JP6133885B2 - 連続的に展開された経カテーテル僧帽弁補綴 - Google Patents
連続的に展開された経カテーテル僧帽弁補綴 Download PDFInfo
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- JP6133885B2 JP6133885B2 JP2014542648A JP2014542648A JP6133885B2 JP 6133885 B2 JP6133885 B2 JP 6133885B2 JP 2014542648 A JP2014542648 A JP 2014542648A JP 2014542648 A JP2014542648 A JP 2014542648A JP 6133885 B2 JP6133885 B2 JP 6133885B2
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Classifications
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- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- 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
- A61F2/02—Prostheses implantable into the body
- 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
- A61F2/2403—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 pivoting rigid closure members
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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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- A61F2/00—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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- 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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- 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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- A61F2/24—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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- A61F2/00—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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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0058—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements soldered or brazed or welded
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- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2220/0075—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
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Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Description
本出願は、2011年11月23日に出願された米国仮特許出願第61/563,156号(代理人番号:42194−704.101)の正規の出願であり、上記米国仮特許出願の利益を主張する。上記文献の全内容は、参照することによって本明細書において援用される。
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治療に関する。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治療である。
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決定さ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補綴を説明する。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。弁補綴はまた、弁補綴の周囲の血液の逆流に対して弁補綴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。
(項目1)
患者の心臓に埋込型人工弁を送達する方法であって、前記患者の心臓は、前尖および後尖を伴う僧帽弁を有し、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、前記第1の端部と反対の第2の端部、前記拡張可能なフレームの前部分上の第1の前タブ、前記拡張可能なフレームの後部分上の後タブ、および前記拡張可能なフレームの前記第1の端部に隣接する心室スカートを有し、前記人工弁は、前記心臓に係合するための拡張構成、および折り畳み構成を有する、ことと、
前記折り畳み構成の前記人工弁を前記僧帽弁に隣接して前記患者の心臓に送達することと、
前記第1の前タブの先端部分が、前記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、前記第1の前タブを半径方向外向きに拡張することであって、前記前尖および隣接する前腱索は、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配置される、ことと、
