JP4294735B2 - 心臓壁張力を低減する装置 - Google Patents

心臓壁張力を低減する装置 Download PDF

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JP4294735B2
JP4294735B2 JP53029298A JP53029298A JP4294735B2 JP 4294735 B2 JP4294735 B2 JP 4294735B2 JP 53029298 A JP53029298 A JP 53029298A JP 53029298 A JP53029298 A JP 53029298A JP 4294735 B2 JP4294735 B2 JP 4294735B2
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ジェイ．，ジュニア シュウェイク，シリル
ジェイ． モーティアー，トッド
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マイオコール，インコーポレイティド
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Description

【０００１】
【技術分野】
本発明は弱った心臓を治療する装置の分野に関する。特に、本発明の装置は弱った心臓の壁応力を低減することを目的とする。
【０００２】
【背景技術】
心不全症候群は多くの形態の心臓病が進行する一般的な経過である。心不全は心機能の異常のため心臓が代謝組織の要求に見合った速度で血液を循環させることができないか、又は異常に高い充満圧力でしか循環させることができない状態であると考えられる。心不全に至る多くの固有の疾患の進行があり、左心室の拡張といった弱った心臓の様々な病理生理学に帰結する。この形態の不全につながる病因には突発性心筋症、ウイルス性心筋症、及び虚血性心筋症が含まれる。
【０００３】
心室拡張の進行は一般に、心筋への慢性的な容量過負荷又は特定の損傷の結果である。例えばスポーツ選手の心臓のような長期的に増大した心搏出量の要求にさらされている正常な心臓では、わずかな心室拡張及び筋細胞肥大の適応進行が存在する。こうして、心臓は増大した心搏出量の要求を十分に補償する。しかし、心筋の損傷又は慢性容量過負荷の場合、収縮する心筋に対する要求は補償された状態が達成されず心臓が拡張を続ける程度まで増大する。
【０００４】
大きく拡張した左心室にまつわる基本的問題は拡張充満時と収縮時との両方で、壁の張力及び応力が著しく増大することである。正常な心臓では、筋肥大（厚くなること）と心室拡張との適応によって、収縮のため壁張力がかなり一定に維持される。しかし、弱った心臓では、進行する拡張が肥大よりも大きく、その結果収縮のための壁張力の要求が増大する。これは筋細胞への障害の進行と考えられ、その結果さらに筋が損傷を受ける。壁応力の増大は拡張充満についても言える。さらに、心搏出量の不足のため、いくつかの生理的機構からの心室充満圧は一般に上昇する。さらに、拡張期には直径及び圧力がどちらも正常値以上に増大し、どちらも壁応力レベルを高める一因となる。拡張期の壁応力の増大は心腔拡張の進行の主要な誘因と考えられる。
【０００５】
心不全に対する従来技術の治療は三つの一般的なカテゴリーに分けられる。第１は薬理学的なもの、例えば利尿剤である。第２は補助システム、例えばポンプである。さらに、外科的治療が実験されており、これは以下より詳細に説明する。
【０００６】
薬理学的治療に関しては利尿剤が使用され、血液の量及び予圧を下げることで心臓の作業負荷を低減している。臨床的には予圧は左心室拡張終期圧（ＬＶＥＤＰ）又は左心室拡張終期容積（ＬＶＥＤＶ）を含む様々な方法で定義される。生理学的には好適な定義は拡張終期の筋節の伸びの長さである。利尿剤は鬱血性心不全患者に予圧の増大した状態を作り出す過剰な細胞液を減少させる。硝酸塩、細動脈血管拡張神経剤、アンジオテンシン転換酵素阻害剤が使用され、後負荷の低減による心臓作業負荷の低減を通じて心不全を治療している。後負荷は駆出時に心室の壁で必要とされる張力又は応力として定義される。ジゴキシンのような強心剤は強心配糖体であり、心筋収縮の力及び速度を増大することで心搏出量を増大する役目を果たす。こうした薬物療法はある程度有益な効果を提供するが、疾患の進行を止めるものではない。
【０００７】
