JP2016526438A - 閉塞デバイス - Google Patents
閉塞デバイス Download PDFInfo
- Publication number
- JP2016526438A JP2016526438A JP2016524177A JP2016524177A JP2016526438A JP 2016526438 A JP2016526438 A JP 2016526438A JP 2016524177 A JP2016524177 A JP 2016524177A JP 2016524177 A JP2016524177 A JP 2016524177A JP 2016526438 A JP2016526438 A JP 2016526438A
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/01—Filters implantable into blood vessels
- A61F2002/016—Filters implantable into blood vessels made from wire-like elements
Abstract
Description
本開示は、患者内の開口部、導管又は構造を閉塞するために使用することができるインプラント可能なメディカルデバイスに関する。
心耳等の心臓特徴部は心血流障害の原因となることがあり、これは多数の心臓関連病理と関連している。例えば、左心耳(LAA)内血流障害によって生じる、心房細動に伴う合併症は、塞栓性脳卒中を引き起こす場合がある。LAAは筋肉からなる袋状物であり、心臓の左心房の前外側壁から延在し、左心房のための貯留部として機能する。正常な心周期では、LAAは左心房と共に収縮し、血液をLAAから送出する。これにより、血液がLAA内で滞留するのを一般に防いでいる。しかし、不整脈(例えば、心房細動)を特徴とする心周期では、LAAがしばしば十分に収縮できず、血液がLAA内に滞留してしまう場合がある。LAA内に滞留する血液は凝固して血栓を生じやすく、これがLAAから逸失して、最終的に塞栓性脳卒中を引き起こすことがある。
第一の一般的な態様において、閉塞デバイスはカバー構成要素を通した血液又は血栓の通過を調節するように構成されている、カバー構成要素を含む。閉塞デバイスはまた、長尺フレーム部材のそれぞれが、チューブの部分を含む複数の長尺フレーム部材を含む閉塞フレームを含む。長尺フレーム部材は閉塞フレームが拡張形態を取るときに、ほぼディスク形状部材を形成するように構成されており、長尺フレーム部材のそれぞれはほぼディスク形状部材のペタルを形成する。ほぼディスク形状部材の隣接ペタルは互いに少なくとも部分的にオーバーラップしており、そして閉塞フレームはカバー構成要素により少なくとも部分的に被覆されている。閉塞デバイスはインプラント位置で閉塞デバイスを固定するように構成された複数のアンカー部材を含むアンカーフレームをさらに含む。閉塞デバイスは第一のハブ構成要素をさらに含み、該第一のハブ構成要素から複数の長尺フレーム部材は延在しており、ここで、第一のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている。閉塞デバイスは第二のハブ構成要素をさらに含み、該第二のハブ構成要素からアンカー部材は延在しており、ここで、第二のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている。閉塞デバイスは結合部材をさらに含み、該結合部材は第一のハブ部材を第二のハブ部材に結合する。
本ドキュメントは、例えば、患者の体内のスペース、穴、欠損部、開口部、アペンデージ、脈管又は導管を完全に、部分的に又は実質的に閉塞するのに有用なデバイス、システム及び方法を記載する。追加の用途は、幾つかの実施形態では、フィルタリングを含むことができる。幾つかのインプラント可能なメディカルデバイスは本明細書中に記載され、そして一般に、特定のデバイスに関連して記載される任意の特徴部は本明細書中に記載の任意の他のデバイスとともに使用することができる。幾つかの例では、特定のデバイスに関連して記載される1つ以上の特徴部は、別のデバイスの1つ以上の特徴部を交換するか又は置換することができる。幾つかの例では、特定のデバイスに関連して記載される1つ以上の特徴部は別のデバイスに追加されるか又は含まれることができる。また、本明細書中に記載の任意の特徴部の組み合わせ又は副次組み合わせは、一般に、本明細書中に記載の任意のデバイスとともに使用することができる。
