JP5148598B2 - 組織閉鎖のシステムおよび方法 - Google Patents
組織閉鎖のシステムおよび方法 Download PDFInfo
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Description
(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 (59)
- 2つの対向する順応性のある組織係合表面を有する一対の平行な脚を備える圧縮可能な本体であって、該脚が各々柔軟な生物学的に適合性のポリマーを含む、本体と、
該脚に沿って間隔を置いて離れて配置され、そして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複数の組織貫通ファスナとを備え、
該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、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3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3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3に記載の組織閉鎖装置。
- 前記圧縮可能な本体は、各凹部に対応するウェルを含む、請求項6に記載の組織閉鎖装置。
- 前記圧縮可能な本体は、全体が前記柔軟な生物学的に適合性のポリマーで形成される、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。
- 前記柔軟な順応性のあるポリマーは、シリコンまたはポリウレタンを含む、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1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1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1に記載の組織閉鎖装置。
- 前記圧縮可能な本体は、該圧縮可能な本体の各脚とともに真空プレナムをさらに備える、請求項1に記載の組織閉鎖装置。
- 前記真空プレナムは、前記圧縮可能な本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16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17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16に記載の組織閉鎖装置。
- 前記柔軟な生物学的に適合性のポリマーは、生分解性材料を含む、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、展開前は前記圧縮可能な本体内に完全に含まれ、展開後は該圧縮可能な本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、
対向する順応性のある組織係合表面を有する一対の平行な脚を備える圧縮可能な本体を含む閉鎖装置であって、該脚が各々柔軟な生物学的に適合性のポリマーを含む、閉鎖装置と、
該閉鎖装置の脚を取り外し可能に固定し、該脚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、該脚が該組織構造上にある場合に、該閉鎖装置の脚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の脚を閉鎖する複数のファスナとを備え、該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、システム。 - 前記組織係合表面の前記表面は、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23に記載のシステム。
- 前記柔軟な生物学的に適合性のポリマーは、シリコンまたはポリウレタンを含む、請求項23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23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23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23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、前記圧縮可能な本体の一方の脚を取り外し可能に係合する、請求項23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29に記載のシステム。
- 前記少なくとも1つのプローブは、前記閉鎖装置の圧縮可能な本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30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31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32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31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29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35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35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一対の脚を備える圧縮可能な本体を含む閉鎖装置であって、該脚が各々柔軟な生物学的に適合性のポリマーを含む、閉鎖装置と、
該脚に沿って間隔を置いて離れて配置され、そして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複数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、該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、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38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38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38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38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42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43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44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44に記載のシステム。
- 前記圧縮可能な本体は、全体が前記柔軟な生物学的に適合性のポリマーで形成される、請求項38に記載のシステム。
- 前記圧縮可能な本体はウェルを含み、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38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43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38に記載のシステム。
- 前記前記柔軟な生物学的に適合性のポリマーは、シリコンまたはポリウレタンを含む、請求項50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38に記載のシステム。
- 前記圧縮可能な本体は、生分解性材料で形成される、請求項38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38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38に記載のシステム。
- 前記オフセットは10〜45°である、請求項55に記載のシステム。
- 前記オフセットは10〜25°である、請求項55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38に記載のシステム。
- 前記組織構造に送達される物質の供給源をさらに備え、該供給源が真空パスに接続され、真空でなくなるとき、該物質が送達され得る、請求項23に記載のシステム。
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PCT/US2007/068147 WO2007131110A2 (en) | 2006-05-03 | 2007-05-03 | Systems and methods of tissue closure |
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US20160270784A1 (en) | 2016-09-22 |
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