補助装置には機械式ポンプ及び電気式刺激器が含まれる。機械式ポンプは心臓が通常行うポンプ機能のすべて又は一部を行うことで心臓への負荷を低減する。現在、機械式ポンプは患者のために移植用のドナーの心臓が入手できるまで患者を維持するために使用される。拡張型心筋症の患者を治療するため、両心室ペーシングのような電気式刺激が研究されてきている。
【０００８】
心不全治療のために、１）心移植、２）動的心筋形成術、３）バティスタ（Ｂａｔｉｓｔａ）左室部分切除術という、少なくとも三つの外科的処置がある。心移植は臓器の利用可能性が制限されていることと、心移植後に必要となる免疫抑制療法の有害な影響とを含む重大な制限を有する。心筋形成術には心臓を骨格筋で包み、その筋を電気的に刺激し心臓と同期して収縮させ、心臓のポンプ機能を助けることが含まれる。バティスタ左室部分切除術には筋肉の壁の一部を切除することで外科的に左心室を再建することが含まれる。この処置によって拡張した心臓の直径が減少し、ひいては心臓の負荷が軽減される。しかし、この非常に侵入性のある処置は心臓の筋質量を減少させる。
【０００９】
【発明の開示】
本発明は弱った心臓を治療する非薬理学的受動装置及び方法に関する。本発明の装置は心臓壁の張力を低減するよう構成されている。本発明の装置は弱った心臓のエネルギ消費量を低減し、等容収縮を減少させ、収縮時の筋節の短縮を増大し、等張短縮を増大することで拍出量を増大するので、弱った心臓の疾患の進行を逆転、停止又は遅らせると考えられている。本発明の装置は拡張期と収縮期との両方で壁張力を低減する。
【００１０】
一実施形態において、本発明の装置には心腔の少なくとも二つの壁を互いの方向に引っ張り、少なくとも一つの断面で心腔の半径又は面積を減少させる引っ張り部材が含まれる。引っ張り部材はその両端に配置されて心臓又は腔の壁と係合するアンカ部材を有する。
【００１１】
別の実施形態では、本発明の装置には心腔の少なくとも二つの壁を互いの方向に引っ張る圧縮部材が含まれる。参考形態において、圧縮部材にはバルーンが含まれる。別の参考では圧縮部材を支持する枠が提供される。
【００１２】
また別の参考形態には、互いの方向に付勢された二つの端部を有し、心腔の少なくとも二つの壁を互いの方向に引っ張るクランプが含まれる。このクランプには少なくとも二つの端部が含まれ、これら端部はその上に配置されて心臓又は腔の壁と係合する非外傷性アンカ部材を有する。
【００１３】
また別の実施形態では、対向して配置された二つの端部を有する第１引っ張り部材と、第１及び第２の細長いアンカ部材とを含む心臓壁張力低減装置が提供される。第２の引っ張り部材を提供することもできる。一つの細長いアンカを二つの小さいアンカで代用してもよい。
【００１４】
心臓壁張力低減装置の代替実施形態では、細長い圧縮部材を提供することができる。第１及び第２の細長いレバー部材が好適には圧縮部材の両端から延びる。引っ張り部材が第１及び第２レバー部材の間に延びる。
【００１５】
上記の実施形態の圧縮部材は心臓の外部又は内部に配置される。引っ張り部材は腔（単数又は複数）を介して延び、レバー部材を心臓の方向に付勢する。
【００１６】
本発明による心臓壁張力低減装置のまた別の実施形態では、剛性のある細長い枠部材が提供される。枠部材は心臓の一つ又はそれ以上の腔を介して延びる。一つ又はそれ以上の片持部材が枠部材の両端に配置される。各片持部材にはその上に配置された少なくとも一つの非外傷性パッドが含まれる。枠部材の両端に配置された非外傷性パッドは互いの方向に付勢されて心腔を圧縮する。
【００１７】
心臓壁張力装置又は副子を人間の心臓に設置する一つの方法には、中空の針を心臓の少なくとも一つの腔を介して延ばして針の各端部が腔の外部にあるようにする工程が含まれる。可撓性のあるリーダが引っ張り部材の第１の端部に結合される。引っ張り部材の第２の端部が非外傷性パッドに結合される。リーダは針を介して針の一方の端部から他方の端部に進行せしめられる。リーダはさらに、引っ張り部材の第２の端部が心臓に近接し、引っ張り部材の第１の端部が心臓の外部に到るまで進行せしめられる。第１及び第２の非外傷性パッドが心臓と係合するように、第２の非外傷性パッドが引っ張り部材の第１の端部に結合される。
【００１８】
心臓壁張力低減装置を心臓に設置する代替方法には、案内部材を心臓の少なくとも一つの腔を介して延ばして案内部材の各端部が腔の外部にあるようにする工程が含まれる。この方法で使用される引っ張り部材は引っ張り部材の少なくとも一部を介して延びる少なくとも一つのルーメンを有する。案内部材はルーメン内に設置される。引っ張り部材の第１の端部が心臓の外側の一側に配置され、引っ張り部材の第２の端部が心臓の外側の他側に配置されるように、引っ張り部材は案内部材上を進行せしめられる。第１の非外傷性パッドは引っ張り部材の一方の端部に結合され、第２非外傷性パッドは引っ張り部材の反対側の端部に結合される。
