JP6240604B2 - 拡張可能な閉塞デバイス及び方法 - Google Patents
拡張可能な閉塞デバイス及び方法 Download PDFInfo
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Description
図4は、心臓の中隔14の通路12に埋め込んだ、第1閉塞部材16及び第2閉塞部材18を含む閉塞デバイス10の一実施例の側面図である。閉塞部材16、18は、夫々のラチス構造19を個々に備えていてもよい。幾つかの実施例では、ラチス構造19は、埋め込み後にディスク形状になる編組ワイヤ等の少なくとも一つのワイヤメッシュを含んでいてもよい。第1閉塞部材16は、更に、外ハブ26及び内ハブ28を含んでいてもよい。これらのハブは、第1閉塞部材16のラチス構造19の端部に連結されている。同様に、第2閉塞部材18は、更に、外ハブ32及び内ハブ30を含んでいてもよい。これらのハブは、第2閉塞部材18のラチス構造19の端部に連結されている。各ハブ26、28、及び30にはチャンネル33が設けられていてもよい。閉塞デバイス10は、更に、ハブ26、28、及び30のチャンネル33に通した繋ぎ紐34を含んでいてもよい。繋ぎ紐34の遠位端は、第2閉塞部材18の外ハブ32に取り付けられていてもよい。この特定の実施例では、第1閉塞部材16のラチス構造19は、第2閉塞部材18のラチス構造19から分離されている。
閉塞デバイス10を埋め込むための送出システム及び方法の実施例を図5乃至図9に示す。明瞭化を図るため、図5乃至図9は、中隔組織14の部分断面図及び第1及び第2の閉塞部材16、18の側面図を示す。
本明細書中に説明した実施例のうちの任意の実施例において、閉塞部材は、布又は開口部を持つ構造(例えば多孔質の布又は構造)を形成するようになった、ワイヤ、フィラメント、糸、縫合糸、ファイバ、等で形成されたラチス(例えばメッシュ)を含んでいてもよい。ラチスは、金属、ポリマー、複合材料、及び/又は生物学的材料を使用して形成されていてもよい。更に、ポリマー材料には、ダクロン、ポリエステル、ポリプロピレン、ナイロン、テフロン(登録商標)、PTFE、ePTEF、TFE、PET、TPE、PGA、PGLA、又はPLA等のポリマーが含まれる。弾性インプラントの技術で周知のこの他の適当な材料を使用してもよい。金属材料には、ニッケル−チタニウム合金(例えばニチノール)、プラチナ、コバルト−クロム合金、エルジロイ、ステンレス鋼、タングステン又はチタニウムが含まれるが、これらに限定されない。幾つかの実施例では、ポリマー材料を全く含まずに、即ちポリマーフリーで、金属材料だけでラチスを形成するのが望ましい。こうした実施例では、閉塞デバイス全体を、ポリマー材料を全く含まずに、金属材料で形成するのが望ましい。幾つかの実施例では、ポリマー材料を除外することにより、デバイスの表面に血栓が形成される可能性が小さくなるものと考えられ、更に、ポリマーを除外し、金属製構成要素だけを使用することにより、ポリマー製の構成要素を含むデバイスと比較して小径のカテーテルで送出できる比較的薄い閉塞デバイスを提供できるものと考えられる。
閉塞部材は、用途に応じて様々な形状を備えていてもよい。例えば、閉塞部材は、同じラチス材料又は異なるラチス材料でできた、全体に円筒形形状、球形形状、楕円体形状、楕円形形状、バレル状、円錐形形状、円錐台形状又は他の幾何学的形状の一つ又はそれ以上の層を含んでいてもよい。ラチスの層は、形状が異なっていてもよく、流れバッフル及び/又は共形シール層として役立つ凹凸のある部分即ち波形部分、又は鋸歯状又はベローズ状の部分等を備えていてもよい。ラチス層には、バッフル又は区画室を形成するため、半径方向凹凸、直径の変化、皺、拡張部、等を形成するようにヒートセットが施されていてもよい。例えば、凹凸は、正弦波状の凹凸であってもよい。
12 通路
12a 開放端
12b 開放端
14 心臓の中隔
16 第1閉塞部材
18 第2閉塞部材
19 ラチス構造
20 周囲部分
26 外ハブ
28 内ハブ
30 内ハブ
32 外ハブ
33 チャンネル
34 繋ぎ紐
36 ラチス層
38 小孔
40 内部容積
Claims (14)
- 左心耳を閉塞するためのデバイスであって、左心耳は、該左心耳の口で左心房に開口しており、前記デバイスは、
拡張可能なラチス構造を含み、該拡張可能なラチス構造は、左心耳の口またはその近くに位置決めされるように構成された遠位閉塞部材と、左心耳の内部内に延びるように構成された近位閉塞部材と、前記遠位閉塞部材と前記近位閉塞部材の間のラチスコアと、を有し、前記拡張可能なラチス構造は、
左心耳の組織と接触し、左心耳の組織とシールを形成するように構成された外ラチス層と、
前記近位閉塞部材に配置され、前記外ラチス層に結合された近位ハブと、
前記遠位閉塞部材に配置された遠位ハブと、
前記外ラチス層によって包囲され、前記遠位ハブで前記外ラチス層に結合されている内ラチス層と、を含み、
前記内ラチス層は、前記外ラチス層を半径方向外方に駆動し、左心耳の口および/または左心耳の口の遠位側で該内ラチス層を左心耳の組織に押し付けるように構成されており、
前記遠位ハブは、前記外ラチス層と面一である、デバイス。 - 前記遠位閉塞部材は、平らな輪郭を有する、請求項1に記載のデバイス。
- 前記ラチス構造に結合され、または、前記ラチス構造と一体である拡張可能な保持部材をさらに含む、請求項2に記載のデバイス。
- 前記外ラチス層は、外層および内層をさらに含む、請求項2に記載のデバイス。
- 前記ハブの少なくとも50%は、前記ラチス構造によって包囲されている、請求項2に記載のデバイス。
- 前記外ラチス層は、第1の孔寸法を有し、前記内ラチス層は、前記第1の孔寸法よりも大きい第2の孔寸法を有する、請求項2に記載のデバイス。
- 前記近位ハブは、第1の近位ハブであり、前記デバイスは、前記内ラチス層に結合された第2の近位ハブをさらに含む、請求項1に記載のデバイス。
- 前記遠位閉塞部材は、平らな形状を有し、前記ラチスコアは、円筒状であり、前記近位閉塞部材は、円錐形である、請求項1に記載のデバイス。
- 前記内ラチス層は、起伏を含む、請求項1に記載のデバイス。
- 前記遠位閉塞部材は、平らな形状を有し、前記近位閉塞部材は、円錐形である、請求項1に記載のデバイス。
- 前記遠位ハブは、前記遠位閉塞部材によって実質的に包囲されている、請求項1に記載のデバイス。
- 前記デバイスの輪郭は、前記外ラチス層の輪郭によって規定される、請求項1に記載のデバイス。
- 前記外ラチス層は、平らな形状を有し、前記ラチス構造の長手方向軸線と垂直に配置されている、請求項1に記載のデバイス。
- 前記遠位ハブは、前記遠位閉塞部材と面一である、請求項1に記載のデバイス。
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PCT/US2012/051502 WO2013028579A1 (en) | 2011-08-19 | 2012-08-17 | Expandable occlusion device and methods |
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US20140343602A1 (en) | 2014-11-20 |
JP2014529441A (ja) | 2014-11-13 |
EP2744423A4 (en) | 2015-06-24 |
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