JP7247132B2 - 弁膜逆流の治療のための僧帽弁インプラント - Google Patents
弁膜逆流の治療のための僧帽弁インプラント Download PDFInfo
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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
- A61F2/2466—Delivery devices therefor
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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
-
- A—HUMAN NECESSITIES
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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
- A61F2/2442—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
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- A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
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- A61B2017/044—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors with a threaded shaft, e.g. screws
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- A61B2017/0446—Means for attaching and blocking the suture in the suture anchor
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- A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
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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
- 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
Description
図6Aを参照すると、小口径の操縦可能なカテーテル600が例示されている。いくつかの実施形態において、操縦可能なカテーテル600のハンドル610の口径615は、操縦可能なカテーテル600の本体部605の口径620に等しいか、または実質的に等しいものとしてよい。操縦可能なカテーテル600は、その中にプルワイヤ625を有することができる。ハンドル610が、たとえば、矢印632の方向に回転させられると、操縦可能なカテーテル600の遠位部分は、矢印635に沿って真っ直ぐな位置630から湾曲した位置640まで移動する。湾曲した位置640は、本明細書で説明されているように心室突出部625を位置決めするのに役立ち得る。ハンドル610が、たとえば、矢印632の反対方向に回転させられると、操縦可能なカテーテル600の遠位部分は、湾曲した位置640から真っ直ぐな位置630まで移動する。操縦可能なカテーテル600の真っ直ぐな位置630は、点線で示されており、同様に点線で示されているプルワイヤ625と混同しないようにされたい。真っ直ぐな位置630は、解剖学的構造からの操縦可能なカテーテル600の挿入または引き込みに役立ち得る。
次に、図7Aを参照して、送達用カテーテル700について説明される。送達用カテーテル700の機能は、接合補助デバイス500を心臓に運ぶ機能である。送達用カテーテル700のシャフト本体部710は、トルクを加えることができ、偏向可能であるものとしてよい。シャフト本体部710は、クロスハッチ線で示されている。送達用カテーテル700は、ハンドル730を備えることができる。ハンドル730は、回転機構、たとえば、プルワイヤなどを有することができる。回転機構は、シャフト本体部710を偏向させ、操縦することができる。ハンドル730の遠位に、本明細書において説明されているように接合補助デバイス500を心臓に運ぶことができるインプラントシース725がある。いくつかの実施形態において、インプラントシース725のなおいっそう離れた遠位に、剥がせる漏斗720がある。剥がせる漏斗720は、接合補助デバイス500の折り畳みを円滑にすることができる。いくつかの実施形態において、シャフト本体部720の最も遠い遠位端は、シャフト本体部710を接合補助デバイス500に係止して、接合補助デバイス500が心臓に輸送され、適切に留置されるようにできる特徴部を有する。次に、係止プロセスおよび特徴部について図7B、図7C、および図7Dに関して説明される。
図8A~図8Dは、送達の方法を示している。いくつかの方法において、インプラントシース725および漏斗720は前進させられて、接合補助デバイス500上に送られる。送達用カテーテル700が接合補助デバイス500とともに係止された後に、インプラントシース725および漏斗720は前進させられて接合補助デバイス500上に送られ得る。漏斗720の形状は、接合補助デバイス500が閉じるか、またはそれ自体の上に折り畳まれるのを補助する。インプラントシース725および漏斗720が前進する様子は、図8Aおよび図8Bに示されている。図8Aの矢印760は、接合補助デバイス500が漏斗720内にどのように引き込まれるかを示している。接合補助デバイス500が、インプラントシース725内に入った後、漏斗720は取り出される。いくつかの実施形態において、漏斗720は、タブ715を引っ張ることによって取り出され、それによって、図8Cに示されている、漏斗720を分割する。次いで漏斗720およびタブ715は破棄してよい。いくつかの方法において、接合補助デバイス500を収容するインプラントシース725は前進させられてガイドワイヤまたは操縦可能なカテーテル600上に送られるものとしてよい。繰り返すと、操縦可能なカテーテル600の設計の利点は、接合補助デバイス500がハンドル610および本体部605の異なるサイズの口径による不都合を生じることなく操縦可能なカテーテル上に滑らかに滑空することができるので明らかである。インプラントシース725は、図8Dに示されているように経中隔シース650内に挿入され得る。
