JP2010119888A - 治療用組織拡張デバイス - Google Patents
治療用組織拡張デバイス Download PDFInfo
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Abstract
【解決手段】開口を画成または管側壁を形成している対向部分をデバイス平面内で外方に拡張または付勢する。この外方への付勢により、開口の対向表面はデバイス平面に垂直な方向に引かれ、並置または接触させられることで、開口が閉鎖される。
【選択図】図30A
Description
図1に示すように、左房室弁すなわち僧帽弁2は二尖(2リーフレット)弁であり、心臓10の左心室8と左心房6との間のオリフィス4に位置している。酸素を豊富に含む血液は、肺から肺静脈を通って左心房6を流れ、僧帽弁2を通過して左心室8に流れ込む。血液はここで大動脈16に圧送され、さらに身体に分配される。僧帽弁2はリーフレット18および20を有し、これらが互いに並置状態となっていることで、リーフレットに平行な弁の面がリーフレット間に画成される。僧帽弁2は一方向弁であって、リーフレット18および20が弁平面22に垂直な方向に互いに離れるよう移動することで左心室8内への流入が許容される。そして、大動脈16を通じて血液を圧送するための左心室8の収縮時に、左心室8内に生じる圧力上昇に応じて、互いに近接(また、「癒合」として知られている)する。健常な弁においては、リーフレットは通常互いにシール(癒合)し、左心房6を通じた肺への逆流が阻止される。しかし疾患のある僧帽弁では、リーフレットは左心房内への脱出(prolapse)を生じさせ、血液の逆流を許してしまう。
図2に示すように、ヒトの循環系の静脈24は26および28で示すような一方向弁のシステムを有しており、2つのリーフレット30および32を具えている。これらは、心拍間での末端部への血液の逆流を阻止しながら、末端部から心臓へ戻る血液の流れを促進するべく作動する。また静脈弁26および28は協働して、循環系の静脈側から心臓へ戻る血液のポンピングを助ける筋肉の動きを許容する。様々な筋肉34の収縮が静脈の収縮を生じさせる傾向があり、これが血液を静脈から流出させる。静脈弁26および28は、弁26が閉じたままとなっているときに弁28が開くように協働し、心臓に戻る一方向への流れのみが許容される。
図3に示すように、小嚢性動脈瘤36は、身体の動脈40の分岐部38に発生する動脈壁42の袋状形成物であって、動脈枝40間の分岐点44から外方に延在する。動脈瘤36は動脈40との連結部をなす径が減少した頸部46を有しており、ドーム48によってキャップされている。動脈瘤の形成過程で、頸部46の部位には動脈内弾性板が見られなくなり、壁42は薄く脆くなり、結合組織が平滑筋細胞に取って代わる。動脈瘤はドーム48の部位で破れやすく、この結果出血が生じる。
図1に示すように、孔(foramen)3は心臓の左右心房(それぞれ、符号6および7)間の筋肉組織の開口である。この開口は、誕生前に母体と胎児との間で血液の流れを許容するために存在している。誕生後には、孔3は通常閉塞されて心房を分離し、乳児の心臓が血液の圧送を行えるようになる。卵円孔開存症は、誕生後にも孔が閉塞されない心臓の欠陥であり、心房間の血液の漏洩を許してしまう。この欠陥は、肺塞栓(pulmonary embolism)および卒中(stroke)の危険を高めるものとなる。
図1Bは図1における1B−1B線に沿った部分断面図であり、左心房6から延在して肺動脈幹9に隣接する心耳5を示している。心耳5はほぼヒトの親指の寸法であり、どのような有用な機能を果たすものかは判っていない。しかしこれは血栓の形成の原因であり、非リウマチ性心房細動ないしは不整脈に伴う発作の90%の原因はこれにあると考えられている。脳梗塞の危険性は、心耳5を左心房6に対して閉じることで大きく低減される。
図1Cに示される心房中隔欠損症は、左心房6および右心房7を分離する中隔すなわち壁15の開口13に特徴がある。同様に、心室中隔欠損症は、左心室8および右心室11を分離する中隔19の開口17に特徴がある。かかる開口は心房間または心室間の血液の流れを許してしまう。
(A)例えば弁の開口面、小嚢性動脈瘤の頸部または左右心房間の開口など、管または開口内に付勢デバイスの脚部を位置づけるステップ、および
(B)互いに離隔している関係にある脚部を付勢し、脚部が開口または管の第1対向部を外方に付勢するようにすることで、例えば弁のリーフレット、動脈瘤の頸部、または開口を形成している対向側部などの側壁部が互いに並置される方向に引かれるようにするステップ、
を具える。
付勢デバイスにシュラウドがないとすると、血流に露出する脚部セグメントが血栓形成の中心となり、これが剥れると卒中を引き起こし得る。シュラウド190によってマトリクスが提供され、そのマトリクス上に血液細胞が付着可能となり、やがては生きている細胞内で付勢デバイスを密閉するものとなる。そのように密閉することで、デバイスの脚部はもはや凝結反応を生じさせるものではなくなるので、血液凝固および卒中の恐れを最小化ないしは排除することができる。
