JP7335305B2 - 弁逆流の経カテーテル治療のためのデバイス、システム、および方法 - Google Patents
弁逆流の経カテーテル治療のためのデバイス、システム、および方法 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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- A61F2/24—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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- A61F2/02—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
- A61F2/2466—Delivery devices therefor
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- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0014—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
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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
- 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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- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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Description
本出願は、米国特許法第120条に基づいて、2016年5月12日出願の米国特許出願第15/153,480号の継続出願として優先権を主張する。また、該出願は、米国特許法第119条(e)項に基づいて、2015年11月6日出願の米国仮特許出願第62/252,336号の本出願としての利益を主張し、上記出願それぞれの開示全体を参照により本明細書に援用し、本明細書の一部とする。
環状区画および接合区画を備え、前記環状区画が弁輪の上方で心臓内に埋め込まれるように構成され、前記接合区画が弁輪の面を横断して心臓内に埋め込まれるように構成された、本体と、
第1の接合表面および対向する第2の表面であって、第1の横縁部、第2の横縁部、下縁部、および上縁部によってそれぞれ境界を定められ、前記上縁部が、リップを形成すると共に、前記下縁部に向かって下向きに、または前記環状区画から上向きにカップ状にされた、第1の接合表面および第2の表面と、
ハブおよびアンカーであって、アンカーがハブに結合されると共に前記環状区画によって保持され、アンカーが第1の標的位置で選択的に配備可能である、ハブおよびアンカーと、
前記ハブから径方向外向きに延在する複数の支柱であって、前記環状区画内に存在する第1の支柱と、前記環状区画から前記接合区画まで延在する第2の支柱とを少なくとも備え、前記第2の支柱が前記第1の支柱よりも長い全長を有する、複数の支柱とを備える、弁輪を有する心臓弁の接合不全を治療するための接合補助要素。
[第2項]
前記複数の支柱のうち少なくとも1つの支柱が、組織を係合するように構成された尖った先端を有する、第1項に記載の接合補助要素。
[第3項]
前記複数の支柱がニチノールを備える、第1項に記載の接合補助要素。
[第4項]
前記アンカーがらせん形状である、第1項に記載の接合補助要素。
[第5項]
1つ以上の追加のアンカーを更に備える、第1項に記載の接合補助要素。
[第6項]
前記1つ以上の追加のアンカーが能動アンカーである、第5項に記載の接合補助要素。
[第7項]
前記ハブが、前記アンカーのらせんを通って延在するように構成されたクロスピンを備える、第1項に記載の接合補助要素。
[第8項]
前記ハブが送達カテーテルと噛合するように構成され、前記送達カテーテルが前記第1の標的位置付近に前記ハブを位置付けるように構成された、第1項に記載の接合補助要素。
[第9項]
前記送達カテーテルが、前記ハブとは独立して前記アンカーを回転させるように構成された、第8項に記載の接合補助要素。
[第10項]
X線不透過性マーカーを更に備える、第1項に記載の接合補助要素。
[第11項]
前記上縁部付近に複数のX線不透過性マーカーを更に備える、第1項に記載の接合補助要素。
[第12項]
リップを形成する前記上縁部が前記下縁部に向かって下向きでカップ状にされる、第1項に記載の接合補助要素。
[第13項]
リップを形成する前記上縁部が前記環状区画から上向きでカップ状にされる、第1項に記載の接合補助要素。
[第14項]
前記ハブが前記環状区画から上向きに延在する、第1項に記載の接合補助要素。
[第15項]
前記下縁部が前記ハブに向かって後方に湾曲する、第1項に記載の接合補助要素。
[第16項]
心臓弁が弁輪を有し、前記弁輪が弁平面を更に規定し、前記弁平面が心房を近位側で、心室を遠位側で分離する、患者の心臓弁の接合不全を治療する方法であって、
送達カテーテルを接合補助要素のハブに結合するステップと、
前記ハブを前記弁輪付近に位置付けるステップと、
前記ハブを通してアンカーを回転させ、前記弁輪の遠位側まで心臓組織内に入れるステップと、
複数の支柱が前記ハブから径方向外向きに拡張するのを可能にすることによって、前記接合補助要素を拡張させるステップとを含む、方法。
[第17項]
接合表面が第1の弁尖と接合し、前記接合補助要素の弁尖表面が第2の弁尖の上に重なるようにして、前記接合補助要素が懸架され、それによって接合不全が軽減される、第16項に記載の方法。
[第18項]
前記複数の支柱のうち1つの支柱の尖った端部を、前記弁輪の遠位側の心臓組織と係合するステップを更に含む、第16項に記載の方法。
[第19項]
1つ以上のマーカーを用いて前記接合補助要素の位置を監視するステップを更に含む、第16項に記載の方法。
[第20項]
前記接合補助要素の上縁部付近の複数のマーカーを用いて、前記接合補助要素の位置を監視するステップを更に含む、第16項に記載の方法。
[第21項]
前記ハブを前記弁輪付近に位置付ける間、前記アンカーの先端が前記ハブ内に入り込んでいる、第16項に記載の方法。
12 前尖
14 後尖
16 接合区域
20 右心房
30 左心室
32 腱索
34 乳頭筋
36 乳頭筋
40 右心室
50 三尖弁
60 僧帽弁
70 肺動脈弁
80 大動脈弁
110 交連
114 交連
120 弁輪
124 線維三角
126 線維三角
128 中心線維体
160 横断面
215 索
220 動揺弁尖
230 心室収縮期
240 弁輪拡張
312 前尖
314 後尖
320 心室
330 乳頭筋