Claims (48)
- カバー構成要素を通した血液又は血栓の通過を調節するように構成されているカバー構成要素、
長尺フレーム部材のそれぞれがチューブの部分を含む、複数の長尺フレーム部材を含む閉塞フレーム、ここで、該長尺フレーム部材は閉塞フレームが拡張形態を取るときに、ほぼディスク形状部材を形成するように構成されており、長尺フレーム部材のそれぞれはほぼディスク形状部材のペタルを形成し、ここで、ほぼディスク形状部材の隣接ペタルは互いに少なくとも部分的にオーバーラップしており、そして閉塞フレームはカバー構成要素により少なくとも部分的に被覆されている、
インプラント位置で閉塞デバイスを固定するように構成されている複数のアンカー部材を含むアンカーフレーム、
第一のハブ構成要素、ここで、第一のハブ構成要素から複数の長尺フレーム部材は延在しており、ここで、第一のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、
第二のハブ構成要素、ここで、第二のハブ構成要素からアンカー部材は延在しており、ここで、第二のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、及び、
第一のハブ構成要素を第二のハブ構成要素に結合する結合部材、
を含む、閉塞デバイス。 - 前記複数のアンカー部材のそれぞれのアンカー部材はワイヤを含む、請求項1記載の閉塞デバイス。
- 前記複数のアンカー部材のそれぞれのアンカー部材はチューブの部分を含む、請求項1記載の閉塞デバイス。
- 前記複数のアンカー部材のそれぞれのアンカー部材は第二のチューブの部分を含む、請求項1記載の閉塞デバイス。
- 前記結合部材は1つ以上のニチノールワイヤを含む、請求項1記載の閉塞デバイス。
- 前記第一のハブ構成要素、第二のハブ構成要素及び結合部材は前記カバー構成要素により被覆されている、請求項1記載の閉塞デバイス。
- 前記アンカーフレームは前記カバー構成要素により少なくとも部分的に被覆されている、請求項1記載の閉塞デバイス。
- 前記アンカー部材のそれぞれは第二のハブ構成要素からほぼ遠位かつ半径方向に延在している第一の部分、第一の部分からほぼ遠位かつ半径方向に延在している第二の部分、及び、第二の部分からほぼ近位かつ半径方向に延在している第三の部分を含む、請求項1記載の閉塞デバイス。
- 前記第一の部分はまさに半径方向から遠位に約30°の角度で第二のハブ構成要素から延在しており、第二の部分はまさに半径方向から遠位に約75°の角度で第一の部分から延在しており、そして第三の部分はまさに半径方向から近位に約60°の角度で第二の部分から延在している、請求項1記載の閉塞デバイス。
- 前記アンカー部材のそれぞれは第二のハブ構成要素からほぼ半径方向に延在している第一の部分、第一の部分からほぼ近位方向に延在している第二の部分を含む、請求項1記載の閉塞デバイス。
- 前記結合部材は可撓性であり、そして第一のハブ構成要素に取り付けられている第一の端部及び第二のハブ構成要素に取り付けられている第二の端部を含む、請求項1記載の閉塞デバイス。
- 前記チューブはニチノールを含む、請求項1記載の閉塞デバイス。
- カバー構成要素を通した血液又は血栓の通過を調節するように構成されている、カバー構成要素、
複数の長尺フレーム部材を含む閉塞フレーム、ここで、該長尺フレーム部材は閉塞フレームが拡張形態を取るときに、ほぼディスク形状部材を形成するように構成されており、長尺フレーム部材のそれぞれはほぼディスク形状部材のペタルを形成し、ここで、ほぼディスク形状部材の隣接ペタルは互いに少なくとも部分的にオーバーラップしており、そして閉塞フレームはカバー構成要素により少なくとも部分的に被覆されている、
