JP4359660B2 - 一定長さのアンカー・アンド・プル僧帽弁治療具および方法 - Google Patents
一定長さのアンカー・アンド・プル僧帽弁治療具および方法 Download PDFInfo
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- 206010027727 Mitral valve incompetence Diseases 0.000 claims description 12
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Description
発明は、より具体的には、僧帽弁輪を再形成するための治療器具および方法に関する。
して知られている。僧帽弁は、左心房と左心室との間の左心房心室開口部に位置する。僧
帽弁は、左心室が収縮するときに、左心室から左心房への血液の逆流を阻止するためのも
のである。血液の逆流を阻止するために、僧帽弁は、左心室が収縮する際のかなりの背圧
に耐えることができなければならない。
の筋肉壁に固定されている。健康な僧帽弁では、僧帽弁の形態が、左心室収縮の際の血液
の逆流が起こらないように尖が互いに重なることを保証する。
生する拡張性心筋症によって障害されることがある。例えば、ある種の疾患は、僧帽弁輪
の拡張を起こすことがある。これは、僧帽弁の形態の変形につながり、左心室収縮の際に
僧帽弁の非効果的な閉鎖を引き起こす。かかる非効果的な閉鎖は、僧帽弁を通じる漏れと
逆流とにつながる。心臓の細菌性炎症または心不全のような疾患が、上記の僧帽弁輪の歪
みまたは拡張を引き起こすことがある。言うまでもなく、僧帽弁閉鎖不全は、治療しない
で済ませるわけにはいかない。
。この方法は、尖の1つが著しく損傷し、あるいは、変形したときに僧帽弁を交換するの
に特に適していることがわかった。弁全体の交換は、拡張した僧帽弁輪に伴う直接的な問
題を除去するが、現在入手可能な心臓の人工弁には天然の心臓の弁と同じ耐久性はない。
を保持するために開発されてきた。これらの外科的技術は、拡張または変形した弁輪の形
状を修復することを伴う。一般に弁輪形成術として知られるかかる技術は、拡張を最小限
にするために、前記弁輪を外科的に拘束する必要がある。ここで、弁輪を再形成し、僧帽
弁の開閉の際に弁の動きを拘束するために、プロテーゼが弁の葉状部のほぼ基部に縫合さ
れるのが典型的である。
ロテーゼは、弁輪の基部の周りに適合する、環状または部分的に環状の形をした部材であ
る。前記環状または部分的に環状の形をした部材は、金属のような剛直な材料か、あるい
は、可撓性の材料かでできている場合がある。
しくない結果に終わる可能性とがないわけではなかった。例えば、これらの手順は心臓を
切開する手術を要する。このような手順は、高額の費用がかかり、かなりの回復時間を要
する非常に侵襲的なものであり、かかる手順に伴う付随的な死のリスクがある。さらに、
かかる心臓切開の手順は、この疾患を含む(comprised)心臓病患者に特に負担
が大きい。これらの因子を考慮して、かかる手順は、最後の手段としてとっておかれるこ
とがしばしばあり、そのため、僧帽弁閉鎖不全の病状進行の後期に適用される。さらに、
かかる手順の有効性は、術中に評価することは困難で、術後かなり後までわからない場合
もある。そのため、最適な効果を得るためにプロテーゼを調整し、あるいは、プロテーゼ
を変化させる能力は非常に制約される。後からの矯正は、行われるとしても、新たな心臓
切開手術を要する。
された。これは、心臓の冠状静脈洞が、僧帽弁輪の近傍にあるか、少なくとも部分的には僧帽弁輪を取り囲んでいて、大心静脈を含む静脈系に伸びることの認識によって可能になった。ここで用いられる「冠状静脈洞」という用語は、前記冠状静脈洞そのものを指すだけではなく、これに加えて、前記大心静脈を含む冠状静脈洞と関連する静脈系をも指す。前記治療法は、僧帽弁輪の形状を再形成して有利な効果を与えるために冠状静脈洞の中に導入される治療器具を使用するものである。