前記第1の前タブを半径方向に拡張した後に、前記僧帽弁の前記後尖および隣接する後腱索が、前記後タブと前記心室スカートの外側後面との間に配置されるように、前記後タブを半径方向外向きに拡張することと、
前記後タブを半径方向に拡張した後に、前記心室スカートを半径方向外向きに拡張し、それによって、前記前および後尖に係合することと
を含み、
前記前尖および前記隣接する前腱索は、前記第1の前タブと前記心室スカートの前記外側前面との間に捕捉され、
前記後尖および前記隣接する後腱索は、前記後タブと前記心室スカートの前記後外面との間に捕捉される、方法。
(項目2)
送達カテーテルを提供することをさらに含み、前記人工弁は、前記送達カテーテルに解放可能に連結される、項目1に記載の方法。
(項目3)
前記人工弁を送達することは、前記心臓の外側の領域から前記心臓の左心室へ前記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4)
前記人工弁を送達することは、前記心臓の右心房から左心房へ前記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5)
前記人工弁を送達することは、前記拡張可能なフレームの前記第1の端部が前記僧帽弁の一部分より下にあり、前記拡張可能なフレームの前記第2の端部が前記僧帽弁の一部分より上にあるように、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、項目1に記載の方法。
(項目6)
前記第1の前タブを拡張することは、前記第1の前タブが自由に半径方向外向きに自己拡張できるように、前記第1の前タブから拘束シースを後退させることを含む、項目1に記載の方法。
(項目7)
前記人工弁はさらに、前記拡張可能なフレームの前記前部分上に第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、前記前尖の前記第1の側面と反対の前記前尖の第2の側面上の第2の線維性三角に係合するように、前記第2の前タブを半径方向外向きに拡張することを含み、
前記前尖および隣接する前腱索は、前記第2の前タブと前記心室スカートの外面との間に配置される、項目1に記載の方法。
(項目8)
前記第2の前タブは、前記第1の前タブの拡張と同時に半径方向外向きに拡張する、項目7に記載の方法。
(項目9)
それぞれの前記第1または第2の前タブに対して前記第1の線維性三角または前記第2の線維性三角に係合することに先立って、および前記第1または第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前記隣接する腱索を配置することに先立って、前記方法は、前記第1または第2の前タブが前記人工弁の縦軸と直角であるように、前記第1または第2の前タブを半径方向外向きに部分的に拡張することを含む、項目7に記載の方法。
(項目10)
前記第2の前タブを拡張することは、前記第2の前タブが自由に半径方向外向きに拡張できるように、前記第2の前タブから拘束シースを後退させることを含む、項目7に記載の方法。
(項目11)
前記後タブと前記心室スカートの前記外側後面との間に前記僧帽弁の前記後尖および前記隣接する腱索を配置することに先立って、前記方法は、前記後タブが前記人工弁の縦軸と直角であるように、前記後タブを半径方向外向きに部分的に拡張することを含む、項目1に記載の方法。
(項目12)
前記前尖および前記隣接する前腱索が、前記第1の前タブと前記心室スカートの前記外側前面との間に配置された後に、前記方法は、前記後タブが前記人工弁の縦軸と直角であるように、前記後タブを半径方向外向きに部分的に拡張することを含み、前記後タブは、前記後タブと前記心室スカートの前記外側後面との間に前記僧帽弁の前記後尖および前記隣接する後腱索を配置することなく、部分的に拡張される、項目1に記載の方法。
(項目13)
前記心室スカートを半径方向に拡張することは、前記心室スカートが自由に半径方向外向きに拡張できるように、前記心室スカートから拘束シースを後退させることを含む、項目1に記載の方法。
(項目14)
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することは、心臓組織の中へ前記複数の返しを係留することを含む、項目1に記載の方法。
(項目15)
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することは、前記前および後僧帽弁尖を半径方向外向きに変位させ、それによって、前記交連と前記前および後尖の両方との間の干渉を防止する、項目1に記載の方法。
(項目16)
前記心室スカートを拡張することは、前記左心室の内壁に接触することなく、かつ左心室流出路を塞ぐことなく、前記前および後弁尖を半径方向外向きに変位させる、項目1に記載の方法。
(項目17)
前記心室スカートを半径方向に拡張することは、前記心室スカートの前部分が実質的に平坦であり、前記心室スカートの後部分が円筒形状であるように、前記心室スカートを非対称に拡張する、項目1に記載の方法。
(項目18)
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19)
前記人工弁は、治療薬を運搬し、前記方法はさらに、前記人工弁から隣接する組織の中へ前記治療薬を溶出することを含む、項目1に記載の方法。
(項目20)
前記人工弁は、整合要素を備え、第2の線維性三角は、前記前尖の前記第1の側面と反対の前記前尖の第2の側面に配置され、前記方法はさらに、前記整合要素を大動脈基部と整合させることと、前記第1および第2の線維性三角の間に前記整合要素を配置することとを含む、項目1に記載の方法。
(項目21)
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、項目20に記載の方法。
(項目22)
前記人工弁はさらに、前記人工弁の上に配置された被覆を伴う複数の交連を備え、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、送達カテーテルから前記複数の人工弁尖を解放することを含む、項目1に記載の方法。
(項目23)
