JP2013525039A5 - - Google Patents
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- JP2013525039A5 JP2013525039A5 JP2013508338A JP2013508338A JP2013525039A5 JP 2013525039 A5 JP2013525039 A5 JP 2013525039A5 JP 2013508338 A JP2013508338 A JP 2013508338A JP 2013508338 A JP2013508338 A JP 2013508338A JP 2013525039 A5 JP2013525039 A5 JP 2013525039A5
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- 230000002861 ventricular Effects 0.000 claims description 64
- 210000003709 Heart Valves Anatomy 0.000 claims description 63
- 230000001746 atrial Effects 0.000 claims description 29
- 238000004873 anchoring Methods 0.000 claims description 23
- 210000004115 Mitral Valve Anatomy 0.000 claims description 18
- 210000001519 tissues Anatomy 0.000 claims description 13
- 230000017531 blood circulation Effects 0.000 claims description 7
- 229920002994 synthetic fiber Polymers 0.000 claims description 7
- 239000003814 drug Substances 0.000 claims description 6
- 230000000747 cardiac effect Effects 0.000 claims description 2
- 230000003176 fibrotic Effects 0.000 claims 1
- 206010027727 Mitral valve incompetence Diseases 0.000 description 3
- 210000002837 Heart Atria Anatomy 0.000 description 2
- 230000000149 penetrating Effects 0.000 description 2
- 210000001765 Aortic Valve Anatomy 0.000 description 1
- 210000001308 Heart Ventricles Anatomy 0.000 description 1
- 210000003102 Pulmonary Valve Anatomy 0.000 description 1
- 210000000591 Tricuspid Valve Anatomy 0.000 description 1
- 210000002073 Venous Valves Anatomy 0.000 description 1
- 230000000903 blocking Effects 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
Description
本発明は、例えば、以下を提供する：
（項目１）
患者の心臓の中に人工弁を固着する方法であって、
該方法は、
該人工弁を提供することであって、該人工弁は、アンカーを備え、該アンカーは、心房スカート、環状領域、心室スカート、および複数の弁尖を有し、該アンカーは、該心臓に送達するための折畳み構成、および該心臓と固着するための拡張構成を有する、ことと、
該患者の心臓の中に該人工弁を設置することと、
該患者の自然僧帽弁の上面の上に横たわるように、半径方向外向きに該心房スカートを拡張し、該心房の一部分に対して該心房スカートを固着することと、
自然僧帽弁輪と一致するように、およびそれに係合するように、該アンカーの該環状領域を半径方向に拡張させることと、
該心室スカートを半径方向に拡張し、それにより、自然僧帽弁尖を半径方向外向きに変位させることと
を含む、方法。
（項目２）
前記人工弁の少なくとも一部分は、組織または合成材料によって覆われている、項目１に記載の方法。
（項目３）
前記人工弁を設置することは、前記心臓の右心房から左心房まで該人工弁を経中隔的に送達することを含む、項目１に記載の方法。
（項目４）
前記人工弁を設置することは、前記心臓の外側の領域から該心臓の前記左心室まで該人工弁を経心尖的に送達することを含む、項目１に記載の方法。
（項目５）
