JP2007509701A - 埋め込み型弁状人工器官 - Google Patents
埋め込み型弁状人工器官 Download PDFInfo
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- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
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- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2412—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
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- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
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Abstract
【解決手段】 本発明は、ステントをベースとする弁(100)に関する。この弁は、放射方向に拡張可能な構造フレーム(101)を備え、この構造フレームは、アンカー構造部(104)と、接続部材(105)と、片持ち梁式弁支柱(107)とを有する。接続部材は、アンカー構造部に取り付けられている。片持ち梁式弁支柱は、接続部材に協働するように結合されている。人工弁は、接続部材の少なくとも一部の回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリ(102)をさらに有する。この膜アセンブリは、第1の径と、第2の径を有する第2の端部とを有し、第1の径が第2の径より大きい。膜アセンブリの端部は、片持ち梁式弁支柱の端部に沿って取り付けられている。
【選択図】 図1
Description
本発明は医療機器、特にフレームをベースとする一方向流人工弁と、このような弁を製造する方法に関するものである。
人間の体は、体の管腔や脈管を通る流体の流れを制御する多くの生物弁を有する。例えば、循環系は様々な心臓弁を有しており、これらは、心室、静脈、および大動脈を通る血流を制御することにより、心臓がポンプとして作用できるようにしている。さらに、静脈系も多くの静脈弁を有し、これらは、心臓に戻る血流、特に下肢から心臓に戻る血流の制御に役立っている。
本発明は、医療機器、特にステントをベースとする弁に関するものである。人工弁は、長手方向軸を規定し、放射方向に広げることができる構造フレームを備えている。この構造フレームは、第1および第2の開口端部を有するアンカー構造部と、第1および第2端部を有する接続部材と、第1および第2端部を有する片持ち梁式弁支柱とを有する。接続部材の第1端部は、アンカー構造部の第2端部に取り付けられている。片持ち梁式弁支柱の第1端部は、接続部材の第2端部に、協働するように結合されている。人工弁は、構造フレーム回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリをさらに有する。この膜アセンブリは、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、第1の径が第2の径より大きい。膜アセンブリの第1端部は、片持ち梁式弁支柱の第2端部に沿って取り付けられている。
本発明のステントをベースとする弁は、弁不全の治療に伴う困難を克服する方法を提供するものである。ステントをベースとする静脈弁を開示して本発明の一実施形態を説明するが、当業者には、開示した発明を体の他の場所や管腔に同様に利用できることがわかるであろう。体の他の場所や管腔とは、例えば、冠状、血管の、非血管の、及び末梢の脈管、管路などであり、本発明を利用できるものには、心臓弁、静脈弁、食道及び胃にある弁、尿管および/または嚢にある弁、胆汁道にある弁、リンパ系にある弁および腸にある弁が含まれるが、これに限定はされない。
(1)人工弁において、
長手方向軸を規定する、放射方向に広げることができる構造フレームであって、第1および第2の開口した端部を有するアンカー構造部と、第1および第2端部を有し、前記接続部材の前記第1端部が前記アンカー構造部の前記第2端部に取り付けられている、接続部材と、第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が、前記接続部材の前記第2端部に、協働するように結合している、片持ち梁式弁支柱とを含む構造フレームと、
前記構造フレーム回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
前記アンカー構造部が、部材を相互接続した格子から形成されており、実質的に円筒状の形状を有する、人工弁。
(3)実施態様1記載の人工弁において、
前記構造フレームが、ステンレススチール、タンタル、プラチナ合金、ニオブ合金、コバルト合金、およびニッケル−チタン合金からなるグループから選択された材料を含む、人工弁。
(4)実施態様1記載の人工弁において、
前記構造フレームがポリマーを含む、人工弁。
(5)実施態様1記載の人工弁において、
前記生体適合性膜アセンブリが、可撓性のある膜状の材料から形成されている、人工弁。
前記膜状の材料が生体物質である、人工弁。
(7)実施態様6記載の人工弁において、
前記生体物質が静脈である、人工弁。
(8)実施態様5記載の人工弁において、
前記膜状の材料が合成材料である、人工弁。
(9)実施態様8記載の人工弁において、
前記合成材料がエラストマーポリマーである、人工弁。
(10)実施態様8記載の人工弁において、
前記合成材料が生体吸収性材料である、人工弁。
前記合成材料が、補強用繊維をさらに含む、人工弁。
(12)実施態様1記載の人工弁において、
前記構造フレームの少なくとも一部が薬剤で被覆されている、人工弁。