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、前記開放構成で相互から離れて配置され、それによって、前記複数の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、前記閉鎖構成で相互に係合し、それによって、前記複数の人工弁尖を通る逆行性血流を実質的に防止する、項目22に記載の方法。
(項目24)
前記人工弁はさらに、心房スカートを備え、前記方法はさらに、
前記僧帽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することと、
前記僧帽弁の前記上面に対して前記心房スカートを係合させることと
を含む、項目1に記載の方法。
(項目25)
前記心房スカートを拡張することは、前記心房スカートが自由に半径方向外向きに拡張できるように、前記心房スカートから拘束シースを後退させることを含む、項目24に記載の方法。
(項目26)
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ように、前記僧帽弁に対して上流または下流に前記人工弁を移動させることをさらに含む、項目24に記載の方法。
(項目27)
前記上面に対して前記心房スカートを係合させることは、その間の血流を防止するか、または実質的に防止するように、前記僧帽弁の前記上面に対して前記心房スカートを密閉する、項目24に記載の方法。
(項目28)
前記人工弁はさらに、環状領域を備え、前記方法はさらに、
前記僧帽弁の弁輪と一致するように前記環状領域を半径方向外向きに拡張することと、
前記環状領域を前記僧帽弁輪と係合させることと
を含む、項目1に記載の方法。
(項目29)
前記環状領域を拡張することは、前記環状領域が自由に半径方向外向きに拡張できるように、前記環状領域から拘束シースを後退させることを含む、項目28に記載の方法。
(項目30)
前記環状領域を拡張することは、前記環状領域の前部分が実質的に平坦であり、前記環状領域の後部分が円筒形状であるように、前記環状領域を非対称に拡張することを含む、項目28に記載の方法。
(項目31)
患者の心臓に埋込型人工弁を送達する方法であって、前記患者の心臓は、前尖および後尖を伴う僧帽弁を有し、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、前記第1の端部と反対の第2の端部、前記拡張可能なフレームの前部分上の第1の前タブ、前記拡張可能なフレームの後部分上の後タブ、および前記拡張可能なフレームの前記第1の端部に隣接する心室スカートを有し、前記人工弁は、前記心臓に係合するための拡張構成、および折り畳み構成を有する、ことと、
前記折り畳み構成の前記人工弁を前記僧帽弁に隣接して前記患者の心臓に送達することと、
前記第1の前タブの先端部分が、前記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、前記第1の前タブを半径方向外向きに拡張することであって、前記前尖および隣接する前腱索は、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配置される、ことと、
前記第1の前タブを半径方向に拡張した後に、前記心室スカートを半径方向外向きに拡張し、それによって、前記前尖に係合することであって、前記前尖および前記隣接する前腱索は、前記第1の前タブと前記心室スカートの前記外側前面との間に捕捉される、ことと、
前記心室スカートを半径方向に拡張した後に、前記僧帽弁の前記後尖および隣接する後腱索が、前記後タブと前記心室スカートの外側後面との間に配置および捕捉されるように、前記後タブを半径方向外向きに拡張することと
を含む、方法。
(項目32)
送達カテーテルを提供することをさらに含み、前記人工弁は、前記送達カテーテルに解放可能に連結される、項目31に記載の方法。
(項目33)
前記人工弁を送達することは、前記心臓の外側の領域から前記心臓の左心室へ前記人工弁を経心尖的に送達することを含む、項目31に記載の方法。
(項目34)
前記人工弁を送達することは、前記心臓の右心房から左心房へ前記人工弁を経中隔的に送達することを含む、項目31に記載の方法。
(項目35)
前記人工弁を送達することは、前記拡張可能なフレームの前記第1の端部が前記僧帽弁の一部分より下にあり、前記拡張可能なフレームの前記第2の端部が前記僧帽弁の一部分より上にあるように、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、項目31に記載の方法。
(項目36)
前記第1の前タブを拡張することは、前記第1の前タブが自由に半径方向外向きに自己拡張できるように、前記第1の前タブから拘束シースを後退させることを含む、項目31に記載の方法。
(項目37)
前記人工弁はさらに、前記拡張可能なフレームの前記前部分上に第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、前記前尖の前記第1の側面と反対の前記前尖の第2の側面上の第2の線維性三角に係合するように、前記第2の前タブを半径方向外向きに拡張することを含み、
前記前尖および隣接する前腱索は、前記第2の前タブと前記心室スカートの外面との間に配置される、項目31に記載の方法。
(項目38)
前記第2の前タブは、前記第1の前タブの半径方向拡張と同時に半径方向外向きに拡張する、項目37に記載の方法。
(項目39)
それぞれの前記第1または第2の前タブに対して前記第1の線維性三角または前記第2の線維性三角に係合することに先立って、および前記第1または第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前記隣接する腱索を配置することに先立って、前記方法は、前記第1または第2の前タブが前記人工弁の縦軸と直角であるように、前記第1または第2の前タブを半径方向外向きに部分的に拡張することを含む、項目37に記載の方法。
(項目40)
前記第2の前タブを拡張することは、前記第2の前タブが自由に半径方向外向きに拡張できるように、前記第2の前タブから拘束シースを後退させることを含む、項目37に記載の方法。
(項目41)
前記心室スカートを半径方向に拡張することは、前記心室スカートが自由に半径方向外向きに拡張できるように、前記心室スカートから拘束シースを後退させることを含む、項目31に記載の方法。
(項目42)
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することは、前記心臓の中へ前記複数の返しを係留することを含む、項目31に記載の方法。