本発明に係るデバイスの種々の使用例を以下に説明する。示される特定の実施形態やその適用に関する特定の使用は、何らの限定を宣明するものでもなく、示唆するものでもないことを理解されたい。
僧帽弁の修復
図16は弾性変形した形状のスリーブ198形態のシュラウド190内に収納される付勢デバイス90を示し、脚部セグメント112、122および132が脚部セグメント114、124および134の近くに位置することで、デバイス90がカテーテル166のルーメン164内で嵌合摺動可能となっている。図8の形状であるとすると、デバイス90は弾性的に付勢され、脚部セグメント112、122および132が脚部セグメント114、124および134と離隔した関係となる。カテーテル166から解放されるとデバイス90はこの離隔形状となるが、カテーテルが拘束力を作用させることで、脚部セグメントが弾性変形した近接形状に保持される。デバイスのこの弾性によって、カテーテルを介し脈管系を通じてデバイスを移送し、移植すべき部位に位置づけることが可能となり、外傷を生じる侵襲的な外科手術を伴うことがない。次に、本発明に係るデバイスは、公知の方法、例えばプッシュロッドを用いてカテーテルから解放され、離隔形状をとり、それが位置づけられた管の柔軟な側壁を付勢する。
静脈弁の修復
図2および図2Aは静脈24内に移植される本発明に係る付勢デバイス90を示し、これは自制できない(incontinent)静脈弁26の修復に有効なものである。僧帽弁の修復と同様に、カテーテル166(図10参照)から出ると、デバイス90は静脈24内で脚部セグメントを弁26の平面22と同一平面に展張する。図2Aに示すように、リーフレット30および32の部位における静脈24の対向部分174および176にアンカー基体126および128が係合し、対向する静脈部分を外方に付勢することで、弁リーフレット30および32は弁26の平面22に直交する方向に互いに引き寄せられる。図2に示すように、リーフレット18および20が互いに近接するよう位置づけることで、筋肉34により静脈24内に矢印175で示すように背圧が作用するとき、リーフレット18および20はむしろ効果的にシールを行えるようになる。自制できない他方の弁が修復されることによって、血液は矢印177で示すように望ましい方向に静脈24内を流れることになる。
小嚢性動脈瘤の修復
図3および図3Aは小嚢性動脈瘤に位置づけられるデバイス90を示す。デバイス90はカテーテルから出て展張し、動脈瘤36の頸部46にアンカー基体126および128を位置づける。アンカー基体126および128は頸部46の対向部分178および180に係合し、これらを外方に付勢することで、頸部の対向部分182および184をデバイス90の平面に直交する方向に互いに引き寄せる。動脈瘤36の頸部46に対するデバイス90の付勢作用によって、図3に示すように頸部が締め付けられ、動脈瘤への血液の流入が減る。これによりドーム48の圧力が減少し、頸部46に停滞領域を提供して凝固を促進し、ついには動脈瘤をシールすることでその破裂を防止することができる。好ましくは、デバイス90は単一の中心層196をなす実施形態のシュラウド188を有する。中心層196はマトリクスを提供し、マトリクス内に頸部の対向部分182および184から細胞が成長してゆくことで、動脈瘤を恒久的にシールして循環系から分離することができる。
心耳の閉鎖
図1Bは肺動脈幹9に隣接して左心房6に位置する心耳5を示す。この心耳5を効果的に閉鎖するために、図18に示すように、例えば符号88で示す付勢デバイスを心耳5に挿入することができ、心耳を心房内に潰すことで、卒中につながる血液凝固が発生する原因と考えられる心耳を除去する。付勢デバイス88をカテーテルを介して挿入することで、この心臓欠陥を強制するための侵襲的技術の適用を最小限にすることができる。
卵円孔開存症および中隔欠損症の治療
卵円孔開存症(図1の符号3)や心房および心室中隔欠損(図1Cの符号13および17)など、血液の異常な流れを許容してしまうような心臓の筋肉組織内の開口に関連した欠陥は、その開口に本発明に係る付勢デバイスを挿入することで治療可能である。カテーテルを用いて付勢デバイスを挿入し、ここから解放すると、付勢デバイスが展張する。これは、脚部セグメントの弾性付勢力によって、または、加熱により所定形状に展張する形状記憶金属の特有の性質によって行われる。付勢デバイスは筋肉組織を伸ばし、対向部分を並置させて互いに接触させ、あるいは、組織が成長して開口を恒久的にシールできるようにするシュラウド層の対向側部に接触させる。
流体の流れの制御
血液以外の流体を導く食道、尿道およびその他の管にも障害が生じ得る。例えば、胃食道逆流の一因として、食道と胃との間の下部食道括約筋の安静状態(resting tone)の減退(decrease)がある。下部食道括約筋が胃酸の食道への流入を許し、これを損傷してしまうことで、通常「胸焼け」として知られている不快感を生じさせる。漏れを生じさせる括約筋は、その径内に本発明に係る付勢デバイスを位置づけてこれを伸ばすことで締め付けることができ、これにより安静時の開口サイズを減らして胃酸の逆流を防ぐことができる。
Claims (11)
