JP6987927B2 - 人工心臓弁用の送達システム - Google Patents
人工心臓弁用の送達システム Download PDFInfo
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- JP6987927B2 JP6987927B2 JP2020109774A JP2020109774A JP6987927B2 JP 6987927 B2 JP6987927 B2 JP 6987927B2 JP 2020109774 A JP2020109774 A JP 2020109774A JP 2020109774 A JP2020109774 A JP 2020109774A JP 6987927 B2 JP6987927 B2 JP 6987927B2
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- 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
- A61F2/48—Operating or control means, e.g. from outside the body, control of sphincters
- A61F2/484—Fluid means, i.e. hydraulic or pneumatic
-
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies 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
- 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
- A61F2002/9583—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
- A61F2002/9586—Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve the means being inside the balloon
-
- 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
- A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
-
- 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
- A61F2250/0021—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 coefficient of friction
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1011—Multiple balloon catheters
- A61M2025/1013—Multiple balloon catheters with concentrically mounted balloons, e.g. being independently inflatable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1084—Balloon catheters with special features or adapted for special applications having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1018—Balloon inflating or inflation-control devices
- A61M25/10184—Means for controlling or monitoring inflation or deflation
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Cardiology (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Transplantation (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Surgical Instruments (AREA)
Description
[付記項1]
半径方向に圧縮可能および拡張可能な人工心臓弁を心臓の本来の心臓弁に植え込む送達装置であって、
近位端部分および遠位端部分を含む細長いシャフトと、
前記シャフトの前記遠位端部分に取り付けられる膨張可能バルーンと、
前記バルーン内の前記シャフトの前記遠位端部分に設けられる弁取付部材であって、前記人工心臓弁が、前記バルーン上に半径方向に圧縮された状態で取り付けられると共に前記取付部材を包囲するときに、前記人工心臓弁と前記バルーンの間の摩擦係合を容易にするように構成される弁取付部材と
