JP2619400B2 - 心臓弁の可撓性サポート - Google Patents

心臓弁の可撓性サポート

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Publication number
JP2619400B2
JP2619400B2 JP62197245A JP19724587A JP2619400B2 JP 2619400 B2 JP2619400 B2 JP 2619400B2 JP 62197245 A JP62197245 A JP 62197245A JP 19724587 A JP19724587 A JP 19724587A JP 2619400 B2 JP2619400 B2 JP 2619400B2
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JPS63109856A (ja
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カルペンティエール アレン
レーン アーネスト
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バクスター インターナショナル インコーポレーテッド
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Classifications

    • 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
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A61F2/2448—D-shaped rings

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (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

【発明の詳細な説明】 発明の背景 人間の心臓弁は、心臓の特定領域への血流を制御する
のに開いたり閉じたりする葉状の器官、すなわち心臓弁
膜尖を備えている。例えば、僧帽弁は後方心臓弁膜尖と
前方心臓弁膜尖とを備え、後方心臓弁膜尖と前方心臓弁
膜尖の双方の基底部が心臓の僧帽弁輪に連結されてい
る。僧帽弁は心房拡張期には開き、心房収縮期には閉じ
る。
僧帽弁が開くとき、その輪は後方心臓弁膜尖の基底部
に沿って拡がり、僧帽弁が閉じるとき、その輪は後方心
臓弁膜尖の基底部に沿って収縮して２つの心臓弁膜尖を
互いに近接させ、すなわち密封接触させる。心臓弁の疾
患のある患者の場合、輪の拡張が慢性化し、僧帽弁の輪
が心房収縮期にゆがめられるようになる。輪の慢性拡張
により、弁を通して僧帽弁逆流、すなわち血液の逆流が
起きる。
弁の輪に沿って心臓にサポートを植え込むことによっ
て、これらの状況その他について対処することができ
る。この種のサポートは、カーペンチィェ氏（Carpenti
er）の米国特許第3,656,185号に開示されているように
剛性であってもよいし、カーペンチィエ氏その他（Carp
entier et al）の米国特許第4,055,861号に開示されて
いるように可撓性であってもよい。剛性サポートは幾つ
かの適用例については満足できるものもあるが、後方心
臓弁膜尖の基底部に沿っての弁の輪の収縮を許容せず、
従って縫合線に大きな応力がかかり、弁が完全に平常通
りに作動しなくなることもある。完全に可撓性のサポー
トは輪の形状の動的変化にはよく追従するが、輪の生理
学的形状に復元し且つ好ましくないゆがみを防止するの
にあまり効率的ではない。結果として、剛性サポートも
可撓性サポートも完全に平常通りに弁を作動させること
ができない。
発明の概要 本発明は、輪をほぼ正常な形状へ引き戻すことができ
且つ輪を正しく収縮させる、新規な心臓弁のサポートを
提供する。従って、縫合線及び葉状器官にかかる応力が
減少し、弁が更に平常通りに作動する。本発明の特徴を
様々な心臓弁に適用可能であるが、本発明の特徴は特に
僧帽弁に対して適応されている。
本発明のサポートは全体的にリング形状で、自然の心
臓弁の輪に合致するような寸法及び形状を有する。本明
細書で使用される用語「リング形状」及び「リング状構
造」は、１つの領域を境界付ける、すなわち包囲するす
べての形態を意味し、円形形態に限定されない。
本発明によれば、全体的にリング形状で且つ自然の心