(13)実施態様12記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。
(14)実施態様12記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。
(15)実施態様12記載の人工弁において、
前記薬剤被覆が薬剤溶出層を含む、人工弁。
前記膜アセンブリの少なくとも一部が薬剤で被覆されている、人工弁。
(17)実施態様16記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。
(18)実施態様17記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。
(19)実施態様17記載の人工弁において、
前記薬剤被覆が薬剤溶出層を備えている、人工弁。
(20)実施態様1記載の人工弁において、
前記膜アセンブリの少なくとも一部が治療薬で飽和している、人工弁。
前記膜アセンブリの少なくとも一部が調合薬で飽和している、人工弁。
(22)実施態様1記載の人工弁において、
前記接続部材が、実質的まっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
(23)実施態様1記載の人工弁において、
前記接続部材が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。
(24)実施態様1記載の人工弁であって、
前記片持ち梁式弁支柱の前記第1端部が半円形のループ状形状に成形されている、弁支柱。
前記片持ち梁式弁支柱の前記第2端部が、実質的まっすぐな形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
(26)実施態様1記載の人工弁であって、
前記片持ち梁式弁支柱の前記第2端部が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。
(27)実施態様1記載の人工弁において、
前記片持ち梁式弁支柱の前記第2端部が、実質的に波形形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。
(28)実施態様1記載の人工弁において、
前記筒状生体適合性膜の前記第2端部が閉じた端部を有する、人工弁。
前記筒状生体適合性膜の前記第2端部が開口した端部を有する、人工弁。
(30)実施態様1記載の人工弁において、
前記筒状生体適合性膜の前記第2端部が、前記片持ち梁式弁支柱によって実質的に開いた状態から実質的に閉じた状態まで動く、弁支柱。
(31)実施態様1記載の人工弁において、
前記構造フレームが近位カラーをさらに備え、前記近位カラーが、前記接続部材の前記第2端部および前記片持ち梁式弁支柱の前記第1端部に取り付けられている、人工弁。
(32)実施態様31記載の人工弁において、
前記構造フレームがセンタリング用足部をさらに備え、前記センタリング用足部は、前記近位カラーに、協働するように結合されている、人工弁。
(33)実施態様31記載の人工弁において、
前記構造フレームが近位アンカーをさらに備え、前記近位アンカーは、前記近位カラーに、協働するように結合されている、人工弁。
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が、前記接続部材の前記第2端部に、協働できるように結合されている、片持ち梁式弁支柱と、
前記接続部材の少なくとも一部の回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
前記放射方向に広げることができるアンカーの近位に配置されたカラーと、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられており、前記接続部材の前記第2端部が前記近位カラーに取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が前記近位カラーに取り付けられており、前記片持ち梁式弁支柱が遠位の方向に前記長手方向軸に実質的に平行に延びている片持ち梁式弁支柱と、
前記接続部材の少なくとも一部の回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
Claims (35)
- 人工弁において、
長手方向軸を規定する、放射方向に広げることができる構造フレームであって、第1および第2の開口した端部を有するアンカー構造部と、第1および第2端部を有し、前記接続部材の前記第1端部が前記アンカー構造部の前記第2端部に取り付けられている、接続部材と、第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が、前記接続部材の前記第2端部に、協働するように結合している、片持ち梁式弁支柱と、を含む構造フレームと、
前記構造フレーム回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。 - 請求項1記載の人工弁において、
前記アンカー構造部が、部材を相互接続した格子から形成されており、実質的に円筒状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームが、ステンレススチール、タンタル、プラチナ合金、ニオブ合金、コバルト合金、およびニッケル−チタン合金からなるグループから選択された材料を含む、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームがポリマーを含む、人工弁。 - 請求項1記載の人工弁において、
前記生体適合性膜アセンブリが、可撓性のある膜状の材料から形成されている、人工弁。 - 請求項5記載の人工弁において、
前記膜状の材料が生体物質である、人工弁。 - 請求項6記載の人工弁において、
前記生体物質が静脈である、人工弁。 - 請求項5記載の人工弁において、
前記膜状の材料が合成材料である、人工弁。 - 請求項8記載の人工弁において、
前記合成材料がエラストマーポリマーである、人工弁。 - 請求項8記載の人工弁において、
