JP2020099721A - 人工治療装置 - Google Patents
人工治療装置 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
- 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
- A61F2/2412—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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- A61F2/02—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
- 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
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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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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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
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
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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
- 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
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- A61F2/2466—Delivery devices therefor
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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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- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
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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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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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
- A61F2220/0025—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
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Abstract
Description
僧帽弁等の天然心臓弁の経皮的置換のためのシステム、本デバイス、および方法が、本明細書に提供される。以下に記載される詳細のいくつかは、当業者が、それらを実践、作製、および使用することを可能にするために十分な様式において、以下の実施例および方法を説明するために提供される。しかしながら、以下に説明される詳細および利点のいくつかは、本技術のある実施例および方法を実践するために必要でなくてもよい。加えて、本技術は、請求項の範囲内であるが、詳細に説明されない、他の実施例および方法を含んでもよい。
(項目1)
患者の心臓の心房と心室との間に位置する天然弁に埋め込むための人工心臓弁デバイスであって、前記天然弁は、弁輪と、前記弁輪に連結された弁尖とを有し、
外側表面を有する拡張可能支持体であって、前記弁尖間に留置するために構成される、拡張可能支持体と、
前記拡張可能支持体に連結され、前記弁尖を前記アームと前記外側表面との間に受容するように構成される、複数のアームであって、少なくとも2つのアームは、異なる長さを有し、前記弁尖の背後の異なる距離に延在し、前記弁輪の弁輪下表面に係合する、アームと
を備える、デバイス。
(項目2)
患者の心臓の心房と心室との間に位置する天然弁に埋め込むための人工心臓弁デバイスであって、前記天然弁は、弁輪と、前記弁輪に連結された弁尖とを有し、
外側表面を有する拡張可能支持体であって、前記弁尖間に留置するために構成される、拡張可能支持体と、
前記拡張可能支持体の円周の周囲に非対称的に配列され、前記弁尖を前記アームと前記外側表面との間に受容するように構成される、複数のアームと
を備える、デバイス。
(項目3)
患者の心臓の心房と心室との間に位置する天然二尖弁に埋め込むための人工心臓弁デバイスであって、前記二尖弁は、弁輪と、前記弁輪に連結された2つの弁尖とを有し、
外側表面を有する拡張可能支持体であって、前記2つの弁尖間に留置するために構成される、拡張可能支持体と、
前記拡張可能支持体に連結され、個々の弁尖を前記アームと前記外側表面との間に受容するように構成される、複数のアームと、
前記拡張可能支持体および前記アームのうちの少なくとも1つに連結され、前記拡張可能支持体から、前記天然二尖弁の交連領域内に外向きに延在する、封止部材であって、前記交連領域を通る血流を阻止するように構成される、封止部材と
を備える、デバイス。
(項目4)
心臓の天然弁領域に埋め込むための人工心臓弁デバイスであって、
上流部分および下流部分を有する拡張可能支持体であって、前記上流部分が、第1の心臓内腔と流体連通し、前記下流部分が、第2の心臓内腔と流体連通するように、前記天然弁領域に位置するように構成される、拡張可能支持体と、
前記下流部分において、前記拡張可能支持体に連結される複数のアームであって、各個々のアームは、前記下流部分から延在し、前記第2の内腔内の前記天然弁領域の弁輪下表面に係合するように構成され、前記個々のアームの少なくともいくつかは、独立して、調節可能な長さを有する、アームと