臓弁の輪に合致する寸法及び形状を有する、自然の心臓
に植込み可能なサポートであって、上記形状のサポート
は、対向した端部を有するフレーム部材と、上記フレー
ム部材の対向した端部に取り付けられ、かつ、上記フレ
ーム部材の対向した端部の間に延びる可撓性部材と、上
記フレーム部材と上記可撓性フレームのまわりに形成さ
れたシースと、上記フレーム部材と上記可撓性フレーム
のまわりの上記シースを充填し、上記フレーム部材の対
向した端部の間で上記可撓性部材を形状決めする柔軟な
圧縮性材料と、を含むことを特徴とするサポートが提供
される。
サポートの可撓性部材は、可撓性コードからなり、フ
レーム部材よりも可撓性であるのが好ましい。可撓性コ
ードは、両端部を有し、可撓性コードの両端部は上記フ
レーム部材の対向した端部に連結されているのがよい。
上記フレーム部材には、互いに向かって湾曲した対向し
た端部を有する実質的に直線状の部分が形成されている
のがよい。フレーム部材の末端領域は、末端へ延びるに
つれて可撓性が次第に増大し、末端へ延びるにつれて横
断面積が次第に増大するのがよい。この構成により、よ
り剛性であるフレーム部材は、より剛性な制御を受ける
べき輪の領域に沿って置かれ、可撓性コードは、可撓性
コードの可撓性が必要な収縮に追従できるように容易に
収縮が許容されるべき輪の領域に沿って置かれる。かく
して、サポートの可撓性の変化は、輪の要件に合わせて
調整される。
可撓性部材は１つの領域を包囲する構造を形成するた
めにフレーム部材の対向した端部の間に延びており、可
撓性部材は、フレーム部材の対向した端部の間で一体で
あり、途切れのないのがよい。フレーム部材の対向した
端部の間の可撓性部材の長さは、フレーム部材の対向し
た端部の間を直線状に延びるのに必要とされる長さより
も長いのがよい。この構造により、可撓性部材が輪の運
動に追従できるように可撓性部材にたるみができる。輪
を正常な形状に引き戻すのに効率的であるように、可撓
性部材は非伸長性であるのがよい。圧縮性材料は、フレ
ーム部材の対向した端部の間で可撓性部材を弧状に形成
するのがよい。
本発明並びに本発明のその他の特徴及び利点は、例示
的な添付図面に関連してなされる次の記載を参照して最
もよく理解されるであろう。
実施例 第１図は、フレーム部材13（第３図）と、コード15
と、シース17と、フレーム部材及びコードの全長を包囲
するシース内に設けられた柔軟な圧縮性材料を全体的に
含んだサポート11を示している。サポート11は実質的に
同一平面内に位置し、全体的にリング形状である。サポ
ート11は、人間の自然の心臓の僧帽弁の輪に合致するよ
うな寸法と形状を有する。
様々な構成が可能であるが、この実施例のフレーム部
材13は、チタン6A1−4Vのような生物学的適合性をもっ
た金属から構成され、細長くて対向した端部分を有す
る。細長いフレーム部材は同一平面内に位置し、セグメ
ント25と一体に連結した湾曲セグメント23を備えてい
る。湾曲セグメント23は、フレーム部材13がチャンネル
状になるように全体的に同じ方向へ直線セグメント25か
ら離れて延びている。この実施例では、湾曲セグメント
23は互いに同一であり、約120度延びた全体的に円形な
セグメントで端部分21まで及んでいる。様々な横断面形
態を使用することができるが、この実施例ではフレーム
部材13は、そのほぼ全長にわたって、横断面の厚さが湾
曲セグメント23（第７図）におけるよりも直線セグメン
ト25（第６図）においてより大きい矩形横断面形態から
なっている。湾曲セグメントの応力を全体にわたって均
一に保持するには、湾曲セグメント23の横断面積は、端
部分21に達するまで末端へ延びるにつれて次第に減少
し、端部分21で増大しているのが好ましい。この構成に
より、直線セグメント25は実質的に剛性であり、湾曲セ
グメント23は末端方向に端部分21へ延びるにつれて次第
に可撓性が増大、すなわち剛性が減少している。
端部分21は互いに同一であるのがよく、湾曲セグメン
ト23の末端領域を形成する。端部分21の各々の横断面は
第３図及び第８図に示すように拡大され、貫通して延び
る通路27を備えている。通路27は、横フランジ29に隣接
した位置まで及んでいる。
コード15は可撓性で、例えばダクロン（デュポン社
（Du Pont）製のポリエステル繊維を表す商標）のよう
な生物学的適合性をもった適当な編組材料又は織物材料
から構成されているのがよい。コード15の両端は、何か
適当な方法によって、例えば端部分の通路27を通してコ