前記心房スカートを拡張させることは、該心房スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心房スカートの半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目６）
前記心房スカートは、前記制約シースが該心房シースから除去されたときに自己拡張する、項目５に記載の方法。
（項目７）
前記人工弁に力を印加することをさらに含み、該力を印加することにより、前記心房スカートが前記僧帽弁の前記上面に係合することを確実にする、項目１に記載の方法。
（項目８）
前記心房スカートは、複数の鉤を備え、該心房スカートを拡張することは、前記僧帽弁の前記上面の中に該鉤を固着することを含む、項目１に記載の方法。
（項目９）
前記心房スカートを拡張することは、前記自然僧帽弁の前記上面に対して該心房スカートを密閉することを含む、項目１に記載の方法。
（項目１０）
前記環状領域を半径方向に拡張することは、該環状領域から離れるように制約シースを摺動可能に移動させ、それにより、該環状領域の半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目１１）
前記環状領域は、前記制約シースが該環状領域から除去されたときに自己拡張する、項目１０に記載の方法。
（項目１２）
前記環状領域を半径方向に拡張することは、該環状領域を非対称的に拡張することを含み、該非対称に拡張することにより、該環状領域の前方部分は実質的に平坦であり、該環状領域の後方部分は円筒形状である、項目１に記載の方法。
（項目１３）
前記心室スカートは、該心室スカートの前方部分上に三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の前尖の第１の側面上の第１の線維性三角に対して該三角固着タブを固着することを含み、該三角固着タブを固着することにより、該自然前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目１に記載の方法。
（項目１４）
前記心室スカートは、該心室スカートの前記前方部分上に第２の三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記第１の線維性三角の反対側の第２の線維性三角に対して該第２の三角固着タブを固着することを含み、該第２の三角固着タブを固着することにより、前記自然前尖および隣接腱索が、該第２の三角固着タブと前記アンカーの前面との間に捕捉される、項目１３に記載の方法。
（項目１５）
前記心室スカートは、該心室スカートの後方部分上に後方心室固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の後尖を覆って該後方心室固着タブを固着することを含み、該後方心室固着タブを固着することにより、該心室スカートは、該後尖と前記心臓の心室壁との間に着座する、項目１に記載の方法。
（項目１６）
前記心室スカートを半径方向に拡張することは、該心室スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心室スカートの半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目１７）
前記心室スカートは、前記制約シースが該心室スカートから除去されたときに自己拡張する、項目１６に記載の方法。
（項目１８）
前記心室スカートは、複数の鉤を備え、該心室スカートを拡張することは、心臓組織の中に該鉤を固着することを含む、項目１に記載の方法。
（項目１９）
前記人工弁は、複数の人工弁尖を備え、前記心室スカートを半径方向に拡張することは、前記自然僧帽弁尖を半径方向外向きに変位させ、それにより、該人工弁尖への該自然僧帽弁尖の干渉を防止することを含む、項目１に記載の方法。
（項目２０）
前記心室スカートを半径方向に拡張することは、心室壁に接触することなく、および左心室流出路を塞ぐことなく、前記自然僧帽弁尖を半径方向外向きに変位させることを含む、項目１に記載の方法。
（項目２１）
前記心室スカートを半径方向に拡張することは、該心室スカートを非対称的に拡張することを含み、該非対称に拡張することにより、該心室スカートの前方部分は実質的に平坦であり、該心室スカートの後方部分は円筒形状である、項目１に記載の方法。
（項目２２）
前記心房スカートは、整列要素を備え、前記方法は、前記患者の弁に対して該整列要素を整列させることをさらに含む、項目１に記載の方法。
（項目２３）
前記弁は、僧帽弁を備え、前記整列させることは、前記整列要素を大動脈起始部と整列させ、該僧帽弁の前尖の２つの線維性三角の間に該整列要素を配置することを含む、項目２２に記載の方法。
（項目２４）
前記整列させることは、前記人工弁を回転させることを含む、項目２２に記載の方法。
（項目２５）
前記人工弁は、交連に連結される複数の人工弁尖を備え、前記方法は、送達カテーテルから該交連を解放することを含む、項目１に記載の方法。
（項目２６）
前記人工弁は、三尖弁尖構成を備える、項目２５に記載の方法。
（項目２７）
前記人工弁は、開放構成および閉鎖構成を有し、該開放構成において、前記人工弁尖が相互から離れて配置され、該閉鎖構成において、該人工弁尖が相互に係合し、血液は、該開放構成における該人工弁を通って自由に流れ、該人工弁を横断する逆行血流は、該閉鎖構成において実質的に妨げられる、項目１に記載の方法。