を備える、デバイス。
(項目5)
心臓の天然弁領域に埋め込むための人工心臓弁デバイスであって、
上流部分、下流部分、および外側表面を有する、拡張可能支持体であって、前記上流部分が、第1の心臓内腔と流体連通し、前記下流部分が、第2の心臓内腔と流体連通するように、前記天然弁領域に位置するように構成される、拡張可能支持体と、
前記下流部分に連結される複数のアームであって、各個々のアームは、基部分、延在部分、および前記基部分を前記延在部分に接続する肘部分を有し、前記延在部分は、前記第2の内腔内の前記天然弁領域の弁輪下表面に係合するように構成される、アームと
を備え、
個々のアームは、異なる広がり角において、前記支持体から延在する、デバイス。
(項目6)
患者の心臓弁を治療するためのデバイスであって、前記弁は、弁輪と、前記弁輪に連結された弁尖とを備え、
外側表面を備える拡張可能支持体であって、前記弁尖間に留置するために構成され、上流部分および下流部分を備える、拡張可能支持体と、
前記拡張可能支持体に連結された複数のアームであって、第1の複数のアームおよび第2の複数のアームを備え、前記第1の複数のアームは、前記支持体の第1の部分上に配列され、第1の弁尖を受容し、前記第2の複数のアームは、前記支持体の第2の部分上に配列され、第2の弁尖を受容し、前記第1の複数のアームは、前記第2の複数のアームより多い数のアームを含む、複数のアームと
を備える、デバイス。
(項目7)
弁輪、前記弁輪に連結された弁尖、および前記弁尖に連結された腱索を有する二尖心臓弁の修復または置換のためのデバイスであって、
前記弁尖間に位置付け可能であって、弁が連結され得る内部を有する、中空支持体と、
前記支持体に連結される係留部分であって、少なくとも1つの弁尖の下流縁の周囲に延在するように構成される、弓状領域と、前記腱索間の下流縁から前記弁輪に延在するように構成される、延在部領域と、上流方向における前記デバイスの移動を阻止するように、前記弁輪の弁輪下表面に係合するように構成される、係合領域とを有する、係留部分と、
前記支持体および前記係留部分のうちの少なくとも1つに連結され、前記支持体から前記二尖心臓弁の交連領域内に外向きに延在する、封止部材であって、前記交連領域を通る血流を阻止するように構成される、封止部材と
を備える、デバイス。
(項目8)
弁輪、前記弁輪に連結された弁尖、および前記弁尖に連結された腱索を有する心臓弁の修復または置換のためのデバイスであって、
前記弁尖間に留置するために構成される円筒形支持体であって、近位および遠位部分と、弁が連結され得る内部とを有する、支持体と、
前記円筒形支持体の後方側に連結される第1のアーム群と、
前記後方側と反対の前記円筒形支持体の前方側に連結される第2のアーム群と
を備え、
各アームは、上流方向における前記支持体の移動を阻止するように、前記腱索間の弁尖の下流縁の周囲に延在し、弁輪の弁輪下表面に係合するように構成され、
前記第1のアーム群は、第1の線に沿って、第1の弁輪下表面に係合するように構成され、前記第2のアーム群は、第2の線に沿って、第2の弁輪下表面に係合するように構成され、前記第1および第2の線は、前記弁輪に非平行である、デバイス。
(項目9)
弁輪および前記弁輪に連結された弁尖を有する心臓弁の修復または置換のためのデバイスであって、
前記弁尖間に留置するために構成される円筒形支持体であって、上流および下流部分と、弁が連結され得る内部とを有する、支持体と、
前記下流部分に連結され、外向きかつ上流方向に延在する、複数の係留アームであって、前記心臓弁の弁輪に非外傷的に係合するように構成される、遠位先端を有する、アームと
を備え、
前記複数の係留アームは、第1および第2の複数の係留アームを含み、前記第1の複数の係留アームは、前記第2の複数の係留アームと異なる特性を有し、前記特性は、サイズ、形状、靭性、広がり角、前記支持体からの間隔、および前記支持体の所与の面積内のアームの数から成る群から選択される、デバイス。
(項目10)
弁輪を有する心臓弁の修復または置換のためのデバイスであって、
上流および下流端と、弁が連結され得る内部と、周縁とを有する、円筒形支持体と、
前記円筒形支持体に連結され、外向きかつ上流方向に延在する、複数のアームであって、前記心臓弁の弁輪に非外傷的に係合するように構成される、遠位先端を含む、アームと、
を備え、
前記アームは、少なくとも第1の隣接する対のアームが、少なくとも第2の隣接する対のアームよりともに近接して離間されるように、前記周縁を中心として、不均一に分散される、デバイス。
(項目11)
人工心臓弁デバイスであって、
上流および下流端と、弁が連結され得る内部と、中心縦軸とを有する、円筒形支持体と、
前記円筒形支持体に連結され、外向きかつ上流方向に延在する、複数のアームであって、天然心臓弁の弁輪下表面に非外傷的に係合するように構成される、遠位先端を有する、アームと、
を備え、
前記アームのうちの少なくとも1つは、前記縦軸から、少なくとも第2の前記アームより大きな距離に外向きに延在する、デバイス。
(項目12)
人工心臓弁デバイスであって、
上流部分および下流部分を有する拡張可能支持体であって、前記上流部分が、第1の心臓内腔と流体連通し、前記下流部分が、第2の心臓内腔と流体連通するように、天然弁領域に位置するように構成される、拡張可能支持体と、
前記支持体に連結され、上流方向に延在し、遠位先端が、前記第2の心臓内腔内の前記天然弁領域の弁輪に係合するように構成される、少なくとも1つのアームであって、前記上流方向において、前記支持体に対して付与される少なくとも約0.5lbfの力下、前記心臓弁に対する前記支持体の位置を維持するように選択される柱強度を有する、少なくとも1つのアームと
を備える、デバイス。
(項目13)
人工心臓弁デバイスであって、
縦軸と、血液が流動し得る、前記縦軸に沿った内部とを有する、円筒形支持体と、
前記支持体の内部に連結され、上流方向において、前記支持体を通る血流を遮断し、下流方向において、前記支持体を通る血流を可能にするように構成される、弁と、
前記支持体に連結され、前記支持体の外部壁に沿って、前記上流方向に延在する、複数のアームと
を備え、前記デバイスは、
前記支持体が、半径方向に収縮され、各アームが、前記支持体の外部壁に対して、またはそれに隣接して、内向き位置にある、第1の構成と、
前記支持体が、半径方向に収縮され、各アームが、前記心臓弁の弁尖をその間に受容するために十分な距離だけ、前記外部壁から空間的に分離された外向き位置にある、第2の構成と、
