JP2007519483A - 心臓弁アセンブリおよびそれを使用する方法 - Google Patents
心臓弁アセンブリおよびそれを使用する方法 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
- A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
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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
- A61F2/2412—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
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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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- 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
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0097—Visible markings, e.g. indicia
-
- 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
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Heart & Thoracic 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)
Abstract
Description
本発明は、概して、患者に埋め込み得る心臓弁に関し、より特には、一体に組み立て得る複数の部品から成る心臓弁アセンブリに関し、また、それを製造する装置および方法、ならびにそれを使用する装置および方法に関する。
患者の欠陥のあるヒトの弁を人工心臓弁で置換し得る。人工弁は一般に、人工弁のオリフィスの外周に取り付けられ、それに沿って延びる、縫合リングあるいは縫合糸(または接合)カフもしくはリングを含む。それらの断面が円形であるために、埋め込まれる縫合リングは、弁が埋め込まれ得る生体の環状部に最適にはフィットしないことがある。その結果、バルブを通過する又はバルブの周囲における、生来の血液の血行動態が損なわれることがあり、凝血、および考えられ得る塞栓形成をもたらし、最終的には、弁構造の石灰化に至る。
本発明は、患者に埋め込むことができる心臓弁、より特には、一体に組み立てることができる、複数の部品(またはコンポーネント)から成る心臓弁アセンブリに関し、また、それを製造する装置および方法、ならびにそれを埋め込む装置および方法に関する。
1.複数の部品から成る心臓弁アセンブリ
図面を参照すると、図1は、一般に、ベース部材12、弁部材または「冠」(もしくはクラウン)14を有する、心臓弁アセンブリ10を示す。さらに以下に説明するように、ベース部材12および/または冠14は、冠14をベース12に取り付けるための一もしくは複数のコネクタ、ならびに/または冠14をベース12と整列させる及び/もしくは接続するのを容易にする一もしくは複数のガイドを有してよい。
本明細書で説明する心臓弁アセンブリの部品は、当業者に周知の方法を用いて製造することができる。使用可能な製造技術として、例えば、成形、機械加工、注型、二次成形(例えば、圧力成形)、クリンピング(もしくは襞付け)、型押し、溶融、ねじ止め、接着、溶接、打抜き、レーザ切断、放電加工(EDM)、エッチング、またはそれらの組み合わせが挙げられる。
図30を参照すると、ツール、即ち、弁ドライバまたはホルダー60の例示的な形態が示されている。概して、ホルダー60は、細長いシャフト62を含み得、当該シャフトは、近位端66にハンドル64を有し、遠位端70に複数のアーム68を有する。シャフト62は、アーム68に固定され得る、又はアーム68に対して回転可能であり得る、実質的に硬質な及び/又は展性を有する(または柔軟な)ボディである。アーム68の自由端部72は、上述したようなベース部材及び/又は冠(図示せず)を解除可能なように保持するように構成され得る、コネクタ74を含み得る。3つのアーム68が図示されているが、所望の場合には、より多い又はより少ない数のアームを設けてよいことが理解されよう(図示せず)。コネクタ74は遠隔操作により、例えば、ハンドル64上のアクチュエータ(図示せず)から、作動させて、ベースおよび/もしくは冠を取り付け、並びに/または解放してよい。図33は、アーム68上のコネクタ74を用いて、冠12を保持するホルダー60を示す。
Claims (30)
- 概して面を規定し、当該面内に多小葉環形状を含む、ベース部材;
ベース部材の多小葉形状と相補的である多小葉形状を含む、環状体;ならびに