用いられる技術に類似する経皮的技術だけを用いて冠状静脈洞中に埋め込まれる場合がある。前記治療器具を埋め込むために提案された1つのシステムは、前記治療器具と着脱可能に連結するように形作られた細長いイントロデューサを含む。前記イントロデューサは、
前記治療器具を心臓の中の冠状静脈洞口を通って冠状静脈洞中に移動させることができるように可撓性であることが好ましい。誘導を促進するために、細長いシース(sheath)が冠状静脈洞の中に最初に進入させられる。それから、前記治療器具とイントロデューサとは、該治療器具が冠状静脈洞の中に配置されるまで、前記シースの内腔を通って移動させられる。前記治療器具は、弾性材料でできているため、前記シースを通って前進する際に前記内腔の湾曲に適合する。そして、前記シースは、前記治療器具が応力のかからない弓形の形状をとることができるように部分的に抜き出される。いったん前記治療器具が適当に配置されると、前記イントロデューサは前記治療器具から脱離して、前記シースに格納される。その後、前記シースの取り出しにより手順は完了する。結果として、前記治療器具は冠状静脈洞の中に留置され、僧帽弁の形態を回復するために僧帽弁に内向きの圧力を加える。
療器具、システムおよび方法は比較的非侵襲的な手順に用いられるため、僧帽弁閉鎖不全
は、前記治療器具、システムおよび方法で僧帽弁閉鎖不全の病状進行の初期に治療するこ
とができる。前記治療器具は、いかなる非侵襲的な心臓専門医によっても比較的容易に設
置できる。心臓は前記手順の間中完全に無傷のままに保たれるため、前記手順の有効性は
容易に決定することができる。調整が望ましいと思われる場合には、かかる調整は患者が
回復室に送られる前に実行される。
を提供する。前記治療器具は、心臓内部の僧帽弁輪に隣接する心臓の冠状静脈洞の中に配置および固定されるように形作られた、第1のアンカーと、第1のアンカーに固定され、第1のアンカーから心臓内に近位側の向きに伸びるケーブルと、第1のアンカーより近位側の心臓内に配置および固定されるように形作られて、前記ケーブルを摺動可能に受け入れるように配列された、第2のアンカーと、第2のアンカー上で前記ケーブルを固定するロックとを含む。第1および第2のアンカーが心臓内で固定されるとき、前記ケーブルは近位側の向きに引かれ、該ケーブルが第2のアンカー上にロックされる。このようにして、
僧帽弁の幾何学的配置に影響を与える。このアプローチは、第2のアンカーが、冠状静脈洞内に配置および固定されても、あるいは、右心房内に配置および固定されてもかまわないという柔軟性を提供する。このアプローチは、さらに、埋め込み後にケーブルの張力を調整することを可能にする。本発明は、僧帽弁輪に隣接する冠状静脈洞内に配置された治療器具を用いて僧帽弁逆流を治療する、さらに別の代替策を提供する。
本発明は、心臓内の僧帽弁輪の幾何学的配置に効果がある治療器具を提供する。前記治
療器具は、僧帽弁輪に隣接する心臓の冠状静脈洞内に配置および繋止されるための第1のアンカーと、第1のアンカーより近位側で心臓内の僧帽弁輪に隣接して配置されるように形作られた第2のアンカーとを含む。前記治療器具は、さらに、一定長さを有し、第1および第2のアンカーに恒久的に取り付けられた連結部材を含む。その結果、第1および第2のアンカーが心臓内にあって、第1のアンカーが冠状静脈洞内に繋止されると、第2のアンカーは近位側に変位して僧帽弁輪の幾何学的配置に作用し、僧帽弁の幾何学的配置への効果を維持するために脱離される場合がある。第2のアンカーは、配設されたときに、遠位側への移動をしないように繋止されるように形作られるが、近位側への移動は可能で、第2のアンカーが冠状静脈洞内で近位側に変位することを可能にする。
療器具は、僧帽弁輪に隣接する心臓の冠状静脈洞内に繋止されるための第1のアンカー手段と、第1のアンカー手段の近位側で僧帽弁輪に隣接する心臓内に配設される第2のアンカー手段と、一定長さを有し、第1のアンカー手段を第2のアンカー手段に恒久的に連結手段とを含む。その結果、第1および第2のアンカー手段が心臓内にあって第1のアンカー手段が冠状静脈洞内に繋止されているとき、第2のアンカー手段は、第1のアンカー手段および前記連結手段と協動して僧帽弁輪の幾何学的配置に効果があるように近位側に変位する場合と、僧帽弁の幾何学的配置への効果を維持するために脱離される場合とがある。