前記支持体が、半径方向に拡張され、各アームが、前記第2の構成より前記支持体の外部壁に近接して位置付けられる、第3の構成と
を含む、複数の構成に移動可能である、デバイス。
(項目14)
前記アームは、前記第2の構成におけるよりも前記第3の構成において、前記縦軸に対してさらに内向きに位置付けられる、項目13に記載のデバイス。
(項目15)
前記アームは、非偏向状態では、前記内向き位置をとる、項目13に記載のデバイス。(項目16)
前記アームは、非偏向状態では、前記外向き位置をとる、項目13に記載のデバイス。(項目17)
前記アームは、前記第2の構成から前記第3の構成に可鍛性かつ変形可能である、項目13に記載のデバイス。
(項目18)
前記デバイスは、天然僧帽弁に埋め込まれることができる、項目1−13のいずれかに記載のデバイス。
(項目19)
前記弁は、前記僧帽弁を備え、前記第1の複数のアームは、前尖の背後の前記弁輪に係合するように構成され、前記第2の複数のアームは、後尖の背後の前記弁輪に係合するように構成される、項目6に記載のデバイス。
(項目20)
前記弁は、大動脈弁または三尖弁を備える、項目1−6、9−13のいずれかに記載のデバイス。
(項目21)
前記支持体は、内方側および外方側を有し、前記後方および前方側のアームの密度は、前記内方および外方側のアームの密度より高い、項目8に記載のデバイス。
(項目22)
前記複数のアームは、前記弁輪の係合によって、前記心房に向かっての前記支持体の移動を阻止するように構成される、項目1、2、または3のいずれかに記載のデバイス。
(項目23)
前記複数のアームは、複数の伸長アームを備え、前記複数の伸長アームは、少なくとも約0.5ポンド(230グラム)の荷重を支持するために十分な柱強度を有する、項目1−6、10、11、または13のいずれかに記載のデバイス。
(項目24)
前記支持体に連結され、逆行血流を妨害する弁をさらに備える、項目1−13のいずれかに記載のデバイス。
(項目25)
前記複数のアームは、血液が、前記支持体を通って下流方向に流動するとき、移動を制限するように、前記弁尖に接触するように構成される、項目1、2、3、6、または9のいずれかに記載のデバイス。
(項目26)
前記複数のアームはそれぞれ、前記弁尖が、前記複数のアームと前記支持体との間に受容されるように、前記弁尖を受容するように定寸された間隙距離を伴って、前記外側表面から分離される、項目1−3または6のいずれかに記載のデバイス。
(項目27)
前記支持体は、弁輪の曲率半径未満の第1の曲率半径を有し、前記複数のアームのそれぞれの間隙距離は、前記複数のアームのそれぞれが、前記弁輪の曲率半径において、前記弁輪に係合するように定寸される、項目26に記載のデバイス。
(項目28)
前記複数のアームはそれぞれ、組織抵抗に応答して、前記間隙距離を変動させるように偏向可能である、項目27に記載のデバイス。
(項目29)
前記複数のアームはそれぞれ、前記腱索との接触に応答して、偏向するように構成される、項目28に記載のデバイス。
(項目30)
前記複数のアームは、前記患者の血管系を通した前記デバイスの送達のための内向き構成から、前記弁輪の係合のための外向き構成に移動可能である、項目1−3のいずれかに記載のデバイス。
(項目31)
前記複数のアームはそれぞれ、前記内向き構成にあるとき、前記拡張可能支持体の外側表面に沿って延在し、前記複数のアームはそれぞれ、前記外向き構成にあるとき、ある間隙距離だけ、前記外側表面から分離される、項目30に記載のデバイス。
(項目32)
前記弁輪は、頂部分および谷部分を備え、前記複数のアームはそれぞれ、少なくとも前記頂部分に沿って、前記弁輪に連結するように構成される、項目1、2、3、6、9、または10のいずれかに記載のデバイス。
(項目33)
前記複数のアームはそれぞれ、前記弁輪下表面に係合するように構成される、先端部分を備える、項目4または5のいずれかに記載のデバイス。
(項目34)
前記複数のアームはそれぞれ、前記拡張可能支持体に連結された基部分から前記先端部分に延在する、項目33に記載のデバイス。
(項目35)
前記先端部分は、減圧先端部分を備える、項目33に記載のデバイス。
(項目36)
各個々のアーム上に減圧先端部分をさらに備え、前記先端部分は、バンパ、アンカ、湾曲先端、ループ、平坦化された部分、管、キャップ、湾曲ワイヤ、ワイヤのループ、***、T−形状、涙滴形状、またはボールのうちの1つ以上を有する、項目1−6または8−13のいずれかに記載のデバイス。
(項目37)
前記間隙距離は、減圧先端部分と前記拡張可能支持体の外側表面との間に延在する、項目26に記載のデバイス。
(項目38)
前記減圧先端部分は、第1の断面寸法を備え、個々のアームの第2の部分は、第2の断面寸法を備え、前記第1の断面寸法は、前記先端において接触する組織への圧力を低下させるように、前記第2の断面寸法を上回る、項目35、36、または37のいずれかに記載のデバイス。
(項目39)
前記支持体は、縦軸を有し、各先端部分は、前記縦軸に横断する平面に沿って延在する、最大寸法を備え、前記最大寸法は、前記複数のアームが、前記内向き構成にあるとき、概して、前記支持体の外側表面またはその接線に平行である、項目35に記載のデバイス。
(項目40)
前記複数のアームはそれぞれ、湾曲肘部分を備え、前記肘部分は内向き構成から外向き構成に、個々のアーム半径方向外向きに押勢するように構成される、項目1−6、9−11、または13のいずれかに記載のデバイス。
(項目41)
前記支持体は、縦軸を有し、前記湾曲肘部分は、前記縦軸に非平行な回転軸を中心として延在する、項目40に記載のデバイス。
(項目42)
前記湾曲肘部分は、送達カテーテルシースが、近位に引張され、前記複数のアームを露出させると、各アームの先端部分が、前記支持体から離れるように揺動されるような纏度を備え、前記纏度は、前記回転軸に非平行な第2の軸の周囲における前記先端部分の屈曲に対応する、項目41に記載のデバイス。
(項目43)
前記湾曲肘部分は、第1の回転軸を中心として、第1の方向に延在し、各個々のアームの端部における先端部分は、第2の回転軸を中心として、第2の方向に延在し、前記第1の回転軸は、前記第2の回転軸に非平行である、項目40に記載のデバイス。
(項目44)
前記湾曲肘部分は、前記支持体から離れるように、第1の方向に延在し、各個々のアームの端部における先端部分は、前記第1の方向から離れるように、第2の方向に延在する、最大寸法を備える、項目40に記載のデバイス。
