JP2021037362A - 拡張可能シース - Google Patents
拡張可能シース Download PDFInfo
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- 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
- A61F2/2436—Deployment by retracting a sheath
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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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
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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
- 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
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- A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
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- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
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- A61M25/00—Catheters; Hollow probes
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- 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
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- 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
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- 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
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- A61M25/00—Catheters; Hollow probes
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Abstract
【解決手段】送達シースは、弾性外方管状層と、薄壁部分に一体的に連結された厚壁部分を有する内方管状層とを備える。内方管状層は、薄壁部分が弾性外方管状層の付勢下において厚壁部分の外方表面上に折り畳まれる圧縮状態または折畳み状態を有することが可能である。インプラントが通され送られるときに、外方管状層は伸張し、内方管状層は拡張ルーメン直径へと拡がる。インプラントが通過すると、外方管状層は、シースがそのより小さな輪郭を再び呈する状態である圧縮状態へと内方管状層を再び付勢する。また、シースは、容易な拡張および圧壊を助長するために内方管状層と外方管状層との間の摩擦に仲介することによりシースのルーメンに通してインプラントを前進させるために必要な押力を軽減させる選択的に配置された長手方向ロッドを備え得る。
【選択図】図1
Description
10 送達装置
12 インプラント
14 操縦可能ガイドカテーテル
16 バルーンカテーテル
20 ハブ
21 ハブルーメン
22 フレア状近位端部
24 遠位先端部
26 止血弁
28 側部ポート
30 ねじ山付き遠位雄端部
32 ねじ山付き雌コネクタ
34 管状壁部構造体
38 中央ルーメン
40 弾性外方管状層
42 内方管状層
44 外方壁部
46 内方壁部
48 保持具
50 円筒状バルジ
52 ネック
54 環状空間
56 三日月形状空間
58 初期弾性ルーメン
60 長手方向ロッド
62 厚壁部分
64 薄壁部分
66 第1の長手方向延在端部
68 第2の長手方向延在端部
70 ストリップ
72 放射線不透過性リング
74 熱収縮層
76 細長セグメント
78 フレア状部分
80 導入針
81 内方先端部層
82 ひずみ逃がし管状層
84 外方先端部層
86 放射線不透過性マーカバンド、放射線不透過性層部分
90 V字形状切欠部
92 追加管状層
94 マンドレル
96 近位封止層
98 近位セクション
100 遠位封止層
Claims (19)
- 軸方向に貫通して延在する初期弾性ルーメンを画成する弾性外方管状層であって、前記初期弾性ルーメンは初期直径を有する、弾性外方管状層と、
