JP6151177B2 - 安定管を有する経カテーテル補綴心臓弁送達装置 - Google Patents
安定管を有する経カテーテル補綴心臓弁送達装置 Download PDFInfo
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Classifications
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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
- A61F2/2436—Deployment by retracting a sheath
-
- 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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00636—Sensing and controlling the application of energy
- A61B2018/00696—Controlled or regulated parameters
- A61B2018/00767—Voltage
-
- 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
- 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
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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)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Description
Claims (18)
- ステント付き補綴心臓弁を経皮的に送達するための送達装置であって、前記補綴心臓弁が収縮配置から通常の拡張配置へ径方向に自己拡張可能である前記送達装置であって、
管腔を構成し、遠位カプセルおよび近位シャフトを含む送達シース組立体であって、前記カプセルが前記補綴心臓弁を収縮して収容するように構成されている送達シース組立体と、
ハンドルと、を備え、
該ハンドルが、近位側および遠位側を構成するハウジングと、該ハウジングによって保持され前記シャフトが前記遠位側から遠位方向に延在するように前記シャフトに連結される作動装置機構であって、前記シャフトを前記ハウジングに対して選択的に移動させるように構成される作動装置機構と、を備え、
前記送達装置が、さらに、
前記ハウジングに連結される外部安定管であって、前記シャフトが前記外部安定管に対して摺動可能であるように前記シャフト上に同軸に受け入れられ、前記外部安定管の遠位端が前記カプセルの近位にある外部安定管、を備え、
前記補綴心臓弁が不均一な圧縮形態である時に、前記外部安定管が前記カプセルの全体を超えて、かつ、前記補綴心臓弁の少なくとも一部を超えて延びる再捕捉手順を実行するように前記外部安定管が構成されており、
前記作動装置機構が、前記送達装置を、前記カプセルが前記補綴心臓弁を包囲する送達状態から、前記カプセルが前記補綴心臓弁から退避した展開状態に移行するように操作可能であり、前記シャフトが、前記外部安定管に対して摺動し、前記送達状態から前記展開状態へ移行する、
ことを特徴とする送達装置。 - 前記外部安定管が、前記送達装置が通って患者に挿入される別個の導入弁構成要素から、前記送達シース組立体を分離するように構成されている、
請求項1に記載の送達装置。 - 前記管腔内に配置され、前記送達状態において、前記カプセル内で前記補綴心臓弁を支持するように構成される保持部材をさらに備えている、
請求項1に記載の送達装置。 - 前記保持部材は、前記送達状態から前記展開状態へ移行する際に、前記カプセルが前記保持部材に対して摺動するように前記ハウジングに連結されている、
請求項3に記載の送達装置。 - 前記ハウジングによって維持され、前記送達シース組立体の外径と前記外部安定管の内径との間の領域に流体接続される管を有するフラッシュポート構造をさらに備えている、 請求項1に記載の送達装置。
- 前記カプセルの外径が、前記シャフトの外径よりも大きく、
前記シャフトが、接続点で前記カプセルに取り付けられ、
さらに、前記送達状態において、前記接続点が、前記安定管の前記遠位端から3〜13cmの範囲の距離だけ遠位にある、
請求項1に記載の送達装置。 - 前記カプセルの外径が、前記シャフトの外径よりも大きく、前記カプセルが、接続点で前記シャフトに取り付けられ、
さらに、前記展開状態において、前記接続点が、前記安定管の遠位端から遠位にある、
請求項1に記載の送達装置。 - 前記シャフトが、編状管であり、前記カプセルが、前記シャフトのものとは異なる構造を有する、
請求項1に記載の送達装置。 - 前記外部安定管が、
管状体と、
前記管状体を円周方向に支持する補強部材と、を含む、
請求項1に記載の送達装置。 - 患者の欠陥のある心臓弁を復元させるためのシステムであって、
送達装置を備え、該送達装置は、
遠位端を形成する外部安定管と、
管腔を形成し遠位カプセルおよび近位シャフトを含む送達シース組立体であって、前記シャフトが前記外部安定管内で摺動可能に受入れられる送達シース組立体と、
ハンドルと、を有し、該ハンドルが、
遠位側を構成し、前記外部安定管が前記遠位側から遠位方向に延在するように前記外部安定管に連結されるハウジングと、
前記ハウジングによって維持され前記シャフトに連結される作動装置機構であって、前記送達シース組立体が、前記遠位端から遠位方向に延在し、前記作動装置機構の操作で前記外部安定管に対して選択的に可動になるようにする作動装置機構と、を含み、前記送達装置が、さらに、
ステントフレームと、該ステントフレームに取り付けられ少なくとも2つの弁小葉を形成する弁構造体とを有する補綴心臓弁であって、収縮配置から初期配置へ自己拡張可能である補綴心臓弁と、を備え、
前記システムが、前記補綴心臓弁が前記カプセル内に保持された装着状態から、前記カプセルが前記補綴心臓弁から退避させられ、前記補綴心臓弁が前記初期配置へ自己拡張し、前記送達装置からリリースすることができる展開状態に移行可能なように構成され、前記作動装置機構が、前記送達シース組立体を前記補綴心臓弁および前記安定管に対して摺動させることによって、前記装着状態から前記展開状態への移行を遂行するように構成されており、