(項目45)
前記湾曲肘部分は、前記支持体の下流端を越えて、下流方向に延在する、項目40に記載のデバイス。
(項目46)
前記湾曲肘部分は、送達カテーテルシースが、前記複数のアームにわたって留置されると、前記支持体の内部領域に向かって、内向きに偏向するように構成される、項目45に記載のデバイス。
(項目47)
前記複数のアームはそれぞれ、前記支持体の下流部分の近傍において、前記拡張可能支持体に連結された基部を含み、かつ前記基部から上流方向に配向された先端部分を含む、項目1−3、および6のいずれかに記載のデバイス。
(項目48)
前記複数のアームのうちの少なくとも1つは、前記先端部分が、前記弁輪に接触すると、前記基部から前記先端部分までの距離を変動させるための機構を備える、項目47に記載のデバイス。
(項目49)
前記拡張可能支持体は、上流部分と前記下流部分との間に延在する軸を備え、前記基部は、前記軸に沿った第1の場所に対応し、前記先端部分は、前記軸に沿った第2の場所に対応し、前記軸に沿った前記基部と前記先端部分との間の距離は、前記機構によって変動される、項目48に記載のデバイス。
(項目50)
前記機構は、前記支持体が、前記弁輪の下流の第1の位置から、前記アームのうちの少なくとも1つが、前記弁輪に係合する、第2の位置に移動されると、前記距離が、自動的に、変動されるように、自己調節式である、項目48に記載のデバイス。
(項目51)
前記機構は、バネ、スライダ、ハイポチューブ、伸縮自在継手、ベルト、ワイヤ、または前記複数のアームの偏向可能部分のうちの1つ以上を備える、項目48に記載のデバイス。
(項目52)
前記機構は、前記距離が、固定されるように、前記先端部分と前記弁輪の係合後、各アームに係止する、項目48に記載のデバイス。
(項目53)
前記機構は、血液への暴露に応答して、係止する、項目52に記載のデバイス。
(項目54)
前記機構は、前記先端部分を前記弁輪に向かって付勢するように構成される、項目48に記載のデバイス。
(項目55)
前記機構は、前記先端部分が、前記弁輪に係合すると、前記距離を短縮するように偏向されるように、前記先端部分の偏向可能部分を備える、項目48に記載のデバイス。
(項目56)
前記複数のアームのうちの少なくとも1つは、アーム長を変動させるための機構を備える、項目4または5のいずれかに記載のデバイス。
(項目57)
前記機構は、バネ、スライダ、ハイポチューブ、伸縮自在継手、ベルト、ワイヤ、または前記アームの偏向可能部分のうちの1つ以上を備える、項目56に記載のデバイス。
(項目58)
各個々のアームは、前記弁輪下表面に係合するために、上流方向に付勢される伸長湾曲先端部分を含み、各個々の湾曲先端部分は、前記デバイスが、前記天然弁領域に埋め込まれると、各個々のアームの長さが、相互のアームに対して変動するように、前記先端に沿って、可変長において、前記弁輪下表面に接触する、項目4に記載のデバイス。
(項目59)
前記複数のアームはそれぞれ、前記支持体から離れるように傾斜される、項目1−6、9−11、または13のいずれかに記載のデバイス。
(項目60)
前記複数のアームは、前記支持体の外側表面に対して、前記弁尖を圧縮し、前記支持体の下流移動を阻止するように構成される、項目1、2、3、または6のいずれかに記載のデバイス。
(項目61)
前記複数のアームのうちの少なくとも1つは、係留構造、返し、***、リッジ、陥凹、孔、摩擦強化カバーまたはコーティング、焼結、粗面化された表面、またはフックのうちの1つ以上を備え、前記弁尖に連結し、下流方向における前記支持体の移動を阻止する、項目1、2、3、6、または9のいずれかに記載のデバイス。
(項目62)
前記アームは、高密度のアームを有する、少なくとも2つの群において、前記支持体の周囲に配列され、前記2つの群は、低密度のアームを伴う、前記支持体の領域によって、相互から離間される、項目1−6、8−11、または13のいずれかに記載のデバイス。(項目63)
前記複数のアームは、前記拡張可能支持体の第1の側に位置し、前記弁輪の前方部分に係合する、第1のアーム群を含み、かつ前記拡張可能支持体の第2の側に位置し、前記弁輪の後方部分に係合する、第2のアーム群を含み、前記弁輪は、第1の軸に沿った短寸法と、前記第1の軸に横断する第2の軸に沿った長寸法とを備え、前記短寸法は、前記弁輪の前記前方部分と後方部分との間に延在する、項目1−3または6のいずれかに記載のデバイス。
(項目64)
前記第1および第2の群間の前記支持体の領域は、アームを含有しない、項目63に記載のデバイス。
(項目65)
前記支持体は、第3の側と、前記第3の側と反対の第4の側とを有し、前記第3および第4の側は、前記第1および第2の側間に点在され、前記第3および第4の側に沿って前記支持体に連結されるより多くの数のアームが、前記第1および第2の側のそれぞれに沿って前記支持体に連結される、項目63に記載のデバイス。
(項目66)
アームは、前記第3および第4の側の前記支持体には連結されない項目65に記載のデバイス。
(項目67)
前記弁は、僧帽弁であって、前記第3および第4の側は、概して、それぞれ、前記僧帽弁の前交連および後交連と整合するように構成される、項目65に記載のデバイス。
(項目68)
各アームは、前記弁輪に係合するように構成される、先端部分を有する、項目63に記載のデバイス。
(項目69)
付勢されていない外向き構成では、前記第1のアーム群の先端部分は、前記支持体の第1の側の第1の列に配列され、前記第2のアーム群の先端部分は、前記支持体の第2の側の第2の列に配列される、項目86に記載のデバイス。
(項目70)
前記拡張可能支持体は、上流部分と下流部分との間に延在する中心縦軸を備え、外向き構成では、前記第1の複数の先端部分は、前記中心縦軸から、前記第2の複数の先端部分より離れて配置される、項目86に記載のデバイス。
(項目71)
前記第1の複数の先端部分は、第1の弧に沿って配置され、前記第2の複数の先端部分は、第2の弧に沿って配置され、前記第1および第2の弧は、前記支持体の外側表面の曲率半径より大きい曲率半径を有する、項目70に記載のデバイス。
(項目72)
前記第1の複数の先端部分は、第1の略直線列に配置され、前記第2の複数の先端部分は、第2の略直線列に配列され、前記第1および第2の列は、実質的に、平行である、項目70に記載のデバイス。
(項目73)
