JP6018064B2 - 外科的心臓弁を迅速に配置するためのシステムおよび方法 - Google Patents
外科的心臓弁を迅速に配置するためのシステムおよび方法 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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
- A61F2/243—Deployment by mechanical expansion
- A61F2/2433—Deployment by mechanical expansion using balloon catheter
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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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
-
- 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
- A61F2/2412—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 with soft flexible valve members, e.g. tissue valves shaped like natural valves
- A61F2/2418—Scaffolds therefor, e.g. support stents
-
- 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
-
- 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
-
- 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
- A61F2220/005—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
-
- 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
- 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
- A61F2220/0083—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using hook and loop-type fasteners
-
- 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
- A61F2230/0067—Three-dimensional shapes conical
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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
- 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
- A61F2250/0014—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
- A61F2250/0039—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 diameter
-
- 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
- A61F2250/0048—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 mechanical expandability, e.g. in mechanical, self- or balloon expandability
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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
- 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
- A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Mechanical Engineering (AREA)
- Prostheses (AREA)
Description
本出願は、2010年9月10日に出願された米国仮出願第61/381,931号および2011年6月23日に出願された米国非仮出願第13/167,639号の、米国特許法第119条(e)に基づく優先権を主張するものである。
a. 血流弁口を画定し、かつ流入端部を有する拡張不能で折畳み不能な環状支持構造と、
b. 支持構造に取り付けられ、血流弁口上で交互に開閉するように装着された弁尖と、
c. 血流弁口の周りに延び、弁に支持構造の流入端部の所で連結された第1の端部を有する塑性的に拡張可能なフレームであって、支持構造から離れる流入方向に突き出て、移植位置に送るための収縮状態および外側において弁輪に接触するためのより広い拡張状態をとることのできる第2の端部を有する、塑性的に拡張可能なフレームと、
d. 塑性的に拡張可能なフレームの周りに位置し、第2の端部を囲む拡大シーリングフランジを含む布製カバリングと、
を備える。