【００１９】
心臓壁張力装置を心臓に設置するまた別の方法には、可撓性のある引っ張り部材が心臓の少なくとも一つの腔を介し取り外し可能に結合されている針を延ばして引っ張り部材の両端が腔の外部でかつその両側に露出するようにする工程が含まれる。針は引っ張り部材から取り外される。次いで、第１及び第２の非外傷性パッドが引っ張り部材の両端で引っ張り部材に結合される。
【００２０】
【発明を実施するための最良の形態】
同じ参照符号が多数の図面を通じて同じ構成要素を示す図面を参照すると、図１は人間の心臓１４の左心室１０及び右心室１２の横断面図を示す。引っ張り部材１８と、互いに対向して配置されたアンカ２０とを含む副子１６が左心室を介して延びる。副子１６は図１に示されるように、左心室１０の向かい合う壁を互いの方向に引っ張るよう配置され、左心室断面の「半径」又はその断面積を縮小し、左心室壁の応力を低減する。本明細書で開示される副子１６及びその代替装置は人間の心臓の左心室に関連して説明されるが、これらの装置を使用して横断又は鉛直方向、又は横断方向と鉛直方向との間の角度で、人間の心臓の他の腔の半径又は断面積を縮小することもできるということが理解されるべきである。
【００２１】
図２は参考形態を開示している。図２では、左心室に隣接してバルーン２００が配置される。バルーンの大きさ及び拡張の度合いを変化させて心臓１４の左心室１０の半径又は断面積を縮小させることができる。
【００２２】
図３は人間の心臓１４の左心室１０に関して配置されたまた別の参考形態を示す。ここでは圧縮枠構造３００が非外傷性アンカパッド３１０において心臓１４と係合せしめられる。非外傷性表面３１４を有する圧縮部材３１２が左心室１０の壁を押し、その半径又は断面積を縮小する。
【００２３】
図４はまた別の参考形態を示す、人間の心臓１４の横断面図である。この場合、互いの方向に付勢された非外傷性アンカパッド４１０を有するクランプ４００が、左心室１０の壁に配置されることが示される。ここでパッド４１０の間の部分を締め付けることによって、左心室１０の半径又は断面積が縮小される。パッド４１０を互いの方向に付勢しかつ／又は施錠装置によって保持することができる。
【００２４】
図１から図４で開示された様々な実施形態及び参考形態は各々、人体に無期限に埋め込むことのできる材料から製造される。こうした生体適合性材料は臨床医療用具の当業者には周知である。
【００２５】
図５は参照符号１１６によって示される、図１の副子の代替実施形態を示す。図５に示される実施形態には図１に示される単一の引っ張り部材１８と異なって、三つの引っ張り部材１１８が含まれる。図６は四つの引っ張り部材２１８を有する副子２１６のまた別の実施形態を示す。患者によっては弱った心臓の疾患が進んでいるため、図１で示される単一の引っ張り部材で可能な程度以上に心臓の壁応力を低減するために三つ、四つ又はそれ以上の引っ張り部材が望ましいということが予想される。
【００２６】
図７は左心室１０を示す人間の心臓１４の部分縦断面図である。図７には、左心室１０を介して延びる引っ張り部材３１８を有する別の副子実施形態３１６が示される。引っ張り部材３１８の両端に細長いアンカ又はパッド３２０が配置される。図８は細長いアンカ３２０を示す引っ張り部材３１８の端面図である。
【００２７】
図９は人間の心臓１４の部分縦断面図に配置された副子４１６の別の実施形態を示す。副子４１６には図７及び図８に示されたものと同様の細長いパッド４２０が二つ含まれる。しかし図９では、二つの引っ張り部材４１８は左心室１０を介して延び、心臓１４の両側でアンカ４２０と相互結合する。
【００２８】
図１０は左心室１０を示す心臓１４の縦断面図である。この場合、二つの副子１６が左心室１０を介して、鉛直方向に互いに間隔を置いて配置され、図９の構成に類似せしめられる。
【００２９】
図１１は心臓１４の左心室の縦断面図である。左心室１０を介して延びる二つの代替実施形態副子５１６が示される。各副子５１６には二つのアンカ又はパッド５２０を相互結合する二つの引っ張り部材５１８が含まれる。
【００３０】
図１２は心臓１４の左心室１０のまた別の縦断面図である。左心室１０を介して延びる副子の代替実施形態６１６が示される。副子６１６には細長いアンカパッド６２０と二つの短いアンカ又はパッド６２１が含まれる。副子６１６には二つの引っ張り部材６１８が含まれる。各引っ張り部材６１８はアンカ６２０と対応するアンカ６２１との間に延びる。
