JP7159230B2 - 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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- JP7159230B2 JP7159230B2 JP2019572351A JP2019572351A JP7159230B2 JP 7159230 B2 JP7159230 B2 JP 7159230B2 JP 2019572351 A JP2019572351 A JP 2019572351A JP 2019572351 A JP2019572351 A JP 2019572351A JP 7159230 B2 JP7159230 B2 JP 7159230B2
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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
- A61F2/246—Devices for obstructing a leak through a native valve in a closed condition
-
- 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
- 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
- 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
- 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
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0006—Rounded shapes, e.g. with rounded corners circular
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
-
- 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
- A61F2250/0014—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
- A61F2250/0018—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
-
- 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119条(e)項に基づいて、2017年3月13日出願の米国仮特許出願第62/470,684号の優先権を主張し、上記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。
できる。いくつかの実施形態では、支柱430、530、630、730はC字形の曲線を含むことができる。いくつかの実施形態では、支柱430、530、630、730はS字形の曲線を含むことができる。いくつかの実施形態では、支柱430、530、630、730はL字形の曲線を含むことができる。
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
100 インプラント送達システム
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
400 接合補助要素
405 第1の表面
410 弁輪区画
415 第2の表面
420 弁輪ハブ
425 雄ねじ部分
430 支柱
435 弁輪アンカー部位
440 上縁部
450 接合補助要素本体カバー
455 縫合縁部
460 接合表面
465 フレーム
470 横縁部
475 横縁部
480 下縁部
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
525 雄ねじが切られた部分
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
625 雄ねじが切られた部分
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
725 雄ねじが切られた部分
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
802 クロスバー
805 肩部
810 窓
815 らせん構造
820 クロスピン
850 補助アンカー
852 らせん構造
854 先端
856 ハブ
858 噛合機構
860
862 トルク軸
864 管腔
866 らせん構造
868 係止ハブ
870 噛合機構
872 係止軸
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
1100 積層体
1102 後層
1104 第1の支持構造層
1106 第1の布地層
1108 第1の心室層
1110 アンカー層
1112 第2の支持構造層
1114 第2の心室層
1116 第3の支持構造層
1118 第2の布地層
1120 第4の支持構造層
1122 前層
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
1402 送達カテーテル
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
1700 経中隔シースイントロデューサ
1705 縁部
1710 多管腔カテーテル
1715 経中隔シース
1720 ハブ
1725 マーキング
1730 第1のガイドワイヤ
1735 第2のガイドワイヤ
1740 ドッキングチューブ
1745 アンカードライバ
1750 係留具レール
1755 第1のガイドレール
1760 第2のガイドレール
1765 遠位端
1770 補助アンカー
1775 ドライバ
1780 補助アンカー
1785 スネア
1790 補助アンカー
1795 追加の層
1800 インプラント送達システム
1805 ドッキングチューブ
1810 インプラントトルク軸
1815 スロット
1820 ピン
1825 ばね
1830 引っ張りワイヤ
1835 溝
1840 雌ねじが切られた部分
1845 ドライバ
1850 内部トルク軸
1855 係留具レール
1860 雄ねじが切られた部分
1865 雌ねじが切られた部分
1870 陥凹部
1875 肩部
1900 接合補助要素
1905 ドッキングチューブ
1910 インプラントトルク軸
1915 ハイポチューブ
1920 係留具
1945 ドライバ
1950 内部トルク軸
1955 係留具レール
1960 雄ねじが切られた部分
1970 陥凹部
2000 インプラント送達システム
2005 ドッキングチューブ
2010 インプラントトルク軸
2015 ドッキングエンドキャップ
2020 保定アーム
2025 窓
2030 タブ
2035 面
2045 ドライバ
2050 内部トルク軸