ードを延ばし通路27を貫通するには大きすぎる寸法の結
び目を形成することによって、フレーム部材13の対向し
た端部分21に取り付けられている。
コード15は、端部分21間を単に直線状に延びるのに必
要な長さよりも長い。この実施例では、コード15は、該
コード及びフレーム部材13を完全に包囲した柔軟な材料
19によって弧状に形成されている。柔軟な材料19は生物
学的適合性を有し、必要に応じて放射線不透過性にする
のに例えば硫酸バリウムを含有する例えばシリコンゴム
であるのがよい。材料19によりサポート11全体が柔軟且
つ圧縮性になり、端部分21間のコード15に沿ったサポー
トの可撓性長さ部分33は第１図に示すように無応力弧状
形態に保持されているが、材料19により長さ部分33が弾
性になっている。かくして、長さ部分33は通常第１図に
示した形状をしているが、半径方向の内方力に応答して
半径方向に内方へ容易に移動でき、力が除かれると第１
図の示す形状に戻る。材料19はまた、通路27におけるコ
ード15及びフレーム部材13の相対的な摩耗運動を妨げ
る。
コード15は、実質的に非伸長性である。コード15がフ
レーム部材13の端部分21に連結されると、コード及びフ
レーム部材は完全に１つの領域を構成する。
この実施例では、可撓性シース17は柔軟な材料19、コ
ード15及びフレーム部材13を完全に包囲する織物ジャケ
ットの形態をしている。例えば、シース17をダクロンで
編まれた布で構成するのがよい。
このように構成すると、長さ部分33は弾性的に可撓性
であり、フレーム部材13と同一の長さを有するサポート
11の長さ部分35は長さ部分33より可撓性が小さい。事
実、直線セグメント25に沿ったサポート11の長さ部分は
実質的に剛性であると考えられ、湾曲セグメント23に沿
った長さ部分35の末端領域の可撓性は末端へ延びるにつ
れて次第に増大している。かくして、このような末端領
域は弾性的に可撓性であるが、長さ部分33よりもはるか
に剛性が大きい。
サポート11は、心臓の僧帽弁37（第９図及び第10図）
に使用するようになっている。心臓の僧帽弁は、後方心
臓弁膜尖39と、前方心臓弁膜尖41と、心臓弁膜尖39及び
41の基底部位に隣接して心臓弁膜尖39及び41を包囲する
輪43とを備えている。
可撓性長さ部分33が後方心臓弁膜尖39の基底部で輪43
に沿って全体的に延び、可撓性のより小さい長さ部分35
が前方心臓弁膜尖41の基底部で輪に沿って延びるよう
に、第９図及び第10図に示すような縫合線45を用いて輪
43にサポート11を縫合することができる。縫合線45は、
互いに結合してサポート11のための縫合リングとして役
立つシース17及び柔軟な材料19を貫通して延びている。
サポート11と輪43との縫合により、輪43はそのほぼ正常
な形状に引き戻される。
第９図に示すように、心房拡張期中、心臓弁の心臓弁
膜尖39及び41は分離されて開口部47を形成する。この期
間中、輪43は半径方向に内方へ広がろうとし、すなわち
後方心臓弁膜尖39の基底部に沿って広がろうとする。心
房収縮期中、心臓弁膜尖39及び41は閉じて開口部47を閉
鎖する。心房収縮期中、輪43は後方心臓弁膜尖39の基底
部に沿って収縮する。輪の隣接領域を収縮させてこの収
縮に追従することによって、可撓性長さ部分33を半径方
向に内方へ容易に移動させることができる。その結果、
縫合線45及び心臓弁膜尖39及び41にかかる応力を最小に
することができる。従って、サポート11は、心臓弁膜尖
39の基底部に沿った輪の通常の、しかしながら非常に著
しい収縮を許容しながら、輪43に正しく合致している。
本発明の例示的な実施例を示し説明したが、当業者で
あれば本発明の要旨及び範囲を必ずしも逸脱することな
く多くの変更、修正及び置換が可能である。
【図面の簡単な説明】
第１図は、本発明の開示により構成されるサポートの一
形態の一部断面平面図であり、 第２図は、第１図の線２−２に全体的に沿った断面図で
あり、 第３図は、フレーム部材の好ましい形態の平面図であ
り、 第４図は、第３図の線４−４に全体的に沿った拡大部分
図であり、 第５図及び第６図は、それぞれ第３図の線５−５及び線
６−６に全体的に沿った図であり、 第７図及び第８図は、それぞれ第５図の線７−７及び線
８−８に全体的に沿った断面図であり、 第９図及び第10図は、それぞれ弁が心房拡張期及び心房
収縮期にあるときの、自然の心臓の僧帽弁に植え込まれ
たサポートを示す図である。 11……サポート、33、35……長さ部分、43……輪