(項目43)
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することは、前記前および後僧帽弁尖を半径方向外向きに変位させ、それによって、前記交連と前記前および後尖の両方との間の干渉を防止する、項目31に記載の方法。
(項目44)
前記心室スカートを拡張することは、前記左心室の内壁に接触することなく、かつ左心室流出路を塞ぐことなく、前記前および後弁尖を半径方向外向きに変位させる、項目31に記載の方法。
(項目45)
前記心室スカートを半径方向に拡張することは、前記心室スカートの前部分が実質的に平坦であり、前記心室スカートの後部分が円筒形状であるように、前記心室スカートを非対称に拡張する、項目31に記載の方法。
(項目46)
前記後タブと前記心室スカートの前記外側後面との間に前記僧帽弁の前記後尖および前記隣接する後腱索を配置することに先立って、前記方法は、前記後タブが前記人工弁の縦軸と直角であるように、前記後タブを半径方向外向きに部分的に拡張することを含む、項目31に記載の方法。
(項目47)
前記前尖および前記隣接する腱索が、前記第1の前タブと前記心室スカートの前記外側前面との間に配置された後に、前記方法は、前記後タブが前記人工弁の縦軸と直角であるように、前記後タブを半径方向外向きに部分的に拡張することを含み、前記後タブは、前記後タブと前記心室スカートの前記外側後面との間に前記僧帽弁の前記後尖および前記隣接する後腱索を配置することなく、部分的に拡張される、項目31に記載の方法。
(項目48)
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31に記載の方法。
(項目49)
前記人工弁は、治療薬を運搬し、前記方法はさらに、前記人工弁から隣接する組織の中へ前記治療薬を溶出することを含む、項目31に記載の方法。
(項目50)
前記人工弁は、整合要素を備え、第2の線維性三角は、前記前尖の前記第1の側面と反対の前記前尖の第2の側面に配置され、前記方法はさらに、前記整合要素を大動脈基部と整合させることと、前記第1および第2の線維性三角の間に前記整合要素を配置することとを含む、項目31に記載の方法。
(項目51)
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、項目50に記載の方法。
(項目52)
前記人工弁はさらに、前記人工弁の上に配置された被覆を伴う複数の交連を備え、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、送達カテーテルから前記複数の人工弁尖を解放することを含む、項目31に記載の方法。
(項目53)
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、前記開放構成で相互から離れて配置され、それによって、前記複数の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、前記閉鎖構成で相互に係合し、それによって、前記複数の人工弁尖を通る逆行性血流を実質的に防止する、項目52に記載の方法。
(項目54)
前記人工弁はさらに、心房スカートを備え、前記方法はさらに、
前記僧帽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することと、
前記僧帽弁の前記上面に対して前記心房スカートを係合させることと
を含む、項目31に記載の方法。
(項目55)
前記心房スカートを拡張することは、前記心房スカートが自由に半径方向外向きに拡張できるように、前記心房スカートから拘束シースを後退させることを含む、項目54に記載の方法。
(項目56)
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ように、前記僧帽弁に対して上流または下流に前記人工弁を移動させることをさらに含む、項目54に記載の方法。
(項目57)
前記上面に対して前記心房スカートを係合させることは、その間の血流を防止するか、または実質的に防止するように、前記僧帽弁の前記上面に対して前記心房スカートを密閉する、項目54に記載の方法。
(項目58)
前記人工弁はさらに、環状領域を備え、前記方法はさらに、
前記僧帽弁の弁輪と一致するように前記環状領域を半径方向外向きに拡張することと、
前記環状領域を前記僧帽弁輪と係合させることと
を含む、項目31に記載の方法。
(項目59)
前記環状領域を拡張することは、前記環状領域が自由に半径方向外向きに拡張できるように、前記環状領域から拘束シースを後退させることを含む、項目58に記載の方法。
(項目60)
前記環状領域を拡張することは、前記環状領域の前部分が実質的に平坦であり、前記環状領域の後部分が円筒形状であるように、前記環状領域を非対称に拡張することを含む、項目58に記載の方法。
(項目61)
連続的に展開された人工心臓弁であって、前記弁は、
第1の端部、前記第1の端部と反対の第2の端部、前記第2の端部の付近の心房領域、および前記第1の端部の付近の心室領域を有する自己拡張式フレームであって、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、前記拡張構成が心臓組織に係合するように適合され、前記折り畳み構成が患者の心臓に送達されるように適合される、自己拡張式フレームと、
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、
前記心室領域中で前記自己拡張式フレームの後部分上に配置される自己拡張式後タブと
を備え、
前記第1の自己拡張式前タブの一部分および前記自己拡張式後タブの一部分は、拘束がそこから除去されたときに、半径方向外向きに部分的に自己拡張し、
前記第1の前タブは、前記拘束がそこから除去されたときに、前記後タブが半径方向外向きに完全に自己拡張する前に、半径方向外向きに完全に自己拡張し、
前記後タブは、前記拘束がそこから除去されたときに、前記心室スカートが自己拡張する前に、半径方向外向きに完全に自己拡張し、
前記心室スカートは、最後に完全に拡張する、人工心臓弁。
(項目62)
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で覆われる、項目61に記載の人工心臓弁。
(項目63)