2055 係留具レール
2060 雄ねじが切られた部分
2065 雌ねじが切られた部分
2070 陥凹部
2100 インプラント送達システム
2105 ドッキングチューブ
2110 インプラントトルク軸
2115 ドッキングエンドキャップ
2120 スロット
2125 リンク
2130 保定ピン
2145 ドライバ
2150 内部トルク軸
2155 係留具レール
2160 雄ねじが切られた部分
2165 雌ねじが切られた部分
2170 陥凹部
2200 インプラント送達システム
2202 主要アンカーハウジング
2204 主要アンカードライバ
2206 解放ワイヤ
2208 解放ワイヤ
2210 スロット
2212 スロット
2214 スロット
2216 スロット
2220 補助アンカー
2222 補助アンカー
2224 補助アンカー
2226 補助アンカー
2230 補助アンカードライバ
2232 補助アンカードライバ
2234 補助アンカードライバ
2236 補助アンカードライバ
2240 補助アンカーガイドレール
2242 補助アンカーガイドレール
2244 補助アンカーガイドレール
2246 補助アンカーガイドレール
2250 補助アンカー係留具
2252 補助アンカー係留具
2254 補助アンカー係留具
2256 補助アンカー係留具
2260 ハブ
2262 延長部
2264 延長部
2270 らせん本体
2272 肩部
2274 窓
2276 細長い軸
2278 係止タブ
2280 補助アンカーガイドレールロック
2282 補助アンカー係留具ロック
2284 回転防止機構
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 (25)
- 第1の接合表面および反対側の第2の表面と、
第1の横縁部、第2の横縁部、下縁部、および上縁部と、
心臓弁の弁輪の面内にあるように構成された上側区域、ならびに前記第1の接合表面および前記反対側の第2の表面を備える下側区域と、
前記第1の横縁部、前記第2の横縁部、前記下縁部、および前記上縁部それぞれから内向きに離隔されたハブと、
前記ハブに結合するように構成され、能動アンカーを第1の標的位置で選択的に配備するために前記ハブに対して回転させられるように構成された、能動アンカーと、
前記ハブの周りで離隔されると共に前記ハブから外向きに延在する複数の支柱であって、少なくとも、前記第1の接合表面が前記心臓弁の第1の弁尖と接合し、前記反対側の第2の表面が前記心臓弁の第2の弁尖の上に重なるようにして、心臓内に埋め込まれるように構成された第1の支柱と、前記心臓内に埋め込まれるように構成された第2の支柱とを備え、
前記下側区域の厚さが前記上側区域の一部分の厚さよりも厚いように、前記下側区域が積層体を備える、心臓の心臓弁の接合不全を治療するための接合補助要素。 - 前記積層体がePTFEを含む、請求項1に記載の接合補助要素。
- 前記下側区域の前記厚さが、前記上側区域の前記一部分の前記厚さよりも少なくとも約25%厚い、請求項1に記載の接合補助要素。
- 前記下側区域の前記厚さが、前記上側区域の前記一部分の前記厚さよりも少なくとも約50%厚い、請求項1に記載の接合補助要素。
- 前記接合補助要素の周縁部が、前記接合補助要素の周りを部分的にのみ取り囲む隆起した非外傷性縁部を備える、請求項1に記載の接合補助要素。
- 前記接合補助要素の前記周縁部が、前記接合補助要素の前記下側区域のみを取り囲む隆起した非外傷性縁部を備える、請求項5に記載の接合補助要素。
- 前記隆起した非外傷性縁部が縫合糸を含む、請求項5に記載の接合補助要素。
- 前記接合補助要素の前記周縁部が、前記接合補助要素の上側区域のみの前記周縁部から径方向外向きに延在する離隔した返しを備える、請求項5に記載の接合補助要素。
- 前記接合補助要素がメッシュ層を含む、請求項1に記載の接合補助要素。
- 前記接合補助要素が少なくとも1つのePTFE層を備える、請求項1に記載の接合補助要素。
- 前記接合補助要素が少なくとも1つのUHMWPEメッシュ層を備える、請求項1から10のいずれか一項に記載の接合補助要素。
- 前記接合補助要素が少なくとも1つの布地層を備える、請求項1から11のいずれか一項に記載の接合補助要素。
- 前記接合補助要素が少なくとも1つのポリエステル布地層を備える、請求項1から12のいずれか一項に記載の接合補助要素。
- 前記第1の接合表面が補強された、請求項1から13のいずれか一項に記載の接合補助要素。
- 前記反対側の第2の表面が補強された、請求項1から14のいずれか一項に記載の接合補助要素。
- 心室表面が補強された、請求項1から15のいずれか一項に記載の接合補助要素。
- 接合表面が補強された、請求項1から16のいずれか一項に記載の接合補助要素。
- アンカー区域が補強された、請求項1から17のいずれか一項に記載の接合補助要素。
- 少なくとも1つの縁部が隆起した縁部を含む、請求項1から18のいずれか一項に記載の接合補助要素。
- 前記接合補助要素が後尖との接触を最小限に抑えるように構成された、請求項1から19のいずれか一項に記載の接合補助要素。
- 前記接合補助要素が前記弁輪を係合し前記弁輪内に埋め込まれるように構成された、請求項1から20のいずれか一項に記載の接合補助要素。
- メッシュを含む第1の支持構造層と、メッシュを含む第2の支持構造層とを更に備える、請求項1に記載の接合補助要素。
- 前記第2の支持構造層が、前記接合補助要素の一部分のみに沿って延在する、請求項22に記載の接合補助要素。
- 前記接合補助要素が2つ以上の層を含む、請求項1に記載の接合補助要素。
- X線不透過性マーカーを更に備える、請求項1に記載の接合補助要素。
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CN110913801A (zh) | 2020-03-24 |
JP2020512165A (ja) | 2020-04-23 |
EP3595587A1 (en) | 2020-01-22 |
CN114587711A (zh) | 2022-06-07 |
JP2022183234A (ja) | 2022-12-08 |
US20200397567A1 (en) | 2020-12-24 |
CN115040289A (zh) | 2022-09-13 |
US20180256318A1 (en) | 2018-09-13 |
CN110913801B (zh) | 2022-04-15 |
WO2018169878A1 (en) | 2018-09-20 |
US20190282358A1 (en) | 2019-09-19 |
US10123874B2 (en) | 2018-11-13 |
US20230404757A1 (en) | 2023-12-21 |
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US10702386B2 (en) | 2020-07-07 |
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