JP2016508858A - 枢動防止機構を伴う人工弁 - Google Patents
枢動防止機構を伴う人工弁 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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- 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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- 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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Abstract
Description
本願は、2013年3月11日に出願された米国仮特許出願第61/776,566号(代理人事件番号42194−709.101)および2014年3月3日に出願された米国特許出願第14/195,576号(代理人事件番号42194−709.201)の利益を主張し、それら全体の内容は、参照によって本明細書に援用される。
(1.発明の分野)
本発明は、概して、医療デバイスおよび方法に関し、より具体的には、僧帽弁逆流とも呼ばれる僧帽弁閉鎖不全症等の弁閉鎖不全症の処置に関する。従来の外科的埋込方法によって、または低侵襲経カテーテルによって、または低侵襲経心尖方法によって送達される人工弁の使用が、弁閉鎖不全症(逆流とも呼ばれる)の1つの可能性として考えられる処置である。
一例として、その開示が参照することにより本明細書に組み込まれる、PCT国際特許第PCT/US2008/054410号(PCT国際公開第WO2008/103722号として公開されている)は、弾性リングと、1つの方向へそれを通る血流を可能にするようリングに対して搭載される複数の弁尖膜と、リングに対して移動可能に搭載され、心臓弁輪、心臓弁尖、および/または心臓壁の解剖学的構造を握持するようにサイズを合わせられる複数の組織係合位置付け要素とを備える、経カテーテル僧帽弁人工装具を説明する。位置付け要素のそれぞれは、解剖学的構造の組織の別個の対応領域に同時に係合するように協調的に構成および寸法決定される、それぞれの近位、中間、および遠位組織係合領域を画定し、それぞれの第1、第2、および第3の組織穿刺要素を含んでもよい。弁人工装具はまた、弁人工装具の周囲の血液の逆流に対して弁人工装具の周囲を密閉するために弾性リングに対して搭載されるスカートを含んでもよい。
本発明は、概して、医療デバイスおよび方法に関し、より具体的には、僧帽弁逆流を処置するために使用される人工弁に関する。本開示は、僧帽弁逆流を処置するための人工弁の使用に焦点を当てているが、これは限定的であることを目的としていない。本明細書で開示される人工弁はまた、他の心臓弁または静脈弁を含む、他の身体弁を処置するために使用されてもよい。例示的な心臓弁は、大動脈弁、三尖弁、または肺動脈弁を含む。
本明細書で記述される全ての出版物、特許、および特許出願は、各個別出版物、特許、または特許出願が、参照することにより援用されるように具体的かつ個別に示された場合と同一の程度に、参照することにより本明細書に援用される。
前述のように、デバイスの好ましい実施形態は、人工弁を前および後弁尖に係留する。図15は、この実施例を図示しており、本明細書に説明される前および後タブの両方を有する実施形態のいずれかであり得る、人工弁1506は、患者の心臓Hの僧帽弁1502に正常に係留されている。後タブ1508は、後尖1504に正常に係合され、前タブ1510は、前尖1512に正常に係合されている。適切な前および後係留は、人工弁の下部分に固着し、人工弁の望ましくない回転または枢動を防止し、かつ上流または下流の望ましくない軸方向移動を防止する。しかしながら、前述のように、ある状況では、後タブは、人工デバイスを自然弁の後尖に係留しない場合がある。例えば、医師が、人工弁を不適切に送達し、それを展開する場合、後尖に適切に係合しない場合がある。または、いくつかの状況では、後尖は、不規則形状を有し得る、または脆弱であって、したがって、後タブとの係留に十分に強固ではない場合がある。
Claims (72)
- 患者の自然弁内に埋め込むための人工弁であって、前記人工弁は、
第1の端部と、前記第1の端部と反対の第2の端部と、前記第2の端部の付近の心房領域と、前記第1の端部の付近の心室領域と、前部分と、後部分とを有する自己拡張式フレームを備え、