342 前尖
344 後尖
430 支柱
500 接合補助要素
505 第1の表面
510 環状区画
515 第2の表面
520 弁輪ハブ
530 支柱
535 弁輪アンカー部位
540 上縁部
545 弁尖アンカー部位
550 接合補助要素本体カバー
560 接合表面
565 フレーム
570 横縁部
575 横縁部
580 下縁部
585 バッキング
600 接合補助要素
610 環状区画
620 弁輪ハブ
630 支柱
640 上縁部
650 接合補助要素本体カバー
660 接合表面
670 横縁部
675 横縁部
680 下縁部
700 接合補助要素
705 第1の表面
710 環状区画
715 第2の表面
720 弁輪ハブ
730 支柱
735 弁輪アンカー部位
740 上縁部
750 弁体カバー
760 接合表面
770 横縁部
775 横縁部
780 下縁部
800 弁輪アンカー
805 肩部
810 窓
815 らせん構造
820 クロスピン
900 マーカー
1000 送達カテーテル
1001 先端偏向制御部
1002 ポート
1003 インプラント制御ノブ
1003a 矢印
1003b 矢印
1004 アンカー制御ノブ
1006 カテーテル軸
1007 インプラントインサータ
1010 巾着縫合糸
1200 ドライバ
1205 トルク軸
1210 ループ
1215 ピン
1220 トルク軸
1225 アンカードッキングキャップ
1230 突起
1235 ドライバ
1240 ワイヤ
1245 ワイヤ
1255 トルク軸
1260 ドライバ
1265 係止タブ
1270 張力クロスピン
1275 トルククロスピン
1300 先端、右心房
1320 左心房
1330 経中隔キット
1350 シース
1360 乳頭筋
1380 左心室
1400 経中隔シース
1420 中央ハブ
1440 左心室
1540 アンカートルク軸
1580 弁開口部
1600 シース
1620 周囲
1800 交連アンカー
A 寸法
A1 前尖の弁帆
A2 前尖の弁帆
A3 前尖の弁帆
B 寸法
BF 逆流
C 寸法
CA 弁輪中心
CL 接合区域
CO 開口部
D 寸法
D1 直径
E 寸法
FP 流路
L 長さ
P1 後尖の弁帆
P2 後尖の弁帆
P3 後尖の弁帆
W 幅
Claims (19)
- 弁輪と後尖および前尖を備える天然の弁尖とを有する心臓弁の接合不全を治療するためのシステムにおいて、
環状区画を備えた本体とハブとを備えた接合補助要素であって、
前記本体は、前記環状区画が弁輪の上方で心臓内に埋め込まれるように構成され、接合補助要素が展開されたときに、前記環状区画が、天然の弁尖の上に位置するように構成され、
前記本体は、後尖に向かって配置される第1の接合表面と、前尖に向かって配置される第2の表面とを備え、
前記本体は、第1の横縁部、第2の横縁部、下縁部、および上縁部をさらに備えており、
前記ハブは、前記第1の横縁部、第2の横縁部、下縁部、および上縁部のそれぞれから半径方向内側に間隔を置いて配置されている、
接合補助要素と、
前記ハブと結合するように構成されている送達カテーテルと、
を含んでなることを特徴とする、システム。 - アンカーをさらに含み、前記アンカーが前記ハブに対して回転するように構成されていることを特徴とする、請求項1に記載のシステム。
- 前記第2の表面が前尖と接合し、前記第1の接合表面が後尖の上に重なるようにして、前記接合補助要素が懸架され、それによって接合不全が軽減されていることを特徴とする、請求項1に記載のシステム。
- 前記ハブが、前記送達カテーテルと係合するための特徴を備えていることを特徴とする、請求項1に記載のシステム。
- 前記接合補助要素および前記送達カテーテルは除去可能に結合され、その結果、前記接合補助要素が、処置中に前記送達カテーテルから解放されるように構成されていることを特徴とする、請求項1に記載のシステム。
- 縫合糸を含む1つ以上の補助構造をさらに含むことを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルと共に配置されたドライバをさらに含むことを特徴とする、請求項1に記載のシステム。
- アンカーが、前記送達カテーテルと共に配置されたドライバに独立して結合されていることを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルが前記ハブの位置を保持している間に、アンカーが組織内に打ち込まれるように構成されていることを特徴とする、請求項1に記載のシステム。
- 前記ハブは、アンカーが回転されて組織と係合するときに静止したままであるように構成されていることを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルが、先端偏向制御部を備えていることを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルが、アンカー制御ノブを備えていることを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルの移動が前記接合補助要素の移動を引き起こすように、前記送達カテーテルは、前記ハブにロックするように構成されていることを特徴とする、請求項1に記載のシステム。
- 前記送達カテーテルと前記ハブとの間に解放メカニズムをさらに備えていることを特徴とする、請求項1に記載のシステム。
- 1つまたは複数の追加のアンカーをさらに備えていることを特徴とする、請求項1に記載のシステム。
- X線不透過性マーカーをさらに備えていることを特徴とする、請求項1に記載のシステム。
- 前記ハブと複数の支柱とが一体的に形成されていることを特徴とする、請求項1に記載のシステム。
- 前記ハブから半径方向外向きに延在する複数の支柱をさらに備えていることを特徴とする、請求項1に記載のシステム。
- 前記複数の支柱のうちの2つの支柱が異なる長さを有していることを特徴とする、請求項18に記載のシステム。
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US15/153,480 US9592121B1 (en) | 2015-11-06 | 2016-05-12 | Device, system, and method for transcatheter treatment of valvular regurgitation |
JP2018543021A JP6974335B2 (ja) | 2015-11-06 | 2016-11-02 | 弁逆流の経カテーテル治療のためのデバイス、システム、および方法 |
PCT/US2016/060094 WO2017079279A1 (en) | 2015-11-06 | 2016-11-02 | Device, system, and method for transcatheter treatment of valvular regurgitation |
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