a. 拡張可能なフレームを有する人工弁を含み、フレームが移植位置に送るための収縮状態および外側の弁輪に連結されるように構成された拡張状態を有する心臓弁であって、心臓弁が近位ハブおよび内部を貫通するルーメンを有するホルダ上に装着され、近位ハブが内部を貫通するルーメンを有するハンドルシャフトの遠位側端部に連結される、心臓弁を設けるステップと、
b. フレームが収縮状態にある心臓弁を弁輪に隣接する移植位置に前進させるステップと、
c. 第1のバルーンカテーテルをハンドルシャフトおよびホルダのルーメンを通過させて心臓弁内に送り込み、第1のバルーンカテーテル上のバルーンを膨張させるステップと、
d. バルーンをしぼませて第1のバルーンカテーテルを心臓弁内から引き込み、第1のバルーンカテーテルをハンドルシャフトから取り外すステップと、
e. 第2のバルーンカテーテルをハンドルシャフトに挿入し、第2のバルーンカテーテルをハンドルシャフトおよびホルダのルーメンを通過させて心臓弁内に送り込み、第2のバルーンカテーテル上のバルーンを膨張させてフレームを拡張するステップと、
を含む方法も開示する。
22 弁ホルダ
24 弁部材
26 固着スカート
32 安定化脚部
34 カスプ部
36 内部星形ボア
37 貫通穴
38 遠位足部
40 内側構造バンドサブアセンブリ
42 内側ポリマーバンド
44 直立支柱
46 貝殻形下側リング
48 剛性を有する外側バンド
50 布で覆われた波状ワイヤフォーム
52 内側ワイヤ部材
54 管状部
56 外側に突き出るフラップ
58 直立交連支柱
62 ソーイングリング
64 布製カバー
66 周囲タブ
68 内側縫合糸透過部材
70 第2の布製カバー
74 可撓性の弁尖
75 布で覆われた交連支柱
80 内側ステントフレーム
82 布製カバリング
84 バンド状下部シーリングフランジ
86 波状または貝殻形の上端部
88 布で覆われた中間フレーム
90 直線状バンド
92 孔またはアイレット
94 下縁部
98 拡張可能なストラット
100 軸方向に延びるストラット
102 案内縫合糸
110 送りシステム
112 膨張バルーン
120 縫合糸スネア
122 鉗子
130 展性を有するハンドルシャフト
140 保存クリップ
142 保存ジャー
144 ふた
150 小さいラグ
152 より長いラグ
154 単一のより長いラグ
160 ハンドリングロッド
162 バルーンイントロデューサスリーブ
164 雄ねじ
166 円形フランジ
168 遠位側端部
170 細長い第1の端部
172 円形の溝
174 第2の端部
176 円形の溝
180 定直径部分
182 徐々に狭くなるテーパ
184 第2の定直径部分
190 エンドキャップ
192 ルアーアダプタ
194 バルーン伸長ばね
196 ばね圧縮ピン
198 バルーンディスプレーサ
199 膨張チューブ
200 バルーン伸長ワイヤ
202 センタリングワッシャ
204 ハンドピース
206 管状のロッキングスリーブ
208 弁ホルダアダプタ
210 インサート成形された先端部
212 遠位ショルダ
214 細長い貫通穴
216 片持ち梁式フィンガ
218 隆起部
220 外部星形リム
230 遠位ショルダ
232 小さい弾性戻り止め
234 切欠き
240 ロッキングクリップ
242 半管状本体
244 サムレッジ
246 細長いレール
248 近位ブリッジ
250 内側に向けられた膨出部
260 トグルレバー
262 サムピース
264 ヒンジ
266 遮断端部
268 カムリンケージ
272 遠位側先端部
280 正中線
282 最遠位端部
290 管状の端部
294、296 軸方向側壁
298 段
300 J字形屈曲部
300’ ビード
302 円筒形のシャフト領域
304 半球状のバルブ
306 マンドレル位置合わせ導管
308 幅の狭いブリッジ
310 小さいショルダ
320 機械的フィンガ
322 膨張可能なバルーン
324 ハンドル取付け部材
326 ルーメン
330 リビングヒンジ
340 戻り止め
350 管状伸長部
352 閉じられた遠位側端部
354 サイドポート
356 ボア
358 より大きいチャンバ
360 管状伸長部
362 プランジャ
364 サイドポート
366 ボア
368 より大きいチャンバ
400 人工心臓弁
402 弁部材
404 スカートステント
406 布製カバー
410 ワイヤフォーム
412 布製カバー
414 布で覆われた固着スカート軸方向バンド構造
416 非常に可撓性の高いソーイングリング
418 壁が比較的薄いシリコーンインサート
420 代替人工心臓弁
422 ソーイングリング
424 円筒形の縫合領域
430 独立気泡フォームインサート
432 追加的な補強部材
AA 大動脈弁輪
AO 上行大動脈
CA 冠動脈
LV 左心室
Claims (14)
- 弁尖と、拡張可能なフレームと、を有する人工弁を含む心臓弁であって、前記フレームが移植位置に送るための収縮状態および外側において弁輪に連結されるように構成された拡張状態を有し、前記心臓弁が、近位ハブおよび内部を貫通するルーメンを有するホルダ上に装着され、前記近位ハブがバルーンイントロデューサスリーブに連結され、該バルーンイントロデューサスリーブは前記弁尖の位置及びその近傍にルーメンを画定し、前記バルーンイントロデューサスリーブが、内部を貫通するルーメンを有するハンドルシャフトの遠位側端部に連結される、心臓弁と、
前記ハンドルシャフトの中に挿入され、前記ハンドルシャフトの前記ルーメンと前記ホルダの前記ルーメンとを通過して前記心臓弁内に入るように構成されたバルーンカテーテルと、
を備える人工心臓弁システムであって、
前記人工弁を含む前記心臓弁を提供するステップと、
前記フレームが前記収縮状態にある前記心臓弁を、前記弁輪に隣接する移植位置まで前進させるステップと、
前記バルーンカテーテルを前記ハンドルシャフトの中に挿入するステップと、
前記バルーンカテーテルを前記ハンドルシャフトのルーメン、前記バルーンイントロデューサスリーブのルーメン、及び前記ホルダのルーメンを通じて前記心臓弁内に送り込むステップと、