前記合成材料が生体吸収性材料である、人工弁。 - 請求項8記載の人工弁において、
前記合成材料が、補強用繊維をさらに含む、人工弁。 - 請求項1記載の人工弁において、
前記構造フレームの少なくとも一部が薬剤で被覆されている、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。 - 請求項12記載の人工弁において、
前記薬剤被覆が薬剤溶出層を含む、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が薬剤で被覆されている、人工弁。 - 請求項16記載の人工弁において、
前記薬剤被覆が治療薬を含んでいる、人工弁。 - 請求項17記載の人工弁において、
前記薬剤被覆が調合薬を含んでいる、人工弁。 - 請求項17記載の人工弁において、
前記薬剤被覆が薬剤溶出層を備えている、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が治療薬で飽和している、人工弁。 - 請求項1記載の人工弁において、
前記膜アセンブリの少なくとも一部が調合薬で飽和している、人工弁。 - 請求項1記載の人工弁において、
前記接続部材が、実質的まっすぐな部材であり、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記接続部材が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱の前記第1端部が半円形のループ状形状に成形されている、弁支柱。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱の前記第2端部が、実質的まっすぐな形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱の前記第2端部が前記長手方向軸回りの実質的に螺旋状の形状を有する、人工弁。 - 請求項1記載の人工弁において、
前記片持ち梁式弁支柱の前記第2端部が、実質的に波形形状をしており、前記長手方向軸に実質的に平行な方向に向けられている、人工弁。 - 請求項1記載の人工弁において、
前記筒状生体適合性膜の前記第2端部が閉じた端部を有する、人工弁。 - 請求項1記載の人工弁において、
前記筒状生体適合性膜の前記第2端部が開口した端部を有する、人工弁。 - 請求項1記載の人工弁において、
前記筒状生体適合性膜の前記第2端部が、前記片持ち梁式弁支柱によって実質的に開いた状態から実質的に閉じた状態まで動く、弁支柱。 - 請求項1記載の人工弁において、
前記構造フレームが近位カラーをさらに備え、前記近位カラーが、前記接続部材の前記第2端部および前記片持ち梁式弁支柱の前記第1端部に取り付けられている、人工弁。 - 請求項31記載の人工弁において、
前記構造フレームがセンタリング用足部をさらに備え、前記センタリング用足部は、前記近位カラーに、協働するように結合されている、人工弁。 - 請求項31記載の人工弁において、
前記構造フレームが近位アンカーをさらに備え、前記近位アンカーは、前記近位カラーに、協働するように結合されている、人工弁。 - 人工弁において、
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の第1端部が、前記接続部材の前記第2端部に、協働できるように結合されている、片持ち梁式弁支柱と、
前記接続部材の少なくとも一部の回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。 - 人工弁において、
放射方向に広げることができるアンカー構造部であって、部材を相互接続した格子から形成されており、実質的に円筒形状をしていて、第1および第2開口端部があり、前記第1および第2開口端部の間に延びる長手方向を規定する長手方向軸を有するアンカー構造部と、
前記放射方向に広げることができるアンカーの近位に配置されたカラーと、
第1および第2端部を有する接続部材であって、前記接続部材の前記第1端部が前記アンカーの前記第2端部に取り付けられており、前記接続部材の前記第2端部が前記近位カラーに取り付けられている、接続部材と、
第1および第2端部を有する片持ち梁式弁支柱であって、前記片持ち梁式弁支柱の前記第1端部が前記近位カラーに取り付けられており、前記片持ち梁式弁支柱が遠位の方向に前記長手方向軸に実質的に平行に延びている片持ち梁式弁支柱と、
前記接続部材の少なくとも一部の回りに長手方向に配置された実質的に筒状形状の生体適合性膜アセンブリであって、第1の径を有する第1の端部と、第2の径を有する第2の端部とを有し、前記第1の径が前記第2の径より大きく、前記膜アセンブリの前記第1端部が、前記片持ち梁式弁支柱の前記第2端部に沿って取り付けられている、生体適合性膜アセンブリと、
を備える人工弁。
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AU2004289196B2 (en) | 2011-03-24 |
WO2005046529A1 (en) | 2005-05-26 |
CA2544296A1 (en) | 2005-05-26 |
JP4739223B2 (ja) | 2011-08-03 |
DE602004026089D1 (de) | 2010-04-29 |
CA2544296C (en) | 2012-06-19 |
ATE460906T1 (de) | 2010-04-15 |
US20050096734A1 (en) | 2005-05-05 |
AU2004289196A1 (en) | 2005-05-26 |
US7070616B2 (en) | 2006-07-04 |
EP1682048B1 (en) | 2010-03-17 |
EP1682048A1 (en) | 2006-07-26 |
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