JP2016516467A - 光学圧力センサアセンブリ - Google Patents
光学圧力センサアセンブリ Download PDFInfo
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Abstract
Description
本特許出願は、下記の係属特許出願の1つ以上に関係している。米国出願(番号12/790,703、名称"OPTICAL COHERENCE TOMOGRAPHY FOR BIOLOGICAL IMAGING"、2010年5月28日出願)、米国出願(番号12/829,267、名称"CATHETER-BASED OFF-AXIS OPTICAL COHERENCE TOMOGRAPHY IMAGING SYSTEM"、2010年7月1日出願)、国際出願(名称"OPTICAL COHERENCE TOMOGRAPHY WITH GRADED INDEX FIBER FOR BIOLOGICAL IMAGING"、同時出願)、米国出願(番号13/433,049、名称"OCCLUSION-CROSSING DEVICES, IMAGING, AND ATHERECTOMY DEVICES"、2012年3月28日出願)、国際出願(名称"OCCLUSION-CROSSING DEVICES"、同時出願)、国際出願(名称"CHRONIC TOTAL OCCLUSION CROSSING DEVICES WITH IMAGING"、同時出願)、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)、米国出願(番号13/675,867、名称"OCCLUSION-CROSSING DEVICES, ATHERECTOMY DEVICES, AND IMAGING"、2012年11月13日出願)、国際出願(名称"ATHERECTOMY CATHETERS WITH IMAGING"、同時出願)、国際出願(名称"BALLOON ATHERECTOMY CATHETERS WITH IMAGING"、同時出願)、国際出願(名称"ATHERECTOMY CATHETER DRIVE ASSEMBLIES"、同時出願)。これらの特許出願の各々が参照により全体としてここに組み込まれる。
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。
ここでは、生理学的パラメータ、例えば、末梢血管系および冠血管系での血圧、血流予備量比(FFR)などを測定するための光学圧力センシング/センサアセンブリを説明している。特に、光学圧力センサおよびアセンブリは、光干渉法を用いて血管内圧を計算する。説明する実施形態は、既存のイメージングシステム、例えば、光コヒーレンストモグラフィなどを用いた使用と適合しており、アテローム切除術(atherectomy)または他の閉塞横断(occlusion-crossing)装置とともに使用できる。
光ファイバと、
第1端および第2端を有するハウジングであって、光ファイバが通って延びる管腔を含み、第1端において開口を有する該ハウジングと、
ハウジングに装着され、開口に位置決めされた弾性膜であって、圧力に応じてハウジングに対して相対移動可能に構成された弾性膜と、
光ファイバの近位端に装着され、光源との光通信のために構成された光ファイバコネクタとを有する。
光源からの光を光ファイバに通して送信するステップと、
光ファイバからの光を、膜に作用した圧力に応じて移動可能である弾性膜の偏位した面に送信するステップと、
弾性膜から反射または散乱した光を、検出器へ送信するステップと、
反射または散乱した光を検出器で受信するステップと、
弾性膜から検出器によって受信した光から、血管内圧力測定値を発生するステップとを含む。
光ファイバをカテーテルの管腔に通して前進させるステップと、
光源からの光を光ファイバに通して送信するステップと、
光ファイバからの光を、圧力の下でファイバに向けて偏位する、カテーテル上の可撓性膜に送信するステップと、
弾性膜から反射または散乱した光を、検出器へ送信するステップと、
反射または散乱した光を検出器で受信するステップと、
弾性膜から検出器によって受信した光に基づいて、血管内圧力測定値を発生するステップとを含む。
細長い本体と、
細長い本体内で、細長い本体の近位端から細長い本体の遠位端へ延びている中心管腔と、
細長い本体の遠位端にあり、細長い本体に対して相対回転するように構成され、弾性膜が横断して位置している開口を有する回転可能な先端であって、膜は、膜の外面に対して作用する圧力に応じて、偏位するように構成されている、回転可能な先端と、
回転可能な先端と接続され、それとともに回転するように構成された光ファイバと、を含む。
