JP2014521446A - 人工心臓弁のためのデリバリーシステム - Google Patents
人工心臓弁のためのデリバリーシステム Download PDFInfo
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Images
Classifications
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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
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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
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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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- A61M25/10184—Means for controlling or monitoring inflation or deflation
Abstract
Description
補綴
この説明のために、本開示の実施形態のいくつかの態様、利点、および新規な特徴を本明細書において説明する。開示する方法、装置、およびシステムは、いかなる形であれ限定的と解釈されるべきではない。代わりに、本開示は、単独で、ならびに互いとのさまざまな組み合わせおよび副組み合わせにおける、種々の開示されている実施形態のあらゆる新規な自明でない特徴および態様を対象とする。方法、装置、およびシステムは、いかなる具体的な態様または特徴またはそれらの組み合わせに限定されず、開示される実施形態は、任意の1つまたは複数の具体的な利点が存在するまたは問題を解決することを必要としない。
12 人工心臓弁
14 ガイドカテーテル
16 バルーンカテーテル
20 ハンドル部分
22 ガイドチューブ、シャフト、ガイドカテーテルシャフト
24 近位部分
26 外側バルーンカテーテルシャフト
27 サイドアーム
28 バルーン
32 ノーズピース、ノーズコーン
34 内側シャフト
36 近位端部分
38 管腔
46 遠位ハンドル部分
48 近位ハンドル部分
50 撓曲作動部材
52 インジケータピン
54 ハウジング、本体
56 調整ノブ
58 シャフト
62 雄ネジ付き表面部分、雄ネジ式部分
64 スリーブ、基部部分
66 長手方向スロット
68 操縦可能区間、摺動ナット
70 内側スリーブ
72 ネジ付き摺動ナット
74 両方向矢印
76 ナットガイド
78 プルワイヤ
80 ピン、外側ハウジング
82 スロット、調整機構
84 調整ノブ
86 シャフト
88 内側支持部
90 内側シャフト
92 遠位端部分
94 雌ネジ
96 近位端部分
98 固着機構
100 プッシャ要素
102 コレット
104 遠位端部分
106 近位端部分
108 管腔
110 スロット
112 可撓性指部
114 テーパ付き端表面、テーパ付き表面
120 装着領域
122 遠位端
124 装着部材
124a 第1の区間
124b 第2の区間
124c 第3の区間
124d 第4の区間
124e 第5の区間
126 近位ノーズコーン部分
126 テーパ付き部材
128 矢印
130 スロット
140 装着部材
142 内壁
144 外壁
146 リブ
148 空間
150 調整ノブ
152 内側ナット
154 ワッシャ
156 リング
158 ばね
160 プッシャ要素
162 内側ネジ
164 シャフト
166 遠位端部分
168 突出部
170 突出部
172 半環状部分、半環状壁
174 溝
176 インジケータリング
178 インジケータタブ
180 壁端部
182a 印
182a 第1の印
182b 第2の印
200 バルーンカテーテル
202 人工弁
204 バルーンカテーテルシャフト
206 バルーンアセンブリ
208 内側バルーン
210 外側バルーン
212 矢印
300 デリバリーシステム
302 バルーンカテーテル
304 イントロデューサ
306 ローダ
308 ハンドル
310 外側フラッシュシャフト
312 関節動作式メインシャフト、バルーンカテーテルシャフト
313 内側シャフト
314 バルーン
316 ノーズコーン
318 プッシャ要素、止め具部材
320 止め具部材
322 イントロデューサハウジング
324 遠位シース
326 弁
328 近位キャップ
330 保持アーム
332 ハンドル
334 シャフト
336 摺動機構
338 ねじりばね
340 近位ラック歯車
342 遠位ラック歯車
344 近位平歯車
346 遠位平歯車
348 近位クラッチ
350 遠位クラッチ
352 アクチュエータ
354 アーム
356 近位リング