前記自己拡張式フレームは、拡張構成および折り畳み構成を有し、前記拡張構成は、処置部位において組織に係合するように適合され、前記折り畳み構成は、前記処置部位に送達されるように適合され、前記拡張可能なフレームは、
前記心房領域中に配置される自己拡張式心房スカートと、
前記心室領域中に配置される自己拡張式心室スカートと、
前記心房領域と前記心室領域との間に配置される自己拡張式環状領域と、
前記心室領域中で前記自己拡張式フレームの前部分上に配置される第1の自己拡張式前タブと、
前記心室領域に結合される自己拡張式足部であって、前記足部は、前記後部分内に配置され、前記自己拡張式フレームから半径方向外向きに延在し、前記組織に係合するための外側表面を有し、それによって、前記人工弁の係留を促進し、前記人工弁の回転を最小限化または防止する、足部と
を備える、人工弁。 - 前記人工弁は、人工僧帽弁である、請求項1に記載の人工弁。
- 前記心房スカートは、折り畳み構成および拡張構成を有し、前記折り畳み構成は、前記処置部位への送達のために適合され、前記拡張構成は、前記折り畳み構成に対して半径方向に拡張され、前記患者の自然弁の上面を覆って位置するように適合され、それによって、前記自然弁の上部分に対して前記心房スカートを係留する、請求項1に記載の人工心臓弁。
- 前記心房スカートは、コネクタ要素を用いてともに接続された複数の軸方向に配向された支柱を備え、前記複数の相互接続された支柱は、一連の頂点および谷部を形成する、請求項1に記載の人工弁。
- 前記心房スカートの自己拡張後に、前記心房スカートは、前記自己拡張式フレームの前記第2の端部に隣接するフランジ付き領域を形成する、請求項1に記載の人工弁。
- 自己拡張後に、前記心房スカートは、実質的に平坦な前部分と円筒形状の後部分とを有する非対称D字形断面を有する、請求項5に記載の人工弁。
- 前記心房スカートの前部分に結合される整合要素をさらに備え、前記整合要素は、患者の心臓の大動脈根と整合させられるように適合され、かつ前記患者の僧帽弁の前尖の2つの線維性三角の間に配置されるように適合される、請求項1に記載の人工弁。
- 前記心室スカートの少なくとも一部分は、組織または合成材料で被覆される、請求項1に記載の人工弁。
- 自己拡張後に、前記心室スカートは、実質的に平坦な前部分と円筒形状の後部分とを有する非対称D字形断面を備える、請求項1に記載の人工弁。
- 前記心室スカートは、折り畳み構成および拡張構成を有し、前記折り畳み構成は、前記処置部位への送達のために適合され、前記拡張構成は、前記折り畳み構成に対して半径方向に拡張され、天然僧帽弁尖を半径方向外向きに変位させるように適合される、請求項1に記載の人工弁。
- 前記心室スカートはさらに、前記心室スカートに結合された複数の返しを備え、前記複数の返しは、前記心室スカートを前記組織の中に係留するように適合される、請求項1に記載の人工弁。
- 前記心室スカートは、コネクタ要素を用いてともに接続された複数の支柱を備え、前記複数の相互接続された支柱は、一連の頂点および谷部を形成する、請求項1に記載の人工弁。
- 支柱のうちの1つ以上は、前記支柱を通って延在する1つ以上の縫合糸穴を備え、前記縫合糸穴は、縫合糸を受け取るようにサイズを合わせられる、請求項12に記載の人工弁。
- 前記環状領域は、折り畳み構成および拡張構成を有し、前記折り畳み構成は、前記処置部位への送達のために適合され、前記拡張構成は、前記折り畳み構成に対して半径方向に拡張され、前記自然弁の弁輪と一致するように適合され、前記弁輪に係合するように適合される、請求項1に記載の人工弁。
- 自己拡張後に、前記環状領域は、実質的に平坦な前部分と円筒形状の後部分とを有する非対称D字形断面を有する、請求項1に記載の人工弁。
- 前記環状領域は、複数のコネクタ要素を用いてともに接続された軸方向に配向された支柱を備え、前記複数の相互接続された支柱は、一連の頂点および谷部を形成する、請求項1に記載の人工弁。
- 前記複数の軸方向に配向された支柱のうちの1つ以上は、前記支柱を通って延在する1つ以上の縫合糸穴を備え、前記縫合糸穴は、縫合糸を受け取るようにサイズを合わせられる、請求項16に記載の人工弁。
- 前記第1の前タブは、前記患者の僧帽弁の前記前尖の第1の側面上の第1の線維性三角に係合するように適合される先端部分を有し、前記第1の前タブは、前記第1の前タブと前記心室スカートの外側前面との間に前記前尖および隣接する腱索を捕捉するように適合される、請求項1に記載の人工弁。
