JP2007526789A - 特に大動脈弁狭窄症の治療における経動脈的デリバリに適した移植可能な人工補綴装置、及び同人工補綴装置を移植する方法 - Google Patents
特に大動脈弁狭窄症の治療における経動脈的デリバリに適した移植可能な人工補綴装置、及び同人工補綴装置を移植する方法 Download PDFInfo
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- 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
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- A61F2220/00—Fixations or connections for 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
Description
本発明の他の特徴及び利点は、以下の説明から明らかとなるであろう。
上記図面及び以下の説明は、主として本発明の概念的態様及び現時点で好ましい実施形態であると考えられるものを含む本発明の様々な可能な実施形態の理解を容易にするために提供されているものであることは理解されるべきである。簡明化の利益にあたって、当業者が通常の技術及び設計を用いて記載された発明を理解し且つ実施することを可能とさせるのに必要である以上の詳細を提供しようとするものではない。さらに、記載される実施形態は例示のためのものに過ぎず、本発明が本願に記載されている以外の形態及び用途で具体化され得ることは理解されるべきである。
上述したように、本発明は、主として、大動脈狭窄症の利用において使用するための人工補綴装置を疾患大動脈弁へ移植することに向けたものである。この人工補綴装置は、左心室と大動脈との間の圧力勾配を減少させて心臓にかけられる仕事量を軽減するために、血液の圧力回復を助けるように設計されている。図2は、本発明による人工補綴装置の一つの構造を線図で示しており、図1a〜図1cは、深刻な大動脈狭窄症を患った大動脈弁によって心臓にかけられる仕事量を軽減させるためにこのような人工補綴装置が使用される様子を線図で示している。
前に指摘したように、本発明に従って構成された人工補綴装置は、また、発散錘状部分5の遠位端部DEに、人工補綴装置と共に移植される人工弁を備えていることが好ましい。しかしながら、用途によっては、人工補綴装置が人工弁なしで移植されてもよく、人工弁が続く第2の工程で人工補綴装置の大動脈下流側に移植されてもよいことは予期される。
このように、図5の断面図において特に示されているように、図示される人工補綴装置は、カテーテルを介して移植部位(この場合、大動脈閉塞によって影響を受ける大動脈弁輪又は大動脈弁口)に経動脈的に送達できるように、拡張可能な金属製ベース10(例えば、メッシュ構造のもの)を備える。図示される人工補綴装置は、さらに、例えば可撓性ポリマ材料又は他の生体適合性材料からなる内側エンベロープ(内包体)11を備え、内側エンベロープ11で金属製ベース10の全内側表面を覆っている。
図9は、図4〜図8に関して上記で説明したものと類似の人工補綴装置であり、したがって理解を容易にするために、対応する部分は同じ参照番号によって識別されている。図9に示されている人工補綴装置の主たる相違点は複数の支え要素20が設けられていることであり、これら支え要素20は、金属製ベース10の遠位端部DEによって担持されており、人工補綴装置、特にその遠位端部を補強するために図10に示されているように大動脈内で大動脈の内側表面と係合可能である。
図12〜図14は、金属製ベースが大動脈弁輪に取り付けられた人工補綴装置の喉部分(図2の参照番号2)のみを占める点、すなわち図12〜図14において参照番号110によって示されている金属製ベースが人工補綴装置の発散錘状部分(図2の参照番号5)まで延びていない又は当該発散錘状部分の一部を構成していない点において、上述したものと大きく異なっている人工補綴装置を示している。人工補綴装置の発散錘状部分(図2の参照番号5)は、図12〜図14において参照番号111によって示されているエンベロープによってのみ占められており、このプラスチック製エンベロープが人工弁としても機能している。よって、心収縮期に、エンベロープ111が開き、エンベロープの遠位端部における圧力回復によって大動脈への非乱流血流を生じさせるように、発散していく錘状形態をとる。これに対して、心拡張期には、エンベロープ111が潰れて、中の流れを妨げる。
上記で指摘したように、本発明の人工補綴装置は、身体の通路壁に形成された開口に移植されることを意図されたものである。したがって、本発明の人工補綴装置は、身体通路を介して移植部位に送達するのに適した圧縮された状態を有し且つ移植部位で開口への移植に適した拡張された状態に拡張できるように構成されている。上述した本発明の好ましい実施形態は、患者の心臓の大動脈弁輪への移植を意図したものであるので、大動脈弁輪への経動脈デリバリ(経動脈送達)及び大動脈弁輪への移植のための大動脈弁輪での拡張に適するように構成されている。