を備え、前記取付部材が、長手方向に延びる少なくとも1つの流体通路を備え、前記バルーン中の膨張流体は前記流体通路を通って流れることができる送達装置。
[付記項2]
前記取付部材が、前記シャフトに固定されたコイル状ワイヤを備え、前記少なくとも1つの流体通路が、前記コイル状ワイヤの管腔から構成される、付記項1に記載の送達装置。
[付記項3]
前記コイル状ワイヤが、第1のセクションと、第2のセクションと、前記第1のセクションおよび第2のセクションの中間の第3のセクションとを備え、前記第1のセクションおよび第2のセクションのコイルが、前記第3のセクションのコイルのピッチより大きいピッチを有する、付記項2に記載の送達装置。
[付記項4]
前記取付部材が、前記シャフトに取り付けられた内壁と、前記内壁から半径方向に間隔をおいて配置された外壁とを備え、前記少なくとも1つの流体通路が、前記内壁と前記外壁の間に画定された少なくとも1つの管腔を備える、付記項1に記載の送達装置。
[付記項5]
前記取付部材を包囲する圧着状態の前記バルーン上に取り付けられた人工心臓弁と組み合される送達装置であって、
前記少なくとも1つの流体通路が、前記人工心臓弁の第1の端部および第2の端部にそれぞれ隣接した第1の開口部および第2の開口部を有し、前記バルーン中の膨張流体が、前記人工弁の前記第1の端部に対して近位の前記バルーンの第1の領域から、前記第1の開口部を通じて内側に向かって、前記流体通路を通り、前記第2の開口部を通じて外側に向かって、前記人工弁の前記第2の端部に対して遠位の前記バルーンの第2の領域の中に流れることを可能にする、付記項1に記載の送達装置。
[付記項6]
半径方向に圧縮可能および拡張可能な人工心臓弁を心臓の本来の心臓弁に植え込む送達装置であって、
ハンドル部分と、
前記ハンドル部分から延び、前記ハンドル部分に結合された近位端部分および半径方向に圧縮された状態で人工心臓弁を取り付けるように構成される遠位端部分を備える細長いシャフトと、
前記シャフトの前記近位端部分に設けられた摺動部材と
を備え、
前記ハンドル部分が、回転部材を備え、この回転部材が、前記回転部材の回転に基づいて前記摺動部材の平行運動を引き起こさせるように前記摺動部材に動作可能に結合されており、
前記シャフトに設けられると共に、前記シャフトを前記摺動部材に結合するシャフト係合部材をさらに備え、
前記シャフト係合部材が、前記シャフトが前記摺動部材および前記回転部材に対して長手方向に自由に移動できる第1の状態と、前記シャフト係合部材が前記シャフトに摩擦係合すると共に、前記摺動部材に対して前記シャフトの回転移動および長手方向移動を防ぐ第2の状態との間で操作されるように構成されており、前記回転部材の回転によって前記摺動部材および前記シャフトの対応する長手方向の移動を引き起こすようになっている送達装置。
[付記項7]
前記シャフト係合部材がコレットを含む、付記項6に記載の送達装置。
[付記項8]
前記回転部材が、使用者によって係合可能な回転ノブを含む、付記項6に記載の送達装置。
[付記項9]
前記摺動部材に結合された回転ノブをさらに備え、前記ノブが第1の位置と第2の位置との間で回転可能であり、前記ノブが前記第1の位置にあるとき、前記シャフト係合部材が、前記シャフトを前記第1の状態に摩擦保持するようにさせられ、前記ノブが前記第2の位置にあるとき、前記シャフト係合部材が、前記シャフトを解放する、付記項6に記載の送達装置。
[付記項10]
前記ノブと前記シャフト係合部材の間で前記シャフトに設けられた付勢部材をさらに備え、前記ノブが前記第1の位置にあるとき、前記付勢部材が、前記シャフト係合部材に前記シャフトを前記第1の状態に摩擦保持させる付勢力を与え、前記ノブが前記第2の位置にあるとき、前記シャフト係合部材に対しての前記付勢力が減少させられ、前記シャフト係合部材が前記シャフトを解除する、付記項9に記載の送達装置。
本説明のために、本開示の本実施形態のいくらかの態様、利点、および新規な特徴が、本明細書に記載されている。開示した方法、装置、およびシステムは、形はどうであれ限定として解釈されるべきではない。そうではなく、本開示は、単独ならびに互いの様々な組み合せおよびサブコンビネーションで、様々な開示した実施形態の全ての新規かつ自明でない特徴および態様に向けられている。この方法、装置、およびシステムは、任意の特定の態様または特徴あるいはその組み合せに限定されず、開示した実施形態は、何らかの1つまたは複数の特定の利点が存在し、または課題が解決されることを必要ともしない。
10’ 送達デバイス
12 人工心臓弁、人工弁、圧着式弁、ノブ
14 操作可能ガイドカテーテル、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、ハンドル
22 細長いガイドチューブまたはシャフト、ガイドカテーテルシャフト、ガイドチューブ、シャフト
