JP6517198B2 - 介入療法を案内する弾性層の識別 - Google Patents
介入療法を案内する弾性層の識別 Download PDFInfo
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- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
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Description
（優先権主張）
本願は、米国仮出願（番号61/843,866、名称"IDENTIFICATION OF ELASTIC LAMINA TO GUIDE INTERVENTIONAL THERAPY"、２０１３年７月８日出願）への優先権を主張しており、その全体内容は参照によりここに組み込まれる。
本願は、米国仮出願（番号61/843,866、名称"IDENTIFICATION OF ELASTIC LAMINA TO GUIDE INTERVENTIONAL THERAPY"、２０１３年７月８日出願）への優先権を主張しており、その全体内容は参照によりここに組み込まれる。
（参照による組込み）
本明細書で言及されるすべての刊行物及び特許出願は、あたかも個々の刊行物又は特許出願が具体的にかつ個々に提示されて参照により組み込まれていると言える程度に、参照により本明細書に組み込まれる。
本明細書で言及されるすべての刊行物及び特許出願は、あたかも個々の刊行物又は特許出願が具体的にかつ個々に提示されて参照により組み込まれていると言える程度に、参照により本明細書に組み込まれる。
図１を参照して、通常の健康な動脈壁(artery wall)が組織の層、例えば、最内側の内膜(intima)１１１、中膜(media)１０７、外膜(adventitia)１０３、および外膜周囲(periadventitia)１０１を含む。内膜１１１、中膜１０７および外膜１０３は、２つの膜によって分離される。内側の膜は、内部弾性層（ＩＥＬ）１０９であり、内膜１１１を中膜１０７から分離する。外側の膜は、外部弾性層（ＥＥＬ）１０５であり、中膜１０７を外膜１０３から分離する。
冠動脈疾患（ＣＡＤ）および末梢動脈疾患（ＰＡＤ）はともに、欠陥の進行性狭窄によって生じ、しばしばアテローム性動脈硬化症、動脈壁の内壁または内膜に沿ったプラークまたは脂肪性物質の集積によって生ずる。時間経過とともに、この物質は、硬化して厚くなり、動脈内に閉塞を生じさせ、動脈を通る流れを完全または部分的に制限する。腕、脚、胃および肝臓、脳、心臓への血液循環が減少すると、脳卒中および心臓疾患のリスクを増加させる。
末梢動脈疾患（ＰＡＤ）および冠動脈疾患（ＣＡＤ）は、米国だけで数百万人に影響している。ＰＡＤおよびＣＡＤは、未治療で放置すると、重大な結果を有する静かで危険な疾患である。ＣＡＤは、米国において主要な死因であるが、ＰＡＤは５０歳以上の患者で切断手術の主要な要因であり、米国で毎年約１６００００の切断手術の原因となる。
ＰＡＤおよびＣＡＤのための介入治療が、動脈内膜切除術および／またはアテローム切除術を含むことがある。動脈内膜切除術が、血流を回復または改善するために、閉塞した動脈からのプラークの手術除去である。血管内療法、例えば、アテローム切除術(atherectomy)は、典型的には、狭窄または遮断した動脈を広げたり、拡大する最小侵襲手法である。他の治療が、動脈を広げる血管形成術を含む。例えば、バルーン血管形成術が、典型的には、脚または腕の動脈へのカテーテルの挿入と、バルーンが閉塞物内に位置するようにカテーテルの位置決めとを含む。バルーンは、カテーテルと接続され、拡大して動脈を広げる。そして執刀医は、ステントと称されるワイヤメッシュチューブを閉塞エリアに置いて、血管を広げたままする。
介入治療の際、ＩＥＬ１０９、中膜１０７、ＥＥＬ１０５および外膜１０３に外傷がしばしば生ずる。ＥＥＬ１０５及び／又は外膜１０３への外傷は、重大な炎症反応を引き起こすことがあり、瘢痕化を加速し、欠陥の可能性ある閉止を生じさせる。ＥＥＬ１０５の崩壊は、再狭窄を加速しさらに促進する補完的な炎症要因を信号伝達できる。従って、ＥＥＬ１０５および外膜１０３への外傷を回避する介入治療が要望されている。