358 遠位リング
360 コイルばね
362 歯
364 ネジ付きナット
364a ネジ付きナット、近位ナット
364b ネジ付きナット、遠位ナット
366 平面
368 下部ハウジング区間、下部ハウジング部分
370 上部ハウジング区間、上部ハウジング部分
370a ハウジング区間
370b ハウジング区間
374 矢印
376a アーム
376b アーム
380 フランジ
382 スロット
400 ハンドル
402 ハウジング
402a 半分
402b 半分
404a 回転可能ノブ
404b ノブ
406 シャフト
408 歯
410 中空シリンダ
412 歯
414 雌ネジ
416a 近位ネジ付きナット
416b 遠位ネジ付きナット
418 レール
420 平面
422 プッシャ作動機構
424 リンケージアーム
426 近位ホルダ
500 ハンドル
502 ハウジング
504 第1の遠位ハウジング部分
506 第2の遠位ハウジング部分
508 第1の近位ハウジング部分
510 第2の近位ハウジング部分
512 近位シリンダ
514 遠位シリンダ
516 近位ナット
518 遠位ナット
520 レール
522 回転可能ノブ
600 送達装置
602 イントロデューサ
604 ローダ
606 ハンドル
608 操縦可能シャフト、外側シャフト、バルーンカテーテルシャフト
610 内側シャフト
612 膨張可能バルーン
614 近位止め具部材
616 ノーズコーン
618 遠位止め具部材
620 近位端部分、端部部分
622 近位端部分
624 遠位端部分
626 遠位端部分
628 近位端部分、円錐状部材、近位止め具部材
630 遠位端部分、遠位部材、円錐状部材、遠位止め具
632 スロット
634 ハウジング
636 ネジ付きシャフト
638 ネジ付きナット
640 フランジ
642 回転可能ノブ
644 プルワイヤ
646 開口
650 イントロデューサハウジングアセンブリ
652 シース
654 弁、内部シール部材
656 遠位キャップ
658 近位キャップ
660 遠位ローダアセンブリ
662 近位ローダアセンブリ
664 ローダチューブ
666 遠位ローダキャップ、ローダ遠位キャップ
668 ローダハウジング
670 ボタン弁、ボタン
672 ワッシャ
674 円板弁、シール部材
676 近位ローダキャップ
678 ルアー付きポート
680 雌ネジ
682 雄ネジ
684 環状リップ
686 環状リング
688 突出部
690 開口
692 開口
694 リブ付き部分
694 第2のリブ付き部分
696 係合部分
700 人工心臓弁
702 ステント、フレーム
704 弁尖構造
Claims (21)
- 身体内での補綴デバイスの移植のための送達デバイスであって、前記補綴デバイスは半径方向に圧縮された状態から半径方向に拡張された状態へと半径方向に拡張可能であり、前記送達デバイスは、
膨張可能なバルーンと、
前記補綴デバイスが前記バルーン上に前記半径方向に圧縮された状態で近位止め具と遠位止め具との間に装着される間、前記バルーンに対する前記補綴デバイスの長手方向の移動を制限するように構成された近位止め具および遠位止め具と
を備え、
前記近位止め具および前記遠位止め具がそれぞれ、前記バルーンの中に位置決めされ且つ前記補綴デバイスが前記近位止め具と前記遠位止め具との間で半径方向に圧縮されると前記補綴デバイスのそれぞれの端部に隣接して位置決めされるように構成された端部部分を備え、前記端部部分のそれぞれが、前記それぞれの止め具の前記端部部分を半径方向に圧縮して直径を小さくすることを可能にした少なくとも1つの長手方向に延びたスロットを備えている、送達デバイス。 - 各止め具端部部分内の前記少なくとも1つの長手方向に延びたスロットが、バルーン膨張流体を、前記それぞれの止め具を通して半径方向に流れさせるように構成されている、請求項1に記載の送達デバイス。
- 前記補綴デバイスが前記送達デバイス上に前記半径方向に圧縮された状態で装着されたとき、前記近位止め具および前記遠位止め具が、バルーン膨張流体を前記バルーンの近位部分から前記近位止め具内の前記少なくとも1つのスロットを通らせ、前記補綴デバイス内に位置決めされた前記バルーンの中間部分を通過させ、前記遠位止め具内の前記少なくとも1つのスロットを通らせ、前記バルーンの遠位部分へと流れ込ませるように構成されている、請求項2に記載の送達デバイス。
- 前記バルーンの近位端が前記近位止め具に取り付けられ、前記バルーンの遠位端が前記遠位止め具に取り付けられている、請求項1に記載の送達デバイス。
- 前記送達デバイスが、管腔を有する外側シャフトと、前記外側シャフトの前記管腔を通って延びた内側シャフトと、をさらに備え、前記近位止め具が、前記外側シャフトの遠位端に取り付けられ、且つ/または前記内側シャフトの外表面に取り付けられ、前記遠位止め具が前記内側シャフトの外表面に取り付けられている、請求項1に記載の送達デバイス。
- 前記近位止め具が、
前記外側シャフトの前記遠位端に、且つ前記バルーンの近位端に取り付けられた近位部分と、
