JP4413928B2 - 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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- JP4413928B2 JP4413928B2 JP2006551359A JP2006551359A JP4413928B2 JP 4413928 B2 JP4413928 B2 JP 4413928B2 JP 2006551359 A JP2006551359 A JP 2006551359A JP 2006551359 A JP2006551359 A JP 2006551359A JP 4413928 B2 JP4413928 B2 JP 4413928B2
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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
-
- 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
Landscapes
- 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)
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 (22)
- 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1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。
- 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1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1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1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8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9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8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11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、当該面内に環形状を含む、ベース部材;
ベース部材から延びる複数のテザー;
複数の弁葉および多小葉形状を有する環状フレームを含む弁部材
弁部材上のガイドチャンネルであって、弁部材がベース部材の方に導かれると、弁部材をベース部材と整列させるために、テザーが当該ガイドチャンネルに導入され得る、ガイドチャンネル
を含む、心臓弁アセンブリ。 - 弁部材が降下させられて、弁部材と接すると、テザーが、弁部材をベース部材に取り付けるように構成されている、請求項13に記載のアセンブリ。
- テザーがさらにラチェット要素を含み、ラチェット要素は、傾斜した近位表面および尖っていない遠位表面を有し、弁部材がテザーを下って、ベース部材の方へ導かれることを許容するが、弁部材がテザーに沿って上向きに戻ることを防止する、請求項13に記載のアセンブリ。
- テザーが、1また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要素を含み、それにより、弁部材がベース部材の方へ導かれると、触知による表示および聴覚による表示の少なくとも一つを与える、請求項13に記載のアセンブリ。
- テザーがガイドチャンネルを通過して延び、ラチェット要素がガイドチャンネルと係合して、弁部材がベース要素の方へ導かれることを許容するが、弁部材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16に記載のアセンブリ。
- 1また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13に記載のアセンブリ。
- 1また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18に記載のアセンブリ。
- ベース部材が、前記面内にて、弁部材のフレームの多小葉形状に相補的な多小葉形状を含む、請求項13に記載のアセンブリ。
- ベース部材が環状のリング、および当該リングの周縁に沿って延びる可撓性を有するカフを含む、請求項13に記載のアセンブリ。
- 可撓性のカフが環状リングから放射状に延びる、請求項21に記載のアセンブリ。
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 |
---|---|
JP2007519483A JP2007519483A (ja) | 2007-07-19 |
JP2007519483A5 JP2007519483A5 (ja) | 2008-03-13 |
JP4413928B2 true JP4413928B2 (ja) | 2010-02-10 |
Family
ID=34795548
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 |
---|---|
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 (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2011522604A (ja) * | 2008-06-05 | 2011-08-04 | メドトロニック,インコーポレイテッド | ツーピース型の人工心臓弁アセンブリための接続システム、作製方法、および使用方法 |
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2011522604A (ja) * | 2008-06-05 | 2011-08-04 | メドトロニック,インコーポレイテッド | ツーピース型の人工心臓弁アセンブリための接続システム、作製方法、および使用方法 |
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US9474601B2 (en) | 2016-10-25 |
US20200246139A1 (en) | 2020-08-06 |
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US7597711B2 (en) | 2009-10-06 |
JP2007519483A (ja) | 2007-07-19 |
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US20050165479A1 (en) | 2005-07-28 |
CA2552646A1 (en) | 2005-08-11 |
AU2005209263A1 (en) | 2005-08-11 |
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