接合補助デバイス500が開いた後に、方法は、僧帽弁の心房面上、すなわち、僧帽弁輪上に接合補助デバイス500を固定するステップを含み得る。次にいくつかの実施形態で、固定を行うための方法およびシステムについて説明する。
いくつかの実施形態は、交連固定を例示している。そのような一実施形態は、図9Aに示されている。送達用カテーテル700(図示せず)は、引っ込められており、アンカーカテーテル900は前進させられて、大腿アクセス部に通されている。アンカーカテーテル900は、トルクをかけることができる。1つまたは複数のアンカーカテーテル900が備えられ得る。アンカーカテーテル900の遠位先端部は、アンカーの送達中にアンカーを適所に係止するための1つまたは複数の特徴部を有し得る。図9Aにおいて、遠位先端部は、螺旋状アンカー915の一部を受け入れることができる切欠905を有する。アンカーカテーテル900は、中心ピン920も有し得る。中心ピン920は、先の尖った端部を遠位先端部に有し得る。いくつかの実施形態において、中心ピン920は、引っ込めることができるものとしてよい。
図10Aは、別の実施形態における代替的な固定技術を示している。この実施形態では、送達用カテーテル1000は、複数の内腔1040を有し得る。送達用カテーテル1000は、図10Bに示されているような断面を有するものとしてよい。内腔1040は、個別のトルクをかけることができる駆動シャフトを運ぶことができる。各駆動シャフトは、シャフト1020および1030の場合のようにアンカー上に、またはシャフト1010について示されているように環状ハブ510上に係止され得る。各トルクをかけることができるシャフト1010、1020、1030は、図9Aに例示されているアンカーカテーテル900の設計を有することができる。送達用カテーテル1000は、ガイドワイヤまたは操縦可能なカテーテル600が通過できる中心内腔1050を有し得る。複数のトルクをかけられる駆動シャフト1010、1020、1030、ガイドワイヤまたは操縦可能なカテーテル600は接合補助デバイス500とともにすべて、経中隔シース内に入る前に送達用カテーテル1000のインプラントシース内に装填され、引っ込められ得る。この配置構成全体は、前進させられ、本明細書で説明されているのと同じ手順に従って、接合補助デバイス500を留置することができる。この配置構成の有利な側面は、固定プロセスが、アンカーカテーテルを複数回引っ込める必要なく実行され、アンカーを再装填し身体に再入することができるという点である。
本明細書ではいくつかのアンカーについて説明されているが、他の代替的実施形態も企図される。図11Aは、引っ掛けフックを備えるアンカーを示している。図11Bは、傘に似たアンカーを示している。両方の実施形態において、アンカーは、形状記憶材料から作られ得る。両方の実施形態において、アンカーは、図11Cに例示されている送達用カテーテルなどの送達用カテーテル内に装填され得る。
図5A~図5Fで説明されている接合補助デバイス500は、支持構造体505を備え得る。支持構造体505は、本明細書で説明されているような形状記憶材料から作られ得る。接合補助デバイスのいくつかの実施形態において、別の構成が企図される。この構成は、心臓内に接合補助デバイスを留置した後に支持構造体が取り除かれることを指示するために棘状突起部のない接合補助デバイスと呼ばれ得る。両方の種類の接合補助デバイスが、いくつかの利点を有し得る。棘状突起部のない接合補助デバイスは、構成要素および材料が少なく、可能な金属疲労もないので、有利であり得る。
図13Aおよび図13Bは、接合補助デバイス1200の送達手順を例示している。図13Aは、図12の接合補助デバイス1200を示している。図13Aは、追加の特徴部、アンカー部位1300を示している。このアンカー部位1300について、以下でより詳しく説明する。
図14Aは、接合補助デバイス1200を固定するための一実施形態を示している。植え込み後に支持構造体1210.1、1210.2、1210.3などの剛構造体が存在し得ないので、接合補助デバイス1200は、追加のアンカーを必要とし得る。いくつかの実施形態において、接合補助デバイスは、密集したアンカーを利用することができる。いくつかの実施形態において、接合補助デバイス1200は、本明細書で説明されている、支持構造体505を備える類似の接合補助デバイスよりも追加の、密集したアンカーを利用し得る。図14Aは、接合補助デバイス1200と組織を結合するために使用され得る、アンカー1400の一実施形態を示している。図14Bは、別の実施形態を示している。図14Bにおいて、接合補助デバイス1200を組織に「縫い付ける」ために縫合糸またはテープ1410が使用される。縫合糸またはテープ1410は、限定はしないが、ポリプロピレンまたはナイロンを含む、複数の材料のうちの1つから作られ得る。次に、複数のアンカーが留置される仕方を説明するいくつかの実施形態が、本明細書において説明される。
図17Aは、棘状突起部のない接合補助デバイス1800の別の実施形態を例示している。この実施形態において、支持構造体1810は、心室突出部1820を下へ横断するのみであるものとしてよい。チューブまたは通路1830は、接合補助デバイス1800の環状縁の周りに存在し得る。支持構造体1810を利用して接合補助デバイス1800の形状を維持する代わりに、アンカーカテーテル1850が、図17Bに示されているようにチューブ1830内に挿入され得る。図17Bにおいて、アンカーカテーテル1850は、偏向可能なアンカーカテーテルとすることができる。
12 前尖
14 後尖
16 接合ゾーン
20 右心房
30 左心室
32 腱索
34、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、114 交連
120 線維性弁輪
124 左(外側)線維性三角
126 右(中隔)線維性三角
128 中心線維体
160 横断面
215 腱索
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