複数のアンカー部材を含むアンカーフレーム、ここで、アンカー部材のそれぞれはチューブの部分を含み、アンカー部材はインプラント位置で閉塞デバイスを固定するように構成されている、
第一のハブ構成要素、ここで、第一のハブ構成要素から複数の長尺フレーム部材は延在しており、第一のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、
第二のハブ構成要素、ここで、第二のハブ構成要素からアンカー部材は延在しており、第二のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、及び、
第一のハブ構成要素を第二のハブ構成要素に結合する結合部材、
を含む、閉塞デバイス。 - 前記複数の長尺フレーム部材のそれぞれの長尺フレーム部材はワイヤを含む、請求項13記載の閉塞デバイス。
- 前記複数の長尺フレーム部材のそれぞれの長尺フレーム部材はチューブの部分を含む、請求項13記載の閉塞デバイス。
- 前記複数の長尺フレーム部材のそれぞれの長尺フレーム部材は第二のチューブの部分を含む、請求項13記載の閉塞デバイス。
- 前記結合部材は1つ以上のニチノールワイヤを含む、請求項13記載の閉塞デバイス。
- 前記第一のハブ構成要素、第二のハブ構成要素及び結合部材は前記カバー構成要素により被覆されている、請求項13記載の閉塞デバイス。
- 前記アンカーフレームは前記カバー構成要素により少なくとも部分的に被覆されている、請求項13記載の閉塞デバイス。
- 前記アンカー部材のそれぞれは第二のハブ構成要素からほぼ遠位かつ半径方向に延在している第一の部分、第一の部分からほぼ遠位かつ半径方向に延在している第二の部分、及び、第二の部分からほぼ近位かつ半径方向に延在している第三の部分を含む、請求項13記載の閉塞デバイス。
- 前記第一の部分はまさに半径方向から遠位に約30°の角度で第二のハブ構成要素から延在しており、第二の部分はまさに半径方向から遠位に約75°の角度で第一の部分から延在しており、そして第三の部分はまさに半径方向から近位に約60°の角度で第二の部分から延在している、請求項13記載の閉塞デバイス。
- 前記アンカー部材のそれぞれは第二のハブ構成要素からほぼ半径方向に延在している第一の部分、第一の部分からほぼ近位方向に延在している第二の部分を含む、請求項13記載の閉塞デバイス。
- 前記結合部材は可撓性であり、そして第一のハブ構成要素に取り付けられている第一の端部及び第二のハブ構成要素に取り付けられている第二の端部を含む、請求項13記載の閉塞デバイス。
- 前記チューブはニチノールを含む、請求項13記載の閉塞デバイス。
- カバー構成要素を通した血液又は血栓の通過を調節するように構成されている、カバー構成要素、
閉塞フレームが拡張形態を取るときに、ほぼディスク形状部材を形成するように構成されている複数の長尺フレーム部材を含む閉塞フレーム、ここで、長尺フレーム部材のそれぞれはほぼディスク形状部材を形成し、ほぼディスク形状部材の隣接ペタルは互いに少なくとも部分的にオーバーラップしており、そして閉塞フレームはカバー構成要素により少なくとも部分的に被覆されている、
インプラント位置で閉塞デバイスを固定するように構成されている第一のアンカーアーム及び第二のアンカーアームを含むアンカーフレーム、ここで、第一のアンカーアームは第二のアンカーアームとは反対に向いている、
第一のハブ構成要素、ここで、第一のハブ構成要素から複数の長尺フレーム部材は延在しており、そして第一のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、
第二のハブ構成要素、ここで、第二のハブ構成要素から第一のアンカーアーム及び第二のアンカーアームは延在しており、第二のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、及び、
第一の端部及び第二の端部を含む可撓性結合部材、ここで、第一の端部は第一のハブ構成要素に取り付けられており、そして第二の端部は第二のハブ構成要素に取り付けられている、