- 心臓の卵円孔開存症の開口内に位置づけ可能な付勢デバイスであって、該デバイスはカテーテルを通じた挿入に適するよう変形した第1形状を有するとともに、前記カテーテルから解放されたときに自動的に第2形状に拡張可能であり、
同一平面上に配置され、前記付勢デバイスの前記第2形状への拡張を通じて前記卵円孔開存症の開口の対向側部上の対向部分に係合して外側に拡張させ、前記卵円孔開存症の対向表面を付勢デバイスに向けて引き寄せることで前記卵円孔開存症の開口を閉鎖するべく作動可能な第1および第2のセグメントであって、前記第1のセグメントおよび前記第2のセグメントは、前記第1形状において互いに近接し、前記第2形状において互いに距離を置いた関係となるように構成および配置され、第1カラーおよび第2カラーにそれぞれ取り付けられている当該第1のセグメントおよび第2のセグメントと、
前記付勢デバイスが前記第2形状にあるときに、前記卵円孔開存症の開口に隣接する柔軟な組織に係合するよう構成および配置された第1および第2のアンカーと、
フレームに支持され、前記第1および第2のセグメント間に延在するシュラウドと、
を具えたことを特徴とする付勢デバイス。 - 前記シュラウドは織り交ぜられたフィラメント状部材を複数具え、当該複数のフィラメント状部材間に複数の間隙が形成されていることを特徴とする請求項1に記載の付勢デバイス。
- 前記複数の間隙は生きている組織の内側への伸びを促進する寸法となっていることを特徴とする請求項2に記載の付勢デバイス。
- 前記シュラウドが金属で形成されていることを特徴とする請求項1に記載の付勢デバイス。
- 前記シュラウドがポリマーで形成されていることを特徴とする請求項1に記載の付勢デバイス。
- 前記フレームは、前記付勢デバイスの前記第2形状への拡張を通じて前記卵円孔開存症の開口の対向側部上の対向部分に係合して外側に拡張させるべく作動可能な第3および第4のセグメントをさらに具え、該第3および第4のセグメントは、前記第1形状において互いに近接し、前記第2形状において互いに距離を置いた関係となるように構成および配置されていることを特徴とする請求項1に記載の付勢デバイス。
- 前記付勢デバイスが前記第2形状にあるときに、前記卵円孔開存症の開口に隣接する柔軟な組織に係合するよう構成および配置された第3および第4のアンカーをさらに具えたことを特徴とする請求項1に記載の付勢デバイス。
- 前記第1および第2のセグメントの少なくとも一方がフック部を含んでいることを特徴とする請求項1に記載の付勢デバイス。
- 前記第1および第2のカラーを通してガイドワイヤが挿入可能であることを特徴とする請求項1に記載の付勢デバイス。
- 前記第1および第2のカラーの少なくとも一方が放射線不透過性材料を含んでいることを特徴とする請求項1に記載の付勢デバイス。
- 少なくとも、前記第1のアンカーの少なくとも一部がタンタル製コイルで被覆されていることを特徴とする請求項1に記載の付勢デバイス。
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- 2004-05-19 WO PCT/US2004/015734 patent/WO2004103209A2/en active Application Filing
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2005
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Also Published As
Publication number | Publication date |
---|---|
EP2191790A3 (en) | 2012-10-17 |
EP1648340A4 (en) | 2007-12-19 |
US20060178694A1 (en) | 2006-08-10 |
JP4547381B2 (ja) | 2010-09-22 |
WO2004103209A9 (en) | 2005-01-13 |
EP1648340B1 (en) | 2010-03-03 |
WO2004103209A2 (en) | 2004-12-02 |
US7122043B2 (en) | 2006-10-17 |
CN1852688A (zh) | 2006-10-25 |
EP1648340A2 (en) | 2006-04-26 |
JP4940318B2 (ja) | 2012-05-30 |
JP2007501093A (ja) | 2007-01-25 |
DE602004025814D1 (de) | 2010-04-15 |
US20060009799A1 (en) | 2006-01-12 |
US7648532B2 (en) | 2010-01-19 |
EP2191790A2 (en) | 2010-06-02 |
US20090275976A1 (en) | 2009-11-05 |
WO2004103209A3 (en) | 2005-12-29 |
US8758395B2 (en) | 2014-06-24 |
US20050049681A1 (en) | 2005-03-03 |
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