前記第1のアーム群はそれぞれ、基部と、先端部分と、前記基部を前記先端部分に接続する肘部分とを含み、前記第1のアーム群は、延在角度によって、前記支持体の外側表面から分離され、前記延在角度は、前記支持体の外側表面からの距離の変動に伴って、各個々のアームの先端部分を前記支持体から離して配列する、項目63に記載のデバイス。
(項目74)
前記第1の複数のアームは、前記弁輪の第1の頂部分に連結するように構成され、前記第2の複数のアームは、前記弁輪の第2の頂部分に連結するように構成される、項目63に記載のデバイス。
(項目75)
前記複数のアームはそれぞれ、前記支持体内に搭載される弁に対する収縮期血圧の力下、前記弁輪に対する前記支持体の移動を阻止するために十分な柱強度を有する、項目1−3、6、9、または10のいずれかに記載のデバイス。
(項目76)
前記アームは、集合的に、前記支持体に対して上流方向に付与される少なくとも2lbfの力下、前記弁輪に対する前記支持体の移動を阻止するために十分な強度を有する、項目75に記載のデバイス。
(項目77)
前記拡張可能支持体は、軸を備え、前記拡張可能支持体は、送達構成および拡張された構成を備え、前記外側表面は、前記送達構成におけるより拡張された構成において、前記軸から離れ、前記複数のアームは、前記軸から離れるように延在する、項目1−3または6のいずれかに記載のデバイス。
(項目78)
前記拡張可能支持体は、複数の円周方向場所において、前記外側表面に沿って位置する複数のノードを備え、前記複数のアームは、前記複数のノードに連結され、前記複数のノードは、前記支持体が前記軸から半径方向外向きに拡張すると、隣接するアーム間の分離距離を増加させるように分離する、項目77に記載のデバイス。
(項目79)
前記拡張可能支持体は、送達カテーテルの管腔内への前記デバイスの留置のための送達構成と、僧帽弁内への留置のための拡張された構成との間で移動可能である、項目1−6または12のいずれかに記載のデバイス。
(項目80)
前記支持体の上流部分から延在し、弁輪上表面に係合する、フランジをさらに備える、項目1−13のいずれかに記載のデバイス。
(項目81)
前記支持体は、前記弁輪に対する下流方向における移動に抵抗するように成形される、項目1−3、6−10、または12のいずれかに記載のデバイス。
(項目82)
前記支持体は、前記支持体の上流端と下流端との間において、円錐形またはテーパ状である、項目81に記載のデバイス。
(項目83)
前記上流部分は、前記下流部分の外径より大きい外径を有する、項目4または5のいずれかに記載のデバイス。
(項目84)
1つ以上のアームは、僧帽弁輪に係合するように構成された先端であって、前記僧帽弁内に位置付けられると、前記僧帽弁輪が、先端とスカートとの間に位置付けられるような距離だけ、前記スカートから離間される、先端を有する、項目80に記載のデバイス。
(項目85)
前記スカートは、僧帽弁輪の心房側面に沿って延在し、前記複数のアームは、前記僧帽弁輪の心室側面に沿って延在する、項目80に記載のデバイス。
(項目86)
前記スカートは、血液が、前記心房から前記心室に、下流方向に流動するとき、前記支持体の移動に抵抗する、項目85に記載のデバイス。
(項目87)
封止部材が、前記支持体または前記アームのうちの少なくとも1つに連結され、前記天然弁または心臓弁の交連領域を通る血流を阻止するように、前記弁輪の長寸法に沿って延在するように構成される、項目1、2、6、または8−11のいずれかに記載のデバイス。
(項目88)
前記封止部材は、ポリマー、熱可塑性ポリマー、ポリエステル、合成繊維、繊維、テレフタル酸ポリエチレン(以下「PET」)、PTFE、またはDacronTMのうちの1つ以上を備える、項目87に記載のデバイス。
(項目89)
前記封止部材は、前記アームのうちの1つ以上に連結され、前記天然弁または心臓弁の心室側に位置付けられるように構成される、項目87に記載のデバイス。
(項目90)
前記拡張可能支持体は、前記弁輪下表面と係合された前記複数のアームが、前記第2の心臓内腔の収縮に応答して、前記拡張可能支持体の下流部分を内向きに押勢するとき、変形に抵抗するために十分なフープ強度を備える、項目4または5のいずれかに記載のデバイス。
(項目91)
前記支持体に連結された一時的弁をさらに備え、前記支持体はさらに、前記支持体が、天然弁場所に埋め込まれた後、置換弁を受容するように構成される、項目1−13のいずれかに記載のデバイス。
(項目92)
前記一時的弁は、前記置換弁が、前記支持体内に受容されると、前記支持体の内側壁に対して変位されるように適合される、項目91に記載のデバイス。
(項目93)
前記一時的弁は、可撤性弁を備え、前記置換弁は、前記一時的弁が除去された後、前記支持体内に固着される、項目91に記載のデバイス。
(項目94)
前記置換弁は、拡張可能フレームを備え、前記支持体は、前記拡張可能フレームの外側部分に連結するように構成される、前記支持体の内側部分上に保持構造物を備える、項目91に記載のデバイス。
(項目95)
前記一時的弁は、前記置換弁と前記支持体との間に狭入される、項目94に記載のデバイス。
(項目96)
前記一時的弁は、前記置換弁の外側表面と前記支持体の内側表面との間の血流を阻止する、項目95に記載のデバイス。
(項目97)
前記一時的弁は、前記置換弁の外側表面と前記支持体の内側表面との間の圧縮または摩擦を増加させる、項目95に記載のデバイス。
(項目98)
前記拡張可能フレームは、ステントを備える、項目94に記載のデバイス。
(項目99)
前記支持体の内側部分は、前記拡張可能フレームの外側部分に係合するように構成される、支材、***、リッジ、タブ、またはフックのうちの1つ以上を備える、項目94に記載のデバイス。
(項目100)
前記内側部分上の保持構造物は、摩擦によって、前記拡張可能フレームの外側部分に連結する、項目94に記載のデバイス。
(項目101)
前記一時的弁は、前記置換弁が、前記支持体に連結されると、前記置換弁が、実質的に、前記一時的弁の弁尖を変位させるように、前記置換弁を受容するように構成される、項目94に記載のデバイス。
(項目102)
前記支持体は、前記内側部分上に被覆を備え、前記被覆は、前記置換弁の拡張可能フレームが、前記1つ以上の弁尖に対して押勢されると、摩擦または圧縮のうちの1つ以上を提供するように十分な厚さを有する、項目101に記載のデバイス。
(項目103)
前記一時的弁は、前記置換弁の拡張可能フレームが、前記1つ以上の弁尖に対して押勢されると、前記置換弁との圧縮または摩擦のうちの1つ以上を増加させるように適合される、1つ以上の弁尖を備える、項目101に記載のデバイス。