OCTは、血管などの身体管腔内を含む組織の領域を撮像するのに特に有用である1つのテクニックとして提案されている。基本レベルにおいて、OCTは、光源から進んでより遠くの物体から散乱する光が、近隣の物体から散乱する光より、逆行するのがより長いという事実に依拠している。光の波の性質に起因して、ミクロンスケールで異なる距離を進行する光信号によって生ずる極めて小さい時間差が、基準光信号との建設的干渉または破壊的干渉を生じさせる。OCTシステムは、得られた干渉を測定して、目標の画像を得る。典型的なOCTシステムが、信号を印加された光から区別するために、1つ以上の干渉計を必要とする。
上述のように、血管内圧測定のための挑戦の1つが、例えば、ドリフトなどの電気的干渉の不具合を回避する圧力センサのニーズであり、これは、電気圧力センサの精度および信頼性に影響を与える。このニーズに対処するために、説明する実施形態は、干渉計を使用して血管内圧を決定する光学ベースの圧力センサを提供する。特に、想定される圧力センサは、血管圧力によって偏位する弾性膜からの反射または散乱した光を使用して、目標血管場所での血圧を決定する。機構が光ベースであるため、ドリフトなどの電気的外乱が回避される。
このセクションでは、光学圧力センサアセンブリを用いて圧力を測定する方法を説明する追加の詳細を提供する。一般的事項として、光干渉計のために使用される任意の方法が、基準および目標からの反射し散乱した光を検出することに適用できる。典型的には、干渉計が、光源からの光を光ファイバを通じて送信する。送信された光は、しばしば2つのビームに分岐され、第1ビームは、基準構造に向けられ、第2ビームは、目標構造に向けられる。各ビームが構造に出会うと、構造は、受けた光を反射及び/又は散乱することになる。反射/散乱した光の幾つかは、光ファイバに入って、検出器まで進行する。検出器または検出器と通信する別個のプロセッサが、受信した光を用いて、光ファイバの送信端と出会った構造の散乱/反射ポイントとの間の距離を決定できる。
Claims (63)
- 光ファイバと、
光ファイバが通過する管腔を含み、開口を有するハウジングと、
ハウジングに装着され、開口に位置決めされた弾性膜であって、ハウジング外側の圧力に応じてハウジングに対して相対移動可能に構成された弾性膜とを備え、
光ファイバは、光源との光通信用に構成される、光学圧力センサアセンブリ。 - 光ファイバの遠位端が、ハウジング内で開口近くに固定され、ファイバの遠位端は、光源からの光を弾性膜へ送信し、弾性膜によって反射または散乱した光を受信するように構成される請求項1記載のアセンブリ。
- 光ファイバは、ハウジングに対して相対移動可能である請求項1記載のアセンブリ。
- 弾性膜は、正の圧力下で光ファイバに向けて偏位するように構成される請求項1記載のアセンブリ。
- 弾性膜は、膜が正の圧力下で偏位した場合、光ファイバに面する凸面を含む請求項1記載のアセンブリ。
- 弾性膜は、開口を覆うように構成される請求項1記載のアセンブリ。
- 弾性膜は、光ファイバの遠位端に向けて光を反射し散乱するように構成される請求項1記載のアセンブリ。
- 弾性膜は、フッ素化エチレンプロピレンで製作される請求項1記載のアセンブリ。
- 弾性膜は、光ファイバに面した第1面と、血管内腔に面するように構成された第2面とを含み、正の圧力が弾性膜の第2面に印加された場合、第1面と光ファイバとの間の距離が減少する、請求項1記載のアセンブリ。
- 弾性膜は、正の圧力下でハウジングの中心長手軸に向けて移動するように構成される請求項1記載のアセンブリ。
- 圧力センサ較正データを保存するメモリストレージ装置をさらに備える請求項1記載のアセンブリ。
- アセンブリについての圧力センサ較正データを保存するEEPROMをさらに備える請求項1記載のアセンブリ。
- 較正データは、弾性膜について圧力対偏位の関係を含む請求項11記載のアセンブリ。
- ファイバを出射した光を弾性膜に向けて反射させる、開口に対して整列したミラーをさらに備える請求項1記載のアセンブリ。
- 光ファイバの遠位端において界面媒体をさらに備え、該界面媒体は、光ファイバの第2屈折率とは異なる第1屈折率を有し、屈折率の相違は、フレネル反射を生じさせる請求項2記載のアセンブリ。
- 界面媒体は、Masterbond社のEP42HT−2、EpoTek社のOG127−4またはOG116、あるいはUV硬化性光接着剤OP−4−20658からなるグループから選択された接着剤である請求項15記載のアセンブリ。
- アセンブリの一部を回転し、OCT画像を発生するように構成された回転機構をさらに備える請求項1記載のアセンブリ。
- カテーテルがハウジングを形成し、カテーテルは、約0.014インチ〜約0.019インチの外径を有する請求項1記載のアセンブリ。
- コリメートした光をファイバの近位端の中に送信するように構成されたレンズをさらに備える請求項1記載のアセンブリ。
- アセンブリは、カテーテル管腔を通る挿入のための寸法を有する請求項1記載のアセンブリ。
- 血管内血圧を検知するための光学圧力センサシステムであって、
圧力ワイヤアセンブリと、光学イメージングシステムとを備え、
a)圧力ワイヤアセンブリは、近位端および遠位端を有し、遠位端において先端部分を有する細長い本体と、
細長い本体の壁を通って形成された、先端部分での開口と、