。前記システムは、心臓内の僧帽弁輪に隣接する冠状静脈洞に配置され繋止されるように形作られた第1のアンカーと、第1のアンカーの遠位側で僧帽弁輪に隣接する心臓内に配置されるように形作られた第2のアンカーと、第1および第2のアンカーに恒久的に取り付けられた一定長さを有する連結部材とを含む、僧帽弁治療器具を含む。
ルと、第2のアンカーに着脱可能に連結され、前記内腔内を通って前記カテーテルの近位
端から外に伸びるテザー(tether)をさらに含み、該カテーテルは僧帽弁輪に隣接
する冠状静脈洞内に案内でき、前記治療器具の第1および第2のアンカーを僧帽弁輪に隣接する冠状静脈洞内に配設される。その結果、第1のアンカーが冠状静脈洞内のカテーテルによって配設されるとき、第2のアンカーが前記テザー上を近位側に引くことにより近位側の向きに変位して僧帽弁輪の幾何学的配置に影響を与え、その後、脱離されて、僧帽弁の幾何学的配置への効果を維持するために配設される。
は、第1のアンカーを僧帽弁輪に隣接する冠状静脈洞内に固定するステップと、第2のアンカーを僧帽弁輪に隣接し第1のアンカーの近位側にある冠状静脈洞内に配置するステップと、一定長さの連結部材を第1および第2のアンカーの間に固定するステップと、第2のアンカーを近位側の向きに遠位させて僧帽弁輪の幾何学的配置に影響をを与えるステップと、第2のアンカーをさらに近位側の向きの変位から脱離させて、僧帽弁の幾何学的配置への効果を維持するステップとを含む。
前記治療器具は、心臓内の僧帽弁輪に隣接する冠状静脈洞に配置繋止されるように形作られた第1のアンカーと、第1のアンカーより近位側で僧帽弁輪に隣接する心臓内に配置されるように形作られた第2のアンカーと、第1および第2のアンカーの間に取り付けられた連結部材とを含む。第1および第2のアンカーのうち少なくとも1つは、第1の向きへの動きに抗して繋止されるが、第1の向きの反対向きの第2の向きに動くことができる。
で第2の向きが遠位側の向きであってもかまわない。前記少なくとも1つのアンカーが第
2のアンカーであって、第1の向きが遠位側の向きで第2の向きが近位側の向きであって
もかまわない。好ましい実施態様では、第1のアンカーは近位側の向きへの動きに抗して
繋止され、遠位側の向きに動くことができ、第2のアンカーは遠位側の向きへの動きに抗
して繋止され、近位側の向きに動くことができる。
込むことを可能にする治療器具をさらに提供する。前記治療器具は、心臓内で僧帽弁輪に
隣接する冠状静脈洞内に配置および繋止されるように形作られた第1のアンカーと、第1のアンカーより近位側で僧帽弁輪に隣接する心臓内に配置されるように形作られた第2のアンカーと、第1および第2のアンカーの間に取り付けられた連結部材とを含む。第1のアンカーは、心臓のリード線が第1のアンカーの横を通ることができるように、冠状静脈洞の全てを占めることがないように形作られている。
ンカーは、冠状静脈洞内に配置可能で、心臓のリード線が第2のアンカーの横を通ることができるように、冠状静脈洞の全てを占めることがないように形作られている。第2のアンカーも、心臓のリード線が貫通するループを含む場合がある。
冠状静脈洞14、冠状動脈15および回旋枝17を露出するべく心房を除去した、ヒトの心臓10の上面図である。図1に一般的に示されるのは、心臓10の肺動脈弁22、大動脈弁24および三尖弁26である。
び18を取り囲み、左心室収縮の間、完全な閉鎖を提供するために、これらの間隔を保持
する。周知のとおり、冠状静脈洞14は、僧帽弁輪20に隣接する僧帽弁12を部分的に取り囲む。同じく周知のとおり、冠状静脈洞は心臓の静脈系の一部であり、左心房と左心室の間の房室間溝(AV groove)に沿って伸びる。これは、冠状静脈洞を実質的に僧帽弁輪と同じ平面上に配置し、本発明の僧帽弁治療具を内部に配置するために冠状静脈洞が利用できるようにする。