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、患者の心臓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、前記患者の天然僧帽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、左心房の一部分に対して前記心房スカートを係留する、項目61に記載の人工心臓弁。
(項目64)
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61に記載の人工心臓弁。
(項目65)
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る複数の軸方向に配向した支柱を備え、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、項目61に記載の人工心臓弁。
(項目66)
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、項目61に記載の人工心臓弁。
(項目67)
自己拡張式後に、前記心房スカートは、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を有する、項目61に記載の人工心臓弁。
(項目68)
前記心房スカートの前部分に連結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基部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、項目61に記載の人工心臓弁。
(項目69)
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で覆われる、項目61に記載の人工心臓弁。
(項目70)
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、前記患者の心臓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、患者の天然僧帽弁の弁輪と一致するように適合され、かつそれに係合するように適合される、項目61に記載の人工心臓弁。
(項目71)
自己拡張式後に、前記環状領域は、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を有する、項目61に記載の人工心臓弁。
(項目72)
前記環状領域は、コネクタ要素を用いてともに接続される複数の軸方向に配向した支柱を備え、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、項目61に記載の人工心臓弁。
(項目73)
前記複数の軸方向に配向した支柱のうちの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、前記縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目72に記載の人工心臓弁。
(項目74)
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覆われる、項目61に記載の人工心臓弁。
(項目75)
自己拡張式後に、前記心室スカートは、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を備える、項目61に記載の人工心臓弁。
(項目76)
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、前記患者の心臓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、項目61に記載の人工心臓弁。
(項目77)
前記第1の前タブは、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、項目61に記載の人工心臓弁。
(項目78)
前記人工心臓弁はさらに、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、項目77に記載の人工心臓弁。
(項目79)
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、前記心臓組織とのそれぞれの前記第1または第2の前タブの接触表面積を増加させる、項目78に記載の人工心臓弁。
(項目80)
前記被覆は、前記第1または第2の前タブに連結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、項目79に記載の人工心臓弁。
(項目81)
前記後タブが患者の心臓の後尖と心室壁との間に着座されるように、前記後タブは、前記患者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、項目61に記載の人工心臓弁。
(項目82)
前記後タブは、複数の支柱を備え、隣接する支柱は、複数の拡張可能なヒンジ連結接合部を形成するようにともに連結され、前記後タブの半径方向拡張時に、前記複数の支柱は、相互から離れて移動し、それによって、前記ヒンジ連結接合部を開放し、後尖と心室壁との間の前記僧帽弁の弁輪下領域との前記後タブの係合および係留を可能にする細長い水平区分を形成する、項目61に記載の人工心臓弁。
(項目83)
前記心室スカートはさらに、前記心室スカートに連結される複数の返しを備え、前記複数の返しは、心臓組織の中へ前記心室スカートを係留するように適合される、項目61に記載の人工心臓弁。
(項目84)
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る複数の支柱を備え、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、項目61に記載の人工心臓弁。
(項目85)
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、前記縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目84に記載の人工心臓弁。
(項目86)
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連結され、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、項目61に記載の人工心臓弁。
(項目87)
前記複数の人工弁尖は、三尖弁を形成する、項目86に記載の人工心臓弁。
