JP6974335B2 - 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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- JP6974335B2 JP6974335B2 JP2018543021A JP2018543021A JP6974335B2 JP 6974335 B2 JP6974335 B2 JP 6974335B2 JP 2018543021 A JP2018543021 A JP 2018543021A JP 2018543021 A JP2018543021 A JP 2018543021A JP 6974335 B2 JP6974335 B2 JP 6974335B2
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2466—Delivery devices therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/064—Surgical staples, i.e. penetrating the tissue
- A61B2017/0649—Coils or spirals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
- A61F2220/0016—Fixation appliances for connecting prostheses to the body with sharp anchoring protrusions, e.g. barbs, pins, spikes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- 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
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。
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 (15)
- 弁輪を有する心臓僧帽弁の接合不全を治療するための接合補助要素(500、600、700)であって、
環状区画(510、610、710)および接合区画を備え、前記環状区画(510、610、710)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(560、660、760)および対向する第2の表面(505、705)であって、第1の横縁部(570、670、770)、第2の横縁部(575、675、775)、下縁部(580、680、780)、および上縁部(540、640、740)によってそれぞれ境界を定められた、第1の接合表面(560、660、760)および第2の表面(505、705)と、
ハブ(520、620、720)およびアンカー(800)であって、該アンカー(800)が該ハブ(520、620、720)に結合されると共に前記環状区画(510、610、710)によって保持され、該アンカー(800)が最初の標的位置に配置可能である、ハブ(520、620、720)およびアンカー(800)と、
前記ハブ(520、620、720)から径方向外向きに延在する複数の支柱(530、630、730)であって、前記環状区画(510、610、710)内に存在し、前記ハブ(520、620、720)で終端する一端と前記上縁部(540、640、740)に向かって半径方向外向きに延在する他端を有する第1の支柱と、前記ハブ(520、620、720)で終端する一端と前記下縁部(580、680、780)に向かって半径方向外向きに延在する他端を有する第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(530、630、730)と、
を備えていることを特徴とする、接合補助要素(500、600、700)。 - 複数の前記支柱(530、630、730)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していることを特徴とする、請求項1に記載の接合補助要素(500、600、700)。
- 複数の前記支柱(530、630、730)がニチノールを備えていることを特徴とする、請求項1または2に記載の接合補助要素(500、600、700)。
- 前記アンカー(800)がらせん形状であることを特徴とする、請求項1〜3のいずれか一項に記載の接合補助要素(500、600、700)。
- 1つ以上の追加のアンカーを更に備えていることを特徴とする、請求項1〜4のいずれか一項に記載の接合補助要素(500、600、700)。
- 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ていることを特徴とする、請求項1〜5のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記ハブ(520、620、720)が送達カテーテル(1000)と噛合するように構成され、前記送達カテーテル(1000)が最初の標的位置付近に前記ハブ(520、620、720)を配置するように構成されていることを特徴とする、請求項1〜6のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記送達カテーテルが、前記ハブ(520、620、720)とは独立して前記アンカー(800)を回転させるように構成されていることを特徴とする、請求項7に記載の接合補助要素(500、600、700)。
- X線不透過性マーカー(900)を更に備えていることを特徴とする、請求項1〜8のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記上縁部(540、640、740)付近に複数のX線不透過性マーカー(900)を更に備えていることを特徴とする、請求項1〜9のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記上縁部(540、640、740)がリップを形成していることを特徴とする、請求項1〜10のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記ハブ(520、620、720)が前記環状区画(510、610、710)から上向きに延在していることを特徴とする、請求項1〜11のいずれか一項に記載の接合補助要素(500、600、700)。
- 複数の前記支柱(530、630、730)が、前記ハブ(520、620、720)の外周の周りに等間隔で配置されていることを特徴とする、請求項1〜12のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記ハブ(520、620、720)が中立の中央に配置されていることを特徴とする、請求項1〜13のいずれか一項に記載の接合補助要素(500、600、700)。
- 前記ハブ(520、620、720)が、前記上縁部(540、640、740)と前記第1の接合表面(560、660、760)との間に配置されていることを特徴とする、請求項1〜14のいずれか一項に記載の接合補助要素(500、600、700)。
Priority Applications (1)
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JP2021176431A JP7335305B2 (ja) | 2015-11-06 | 2021-10-28 | 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 |
Applications Claiming Priority (5)
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US201562252336P | 2015-11-06 | 2015-11-06 | |
US62/252,336 | 2015-11-06 | ||
US15/153,480 US9592121B1 (en) | 2015-11-06 | 2016-05-12 | Device, system, and method for transcatheter treatment of valvular regurgitation |
US15/153,480 | 2016-05-12 | ||
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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JP2021176431A Division JP7335305B2 (ja) | 2015-11-06 | 2021-10-28 | 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 |
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JP2018532556A JP2018532556A (ja) | 2018-11-08 |
JP2018532556A5 JP2018532556A5 (ja) | 2019-12-12 |
JP6974335B2 true JP6974335B2 (ja) | 2021-12-01 |
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JP2021176431A Active JP7335305B2 (ja) | 2015-11-06 | 2021-10-28 | 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 |
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US (4) | US9592121B1 (ja) |
EP (2) | EP4176843A1 (ja) |
JP (2) | JP6974335B2 (ja) |
CN (2) | CN113974907A (ja) |
CA (1) | CA3004418C (ja) |
ES (1) | ES2940414T3 (ja) |
WO (1) | WO2017079279A1 (ja) |
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EP3007652A2 (en) | 2013-06-14 | 2016-04-20 | Hazu GmbH | Method and device for treatment of valve regurgitation |
US10166098B2 (en) | 2013-10-25 | 2019-01-01 | Middle Peak Medical, Inc. | Systems and methods for transcatheter treatment of valve regurgitation |
ES2908178T3 (es) | 2014-06-18 | 2022-04-28 | Polares Medical Inc | Implantes de válvula mitral para el tratamiento de la regurgitación valvular |
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EP3160396B1 (en) | 2014-06-24 | 2022-03-23 | Polares Medical Inc. | Systems for anchoring an implant |
US9592121B1 (en) | 2015-11-06 | 2017-03-14 | Middle Peak Medical, Inc. | Device, system, and method for transcatheter treatment of valvular regurgitation |
US20200146854A1 (en) | 2016-05-16 | 2020-05-14 | Elixir Medical Corporation | Methods and devices for heart valve repair |
US11419719B2 (en) | 2017-02-06 | 2022-08-23 | Mtex Cardio Ag | Methods and systems for assisting or repairing prosthetic cardiac valves |
US10441266B2 (en) * | 2017-03-01 | 2019-10-15 | 4Tech Inc. | Post-implantation tension adjustment in cardiac implants |
US10478303B2 (en) | 2017-03-13 | 2019-11-19 | Polares Medical Inc. | Device, system, and method for transcatheter treatment of valvular regurgitation |
CN110913801B (zh) * | 2017-03-13 | 2022-04-15 | 宝来瑞斯医疗有限公司 | 用于治疗心脏的心脏瓣膜的不良对合的对合辅助元件及用于输送其的系统 |
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ES2940414T3 (es) | 2023-05-08 |
EP3370650B1 (en) | 2022-12-21 |
US9592121B1 (en) | 2017-03-14 |
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CN113974907A (zh) | 2022-01-28 |
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