【００３１】
図１３は心臓１４の左心室１０の縦断面図である。心臓１４に配置された副子５０が示される。副子５０には左心室１０を介して延びることが示される圧縮部材５２が含まれる。圧縮部材５２の両端は左心室１０の外部に配置される。レバー部材５４が圧縮部材５２の各端部から心室１０の外面に沿って上向きに延びる。引っ張り部材５６がレバー部材５４の間に延び、レバー部材５４を心臓１４の方向に付勢して腔１０を圧縮する。圧縮部材５２は概ね剛体であるべきだが、レバー部材５４と、ある程度圧縮部材５２とは引っ張り部材５６がレバー部材５４を心臓１４の方向に付勢することができるのに十分な可撓性を有するべきである。代替可能には、引っ張り部材５６によって心臓１４の方向に付勢されるとき、レバー部材５４が蝶番回りに旋回できるようにレバー部材５４を圧縮部材５２に蝶着することができる。
【００３２】
図１４は図１３に示される副子の代替実施形態１５６を示す。この場合、副子１５０の圧縮部材１５２が左心室１０の外部に配置されているので、レバー部材１５４は部材５４よりも長い。
【００３３】
図１５は心臓１４の左心室１０の縦断面図である。副子の代替実施形態２５０が心臓１４の上に示される。好適には比較的剛性のある枠部材２５６が心室１０を介して延びる。片持部材２５４が枠２５０の両端に配置される。非外傷性パッド２５８が片持部材２５４に配置される。片持部材２５４は非外傷性パッド２５８が心臓を押して腔室１０を圧縮するように枠部材２５６に沿って配置される。図１６は片持部材２５４とパッド２５８を示す、枠部材２５６の端面図である。
【００３４】
これまで説明された各実施形態は当業者に周知の適切な生体適合性材料から形成されるべきことが理解されるべきである。引っ張り部材は可撓性を有し、又は比較的より剛性のある材料から形成される。圧縮部材及び枠部材は一般に剛性のある材料から形成され、負荷によって曲がるが、その形状を概ね保持する。
【００３５】
図１７は左心室１０及び左心房２２を示す、人間の心臓１４の部分断面図である。図１７に示されるように、心臓１４には動脈瘤又は虚血に関連する傷組織２４の範囲が含まれる。図１７に示されるように、傷組織２４は傷組織に影響された範囲で左心室１０の半径又は断面積を増大させる。左心室の半径又は断面積のこうした増大によって、左心室の壁応力が大きくなる。
【００３６】
図１８は図１７に示されるような心臓１４の縦断面図である。図１８では副子１６が設置され、傷組織２４を左心室１０の反対側の壁の方向に引っ張る。副子１６を設置した結果、傷組織２４に影響された左心室の半径又は断面積は縮小する。この半径又は断面積の縮小の結果、左心室壁の壁応力が低減され、心臓の吐出効率が改善される。
【００３７】
図１９は副子１６が設置された心臓１４の左心室１０及び左心房２２の縦断面図である。図１９に示されるように、副子１６には代替アンカ２６が示される。アンカ２６は好適にはその幅（図示せず）よりもはるかに大きい、図１９に示すような長さを有する細長い部材である。突発性拡張心筋症のような左心室１０の全体的な拡大が存在する場合、アンカバー２６を使用して左心室の半径又は断面積を縮小してもよい。この場合、バー式アンカ２６はアンカ２０よりも広く力を分散することができる。
【００３８】
図２０及び図２１はそれぞれ展開していない位置と展開した位置とにおける、アンカ２０と代替可能な蝶番付きアンカ２８の側面図である。アンカ２８には図２０に示されるように、バー式アンカ２６と同様の二つの脚が含まれる。蝶番付きアンカ２８に追加の脚が含まれてもよく、こうした脚の長さは心臓の壁の表面全体に力を分散させるために変更できる。さらに、アンカ２８に傘状の外観を与える膜を各脚の間に設けることもできる。好適には、膜は心臓の壁に接触する脚の表面に配置される。
【００３９】
図２２は捕獲ボール式アンカ３０の断面図である。捕獲ボール式アンカ３０はアンカ２０の代わりに使用されうる。捕獲ボール式アンカ３０にはアンカの力を心臓の壁に分散するディスク部分３２と、引っ張り部材３８の端部に固定されたボールを受けるくぼみ３４とが含まれる。ディスク３２及びくぼみ３４には側面溝が含まれるので、引っ張り部材３８はディスク３２の外側からくぼみ３４に通過できる。ディスク３２に向かい合うくぼみ３４の開口３８を介して引っ張り部材１８を引っ張ることで、ボール３６はくぼみ３４内に進行する。
【００４０】