- 前記心室領域中で前記自己拡張式フレームの前記前部分上に配置される第2の自己拡張式前タブをさらに備え、前記第2の前タブは、前記前尖の前記第1の側面と反対の前記患者の僧帽弁の前記前尖の第2の側面上の第2の線維性三角に係合するように適合される先端部分を有し、前記第2の前タブは、前記第2の前タブと前記心室スカートの前記外面との間に前記前尖および隣接する腱索を捕捉するように適合される、請求項18に記載の人工弁。
- 前記第1または第2の前タブを覆って配置される被覆をさらに備え、前記被覆は、前記第1の前タブまたは第2の前タブそれぞれの心臓組織との接触表面積を増加させる、請求項19に記載の人工弁。
- 前記被覆は、前記第1の前タブまたは第2の前タブに結合されるポリマータブを覆って配置される織物材料を含む、請求項20に記載の人工弁。
- 前記後部分の回転は、前記人工弁の前部分に対して最小限化または防止される、請求項1に記載の人工弁。
- 回転は、前記患者の心臓の左心房に向かう方向に最小限化または防止される、請求項1に記載の人工弁。
- 前記足部は、合成材料または組織で被覆される、請求項1に記載の人工弁。
- 前記足部は、前記自己拡張式フレームから半径方向外向きに延在する楔形状要素を備える、請求項1に記載の人工弁。
- 前記足部は、中心の細長い要素と、カバーとを備え、前記カバーは、前記中心の細長い要素を覆って配置され、前記カバーは、その両側が支柱に結合される、請求項1に記載の人工弁。
- 前記中心の細長い要素は、一対の支柱を備え、前記一対の支柱は、ともに結合されて、U−形状またはV−形状を形成する、請求項26に記載の人工弁。
- 前記足部は、前記後部分上に前庭を形成する、請求項1に記載の人工弁。
- 前記足部は、前記足部を組織に係留するために、返し、テクスチャ加工、または他の表面特徴を備える、請求項1に記載の人工弁。
- 複数の人工弁尖をさらに備え、前記弁尖のそれぞれは、第1の端部および自由端を有し、前記第1の端部は、前記自己拡張式フレームと結合され、前記自由端は、前記第1の端部の反対側にあり、前記人工弁尖は、前記人工弁尖を通り過ぎる順行性血流を可能にするように、前記人工弁尖の前記自由端が相互から離れて配置される開放構成と、前記人工弁尖の前記自由端が相互に係合し、前記人工弁尖を通り過ぎる逆行性血流を実質的に防止する閉鎖構成とを有する、請求項1に記載の人工弁。
- 前記複数の人工弁尖は、三尖弁を形成する、請求項30に記載の人工弁。
- 前記1つ以上の人工弁尖の少なくとも一部分は、組織または合成材料を含む、請求項30に記載の人工弁。
- 前記人工弁尖のうちの1つ以上は、交連タブを有する交連柱を備え、前記交連タブは、送達デバイスと解放可能に係合させられるように適合される、請求項30に記載の人工弁。
- 前記人工弁は、治療剤を運搬し、前記治療剤は、前記人工弁から溶出するように適合される請求項1に記載の人工弁。
- 前記自己拡張式フレームの後部分上に配置される後心室係留タブをさらに備え、前記後心室係留タブは、前記後心室係留タブが前記患者の心臓の後尖と心室壁との間に固定されるように、前記患者の僧帽弁の前記後尖を覆って係留されるように適合される、請求項1に記載の人工弁。
- 前記後心室係留タブ上に配置され、かつ、組織に係合して前記後心室タブを前記組織に係留するように適合される、返し、テクスチャ加工、または他の表面特徴をさらに備える、請求項35に記載の人工弁。
- 人工弁を患者の心臓の自然弁内に係留するための方法であって、前記方法は、
人工弁を提供することであって、前記人工弁は、拡張可能なフレームを備え、前記拡張可能なフレームは、第1の端部と、前記第1の端部と反対の第2の端部と、前記第1の端部に隣接する前記拡張可能なフレームの前部分上の第1の前タブと、前記第1の端部に隣接する前記拡張可能なフレームの後部分上の足部と、前記拡張可能なフレームの第1の端部に隣接する心室スカートと、前記第1の端部と第2の端部との間に配置される環状領域とを有し、前記人工弁は、前記自然弁に係合するための拡張構成と、折り畳み構成とを有する、ことと、
前記折り畳み構成における前記人工弁を前記自然弁まで前進させることと、
前記第1の前タブの先端が前記自然弁の前尖の第1の側の第1の線維性三角に係合するように、前記第1の前タブを半径方向外向きに拡張させることであって、前記前尖は、前記第1の前タブと前記心室スカートの外側表面との間に配置される、ことと、
前記足部が前記自然弁の後部分に係合し、それによって、前記人工弁を前記自然弁の後部分に係留させ、前記人工弁の回転を防止または最小限化するように、前記足部を半径方向外向きに拡張させることと