環状体をベース部材に接続する、ベース部材および環状体に位置する協働コネクタ
を含む、心臓弁アセンブリ。 - 協働コネクタが、ベース部材および環状体に、第1および第2のコネクタをそれぞれ含む、請求項1に記載のアセンブリ。
- 第1のコネクタが、ベース部材の外周にそって実質的に連続的に延びている、請求項2に記載のアセンブリ。
- 第1のコネクタが、ベース部材の外周に沿って、間隔をあけて配置された複数のコネクタ要素を含む、請求項2に記載のアセンブリ。
- 第1および第2のコネクタの一方が突起を含み、第1および第2のコネクタの他方が当該突起をその中に受け入れる開口部を含む、請求項2に記載のアセンブリ。
- 突起が弾力性を有する、請求項5に記載のアセンブリ。
- 開口部が、ポート、ポケット、キャビティおよびホールのうち少なくとも1つを含む、請求項5に記載のアセンブリ。
- ベース部材が、硬質のベース、および当該ベースを生体の環状部に取り付ける可撓性のカフを含む、請求項1に記載のアセンブリ。
- 環状体が、弁部材をベース部材に接続するための接続部材を含む、請求項1に記載のアセンブリ。
- 環状体が、弁部材を含む、請求項1に記載のアセンブリ。
- 面および当該面と実質的に直交する縦方向の軸を概して規定し、当該面内に多小葉環形状を含む、ベース部材;
ベース部材の多小葉形状と相補的である、多小葉形状を含む環状体、ならびに
ベース部材および環状体の少なくとも一方に位置する、縦方向の軸の周囲で、多小葉形状を互いに整列させる、ガイド
を含む、心臓弁アセンブリ。 - 環状体をベース部材に取り付ける、ベース部材および環状体に位置する協働コネクタをさらに含む、請求項11に記載のアセンブリ。
- ベース部材が、硬質のベース、および当該ベースを生体の環状部に取り付ける可撓性のカフを含む、請求項1に記載のアセンブリ。
- 環状体が、弁部材をベース部材に接続するための接続部材を含む、請求項11に記載のアセンブリ。
- 環状体が、弁部材を含む、請求項11に記載のアセンブリ。
- ガイドが、環状体の多小葉形状がベース部材の多小葉形状と整列したときに、互いに整列し得る視覚によるマーカを、環状体およびベース部材にて含む、請求項11に記載のアセンブリ。
- ガイドが、環状体の多小葉形状がベース部材の多小葉形状と整列したときに、互いに相互作用し得る触知によるマーカを環状体およびベース部材にて含む、請求項11に記載のアセンブリ。
- ガイドが、ベース部材から環状体を経由して延びる、1または複数のテザーを含み、環状体がベース部材の方に導かれると、環状体がテザーに沿ってスライド可能であって、環状体をベース部材と整列させるようになっている、請求項11に記載のアセンブリ。
- 前記一又は複数のテザーが、当該一又は複数のテザーの一部に沿って間隔をあけて設けられたラチェットを含み、それにより、環状体がベース部材の方に導かれると、触知による表示および聴覚による表示のうち少なくとも1つを与える、請求項18に記載のアセンブリ。
- テザーの各々が環状体にてガイドチャンネルを経由して延び、ラチェット要素がガイドチャンネルに係合して、環状体がベース要素の方に導かれることを許容するが、環状体がベース部材から遠ざかるように導かれることを防止する、請求項19に記載のアセンブリ。
- 前記一又は複数のテザーがベース部材に取り付けられている、請求項18に記載のアセンブリ。
- 前記一又は複数のテザーがベース部材から取り外し可能である、請求項21に記載のアセンブリ。
- 多小葉環形状を含むベース部材、およびベース部材の多小葉形状と相補的である多小葉形状を含む第2のデバイスを含む心臓弁を組み立てる方法であって、
第2のデバイスをベース部材に隣接するように移動させて、第2のデバイスの多小葉形状をベース部材の多小葉形状と整列させること、および
第2のデバイスをベース部材に取り付けること
を含む方法。 - 第2のデバイスをベース部材に隣接するように移動させることが、第2のデバイスを、ベース部材に向けて、一又は複数のガイド部材に沿ってスライドさせることを含む、請求項23に記載の方法。
- 第2のデバイスをベース部材に取り付けることが、第2のデバイスおよびベース部材にある協働コネクタを係合させることを含む、請求項23に記載の方法。
- 協働コネクタが、第2のデバイス及びベース部材のうち少なくとも1つにある突起であって、第2のデバイス及びベース部材の他方にある対応する開口部に受け入れられる、
突起を含む、請求項25に記載の方法。 - 第2のデバイスが、弁部材を含む、請求項23に記載の方法。
- 第2のデバイスおよびベース部材にあるガイドを用いて、第2のデバイスの多小葉形状を、ベース部材の多小葉形状と整列させる、請求項23に記載の方法。
- ガイドが、視覚によるマーカおよび触知によるマーカのうち少なくとも1つを含む、請求項28に記載の方法。
- ガイドが、ベース部材から延びる一又は複数のテザーを含み、環状体をベース部材と隣接するように移動させるときに、環状体を当該一又は複数のテザーに沿ってスライドさせる、請求項28に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/765,725 US7597711B2 (en) | 2004-01-26 | 2004-01-26 | Heart valve assembly with slidable coupling connections |