薄壁部分に一体的に連結された厚壁部分を有する内方管状層であって、前記厚壁部分は、第1の長手方向延在端部および第2の長手方向延在端部を有するC字形状断面を有し、前記薄壁部分は、前記内方管状層を貫通して軸方向に延在する拡張ルーメンを画成するように前記第1の長手方向延在端部と前記第2の長手方向延在端部との間に延在し、前記拡張ルーメンは、前記初期弾性ルーメンの前記初期直径よりも大きな拡張直径を有する、内方管状層と、
を備え、
前記内方管状層は、圧縮状態では、前記弾性外方管状層が前記内方管状層の前記第2の長手方向延在端部の下方に前記第1の長手方向延在端部を付勢する状態において、前記弾性外方管状層の前記初期弾性ルーメンを貫通して延在し、
前記内方管状層は、局所的拡張状態では、インプラントの通過による前記弾性外方管状層の付勢に対して、前記薄壁部分が前記第1の長手方向延在端部と前記第2の長手方向延在端部との間に延在して前記拡張ルーメンを形成するより少ない重畳状態へと、前記第1の長手方向延在端部および前記第2の長手方向延在端部を離れるように径方向に拡張させ、
前記内方管状層は、前記拡張ルーメンを前記インプラントが通過した後に、前記弾性外方管状層により前記圧縮状態へと付勢されるように構成される、シース。 - 前記内方管状層の外方表面または前記弾性外方管状層の内方表面の少なくとも一方が、前記弾性外方管状層および前記内方管状層の自由な相対摺動を可能にするように構成された潤滑コーティングを有する、請求項1に記載のシース。
- 前記内方管状層の外方表面の少なくとも1つの長手方向延在部分が、前記弾性外方管状層の内方表面の対応する長手方向延在部分に接着される、請求項1または2に記載のシース。
- 前記弾性外方管状層の内方表面に結合され前記初期弾性ルーメン内に延在する少なくとも1つの長手方向ロッドをさらに備え、前記長手方向ロッドは、前記局所的拡張状態と前記圧縮状態との間で移動する場合の前記弾性外方管状層内における前記内方管状層の相対移動を容易にするように軸受表面を形成するように構成される、請求項1から3のいずれか一項に記載のシース。
- 前記少なくとも1つの長手方向ロッドは、前記弾性外方管状層の内方表面の周囲に周方向に離間された複数の長手方向ロッドを備える、請求項1から4のいずれか一項に記載のシース。
- 前記内方管状層の内方表面に結合された少なくとも1つの長手方向ロッドをさらに備える、請求項1から5のいずれか一項に記載のシース。
- 前記内方管状層の内方表面に結合された前記少なくとも1つの長手方向ロッドは、前記内方管状層の前記内方表面の周囲に周方向に離間された複数の長手方向ロッドを備える、請求項1から6のいずれか一項に記載のシース。
- 前記内方管状層の内方表面に結合された少なくとも1つの長手方向ロッドをさらに備える、請求項1から7のいずれか一項に記載のシース。
- 前記内方管状層の内方表面に結合された前記少なくとも1つの長手方向ロッドは、前記内方管状層の前記内方表面の周囲に周方向に離間された複数の長手方向ロッドを備える、請求項1から8のいずれか一項に記載のシース。
- 前記弾性外方管状層の長手方向部分の周囲に延在する放射線不透過性管状層をさらに備える、請求項1から9のいずれか一項に記載のシース。
- 前記弾性外方管状層の遠位部分が、前記内方管状層の拡張外方表面に接着される、請求項1から10のいずれか一項に記載のシース。
- 前記弾性外方管状層の遠位部分および前記内方管状層は相互に接着される、請求項1から11のいずれか一項に記載のシース。
- 前記弾性外方管状層の遠位部分および前記内方管状層は、封止構成へと相互にリフロー接合される、請求項1から12のいずれか一項に記載のシース。
- 前記弾性外方管状層内に埋設された複数の長手方向ロッドをさらに備える、請求項1から13のいずれか一項に記載のシース。
- 前記シースの遠位部分がフレア形状を有する、請求項1から14のいずれか一項に記載のシース。
- フレア形状は、重畳構成へと折り畳まれる、請求項1から15のいずれか一項に記載のシース。
- 患者の血管にインプラントを挿入する方法であって、
請求項1から16のいずれか一項に記載の前記シースを用意するステップと、
前記患者の前記血管内に少なくとも部分的に前記シースを挿入するステップと、
前記シースの前記内方管状層を通してインプラントを前進させるステップと、
前記インプラントの径方向外方力を利用して前記圧縮状態から前記局所的拡張状態へと前記内方管状層を局所的に拡張させるステップと、
前記弾性外方管状層の径方向内方力を利用して前記局所的拡張状態から前記圧縮状態へと少なくとも部分的に戻るように前記内方管状層を局所的に収縮させるステップと
を含む、方法。 - 局所的に拡張させる前記ステップは、前記第1の長手方向延在端部および前記第2の長手方向延在端部を相互方向におよび次いで相互から離れるように移動させて、前記局所的拡張状態を達成するステップをさらに含む、請求項17に記載の方法。
- 局所的に収縮させる前記ステップは、前記第1の長手方向延在端部および前記第2の長手方向延在端部を相互方向におよび次いで相互から離れるように移動させて、前記圧縮状態を少なくとも部分的に達成するステップをさらに含む、請求項17または18に記載の方法。
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