30は、第1のアンカー32と、連結部材34と、第2のアンカー36とを含む。アンカ
ー32および36と、連結部材34とは、一体構造(integral structu
re)を提供するため、同一の材料でできている場合がある。
状静脈14内で脱離されるとき、自動的に配設可能であるように、鉤状(hook−sh
aped)をしている。より具体的には、治療器具30は、ステンレス鋼か、形状記憶性
を有することが当業者に周知であるタイプのニッケル/チタン合金であるニチノール(N
itinol)か、プラスチックかのようなたいていの生体適合性の材料のいずれかでで
きている場合がある。アンカー32の鉤状の形状は、脱離されるとき、アンカー32を少
なくとも近位側の向きへの動きに抗して繋止または固定するために、冠状静脈洞14の内壁に食い込むように伸展する。しかし、アンカー32は遠位側の向きへの動きを許す場合がある。アンカー32は、冠状静脈洞14と回旋枝17との交差点19よりほんの少し近位側に配置されることが好ましい。
輪郭にほぼ対応する弓状の形状を有するように前処理される。連結部材34は、一定長さ
で、第1および第2のアンカー32および36に恒久的に取り付けられている。ここで、
第2のアンカーは冠状静脈洞14の冠状静脈洞口21のほんの少し遠位側の冠状静脈洞内に配置される点が特記される。第2のアンカー36は、同様の鉤状の形状を有し、自動的に配設されるために自動的に伸展することが好ましい。アンカー36の鉤状部分は、アンカー36を遠位側の向きへの動きに抗して繋止または固定するが、該アンカーが近位側の向きに引かれることを許す。これは、アンカー32および36が最初に配設された後で治療器具30を調整することを可能にするため、治療器具30の特に意義深い局面である。
い)。前記外被は、冠状静脈洞14の内壁に抗して加えられる前記連結部材の力を和らげるうえで役立つ、圧縮可能な材料でできているのが好ましい場合がある。
を示す。図3に示すとおり、配設アッセンブリ50は、カテーテル52と、テザー54と
を含む。カテーテル52は、配設前の状態で摺動可能に治療器具30を受け入れるための
寸法を持つ内腔56を有し、テザー54は第2のアンカー36の周りにループを作ってカ
テーテル52の近位端から外に伸びる。
中に留まっている間に配設される。これは、カテーテル52を第1のアンカーが望ましい
位置に達するまで冠状静脈洞内に挿入するのと同時に起こる。カテーテル52は、第1のアンカー32を動きに抗して保持しながら近位側の向きに動かされる場合がある。カテーテル52の近位側の向きへの動きがアンカー32を脱離する。前記アンカーが脱離するとき、自動的に配設するために自動的に伸展して、近位側の向きへの動きに抗して固定される。
に伸展して自動的に配設されることを可能にする。第2のアンカー36は遠位側の向きへ
の動きに抗して固定されるが、近位側の向きへ動くことは許される。テザー54はカテー
テル52の近位端の外へ伸びつづける。
とによって連結部材34に、そして第2のアンカー36に加えられるが、一方で第1のア
ンカー32は近位側の向きへの動きに抵抗する。望ましい張力が連結部材34上に加えら
れるとき、第2のアンカー36は脱離して再度自動的に配設される。これが完了するとき
、第1のアンカー32および第2のアンカー36は連結部材34の張力で配置および固定
される。その後、カテーテル52およびテザー54は、配設の工程を完了するために除去
される場合がある。近位側のアンカー36は最終的に冠状静脈洞内に配設されることが示されるが、近位側のアンカー36は、近位側の向きに変位された後、冠状静脈洞14の冠状静脈口21よりほんの少し近位側の右心房内に最終的に配設される場合がある。したがって、遠位側のアンカー32より近位側で心臓内にある近位側のアンカー32のいかなる最終的な配置も本発明によって意図されている。
ここで、第1のアンカー32は上記のとおり配設され、第2のアンカー36は、近位側の
向きに動く間、カテーテル52の中に入ったままの場合がある。第2のアンカー36が望
ましい位置に到達すると、カテーテル52は、脱離して第2のアンカー36を配設するた