（項目２８）
僧帽弁逆流を低減または排除することをさらに含む、項目１に記載の方法。
（項目２９）
前記人工弁は、治療薬を備え、前記方法は、該人工弁から隣接組織の中に該治療薬を溶出することをさらに含む、項目１に記載の方法。
（項目３０）
人工心臓弁であって、
該人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーであって、該アンカーは、心臓に送達するための折畳み構成、および該人工心臓弁を患者の心臓に固着するための拡張構成を有する、アンカーと、
複数の人工弁尖であって、該弁尖の各々は、第１端および自由端を有し、該第１端は、該アンカーと連結され、該自由端は、該第１端の反対側にある、人工弁尖と
を備え、
該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工心臓弁。
（項目３１）
前記心房スカートの少なくとも一部分は、組織または合成材料によって覆われている、項目３０に記載の人工心臓弁。
（項目３２）
前記心房スカートは、それに連結される複数の鉤を備え、該複数の鉤は、前記患者の僧帽弁の上面の中に該心房スカートを固着するようにさらに適合される、項目３０に記載の人工心臓弁。
（項目３３）
前記心房スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、該患者の自然僧帽弁の上面の上に横たわるように適合されており、それにより、心房の一部分に対して該心房スカートを固着する、項目３０に記載の人工心臓弁。
（項目３４）
前記心房スカートは、拘束されていないときに、前記折畳み構成から前記半径方向拡張構成まで自己拡張する、項目３３に記載の人工心臓弁。
（項目３５）
前記心房スカートは、１つ以上の放射線不透過性マーカーを備える、項目３０に記載の人工心臓弁。
（項目３６）
前記心房スカートは、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目３７）
前記環状領域の少なくとも一部分は、組織または合成材料によって覆われている、項目３０に記載の人工心臓弁。
（項目３８）
前記環状領域は、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自然僧帽弁環に順応し、それに係合するように適合される、項目３０に記載の人工心臓弁。
（項目３９）
前記環状領域は、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目３８に記載の人工心臓弁。
（項目４０）
前記環状領域は、非対称的なＤ字形の断面を備え、該非対称的なＤ字形の断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目３０に記載の人工心臓弁。
（項目４１）
前記環状領域は、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目４２）
前記軸方向に配向された支柱のうちの１つ以上は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目４１に記載の人工心臓弁。
（項目４３）
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によって覆われている、項目３０に記載の人工心臓弁。
（項目４４）
前記心室スカートは、非対称的なＤ字形の断面を備え、該断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目３０に記載の人工心臓弁。
（項目４５）
前記心室スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自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、項目３０に記載の人工心臓弁。
（項目４６）
前記心室スカートは、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目４５に記載の人工心臓弁。
（項目４７）
前記心室スカートは、該心室スカートの前方部分上に配置された三角固着タブをさらに備え、該三角固着タブは、前記患者の僧帽弁の前尖の第１の側面上の第１の線維性三角に対して固着されるように適合され、それにより、該前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目３０に記載の人工心臓弁。
（項目４８）
前記心室スカートは、該心室スカートの前記前方部分上に配置される第２の三角固着タブをさらに備え、該第２の三角固着タブは、前記第１の線維性三角の反対側の第２の線維性三角に対して固着されるように適合されることにより、前記前尖および隣接腱索が、該第２の三角固着タブと前記アンカーの前面との間に捕捉される、項目４７に記載の人工心臓弁。
（項目４９）