(項目104)
前記置換弁は、前記置換弁の拡張可能フレームが、前記一時的弁の弁尖に対して押勢されると、摩擦または圧縮のうちの1つ以上を提供するように、十分な厚さを有する、前記外側部分にわたる被覆を備える、項目101に記載のデバイス。
(項目105)
前記弁尖のうちの1つ以上は、前記拡張可能支持体と前記置換弁の拡張可能フレームとの間に狭入されると、圧縮または摩擦のうちの1つ以上を増加させるように適合される、項目103に記載のデバイス。
(項目106)
前記置換弁は、拡張可能フレームを備え、前記拡張可能支持体は、前記拡張可能フレームを受容し、前記フレームが拡張されると、半径方向外向きに押勢されるように定寸され、前記拡張可能支持体は、前記拡張可能フレームの拡張に抵抗するように構成される、項目91に記載のデバイス。
(項目107)
前記拡張可能支持体は、前記拡張可能フレームに対して、半径方向内向きに指向された反跳力を提供し、前記拡張可能フレームは、前記支持体に対して、半径方向外向きに押動する、項目91に記載のデバイス。
(項目108)
前記支持体は、前記拡張可能フレームの内部で膨張されたバルーンによって拡張されると、前記拡張可能フレームとともに、半径方向外向きに拡張する、項目107に記載のデバイス。
(項目109)
前記拡張可能フレームの拡張後、前記支持体は、第1の量だけ、半径方向内向きに反跳し、前記フレームは、第2の量だけ、半径方向内向きに反跳し、前記第1の量は、前記第2の量を上回る、項目108に記載のデバイス。
(項目110)
前記支持体は、第1の支材配列、第1の支材寸法、第1の支材幾何学形状、または第1の支材材料のうちの1つ以上を備え、前記拡張可能フレームは、前記第1の支材配列、前記第1の支材寸法、前記第1の支材幾何学形状、または前記第1の支材材料のうちの1つ以上と異なる、第2の支材配列、第2の支材寸法、第2の支材配列、または第2の支材材料のうちの1つ以上を備え、前記拡張可能フレームの拡張後、前記支持体は、前記拡張可能フレームの第2の反跳力を上回る第1の反跳力において、半径方向内向きに反跳する、項目109に記載のデバイス。
(項目111)
前記支持体は、前記支持体の内部で拡張された拡張可能部材による拡張のために構成される、可鍛性材料を備える、項目1−13のいずれかに記載のデバイス。
(項目112)
前記可鍛性材料は、ステンレス鋼、コバルトクロム合金、L605、またはMP35Nのうちの1つ以上を備える、項目111に記載のデバイス。
(項目113)
前記支持体は、バルーンを受容するように定寸される、内部を備え、前記バルーンは、前記支持体を送達構成から拡張された構成に拡張させる、項目1−13のいずれかに記載のデバイス。
(項目114)
前記支持体は、弾性材料、形状記憶材料、超弾性材料、またはニッケルチタン合金のうちの1つ以上を備え、前記支持体は、拘束された状態から解放されると、送達構成から拡張された構成に自己拡張するように構成される、項目1−13のいずれかに記載のデバイス。
(項目115)
前記複数のアームは、可鍛性材料を備える、項目1−6、9−11、または13のいずれかに記載のデバイス。
(項目116)
前記複数のアームは、拘束された状態から解放されると、内向き構成から外向き構成に自己拡張するために十分に弾性の材料から成る、項目1−6、9−11、または13のいずれかに記載のデバイス。
(項目117)
前記支持体は、前記支持体の内部で拡張される拡張可能部材によって拡張されるように構成される、可鍛性材料を備える、項目116に記載のデバイス。
(項目118)
前記アームは、弾性材料、形状記憶材料、超弾性材料、またはニッケルチタン合金から選択される材料から作製される、項目116に記載のデバイス。
(項目119)
前記アームは、第1の材料から作製され、前記支持体は、前記第1の材料と異なる第2の材料から作製される、項目116に記載のデバイス。
(項目120)
前記複数のアームは、ステンレス鋼、コバルトクロム合金、L605、またはMP35Nのうちの1つ以上を備える、項目116に記載のデバイス。
(項目121)
前記複数のアームにわたって延在する被覆をさらに備え、前記被覆は、組織の内部成長を助長するための材料を備える、項目1−6、9−11、または13のいずれかに記載のデバイス。
(項目122)
前記被覆は、前記複数のアームにわたって延在するシースを備える、項目121に記載のデバイス。
(項目123)
前記被覆は、前記複数のアームにわたって延在する複数のシースを備え、各個々のシースは、個々のアームにわたって延在する、項目121に記載のデバイス。
(項目124)
前記被覆は、布地、繊維、合成繊維、ポリエステル布地、PTFE、またはDacronTMのうちの1つ以上を備える、項目121に記載のデバイス。
(項目125)
前記第1および第2の線は、実質的に、直線である、項目8に記載のデバイス。
(項目126)
前記第1および第2の線は、実質的に、前記弁輪の半径より大きい半径を伴う、曲率を有する、項目8に記載のデバイス。
(項目127)
患者の僧帽弁を治療する方法であって、前記僧帽弁は、弁輪および弁尖を有し、
前記弁輪内またはそれに隣接して、デバイスを埋め込むステップであって、前記デバイスは、複数のアームに連結された拡張可能支持体を備え、前記支持体は、前記弁尖間に配置され、前記複数のアームは、前記弁尖の背後の前記弁輪に係合する、ステップを含み、
前記デバイスは、項目1−126のいずれかに記載のデバイスを備える、方法。
(項目128)
前記弁尖は、前記複数のアームと前記拡張可能支持体との間に延在する、項目127に記載の方法。
(項目129)
前記僧帽弁は、前記弁尖に連結された複数の腱索を有し、前記方法はさらに、前記弁輪との係合に先立って、前記アームのそれぞれを前記腱索間に通過させるステップを含む、項目128に記載の方法。
(項目130)
前記埋込ステップは、
前記複数のアームが、前記弁尖の背後に延在し、前記弁輪に係合するように、前記複数のアームが、外向き構成に配置される、送達構成において、前記支持体を上流に移動させるステップと、
前記送達構成から、前記弁尖が、前記複数のアームと前記支持体との間に延在する、拡張された構成に、前記支持体を拡張させるステップと
を含む、項目127に記載の方法。
(項目131)
心エコー検査または蛍光透視法によって、前記複数のアームおよび前記僧帽弁を視認するステップと、
前記心エコー検査または蛍光透視法に基づいて、前記複数のアームを前記弁尖と整合させるステップと
をさらに含む、項目130に記載の方法。