介入手術および治療の際に、弾性層を識別するためのシステムおよび方法がここでは説明している。こうした識別は、こうした手術および治療の際に、外部弾性層への外傷を回避するために使用できる。
一般に、一実施形態において、アテローム切除術を実施する方法が、（１）アテローム切除術装置を血管内に挿入すること、（２）装置上の画像センサを用いて光コヒーレンストモグラフィ（ＯＣＴ）画像を収集すること、（３）ＯＣＴ画像内での外部弾性層を識別すること、（４）識別に基づいて、血管内の組織を切断することを含む。
本実施形態および他の実施形態は、下記特徴の１つ以上を含むことができる。ＯＣＴ画像は、血管のトロイダル視野となり得る。外部弾性層を識別することは、トロイダル視野内で最外側の明るいラインを識別することを含むことができる。識別に基づいて、血管内の組織を切断することは、識別に基づいて、装置の遠位先端を再配向させることを含むことができる。血管内の組織を切断することは、外部弾性層に至るまでを切断することを含むことができるが、外部弾性層を通らない。識別は、自動的に実施できる。切断の深さを調整することは、カッタを能動モードから受動モードへ移動することを含むことができる。カッタを能動モードから受動モードへ移動することは、装置上でバルーンを少なくとも部分的に収縮させることを含むことができる。調整ステップは、自動的に実施できる。再配向ステップは、ＯＣＴ画像内のマーカーを用いて、先端を再配向させることを含むことができる。方法はさらに、カッタと外部弾性層との間の距離を判断することを含むことができる。方法はさらに、もし距離が閾値未満である場合、アラームを起動することを含むことができる。方法はさらに、もし距離が閾値未満である場合、切断を停止させることを含むことができる。方法はさらに、識別ステップの後、ＯＣＴ画像内の外部弾性層を強調することを含むことができる。
一般に、一実施形態において、アテローム切除術システムが、ＯＣＴ画像を収集するように構成され、装着されたＯＣＴ画像センサを有するカテーテルと、コントローラとを含む。コントローラは、ＯＣＴ画像内の外部弾性層を自動的に識別するように構成される。
本実施形態および他の実施形態は、下記特徴の１つ以上を含むことができる。システムはさらに、コントローラと接続されたディスプレイを含むことができ、ディスプレイは、血管のトロイダル視野としてＯＣＴ画像を表示するように構成できる。コントローラはさらに、識別の後、ディスプレイにおいてＯＣＴ画像内の外部弾性層を強調するように構成できる。コントローラはさらに、識別に基づいて切断の深さを調整するように構成できる。切断の深さを調整することは、カッタを能動モードから受動モードへ移動することを含むことができる。カッタを能動モードから受動モードへ移動することは、装置上でバルーンを少なくとも部分的に収縮させることを含むことができる。コントローラはさらに、識別に基づいて、装置の遠位先端を再配向させるように構成できる。コントローラはさらに、カッタと外部弾性層との間の距離を判断するように構成できる。コントローラは、もし距離が閾値未満である場合、アラームを起動するように構成できる。コントローラは、もし距離が閾値未満である場合、切断を防止するように構成できる。
本発明の新規な特徴は、下記請求項での詳細とともに説明する。本発明の特徴および利点のより良い理解が、本発明の原理が利用されている例示の実施形態を説明する下記詳細な説明、および添付図面を参照して得られるであろう。
オンボードイメージングを有するカテーテルを用いた介入治療の際、弾性層を識別するためのシステムおよび方法をここでは説明している。