を含む、閉塞デバイス。 - 第一の形状を形成するように構成されている1つ以上の第一の部分の長尺部材を含む第一の部分、
第一の中央ハブ、ここで、第一の中央ハブから第一の部分の長尺部材の少なくとも幾つかは延在している、
第二の形状を形成するように構成されている1つ以上の第二の部分の長尺部材を含む第二の部分、
第二の中央ハブ、ここで、第二の中央ハブから第二の部分の長尺部材の少なくとも幾つかは延在しており、第二の中央ハブは第一の中央ハブとインターロックされるように構成されている、及び、
第一の部分又は第二の部分のうちの少なくとも1つの上のカバー構成要素、ここで、カバー構成要素はカバー構成要素を通した身体材料の通過を調節するように構成されている、
を含む、閉塞デバイス。 - 前記第一の形状又は第二の形状の少なくとも一方はディスク形状である、請求項26記載の閉塞デバイス。
- 前記カバー構成要素はePTFE又はPTFEを含む、請求項26記載の閉塞デバイス。
- カバー構成要素を通した血液又は血栓の通過を調節するように構成されているカバー構成要素、
長尺閉塞フレーム部材のそれぞれがチューブの部分を含む、複数の長尺閉塞フレーム部材を含む閉塞フレーム、ここで、該長尺閉塞フレーム部材は、閉塞フレームが拡張形態を取るときに、相互結合された閉塞構造を形成するように構成されており、該相互結合された閉塞構造はほぼディスク形状部材を含み、そして閉塞フレームはカバー構成要素により少なくとも部分的に被覆されている、
長尺アンカーフレーム部材のそれぞれがチューブの部分を含む複数の長尺アンカーフレーム部材を含むアンカーフレーム、ここで、該アンカーフレームはインプラント位置で閉塞デバイスを固定するように構成されており、該長尺アンカーフレーム部材は、アンカーフレームが拡張形態を取るときに、相互結合されたアンカー構造を形成するように構成されており、該相互結合されたアンカー構造はほぼ筒形部材を含む、
第一のハブ構成要素、ここで、第一のハブ構成要素から長尺閉塞フレーム部材の少なくとも幾つかは延在している、及び、
第二のハブ構成要素、ここで、第二のハブ構成要素から長尺閉塞フレーム部材の少なくとも幾つかは延在しており、そして第二のハブ構成要素から長尺アンカーフレーム部材の少なくとも幾つかは延在しており、第二のハブ構成要素は閉塞フレームとアンカーフレームとの間に配置されている、
を含む、閉塞デバイス。 - 前記アンカーフレームはカバー構成要素により少なくとも部分的に被覆されている、請求項29記載の閉塞デバイス。
- 前記第一のハブ構成要素から延在している前記長尺閉塞フレーム部材は二股に分かれて、二股枝を形成する第一の長尺閉塞フレーム部材であり、そして該二股枝は他の二股枝と結合して、第二のハブ構成要素から延在している第二の長尺閉塞フレーム部材を形成する、請求項29記載の閉塞デバイス。
- ハブ、
ハブから半径方向外側に延在しており、そしてフレームの閉塞面を画定している複数の湾曲半径方向支柱、及び、
前記複数の湾曲半径方向支柱から延在しており、そしてフレームの側方外側表面を画定するように、相互結合されたセルの列で構成されている、複数のセル、
を含む、フレーム、
カバー構成要素の少なくとも一部が閉塞デバイスの少なくとも一部を通した血液又は血栓の通過を調節するように、フレームに取り付けられたカバー構成要素、
を含む、閉塞デバイス。 - 前記フレームはフレームの側方外側表面から半径方向外側に延在している複数のアンカー要素をさらに含む、請求項32記載の閉塞デバイス。
- 前記複数のアンカー要素は複数のセルのうちの少なくとも幾つかのセルにより画定されている空隙空間内に少なくとも部分的に配置されている、請求項33記載の閉塞デバイス。
- 前記フレームは前駆体材料の単一のチューブ片から形成されている、請求項32記載の閉塞デバイス。
- 前記セルの少なくとも幾つかは矩形形状を含むらせんバイアスされた六角形セルである、請求項32記載の閉塞デバイス。
- ギャザリング部材をさらに含み、ここで、該ギャザリング部材はセルの最端列の頂点を通して編みこまれている、請求項32記載の閉塞デバイス。