前記心室スカートは、該心室スカートの後方部分上に配置される後方心室固着タブをさらに備え、該後方心室固着タブは、前記患者の僧帽弁の後尖を覆って固着されるように適合され、それにより、該後方心室固着タブは、該後尖と該患者の心臓の心室壁との間に着座させられる、項目３０に記載の人工心臓弁。
（項目５０）
前記心室スカートは、それに連結される複数の鉤をさらに備え、該複数の鉤は、心臓組織の中に該心室スカートを固着するように適合される、項目３０に記載の人工心臓弁。
（項目５１）
前記心室スカートは、複数の支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目５２）
前記支柱のうちの１つ以上は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目５１に記載の人工心臓弁。
（項目５３）
前記複数の人工弁尖は、三尖弁尖構成を備える、項目３０に記載の人工心臓弁。
（項目５４）
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備える、項目３０に記載の人工心臓弁。
（項目５５）
前記複数の人工弁尖のうちの１つ以上は、１つ以上の支柱に連結され、該１つ以上の支柱は、前記心室スカートに対して半径方向内向きに付勢される、項目３０に記載の人工心臓弁。
（項目５６）
前記１つ以上の支柱は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目５５に記載の人工心臓弁。
（項目５７）
前記人工弁尖のうちの１つ以上は、交連柱に連結され、該交連柱は、該交連柱を送達デバイスと解放可能に係合させるように適合される交連タブを有する、項目３０に記載の人工心臓弁。
（項目５８）
前記アンカーの前方部分に連結される整列要素をさらに備え、該整列要素は、前記患者の心臓の大動脈起始部と整列させられ、該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、項目３０に記載の人工心臓弁。
（項目５９）
前記整列要素は、前記心房スカートと連結される、項目５８に記載の人工心臓弁。
（項目６０）
前記人工心臓弁は、それに連結される治療薬をさらに備え、該治療薬は、そこから溶出されるように適合される、項目３０に記載の人工心臓弁。
（項目６１）
人工心臓弁を患者の心臓に送達するための送達システムであって、
該システムは、
管腔が自身を通って延在している内側ガイドワイヤシャフトであって、該管腔は、ガイドワイヤを摺動可能に受容するように適合されている、内側ガイドワイヤシャフトと、
該内側ガイドワイヤシャフトを覆って同心円状に配置されるハブシャフトと、
該ハブシャフトを覆って摺動可能および同心円状に配置されるベルシャフトと、
該ベルシャフト覆って摺動可能および同心円状に配置されるシースと、
該送達システムの近位端付近のハンドルであって、該ハンドルは、アクチュエータ機構を備え、該アクチュエータ機構は、該ベルシャフトおよび該シースを前進および後退させるように適合される、ハンドルと
を備える、システム。
（項目６２）
前記人工心臓弁をさらに備え、該人工心臓弁は、半径方向の折畳み構成で前記シースの中に収納される、項目６１に記載のシステム。
（項目６３）
前記人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーと、
複数の人工弁尖であって、該弁尖の各々は、第１端および自由端を有し、該第１端は、該アンカーと連結され、該自由端は、該第１端の反対側にあり、該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工弁尖と
を備える、項目６２に記載のシステム。
（項目６４）
前記ベルシャフトに対する前記シースの近位への後退は、前記人工心臓弁から拘束を除去し、それにより、該人工心臓弁が自己拡張して前記患者の自然心臓組織と係合することを可能にする、項目６２に記載のシステム。
（項目６５）
前記人工心臓弁は、前記ハブシャフトと解放可能に連結され、該ハブシャフトに対する前記ベルシャフトの近位への後退は、該ハブシャフトから該人工心臓弁を解放する、項目６２に記載のシステム。
（項目６６）
前記アクチュエータ機構は、回転ホイールを備える、項目６１に記載のシステム。
（項目６７）
前記ハブシャフトに連結される組織貫通遠位先端をさらに備え、該組織貫通遠位先端は、前記患者の心臓を通過し、該患者の心臓の切開を拡張するように適合される、項目６１に記載のシステム。
（項目６８）
ピンロック機構をさらに備え、該ピンロック機構は、前記ハンドルと解放可能に連結され、該ピンロック機構は、前記シースの近位への後退を制限する、項目６１に記載のシステム。
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、僧帽弁逆流を治療するために使用される人工弁に関する。本開示は、僧帽弁逆流を治療するための人工弁の使用に焦点を当てているが、これは、限定的となることを目的としない。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治療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。
（項目１）
患者の心臓の中に人工弁を固着する方法であって、