前記バルーンを前記バルーンカテーテル上で膨張させて、前記フレームを拡張させるステップと、
を有する人工心臓弁システムを送り、移植する方法における使用のための人工心臓弁システム。 - 前記方法が、前記ホルダ上に装着された前記心臓弁を、前記ハンドルシャフトおよび前記バルーンカテーテルとは別個にパッケージングするステップをさらに含む請求項1に記載の人工心臓弁システム。
- 前記フレームの前記収縮状態は円錐状であり、前記バルーンカテーテル上の前記バルーンは、膨張させる前に前記フレームの前記遠位側端部の近傍に位置する正中線を有する、請求項1に記載の人工心臓弁システム。
- 前記フレームの前記収縮状態は円錐状であり、前記フレームは半径方向に拡張可能な複数のストラットを備え、該ストラットのうちの少なくともいくつかは列の状態に配置されており、前記人工弁から最も遠い前記列は、前記収縮状態から前記拡張状態への拡張に関して最大の容量を有する、請求項1に記載の人工心臓弁システム。
- 前記方法が、前記心臓弁の前記弁輪の弁口サイズを、前記フレームを塑性的に拡張することによって、1.0mm〜5.0mmだけ増加させる、請求項1に記載の人工心臓弁システム。
- 弁構成要素の前記人工弁が、前記心臓弁輪の大きくされた弁口サイズに一致する弁口サイズを有するように選択されている、請求項1に記載の人工心臓弁システム。
- 人工心臓弁を送るためのシステムであって、
弁口を画定する拡張不能かつ折畳み不能な支持構造と、該支持構造に取り付けられているとともに前記弁口を横切って交互に開閉するように装着されている弁尖と、を有する人工弁を含む心臓弁であって、該心臓弁が、該心臓弁の流入端部から延びる拡張可能なフレームをさらに含み、該フレームが移植位置に送るための収縮状態および拡張状態を有する、心臓弁と、
前記心臓弁に連結された弁ホルダと、
バルーンを有するバルーンカテーテルと、
バルーンカテーテルが前記心臓弁の流出側から通過するための貫通孔を前記弁尖の位置及びその近傍に画定するための、前記弁ホルダに取り付け可能な管状バルーンイントロデューサスリーブと、
その遠位部分が管状バルーンイントロデューサに取り付けられている、展性を有するハンドルシャフトであって、前記ハンドルシャフトが前記カテーテルを通過させるためのルーメンを有し、前記バルーンが、遠位方向に前記ハンドルシャフトを貫通し、前記弁ホルダを通過し、前記管状バルーンイントロデューサを通じ、前記心臓弁を貫通して延びる、展性を有するハンドルシャフトと、
を備えるシステム。 - 前記人工弁は、ソーイングリングを備え、前記フレームは前記ソーイングリングに取り付けられる、請求項7に記載のシステム。
- 前記フレームの前記収縮状態は、円錐状であり、遠位方向にテーパ状になる、請求項7に記載のシステム。
- 前記フレームの前記収縮状態は、円錐状であり、遠位方向にテーパ状になり、前記バルーンは、膨張する前に前記フレームの遠位側端部の近傍に位置する視認可能な正中線をさらに含む、請求項7に記載のシステム。
- 前記弁ホルダ上に装着された前記心臓弁は、前記ハンドルシャフトおよび前記バルーンカテーテルとは別個にパッケージングされる、請求項7に記載のシステム。
- 前記展性を有するハンドルシャフトは、アルミニウムから成る、請求項7に記載のシステム。
- 前記バルーンカテーテルは、前記ハンドルシャフトの前記ルーメン内を貫通して延びる膨張チューブを有し、前記膨張チューブの外径は、前記ハンドルシャフトのルーメンの内径の90%よりも大きい、請求項7に記載のシステム。
- 前記拡張可能なフレームは、前記人工弁を有する硬質の構成要素に堅く接続されている、請求項7に記載のシステム。
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US20120065729A1 (en) | 2012-03-15 |
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CA2811043C (en) | 2017-03-28 |
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US20180338828A1 (en) | 2018-11-29 |
US20170224484A1 (en) | 2017-08-10 |
JP2013540469A (ja) | 2013-11-07 |
AU2011299446A1 (en) | 2013-04-04 |
WO2012033604A2 (en) | 2012-03-15 |
US10039641B2 (en) | 2018-08-07 |
CA2811043A1 (en) | 2012-03-15 |
EP2613738A2 (en) | 2013-07-17 |
CN103200900A (zh) | 2013-07-10 |
US20200352713A1 (en) | 2020-11-12 |
CN103200900B (zh) | 2016-05-25 |
US10722358B2 (en) | 2020-07-28 |
BR112013005665A2 (pt) | 2016-05-03 |
BR112013005665B1 (pt) | 2020-09-01 |
WO2012033604A3 (en) | 2012-05-18 |
EP2613738B1 (en) | 2019-10-23 |
US11471279B2 (en) | 2022-10-18 |
US8641757B2 (en) | 2014-02-04 |
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EP2613738A4 (en) | 2015-07-15 |
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