前記近位部分と前記端部部分との間の中間部分であって、前記近位部分の外径よりも小さく且つ前記端部部分の前記直径よりも小さい外径を有する中間部分と
をさらに備えている、請求項5に記載の送達デバイス。 - 前記近位止め具が前記外側シャフトの前記遠位端に取り付けられ、膨張流体を前記少なくとも1つの通路を通って前記バルーン内へと流れ込ませる少なくとも1つの流体通路をさらに備えている、請求項5に記載の送達デバイス。
- 前記遠位止め具が、
前記バルーンの遠位端に取り付けられた遠位部分と、
前記遠位部分と前記端部部分との間の中間部分であって、前記遠位部分の外径よりも小さく且つ前記端部部分の前記直径よりも小さい外径を有する中間部分と
をさらに備えている、請求項5に記載の送達デバイス。 - 各止め具の前記端部部分が、前記補綴デバイスから離れるように延びた方向において直径が減少する、請求項1に記載の送達デバイス。
- 前記送達デバイスが、前記遠位止め具の遠位端に取り付けられたノーズコーンをさらに備えている、請求項1に記載の送達デバイス。
- 前記止め具端部部分のうちの少なくとも1つが、前記補綴デバイスが前記送達デバイス上に圧着されたとき前記止め具端部部分を半径方向に圧縮して直径を小さくすることを可能にした少なくとも3つの長手方向スロットを備えている、請求項1に記載の送達デバイス。
- 前記バルーン上において前記近位止め具と前記遠位止め具との間に圧着された人工心臓弁と組み合わされた、請求項1に記載の送達デバイス。
- 心臓の中に人工心臓弁を移植する方法であって、
送達デバイスの遠位端部分を心臓の自己大動脈弁内に導入する段階であって、前記送達デバイスの遠位端部分が、膨張可能なバルーンと、前記バルーン内に少なくとも部分的に位置決めされた近位止め具および遠位止め具と、前記バルーン上において前記近位止め具と前記遠位止め具との間に半径方向に圧縮された状態で装着された半径方向に拡張可能な人工心臓弁と、を備えている、段階と、
前記バルーンを膨張させて前記自己大動脈弁の中で前記人工心臓弁を半径方向に拡張する段階であって、前記バルーンを、前記近位止め具および前記遠位止め具を通して半径方向に流れる膨張流体によって膨張させる、段階と、
前記バルーンを収縮させる段階と、
心臓から前記送達デバイスを引き込む段階と、
を含んでいる方法。 - 前記近位止め具が前記人工心臓弁の近位端に隣接して位置決めされ、前記遠位止め具が前記人工心臓弁の遠位端に隣接して位置決めされ、したがって、前記補綴デバイスが、前記送達心臓弁の心臓内への導入中に前記近位止め具と前記遠位止め具との間において長手方向に収容される、請求項13に記載の方法。
- 前記バルーンを膨張させる段階が、前記膨張流体を、
前記近位止め具内の第1の通路を通らせて、前記バルーンの近位部分へと流れ込ませ、
前記バルーンの前記近位部分から、前記近位止め具内の第2の通路を通らせて、前記補綴デバイス内の前記バルーンの中間部分内へと流れ込ませ、
前記バルーンの前記中間部分から、前記遠位止め具内の通路を通らせ、前記バルーンの遠位部分内へと流れ込ませる
段階を含んでいる、請求項13に記載の方法。 - 前記送達デバイスを心臓に導入する段階の前に、前記近位止め具および前記遠位止め具を同時に半径方向に圧縮しながら、前記人工心臓弁を送達デバイス上で前記半径方向に圧縮された状態に圧着する段階をさらに含んでいる、請求項15に記載の方法。
- 前記人工心臓弁が前記半径方向に圧縮された状態において第1の外径を有し、前記近位止め具および前記遠位止め具が前記圧着中に第2の外径からほぼ前記第1の外径に圧縮される、請求項16に記載の方法。
- 前記圧着の後で圧縮圧力が開放されると、前記近位止め具および前記遠位止め具がほぼ前記第1の外径からほぼ前記第2の外径に弾性的に拡張する、請求項17に記載の方法。
- 送達デバイスの前記遠位端部分を心臓の前記自己大動脈弁内に導入する段階が、送達デバイスの前記遠位端部分を患者の胸部の切開部を通して挿入して心臓に到達する段階を含んでいる、請求項13に記載の方法。
- 補綴デバイスを患者へと送達するためのシステムであって、
患者に部分的に挿入されるように構成されたイントロデューサシースと、
前記イントロデューサシースの近位端に挿入されるように構成されたローダと、
前記患者内に移植されるべき補綴デバイスを付けた前記患者へと、前記ローダおよび前記イントロデューサシースを通過するように構成された送達デバイスと
を備え、
前記ローダが、流体を前記ローダ内に選択的に導入するためのフラッシュポートと、前記ローダ内から流体を選択的に放出するための放出ポートと、を備え、前記フラッシュポートと前記放出ポートの両方が、弾性的に可撓性の環状シール部材によって封止されている、システム。 - 前記シール部材が、前記放出ポートを通って半径方向に延びたプッシュタブを備え、したがって、前記放出ポートが、前記半径方向内側方向に前記プッシュタブを押し下げることによって選択的に開放されるように構成されている、請求項20に記載のシステム。
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