細長い本体を通って延びており、光を放出する遠位端を有する光ファイバと、
開口において、圧力下で移動するように構成された可撓性膜とを含み、
b)光学イメージングシステムは、コントローラ、光源および検出器を有し、光源は、ファイバと光通信し、検出器は、膜によって反射または散乱した光を受信するように構成される、
システム。 - コントローラは、検出器を動作させ、光源からの光の送信を制御するように構成される請求項21記載のシステム。
- コントローラは、光スイッチと電気通信し、光スイッチは、少なくとも2つのモード間で移動するように構成され、モードの1つは、光源から光スイッチを通って、光ファイバの近位端にある光コネクタの中への光通信を提供する請求項22記載のシステム。
- 圧力ワイヤアセンブリは、膜の外面に作用する圧力を測定するように構成される請求項22記載のシステム。
- コントローラは、膜の外面に作用する圧力について圧力値を発生するように構成され、圧力値は、膜の外面に作用する圧力に応じて、可撓性膜の移動に基づいて発生する請求項24記載のシステム。
- 圧力ワイヤアセンブリは、フレネル基準光を発生するように構成される請求項22記載のシステム。
- 検出器は、フレネル基準光と、膜によって反射または散乱した光との相互作用から得られる干渉信号を受信する請求項26記載のシステム。
- コントローラは、検出器からの干渉信号を受信し、干渉信号に基づいて圧力測定値を演算する請求項27記載のシステム。
- コントローラは、検出器からの干渉信号を受信し、干渉信号に基づいて圧力測定値、および膜についての偏位対圧力の関係を演算する請求項27記載のシステム。
- コントローラは、第1遠位端と膜との間の距離に基づいて圧力値を演算する請求項22記載のシステム。
- 血管内への挿入のために構成された中空シャフトを有する血管内カテーテル装置をさらに備え、圧力ワイヤアセンブリは、中空シャフトを通る挿入のための寸法を有する請求項21記載のシステム。
- 圧力ワイヤアセンブリは、約0.014インチ〜約0.019インチの外径を有する請求項21記載のシステム。
- 圧力ワイヤアセンブリは、ファイバの遠位端において界面媒体をさらに備え、界面媒体は、光ファイバでのファイバコアの第2屈折率とは異なる第1屈折率を有する請求項21記載のシステム。
- 圧力測定システムであって、
a)光放射光源と、
b)圧力プローブとを備え、該圧力プローブは、
光ファイバと、
光ファイバの一部を包囲するハウジングであって、ファイバの遠位端がハウジングの第1端においてハウジングの開口に位置決めされている、ハウジングと、
ハウジングの開口を横断して被される弾性鞘であって、鞘は、鞘の外面に作用する圧力に応じて偏位するように構成されており、光ファイバは、光放射を鞘に送信し、鞘が偏位しつつ、鞘によって反射または散乱した光放射を受信するように構成されている、弾性鞘と、を含み、さらに、
c)光ファイバから反射または散乱した光放射を受信する受信電子回路と、
d)受信電子回路によって受信された光放射に基づいて、圧力値を演算するように構成されたプロセッサと、を備える圧力測定システム。 - プロセッサと通信するディスプレイをさらに備え、ディスプレイは、測定した圧力値を表示するために構成される請求項34記載のシステム。
- 弾性鞘は、環境からの正の圧力下で、光ファイバに向けて偏位するように構成された可撓性膜である請求項34記載のシステム。
- 光ファイバは、ハウジングから取り外し可能である請求項34記載のシステム。
- 弾性鞘は、外面に作用した圧力によって偏位した場合、光ファイバに面する凸面を有する可撓性膜である請求項34記載のシステム。
- プロセッサは、受信電子回路によって受信された光放射を、プローブ用の圧力較正データのセットと比較することによって、圧力値を発生するように構成される請求項34記載のシステム。
- 較正データのセットが保存されるメモリストレージ装置をさらに備える請求項39記載のシステム。
- メモリストレージ装置は、EEPROMである請求項40記載のシステム。
- 較正データは、弾性鞘についての圧力−偏位の関係を含む請求項39記載のシステム。
- ハウジングを形成するカテーテルをさらに備える請求項34記載のシステム。
- 光ファイバは、ハウジングに接着される請求項34記載のシステム。
- プローブを回転し、OCT画像を発生するように構成された回転機構をさらに備える請求項34記載のシステム。
- 開口の近くにミラーをさらに備え、該ミラーは、ファイバからの光放射を鞘に反射するように構成される請求項34記載のシステム。
- 光ファイバは、基準および鞘から反射した光放射のための共通経路を提供するコアを含む請求項34記載のシステム。
- 受信電子回路は、検出器を含む請求項34記載のシステム。
- 血管内の圧力を決定する方法であって、
光源からの光を光ファイバに通して送信するステップと、
光ファイバからの光を、膜に作用した圧力に応じて移動可能である弾性膜の面に送信するステップと、