- 前記ギャザリング部材は張力下にあり、それにより、セルの最端列のそれぞれのセルは張力なしの場合よりもセルの最端列の他のセルの近くに配置されるようになる、請求項37記載の閉塞デバイス。
- 前記セルの少なくとも幾つかはひし形形状又は六角形形状を含む、請求項32記載の閉塞デバイス。
- アンカーフレームをさらに含み、該アンカーフレームはアンカーフレームハブ及び該アンカーフレームハブから延在している1つ以上のアンカーアームを含み、該1つ以上のアンカーアームはそれぞれ自由端を画定しており、該アンカーフレームハブはフレームのハブと結合されており、そして該1つ以上のアンカーアームの前記自由端はフレームの側方外側表面から突出している、請求項32記載の閉塞デバイス。
- 前記フレームは第一の材料を含み、そして前記アンカーフレームは第一の材料とは異なる第二の材料を含む、請求項40記載の閉塞デバイス。
- 前記アンカーフレームハブはフレームのハブの内部でネスティングされている、請求項40記載の閉塞デバイス。
- ハブ、
ハブから半径方向外側に延在しており、そしてフレームの閉塞面を画定している、複数の半径方向支柱、及び、
複数の湾曲半径方向支柱から延在しており、そしてフレームの側方外側表面を画定するように、相互結合されたセルの列で構成されている、複数のセル、
を含む、フレーム、
カバー構成要素の少なくとも一部が閉塞デバイスの少なくとも一部を通した血液又は血栓の通過を調節するようにフレームに取り付けられているカバー構成要素、及び、
ギャザリング部材、ここで、該ギャザリング部材はセルの最端列の頂点を通して編みこまれている、
を含む、閉塞デバイス。 - 前記ギャザリング部材は張力下にあり、それにより、セルの最端列のそれぞれのセルは張力なしの場合よりもセルの最端列の他のセルの近くに配置されるようになる、請求項43記載の閉塞デバイス。
- 前記フレームはフレームの側方外側表面から半径方向外側に延在している複数のアンカー要素をさらに含む、請求項43記載の閉塞デバイス。
- 前記複数のアンカー要素は前記複数のセルのうちの少なくとも幾つかのセルにより画定されている空隙空間内に少なくとも部分的に配置されている、請求項43記載の閉塞デバイス。
- 前記セルの少なくとも幾つかは六角形形状を含む、請求項43記載の閉塞デバイス。
- 前記六角形形状セルはらせんバイアスされそして矩形形状を含む、請求項47記載の閉塞デバイス。
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CN105658148B (zh) | 2020-07-14 |
CA2917010C (en) | 2018-03-20 |
US20220125567A1 (en) | 2022-04-28 |
EP3013249A1 (en) | 2016-05-04 |
AU2017228585B2 (en) | 2019-10-31 |
AU2014302373A1 (en) | 2016-02-11 |
US20150005810A1 (en) | 2015-01-01 |
AU2017228585A1 (en) | 2017-10-05 |
EP3013249B1 (en) | 2018-08-01 |
CA2917010A1 (en) | 2014-12-31 |
JP6457507B2 (ja) | 2019-01-23 |
US11911258B2 (en) | 2024-02-27 |
BR112015032317A2 (pt) | 2017-07-25 |
ES2693782T3 (es) | 2018-12-13 |
HK1223259A1 (zh) | 2017-07-28 |
WO2014210263A1 (en) | 2014-12-31 |
CN105658148A (zh) | 2016-06-08 |
KR20160024997A (ko) | 2016-03-07 |
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