図２３はクロスバー式アンカ４０の斜視図である。クロスバー式アンカ４０はアンカ２０の代わりに使用されうる。アンカ４０には好適には、パッド４２の開口４６の上に延びるクロスバー４４を有するディスク又はパッド部分４２が含まれる。引っ張り部材１８は図示されるように、開口を介して延び、クロスバー４２に結び付けられる。
【００４１】
使用の際、本発明の様々な実施形態は人間の心臓内又はその近くに設置され、心臓の少なくとも一つの腔の半径又は断面積を縮小する。これは心臓又は腔の壁の応力又は張力を低減して心不全の進行を遅らせるか、停止するか、又は逆行させるためになされる。図１に示される副子１６の場合、心臓の二つの壁を貫通するカニューレが使用することができ、副子の一端がカニューレを介して心臓の一方から反対側に進み、そこでアンカが固定又は展開される。同様に、アンカは副子１６の反対側で固定又は展開される。
【００４２】
図２４は心臓１４の腔１０の縦断面図である。内部に挿入されたスタイレットを有する針６０が腔１０に挿入される。図２５は図２４に示されたような心臓４０に配置された針６０を示す。図２５ではスタイレット６２は除去されている。引っ張り部材６４の一端に取り付けられた可撓性のあるリーダ６６を有する引っ張り部材６４が、針６０及びアンカ６８を通過する。
【００４３】
図２５に示されるように、引っ張り部材６４には二つの円筒形状端部７２を有する細長い円筒形状のシャフト７０が含まれる。端部７２の直径は好適にはシャフト７０の直径よりも大きい。図２５にはまた、アンカ６８を介して延びる開口７３を示すアンカ６８の斜視図が示される。開口７３にはアンカ６８を介して完全に延びる第１の円筒形開口７４が含まれる。開口７４の直径は好適には引っ張り部材６４の端部７２の直径よりもわずかに大きい。好適には引っ張り部材６４のシャフト７０の直径よりもわずかに大きい幅を有する溝７６が開口７４から円筒形状開口７８に延びる。円筒形状開口７８の直径は端部７２の直径にほぼ等しい。しかし、開口７４と異なって、開口７８には溝７６の幅とほぼ等しい幅を有する縮小された基部開口８０が含まれる。開口８０の幅も、引っ張り部材６４の端部７２の直径よりも小さい。
【００４４】
引っ張り部材６４を開口７４を介して、シャフト７０が内部に配置されるまで進めることができることが認識される。シャフト７０はその後溝７６を介して横に摺動されうる。引っ張り部材６４はその後、端部７２が開口７８に入り基部８０に入るまで開口７３を介して進められうる。
【００４５】
図２６は図２５に示される心臓１４の図を示す。針６０は心臓１４から除去されている。引っ張り部材６４は腔１０内に進められており、それに結合されたアンカ６８は心臓の壁と係合している。リーダ６６は心臓１４の反対側に配置されたまた別のアンカ６８を介して進められている。
【００４６】
図２７は図２６の心臓１４の図である。二つの引っ張り部材６４が腔１０を介して進められている。各引っ張り部材は対応する基部８０の対応する開口７８に着座し、図９に示されるような構成の副子を形成している。
【００４７】
他の引っ張り部材の副子構成も、各々同様に心臓に設置されうることが認識される。また、アンカ６８が最初に心臓に対して保持され、リーダ６６が針を介して延びる前に針６０がアンカ６８及び腔１０を介して進められることができることも認識される。
【００４８】
図２８は本発明による引っ張り部材１６４の斜視図である。引っ張り部材１６４は細長い円筒形状シャフト１７０と円筒形状端部１７２とを有する点で、上記で説明された引っ張り部材６４と同様である。しかし、ルーメンは軸線Ａに沿い引っ張り部材１６４を介して長手方向に延びる。
【００４９】
図２９は引っ張り部材２６４のまた別の実施形態の斜視図である。引っ張り部材２６４は引っ張り部材１６４と同様であり、細長い円筒形シャフト２７０と円筒形端部２７２を含む。しかし、ルーメン２８２は軸線Ｂと整列されて端部２７２を介し延びる。
【００５０】
図３０は心臓１４の左心室１０の縦断面図である。アンカ６８は心臓１４の両側に設置されている。針１６０は引っ張り部材１６４のルーメン、左心室１０、及びアンカ６８の開口７３を介して延びる。引っ張り部材６４がアンカ６８と左心室１０を介して進み、引っ張り部材６４に関して上記で説明されたように開口７８内に着座することが認識される。
【００５１】
図３１は心臓１４の左心室１０の縦断面図である。針６０が左心室１０の壁を介して進められ、案内ワイヤ１６２が針６０を介して進められている。
【００５２】