(項目88)
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、項目86に記載の人工心臓弁。
(項目89)
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、項目86に記載の人工心臓弁。
(項目90)
前記人工心臓弁は、治療薬を運搬し、前記治療薬は、前記人工心臓弁から溶出するように適合される、項目61に記載の人工心臓弁。
(項目91)
連続的に展開された人工心臓弁であって、前記弁は、
第1の端部、前記第1の端部と反対の第2の端部、前記第2の端部の付近の心房領域、および前記第1の端部の付近の心室領域を有する自己拡張式フレームであって、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、前記拡張構成が心臓組織に係合するように適合され、前記折り畳み構成が患者の心臓に送達されるように適合される、自己拡張式フレームと、
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、
前記心室領域中で前記自己拡張式フレームの後部分上に配置される自己拡張式後タブと
を備え、
前記第1の自己拡張式前タブの一部分および前記自己拡張式後タブの一部分は、拘束がそこから除去されたときに、半径方向外向きに部分的に自己拡張し、
前記第1の前タブは、前記拘束がそこから除去されたときに、前記心室スカートが半径方向外向きに自己拡張する前に、半径方向外向きに自己拡張し、
前記心室スカートは、前記後タブが自己拡張し終える前に、半径方向外向きに自己拡張し、
前記後タブは、前記心室スカートが自己拡張した後に、自己拡張し終える、人工心臓弁。
(項目92)
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で覆われる、項目91に記載の人工心臓弁。
(項目93)
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、前記患者の心臓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、患者の天然僧帽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、左心房の一部分に対して前記心房スカートを係留する、項目91に記載の人工心臓弁。
(項目94)
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91に記載の人工心臓弁。
(項目95)
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る複数の軸方向に配向した支柱を備え、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、項目91に記載の人工心臓弁。
(項目96)
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、項目91に記載の人工心臓弁。
(項目97)
自己拡張式後に、前記心房スカートは、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を有する、項目91に記載の人工心臓弁。
(項目98)
前記心房スカートの前部分に連結される整合要素をさらに備え、前記整合要素は、前記患者の心臓の大動脈基部と整合させられるように適合され、かつ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91に記載の人工心臓弁。
(項目99)
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で覆われる、項目91に記載の人工心臓弁。
(項目100)
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、前記患者の心臓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、患者の天然僧帽弁の弁輪と一致するように適合され、かつそれに係合するように適合される、項目91に記載の人工心臓弁。
(項目101)
自己拡張式後に、前記環状領域は、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を有する、項目91に記載の人工心臓弁。
(項目102)
前記環状領域は、コネクタ要素を用いてともに接続される複数の軸方向に配向した支柱を備え、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、項目91に記載の人工心臓弁。
(項目103)
前記複数の軸方向に配向した支柱のうちの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、前記縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目102に記載の人工心臓弁。
(項目104)
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覆われる、項目91に記載の人工心臓弁。
(項目105)
自己拡張式後に、前記心室スカートは、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を備える、項目91に記載の人工心臓弁。
(項目106)
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、前記患者の心臓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、項目91に記載の人工心臓弁。
(項目107)
前記第1の前タブは、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、項目91に記載の人工心臓弁。
(項目108)
前記人工心臓弁はさらに、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、項目107に記載の人工心臓弁。
(項目109)
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、前記心臓組織とのそれぞれの前記第1または第2の前タブの接触表面積を増加させる、項目108に記載の人工心臓弁。
(項目110)