図２を参照して、介入カテーテル２００、例えば、アテローム切除術カテーテルまたは閉塞横断カテーテルなどが、細長い本体２１１を含むことができ、そこから延びるカッタ２１３を備える。撮像センサ２１７が、光コヒーレンストモグラフィ（ＯＣＴ）画像を収集するように構成できる。遠位ノーズコーン２１９が、カッタ２１３によって切断された組織カットを回収するように構成できる。いくつかの実施形態において、装置２００は、方向性アテローム切除術装置でもよく、バルーン２２１が、カッタ２１３を露出して、及び／又は、切断のためにカッタ２１３を血管壁に付勢するために使用できる。バルーン２２１の膨張の量は、カッタ２１３によって血管壁に作られる切断の深さを変更するために変化できる。例示のアテローム切除術装置はさらに、米国出願（番号12/829,277、名称"ATHERECTOMY CATHETER WITH LATERALLY-DISPLACEABLE TIP"、２０１０年７月１日出願、米国公開番号2011/0004107）、米国出願（番号13/175,232、名称"ATHERECTOMY CATHETERS WITH LONGITUDINALLY DISPLACEABLE DRIVE SHAFTS"、２０１１年７月１日出願、米国公開番号2012/0046679）、米国出願（番号13/654,357、名称"ATHERECTOMY CATHETERS AND NON-CONTACT ACTUATION MECHANISM FOR CATHETERS"、２０１２年１０月１７日出願、米国公開番号2013/0096589）、国際出願（番号PCT/US2013/031901、名称"ATHERECTOMY CATHETERS WITH IMAGING"、２０１３年３月１５日出願、国際公開WO2013/172970）、国際出願（番号PCT/US2013/032494、名称"BALLOON ATHERECTOMY CATHETERS WITH IMAGING"、２０１３年３月１５日出願、国際公開WO2014/039099）に記載されており、これらの全体が参照によりここに組み込まれる。
図３ａ〜図３ｉｉを参照して、こうしたオンボード撮像カテーテルを用いて得られるＯＣＴ画像が、血管の壁、例えば、壁のトロイダル視野を示すことができる。得られた画像は、例えば、プラークまたは血栓形成(thrombosis)そして血管の層を示すことができ、これは、後方散乱または信号豊富な内膜１１１、しばしば低い後方散乱を有し、または信号貧弱である中膜１０７、異質でしばしば高い後方散乱の外膜１０３、及び／又は、大きくクリアな構造によって特徴付けられる外膜周囲１０１を含む。ＯＣＴ画像はさらに、好都合には、ＩＥＬ１０９を、中膜１０７と内膜１１１との間の明確なラインとして、そしてＥＥＬ１０５を、中膜１０７と外膜１０３との間の明確なラインとして明確に示すことができる。例えば、ＩＥＬ１０９およびＥＥＬ１０５は、薄く明るい構造として表示できる（即ち、大きく後方散乱している）。多くの場合、ＩＥＬ１０９およびＥＥＬ１０５は、中膜１０７の内周および外周に沿って（ほぼ平行に）続く連続的なラインとして現れる。
カテーテルを用いて収集されるＯＣＴ画像は、ＥＥＬ１０５を明確に識別するために使用できる。さらに、ＯＣＴは、好都合には、他のタイプのイメージング、例えば、超音波より高い分解能を有するため、ＥＥＬ１０５の明確な識別を可能にする。さらに、画像内でのＥＥＬ１０５の識別の際、介入療法（例えば、アテローム切除術）は、ＥＥＬ１０５および外膜１０３との相互作用を回避または制限するように調整でき、これによりもしＥＥＬ１０５または外膜１０３が傷ついた場合に発生する炎症反応を回避している。
図４ａと図４ｂを参照して、一実施形態において、アテローム切除術カテーテルを用いた切断の深さは、ＥＥＬ１０５の識別に基づいて、例えば、バルーンを収縮させることによって調整でき、あるいは他の方法で切断の深さを調整して、ＥＥＬ１０５または外膜１０３の摘出を回避している。例えば、図４ａは、バルーン２２１が完全に膨張しているＯＣＴ画像を示す。得られた切断は（カッタ位置が中央に黒い円で示され、その方向は中間マーカー３３３とは反対である）、中膜１０７およびＥＥＬ１０５に近い。これに対して図４ｂにおいて、バルーン２２１が収縮して、カッタを引き離し、カッタとＥＥＬ１０５との間に空間１６６を残している（図４ｂは、図４ａの切断によって生成された、ＥＥＬ１０５の近くに切断マーク１７７を示していることに留意する）。