を含む、方法。 - 前記人工弁を提供することはさらに、前記人工弁を前記自然弁に送達するための送達デバイスを提供することを含み、前記人工弁は、前記送達デバイスに取り外し可能に結合される、請求項37に記載の方法。
- 前記人工弁を前進させることは、前記人工弁を前記患者の外側の領域から前記患者の心臓に経心尖的に送達することを含む、請求項37に記載の方法。
- 前記人工弁を前進させることは、前記人工弁を前記患者の心臓の右心房から左心房に経中隔的に送達することを含む、請求項37に記載の方法。
- 前記人工弁を前進させることは、前記第1の端部が僧帽弁の下に来て、前記第2の端部が前記僧帽弁の上に来るように、前記患者の前記僧帽弁を横断して前記人工弁を位置付けることを含む、請求項37に記載の方法。
- 前記第1の前タブを拡張させることは、拘束シースを前記第1の前タブから後退させ、前記第1の前タブを半径方向外向きに自己拡張させることを含む、請求項37に記載の方法。
- 前記人工弁はさらに、前記拡張可能なフレームの前部分上に第2の前タブを備え、前記方法はさらに、前記第2の前タブの先端部分が前記前尖の第1の側と反対の前記前尖の第2の側の第2の線維性三角に係合するように、前記第2の前タブを半径方向外向きに拡張させることを含む、請求項37に記載の方法。
- 前記第2の前タブは、前記第1の前タブの拡張と並行して、半径方向外向きに拡張する、請求項43に記載の方法。
- 前記第2の前タブを拡張させることは、前記第2の前タブが半径方向外向きに自由に自己拡張するように、拘束シースを前記第2の前タブから後退させることを含む、請求項43に記載の方法。
- 前記足部を拡張させることは、前記人工弁の第1の端部に隣接して前庭を形成する、請求項37に記載の方法。
- 前記足部を拡張させることは、前記第1の端部が前記自然弁を通過することができないように、前記人工弁の第1の端部のサイズを増加させる、請求項37に記載の方法。
- 前記足部を拡張させることは、前記足部が半径方向外向きに自己拡張するように、拘束具を前記足部から後退させることを含む、請求項37に記載の方法。
- 後尖腱索は、前記拡張された足部に係合する、請求項37に記載の方法。
- 前記足部は、返し、テクスチャ加工、または他の表面特徴を備え、前記足部を拡張させることは、前記返し、テクスチャ加工、または他の表面特徴と組織とを係合させ、それによって、前記足部と前記組織とを係留させる、請求項37に記載の方法。
- 前記心室スカートを半径方向外向きに拡張させて、前記自然弁の前尖および後尖と係合させることをさらに含む、請求項37に記載の方法。
- 前尖腱索は、前記第1の前タブと前記心室スカートの外側表面との間に配置される、請求項51に記載の方法。
- 前記心室スカートを拡張させることは、前記心室スカートが半径方向外向きに自由に自己拡張するように、拘束シースを前記心室スカートから後退させることを含む、請求項51に記載の方法。
- 前記心室スカートは、複数の返しを備え、前記心室スカートを拡張させることは、前記複数の返しを心臓組織の中に係留させることを含む、請求項51に記載の方法。
- 前記人工弁はさらに、複数の交連を備え、前記心室スカートを拡張させることは、前記自然弁の前尖および後尖を半径方向外向きに変位させ、それによって、前記交連と前記弁尖との間の干渉を防止する、請求項37に記載の方法。
- 前記心室スカートを拡張させることは、左心室の内壁に接触せず、かつ左心室流出路を塞ぐことなく、前記自然弁の前尖および後尖を半径方向外向きに変位させる、請求項37に記載の方法。
- 前記心室スカートを半径方向に拡張させることは、前記心室スカートの前部分が実質的に平坦であり、かつ前記心室スカートの後部分が円筒形形状であるように、前記心室スカートを非対称的に拡張させる、請求項37に記載の方法。
- 前記自然弁の弁輪に係合するように、前記環状領域を半径方向外向きに拡張させることをさらに含む、請求項37に記載の方法。
- 前記環状領域を拡張させることは、前記環状領域が半径方向外向きに自由に自己拡張するように、拘束シースを前記環状領域から後退させることを含む、請求項58に記載の方法。
- 前記環状領域を拡張させることは、前記環状領域の前部分が実質的に平坦であり、かつ前記環状領域の後部分が円筒形形状であるように、前記環状領域を非対称的に拡張させることを含む、請求項58に記載の方法。
- 前記自然弁は、僧帽弁であって、前記方法はさらに、僧帽弁逆流を低減また排除することを含む、請求項37に記載の方法。