前記被覆は、前記第1または第2の前タブに連結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、項目109に記載の人工心臓弁。
(項目111)
前記後タブが患者の心臓の後尖と心室壁との間に着座されるように、前記後タブは、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、項目91に記載の人工心臓弁。
(項目112)
前記後タブは、複数の支柱を備え、隣接する支柱は、複数の拡張可能なヒンジ連結接合部を形成するようにともに連結され、前記後タブの半径方向拡張時に、前記複数の支柱は、相互から離れて移動し、それによって、前記ヒンジ連結接合部を開放し、後尖と心室壁との間の前記僧帽弁の弁輪下領域との前記後タブの係合および係留を可能にする細長い水平区分を形成する、項目61に記載の人工心臓弁。
(項目113)
前記心室スカートはさらに、前記心室スカートに連結される複数の返しを備え、前記複数の返しは、心臓組織の中へ前記心室スカートを係留するように適合される、項目91に記載の人工心臓弁。
(項目114)
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る複数の支柱を備え、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、項目91に記載の人工心臓弁。
(項目115)
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、前記縫合糸穴は、縫合糸を受容するようにサイズ決定される、項目114に記載の人工心臓弁。
(項目116)
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連結され、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、項目91に記載の人工心臓弁。
(項目117)
前記複数の人工弁尖は、三尖弁を形成する、項目116に記載の人工心臓弁。
(項目118)
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、項目116に記載の人工心臓弁。
(項目119)
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、項目116に記載の人工心臓弁。
(項目120)
前記人工心臓弁は、治療薬を運搬し、前記治療薬は、前記人工心臓弁から溶出するように適合される、項目91に記載の人工心臓弁。
(項目121)
患者の心臓に人工心臓弁を送達するための送達システムであって、前記心臓は、前尖および後尖を伴う僧帽弁を有し、前記送達システムは、
人工心臓弁と、
内側ガイドワイヤシャフトであって、前記内側ガイドワイヤシャフトは、それを通って延在する管腔を有し、前記管腔は、ガイドワイヤを摺動可能に受容するようにサイズ決定される、内側ガイドワイヤシャフトと、
前記内側ガイドワイヤシャフトの遠位部分に連結される遠位組織貫通先端であって、前記遠位先端は、前記心臓内の組織を通過して拡張するように適合され、連続的な広口領域は、前記内側ガイドワイヤシャフトを前記遠位先端と連結し、前記連続的な広口領域は、前記人工心臓弁を支持し、それによって、前記人工心臓弁の不要な屈曲を低減または排除するように構成される、遠位組織貫通先端と、
前記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であって、前記人工心臓弁は、前記ハブシャフトの遠位部分に解放可能に連結される、ハブシャフトと、
前記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、
前記ベル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外側シースであって、前記人工心臓弁は、半径方向折り畳み構成で前記外側シースの中に収納される、外側シースと、
前記送達システムの近位端の付近のハンドルであって、前記ハンドルは、前記ベルシャフトおよび前記シースを前進および後退させるように適合されるアクチュエータ機構を備える、ハンドルと
を備える、送達システム。
(項目122)
前記ベルシャフトに対する前記外側シースの近位後退は、前記人工心臓弁から拘束を除去し、それによって、前記人工心臓弁が前記患者の僧帽弁と係合するように自己拡張することを可能にする、項目121に記載の送達システム。
(項目123)
前記人工心臓弁は、複数の交連柱を備え、前記交連柱は、前記ハブシャフトの遠位部分と解放可能に連結され、前記ハブシャフトに対する前記ベルシャフトの近位後退は、前記交連柱が前記ハブシャフトから分断することを可能にする、項目121に記載の送達システム。
(項目124)
前記アクチュエータ機構は、回転可能なホイールを備える、項目121に記載の送達システム。
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。
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組み込ま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組み込まれる。
Claims (15)
- 人工弁送達システムであって、前記人工弁送達システムは、連続的に展開された人工心臓弁と、前記人工心臓弁を拘束するための外側シースとを備え、前記人工心臓弁は、
第1の端部、前記第1の端部と反対の第2の端部、前記第2の端部の付近の心房領域、および前記第1の端部の付近の心室領域を有する自己拡張式フレームであって、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、前記拡張構成が心臓組織に係合するように適合され、前記折り畳み構成が患者の心臓に送達されるように適合される、自己拡張式フレームと、
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、
前記心室領域中で前記自己拡張式フレームの後部分上の自己拡張式後タブと
を備え、
前記自己拡張式心室スカート、前記第1の自己拡張式前タブおよび前記自己拡張式後タブの各々は、複数の支柱を備え、
前記自己拡張式心室スカート、前記第1の自己拡張式前タブおよび前記自己拡張式後タブの前記支柱の長さ、または、前記自己拡張式フレームに沿っていてかつ前記自己拡張式心室スカートの軸方向位置と相対的な前記第1の自己拡張式前タブまたは前記自己拡張式後タブの軸方向位置は、
