JP2017529908A - 心臓の流量調整デバイス - Google Patents
心臓の流量調整デバイス Download PDFInfo
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Abstract
Description
本発明のいくつかの実施形態では、遠位要素102を形成するワイヤーはすべてループワイヤー107であり、それゆえ遠位要素102はワイヤー端末がなく、前記した利点により滑らかで、均一で、連続な遠位面を提供する。図2aは、血流調整装置100の遠位要素又は円盤102の平面図を示し、遠位円盤102の周辺領域でそれらの頂点を有するループワイヤー107を示している。この実施形態では、また遠位要素の編組を形成するワイヤーはすべてループワイヤー107であり、それによって遠位要素はワイヤー端末がない。
なぜなら組織過剰成長がより速くなりえるからである。非編組フィラメントはいくつかの適用において有利であり得る異なる剛性又はたわみ性を有し得る。遠位要素102の円盤状の領域の強度は、近位要素101の強度に影響しない。
言及された要素の卵形か異形はそれぞれ形作られた型でヒートセット処置により形成され、その結果、形状が維持することができる。
図5aで例証されるように、大きさD3は、流量調整装置直径の外部の接線と接続要素109の中心の間の距離である。
図7a−7cは、例えば図5a−5cおよび図6a−6cで例証された装置100より大きい直径を備えたキャビティー106を有する流量調整装置100を例証し、より大きい開口部の提供のために使用される。図8a−8cは、流量調整装置100を例証し、それはより長い接続ネックを備えた本体に穴部を作るために使用される、つまり後下行枝(PDA)を広げるような異なる適用のために、より長い大きさ(h)を持っている。一般に、装置の2つの横の2つの円盤は、締め付け力と円盤間の非常に限定した距離を備えた最大の支持を提供し、移植の後に装置の改善された固着および安定化に提供し、チャネルの調整された大きさを維持する。
その結果、装置の遠位のユニットの遠位部が装置によって形作られる裂創の内部に置かれる工程。図9は、身体の穴部の閉鎖用の上述された医療手技で使用するに適しているカテーテルの側面図を示す。カテーテルは、所要の位置に、血流調整装置100と言及された流量調整装置を送達する、かつ正確な移植を実行するために使用される。1つの典型的な使用では、送達シースはガイドワイヤーの援助によって動脈の隔壁に刺された穴部に置かれる。プラスチック・トルク制御を備えた押しケーブルは、所要の位置へ流量調整装置を進めて、かつそれが右位置へ進められる場合、流量調整装置を展開させるために使用される。
より一般には、当業者は、本明細書に記載されたすべてのパラメータ、大きさ、材料、および構成が例示であり、実際のパラメータ、大きさ、材料および/または構成が、本発明の開示教示が用いられる特定の適用又は適用に依存することを容易に認識するであろう。
Claims (18)
- 心臓に分路を作成するための血流調整装置(100)であって;
略円盤形状を有する近位要素(101)であって、該近位要素(101)の中心開口部(103)のまわりに伸びる1本以上のワイヤーの編組によって定義された近位要素(101);
略円盤形状を有する遠位要素(102)であって、該遠位要素(102)の中心開口部(104)のまわりに1本以上のワイヤーの編組によって定義された遠位要素(102);および、
近位要素と遠位要素の中間のネック部を定義し、遠位要素及び近位要素の各々の直径より大きくない直径を有するキャビティー(106)を形成する第3の要素(105)を含み、
前記遠位要素はワイヤーの少なくとも1のループ(107)を含み、該ワイヤーは遠位要素の中心(108)から放射状に外側に伸び、前記遠位要素の前記中心に向かって戻る
心臓に分路を作成するための血流調整装置(100)。 - 前記近位要素、前記遠位要素、及び前記第3の要素は、1本以上のワイヤーの同じ編組から形成されてなる請求項1に記載の血流調整装置。
- 前記近位要素は、繰出装置用の接続要素(109)を含み、
前記1本以上の前記ワイヤーの端末は前記接続要素に固着され、
前記遠位要素は前記1本以上のワイヤーの戻りループ(107)を含み、
それによって、前記遠位要素を形成する1本以上のワイヤーの対向端部は、前記接続要素に固着される請求項2に記載の血流調整装置。 - 前記遠位要素の外周(110)の編組は前記遠位要素の前記外周のまわりの二重層(111)編組を形成するために放射状に内側へ折り重ねられる請求項1−3のいずれかに記載の血流調整装置。
- 前記キャビティーのまわりで配列された配列された膜(112)を更に含む請求項1−4のいずれかに記載の血流調整装置。
