JP2010042280A - 心臓弁送達ための方法およびシステム - Google Patents
心臓弁送達ための方法およびシステム Download PDFInfo
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Abstract
【解決手段】心臓12中、または心臓の尖部またはその近傍に送達デバイスを導入するための方法およびシステムを提供し、ここで、この送達デバイスは補綴具29を含み、この補綴具を標的部位に進行する工程、およびこの補綴具を上記送達デバイスから、移植のために標的部位で取り外す工程を含む。詳細には、本発明は、置換心臓弁を、心臓中またはその近傍の標的部位に送達するための弁置換システムを提供する。この弁置換システムは、心臓の尖部またはその近傍で心臓を貫通するためのトロカールまたはその他の適切なデバイス、このトロカール内に移動可能に配置される送達部材、および上記送達部材上に配置された置換心臓弁を備える。上記送達部材は、さらに、標的部位において補綴具弁の移植を容易にするための機械的または膨張可能な拡大部材をさらに備え得る。
【選択図】図1
Description
本発明は、一般に、心臓血管手術のための方法およびシステムに関する。より詳細には、本発明は、心臓弁の修復、除去、および/または置換のため、そしてまた心臓血管手術の間の一時弁および/または遠位栓塞保護を提供するための方法およびシステムに関する。
(弁の輪を収縮する)輪状形成術、(弁の小葉を狭める)四角切除、(弁の小葉を分離するための弁交連を切断する)交連切開術、または弁および輪組織の脱灰のような、種々の外科的技法が、疾患または損傷心臓弁を修復するために用いられ得る。あるいは、疾患腎臓弁は、補綴具弁によって置換され得る。心臓弁の置換が示される場合、この機能不全弁は、代表的には、除去され、そして機械的または組織弁のいずれかで置換される。組織弁は、しばしば、機械的弁より好まれる。なぜなら、それらは、代表的には、抗凝固剤での長期間処理を必要としないからである。
本発明は、心臓血管手術を実施するための方法およびシステムを提供し、ここで、心臓または大血管への接近が、心臓の尖部領域を通じて提供される。この心臓の尖部領域は、一般に、左心室および右心室によって形成される心臓の鈍い丸まった下部末端である。モ通常の健常なヒトでは、それは、中央胸骨線から第5肋間スペースの後にある。
より特定すれば、本願発明は以下の項目に関し得る。
(項目1)
心臓中または心臓近傍の標的部位に補綴具を送達する方法であって:
心臓の尖部またはその近傍で、心臓中に送達デバイスを導入する工程であって、上記送達デバイスが補綴具を含む、工程;
上記補綴具を上記標的部位に進行する工程;および
上記標的部位で、上記送達デバイスから上記補綴具を外す工程、を包含する、方法。
(項目2)
手術の間に上記心臓を造影する工程をさらに包含する、項目1に記載の方法。
(項目3)
上記心臓を造影する工程が:超音波観察器具、血管内超音波システム、経食道エコーシステム、経胸腔エコーシステム、蛍光透視法、蛍光像映画撮影、および注入可能な放射線不透過性色素からなる群から選択される造影システムによって実施される、項目2に記載の方法。
(項目4)
上記補綴具が、一時弁である、項目1に記載の方法。
(項目5)
上記補綴具が、遠位栓塞保護アセンブリである、項目1に記載の方法。
(項目6)
上記補綴具が、置換心臓弁である、項目1に記載の方法。
(項目7)
上記標的部位が、大動脈弁および僧帽弁からなる群から選択される、項目6に記載の方法。
(項目8)
上記送達デバイスが、上記心臓の左心室中に導入される、項目7に記載の方法。
(項目9)
上記標的部位が、肺弁および三尖弁からなる群から選択される、項目6に記載の方法。
(項目10)
上記送達デバイスが、上記心臓の右心室中に導入される、項目9に記載の方法。
(項目11)
上記置換心臓弁が、支持構造体に固定された組織弁を備える、項目6に記載の方法。
(項目12)
上記支持体構造が、半径方向に折り畳み可能で、かつ拡大可能な円筒形ステントである、項目11に記載の方法。
(項目13)
上記円筒形ステントが、Nitinolから作製される、項目12に記載の方法。
(項目14)
上記送達デバイスから補綴具を外す工程の前に、機能不全または疾患ネイティブ弁を除去する工程をさらに包含する、項目6に記載の方法。
(項目15)
上記ネイティブ弁を除去する工程の前に、上記標的部位の近傍に遠位栓塞保護アセンブリを移植する工程をさらに包含する、項目14に記載の方法。
(項目16)
上記ネイティブ弁の領域を洗浄する工程をさらに包含する、項目6に記載の方法。
(項目17)
置換弁を、心臓中または心臓近傍の標的部位に送達するための弁置換システムであって:
心臓の尖部またはその近傍で上記心臓を貫通するためのトロカール;
上記トロカール内に移動可能に配置された送達部材であって、遠位端および近位端、ならびに拡大および収縮部材を有する送達部材;および
上記送達部材の拡大および収縮部材上に配置された置換心臓弁、を備える、システム。
(項目18)
上記トロカールが、内部管腔および上記内部管腔内に配置されたストップバルブを備える、項目17に記載のシステム。
(項目19)
上記送達部材が、中空チューブである、項目17に記載のシステム。
(項目20)
上記送達部材が、超音波トランスデューサーをさらに備える、項目17に記載のシステム。
(項目21)
上記送達部材中に、バルーンの両端部に第1および第2の超音波トランスデューサーをさらに備える、項目20に記載のシステム。
(項目22)
