JP5931880B2 - 弁置換装置、弁置換装置とその送達装置とを備えるシステム、および弁置換装置の製造方法 - Google Patents
弁置換装置、弁置換装置とその送達装置とを備えるシステム、および弁置換装置の製造方法 Download PDFInfo
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- 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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Description
大まかに言えば、本発明の1つの局面は、少なくとも2つの弁尖を有する弁構成要素(および/または生体弁)を含む心臓弁置換のための装置を提供する。ここで「弁構成要素」という用語は、弁尖が互いにしっかりと固定されて他の構成要素から独立した単一の弁構造を規定しているか否かに関わらず、弁尖を総称するために用いられる。
(i)各アイレット内に受け入れ可能な突出部を含み得、突出部は、ステント構成要素が折畳状態にあるときに、突出部がアイレット内に捕捉され、隣接する支柱同士の間を通過することができないように寸法決めされ得、および/または、
(ii)少なくともステント構成要素が折畳状態にあるときに、取付要素を実質的に内部に収容するための1つ以上の凹部または隙間
を含み得る。
(i)各アイレット内に受け入れ可能な突出部を含み得、突出部は、ステントが折畳状態にあるときに、突出部がアイレット内に捕捉され、隣接する支柱同士の間を通過することができないように寸法決めされ得、および/または、
(ii)少なくともステントが折畳状態にあるときに、取付要素を実質的に内部に収容するための1つ以上の凹部または隙間
を含み得る。
Claims (19)
- 経カテーテル埋込のための弁置換装置であって、
第1の端と、第2の端と、前記第1の端と前記第2の端との間に配置された少なくとも1つの中間部とを含むステント構成要素を備え、前記ステント構成要素は、埋込部位への送達のための圧縮状態へと半径方向に圧縮可能であるとともに、機能状態へと拡張可能で
あり、前記中間部は少なくとも2つの交連ポストを含み、前記弁置換装置はさらに、
前記ステント構成要素の内部に少なくとも部分的に延在する内側スカートと、
各々が少なくとも2つのタブを含む少なくとも2つの弁尖とを備え、前記タブは、前記内側スカートのスリットを通って突出し、前記交連ポストに直接的に取付けられ、
前記弁尖は前記内側スカートに取付けられ、前記内側スカートは扇形の間隙によって間隔を空けられた交連部分を有し、各間隙には弁尖が及び、前記内側スカートの各交連部分は、それぞれの交連ポストの周りに少なくとも部分的に折返された少なくとも1つのフラップを含む、弁置換装置。 - 2つの隣接した弁尖のタブは、合流し、前記内側スカートの同一のスリットを通って突出し、同一の交連ポストに直接的に取付けられる、請求項1に記載の装置。
- 各タブは、前記交連ポストのスロットを通過することによって、および/または前記交連ポストに前記タブを取り付ける縫合部によって、前記交連ポストに直接的に取付けられる、請求項1または請求項2に記載の装置。
- 前記内側スカートの各交連部分は、それぞれの交連ポストの周りに少なくとも部分的に折返された2つのフラップを含む、請求項1から請求項3のいずれかに記載の装置。
- 前記少なくとも1つのフラップは、前記交連ポストに取付けられる前記タブの一部を実質的に覆う、請求項1から請求項4のいずれかに記載の装置。
- 前記少なくとも1つのフラップは、前記交連ポストに取付けられる前記タブの縁を越えて軸方向に延在する、請求項1から請求項5のいずれかに記載の装置。
- 前記交連ポストの各々は、隣接したステント構造と連通するステムと、隣接したステント構造と連通する2本の脚部とを有する叉骨形状である、請求項1から請求項6のいずれかに記載の装置。
- 経カテーテル埋込のための弁置換装置であって、
流入末端および流出末端を有するステント構成要素を備え、前記ステント構成要素は、埋込部位への送達のための圧縮状態へと半径方向に圧縮可能であるとともに、機能状態へと半径方向に拡張可能であり、前記弁置換装置はさらに、
前記ステント構成要素の内部に少なくとも部分的に装着された弁尖と、
前記弁尖に取付けられる内側スカートとを備え、前記内側スカートは、前記流入末端に向かって前記ステント構成要素の内部に少なくとも部分的に延在し、前記弁置換装置はさらに、
前記ステント構成要素の外部に少なくとも部分的に延在する外側スカートを備え、前記外側スカートは、前記流入末端に向かって前記内側スカートよりもさらに延在し、