図３２は図３１で示されたものと同じ心臓１４の図である。しかし、針６０は心臓１４から除去され、案内ワイヤ１６２が所定位置に残っている。アンカ６８が、左心室１０の両側で案内ワイヤ１６２上に配置されている。引っ張り部材２６４がルーメン２８２を介して案内ワイヤ１６２に通されている。上記記載で引っ張り部材１６４に関して論じられたように、引っ張り部材２６４の端部２７２が対応する開口７８の基部８０に着座するように、引っ張り部材２６４が左心室１０を介して進むことが認識される。
【００５３】
図３３は心臓１４の左心室１０の縦断面図である。図３４では可撓性を有する引っ張り部材３６４が針３６０に結合されている。心室壁を介して左心室１０内に進む針３６０が示される。
【００５４】
図３４は引っ張り部材３６４が左心室１０及びアンカ６８を介して完全に進められている点以外は、図３３に示されたものと同じ心臓１４の図である。結び目３８４が引っ張り部材３６４の端部で結ばれ、引っ張り部材３６４の端部がアンカ６８の開口７３を通過するのを防止する。
【００５５】
特定の形状の心室を介して望ましい数の引っ張り部材を進行させるために、心室を介して引っ張り部材を進行させる上述した方法を繰り返すことができることが認識される。引っ張り部材の長さは患者の心臓の大きさ及び状態に基づいて決定される。また、ここでは例示目的で左心室が言及されているが、本発明の装置及び方法を使用して右心室や他の心房と同様、患者の心臓の多数の腔に副子を施すこともできることに注意すべきである。
【００５６】
図３５は参考形態を示す、心臓１４の左心室１０の縦断面図である。心臓の周囲に帯７１６が配置される。帯７１６の心臓に対する寸法は、帯の長さ方向に対し平行な平面内での心臓の半径又は断面積が、帯を心臓に設置する前の位置での半径に対し縮小されるように、決定されている。帯に対し垂直方向の心臓の長さも増大される。帯は心臓の半径縮小及び延長の望ましい効果を提供するのに十分な強度を有する弾性材料、又は他の生体適合性材料からなる連続するリボンから形成されうる。
【００５７】
図３６は円筒又は理想化された心腔４８の図であり、本発明による副子を配置した結果としての心腔の壁応力の低減を例示するために使用される。ここで使用されるモデル及びこのモデルに関する計算は単に心腔内の壁応力が低減される機構を例示することだけを目的とするものである。実際の低減を定量化する努力はなされず、それは何らかの特定の生体内適用業務で実現される。
【００５８】
図３７は図３６の理想化された心腔４８の図であるが、そこでは長さに沿って「数字の８」形の断面が形成されるように、腔が長さＬに沿って副子を施されている。図３６の腔の横断面図の外周が、図３７の数字の８形横断面図の外周と等しいことに注意されたい。このモデルの目的のため、断面図の向かい合う円形突部は鏡像であると想定される。
【００５９】
図３８は図３７の副子が施された理想化された心腔の図１の断面図の様々なパラメータを示す。ここで１は腔の向かい合う壁の間の副子の長さであり、Ｒ2は各円形突部の半径であり、θは副子の腔４８内の部分の両端に延びる一つの円形突部の二つの半径の間の角度であり、ｈは二つの半径と副子の腔４８内の部分とによって形成される三角形の高さである（Ｒ1は図３６の円筒形の半径である）。これらの様々なパラメータは以下のように関連付けられる。
ｈ＝Ｒ2ＣＯＳ（θ／２）
ｌ＝２Ｒ2ＳＩＮ（θ／２）
Ｒ2＝Ｒ1π／（２π−θ）
【００６０】
これらの関係から、数字の８形断面の面積が次式によって計算される。
Ａ2＝２π（Ｒ2）2（１−θ／２π）＋ｈｌ
【００６１】
図３６に示されるように腔４８に副子が施されていない場合、円筒形のもとの断面積であるＡ1はＡ2に等しく、θ＝１８０°、ｈ＝０、ｌ＝２Ｒ2である。容積はＡ2と長さＬとの積に等しく、周囲壁張力は腔内の圧力とＲ2と腔の長さＬとの積に等しい。
【００６２】
すなわち、例えば、もとの円筒形半径が４ｃｍで腔内の圧力が１４０ｍｍＨｇの場合、円筒形の壁の壁張力Ｔは１０４．４Ｎである。ｌ＝３．８４ｃｍになるように、３．８４ｃｍの副子を図３７及び図３８に示されるように設置する場合、壁張力Ｔは７７．３３Ｎである。
【００６３】
図３９及び図４０は数字の８形断面に対する壁張力Ｔ及び圧力Ｐの仮定的な分布を示す。θが１８０°から０°に変化すると副子の張力ＴＳは０から２Ｔの負荷に変化し、腔壁はＴの負荷を支える。
【００６４】
また別の例では、腔の長さＬが１０ｃｍで一定であり、かつもとの半径Ｒ１が４ｃｍであると想定すると、１４０ｍｍＨｇで壁張力は７４．７Ｎである。ｌ＝４．５ｃｍとなるように４．５ｃｍの副子が配置されると、壁張力は５２．８Ｎになる。
【００６５】