前記補綴心臓弁が不均一な圧縮形態である時に、前記外部安定管が前記カプセルの全体を超えて、かつ、前記補綴心臓弁の少なくとも一部を超えて延びる再捕捉手順を実行するように前記外部安定管が構成されており、
ことを特徴とするシステム。 - 導入シースおよび弁を含む導入装置であって、前記外部安定管を用いて止血を確立するように構成され、前記外部安定管が、前記導入装置から前記シャフトを分離する、導入装置をさらに備えている、
請求項10に記載のシステム。 - 前記管腔内に配置され、前記装着状態において、前記カプセル内で前記補綴心臓弁を支持するように構成されている保持部材をさらに備える、
請求項10に記載のシステム。 - 前記保持部材は、前記装着状態から前記展開状態への移行の際に、前記カプセルが前記保持部材に対して摺動するように、前記ハウジングに連結されている、
請求項12に記載のシステム。 - 前記ハウジングによって維持され、前記送達シース組立体の外径と前記外部安定管の内径との間の領域に流体接続される管を含む、フラッシュポート構造をさらに備えている、
請求項10に記載のシステム。 - 前記カプセルの外径が、前記シャフトの外径よりも大きく、前記シャフトが、接続点で前記カプセルに取り付けられ、さらに、前記装着状態において、前記接続点が、前記安定管の遠位端から3〜13cmの距離だけ遠位にある、
請求項10に記載のシステム。 - 前記カプセルの外径が、前記シャフトの外径よりも大きく、前記カプセルが、接続点で前記シャフトに取り付けられ、さらに、前記展開状態において、前記接続点が、前記安定管の遠位端から遠位にある、
請求項10に記載のシステム。 - 前記シャフトが、編状管であり、前記カプセルが、前記シャフトのものとは異なる構造を有する、
請求項10に記載のシステム。 - 前記安定管が、管状体と、前記管状体を円周方向に支持する補強部材と、を含む、
請求項10に記載のシステム。
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Application Number | Priority Date | Filing Date | Title |
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US12/759,394 | 2010-04-13 | ||
US12/759,394 US8579963B2 (en) | 2010-04-13 | 2010-04-13 | Transcatheter prosthetic heart valve delivery device with stability tube and method |
PCT/US2011/030554 WO2011130006A1 (en) | 2010-04-13 | 2011-03-30 | Transcatheter prosthetic heart valve delivery device with stability tube |
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JP2013526912A JP2013526912A (ja) | 2013-06-27 |
JP6151177B2 true JP6151177B2 (ja) | 2017-06-21 |
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US (2) | US8579963B2 (ja) |
EP (2) | EP3738552A1 (ja) |
JP (1) | JP6151177B2 (ja) |
CN (1) | CN102834072A (ja) |
AU (1) | AU2011240940B2 (ja) |
WO (1) | WO2011130006A1 (ja) |
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-
2010
- 2010-04-13 US US12/759,394 patent/US8579963B2/en active Active
-
2011
- 2011-03-30 EP EP20183277.1A patent/EP3738552A1/en active Pending
- 2011-03-30 AU AU2011240940A patent/AU2011240940B2/en not_active Ceased
- 2011-03-30 CN CN2011800190975A patent/CN102834072A/zh active Pending
- 2011-03-30 JP JP2013504923A patent/JP6151177B2/ja active Active
- 2011-03-30 WO PCT/US2011/030554 patent/WO2011130006A1/en active Application Filing
- 2011-03-30 EP EP11713597.0A patent/EP2558029B1/en active Active
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CN102834072A (zh) | 2012-12-19 |
US20140074227A1 (en) | 2014-03-13 |
US20110251683A1 (en) | 2011-10-13 |
EP3738552A1 (en) | 2020-11-18 |
AU2011240940B2 (en) | 2014-10-30 |
AU2011240940A1 (en) | 2012-10-25 |
JP2013526912A (ja) | 2013-06-27 |
US8579963B2 (en) | 2013-11-12 |
WO2011130006A1 (en) | 2011-10-20 |
EP2558029A1 (en) | 2013-02-20 |
EP2558029B1 (en) | 2020-07-15 |
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