JP5844792B2 - 内視鏡生検装置、システム、及び方法 - Google Patents
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Description
本出願は、2009年1月20日出願の米国特許出願第61/145914号、及び2009年6月4日出願の米国特許出願第61/184180号の優先権を主張する。これらの出願に開示された内容は、参照により本明細書に組み込まれる。
1951USAF分解能チャートのバーから、エッジ応答関数を撮像して撮像した本発明に係る代表的な実施形態のSECM構成部/プローブの横方向分解能は、スペクトル画角のエッジ中央からそれぞれ、1.25±0.13μmから1.45±0.33μmの範囲であった。焦点を介してミラーをzスキャンすることによって得られた代表的な実施形態のSECM構成部/プローブの軸方向分解能は、スペクトルFOVのエッジ及び中央においてそれぞれ、10μm及び4.4μmと測定された。代表的な実施形態のSECM構成部/プローブの適応合焦機構は、略250μmの変位振幅で1Hzのレートの移動ミラーの正弦波の動きを正確に追尾した。代表的な実施形態の構成部/プローブで使用するソフトウェア及びプローブヘッドの代表的な機械設計は若干、適応合焦機構の速度と範囲に限定された。独立した光電子装置を使用してフィードバック信号を生成することができ、プローブハウジングを修正することができるので、フィードバックループの応答速度と合焦範囲をそれぞれ増加することができる。
代表的な実施形態の内視鏡SECMプローブについて上述の光学的仕様を用いた代表的なSECMシステムは、例えば、人体生検サンプルの全体の撮像に利用することができる(例えば、Kang D. et al, ”Comprehensive imaging of gastroesophagal biopsy samples by spectrally encoded confocal microscopy”, Gastrointest Endosc. 2009を参照)。この代表的なSECMシステムは、波長掃引源(例えば、中心波長=1320nm、バンド幅70nm、反復レート=5kHz)及び0.7NA対物レンズを使用することができる。単一モード照明及び多モード検出撮像構成を使用して、レーザースペックルノイズを削減することができる。上述の代表的な構成部/プローブに採用可能な方法でもある。かかる代表的なSECMシステムの分解能は、例えば、それぞれ横方向及び軸方向に沿って、2.3μm及び9.7μmとすることができる。図7に、通常の胃食道接合部の構造的形態を明示する、代表的な生検研究から得られた第1のデータセットの一つの代表的な画像を示す。
生検を誘導するための顕微内視鏡観察技術を用いて、撮像システムによって特定された異形成及び初期癌の領域をマーキングして、従来の内視鏡検査により可視化できるようにすることができる。
図11は、代表的なSECM誘導式生検を行うための、本発明に係る代表的な実施形態の手順を説明するフロー図である。例えば、センタリングバルーンプローブを、内視鏡によって既に配置された(ブロック1110)ガイドワイヤを介して挿入することができる(ブロック1120)。バルーンプローブが所定の位置に配置されると、ブロック1130でバルーンを膨張させ、ブロック1140でヘリカルスキャンパターンを用いて総合SECMを実行することができる。ブロック1150において、内視鏡から、代表的なSECMデータセットを分析し、画像から生検ターゲットを選択することができる。続いて、ブロック1160においてSECMプローブを患者のそれらの場所に自動的に戻し、レーザーマーキングをターゲットの一方の側に行う。この代表的なレーザーマーキングの後、ブロック1170においてバルーンを収縮させて、取り外すことができる。ブロック1180において、内視鏡医は、マーキングされた部位からの生検を取得することができる。図11に示した代表的な手順では、SECMを使用しているが、OCTを含む他の顕微鏡撮像技術を用いて生検を誘導してもよい。