(項目132)
前記複数のアームは、前記支持体の両側に、第1および第2の列に配列され、前記方法はさらに、前記第1の列を前記弁輪の前方部分に係合するように位置付けるステップと、前記第2の列を前記弁輪の後方部分に係合するように位置付けるステップとを含み、前記第1の列は、前記第2の列より多い数のアームを含む、項目130に記載の方法。
(項目133)
前記複数のアームは、マーカーの配向が、前記複数のアームの配向に対応するように、カテーテルのマーカーに連結され、
蛍光透視法によって、前記カテーテルのマーカーを視認するステップと、
前記マーカーに基づいて、前記複数のアームを前記弁尖と整合させるステップと、
前記複数のアームが、前記弁尖の背後に延在し、前記弁輪に係合するように、前記複数のアームが、外向き構成を備える、送達構成において、前記支持体を上流に移動させるステップと、
前記送達構成から、前記弁尖が、前記複数のアームと前記支持体との間に延在する、拡張された構成に、前記支持体を拡張するステップと
をさらに含む、項目127に記載の方法。
(項目134)
前記弁輪は、長前後軸および短中隔側方軸を備え、前記複数のアームは、前記長前後軸の両側に配列される、項目133に記載の方法。
(項目135)
弁は、前記拡張可能支持体に連結され、前記弁は、左心房から左心室への血流を可能にし、前記左心室から前記左心房への血流を阻止するように構成される、項目127に記載の方法。
(項目136)
前記複数のアームは、前記左心室が収縮すると、前記弁輪に係合することによって、前記左心房に向かっての前記支持体の移動を阻止し、前記弁は、前記左心室から前記左心房への血流を阻止する、項目135に記載の方法。
(項目137)
前記デバイスは、前記僧帽弁の埋込の間、カテーテルに連結される、項目127に記載の方法。
(項目138)
前記カテーテルは、右心房からの経中隔アプローチ、左心室切開または穿通を介した経心尖アプローチ、あるいは大動脈を通した経大動脈アプローチのうちの1つ以上によって送達される、項目137に記載の方法。
(項目139)
前記デバイスの埋込は、前記カテーテル上のシースを後退させ、前記複数のアームを暴露させるステップを含み、前記支持体は、暴露された前記複数のアームとともに、前記弁輪に向かって移動され、前記複数のアームを前記弁輪と係合させる、項目137に記載の方法。
(項目140)
前記アームが、前記弁輪に係合した後、さらに、前記僧帽弁において、前記拡張可能支持体を半径方向外向きに拡張させるステップを含む、項目138に記載の方法。
(項目141)
前記支持体に連結された一時的弁は、前記拡張可能支持体が拡張された後、起動される、項目140に記載の方法。
(項目142)
置換弁を前記支持体の内部に位置付けるステップと、前記支持体と係合するように、前記置換弁を拡張させるステップとをさらに含む、項目140に記載の方法。
(項目143)
置換弁を前記支持体の内部に位置付けるステップと、前記支持体と係合するように、前記置換弁を拡張させるステップとをさらに含み、前記一時的弁は、前記置換弁によって変位される、項目141に記載の方法。
(項目144)
前記置換弁は、カテーテルによって送達される、項目142または143のいずれかに記載の方法。
(項目145)
前記デバイスはさらに、前記支持体に連結された弁を備える、項目127に記載の方法。
(項目146)
前記デバイスが、前記僧帽弁に埋め込まれた後、弁を前記支持体に連結するステップをさらに含む、項目127に記載の方法。
(項目147)
カテーテルによって、前記弁を前記僧帽弁に送達するステップをさらに含む、項目146に記載の方法。
(項目148)
連結は、前記弁内のバルーンを拡張し、前記支持体と係合するように、前記弁を半径方向に拡張させるステップを含む、項目147に記載の方法。
(項目149)
前記アームが、前記弁輪に係合された後、前記拡張可能支持体を半径方向に拡張させるステップをさらに含む、項目127に記載の方法。
(項目150)
半径方向拡張は、前記拡張可能支持体の内部のバルーンを膨張させるステップを含む、項目149に記載の方法。
(項目151)
半径方向拡張は、前記複数のアームに対して、シースを後退させるステップを含み、前記アームは、半径方向外向き構成に自己拡張する、項目149に記載の方法。
(項目152)
前記複数のアームは、前記支持体に連結された基部と、前記弁輪に係合するための遠位先端とを有する、各個々のアームを含み、前記基部から前記遠位先端までの距離は、自動的に、種々の高度を有する前記弁輪の領域に係合するように調節される、項目127に記載の方法。
(項目153)
患者の僧帽弁を治療するためのシステムであって、前記僧帽弁は、弁輪を有し、
項目1−126のいずれかに記載のデバイスを備える、デバイスと、
前記デバイスをその中に保定するように構成される、管腔を有する、カテーテルと
を備える、システム。
(項目154)
天然僧帽弁場所における前記デバイスの留置後、前記デバイスに連結するように構成される、置換弁をさらに備える、項目153に記載のシステム。
(項目155)
前記置換弁に連結された送達カテーテルをさらに備える、項目154に記載のシステム。
(項目156)
前記カテーテルは、前記デバイスの拡張可能支持体を半径方向に拡張するように構成される、拡張可能部材を備える、項目154に記載のシステム。
(項目157)
前記カテーテルは、後退可能シースを備え、前記デバイスは、前記シース内に含有され、前記デバイスは、前記シースが後退されると、弾性的に拡張するように構成される、項目154に記載のシステム。
(項目158)
前記カテーテルはさらに、それにわたって前記シースが摺動可能である、管状部材を備え、前記管状部材は、前記シースが後退されると、前記デバイスに係合し、その位置を維持するように適合される、項目157に記載のシステム。
(項目159)
前記カテーテルは、膨張管腔を有する膨張管と、前記膨張管の遠位端に連結される膨張可能部材とを備え、前記膨張可能部材の内部は、前記膨張管腔と流体連通する、項目154に記載のシステム。
(項目160)
前記カテーテルは、ガイドワイヤを摺動可能に受容するように適合される、ガイドワイヤ管腔を備え、前記ガイドワイヤ管腔は、それを通して前記ガイドワイヤが、摺動可能に挿入され得る、近位および遠位ポートを有する、項目154に記載のシステム。
(項目161)
患者の心臓の天然弁に近接する場所に、治療デバイスを固着する方法であって、前記弁は、弁輪と、少なくとも第1および第2の弁尖とを有し、