- 前記人工弁は、治療剤を運搬し、前記方法はさらに、前記治療剤を前記人工弁から隣接する組織の中に溶出させることを含む、請求項37に記載の方法。
- 前記人工弁は、整合要素を備え、第2の線維性三角は、前記前尖の第1の側と反対の前記前尖の第2の側に配置され、前記方法はさらに、前記整合要素を大動脈根と整合させることと、前記整合要素を前記第1の線維性三角と第2の線維性三角との間に配置することとを含む、請求項37に記載の方法。
- 前記整合要素を整合させることは、前記人工弁を回転させることを含む、請求項63に記載の方法。
- 前記人工弁はさらに、複数の交連を備え、被覆が前記複数の交連を覆って配置され、それによって、複数の人工弁尖が、形成され、前記方法はさらに、前記複数の人工弁尖を送達カテーテルから解放することを含む、請求項37に記載の方法。
- 前記複数の人工弁尖は、三尖弁を形成し、前記三尖弁は、開放構成および閉鎖構成を有し、前記複数の人工弁尖は、前記開放構成では、相互から離れるように配置され、それによって、前記人工弁尖を通る順行性血流を可能にし、前記複数の人工弁尖は、前記閉鎖構成では、相互に係合し、それによって、前記人工弁尖を通る逆行性血流を実質的に防止する、請求項65に記載の方法。
- 前記人工弁はさらに、前記第2の端部に隣接する心房スカートを備え、前記方法はさらに、
前記自然弁の上面を覆って位置するように、前記心房スカートを半径方向外向きに拡張させることと、
前記心房スカートを前記自然弁の上面に対して係合させることと
を含む、請求項37に記載の方法。 - 前記心房スカートを拡張させることは、前記心房スカートが半径方向外向きに自由に自己拡張するように、拘束シースを前記心房スカートから後退させることを含む、請求項67に記載の方法。
- 前記人工弁を前記自然弁に対して上流または下流に移動させ、前記心房スカートが前記自然弁の上面に係合することを確実にすることをさらに含む、請求項67に記載の方法。
- 前記心房スカートを前記上面に対して係合することは、前記心房スカートを前記自然弁の上面に対して密閉し、その間の血流を防止または実質的に防止する、請求項67に記載の方法。
- 前記人工弁はさらに、前記自己拡張式フレームの後部分上に配置される後心室係留タブを備え、前記方法はさらに、前記後心室係留タブが前記患者の心臓の前記後尖と心室壁との間に固定されるように、前記後心室係留タブを前記患者の僧帽弁の後尖を覆って係留することを含む、請求項37に記載の方法。
- 前記後心室タブは、返し、テクスチャ加工、または他の表面特徴を備え、前記後心室タブを係留することは、前記返し、テクスチャ加工、または他の表面特徴と組織とを係合させることを含む、請求項71に記載の方法。
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US10583002B2 (en) | 2020-03-10 |
CA2900571C (en) | 2021-10-19 |
CN105283149A (zh) | 2016-01-27 |
CN105283149B (zh) | 2018-11-02 |
CN113599024A (zh) | 2021-11-05 |
WO2014138868A1 (en) | 2014-09-18 |
DE202014011450U1 (de) | 2020-11-03 |
CN109259895A (zh) | 2019-01-25 |
JP6464101B2 (ja) | 2019-02-06 |
EP2967860B1 (en) | 2020-09-09 |
AU2014231689A1 (en) | 2015-08-13 |
CA3128568A1 (en) | 2014-09-18 |
CN109259895B (zh) | 2021-09-10 |
EP2967860A1 (en) | 2016-01-20 |
EP3799835A1 (en) | 2021-04-07 |
US20140257467A1 (en) | 2014-09-11 |
AU2014231689B2 (en) | 2019-01-17 |
US20200222180A1 (en) | 2020-07-16 |
CA3128568C (en) | 2023-11-28 |
EP2967860A4 (en) | 2016-11-16 |
CA2900571A1 (en) | 2014-09-18 |
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