JP7461446B2 - 改善された塞栓防御デバイスおよび方法 - Google Patents
改善された塞栓防御デバイスおよび方法 Download PDFInfo
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- JP7461446B2 JP7461446B2 JP2022189690A JP2022189690A JP7461446B2 JP 7461446 B2 JP7461446 B2 JP 7461446B2 JP 2022189690 A JP2022189690 A JP 2022189690A JP 2022189690 A JP2022189690 A JP 2022189690A JP 7461446 B2 JP7461446 B2 JP 7461446B2
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- embolic protection
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Description
テザー、より正確にはテザーラインは、周囲の密閉する程度を制御するために提供される。
テザーは大動脈の組織/大脳動脈への並置の方向に提供される。テザーは、末梢部に接続される塞栓防御デバイスに伝えられたテザーへの引く行為によって能動的な牽引を提供し得る。牽引力は、塞栓防御デバイスの送達デバイスの引く力と異なってもよい、したがって、デバイスの周囲がその付属の送達デバイスより大きい程度で大動脈弓移動に続くように、力が選択されると、風を吸い込む効果を有利に回避する。
作用力は、大動脈弓が鼓動する心臓および血液脈波により移動している一方、改善された辺縁の密閉を維持するのに適切なあるテザー内に提供される。
例えば、ポリカーボネート、ポリテトラフルオロエチレン(PTFE)、延伸ポリテトラフルオロエチレン(ePTFE)、ポリフッ化ビニリデン(PVDF)、ポリプロピレン、多孔性ウレタン、ニチノール、フルオロポリマー(Teflon登録商標)、コバルト・クロム合金(CoCr)、及びパラ系アラミド(Kevlar登録商標)、又は織物、例えばナイロン、ポリエステル、(Dacron登録商標)、絹などの任意の非分解性の材料から製造されたコード、ファイバー、フィラメント、ケーブル及び糸。
国際公開第WO2012/094195A1の図(10Aと10B)及び国際公開第WO2012/094195A1の関連する記載参照。
並置保持/支援ユニットは、ついで、能動的牽引ユニットであり得、それは、接続点をオフセットした位置で遠位状に接続された少なくとも1つの操作可能なテザー300を有する。テザーの遠位接続位置は、牽引力を提供するために塞栓防御デバイスのフレーム、周囲および/または血液浸透性ユニットに位置づけられ得る。テザーは1つ以上の遠位端を有する。遠位端は例えば塞栓防御デバイスの周囲に接続される。テザーの遠位端は、フィルターまたは偏向板の膜のような血液浸透性ユニットに接続され得る。例えば、膜が柔軟でかつ、または弾性の場合、膜は牽引によって移動され得る。
テザーは大動脈の組織/大脳動脈への並置の方向に提供される。テザーは、末梢部に接続される塞栓防御デバイスに伝えられたテザーへの引く行為によって能動的な牽引を提供し得る。
したがって、中央のラインは引き上げられ得、周囲は内壁に逆らって伸ばされる。
テザーは、前端への上昇力を提供する。テザーが中央のラインにおいて、例えば、小環を介して糸が通されてガイドされる場合、それは、デバイスに沿って分布した直進性の持ち上げ力を提供し得る。例えば、図2、6、7および8を参照されたい。
血液浸透性ユニット132は非分解性の材料であり得る。例えばポリカーボネート、ポリテトラフルオロエチレン(PTFE)、拡張ポリテトラフルオロエチレン(ePTFE)、ポリフッ化ビニリデン(PVDF)、ポリプロピレン、多孔性のウレタン、ニチノール、フルオロポリマー(Teflonョ)、コバルト・クロム合金(CoCr)、およびパラアラミド(Kevlarョ)又は織物、例えばナイロン、ポリエステル(Dacronョ)、又は絹。血液浸透性ユニット132は、材料の組合せであり得る(例えばDFTとニチノールワイヤーの組合せ)。血液浸透性ユニット132もトロンボゲン形成反応を防ぐために反血栓形成の物質で覆われ得る。デバイス200の大きさは様々な患者群(例えば小児、成体、又は特定の大動脈の解剖学的分類)に適用させるためにあらかじめ分類されあらかじめ形成され得る。
別の例はテザーを例えば、デバイスの基部から伸ばすために活性化される形状記憶バネである。テザーの一部は形状記憶部として提供され得る。そのようなテザーは細長い形状で送達され得、次に、引張力を提供するためにテザーを短くして、記憶が誘導された形状に変更した。記憶が誘導された形状は、螺旋状のコイルであり得、記憶が活性化されたテザーの弾性、とりわけ有利な圧力および/または移動補正を可能にする。
キットは例えば更に、食品と薬の投与による介在物のために指定された情報など使用及び/又は警告説明書でラベルを付けることを含む。そのようなラベル付けは、包装の外部、および/または包装内の離型紙上に存在し得る。