該方法は、
該人工弁を提供することであって、該人工弁は、アンカーを備え、該アンカーは、心房スカート、環状領域、心室スカート、および複数の弁尖を有し、該アンカーは、該心臓に送達するための折畳み構成、および該心臓と固着するための拡張構成を有する、ことと、
該患者の心臓の中に該人工弁を設置することと、
該患者の自然僧帽弁の上面の上に横たわるように、半径方向外向きに該心房スカートを拡張し、該心房の一部分に対して該心房スカートを固着することと、
自然僧帽弁輪と一致するように、およびそれに係合するように、該アンカーの該環状領域を半径方向に拡張させることと、
該心室スカートを半径方向に拡張し、それにより、自然僧帽弁尖を半径方向外向きに変位させることと
を含む、方法。
（項目２）
前記人工弁の少なくとも一部分は、組織または合成材料によって覆われている、項目１に記載の方法。
（項目３）
前記人工弁を設置することは、前記心臓の右心房から左心房まで該人工弁を経中隔的に送達することを含む、項目１に記載の方法。
（項目４）
前記人工弁を設置することは、前記心臓の外側の領域から該心臓の前記左心室まで該人工弁を経心尖的に送達することを含む、項目１に記載の方法。
（項目５）
前記心房スカートを拡張させることは、該心房スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心房スカートの半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目６）
前記心房スカートは、前記制約シースが該心房シースから除去されたときに自己拡張する、項目５に記載の方法。
（項目７）
前記人工弁に力を印加することをさらに含み、該力を印加することにより、前記心房スカートが前記僧帽弁の前記上面に係合することを確実にする、項目１に記載の方法。
（項目８）
前記心房スカートは、複数の鉤を備え、該心房スカートを拡張することは、前記僧帽弁の前記上面の中に該鉤を固着することを含む、項目１に記載の方法。
（項目９）
前記心房スカートを拡張することは、前記自然僧帽弁の前記上面に対して該心房スカートを密閉することを含む、項目１に記載の方法。
（項目１０）
前記環状領域を半径方向に拡張することは、該環状領域から離れるように制約シースを摺動可能に移動させ、それにより、該環状領域の半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目１１）
前記環状領域は、前記制約シースが該環状領域から除去されたときに自己拡張する、項目１０に記載の方法。
（項目１２）
前記環状領域を半径方向に拡張することは、該環状領域を非対称的に拡張することを含み、該非対称に拡張することにより、該環状領域の前方部分は実質的に平坦であり、該環状領域の後方部分は円筒形状である、項目１に記載の方法。
（項目１３）
前記心室スカートは、該心室スカートの前方部分上に三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の前尖の第１の側面上の第１の線維性三角に対して該三角固着タブを固着することを含み、該三角固着タブを固着することにより、該自然前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目１に記載の方法。
（項目１４）
前記心室スカートは、該心室スカートの前記前方部分上に第２の三角固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記第１の線維性三角の反対側の第２の線維性三角に対して該第２の三角固着タブを固着することを含み、該第２の三角固着タブを固着することにより、前記自然前尖および隣接腱索が、該第２の三角固着タブと前記アンカーの前面との間に捕捉される、項目１３に記載の方法。
（項目１５）
前記心室スカートは、該心室スカートの後方部分上に後方心室固着タブをさらに備え、該心室スカートを半径方向に拡張することは、前記自然僧帽弁の後尖を覆って該後方心室固着タブを固着することを含み、該後方心室固着タブを固着することにより、該心室スカートは、該後尖と前記心臓の心室壁との間に着座する、項目１に記載の方法。
（項目１６）
前記心室スカートを半径方向に拡張することは、該心室スカートから離れるように制約シースを摺動可能に移動させ、それにより、該心室スカートの半径方向拡張を可能にすることを含む、項目１に記載の方法。
（項目１７）
前記心室スカートは、前記制約シースが該心室スカートから除去されたときに自己拡張する、項目１６に記載の方法。
（項目１８）
前記心室スカートは、複数の鉤を備え、該心室スカートを拡張することは、心臓組織の中に該鉤を固着することを含む、項目１に記載の方法。
（項目１９）
前記人工弁は、複数の人工弁尖を備え、前記心室スカートを半径方向に拡張することは、前記自然僧帽弁尖を半径方向外向きに変位させ、それにより、該人工弁尖への該自然僧帽弁尖の干渉を防止することを含む、項目１に記載の方法。
（項目２０）
前記心室スカートを半径方向に拡張することは、心室壁に接触することなく、および左心室流出路を塞ぐことなく、前記自然僧帽弁尖を半径方向外向きに変位させることを含む、項目１に記載の方法。