24 近位部分
26 シャフト
27 サイドアーム
28 膨張可能バルーン、バルーン
32 ノーズ部品、ノーズコーン、ノーズコーン
34 内側シャフト、シャフト
36 近位端部分
38 管腔
46 遠位ハンドル部分、ハンドル部分、近位ハンドル部分
48 近位ハンドル部分
50 曲がり活性化部材
52 インジケータピン
54 円筒形本体またはハウジング、ハウジング、本体
56 調整ノブ、ノブ
58 シャフト
60 雌ねじ
62 雄ねじ付き表面部分、雄ねじ付き部分
64 ベース部
66 長手方向スロット、スロット
68 操作可能セクション
70 内側スリーブ、スリーブ
72 ねじ付き摺動ナット、摺動ナット
74 両矢印
76 細長いロッドまたはピン、ナットガイド
78 引張りワイヤ
80 外側ハウジング、ハウジング
82 調整機構
84 調整ノブ
86 シャフト
88 内側支持体
90 内側シャフト
92 遠位端部分
94 雌ねじ
96 近位端部分、遠位端部分
98 保証機構
100 プッシャ要素
102 コレット
104 遠位端部分
106 拡大近位端部分、近位端部分
108 管腔
110 軸方向に延びる周方向に間隔をおいて配置される スロット
112 可撓性フィンガ、フィンガ
114 テーパ状端面、テーパ状表面
120 取付領域
122 遠位端
124 取付部材
124a 第1のセクション
124b 第2のセクション
124c 第3のセクション
124d 第4のセクション
124e 第5のセクション
126 近位部分、テーパ状部材、ノーズコーン部分
130 スロット
140 取付部材
142 円筒形内壁、内壁
144 円筒形外壁
146 角度的に間隔をおいて配置されたリブ
148 空間
150 調整ノブ、ノブ
152 インナナット、ナット
154 ワッシャ
156 リング
158 コイルばね、ばね
160 プッシャ要素
162 雌ねじ
164 近位シャフト
166 拡大した遠位端部分、遠位端部分
168 周方向に間隔をおいて配置される突出部、突出部
170 半径方向に延びる突出部
172 半環状部分、半環状部分
174 溝
176 インジケータリング
178 インジケータタブ
180 一端、他端、壁端
182a 第1のしるし
182b 第2のしるし、しるし
200 バルーンカテーテル
202 人工弁
204 シャフト
206 バルーン組立体
208 内側バルーン
210 外側バルーン
300 送達システム
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、外側シャフト
312 関節式メインシャフト、関節式シャフト、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 膨張可能バルーン、バルーン
316 ノーズコーン
318 プッシャ要素、ストップ部材
320 ストップ部材
322 イントロデューサハウジング、ハウジング
324 遠位外筒
326 弁
328 近位キャップ
330 保持アーム
332 ハウジング、ハンドル
334 シャフト
336 摺動機構
338 ばね、ねじりばね
340 近位ラック歯車、ラック歯車
342 遠位ラック歯車、ラック歯車
344 近位平歯車、平歯車
346 遠位平歯車、平歯車
348 近位クラッチ、クラッチ
350 遠位クラッチ、クラッチ
352 使用者によって係合可能な アクチュエータ、アクチュエータ
354 細長いアーム、アーム
356 近位リング
358 遠位リング
360 コイルばね
362 歯
364 ナット、ねじ付きナット
364a ねじ付きナット、近位ナット
364b ねじ付きナット、遠位ナット
366 平坦部
368 下側ハウジングセクション、下側ハウジング部分
370 上側ハウジングセクション、上側ハウジング部分
370a ハウジングセクション
370b ハウジングセクション
376a 一方のアーム
376b 別のアーム
380 半径方向に延びるフランジ
382 細長いスロット、スロット
400 ハンドル
402 ハウジング
402a 半体
404a ホイールまたは回転ノブ、ノブ
404b ホイールまたは回転ノブ、ノブ
406 シャフト
408 歯車の歯
410 回転可能な中空のシリンダ、シリンダ
411 雌ねじ
412 雄の歯車の歯、歯車の歯
416a 近位ねじ付きナット、ナット
416b 遠位ねじ付きナット、ナット
418 レール
420 平坦部
422 プッシャ作動機構、作動機構
424 連結アーム
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、シリンダ
514 遠位シリンダ、シリンダ
516 近位ナットおよび遠位ナット、ナット
518 近位ナットおよび遠位ナット、ナット
520 レール
522 使用者によって係合可能な回転ノブ、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 操作可能シャフト、外側シャフト、バルーンカテーテルシャフト、シャフト