Claims (10)

    (57)【特許請求の範囲】
  1. 【請求項１】全体的にリング形状で且つ自然の心臓弁の
    輪に合致する寸法及び形状を有する、自然の心臓に植込
    み可能なサポートであって、上記形状のサポートは、 対向した端部を有するフレーム部材と、 上記フレーム部材の対向した端部に取り付けられ、か
    つ、上記フレーム部材の対向した端部の間に延びる可撓
    性部材と、 上記フレーム部材と上記可撓性フレームのまわりに形成
    されたシースと、 上記フレーム部材と上記可撓性フレームのまわりの上記
    シースを充填し、上記フレーム部材の対向した端部の間
    で上記可撓性部材を形状決めする柔軟な圧縮性材料と、 を含むことを特徴とするサポート。
  2. 【請求項２】上記可撓性部材は、上記フレーム部材より
    も可撓性であることを特徴とする特許請求の範囲第１項
    に記載のサポート。
  3. 【請求項３】上記フレーム部材には、互いに向かって湾
    曲した対向した端部を有する実質的に直線状の部分が形
    成されていることを特徴とする特許請求の範囲第１項又
    は第２項に記載のサポート。
  4. 【請求項４】上記可撓性部材は可撓性コードからなるこ
    とを特徴とする特許請求の範囲第１項〜第３項のいずれ
    か１項に記載のサポート。
  5. 【請求項５】上記可撓性コードは両端部を有し、上記可
    撓性コードの両端部は上記フレーム部材の対向した端部
    に連結されていることを特徴とする特許請求の範囲第４
    項に記載のサポート。
  6. 【請求項６】上記フレーム部材の末端領域は、末端へ延
    びるにつれて可撓性が次第に増大することを特徴とする
    特許請求の範囲第１項〜第３項のいずれか１項に記載の
    サポート。
  7. 【請求項７】上記フレーム部材の末端領域は、末端へ延
    びるにつれて横断面積が次第に増大することを特徴とす
    る特許請求の範囲第１項〜第３項のいずれか１項に記載
    のサポート。
  8. 【請求項８】上記可撓性部材は１つの領域を包囲する構
    造を形成するために上記フレーム部材の対向した端部の
    間に延びており、上記可撓性部材は、上記フレーム部材
    の対向した端部の間で一体であり、途切れのないことを
    特徴とする特許請求の範囲第１項、第２項、第６項及び
    第７項のいずれか１項に記載のサポート。
  9. 【請求項９】上記フレーム部材の対向した端部の間の上
    記可撓性部材の長さは、上記フレーム部材の対向した端
    部の間を直線状に延びるのに必要とされる長さよりも長
    いことを特徴とする特許請求の範囲第１項〜第８項のう
    ちのいずれか１項に記載のサポート。
  10. 【請求項１０】上記圧縮性材料は、上記フレーム部材の
    対向した端部の間で上記可撓性を弧状に形成し、上記可
    撓性部材は非伸長性であることを特徴とする特許請求の
    範囲第１項〜第９項のいずれか１項に記載のサポート。
JP62197245A 1986-08-06 1987-08-06 心臓弁の可撓性サポート Expired - Lifetime JP2619400B2 (ja)

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US893679 1986-08-06

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CA1303298C (en) 1992-06-16
JPS63109856A (ja) 1988-05-14
US5061277A (en) 1991-10-29
US5061277B1 (en) 2000-02-29
DE3778247D1 (de) 1992-05-21
EP0257874A1 (en) 1988-03-02
EP0257874B1 (en) 1992-04-15

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