（項目２１）
前記心室スカートを半径方向に拡張することは、該心室スカートを非対称的に拡張することを含み、該非対称に拡張することにより、該心室スカートの前方部分は実質的に平坦であり、該心室スカートの後方部分は円筒形状である、項目１に記載の方法。
（項目２２）
前記心房スカートは、整列要素を備え、前記方法は、前記患者の弁に対して該整列要素を整列させることをさらに含む、項目１に記載の方法。
（項目２３）
前記弁は、僧帽弁を備え、前記整列させることは、前記整列要素を大動脈起始部と整列させ、該僧帽弁の前尖の２つの線維性三角の間に該整列要素を配置することを含む、項目２２に記載の方法。
（項目２４）
前記整列させることは、前記人工弁を回転させることを含む、項目２２に記載の方法。
（項目２５）
前記人工弁は、交連に連結される複数の人工弁尖を備え、前記方法は、送達カテーテルから該交連を解放することを含む、項目１に記載の方法。
（項目２６）
前記人工弁は、三尖弁尖構成を備える、項目２５に記載の方法。
（項目２７）
前記人工弁は、開放構成および閉鎖構成を有し、該開放構成において、前記人工弁尖が相互から離れて配置され、該閉鎖構成において、該人工弁尖が相互に係合し、血液は、該開放構成における該人工弁を通って自由に流れ、該人工弁を横断する逆行血流は、該閉鎖構成において実質的に妨げられる、項目１に記載の方法。
（項目２８）
僧帽弁逆流を低減または排除することをさらに含む、項目１に記載の方法。
（項目２９）
前記人工弁は、治療薬を備え、前記方法は、該人工弁から隣接組織の中に該治療薬を溶出することをさらに含む、項目１に記載の方法。
（項目３０）
人工心臓弁であって、
該人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーであって、該アンカーは、心臓に送達するための折畳み構成、および該人工心臓弁を患者の心臓に固着するための拡張構成を有する、アンカーと、
複数の人工弁尖であって、該弁尖の各々は、第１端および自由端を有し、該第１端は、該アンカーと連結され、該自由端は、該第１端の反対側にある、人工弁尖と
を備え、
該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工心臓弁。
（項目３１）
前記心房スカートの少なくとも一部分は、組織または合成材料によって覆われている、項目３０に記載の人工心臓弁。
（項目３２）
前記心房スカートは、それに連結される複数の鉤を備え、該複数の鉤は、前記患者の僧帽弁の上面の中に該心房スカートを固着するようにさらに適合される、項目３０に記載の人工心臓弁。
（項目３３）
前記心房スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、該患者の自然僧帽弁の上面の上に横たわるように適合されており、それにより、心房の一部分に対して該心房スカートを固着する、項目３０に記載の人工心臓弁。
（項目３４）
前記心房スカートは、拘束されていないときに、前記折畳み構成から前記半径方向拡張構成まで自己拡張する、項目３３に記載の人工心臓弁。
（項目３５）
前記心房スカートは、１つ以上の放射線不透過性マーカーを備える、項目３０に記載の人工心臓弁。
（項目３６）
前記心房スカートは、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目３７）
前記環状領域の少なくとも一部分は、組織または合成材料によって覆われている、項目３０に記載の人工心臓弁。
（項目３８）
前記環状領域は、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自然僧帽弁環に順応し、それに係合するように適合される、項目３０に記載の人工心臓弁。
（項目３９）
前記環状領域は、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目３８に記載の人工心臓弁。
（項目４０）
前記環状領域は、非対称的なＤ字形の断面を備え、該非対称的なＤ字形の断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目３０に記載の人工心臓弁。
（項目４１）
前記環状領域は、複数の軸方向に配向された支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目４２）
前記軸方向に配向された支柱のうちの１つ以上は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目４１に記載の人工心臓弁。
（項目４３）
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によって覆われている、項目３０に記載の人工心臓弁。
（項目４４）
前記心室スカートは、非対称的なＤ字形の断面を備え、該断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、項目３０に記載の人工心臓弁。
（項目４５）