この開示は多くの点で単に例示的であることが理解されるべきである。細部、特に形状、大きさ、材料及び部品の配置の点で、本発明の範囲を越えることなく変更がなされうる。従って、本発明の範囲は添付の請求の範囲の語句で定義されたとおりである。
【図面の簡単な説明】
【図１】図１は本発明による副子の配置を示す、人間の心臓の左右心室の横断面図である。
【図２】図２は参考形態によるバルーン装置の配置を示す、人間の心臓の左右心室の横断面図である。
【図３】図３は参考形態による外部圧縮枠構造の配置を示す、人間の心臓の左右心室の横断面図である。
【図４】図４は参考形態によるクランプを示す、人間の心臓の左右心室の横断面図である。
【図５】図５は図１の副子が三つの引っ張り部材を有する変更態様を示す、人間の心臓の左右心室の横断面図である。
【図６】図６は図１に示される副子が四つの引っ張り部材を有する変更態様を示す、人間の心臓の左右心室の横断面図である。
【図７】図７は本発明による副子の代替態様を示す、人間の心臓の左心室の縦断面図である。
【図８】図８は図７に示される副子の端部である。
【図９】図９は本発明による副子の別の代替実施形態を示す、人間の心臓の腔の縦断面図である。
【図１０】図１０は本発明による副子の別の代替構成を示す、人間の心臓の腔の縦断面図である。
【図１１】図１１は本発明による副子の代替実施形態を示す、人間の心臓の腔の縦断面図である。
【図１２】図１２は本発明による副子の別の実施形態を示す、人間の心臓の腔の縦断面図である。
【図１３】図１３は本発明による副子の圧縮部材の態様を示す、人間の心臓の腔の縦断面図である。
【図１４】図１４は図１３に示される副子の別の態様を示す、人間の心臓の腔の縦断面図である。
【図１５】図１５は本発明による副子の枠部材の態様を示す、人間の心臓の腔の縦断面図である。
【図１６】図１６は図１５の副子の端面図である。
【図１７】図１７は左心室が傷組織を有する、左心室及び心房の縦断面図である。
【図１８】図１８は図１の副子が傷組織を左心室の反対側の壁の方向に引っ張っていることを示す、図７の心臓の縦断面図である。
【図１９】図１９は図１の副子の細長いアンカバーを有する態様を示す、人間の心臓の左心室と心房の縦断面図である。
【図２０】図２０は展開されない蝶番付きアンカ部材の側面図である。
【図２１】図２１は展開された図２０の蝶番付きアンカ部材の側面図である。
【図２２】図２２は捕獲ボール式アンカ部材の断面図である。
【図２３】図２３はクロスバー式アンカ部材の斜視図である。
【図２４】図２４は本発明による副子を配置するために使用される針を示す、人間の心臓の腔の縦断面図である。
【図２５】図２５は心臓に配置された引っ張り部材を示す、図２４の心臓及び針の図である。
【図２６】図２６は反対側に配置されたアンカ部材が引っ張り部材によって接合されている、図２４に示す心臓の図である。
【図２７】図２７は二つの反対側に配置されたアンカパッドが二つの引っ張り部材によって接合された、図２４の心臓の図である。
【図２８】図２８は貫通して延びるルーメンを有する引っ張り部材の図である。
【図２９】図２９は貫通して延びるルーメンを有する引っ張り部材の図である。
【図３０】図３０は心臓の腔と二つのパッド、及び貫通して延びる針の縦断面図である。
【図３１】図３１は貫通して延びる案内ワイヤを示す、心臓の腔の縦断面図である。
【図３２】図３２は図３１の心臓と二つのパッド、及び貫通して延びる案内ワイヤの図である。
【図３３】図３３は腔に挿入された引っ張り部材に結合された針を示す、心臓の腔の縦断面図である。
【図３４】図３４は引っ張り部材によって結合された二つのアンカを示す、心臓の腔の縦断面図である。
【図３５】図３５は心臓を取り囲む帯を示す、心臓の腔の縦断面図である。
【図３６】図３６は人間の心臓の左心室の理想化円筒形モデルである。
【図３７】図３７は図１４の左心室の副子を施したモデルである。
【図３８】図３８は様々なモデル化パラメータを示す、図１５の横断面図である。
【図３９】図３９は仮定的な力の分布を示す、図１５の副子を施した左心室の横断面図である。
【図４０】図４０は仮定的な力の分布を示す、図１５のモデル左心室の第２横断面図である。

Claims (16)

  1. 心臓を治療するための受動装置において、
    該心臓の腔を横切って延びる受動部材であって、該腔の壁に隣接配置されるべく構成された受動部材と、
    該受動部材に結合されて該腔の壁の外面に係合するアンカ機構と、
    を具備し、
    該腔の半径又は断面積を減少させて心臓壁張力を減少させるように、該腔の壁の部分を互いに引き寄せるべく構成され、該腔のすべての内側部位を流体が直接的に流通し続ける受動装置。