図５ａと図５ｂを参照して、一実施形態において、切断の方向は、ＥＥＬ１０５を回避するように変更でき、即ち、カテーテル２００の遠位先端は、ＥＥＬ１０５から遠くに配向できる。いくつかの実施形態において、画像上のマーカーは、カテーテルの方向を配向させるのを支援するために使用でき、ＥＥＬが切断されないことを確保している（即ち、中間マーカー３３３は、切断の方向とは直接反対にある位置を示すことができる）。こうして切断方向は、健康な動脈壁において直接配向（ＥＥＬに垂直）する状態から変更でき、代わりにプラーク３３３に向かう。
方向及び／又は深さの変更の結果として、組織が、ＥＥＬ１０５に至るまで、貫通せずに切断できる。図６ａ〜図６ｈは、ここで説明した識別方法を用いてＯＣＴ画像および得られた組織カットを示す。図示のように、プラーク組織２２２（および図６ｇでのＩＥＬ１０９と中膜１０７）だけが切断され、ＥＥＬ１０５は切断されない。
さらに、もしＯＣＴ画像が、外傷が生じたことを示す場合（即ち、図３ｃｃに示すように、明るいラインの連続性において破損１５５を示す場合）、治療計画は、カテーテルを再配向させたり、切断の深さを調整することによって、更なる外傷を回避するように調整できる。さらに、ＥＥＬ１０５への外傷が識別された場合、治療計画は、薬剤コート付ステント、薬剤溶出バルーンを移植したり、経口投薬（例えば、抗炎症薬、プラビックスなど）によって、炎症カスケードを軽減するように調整できる。
いくつかの実施形態において、ＥＥＬ１０５の識別は、画像を閲覧する医師または専門家によって手動で実施できる。
他の実施形態において、ＥＥＬ１０５の識別は、コントローラを用いて自動的に実施できる。例えば、図７ａ〜図７ｅを参照して、強度対深さのＡライングラフ７１７が、ＯＣＴ画像７０７内の角度αで採取できる。グラフ中のピーク強度は、ＥＥＬ１０５に対応することになり、次に最も高いピークは、ＩＥＬ１０９に対応するようになる。そしてコントローラは、新しい角度に移動して、その輪郭を検索する。例えば、セクタがＢスキャン１２７に展開した場合、ＥＥＬ１０５は、設定した角度αで識別でき、そしてプロセスは連続的なエッジを見つけるように繰り返される。図７ｄに示すように、ラインが連続的である場合、それはＥＥＬ１０５を示す。もしそれが不連続である場合、その特徴はＥＥＬではないか、あるいはＥＥＬが破損している。
いくつかの実施形態において、ＥＥＬは、ＯＣＴ画像の表示において自動的にラベル付与したり、強調したりできる。図８を参照して、ＥＥＬ１０５は、ＯＣＴ画像８０７において、例えば、透明な着色バンド８０８でラベル付与できている。バンド８０８は、例えば、ＥＥＬ検出でより大きな信頼性についてより明るくなることができる。バンド８０８はさらに、異なる色または幅を含むことができ、異なる小さな形状（例えば、ドットまたは三角）で重複できる。さらに、バンド８０８は、ＯＣＴ画像８０７の外側に引き出して、観察を妨害することなく、特徴がどこにあるかを識別できる（例えば、ＯＣＴ領域の外側にある弧として）。
さらに、いくつかの実施形態において、コントローラは、ＥＥＬ１０５の識別を使用して、介入手術を自動的に支援できる。即ち、いくつかの実施形態において、ＥＥＬ１０５および、ＥＥＬとカッタエッジとの間の距離の両方が検出できる。コントローラは、ＥＥＬとカッタとの間の距離を計算でき、該距離が閾値未満である場合、設定した動作をとることができる。例えば、コントローラは、アラーム（例えば、音響ノイズ、光の点滅、グラフィックシンボル）を始動できる。他の実施形態において、もし距離が閾値未満である場合（及び／又は、もしＥＥＬ１０５が図７ｅに示すように、破損または損傷しそう、またはした場合）、コントローラは、カッタ駆動を停止できる。さらにいくつかの実施形態において、カテーテルに対する付勢量は自動的に減少できる（例えば、バルーン膨張量）。付勢量を自動的に減少するために、バルーンの膨張／収縮および、能動（または開放）位置と受動（または閉止）位置との間のカッタの移動は、コントローラによって制御されるサーボ（またはモータやアクチュエータ）を用いて自動化できる。こうしてコントローラは、ＥＥＬ１０５の識別を使用して、バルーンを部分的または完全に収縮でき、これにより切断深さを減少させたり、及び／又は、カッタを能動位置から受動位置へ移動させる。