弾性膜から反射または散乱した光を、光ファイバに通して検出器へ送信するステップと、
弾性膜から検出器によって受信した光から、血管内圧力測定値を発生するステップとを含む方法。 - 発生ステップは、膜表面と光ファイバとの間の膜偏位距離に基づいて圧力測定値を演算することを含む請求項49記載の方法。
- 偏位距離は、弾性膜から検出器によって受信された光について強度値および画素深さ値によって示される請求項50記載の方法。
- 発生ステップは、検出器からのデータをプロセッサへ送信することを含み、データは、基準反射光と膜散乱または反射光との相互作用から得られる干渉信号を表し、プロセッサは、干渉信号に基づいて血管内圧力を演算する請求項49記載の方法。
- 発生ステップは、光ファイバおよび膜の偏位面からの経路長を演算することを含み、演算は、基準反射光と膜散乱または反射光との間の位相、時間または周波数の差に基づく請求項49記載の方法。
- 血管について血流予備量比を計算することをさらに含む請求項49記載の方法。
- 第1場所での第1圧力および第2場所での第2圧力を計算することをさらに含む請求項49記載の方法。
- OCTカテーテルを用いた血管内圧力を決定する方法であって、
光ファイバをカテーテルの管腔に通して前進させるステップと、
光源からの光を光ファイバに通して送信するステップと、
光ファイバからの光を、圧力の下でファイバに対して相対的に偏位する、カテーテル上の可撓性膜に送信するステップと、
弾性膜から反射または散乱した光を、検出器へ送信するステップと、
弾性膜から検出器によって受信した光に基づいて、血管内圧力測定値を発生するステップとを含む方法。 - 発生ステップは、膜偏位距離に基づいて圧力測定値を演算することを含む請求項56記載の方法。
- カテーテルの一部を回転することによって、OCT画像を発生することをさらに含む請求項56記載の方法。
- OCT圧力センシング装置であって、
細長い本体と、
細長い本体の遠位端にあり、細長い本体に対して相対回転するように構成され、弾性膜によって少なくとも部分的に覆われた開口を有する回転可能な先端であって、膜は、膜の外面に対して作用する圧力に応じて、偏位するように構成されている、回転可能な先端と、
回転可能な先端と接続され、それとともに回転するように構成された光ファイバと、を備える装置。 - 光ファイバは、OCTイメージングセンサである請求項59記載の装置。
- 光ファイバおよび弾性膜は、装置に対して作用する圧力を測定するように構成される請求項59記載の装置。
- 光ファイバおよび弾性膜は、圧力を測定するとともに、装置の回転位置は相対的に固定される請求項61記載の装置。
- 細長い本体内で、細長い本体の近位端から細長い本体の遠位端へ延びている中心管腔をさらに備える請求項61記載の装置。
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JP2020508464A (ja) * | 2017-02-24 | 2020-03-19 | オプタセンス・ホールデイングス・リミテツド | 海中ケーブルのモニタリング |
US11287336B2 (en) | 2017-02-24 | 2022-03-29 | Optasense Holdings Limited | Monitoring subsea cables |
KR20200071476A (ko) * | 2018-12-11 | 2020-06-19 | 지오씨 주식회사 | 광압력센서를 이용하는 혈관 압력 측정용 가이드 와이어 핸들러 |
KR102148858B1 (ko) | 2018-12-11 | 2020-10-14 | 지오씨 주식회사 | 광압력센서를 이용하는 혈관 압력 측정용 가이드 와이어 핸들러 |
JP7451535B2 (ja) | 2018-12-31 | 2024-03-18 | バイオセンス・ウエブスター・(イスラエル)・リミテッド | 圧力測定による閉塞検出 |
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US20220039658A1 (en) | 2022-02-10 |
US11723538B2 (en) | 2023-08-15 |
US10932670B2 (en) | 2021-03-02 |
EP2967367B1 (en) | 2019-02-20 |
EP2967367A4 (en) | 2016-11-02 |
WO2014142958A1 (en) | 2014-09-18 |
JP6291025B2 (ja) | 2018-03-14 |
CN105228514A (zh) | 2016-01-06 |
EP2967367A1 (en) | 2016-01-20 |
CN105228514B (zh) | 2019-01-22 |
US20160038030A1 (en) | 2016-02-11 |
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