前記外側シースによって提供される前記拘束の除去時に、前記第1の自己拡張式前タブの一部分および前記自己拡張式後タブの一部分が、半径方向外向きに部分的に自己拡張し、
前記第1の自己拡張式前タブが、前記自己拡張式心室スカートが半径方向外向きに自己拡張する前に、半径方向外向きに自己拡張し、
前記自己拡張式心室スカートが、前記自己拡張式後タブが自己拡張し終える前に、半径方向外向きに自己拡張し、
前記自己拡張式後タブが、前記自己拡張式心室スカートが自己拡張した後に、自己拡張し終える、
ようになっている、人工弁送達システム。 - 前記自己拡張式心房スカートもしくは前記自己拡張式環状領域の少なくとも一部分、または前記自己拡張式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覆われる、請求項1に記載の人工弁送達システム。
- 前記自己拡張式心房スカートは、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、前記患者の心臓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、患者の天然僧帽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、前記患者の心臓の左心房の一部分に対して前記自己拡張式心房スカートを係留する、請求項1に記載の人工弁送達システム。
- 前記自己拡張式心房スカートの自己拡張後に、前記自己拡張式心房スカートは、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に記載の人工弁送達システム。
- 自己拡張式後に、前記自己拡張式心房スカートまたは前記自己拡張式環状領域または前記自己拡張式心室スカートは、実質的に平坦な前部分、および円筒形状の後部分を有する、非対称D字形断面を有する、請求項1に記載の人工弁送達システム。
- 前記自己拡張式心房スカートの前部分に連結される整合要素をさらに備え、前記整合要素は、前記患者の心臓の大動脈基部と整合させられるように適合され、かつ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に記載の人工弁送達システム。
- 前記自己拡張式環状領域は、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、前記患者の心臓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、患者の天然僧帽弁の弁輪と一致するように適合され、かつ前記患者の天然僧帽弁の弁輪に係合するように適合される、請求項1に記載の人工弁送達システム。
- 前記自己拡張式心室スカートは、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、前記患者の心臓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に記載の人工弁送達システム。
- 前記第1の自己拡張式前タブは、患者の僧帽弁の前尖の第1の側面上の第1の線維性三角に係合するように適合される先端部分を有し、前記第1の自己拡張式前タブは、前記第1の自己拡張式前タブと前記自己拡張式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に記載の人工弁送達システム。
- 前記人工心臓弁はさらに、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備え、前記第2の自己拡張式前タブは、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の自己拡張式前タブは、前記第2の自己拡張式前タブと前記自己拡張式心室スカートの前記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9に記載の人工弁送達システム。
- 前記第1または第2の自己拡張式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、前記心臓組織とのそれぞれの前記第1または第2の自己拡張式前タブの接触表面積を増加させる、請求項10に記載の人工弁送達システム。
- 前記自己拡張式後タブが患者の心臓の後尖と心室壁との間に着座されるように、前記自己拡張式後タブは、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に記載の人工弁送達システム。
- 前記自己拡張式後タブは、複数の拡張可能なヒンジ連結接合部を備え、各拡張可能なヒンジ連結接合部は、前記自己拡張式後タブの2つの隣接する支柱を連結することにより形成され、各拡張可能なヒンジ連結接合部は、前記連結された2つの隣接する支柱のそれぞれの先端を備え、前記複数の拡張可能なヒンジ連結接合部は、第1、第2および第3のヒンジ連結接合部を備え、前記第2のヒンジ連結接合部は、前記第1のヒンジ連結接合部と前記第3のヒンジ連結接合部との間に配置され、かつ、前記第1のヒンジ連結接合部を形成する前記支柱のうちの1つと、前記第3のヒンジ連結接合部を形成する前記支柱のうちの1つとから形成され、
前記自己拡張式後タブの半径方向拡張時に、前記複数の支柱は、相互に離れるように移動し、それによって、前記拡張可能なヒンジ連結接合部を開放し、後尖と心室壁との間の患者の僧帽弁の弁輪下領域との前記自己拡張式後タブの係合および係留を可能にする前記第1のヒンジ連結接合部と前記第3のヒンジ連結接合部との間の細長い水平区分を形成する、請求項1に記載の人工弁送達システム。 - 複数の人工弁尖をさらに備え、前記人工弁尖のそれぞれは、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連結され、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に離れるように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に記載の人工弁送達システム。
- 前記人工心臓弁は、治療薬を運搬し、前記治療薬は、前記人工心臓弁から溶出するように適合される、請求項1に記載の人工弁送達システム。
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