めに、後に引かれる場合がある。その結果、この代替的な実施態様では、配設されるとき
には第2のアンカーは遠位側の向きおよび近位側の向きの両方の動きに抗して繋止される
場合がある。
結部材74がスプリング状構造体75を含むことを除いて、上記の治療器具30と類似す
る。スプリング75は最大長さを有し、僧帽弁輪20に加えられた張力をより強制的に維
持するために役立つ。この目的のため、治療器具70は、第1のアンカー72と、連結部
材74と、第2のアンカー76とを含む。
て冠状静脈洞14の内壁にくい込むように形作られる。また、第1のアンカーは近位側の向きへの動きに抵抗し、第2のアンカー76は遠位側の向きへの動きに抵抗する。他のすべての点では、治療器具70は、治療器具30と同じであり、同じやり方で配設される場合がある。
心臓ペースメーカおよび除細動器(defibrillator)を含む場合がある。前
記装置は、一般に、患者の胸部の皮下ポケット(subcutaneous pocke
t)として知られる領域に埋め込まれる。前記埋め込み式装置は、心臓内に埋め込まれる
リード線が接続された1または2以上の電極と協動して機能することが一般的である。前
記電極は、それぞれの心房・心室と電気的な接触をするために、右心内部、すなわち、右
心室または右心房のいずれかまたは両方の内部に配置されるのが通常である。前記リード
線内の導体と、該リード線に運ばれる近位のコネクタとが前記電極を前記装置に接続して
、該装置が心臓の電気活動を感知して所望の治療用送達を行う(deliver the
desired therapy)ことを可能にする。
れてきた。この理由は、埋め込まれた電極が一部の患者に凝血塊形成を起こすことがあり
、凝血塊が動脈を通って左心、例えば、左心室から放出された場合には、直接脳を通過し
て、麻痺性または致死性の卒中を起こす可能性があるからである。しかし、右心、例えば
、右心室から放出された凝血塊は、肺に入るが、肺のろ過作用のために、脳の致死性また
は衰弱性の塞栓症は起こらない。
、実施されてきた。これらのリード線構造および方法は、リード線を心臓の冠状静脈洞内に埋め込むことによって、左心房および左心室内に直接電極を設置することを避ける。上記のとおり、「冠状静脈洞」という語は、冠状静脈洞自体だけでなく、これに加えて、大静脈を含む、冠状静脈洞と協動する静脈系をも指す。
に配設するために上記の鉤状になるループ33および35の形状をとる。したがって、ル
ープ33および35は、心臓のリード線80が左心に埋め込まれるために貫通することを
可能にする。これは、僧帽弁逆流の患者の多くは左心心拍管理療法の候補でもある場合が
あるため、特に望ましい。
請求の範囲では、該請求の範囲によって定義される本発明の趣旨および範囲内に該当する
全てのかかる変更および改変を含むものとする。
、そのさらなる局面および利点とともに、上記の説明と添付する図面とを併用参照するこ
とにより最もよく理解できる場合がある。以下の複数の図面では類似の符号は同一の構成
要素を指す。
した特許請求の範囲では、請求項に記載された発明の趣旨および範囲の範囲内に該当する
全てのかかる変更および改変を含むものとする。
12 僧帽弁
13 右心室
14 冠状静脈洞
20 僧帽弁輪
23 右心房
25 右心房の内壁
30、70 僧帽弁治療器具
32、72 第1のアンカー
34、74 連結部材
36、76 第2のアンカー
50 配設アッセンブリ
52 カテーテル
54 テザー
56 内腔
75 スプリング状構造体
80 心臓のリード線
Claims (16)
- 心臓の僧帽弁輪の幾何学的配置に影響を与える治療器具であって、
第1の伸展可能なアンカーと、第2の伸展可能なアンカーと、前記第1の伸展可能なアンカーと第2の伸展可能なアンカーとを結合させる連結部材とを含み、前記第1のアンカーと第2のアンカーとの間の前記連結部材の長さは一定であり、