カテーテルが、先端部取り付け具をさらに備える、項目17に記載のシステム。
(項目23)
上記先端部取り付け具が、遠位栓塞保護システム、一時弁、造影システム、弁除去システム、および弁洗浄システムからなる群から選択される、項目22に記載のシステム。
(項目24)
上記送達部材が、内部要素をさらに備える、項目17に記載のシステム。
(項目25)
上記内部要素が、ガイドワイヤを挿入するため、または上記先端部の曲げを制御するための引っ張りワイヤを挿入するために用いられる、項目24に記載のシステム。
(項目26)
上記内部要素が、上記拡大および収縮部材のための流体注入導管である、項目25に記載のシステム。
図1〜13は、心臓弁の修復、除去、および/または置換のため、そしてまた心臓血管手術の間に遠位栓塞保護および一時弁を提供するための方法およびシステムの実施形態を示す。
図1は、患者(10)の胸部(11)の部分前部図であり、そして胸骨(13)、剣状突起(14)、肋骨(15)、および心臓(12)のようなその他の解剖学的目印に対する弁置換システム(29)の位置を示す。この弁置換システム(29)は、第5肋間スペース(16)を通り、そして心臓(12)の尖部を通って身体の腔に入るように描写されている。この弁置換システム(29)は、胸部(11)中の種々のその他の位置(17A、17Bおよび17C)を通って身体の腔に入り得る。
操作の場を見るための造影システムは、手術の持続時間の任意の時間、またはその間中用いられ得る。造影システムは、当業者に周知であり、そして経食道エコー、経胸腔エコー、血管内超音波造影(IVUS)、または放射線不透過性である注入可能な色素を含む。蛍光像映画撮影もまた利用され得る。1つの実施形態では、この造影システムは、カテーテルまたはカニューレを通じて操作の場まで送達可能である。
本発明はまた、心臓の尖部領域を通る接近により、弁除去デバイスとともに、弁を除去するための方法およびシステムを提供する。例により、この弁除去は、それらの全体が提示されるように、参考として本明細書中に援用される、同時係属中の米国特許出願番号第10/375,718号および同第10/680,562号に教示されるように達成され得る。
血管また心臓弁のような心臓血管組織上のアテローム性動脈硬化症プラークの形成は、心臓血管疾患の主要構成要素である。種々の異なる方法が、石灰化アテローム性動脈硬化症プラークおよび損傷にともなう心臓血管疾患を処置するために開発されている。このような方法は、バイパス手術、バルーン血管形成,機械的病巣清掃術、アテローム切除術、および弁置換のような、損傷の機械的除去または減少を含む。
弁置換手術の間、置換されているネイティブな弁の機能は停止され、そして心臓中の自然な流体流れの血流は、それ故、破壊される。これは、次いで、心臓および血管中の有意な逆流血液圧力を生じ得る。それ故、置換弁手術の間に、自然の弁機能が停止されるとき、生じる逆流血圧を防ぐか、または減少する必要性がある。
弁修復または置換手術では、重度に石灰化された弁の操作は、次の栓塞および詰まりをともなうカルシウムおよび弁またはその他の周囲組織の剥がれを生じ得る。アテロームの残渣は、脳において最も頻繁に栓塞するが、その他の影響される身体部位は、脾臓、腎臓、膵臓、および胃腸管を含む。これらの末梢器官への栓塞および詰まりは、組織虚血または死亡に至り得る。従って、心臓血管手術の間に安全に塞栓材料を含むための必要性が存在する。
Claims (1)
- 心臓中または心臓近傍の標的部位に補綴具を送達する方法であって:
心臓の尖部またはその近傍で、心臓中に送達デバイスを導入する工程であって、該送達デバイスが補綴具を含む、工程;
該補綴具を該標的部位に進行する工程;および
該標的部位で、該送達デバイスから該補綴具を外す工程、を包含する、方法。
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US10/831,770 US10219899B2 (en) | 2004-04-23 | 2004-04-23 | Cardiac valve replacement systems |
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JP2007509687A Division JP4755176B2 (ja) | 2004-04-23 | 2005-04-22 | 心臓弁送達ための方法およびシステム |
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JP2007509687A Expired - Fee Related JP4755176B2 (ja) | 2004-04-23 | 2005-04-22 | 心臓弁送達ための方法およびシステム |
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EP (1) | EP1755459B1 (ja) |
JP (2) | JP4755176B2 (ja) |
CN (1) | CN1993090B (ja) |
AU (1) | AU2005237510B2 (ja) |
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CN1993090B (zh) | 2012-11-07 |
US10219899B2 (en) | 2019-03-05 |
AU2005237510B2 (en) | 2009-10-08 |
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