500 接合補助デバイス
505 支持構造体
505.1 第2のセクション
505.2 第1のセクション
510 ハブ
512 クロスピン
515 接合補助本体部
520 ミシン目、スロット、交連孔
525 心室突出部
530 遠位端
535 第1の接合面
540 第2の接合面
545 上縁
546 リブ
550.1 断面
550.2 断面
550.3 断面
550.4 断面
550.5 断面
555.1 遠位端
555.2 遠位端
555.3 遠位端
555.4 遠位端
555.5 遠位端
560 チューブ
565.1 チューブ
565.2 チューブ
600 小口径の操縦可能なカテーテル
605 本体部
610 ハンドル
612 エクステンション
615 口径
620 口径
625 プルワイヤ
630 真っ直ぐな位置
632 矢印
635 矢印
640 湾曲した位置
650 経中隔シース
655 左心房
660 左心室
665 僧帽弁の後尖
670 僧帽弁の前尖
700 送達用カテーテル
705 遠位係止タブ
710 シャフト本体部
715 タブ
720 剥がせる漏斗
725 インプラントシース
730 ハンドル
740 ポケット
745 クロスピン
750 ワイヤまたは縫合糸
755 ループ
760 矢印
765 腱索
800 アンカー
805 肩部
810 窓
815 螺旋状構造体
900 アンカーカテーテル
905 切欠
910 ループ
915 螺旋状アンカー
917 クロスバー
920 中心ピン
1000 送達用カテーテル
1010 シャフト
1020 シャフト
1030 シャフト
1040 内腔
1050 中心内腔
1200 棘状突起部のない接合補助デバイス
1210 チューブまたは通路
1210.1、1210.2、1210.3 支持構造体
1212 チューブまたは通路
1212 心室突出部
1220 構造体
1220 棘状ハブ
1300 アンカー部位
1310 シャフト
1320 送達用カテーテル
1330 ハブ係止特徴部
1335 出口開口
1340 インプラント導入器
1350 角度付き側部ポート
1360 漏斗
1370 ハンドル
1400 アンカー
1410 縫合糸またはテープ
1500 アンカーカテーテル
1510 アンカー
1510.1 アンカー
1510.2 アンカー
1520 中心シャフト
1540 バネ
1550 コイルセクション
1560 アンカーヘッド
1570 先の尖った端部
1600 アンカーカテーテル
1605 ハウジング
1610 アンカー
1620 ねじ山
1630 中心シャフト
1635 中心縫合糸
1640 ボール
1645 組織
1700 アンカーカテーテル
1710 アンカー
1710.1 第1のアンカー
1710.2 第2のアンカー
1720 縫合糸
1740 側部開口
1750 プッシャーチューブ
1760 矢印
1800 棘状突起部のない接合補助デバイス
1810 支持構造体
1820 心室突出部
1830 チューブまたは通路
1850 アンカーカテーテル
1860 アンカー部位
1860.1 第1の部位、第1のアンカー配置
1860.2 第2のアンカー配置
Claims (12)
- ハブ、及び、前記ハブの周りに離隔された支持構造体の複数のセクションを備えるインプラントであって、前記ハブ及び前記支持構造体の複数のセクションは一体的に形成され、前記インプラントは、僧帽弁の後尖の上に位置するように構成される、インプラントと、
組織アンカーと、
前記インプラントを心臓に送達するように構成された送達用カテーテルと、
を備え、
前記送達用カテーテルと前記ハブとは直接結合して、回転及び軸方向の動きについて前記送達用カテーテル及び前記インプラントを一時的に係止することができるように構成されていることを特徴とする固定システム。 - 前記組織アンカーは、前記ハブによって送達されることを特徴とする請求項1に記載の固定システム。
- 追加的なアンカーをさらに備えることを特徴とする請求項1または2に記載の固定システム。
- 前記支持構造体の複数のセクションは、形状記憶材料を備え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固定システム。
- 前記送達用カテーテルは、トルクをかけることができ、かつ、偏向可能であ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固定システム。
- 前記インプラントは、送達のために畳まれるように構成され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固定システム。
- 前記インプラントが開くと、前記インプラントは、形状記憶材料の形状をと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固定システム。
- 前記インプラントは、組織に係合するための受動的フックをさらに備えることを特徴とする請求項1~7のいずれか一項に記載の固定システム。
- 交連固定をさらに備え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固定システム。
- 前記組織アンカーは、X線透視マーカーを備え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固定システム。
- 経中隔シースをさらに備え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固定システム。
- 前記組織アンカーは、前記インプラントが前記送達用カテーテルに結合される際、前記インプラントに事前に装填され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固定システム。
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ES2908178T3 (es) | 2022-04-28 |
US20150366666A1 (en) | 2015-12-24 |
EP3157469A4 (en) | 2018-03-14 |
US10500048B2 (en) | 2019-12-10 |
EP3157469A1 (en) | 2017-04-26 |
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