前記第1の弁尖の遊離縁の周囲の前記治療デバイスの第1のアームを前記第1の弁尖の背後の第1の弁輪下空間内に通過させるステップと、
前記第2の弁尖の遊離縁の周囲の前記治療デバイスの第2のアームを前記第2の弁尖の背後の第2の弁輪下空間内に通過させるステップと、
前記弁尖の背後の前記弁輪の表面を前記第1および第2のアームと係合させ、前記天然弁に対して、上流方向における、前記治療デバイスの移動を阻止するステップと
を含み、前記デバイスは、項目1−126のいずれかに記載のデバイスを備える、方法。
図1および1Aは、心臓Hを示す。心臓は、身体から血液を受容し、身体から肺に血液を圧送する、右心房RAおよび右心室RVを備える。左心房は、肺静脈PVを介して、肺から酸素化血液を受容し、僧帽弁MVを通して、左心室LV内に本酸素化血液を圧送する。左心室LVは、大動脈弁AVを通して、大動脈内に血液を圧送し、そこから、血液が、身体全体にわたって流動する。
僧帽弁または他の房室弁へのアクセスは、経皮的様式において、患者の血管系を通して、達成されることができる。経皮的とは、心臓から遠隔の血管系の場所が、典型的には、例えば、Seldinger技法を通して、針アクセスを使用して等、外科的切開手技または低侵襲的手技を使用して、皮膚を通してアクセスされることを意味する。遠隔血管系に経皮的にアクセスする能力は、公知であって、特許および医療文献に説明されている。血管アクセス点に応じて、僧帽弁へのアプローチは、順行性であってもよく、心房中隔を交差することによる左心房内への進入に依拠してもよい。代替として、僧帽弁へのアプローチは、逆行性であることができ、左心室は、大動脈弁を通して進入される。経皮的アクセスが達成されると、介入ツールおよび支持カテーテルが、心臓へと血管内を前進され、本明細書に説明されるように、種々の様式において、標的心臓弁に隣接して位置付けられてもよい。
本明細書に説明されるような本技術の実施形態は、本明細書に説明される心臓の弁のうちの1つ以上を治療するために使用されることができ、僧帽弁、または他の実施形態では、大動脈弁の治療のために使用されることができる。
本技術の実施形態の前述の発明を実施するための形態は、包括的であること、または本技術を前述に開示された精密な形態に限定することを意図するものではない。本技術の具体的実施形態および実施例が、例証的目的のために前述されるが、種々の同等修正も、当業者が認識するであろうように、本技術の範囲内で可能である。例えば、ステップが、所与の順序で提示されるが、代替実施形態は、異なる順序でステップを行なってもよい。本明細書に説明される種々の実施形態はまた、さらなる実施形態を提供するように組み合わせられてもよい。
Claims (17)
- 天然心臓弁輪と天然心臓弁尖とを有する天然心臓弁を治療するための人工心臓弁デバイスであって、
拡張可能なフレームであって、前記拡張可能なフレームは、下流領域と上流領域とを有する第1の部分と、前記第1の部分の前記下流領域から上流方向に外向きに延在する第2の部分とを含み、前記第2の部分は、複数の伸長部材を含み、前記複数の伸長部材は、前記拡張可能なフレームが拡張された構成にあるとき、前記天然心臓弁尖の内側表面に対して力を付与するように構成されている、拡張可能なフレームと、
前記第1の部分の内部に付着された弁部材と、
前記第1の部分の前記下流領域に結合されたスカートであって、前記スカートは、前記上流方向に外向きに拡開し、前記スカートの上流領域は、前記第1の部分から外向きに離間され、前記スカートは、前記第1の部分の円周全体の周囲に延在し、前記スカートは、前記拡張可能なフレームの前記第2の部分の内側で上流方向に延在する、スカートと
を含む、デバイス。 - 前記弁部材は、三葉弁尖アセンブリを含み、前記三葉弁尖アセンブリは、下流方向における血流を可能にし、かつ、前記上流方向における血流を遮断するように構成されている、請求項1に記載のデバイス。
- 前記弁部材は、二葉弁尖アセンブリを含み、前記二葉弁尖アセンブリは、下流方向における血流を可能にし、かつ、前記上流方向における血流を遮断するように構成されている、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第1の部分は、円筒形である、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第2の部分は、前記天然心臓弁輪の拡張または歪曲に対応するように、前記拡張可能なフレームの前記第1の部分に対して内向きまたは外向きに偏向するように十分な可撓性を有する、請求項1に記載のデバイス。
- 前記スカートの形状を維持するために前記スカートに結合された1つ以上のワイヤをさらに含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第2の部分は、前記拡張可能なフレームの前記第1の部分から外向きに付勢される、請求項1に記載のデバイス。
- 前記拡張可能なフレームは、送達のための薄型外形から、前記天然心臓弁における埋め込みのための拡張された構成に拡張可能である、請求項1に記載のデバイス。
- 前記スカートは、前記天然心臓弁における前記人工心臓弁デバイスの埋め込みの際、前記人工心臓弁デバイスと前記天然心臓弁との間の血流を阻止するように構成されている、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第2の部分は、組織穿通要素を含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第2の部分は、返しを含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームの少なくとも一部は、被覆を含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームは、相互接続された支材を含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームは、支柱を含む、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第1の部分は、円形断面を有する、請求項1に記載のデバイス。
- 前記拡張可能なフレームの前記第1の部分は、卵形断面を有する、請求項1に記載のデバイス。
- 前記拡張可能なフレームは、自己拡張可能である、請求項1に記載のデバイス。
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