臨床用の代表的なSECM誘導式生検デバイスは、例えば、a)プローブ、b)プローブコンソールインタフェース、及びc)コンソール、3つの要素を含むことができる。代表的な実施形態のSECM構造部/プローブの代表的な概略図を図12に示す。代表的なSECM構造部/プローブは、撮像光を送受信し、レーザーマーキングビームを透過することもできるダブルクラッドファイバ(DCF)1211を含むことができる。スペックルノイズを削減するため、DCFのコアを介してサンプルを照明し、コアと内部クラッディングの両方を介してサンプルから発光された光を受光することによって、撮像を行うことができる。ファイバは、回転し、1.0cm径の透明なシース1232の内部を並進することができる、巻きケーブル1212の内部に収納することができる。
特注の光学部品及び機械部品を開発することによって代表的な構成部/プローブのサイズをさらに縮小することができる。硬質部の長さを最小化又は縮小するためには、コリメータレンズ115を、DCF1211とレンズ115の間の距離が短くなるように製造すればよい。回折格子120(例えば、Holographix社、Hudson,MA)を設けて、例えば、最大回折効率が2次では略725nmに、1次では1450nmとなるようにしてもよい。代表的な対物レンズ130(例えば、NA=0.4)を設けて(例えば、ZEMAX社製、Bellevue、WA)、製造し(例えば、Optimax Systems Inc., Ontario)、組織の光学切片の深さ範囲略100μmを通して回折限界性能とすることができる。対物レンズ130は、725nmと1450nmにおいて無彩色であり、透明なカテーテルのシース1232により誘発される非点収差を補償するため円筒状の表面を有することができる。
代表的な多層巻き駆動シャフトを使用して、他の撮像モダリティのために患者の内部の遠位端光学系をスキャンすることができる。特注の巻きケーブル1212を製造して(例えば、Asahi Intec, USA)、カテーテルを介した動き変換精度及び再現性を試験することができる。
透明なポリカーボネイトシース1232(例えば、径=略10mm)と透明なプラスチックバルーン328(例えば、Advanced Polymers, Salem, NH、膨張径=略25mm)を使用する代表的なバルーン−センタリングカテーテルを、プローブ光学系及び巻ケーブル(例えば、Device company; Innovative Medical Design, Tyngsboro, MA)を収納するように設けることができる。代表的なカテーテルは、透明度、柔軟性、追尾性能を試験して、食道内の撮像に適切であることを確認することができる。
コンソール/プローブからの光を結合し、代表的なSECM構成部/プローブを透明なシースの内部で回転させる代表的な回転接合部(図13の代表的な実施形態の構成部に示す)を設けることができる。代表的なOCT回転接合部とは異なり、代表的なSECM光学的回転接合部は、光源310からの撮像光をダブルクラッドファイバ(「DCF」)のコア1351に送ることができる。DCFの内部クラッディング1352は、レーザーマーキング光1380を透過させ、サンプルから戻された撮像光を分光計1370に供給することができる。
代表的なコンソール(図14に示す概略図を例にあげる)は、光源及び検出器を備え、撮像、マーキングのために使用することができ、また、フィードバック信号を生成して、プローブの対物レンズの合焦位置を制御するためにも使用できる。撮像のため、広帯域光源310(例えば、Fianium SC450−6)からの光を、725±30nmの広帯域NIRスペクトル1421を有するようにフィルタ1411によってフィルタリングすることができる。分解能、浸透深さ、検出器の感度の間で適当な妥協を得られるように、この代表的な波長範囲を選択することができる。さらに、中心波長を、高出力レーザー1380からのレーザーマーキングビーム1448の波長(例えば、略1450nm)の半分とすることができる。撮像ビームをプローブの2次の回折格子を介して回折し、マーキングレーザーを1次の回折格子を介して回折することによって、両者がサンプルの同一の位置を照射することができる。