610 内側シャフト
612 膨張可能バルーン、バルーン
614 近位肩部またはストップ部材、近位ストップ部材、近位止め部
616 ノーズコーン
618 遠位肩部またはストップ部材、遠位ストップ部材
620 近位端部分、端部分
622 近位端部分、近位端
624 遠位端部分、遠位端
626 遠位端部分
628 遠位端部分、円錐形部材、近位部材、部材、近位ストップ部材
630 近位端部分、円錐形部材、遠位部材、部材、遠位止め部
632 スロット
634 ハウジング
636 ねじ付きシャフト、シャフト
638 ねじ付きナット、ナット
640 フランジ
642 使用者によって係合可能な, 回転ノブ、ノブ
644 引張りワイヤ
646 開口部
650 イントロデューサハウジング組立体、ハウジング組立体、イントロデューサハウジング、イントロデューサハウジング
652 外筒
654 弁、封止部材
656 遠位キャップ
658 近位キャップ
660 遠位ローダ組立体
662 近位ローダ組立体
664 ローダチューブ
666 ローダ遠位キャップ、遠位ローダキャップ、キャップ
668 ローダハウジング、ハウジング
670 ボタン弁、弁、ボタン
672 ワッシャ
674 円板弁、封止部材
676 近位ローダキャップ
678 ルアーポート、ポート
680 雌ねじ、ねじ
682 雄ねじ、ねじ
684 唇部
686 エラストマーの 環状リング、リング
688 使用者によって係合可能な 突出部、突出部
690 開口部
692 別の開口部、開口部
694 第1および第2のリブ部
696 第1および第2の反り可能な係合部分、係合部分
700 人工心臓弁、心臓弁、人工弁
702 フレームまたはステント、フレーム
704 弁膜構造
Claims (14)
- 体内に人工器官(12)を移植するための送達装置(600)であって、前記人工器官(12)が、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に半径方向に拡張可能とされる、前記送達装置(600)において、
前記送達装置(600)が、
膨張可能バルーン(612)と、
近位ストップ部材(614)及び遠位ストップ部材(618)であって、前記人工器官(12)が、前記半径方向に圧縮された状態において、前記近位ストップ部材(614)と前記遠位ストップ部材(618)との間に且つ前記膨張可能バルーン(612)を覆うように取り付けられている際に、前記近位ストップ部材(614)と前記遠位ストップ部材(618)とが、前記膨張可能バルーン(612)に対する前記人工器官(12)の長手方向移動を制限するように構成されており、前記人工器官(12)が、近位端と遠位端とを有している、前記近位ストップ部材(614)及び前記遠位ストップ部材(618)と、
を備えており、
前記近位ストップ部材(614)と前記遠位ストップ部材(618)とがそれぞれ、前記膨張可能バルーン(612)の内部に位置決めされている端部分(628,630)を備えており、前記端部分(628,630)が、前記人工器官(12)が前記近位ストップ部材(614)と前記遠位ストップ部材(618)との間において半径方向に圧縮されている場合に、前記人工器官(12)の前記近位端及び前記遠位端それぞれに隣り合って位置決めされるように構成されており、前記端部分(628,630)それぞれが、少なくとも1つの長手方向に延在しているスロット(632)を備えており、前記スロット(632)が、前記近位ストップ部材(614)及び前記遠位ストップ部材(618)それぞれの前記端部分(628,630)を半径方向に圧縮させることができ、
前記近位ストップ部材(614)が、前記人工器官(12)の前記近位端に当接するように構成されており、前記遠位ストップ部材(618)が、前記人工器官(12)の前記遠位端に当接するように構成されていることを特徴とする送達装置(600)。 - 前記端部分(628,630)それぞれの少なくとも1つの長手方向に延在している前記スロット(632)が、バルーン膨張流体を前記近位ストップ部材(614)及び前記遠位ストップ部材(618)それぞれを通じて半径方向に流すように構成されていることを特徴とする請求項1に記載の送達装置(600)。
- 前記人工器官(12)が前記半径方向に圧縮された状態で前記送達装置(600)に取り付けられている場合に、前記近位ストップ部材(614)と前記遠位ストップ部材(618)とが、前記近位ストップ部材(614)の少なくとも1つの前記スロット(632)を通じて、前記人工器官(12)の内部に位置決めされた前記膨張可能バルーン(612)の中間部分を通じて、及び前記遠位ストップ部材(618)の少なくとも1つの前記スロット(632)を通じて、前記膨張可能バルーン(612)の近位部分から前記膨張可能バルーン(612)の遠位部分に、バルーン膨張流体を流すように構成されていることを特徴とする請求項2に記載の送達装置(600)。