前記第1の伸展可能なアンカーは冠状静脈洞内に繋止されるように形作られており、前記第2の伸展可能なアンカーは僧帽弁輪に隣接した位置に配備されるように形作られており、それによって、前記第1の伸展可能なアンカーは冠状静脈洞内に配置され、前記第2の伸展可能なアンカーは、前記第1のアンカーの近位側に配備されるようになされた治療器具。 - 前記第1のアンカーが冠状静脈洞と側動脈との間に配置されている分かれ目の近位側に繋止される請求項1に記載の治療器具。
- 前記近位側のアンカーが冠状静脈洞の小孔の遠位側に配置される請求項2に記載の治療器具。
- 前記連結部材が弓形の形状を有している請求項3に記載の治療器具。
- 前記連結部材に適用される引っ張り力が僧帽弁輪の幾何学的配置に影響を与える請求項4に記載の治療器具。
- 前記引っ張り力が前記第2のアンカーに力をかけることによって適用される請求項5に記載の治療器具。
- 前記第2のアンカーに解除可能に結合された引っ張り力適用部材を更に含んでいる請求項6に記載の治療器具。
- 僧帽弁輪の幾何学的配置の随伴する変化に影響を与えるために、所望のレベルの引っ張り力が適用される請求項6に記載の治療器具。
- 僧帽弁の幾何学的配置に所望の変化を達成した後に、前記引っ張り力適用部材が前記第2のアンカーから外される請求項7に記載の治療器具。
- 僧帽弁輪の幾何学的配置の所望の変化が監視される請求項8に記載の治療器具。
- 前記僧帽弁輪の幾何学的配置の所望の変化が、患者の僧帽弁逆流の変化によって指示される請求項8に記載の治療器具。
- 僧帽弁輪の幾何学的配置の変化が僧帽弁逆流を減らす請求項8に記載の治療器具。
- 前記連結部材が非外傷性であるような構造とされている請求項1に記載の治療器具。
- カバーを更に含んでいる請求項8に記載の治療器具。
- 前記第1のアンカー、前記第2のアンカー及び前記連結部材が一体化されている請求項1に記載の治療器具。
- 前記固定の長さを有する連結部材がスプリングを含んでいる請求項1に記載の治療器具。
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US10/066,426 US6976995B2 (en) | 2002-01-30 | 2002-01-30 | Fixed length anchor and pull mitral valve device and method |
PCT/US2003/002124 WO2003063735A2 (en) | 2002-01-30 | 2003-01-22 | Fixed length anchor and pull mitral valve device and method |
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JP2005515833A JP2005515833A (ja) | 2005-06-02 |
JP2005515833A5 JP2005515833A5 (ja) | 2009-06-25 |
JP4359660B2 true JP4359660B2 (ja) | 2009-11-04 |
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JP2003563433A Expired - Fee Related JP4359660B2 (ja) | 2002-01-30 | 2003-01-22 | 一定長さのアンカー・アンド・プル僧帽弁治療具および方法 |
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US (15) | US6976995B2 (ja) |
EP (3) | EP1482869B1 (ja) |
JP (1) | JP4359660B2 (ja) |
AU (1) | AU2003211731B2 (ja) |
CA (2) | CA2469460C (ja) |
ES (3) | ES2558860T3 (ja) |
WO (1) | WO2003063735A2 (ja) |
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