本発明に係る適応焦点フィードバック信号を生成する代表的な光電子装置を設けることができる(代表的な図を図15に示す)。図15に示すように、代表的なSECMプローブ(図5参照)からの合焦ビーム1447は、撮像ビーム1446(図14の図に示す)から光学的に分離することができ、回折格子1520を用いてそのスペクトルを位置敏感型検出器1530(PSD、例えば、4象限光検出器)に分散させることができる。PSD1530の個別のセルからの電気信号は、代数演算処理によって、又は、数学的処理によって(例えば、演算又は処理構成部を用いて)、バルーンの内部表面の位置に対応することができるピーク波長を提供する。
例えば、二つの代表的なダイオードレーザ(例えば、それぞれ波長=略1450nm、出力=略200mW)を偏光多重化してSECMシステムに統合し、生検を誘導するためのマーキングを生成することができる。ダイオードレーザからの光は、シャッターを介して透過して、回転接合部を解してSECMプローブの内部クラッディングに結合することができる。コンピュータ、又は、その他の処理デバイスは、ダイオードレーザの強度と露光時間を制御することができる。安全のため、例えば、レーザーシャッターを所与のサイトの露光ごとに最大で、例えば、略10秒のみとするように構成することができる。
代表的な撮像及びマーキングレーザーを、出力及び空間コヒーレンスについて試験することができる。光学系の一部又は全てをスループット及び効率性について試験することができる。光学的レイアウトを、小さなブレッドボード上に組み立て、カートに組み込むことができる。撮像分光計を作成し、そのスペクトル分解能及び光スループット標準的な技術を用いて試験することができる。代表的な個々の部品の組み立てに続いて、代表的なシステムを携帯可能な医療用カートに統合することができる。1以上のコンピュータを用いて回転接合部、適応合焦機構、及びマーキングレーザーを制御するためにソフトウェアを提供することができる。パンやズームでユーザが迅速に、特定した関心エリアに正確に焦点合わせできる、Google Earth(登録商標)と類似の手法で画像のナビゲートを容易にする既存のソフトウェアが、SECMデータセットに適している。観察者が迅速に異なる光学切片を切り替え、ターゲットのサイトを描写して、レーザーマーキングを開始することを可能とする追加のソフトウェアユーザインタフェース入力を提供することができる。
表1は、本発明に係る代表的なSECM構成部/プローブ及びシステムの代表的な仕様と目的とする性能ターゲット(OPT)を記載している。代表的なOPTは、食道のセンタリングバルーン撮像を用いた従来の経験の性能と、総合内視鏡共焦点顕微鏡の性能との好みに基づくことができる。この代表的なOPTに合わせることは、さらに、有利な撮像性能を提供することができる。代表的な構成部/プローブは、収縮径が略1.0cmで、硬質部の長さは略4.5cmと、市販のオーバーザワイヤー超音波内視鏡デバイスのものに適合する仕様とすることができる。DCFの内部クラッディングを介して透過されるモードの数によって規定される横方向と軸方向の分解能は、縦方向の寸法に沿って、円周方向にナイキスト周波数の限界にサンプリングした場合よりも優れたものになる可能性がある。隣接する円周方向のスキャンの間の略72μmの縦方向の間隔は、バルーンの表面を超えて略100μmまで、略10個の離散的な深さの場所における光学切片を提供する。代表的なマーキングビームは、略30μmのサイズのスポットをサンプルに形成することができるが、これは、食道表面に内視鏡で観察可能なマーキングを、例えば、略2秒で生成するためには、十分なものである。
Claims (10)
- 少なくとも一つの第1の構成部と少なくとも一つの合焦用の第2の構成部とを含む装置であって、
前記少なくとも一つの第1の構成部は、分散用の構成部を含み、少なくとも一つのサンプルの少なくとも一つの領域から受けた信号に関連付けられたデータを提供するように構成され、
前記少なくとも一つの合焦用の第2の構成部は、前記データに基づいて前記少なくとも一つの第1の構成部に関連付けられた焦点距離又は焦点位置の少なくとも一つを制御するように構成され、
前記少なくとも一つの第1の構成部と、前記少なくとも一つの合焦用の第2の構成部と、は、バルーンの中に設けられ、
前記データは、バルーンの表面からの反射によって得られる制御信号を備える、装置。 - 前記少なくとも一つのサンプルの少なくとも一つのさらなる領域から受けたさらなる信号に関連付けられたさらなるデータを提供する、少なくとも一つの第3の構成部をさらに含み、