図15a〜図15hは、単一のシース(鞘状体)を用いて例えば図2の人工補綴装置を展開する方法を図式的に示しているのに対して、図16a〜図16fは図11に示されている構成の人工補綴装置すなわち環状配列の支え要素40を備えている人工補綴装置を展開するために使用される方法を示している。
図17a〜図17hは、人工補綴装置の展開の2シース法を図解している。例示のため、この人工補綴装置は上述した図4〜図8に示されているものである。
Claims (40)
- 経動脈デリバリのための圧縮された状態を有し且つ移植のための拡張された状態に拡張可能である、患者の心臓の大動脈弁の大動脈閉塞症の治療において使用するための人工補綴装置であって、
該人工補綴装置を拡張させた状態で大動脈弁の大動脈弁輪に移植可能となるように構成された拡張可能な金属製ベースと、
前記金属製ベースの内側表面を覆っている内側エンベロープと、
を備え、
前記人工補綴装置を拡張させた状態における前記内側エンベロープは、大動脈まで延び、発散していく錘状形態であり、該錘状形態の部分では、心収縮期の際に、プラスチック製エンベロープの遠位端部における圧力回復によって大動脈への非乱流血流を生じさせるように、直径が大動脈弁輪内の近位端部から大動脈内に延びる遠位端部まで徐々に増加していることを特徴とする人工補綴装置。 - 前記人工補綴装置を拡張させた状態では、発散していく錘状形態の前記内側エンベロープは直径5〜20mmの近位端部と直径15〜30mmの遠位端部とを有し、長さが15〜45mmである、請求項1に記載の人工補綴装置。
- 前記内側エンベロープの前記近位端部は、前記プラスチッキ製エンベロープの中での流れの剥離を回避するのに有効となるように、前記大動脈弁輪内に均一な直径の短い直線状部分を含んでいる、請求項2に記載の人工補綴装置。
- 前記短い直線状部分の長さは、2〜10mmである、請求項3に記載の人工補綴装置。
- 患者の心臓の前記大動脈弁は、開いた位置及び閉じた位置に移動可能な複数の小葉を含むタイプであり、前記金属製ベースは、該金属製ベースを前記小葉にクランプするために、開いた位置のときの前記小葉の両側に係合可能な二つの環状クランプ部を含む、請求項1に記載の人工補綴装置。
- 前記二つの環状クランプ部の各々は、環状配列のフィンガを含んでいる、請求項5に記載の人工補綴装置。
- 前記金属製ベースは、前記人工補綴装置の遠位端部に、大動脈内において前記人工補綴装置を補強するために大動脈の内側表面と係合可能な環状配列の支え要素を含んでいる、請求項6に記載の人工補綴装置。
- 前記支え要素は、一方の端部において、前記二つの環状クランプ部の一方の前記環状配列のフィンガと一体的に形成されている、請求項7に記載の人工補綴装置。
- 前記人工補綴装置を拡張させた状態のときに、前記金属製ベースは、前記内側エンベロープが前記前記人工補綴装置の前記近位端部から前記遠位端部まで前記金属製ベースの内側表面を覆うライナとして機能する、請求項1に記載の人工補綴装置。
- 前記金属製ベースは、前記人工補綴装置の遠位端部に、心臓から大動脈への血流を制御する人工弁を有している、請求項9に記載の人工補綴装置。
- 前記人工弁は、開いた位置及び閉じた位置に移動可能な複数の小葉部を含んでいる、請求項10に記載の人工補綴装置。
- 前記人工補綴装置の前記小葉部は、前記金属製ベースの内側表面を覆う前記内側エンベロープと一体的に形成されている、請求項11に記載の人工補綴装置。
- 前記金属製ベースは、移植されたときに大動脈弁の大動脈弁輪のみに係合するような形態及び寸法を有しており、大動脈内に延びる前記内側エンベロープは、心収縮期に発散していく錘状形態となり、前記内側エンベロープ内を順方向に血液が流れることを許容するが、心拡張期には潰れて前記エンベロープ内を血液が逆流することを阻止する、請求項1に記載の人工補綴装置。
- 大動脈内に延びる前記内側エンベロープは、可撓性及び柔軟性を有した材料から形成されている、請求項13に記載の人工補綴装置。
- 大動脈内に延びる前記内側エンベロープは、軸線方向に延びる複数の補強用ストラットを含んでいる、請求項13に記載の人工補綴装置。
- 前記補強用ストラットは、前記金属製ベースにヒンジ結合によって接続されている、請求項15に記載の人工補綴装置。
- 身体通路を介して送達するための圧縮された状態を有し且つ開口部に移植するための拡張された状態に拡張可能である、身体通路の壁に形成された開口部に移植するための人工補綴装置であって、
前記開口部内に受容可能となるように構成された拡張可能な金属製ベースと、
前記金属製ベースによって支持されており、前記開口部内に前記金属製ベースをクランプするために、前記金属製ベースを拡張させた状態において前記壁の両側の面と係合可能である二つの環状クランプ部と、
