通ファスナとは異なる方向に配向される、請求項１８に記載の組織閉鎖装置。
- 前記ポートは、前記ファスナに対して略垂直な角度で配向される、請求項１９に記載の組織閉鎖装置。
- 前記プレナムは、真空プローブを受容する少なくとも１つのポートを有する、請求項１８に記載の組織閉鎖装置。
- 前記圧縮体は、生分解性材料で形成される、請求項１に記載の組織閉鎖装置。
- 前記ファスナは、生分解性材料を備えている、請求項１に記載の組織閉鎖装置。
- 前記ファスナは、展開前は前記圧縮体内に完全に含まれ、展開後は該圧縮体を越えて延在しない、請求項１に記載の組織閉鎖装置。
- 左心耳の基部を閉鎖するシステムであって、
対向する組織係合表面を有する順応性のある圧縮体を含む閉鎖装置と、
該閉鎖装置を取り外し可能に固定し、該装置を該組織構造の周囲または上に配置するために開く、閉鎖装置アプリケータと、
該アプリケータおよび閉鎖装置を通る真空パスであって、該装置を該組織構造に接着させるために、該装置が該組織構造上にある場合に、該閉鎖装置と該組織構造との間に真空を適用する、真空パスと、
一方の組織係合表面から該組織構造を通って他方の組織係合表面に展開可能であり、その間の該組織構造を閉鎖する複数のファスナと
を備える、システム。 - 前記順応性のある圧縮体の前記表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、請求項２５に記載のシステム。
- 前記表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、請求項２５に記載のシステム。
- 前記順応性のある圧縮体は、一対の脚を含み、各脚は対向する組織係合表面を担持する、請求項２５に記載のシステム。
- 前記対向する脚は、連続した環状構造を形成するように接続される、請求項２８に記載のシステム。
- 前記脚は、一端のみにおいて結合される、請求項２８に記載のシステム。
- 前記脚は、いずれの端においても結合されない、請求項２８に記載のシステム。
- 前記閉鎖装置アプリケータは、２つのプローブを担持する顎機構を備え、各プローブは、前記順応性のある圧縮体の一方の脚を取り外し可能に係合する、請求項２８に記載のシステム。
- 前記プローブの少なくとも１つは、前記真空パスの一部を提供する管腔を有する、請求項３２に記載のシステム。
- 前記少なくとも１つのプローブは、前記閉鎖装置の順応性のある圧縮体の少なくとも一方の脚における真空プレナムに受容される、請求項３３に記載のシステム。
- 前記真空プレナムは、前記少なくとも２つの組織係合表面の少なくとも一部の上で開く、請求項３４に記載の組織閉鎖装置。
- 前記プレナムは、前記組織係合表面上に分散した複数のポートを通じて開く、請求項３５に記載の組織閉鎖装置。
- 前記プレナムは、前記プローブを受容するポートを有する、請求項３４に記載の組織閉鎖装置。
- 前記顎機構の前記プローブは、機械的に広がる機構により結合される、請求項３２に記載のシステム。
- 前記機械的に広がる機構は、前記脚を平行に開くラックアンドピニオン機構を備える、請求項３８に記載のシステム。
- 前記機械的に広がる機構は、前記脚を旋回的に開く旋回機構を備える、請求項３８に記載のシステム。
- 組織構造を閉鎖するためのシステムであって、
少なくとも２つの順応性のある組織係合表面が該構造の両側を係合するように、該組織構造上に配置されるように構成された圧縮体と、
該圧縮体を通じて真空を適用し、該表面を該組織構造に接着させるための手段と、
ファスナであって、該真空の適用を継続しながら、該表面の少なくとも１つから該組織を通して他方の表面に展開されて、該組織構造を閉鎖するように構成されたファスナと
を含む、システム。 - 前記組織構造は左心耳である、請求項４１に記載のシステム。
- 前記圧縮体は、肋間部に進められるように構成されている、請求項４２に記載のシステム。
- 前記順応性のある圧縮体を担持するため、前記組織係合表面を広げるため、および前記真空を適用する前に該広げた脚を前記組織構造上で閉鎖するためのアプリケータをさらに含む、請求項４２に記載のシステム。
- 前記ファスナは、雄要素および雌要素を含み、該雄要素は、前記組織係合表面のいずれか一方または両方から対向する組織係合表面における該雌要素に進められるように構成されている、請求項４１に記載のシステム。
- 前記ファスナは、一方の組織係合表面から他方の組織係合表面に進められるように構成されたバーブ針を含む、請求項４１に記載のシステム。
- 手術の少なくとも一部の間、前記組織構造を見るための光学スコープをさらに含む、請求項４１に記載のシステム。