前記内側スカートは、前記ステント構成要素の前記流出末端に向かって前記外側スカートよりもさらに延在する、弁置換装置。 - 経カテーテル埋込のための弁置換装置であって、
流入末端および流出末端を有するステント構成要素を備え、前記ステント構成要素は、埋込部位への送達のための圧縮状態へと半径方向に圧縮可能であるとともに、機能状態へと半径方向に拡張可能であり、前記弁置換装置はさらに、
前記ステント構成要素の内部に少なくとも部分的に装着された弁尖と、
前記弁尖に取付けられる内側スカートとを備え、前記内側スカートは、前記流入末端に向かって前記ステント構成要素の内部に少なくとも部分的に延在し、前記弁置換装置はさらに、
前記ステント構成要素の外部に少なくとも部分的に延在する外側スカートを備え、前記外側スカートは、前記流入末端に向かって前記内側スカートよりもさらに延在し、
前記ステント構成要素の口は、少なくとも一列のセルの格子構造によって規定されるジグザグ形状を有し、前記ジグザグ形状は、前記流入末端における自由頂部と、隣接したセルに接続する接続頂部との交互の配列によって規定され、前記内側スカートは、前記接続頂部の少なくともいくつかに対応するレベルまでしか延在せず、前記外側スカートは、前記自由頂部の少なくともいくつかに対応するレベルまで延在する、弁置換装置。 - 前記内側スカートおよび前記外側スカートは、軸方向において互いに部分的に重畳する、請求項8または請求項9に記載の装置。
- 前記ステント構成要素の前記口における前記列のセルは、前記列の隣接したセルの前記自由頂部を越えて延在し、かつ前記外側スカートによって覆われていない、露出した自由頂部を有する、少なくとも第1のセルおよび第2のセルを含み、露出した前記自由頂部は、前記弁置換装置を埋込部位まで送達するための送達装置のステントホルダに係合する取付要素を提供する、請求項8から請求項10のいずれかに記載の装置。
- 前記ステント構成要素は、第1の端と、第2の端と、前記第1の端と前記第2の端との間に配置された少なくとも1つの中間部とを含み、前記中間部は少なくとも2つの交連ポストを含み、前記交連ポストの各々は、隣接したステント構造と連通するステムと、隣接したステント構造と連通する2本の脚部とを有する叉骨形状であり、
前記弁尖は、前記ステント構成要素によって支持され、各弁尖は、前記交連ポストに直接的に取付けられる少なくとも2つのタブを含む、請求項8から請求項11のいずれかに記載の装置。 - 前記ステント構成要素は、前記中間部と前記第2の端との間に配置された少なくとも一列のセルを含む格子構造を有し、各交連ポストの前記叉骨形状は、少なくとも3つの隣接したセルのそれぞれの配列に及ぶことによって、前記叉骨は、前記配列の少なくとも1つの中間セルに取付けられることなく、前記配列の外側セルから延在する、請求項7から請求項12のいずれかに記載の装置。
- 前記弁尖の前記タブは、前記叉骨形状の交連ポストの前記ステムに取付けられる、請求項7、請求項12および請求項13のいずれかに記載の装置。
- 前記叉骨形状の交連ポストの前記脚部は、前記弁尖の外縁と一致するように成形される、請求項7、請求項12から請求項14のいずれかに記載の装置。
- 前記少なくとも2つの交連ポストは、前記第1の端と前記中間部との間に配置された少なくとも2本の安定化アーチによって互いに接続される、請求項7および請求項12から請求項15のいずれかに記載の装置。
- 複数の弁尖を支持するステント構成要素を備え、前記ステント構成要素は、送達カテーテルのステントホルダと協働する少なくとも1つの取付要素を含み、前記取付要素は、2つのステント支柱を互いに接合するU字形状部分を含み、前記ステント構成要素の前記圧縮状態では、前記支柱は、前記U字形状部分の孤が、前記支柱同士の間隔よりも大きいアパーチャを有する閉じたまたはほぼ閉じたアイレットを規定するように180度よりも大きい第1の角度で周りを延在するように、前記取付要素において互いに隣接して存在し、前記ステント構成要素の前記機能状態では、前記支柱は変位して互いに離れ、前記U字形状部分の孤は、前記アイレットを少なくとも部分的に開くように、前記第1の角度よりも小さい第2の角度で周りを延在する、請求項1から請求項16のいずれかに記載の装置。
- 前記圧縮状態では、前記取付要素の前記U字形状は実質的に蹄鉄形のU字形状である、請求項17に記載の装置。
- 前記機能状態では、前記取付要素の前記U字形状は実質的に非蹄鉄形のU字形状である、請求項17または18に記載の装置。
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