前記領域と前記さらなる領域は、(i)少なくとも部分的に重なる、又は、(ii)近傍に位置する、の少なくとも一つであり、
前記少なくとも一つの合焦用の第2の構成部は、前記データ又は前記さらなるデータの少なくとも一つに基づいて前記少なくとも一つの第1の構成部に関連付けられた前記焦点距離又は前記焦点位置の少なくとも一つを制御するように構成されている、請求項1記載の装置。 - 前記分散用の構成部及び前記合焦用の構成部は、バルーンの中に設けられている、請求項1記載の装置。
- 前記少なくとも一つの第1の構成部と、前記少なくとも一つの合焦用の第2の構成部と、前記少なくとも一つの第3の構成部と、は、バルーンの中に設けられ、
前記データ又は前記さらなるデータの少なくとも一つは、バルーンの表面からの反射によって得られる制御信号を備える、請求項2記載の装置。 - 解剖学的組織の少なくとも一部を撮像する装置であって、
少なくとも一つの第1の電磁放射を前記少なくとも一部に供給して、前記少なくとも一部の表面の面に対して0度より大きく、90度より小さい角度でサンプルの面を形成するように構成された、分散用の構成部を含む少なくとも一つの構成部と、
光学構成であって、前記少なくとも一つの第1の電磁放射に関連付けられた前記サンプルの面から少なくとも一つの第2の電磁放射を受けて、前記少なくとも一つの第2の電磁放射の関数として情報を生成するように構成された、少なくとも一つの第2構成部と、
前記情報に基づいて制御信号を生成し、前記少なくとも一つの第1の電磁放射の焦点面の場所をさらに制御する、少なくとも一つのコンピュータ第3構成部と、を備え、
前記分散用の構成部を含む少なくとも一つの構成部と、前記少なくとも一つの第2構成部と、前記少なくとも一つのコンピュータ第3構成部と、は、バルーンの中に設けられ、
制御信号は、バルーンの表面からの反射によって得られる制御信号を含む、装置。 - 前記少なくとも一つのコンピュータ第3構成部は、前記少なくとも一つの第1の電磁放射の少なくとも一部を用いて、前記サンプルの表面の場所に基づいて前記制御信号を生成するように構成されている、請求項5記載の装置。
- 前記少なくとも一つの第2構成部は、前記少なくとも一つの第2の電磁放射を少なくとも一つの第1の信号と少なくとも一つの第2の信号に分離する、請求項5記載の装置。
- 前記少なくとも一つのコンピュータ第3構成部は、前記少なくとも一つの第1の信号に基づいて、前記制御信号を生成し、
前記少なくとも一つの第2の信号の関数として、前記サンプルに関連付けられた少なくとも一つの画像を生成するようにさらに構成されている、請求項7記載の装置。 - 前記情報の関数として、前記少なくとも一部の少なくとも一つの三次元画像を生成するように構成された少なくとも一つの第4構成部をさらに備える、請求項5記載の装置。
- 解剖学的組織の少なくとも一部を撮像する装置であって、
少なくとも一つの第1の電磁放射を前記少なくとも一部に供給して、前記少なくとも一部の表面の面に対して0度より大きく、90度より小さい角度でサンプルの面を形成するように構成された、分散用の構成部を含む少なくとも一つの構成部と、
光学構成であって、前記少なくとも一つの第1の電磁放射に関連付けられた前記サンプルの面から少なくとも一つの第2の電磁放射を受けて、前記少なくとも一つの第2の電磁放射の関数として情報を生成するように構成された、少なくとも一つの第2構成部と、
前記情報の関数として前記少なくとも一部の少なくとも一つの3次元画像を生成するように構成された、少なくとも一つのコンピュータ第3構成部と、を備え、
前記装置は、前記情報に基づいて制御信号を生成し、前記少なくとも一つの第1の電磁放射の焦点面の場所をさらに制御する、少なくとも一つの第4構成部をさらに備え、
前記分散用の構成部を含む少なくとも一つの構成部と、前記少なくとも一つの第2構成部と、前記少なくとも一つの第4構成部と、は、バルーンの中に設けられ、
制御信号は、バルーンの表面からの反射によって得られる制御信号を備える、装置。
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EP2389093A4 (en) | 2013-07-31 |
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