PCT/US2005/002157 WO2005072655A1 (en) | 2004-01-26 | 2005-01-24 | Heart valve assembly and methods for using them |
Publications (3)
Publication Number | Publication Date |
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JP2007519483A true JP2007519483A (ja) | 2007-07-19 |
JP2007519483A5 JP2007519483A5 (ja) | 2008-03-13 |
JP4413928B2 JP4413928B2 (ja) | 2010-02-10 |
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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JP2006551359A Expired - Fee Related JP4413928B2 (ja) | 2004-01-26 | 2005-01-24 | 心臓弁アセンブリおよびそれを使用する方法 |
Country Status (6)
Country | Link |
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US (5) | US7597711B2 (ja) |
EP (1) | EP1708650B1 (ja) |
JP (1) | JP4413928B2 (ja) |
AU (1) | AU2005209263B2 (ja) |
CA (1) | CA2552646C (ja) |
WO (1) | WO2005072655A1 (ja) |
Cited By (3)
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JP2008531201A (ja) * | 2005-02-28 | 2008-08-14 | アーバー・サージカル・テクノロジーズ・インコーポレイテッド | ツーピース心臓弁を移植するために適合化されたプロテーゼ |
JP2009529401A (ja) * | 2006-03-10 | 2009-08-20 | アーバー・サージカル・テクノロジーズ・インコーポレイテッド | 人工弁イントロデューサ並びにその製造方法及びその使用方法 |
JP2013517006A (ja) * | 2010-01-12 | 2013-05-16 | バルブ メディカル エルティーディー | 経皮弁構造体を微調節するための方法及び装置 |
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2004
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Cited By (4)
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JP2008531201A (ja) * | 2005-02-28 | 2008-08-14 | アーバー・サージカル・テクノロジーズ・インコーポレイテッド | ツーピース心臓弁を移植するために適合化されたプロテーゼ |
JP2012205909A (ja) * | 2005-02-28 | 2012-10-25 | Medtronic Inc | ツーピース心臓弁を移植するために適合化されたプロテーゼ |
JP2009529401A (ja) * | 2006-03-10 | 2009-08-20 | アーバー・サージカル・テクノロジーズ・インコーポレイテッド | 人工弁イントロデューサ並びにその製造方法及びその使用方法 |
JP2013517006A (ja) * | 2010-01-12 | 2013-05-16 | バルブ メディカル エルティーディー | 経皮弁構造体を微調節するための方法及び装置 |
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EP1708650B1 (en) | 2018-11-28 |
WO2005072655A1 (en) | 2005-08-11 |
US7597711B2 (en) | 2009-10-06 |
JP4413928B2 (ja) | 2010-02-10 |
US20050165479A1 (en) | 2005-07-28 |
US8377119B2 (en) | 2013-02-19 |
CA2552646A1 (en) | 2005-08-11 |
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