- 手術の少なくとも一部の間、経皮的開口を通して前記組織構造が直接見られる、請求項４１に記載のシステム。
- 前記圧縮体を通じて物質を前記組織構造に導入するための手段をさらに含む、請求項４１に記載のシステム。
- 前記物質は、抗生物質、防腐剤、または抗炎症薬である、請求項４９に記載のシステム。
- 前記ファスナを展開した後に、前記圧縮体より上の位置において前記組織構造を切除するための手段をさらに含む、請求項４１に記載のシステム。
- 前記ファスナは、展開後に前記圧縮体の外側に延在しない、請求項４１に記載のシステム。
- ０．２５ｐｓｉ〜２０ｐｓｉの範囲の圧力で前記組織に対して前記組織係合表面を閉鎖するように前記ファスナが展開される、請求項４１に記載のシステム。
- 前記圧力は０．２５ｐｓｉ〜１．５ｐｓｉの範囲である、請求項５３に記載のシステム。
- 左心耳の基部を閉鎖するシステムであって、
対向する順応性のある組織係合表面を有する圧縮体を含む閉鎖装置と、
該組織係合表面のうちの第１の組織係合表面から穿刺部位の組織を通って該組織係合表面のうちの第２の組織係合表面に延在し、その間の該組織構造を閉鎖するように配置された１つ以上の組織貫通ファスナであって、該ファスナのそれぞれは、後ろ向きの凹部を含む、ファスナと、
該閉鎖装置を設置するための、一対の顎を含む閉鎖装置アプリケータと、
一対の整列コームであって、それぞれのコームは該アプリケータの顎に連結され、該ファスナの凹部を解放可能に係合するように構成された１つ以上のスタッドを含み、該アプリケータの該顎は、該ファスナを展開させるために、該一対のコームを動かし、より近づけるように構成される、コームと
を備える、システム。 - 前記一対の顎は、前記一対の整列コームおよび一対の外部顎に連結された一対の内部顎を備え、前記アプリケータは、該内部顎を独立に動かして該外部顎から離し、前記スタッドを前記凹部から解放するように構成される、請求項５５に記載のシステム。
- 前記顎は、平行に開くように構成される、請求項５５に記載のシステム。
- 前記顎は、ピボットを中心に開くように構成される、請求項５５に記載のシステム。
- 前記組織閉鎖装置は、前記穿刺部位に隣接する、前記組織係合表面の１つに配置された開放ウェルをさらに備えている、請求項５５に記載のシステム。
- 前記組織貫通ファスナは、前記対向する組織係合表面に整列した雄コネクタおよび雌コネクタを備えている、請求項５９に記載のシステム。
- 前記雄コネクタは、組織を穿通するように構成された鋭利な端部を有するバーブを含む、請求項６０に記載のシステム。
- 前記開放ウェルは、前記バーブの周囲に配置され、前記第１の組織係合表面の中に延在し、該開放ウェルは該バーブの直径より大きい、請求項６１に記載のシステム。
- 前記開放ウェルは、前記雌コネクタに隣接して配置され、前記第２の組織係合表面の中に延在する、請求項６１に記載のシステム。
- 前記圧縮体は、全体が順応性のある材料で形成される、請求項５５に記載のシステム。
- 前記圧縮体はウェルを含み、該ウェルは、前記スタッドが前記凹部に係合するのを可能にするように構成された、該凹部のそれぞれに対応する、請求項５５に記載のシステム。
- 前記雄コネクタおよび雌コネクタは、互いにしっかりと係合し、前記組織係合表面の間に規定の距離を形成するように構成される、請求項６０に記載のシステム。
- 前記組織係合表面は、３ショアＡ〜１５ショアＡの範囲のデュロメータを有する、請求項５５に記載のシステム。
- 前記組織係合表面は、少なくとも一部がシリコンまたはポリウレタンで構成される、請求項６７に記載のシステム。
- 前記圧縮体は、一対の平行に対向する脚を備え、各脚は、組織係合表面と、前記雄コネクタまたは前記雌コネクタのいずれかとを担持する、請求項６０に記載のシステム。
- 前記組織係合表面の一方は、安定化リップを含み、他方の組織係合表面よりも面積が大きい、請求項５５に記載のシステム。
- 前記圧縮体は、生分解性材料で形成される、請求項５５に記載のシステム。
- 前記ファスナは、生分解性材料を備えている、請求項５５に記載のシステム。
- 前記顎は、アプリケータシャフトの平面からオフセットした平面に配置される、請求項５５に記載のシステム。
- 前記オフセットは１０〜４５°である、請求項７３に記載のシステム。
- 前記オフセットは１０〜２５°である、請求項７３に記載のシステム。
- 前記顎のうちの一方の遠位から展開するように構成されたラッソワイヤをさらに備え、該ワイヤは、該顎間のスペースを封鎖するように他方の顎の遠位端に固定される、請求項５５に記載のシステム。
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