- 前記膨張可能バルーン(612)の近位端が、前記近位ストップ部材(614)に取り付けられており、
前記膨張可能バルーン(612)の遠位端が、前記遠位ストップ部材(618)に取り付けられていることを特徴とする請求項1に記載の送達装置(600)。 - 前記送達装置(600)が、管腔を有している外側シャフト(608)と、前記外側シャフト(608)の前記管腔を通じて延在している内側シャフト(610)とを備えており、
前記近位ストップ部材(614)が、前記外側シャフト(608)の遠位端に取り付けられており、及び/又は、前記内側シャフト(610)の外面に取り付けられており、
前記遠位ストップ部材(618)が、前記内側シャフト(610)の外面に取り付けられていることを特徴とする請求項1に記載の送達装置(600)。 - 前記近位ストップ部材(614)が、
前記外側シャフト(608)の前記遠位端に、及び、前記膨張可能バルーン(612)の近位端に取り付けられている近位端部分(620)と、
前記近位端部分(620)と前記端部分(628,630)との間に配置された中間部分であって、前記近位端部分(620)の外径より小さく、且つ、前記端部分(628,630)の直径より小さい外径を有している前記中間部分と、
を備えていることを特徴とする請求項5に記載の送達装置(600)。 - 前記近位ストップ部材(614)が、前記外側シャフト(608)の前記遠位端に取り付けられており、
前記近位ストップ部材(614)が、少なくとも1つの流路を備えており、
バルーン膨張流体が、少なくとも1つの前記流路を通じて前記膨張可能バルーン(612)の内部に向かって流れることを特徴とする請求項5に記載の送達装置(600)。 - 前記遠位ストップ部材(618)が、
前記膨張可能バルーン(612)の遠位端に取り付けられている遠位端部分(626)と、
前記遠位端部分(626)と前記端部分(628,630)との間に配置された中間部分であって、前記遠位端部分(626)の外径より小さく、且つ、前記端部分(628,630)の直径より小さい外径を有している前記中間部分と、
を備えていることを特徴とする請求項5に記載の送達装置(600)。 - 前記近位ストップ部材(614)及び前記遠位ストップ部材(618)それぞれの前記端部分(628,630)の直径が、前記人工器官(12)から離隔する方向において減少していることを特徴とする請求項1に記載の送達装置(600)。
- 前記送達装置(600)が、前記遠位ストップ部材(618)の遠位端に取り付けられているノーズコーン(616)を備えていることを特徴とする請求項1に記載の送達装置(600)。
- 前記端部分(628,630)のうち少なくとも1つの端部分が、少なくとも3つの長手方向に延在している前記スロット(632)を備えており、
前記人工器官(12)が前記送達装置(600)に圧着されている場合に、前記スロット(632)によって、前記端部分(628,630)が小さい直径まで半径方向に圧縮されることを特徴とする請求項1に記載の送達装置(600)。 - 前記送達装置(600)が、前記近位ストップ部材(614)と前記遠位ストップ部材(618)との間において前記膨張可能バルーンに圧着されている人工心臓弁と組み合わせて利用されることを特徴とする請求項1に記載の送達装置(600)。
- 人工器官(12)を患者の内部に送達するためのシステムであって、
前記患者の内部に部分的に挿入されるように構成されているイントロデューサ外筒(304,602)と、
前記イントロデューサ外筒(304,602)の近位端に挿入されるように構成されているローダ(306,604)と、
請求項1〜12のいずれか一項に記載の送達装置(600)であって、前記ローダ(306,604)及び前記イントロデューサ外筒(304,602)を通じて、前記患者の内部に移植すべき前記人工器官(12)を装着している前記患者の内部に至るように構成されている前記送達装置(600)と、
を備えている前記システムにおいて、
前記ローダ(306,604)が、前記ローダ(306,604)の内部に流体を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(306,604)の内部から流体を選択的に放流するための放出ポートとを備えており、前記フラッシュポートと前記放出ポートとが、弾性的な可撓性環状封止部材(686)によって封止されていることを特徴とするシステム。 - 前記可撓性環状封止部材(686)が、前記放出ポートを通じて半径方向に延在している押しタブ(688)を備えており、
前記放出ポートが、前記押しタブ(688)を半径方向内向きに押下す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ことを特徴とする請求項13に記載のシステム。
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