JP5219518B2 - 大動脈弁修復 - Google Patents
大動脈弁修復 Download PDFInfo
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Description
大動脈弁狭窄は、毎年、合衆国で約65,000の大動脈置換手術を生じる一般的な心臓疾患である。大動脈弁狭窄は、リウマチ病、先天性石灰性狭窄および変性石灰性狭窄を含むいくつかの病因を経由して生じ得る。発展途上国では、リウマチ熱が弁組織の厚化および進行性不動状態を生じている。石灰性疾患は、合衆国において、およびリウマチ疾患が稀である国における大動脈狭窄のほとんどすべての場合の原因である。
本発明は、大動脈弁およびその他の心臓弁の修復に、そしてより詳細には、このような修復を達成するためのカルシウム除去および抗再狭窄システムのためのデバイスおよび方法に関する。本発明は、多くの異なる形態をとり得、大動脈修復もしくは弁形成術のときに実施される装置、急性介入、または一時的もしくは永久的インプラントなどを含む。
(処置カテーテル設計−総説)
本発明の処置カテーテル10(図1)は、代表的には、近位端14、遠位端16、およびカテーテル本体内の1つ以上の管腔18、20を備える細長いカテーテル本体12を備える。遠位端16は、必要に応じて、処置の間に小葉を隔離し、かつ処置の間に残渣排出経路を提供し、そして塞栓副作用から血管系を保護するためにカテーテル本体12の遠位端から遠位方向に延びる吸引ハウジング22(図4および5)を備え得る。エネルギー伝達要素24(例えば、駆動シャフト、ワイヤ配線、またはガイドワイヤ−超音波伝達要素など)は、上記細長い本体12中の管腔の1つ内に位置決めされ得、そして、代表的には、カテーテルの近位端から遠位端まで延びる。ハンドル26は、この細長いカテーテル本体12の近位端14に連結される。発生器(例えば、RF電源、超音波発生器、モーター、光学的エネルギー供給源など)が、このハンドルに連結され得、エネルギーを、活動する遠位端28、カテーテル本体の管腔内に配置されるエネルギー伝達要素24に送達する。本明細書中に記載されるように、遠位作業要素28は、エネルギー伝達要素24の遠位端に連結され得、大動脈弁上のカルシウム沈着へのエネルギーの送達を容易にする。
本発明の1つの局面によれば、処置カテーテル50は、小葉を脱石灰化するための超音波プローブを有して提供される。超音波プローブ52は、フレームまたはシース54によって取り囲まれ得る。フレームおよびシースの両方は、超音波振動の供給源(図示されず)に連結され得る。特定の実施形態では、このプローブ52はシースまたはハウジングによって取り囲まれ、これは、システムが、このカテーテルシステムの近位端に取り付けられ、そしてカテーテル本体中の吸引管腔を経由してカテーテルハウジングに連結される吸引の供給源を経由して処置表面に対して実質的にシールされることを可能にする。あるいは、このシステムは、処置領域(輪または小葉)に上記ハウジングを物理的に取り付ける機械的クリップまたはインターフェースで処置部位に配置または局在化され得る。操作において、この超音波プローブ52は、小葉上のカルシウムを分解するために能動化され、次いでカテーテル本体50中の吸引管腔を通って除去され得る残渣を生成する。いくつかの場合には、吸引の付与と同時またはその前にハウジング領域中に生理食塩水またはその他の流体をまた注入することが所望され得る。同様に超音波導波管に、そしてデバイスの遠位端にPZTスタックを備えるようなその他の実施形態に、冷却流体を提供することが有利であり得る。弁の部位に抗石灰化療法を注入することがまた有利であり得、鉄塩および/もしくは錫塩、または、小葉をなめすため、もしくはそうでなければカルシウム増強に対して抵抗性にする公知のようなその他の溶液を含み、これには、その内容が本明細書中に明示して援用される米国特許第5,782,931号に提示されるタイプのものがある。シリコーンカップを有する超音波プローブ60の別の実施形態が図19に示され、ここでは、注入液が矢印62によって示され、そして吸入が矢印64によって示される。
上記に記載の超音波処置カテーテルに加え、本発明は、小葉上のカルシウムを機械的に破壊または除去するために能動化可能な先端部を用いる処置カテーテルおよび方法をさらに提供する。一般に、これらカテーテルは、1つ以上の管腔を備えるカテーテル本体を備える。駆動シャフト(または類似の要素)が、これら管腔の1つの近位端から、この管腔の遠位端まで延び得る。遠位作業要素は、この駆動シャフトに連結され(またはそれから一体に形成され)得、そしてカテーテル本体の遠位端を少なくとも部分的に超えて延びるような形態である。この駆動シャフトの近位端は、機械的運動(回転、振動および/まは軸方向移動)の供給源に連結され得、駆動シャフトおよび遠位作業要素を駆動する。