前記心室スカートは、折畳み構成および拡張構成を有し、該折畳み構成は、前記患者の心臓に送達するために適合され、該拡張構成は、該折畳み構成に対して半径方向に拡張されており、自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、項目３０に記載の人工心臓弁。
（項目４６）
前記心室スカートは、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、項目４５に記載の人工心臓弁。
（項目４７）
前記心室スカートは、該心室スカートの前方部分上に配置された三角固着タブをさらに備え、該三角固着タブは、前記患者の僧帽弁の前尖の第１の側面上の第１の線維性三角に対して固着されるように適合され、それにより、該前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、項目３０に記載の人工心臓弁。
（項目４８）
前記心室スカートは、該心室スカートの前記前方部分上に配置される第２の三角固着タブをさらに備え、該第２の三角固着タブは、前記第１の線維性三角の反対側の第２の線維性三角に対して固着されるように適合されることにより、前記前尖および隣接腱索が、該第２の三角固着タブと前記アンカーの前面との間に捕捉される、項目４７に記載の人工心臓弁。
（項目４９）
前記心室スカートは、該心室スカートの後方部分上に配置される後方心室固着タブをさらに備え、該後方心室固着タブは、前記患者の僧帽弁の後尖を覆って固着されるように適合され、それにより、該後方心室固着タブは、該後尖と該患者の心臓の心室壁との間に着座させられる、項目３０に記載の人工心臓弁。
（項目５０）
前記心室スカートは、それに連結される複数の鉤をさらに備え、該複数の鉤は、心臓組織の中に該心室スカートを固着するように適合される、項目３０に記載の人工心臓弁。
（項目５１）
前記心室スカートは、複数の支柱を備え、該複数の支柱は、コネクタ要素によって一緒に接続され、該複数の相互接続された支柱は、一連の頂点および谷間を形成する、項目３０に記載の人工心臓弁。
（項目５２）
前記支柱のうちの１つ以上は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目５１に記載の人工心臓弁。
（項目５３）
前記複数の人工弁尖は、三尖弁尖構成を備える、項目３０に記載の人工心臓弁。
（項目５４）
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備える、項目３０に記載の人工心臓弁。
（項目５５）
前記複数の人工弁尖のうちの１つ以上は、１つ以上の支柱に連結され、該１つ以上の支柱は、前記心室スカートに対して半径方向内向きに付勢される、項目３０に記載の人工心臓弁。
（項目５６）
前記１つ以上の支柱は、それを通って延在する１つ以上の縫合糸穴を備え、該縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目５５に記載の人工心臓弁。
（項目５７）
前記人工弁尖のうちの１つ以上は、交連柱に連結され、該交連柱は、該交連柱を送達デバイスと解放可能に係合させるように適合される交連タブを有する、項目３０に記載の人工心臓弁。
（項目５８）
前記アンカーの前方部分に連結される整列要素をさらに備え、該整列要素は、前記患者の心臓の大動脈起始部と整列させられ、該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、項目３０に記載の人工心臓弁。
（項目５９）
前記整列要素は、前記心房スカートと連結される、項目５８に記載の人工心臓弁。
（項目６０）
前記人工心臓弁は、それに連結される治療薬をさらに備え、該治療薬は、そこから溶出されるように適合される、項目３０に記載の人工心臓弁。
（項目６１）
人工心臓弁を患者の心臓に送達するための送達システムであって、
該システムは、
管腔が自身を通って延在している内側ガイドワイヤシャフトであって、該管腔は、ガイドワイヤを摺動可能に受容するように適合されている、内側ガイドワイヤシャフトと、
該内側ガイドワイヤシャフトを覆って同心円状に配置されるハブシャフトと、
該ハブシャフトを覆って摺動可能および同心円状に配置されるベルシャフトと、
該ベルシャフト覆って摺動可能および同心円状に配置されるシースと、
該送達システムの近位端付近のハンドルであって、該ハンドルは、アクチュエータ機構を備え、該アクチュエータ機構は、該ベルシャフトおよび該シースを前進および後退させるように適合される、ハンドルと
を備える、システム。
（項目６２）
前記人工心臓弁をさらに備え、該人工心臓弁は、半径方向の折畳み構成で前記シースの中に収納される、項目６１に記載のシステム。
（項目６３）
前記人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーと、
複数の人工弁尖であって、該弁尖の各々は、第１端および自由端を有し、該第１端は、該アンカーと連結され、該自由端は、該第１端の反対側にあり、該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工弁尖と
を備える、項目６２に記載のシステム。
（項目６４）
前記ベルシャフトに対する前記シースの近位への後退は、前記人工心臓弁から拘束を除去し、それにより、該人工心臓弁が自己拡張して前記患者の自然心臓組織と係合することを可能にする、項目６２に記載のシステム。