- 前記遠位要素は、内皮化を促進する膜(113)を更に含み、および/または前記近位要素が内皮化を促進する膜(114)を更に含む請求項1−5のいずれかに記載の血流調整装置。
- 前記遠位要素は、花弁形のループ(116)を形成する非編組フィラメント(115)を含む請求項1−6のいずれかに記載の血流調整装置。
- 前記第3の要素は弾力があり、その結果、少なくとも部分的に長円形など、心臓の隔壁中の非円形の形状に変形可能であり、
及び/または、前記第3の要素は少なくとも部分的に長円形の横断面を有する請求項1 −7のいずれかに記載の血流調整装置。 - 前記接続要素は、屈曲要素(117)を介して前記近位部に結合され、当該屈曲要素(117)は前記接続要素に固定された前記1本以上の前記ワイヤーから形成された請求項3に記載の血流調整装置。
- 前記接続要素は、少なくとも部分的に球形を有する溶着によって形成される請求項3に記載の血流調整装置。
- 前記遠位要素は、前記近位要素に向かう方向に凹部である少なくとも部分的に凹部形状(118)を含む請求項1−10のいずれかに記載の血流調整装置。
- 前記中心開口部は、前記遠位要素及び前記近位要素に同心状に配列される請求項1−11のいずれかに記載の血流調整装置。
- 前記近位要素は楕円形を有し、および/または前記遠位要素は楕円形を有する請求項1−12のいずれかに記載の血流調整装置。
- 前記膜(113及び114)は、
部分的に生分解性素材;
フィラメント;
弾性の高分子材料;
又は1つ以上の天然繊維のうちの少なくとも1つを含む請求項6に記載の血流調整装置。 - 前記膜は、ナイロン、ポリエステル、ポリプロピレン、ポリテトラフルオロエチレンおよび拡張したポリテトラフルオロエチレンからなる群から選択された弾性の高分子材料を含む請求項14に記載の血流調整装置。
- 前記近位要素及び遠位要素は拡張可能で、前記近位要素が遠位要素より低い膨張強度を持っている請求項1に記載の血流調整装置。
- 血流調整装置(100)を製造する方法(200)であって、
ワイヤーの管状の編組を編む編組工程(201)であって、各ワイヤーの対向端部が管状の編組の近位部で配列され、前記ワイヤーのループが前記管状の編組の遠位端で配列される編組工程(201)、
管状の編組の前記遠位端の遠位円盤を形成する工程(202)、
管状の編組の前記近位端の近位円盤を形成する工程(203)、
前記遠位円盤及び近位円盤のおのおのの中心開口部を形成し、その結果、管状の編組の中央チャネル(106)によって中心開口部が連結されて、前記近位円盤の間に伸ばす工程(204)、
前記チャネルを通って伸びる中心軸(108)からオフセットした距離(119)を備えた近位円盤に位置づけられた接続要素のワイヤーの対向端部を固定させる工程(205)を含む血流調整装置(100)を製造する方法(200)。 - 遠位要素の前記外周のまわりの2倍の層状の編組を形成するために、前記遠位要素の外周で編組を放射状に内側へ折り重ねる工程(206)を含む請求項17に記載の方法。
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EP3922218A1 (en) | 2021-12-15 |
US20170273790A1 (en) | 2017-09-28 |
US10595999B2 (en) | 2020-03-24 |
US11839526B2 (en) | 2023-12-12 |
CN112220505A (zh) | 2021-01-15 |
EP3431051A1 (en) | 2019-01-23 |
ES2888910T3 (es) | 2022-01-10 |
EP3193791A1 (en) | 2017-07-26 |
EP3431051B1 (en) | 2021-09-01 |
US20200268515A1 (en) | 2020-08-27 |
WO2016038115A1 (en) | 2016-03-17 |
CN106714698B (zh) | 2020-11-03 |
CN106714698A (zh) | 2017-05-24 |
TR201815290T4 (tr) | 2018-11-21 |
EP3193791B1 (en) | 2018-08-22 |
JP6577574B2 (ja) | 2019-09-18 |
US20240065840A1 (en) | 2024-02-29 |
ES2690259T3 (es) | 2018-11-20 |
CA2960333C (en) | 2023-02-14 |
CA2960333A1 (en) | 2016-03-17 |
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