介入療法の際に撮影される画像内のＥＥＬを識別することによって、これらの構造への損傷または外傷が好都合に回避できる。例えば、図６ａ〜図４ｈを参照して、こうした手法を用いたアテローム切除術の際に切断された組織が、好都合に、ほぼ罹患した血栓形成またはプラークだけ（中膜１０７、外膜１０３またはＥＥＬ１０５はほぼ皆無）を含むことができる。これに対して、こうした方法が使用されないアテローム切除術において、摘出した組織が、罹患した組織に加えて、ＥＥＬ１０５、中膜１０７及び／又は外膜１０３を含むことがあり、アテローム切除術の際に、増強された炎症反応が引き起こされたことを示唆している。
材料及び製造技術を含む、本発明に関連する追加の詳細を、当業者のレベルの範囲内で採用することができる。同じことが、一般に又は論理的に採用される追加の動作の観点で、本発明の方法ベースの態様に対しても当てはまる。また、説明した発明変形例のいずれの任意的特徴も、独立して、或いはここで説明した１つ以上の特徴と組み合わせて説明し、権利請求できることが想定される。同様に、単数の物品への参照は、複数の同じ物品が存在する可能性を含む。詳細には、ここで使用し、または添付の請求項にあるように、単数形、「一つ(a)」、「及び(and)」、「前記(said)」、及び「その(the)」は、文脈が明確に別を指示していない限り、複数の参照を含む。さらに注意すべきは、請求項は、何れか任意的要素を除外するように起案できることはさらに留意する。この宣言は、請求項の要素の引用と関連して、こうした排他的用語、例えば「単に(solely)」、「のみ(only)」等の使用、或いは「否定的(negative)」限定の使用に対する先行詞の基礎として機能することを意図している。ここで定義していなければ、ここで使用する全ての技術的及び科学的用語が、当業者が一般に理解するような同じ意味を有する。本発明の範囲は、ここで説明した例によって限定されることはなく、採用した請求項用語の通常の意味によってのみ限定される。
Claims (8)
- ＯＣＴ画像を収集するように構成され、装着されたＯＣＴ画像センサを有するカテーテルと、
ＯＣＴ画像内の外部弾性層を自動的に識別するように構成されたコントローラと、
カテーテルの遠位端に配置されたカッタとを備え、
コントローラはさらに、カッタと外部弾性層との間の距離を判断するように構成されるカテーテルシステム。 - コントローラと接続されたディスプレイをさらに備え、ディスプレイは、血管のトロイダル視野としてＯＣＴ画像を表示するように構成される請求項１記載のシステム。
- コントローラはさらに、ディスプレイにおいてＯＣＴ画像内の外部弾性層を強調するように構成される請求項２記載のシステム。
- ＯＣＴ画像を収集するように構成され、装着されたＯＣＴ画像センサを有するカテーテルと、
ＯＣＴ画像内の外部弾性層を自動的に識別するように構成されたコントローラと、
カテーテルの遠位端に配置され、能動モードに配置された場合に血管内の組織を切断するように構成された、カッタとを備え、
コントローラはさらに、識別に基づいてカッタによる血管内の組織の切断の深さを調整するように構成され、
切断の深さを調整することは、カッタを能動モードから、血管内の組織を切断しないように構成された受動モードへ移動することを含むカテーテルシステム。 - カテーテルはさらに、カッタを露出または覆うように膨張または収縮するように構成されたバルーンを含み、
カッタを能動モードから受動モードへ移動することは、バルーンを少なくとも部分的に収縮させることを含む請求項４記載のシステム。 - ＯＣＴ画像を収集するように構成され、装着されたＯＣＴ画像センサを有するカテーテルと、
ＯＣＴ画像内の外部弾性層を自動的に識別するように構成されたコントローラとを備え、
コントローラはさらに、識別に基づいて、装置の遠位先端の方向を調整するように構成されるカテーテルシステム。 - コントローラは、もし距離が閾値未満である場合、アラームを起動するように構成される請求項１記載のシステム。
- コントローラは、もし距離が閾値未満である場合、切断を防止するように構成される請求項１記載のシステム。
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