上記のように、超音波処置カテーテルおよび機械的処置カテーテルの大部分の実施形態は、カテーテル本体を通ってその遠位端まである管腔を備える。冷却流体、超音波造影流体などのような媒体を管腔を通って標的小葉に送達し、小葉上の包埋された石灰化の塊へのエネルギー送達の影響を増幅することが有用であり得る。1つの好ましい形態では、この媒体は、マイクロスフェアまたはマイクロバブルを含み得る。本発明の方法および処置カテーテルと用いられ得る1つの有用な造影媒体は、OptisonTM造影剤(GE Healthcare)である。治療効果を増大するためのキャビテーションおよび/またはマイクロバブルを利用する技法の種々の描写は、Tachibanaによる米国特許第USRE036939号、およびBen−Haimによる同第6,321,109号中に見出され得、その内容は、それらの全体が本明細書中に参考として明示して援用される。
本発明のさらなる局面では、保護デバイスおよび方法が、処置部位から残渣を捕捉および排出するために用いられ得る。図61および62に示される実施形態では、フィルターデバイス336が、ガイドカテーテル338のシャフト上に位置される。この構造はまた、大動脈根中にガイドカテーテルの係留を提供し、弁への安定な接近システム、またはさらなる処置カテーテルを配置することを提供する。
本発明の特徴は、手順の前、その間、およびその後のモニタリングおよび撮像のための種々のデバイスおよび方法を含む。種々の撮像診断様式が、この目的のために採用され得、心臓内超音波心臓検査法(ICE)、経食道超音波心臓図検査(TEE)、蛍光透視、血管内超音波(IVUS)、血管顕微鏡検査、赤外、Sensant,Inc./Seimens(San Leandro、CA)から入手可能な容量性超音波トランスデューサー(cMUT)または当該分野で公知のその他の手段を含む。例えば、処置カテーテルは、位相アレイ血管内超音波要素のような、ハウジングまたは処置要素カテーテル中に組み込まれる撮像デバイスを有し得る。いくつかの実施形態では、本発明のデバイスを、それらの作動要素が、シースと同軸である別個で取り外し可能な要素であるように構築することが有利であり得、操作者が作業要素を取り外し、そしてその場所に撮像要素を配置する。
種々のエネルギー様式が、本発明によって想定される処置カテーテルで用いられ得る。カルシウム沈着物を分解または除去するためにより詳細に有用な様式は、超音波エネルギー、レーザーエネルギーなどであり得る。特に、特定のEr:YAGレーザーが、適切な範囲で作動されるとき、カルシウムを特異的に標的とし得る。これを支持する標的とされる骨切除する特定の詳細は、「Er:YAGレーザーおよびCO2レーザーを用いる骨除去の走査電子顕微鏡法およびFourier変換赤外分光法分析」J Periodontol.2002年6月;73(6):643〜52に記載され、その内容は、本明細書中に参考として明示して援用される。あるいは、エネルギーは、高エネルギーパルス化または走査型二酸化炭素レーザー、短パルス化Er:YAG、および調節(短−および−長−パルス化)Er:YAGシステムのような、制御された組織蒸発を生じる水を含有する組織を選択的に標的とする表面付け替えレーザーを採用することにより、カルシウム沈着物の周り、またはその上から組織を選択的に除去するために送達され得る。エネルギーの付与は、小葉間に分布されるプラークまたはカルシウム(海綿体)に接近するために有用であり得る。実際、大部分の小葉が無傷で残り、そして不必要な熱損傷からシールドされるように沈着物を覆う組織の層を除去することが所望され得る。さらに、このような特定組織破壊はまた、本発明の処置の一部として弁の輪内の瘢痕組織または肥大の領域の除去に適用され得る。
一旦修復が達成されると、除去される上記のデバイスの代替物または付属物として、大動脈弁を横切って、または大動脈弁内に一時的または永久的に移植されるデバイスが提供され得る。以下に出現するデバイスは、再石灰化、小葉の融合、および再狭窄のいずれかにより、弁が変性することを防ぐか、または遅延するために、狭窄が終了した後に、身体内で少なくとも所定の時間の間残ることがすべて意図される。本発明のインプラントは、輪の下360または輪の上の位置362いずれかで図67に描写される。
Claims (9)