  2. 少なくとも拡張期に前記腔の壁の部分を互いに引き寄せるべく構成されている請求項１に記載の受動装置。
  3. 心周期を通じて前記腔の壁の部分を互いに引き寄せるべく構成されている請求項１に記載の受動装置。
  4. 前記腔の壁の部分が互いに引き寄せられる量が、腔を横切って延びる前記受動部材の長さにより定まる請求項１に記載の受動装置。
  5. 心臓を治療するための受動装置において、
    該心臓の腔を横切って延びる受動部材であって、該腔の壁の複数部分に隣接配置されるべく構成された受動部材と、
    該受動部材に結合されて該腔の壁の外面に係合するアンカ機構と、
    を具備し、
    該腔のすべての内側部位を流体が直接的に流通し続けるように、該腔の形状を変更しかつ該腔の半径又は断面積を減少させて心臓壁張力を減少させるべく構成されている受動装置。
  6. 少なくとも拡張期に前記腔の形状を変更すべく構成されている請求項５に記載の受動装置。
  7. 心周期を通じて前記腔の形状を変更すべく構成されている請求項５に記載の受動装置。
  8. 前記腔の形状が変更される量が、該腔を横切って延びる前記受動部材の長さにより定まる請求項５に記載の受動装置。
  9. 心臓を治療するための受動装置において、
    該心臓の腔を横切って延びる受動部材であって、該腔の壁の複数部分に隣接配置されるべく構成された受動部材と、
    該受動部材に結合されて該腔の壁の外面に係合するアンカ機構と、
    を具備し、
    該腔のすべての内側部位を流体が直接的に流通し続けるように、該腔の半径を減少させて心臓壁張力を減少させるべく構成されている受動装置。
  10. 少なくとも拡張期に前記腔の半径を減少すべく構成されている請求項９に記載の受動装置。
  11. 心周期を通じて前記腔の半径を減少すべく構成されている請求項９に記載の受動装置。
  12. 前記受動部材が互いに対向する第１及び第２の端部を含み、前記アンカ機構が、これら第１及び第２の端部のそれぞれに設けられたアンカ機構を含んでなる請求項１，５，９のいずれか一項に記載の受動装置。
  13. 前記受動部材が、前記腔を横切って配置されるべく構成された引っ張り部材である請求項１，５，９のいずれか一項に記載の受動装置。
  14. 前記腔の半径の減少される量が、該腔を横切って延びる前記部材の長さにより定まる請求項９に記載の受動装置。
  15. 前記受動部材が、前記腔を横切って配置されるべく構成された複数の部材である請求項１，５，９のいずれか一項に記載の受動装置。
  16. 前記受動部材が、前記腔の外部に位置し続けるようになっている請求項１，５，９のいずれか一項に記載の受動装置。
JP53029298A 1997-01-02 1997-12-31 心臓壁張力を低減する装置 Expired - Lifetime JP4294735B2 (ja)

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CA2275766A1 (en) 1998-07-09
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US6514194B2 (en) 2003-02-04
US6162168A (en) 2000-12-19
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US6165119A (en) 2000-12-26
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US6793618B2 (en) 2004-09-21
JP2001508336A (ja) 2001-06-26
US6755777B2 (en) 2004-06-29
US20040167374A1 (en) 2004-08-26
EP1011461A1 (en) 2000-06-28
IL130653A0 (en) 2000-06-01
IL130653A (en) 2004-06-01
US20030166992A1 (en) 2003-09-04
ATE367768T1 (de) 2007-08-15
JP4339909B2 (ja) 2009-10-07
CA2275766C (en) 2007-04-17
WO1998029041A1 (en) 1998-07-09

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