（項目６５）
前記人工心臓弁は、前記ハブシャフトと解放可能に連結され、該ハブシャフトに対する前記ベルシャフトの近位への後退は、該ハブシャフトから該人工心臓弁を解放する、項目６２に記載のシステム。
（項目６６）
前記アクチュエータ機構は、回転ホイールを備える、項目６１に記載のシステム。
（項目６７）
前記ハブシャフトに連結される組織貫通遠位先端をさらに備え、該組織貫通遠位先端は、前記患者の心臓を通過し、該患者の心臓の切開を拡張するように適合される、項目６１に記載のシステム。
（項目６８）
ピンロック機構をさらに備え、該ピンロック機構は、前記ハンドルと解放可能に連結され、該ピンロック機構は、前記シースの近位への後退を制限する、項目６１に記載のシステム。
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、僧帽弁逆流を治療するために使用される人工弁に関する。本開示は、僧帽弁逆流を治療するための人工弁の使用に焦点を当てているが、これは、限定的となることを目的としない。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治療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。
Claims (14)
- 人工心臓弁であって、
該人工心臓弁は、
心房スカート、環状領域、および心室スカートを有するアンカーであって、該アンカーは、心臓に送達するための折畳み構成、および該人工心臓弁を患者の心臓に固着するための拡張構成を有する、アンカーと、
複数の人工弁尖であって、該弁尖の各々は、第１端および自由端を有し、該第１端は、該アンカーと連結され、該自由端は、該第１端の反対側にある、人工弁尖と
を備え、
該人工心臓弁は、開放構成および閉鎖構成を有し、該開放構成において、該人工弁尖の該自由端が相互から離れて配置されることにより、順行血流がそれを通り越すことを可能にし、該閉鎖構成において、該人工弁尖の該自由端が相互に係合して、逆行血流がそれを通り越すことを実質的に防止する、人工心臓弁。 - 前記心房スカート、前記環状領域、または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によって覆われている、請求項１に記載の人工心臓弁。
- 前記心房スカートは、拘束されていないときに、前記折畳み構成から前記半径方向拡張構成まで自己拡張する、請求項１に記載の人工心臓弁。
- 前記環状領域は、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、請求項１に記載の人工心臓弁。
- 前記環状領域は、非対称的なＤ字形の断面を備え、該非対称的なＤ字形の断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、請求項１に記載の人工心臓弁。
- 前記心房スカートは、非対称的なＤ字形の断面を備える、請求項１に記載の人工心臓弁。
- 前記心室スカートは、非対称的なＤ字形の断面を備え、該断面は、実質的に平坦な前方部分と、円筒形状の後方部分とを有する、請求項１に記載の人工心臓弁。
- 前記心室スカートは、拘束されていないときに、前記折畳み構成から前記拡張構成まで自己拡張する、請求項１に記載の人工心臓弁。
- 前記心室スカートは、該心室スカートの前方部分上に配置された三角固着タブをさらに備え、該三角固着タブは、前記患者の僧帽弁の前尖の第１の側面上の第１の線維性三角に対して固着されるように適合され、それにより、該前尖および隣接腱索が、該三角固着タブと前記アンカーの前面との間に捕捉される、請求項１に記載の人工心臓弁。
- 前記心室スカートは、該心室スカートの前記前方部分上に配置される第２の三角固着タブをさらに備え、該第２の三角固着タブは、前記第１の線維性三角の反対側の第２の線維性三角に対して固着されるように適合されることにより、前記前尖および隣接腱索が、該第２の三角固着タブと前記アンカーの前面との間に捕捉される、請求項９に記載の人工心臓弁。
- 前記心室スカートは、該心室スカートの後方部分上に配置される後方心室固着タブをさらに備え、該後方心室固着タブは、前記患者の僧帽弁の後尖を覆って固着されるように適合され、それにより、該後方心室固着タブは、該後尖と該患者の心臓の心室壁との間に着座させられる、請求項１に記載の人工心臓弁。
- 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備える、請求項１に記載の人工心臓弁。
- 前記アンカーの前方部分に連結される整列要素をさらに備え、該整列要素は、前記患者の心臓の大動脈起始部と整列させられ、該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に記載の人工心臓弁。
- 前記人工心臓弁は、それに連結される治療薬をさらに備え、該治療薬は、そこから溶出されるように適合される、請求項１に記載の人工心臓弁。
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