- 血管に付随する心臓弁の修復のための処置カテーテルであって:
近位端、遠位端およびそれらの間の管腔を備えるカテーテル本体;
該カテーテル本体の遠位端近傍の吸引ハウジングであって、該吸引ハウジングは拡大形態と退却形態との間を移動可能であり、該拡大形態は該弁の小葉に一致するような形態であり、そして該退却形態では該吸引ハウジングは該管腔内に少なくとも部分的に配置され、そして該吸引ハウジングは塞栓残渣を捕捉するための障壁を備え、該吸引ハウジングは該心臓弁上の石灰性部位の周りに一致し、血管をブロックまたは閉塞することなく該石灰性部位のすぐ上に塞栓の閉じ込め領域を生成する吸引ハウジング;および
該石灰性部位を破壊するように適合された作業要素であって、該塞栓の閉じ込め領域内に位置決め可能であり、そして該吸引ハウジングに対して関節運動可能であって、該作業要素の配置を該石灰性部位に対して調節する作業要素、を備え、
ここで、該吸引ハウジングが該作業要素を該拡大形態に安定化または局在化するように構成される、処置カテーテル。 - 前記作業要素が、前記石灰性部位で石灰性沈着物を破壊するように選択された条件下でエネルギーを送達するように構成されたエネルギー送達要素を備え、該エネルギー送達要素が、超音波トランスデューサー、RF電極、または回転可能な先端部を備え得る、請求項1に記載の処置カテーテル。
- 前記カテーテル本体が操縦可能またはそうでなければ位置決め可能であり、使用者が前記遠位端を前記石灰化部位に向けることを可能にする、請求項1〜2のいずれか1項に記載の処置カテーテル。
- 前記処置カテーテルを、前記石灰性部位に位置決め、そして/または安定化することを支援するよう適合された、前記カテーテル本体上の位置決めまたは安定化特徴をさらに備える、請求項1〜3のいずれか1項に記載の処置カテーテル。
- 前記吸引ハウジングがさらに、成形バルーン、バスケット、またはフィルターを備える、請求項1〜4のいずれか1項に記載の処置カテーテル。
- 前記吸引ハウジングが、疾患大動脈弁を通る流れをなお可能にしながら、前記処置カテーテルが処置される位置に接近することを可能にするような形状であるフィルターを備える、請求項5に記載の処置カテーテル。
- 撮像アセンブリをさらに備え、該撮像アセンブリが、心臓内超音波心臓検査法(ICE)アセンブリ、経食道超音波心臓図検査(TEE)アセンブリ、血管内超音波アセンブリ、または血管顕微鏡検査アセンブリを備え得る、請求項1〜6のいずれか1項に記載の処置カテーテル。
- 前記処置カテーテルを受容するような形態である内部管腔を備えるガイドカテーテルをさらに備える、請求項1〜7のいずれか1項に記載の処置カテーテルを備える、システム。
- 前記ガイドカテーテルの内部管腔内、および前記処置カテーテルの周りに位置決め可能である第2の位置決めカテーテルをさらに備える、請求項8に記載のシステム。
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Also Published As
Publication number | Publication date |
---|---|
EP1819304A2 (en) | 2007-08-22 |
US10350004B2 (en) | 2019-07-16 |
US20130345715A1 (en) | 2013-12-26 |
US20060229659A1 (en) | 2006-10-12 |
US9414852B2 (en) | 2016-08-16 |
WO2006063199A2 (en) | 2006-06-15 |
CN101076290A (zh) | 2007-11-21 |
CN101076290B (zh) | 2011-11-23 |
EP1819304A4 (en) | 2015-04-15 |
US20170014183A1 (en) | 2017-01-19 |
WO2006063199A3 (en) | 2007-07-19 |
US20190350651A1 (en) | 2019-11-21 |
US7803168B2 (en) | 2010-09-28 |
US20100324554A1 (en) | 2010-12-23 |
EP1819304B1 (en) | 2023-01-25 |
US11272982B2 (en) | 2022-03-15 |
JP2008522755A (ja) | 2008-07-03 |
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