を備えることを特徴とする人工補綴装置。 - 前記二つの環状クランプ部の各々は環状配列のフィンガを含んでいる、請求項17に記載の人工補綴装置。
- 前記人工補綴装置は、前記金属製ベースの内側表面を覆っている内側エンベロープをさらに備え、該内側エンベロープは、前記人工補綴装置を拡張させた状態において、発散していく錘状形態となり、該錘状形態では、直径が前記開口部内の近位端部から前記開口部から離れて配置される遠位端部へ徐々に増加していく、請求項17に記載の人工補綴装置。
- 前記人工補綴装置を拡張させた状態では、発散していく錘状形態の前記内側エンベロープは直径5〜20mmの近位端部と直径15〜30mmの遠位端部とを有し、長さが15〜45mmである、請求項19に記載の人工補綴装置。
- 発散していく錘状形態の前記内側エンベロープは、さらに、前記近位端部と同じ直径の短い直線状部分を前記近位端部に隣接して含んでいる、請求項20に記載の人工補綴装置。
- 前記短い直線状部分の長さは2〜10mmである、請求項21に記載の人工補綴装置。
- 前記金属製ベースは、前記人工補綴装置を拡張させた状態において、前記内側エンベロープが前記人工補綴装置の前記近位端部から前記遠位端部まで前記金属製ベースの内側表面を覆うライナとして機能するように、前記内側エンベロープの前記近位端部まで延びている、請求項19に記載の人工補綴装置。
- 前記開口部は、患者の心臓の大動脈弁の大動脈弁輪であり、前記金属製ベースの前記遠位端部は、心臓から大動脈への血流を制御する人工弁を有している、請求項23に記載の人工補綴装置。
- 前記人工弁は、心収縮期に開いた位置に移動可能であり且つ心拡張期に閉じた位置に移動可能である複数の小葉部を含んでいる、請求項24に記載の人工補綴装置。
- 前記人工弁の前記小葉部は、前記金属製ベースの内側表面を覆っている前記内側エンベロープと一体的に形成されている、請求項25に記載の人工補綴装置。
- 前記金属製ベースは、前記人工補綴装置の遠位端部に、大動脈内において前記人工補綴装置の遠位端部を補強するために前記大動脈の内側表面と係合可能な環状配列の補強用フィンガを含んでいる、請求項24に記載の人工補綴装置。
- 前記金属製ベースは、移植されたときに大動脈弁の大動脈弁輪にのみ係合するような形態及び寸法になっており、大動脈内に延びる前記内側エンベロープは、心収縮期に前記発散していく錘状形態となり、前記内側エンベロープ内を順方向に血液が流れることを許容するが、心拡張期には潰れて前記内側エンベロープ内を血液が逆流することを阻止する、請求項24に記載の人工補綴装置。
- 大動脈内に延びる前記内側エンベロープは、可撓性及び柔軟性を有した材料から形成されている、請求項28に記載の人工補綴装置。
- 大動脈内に延びる前記内側エンベロープは、軸線方向に延びる複数の補強用ストラットを含んでいる、請求項29に記載の人工補綴装置。
- 前記補強用ストラットは、前記金属製ベースにヒンジ結合によって接続されている、請求項30に記載の人工補綴装置。
- 前記補強用ストラットは、前記金属製ベースと同じ材料から形成されており、一体的に形成されたヒンジによって旋回可能に前記金属製ベースに接続されている、請求項31に記載の人工補綴装置。
- 身体通路の壁に形成された開口部に請求項17に記載の人工補綴装置を移植する方法であって、
前記二つの環状クランプ部と係合可能であり且つ前記二つの環状クランプ部を圧縮させているシースを有したカテーテルに、圧縮された状態の前記人工補綴装置を導入するステップと、
前記身体通路を通して移植部位に前記カテーテル及び前記人工補綴装置を送達し、前記金属製ベースを前記開口部内に配置させ、前記開口部を形成された前記壁の両側に前記二つの環状クランプ部を配置させるステップと、
一方側に前記シースを移動させて、前記二つの環状クランプ部の一方を解放して拡張させた後に前記二つの環状クランプ部の他方を解放して拡張させるステップと、
前記二つの環状クランプ部を前記壁の両側に係合させた状態で前記金属製ベースを前記開口部内に移植した状態のまま、前記身体通路から前記カテーテルを前記シースと共に除去するステップと、
を含む人工補綴装置を移植する方法。 - 前記シースによって圧縮された状態になっている間に、前記カテーテルのバルーンの周りに前記人工補綴装置を取り付け、前記シースを除去した後、前記バルーンを膨張させて前記開口部内で前記金属製ベースを拡張させ、前記バルーンを収縮させて前記身体通路から前記カテーテル及び前記シースを除去する、請求項33に記載の人工補綴装置を移植する方法。
- 前記開口部は患者の心臓の大動脈弁の大動脈弁輪である、請求項33に記載の人工補綴装置を移植する方法。
- 前記人工補綴装置は、その遠位端部に、心臓から大動脈への血流を制御する人工弁を有している、請求項35に記載の人工補綴装置を移植する方法。