右ストランド骨下動脈から腕頭動脈、左頚動脈、左ストランド骨下動脈又は大腿部の流入路の中などの下行大動脈;あるいは前記方法は、上行大動脈の壁を通って大動脈弓に塞栓防御装置を送達する。それは、頚動脈を入力する塞栓の砕片を防ぐために大動脈弓へ塞栓防御装置の位置を決める工程822をさらに含んでいる。前記方法は、その周囲でデバイスを密閉して改善するために防御装置に力を加える工程823を含んでおり、それはデバイスのデリバリー軸ではなく、少なくとも1つの組織並置保持ユニットによってデバイスで接続点に対してオフセットした力を適用することを含んでいる。このように、前記方法は作用力による大動脈弓の内部の血管壁に対する塞栓防御デバイスの並置及び流体密封性の程度を制御することを可能にする。さらに、前記方法は、最初のカテーテルを大動脈弓において下行大動脈、左鎖骨下動脈あるいは大動脈の血管壁を介して心臓まで送達し、心臓の血管内の処置に関係する少なくとも1つの工程への影響を及ぼす工程824を含んでいる。
さらに、心のずれが有効に防がれるように、遠位のガイド要素は、カテーテルに対して塞栓防御装置を有効に安定させる。
これは、組織に対する安全な中心化と柔軟な並置を可能にする。
これは安全で容易な中心化を提供する。外装507あるいは補足外装は膨張を抑制するために拡張可能な構造に関して使用され得、その後、近位へ引っ込ませられ、拡張可能な構造にその拡張した記憶形状を仮定させる。
Claims (9)
- 上行大動脈から下行大動脈へ塞栓の砕片の偏向のために、少なくとも頸動脈を含む側部
脈管の心門を覆うように大動脈弓に一時的に位置づけるための、上行大動脈に向かって配置された遠位端と、下行大動脈に向かって配置された近位端とを有し、折り畳み可能で経腔的に送達可能な塞栓防御デバイスであって、当該塞栓防御デバイスは、
周囲および該周囲内に血液浸透性ユニットを備えたフレームを備えており、および、
前記血液浸透性ユニットが、前記大動脈弓に配置されたときに前記周囲から前記心門へと凸状に形成される表面を有するメッシュであり、
前記塞栓防御デバイスはさらに経血管送達ユニットと結合されており、前記塞栓防御デバイスと前記経血管送達ユニットとの接続点は、前記フレームの近位部分に配置された、
塞栓防御デバイス。 - 少なくとも1つのテザーは、塞栓防御デバイスを冠状方向に上昇させるため、牽引力を加えるように配置される、請求項1に記載の塞栓防御デバイス。
- 前記テザーは、送達カテーテルの開口部から前記フレームの遠位部まで延びる、請求項2に記載の塞栓防御デバイス。
- 前記経血管送達ユニットは、前記フレームに付けられている、請求項1乃至3のいずれか1つに記載の塞栓防御デバイス。
- 前記経血管送達ユニットは、前記フレームと少なくとも一体化されている、請求項4に記載の塞栓防御デバイス。
- 前記経血管送達ユニットが、前記フレームの遠位部に付けられている、請求項4又は5のいずれか1つに記載の塞栓防御デバイス。
- 前記フレームはワイヤーから作られ、当該ワイヤーの2つの枝が結合され、前記経血管送達ユニットの少なくとも一部を形成する、請求項4乃至6のいずれか1つに記載の塞栓防御デバイス。
- 前記血液浸透性ユニットは、ポリマーフィルムでできている、請求項1に記載の塞栓防御デバイス。
- 前記テザーが、少なくとも1つの放射線不透性の標準マーカーを更に備える、請求項2又は3のいずれか1つに記載の塞栓防御デバイス。
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CN107072770B (zh) | 2020-06-16 |
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JP7191339B2 (ja) | 2022-12-19 |
JP2021058601A (ja) | 2021-04-15 |
CA2949585A1 (en) | 2015-11-26 |
EP3563800A1 (en) | 2019-11-06 |
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CA3235511A1 (en) | 2015-11-26 |
US20220151760A1 (en) | 2022-05-19 |
JP2023027136A (ja) | 2023-03-01 |
JP2017516609A (ja) | 2017-06-22 |
CN111728747B (zh) | 2024-08-30 |
EP3145445B1 (en) | 2019-03-20 |
CN111728747A (zh) | 2020-10-02 |
EP3563800B1 (en) | 2023-10-11 |
US11957561B2 (en) | 2024-04-16 |
CN107072770A (zh) | 2017-08-18 |
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US20240245500A1 (en) | 2024-07-25 |
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