- 身体通路の壁に形成された開口部に請求項17に記載の人工補綴装置を移植する方法であって、
前記二つの環状クランプ部の一方を圧縮された状態に保持するように前記二つの環状クランプ部の一方と係合可能な第1のシースと前記二つの環状クランプ部の他方を圧縮された状態に保持するように前記二つの環状クランプ部の他方と係合可能な第2のシースとを有したカテーテルに、圧縮された状態の前記人工補綴装置を導入するステップと、
前記身体通路を通して移植部位に前記カテーテル及び前記人工補綴装置を送達し、前記金属製ベースを前記開口部内に配置させ、前記開口部を形成された前記壁の両側に前記二つの環状クランプ部を配置させるステップと、
前記第1のシースを一方側に移動させ、前記二つの環状クランプ部の一方を解放して拡張された状態にするステップと、
前記第2のシースを他方側に移動させ、前記二つの環状クランプ部の他方を解放して拡張された状態にするステップと、
前記二つの環状クランプ部を前記壁の両側に係合させた状態で前記金属製ベースを前記開口部内に移植した状態のまま、前記身体通路から前記カテーテルと前記第1のシース及び前記第2のシースとを除去するステップと、
を含む人工補綴装置を移植する方法。 - 前記シースによって圧縮された状態になっている間に、前記カテーテルのバルーンの周りに前記人工補綴装置を取り付け、前記第1のシース及び前記第2のシースを除去した後、前記バルーンを膨脹させて前記開口部内に前記金属製ベースをしっかり押し付け、前記バルーンを収縮させて前記身体通路から前記カテーテルと前記第1のシース及び前記第2のシースとを除去する、請求項37に記載の人工補綴装置を移植する方法。
- 前記開口部は、患者の心臓の大動脈弁の大動脈弁輪であり、開いた状態及び閉じた状態に移動可能な小葉部を含んでおり、拡張された前記二つの環状クランプ部の一方が大動脈に面する前記金属製ベースの側に配置され、前記二つの環状クランプ部の他方が心臓に面する前記金属製ベースの側に配置される、請求項37に記載の人工補綴装置を移植する方法。
- 前記人工補綴装置は、その遠位端部に、心臓から大動脈への血流を制御する人工弁を有し、前記人工弁は、前記第1のシースによって圧縮され、前記第2のシースを移動させる前に前記第1のシースを一方側に移動させることによって部分的に拡張され、前記第2のシースを移動させた後に前記第1のシースをさらに移動させることによって完全に拡張されるようになっている、請求項39に記載の人工補綴装置を移植する方法。
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- 2004-07-06 KR KR1020067000423A patent/KR20060112705A/ko not_active Application Discontinuation
- 2004-07-06 WO PCT/IL2004/000601 patent/WO2005002466A2/en active Application Filing
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Also Published As
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AU2004253375A1 (en) | 2005-01-13 |
RU2006103367A (ru) | 2006-06-27 |
WO2005002466A2 (en) | 2005-01-13 |
WO2005002466A3 (en) | 2005-03-03 |
JP4942031B2 (ja) | 2012-05-30 |
CA2531528C (en) | 2013-09-03 |
CN1849102A (zh) | 2006-10-18 |
EP1648339A2 (en) | 2006-04-26 |
AU2004253375A2 (en) | 2005-01-13 |
AU2004253375B2 (en) | 2011-07-14 |
EP1648339A4 (en) | 2011-03-16 |
KR20060112705A (ko) | 2006-11-01 |
US7429269B2 (en) | 2008-09-30 |
US20060259134A1 (en) | 2006-11-16 |
CA2531528A1 (en) | 2005-01-13 |
EP1648339B1 (en) | 2013-02-20 |
CN1849102B (zh) | 2011-01-19 |
BRPI0412362A (pt) | 2006-09-05 |
EP1648339B2 (en) | 2020-06-17 |
NO20060588L (no) | 2006-04-10 |
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