JP2022525307A - 血流量測定システム - Google Patents
血流量測定システム Download PDFInfo
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Abstract
Description
本出願は、すべての目的について参照によりその全内容が本明細書に組み入れられる、2019年3月14日に提出された米国特許出願第16/353,132号「Blood Flow Rate Measurement System」の恩典を主張する。
本発明は血流測定システムに関し、より具体的には、カテーテルマウント式、タービン駆動式の血流測定システムに関する。
冠動脈疾患(CAD)を伴う多くの患者が、ステント経皮的冠動脈インターベンション(CPI)または冠動脈バイパスグラフト手術により利益を受ける。しかし、これら患者の一部は、これらの手技中に生じうる合併症についてリスクが高すぎると考えられる。リスクファクターには、高齢;腎臓疾患、脳卒中、もしくは糖尿病などの疾患歴;左主幹部病変もしくは2枝病変など、CADの位置;石灰化した病変もしくは長い病変など、困難なプラークタイプ;冠動脈の慢性完全閉塞;開胸心臓手術の既往;および、進行した心不全が含まれる。
本発明の1つの態様において血流量測定システムが提供される。同システムは、カテーテルと、タービンと、信号発生器と、信号リードとを含む。カテーテルはある長さを有する。カテーテルは、ヒトなど、生物の血管内に挿入されるよう構成される。タービンはカテーテルの遠位端の近傍に配される。
本発明の諸態様は、カテーテル式心臓ポンプが患者の血管内に挿入された時に、心臓ポンプを駆動するモーターによって引かれる電流の測定に頼ることなく、その血管内における血流、例えば自然な心臓の作用と心臓ポンプの作用とを足した総血流などを測定するための、装置および方法を提供する。本発明の諸態様は、心臓ポンプカテーテルの遠位端またはその近くに配されたタービンを含む。血管を通って流れる血液または他の流体によってタービンブレードの回転が誘発される。タービンは、タービンの回転速度の指標となる信号を発生させる信号発生器に、機械的に連結される;タービンの回転速度は、血管を通って流れる流体の速度に少なくとも部分的に依存する。信号は、リードによって、患者の体外にあるカテーテルの近位端まで搬送され、そこで血流速度計がタービンの回転速度から血流量を計算する。有利な点として、リードは直径が小さい。
本明細書において用いる以下の用語は、別段の提示がない限り以下の定義を有する。
図1に、その遠位部分104が患者の血管106を通って心臓108内まで挿入される細長のカテーテル102を含む、例示的な先行技術の心臓ポンプ100を示す。カテーテル102の近位端110は、Abiomed, Inc., Danvers, MAから入手可能であるAutomated Impella(登録商標)Controllerなどの、外部制御ユニット112に接続される。Impella 2.5(登録商標)およびImpella CP(登録商標)など従来の心臓ポンプは、インペラーブレードを駆動する電気モーターを含む。血液はインレットポート114を通って引き入れられ、そしてアウトレットポート116を通って吐出される。ポンプ送りされる血液が矢印118、120、および122で示されている。モーター124の速度は、そしてゆえにポンプ100の速度およびポンプ送りされる血液の量も、モーター124によって引かれる電流を測定することにより制御ユニット112によって自動的に確かめることができる。しかし、先に言及したように、モーター124は直径が比較的大きい。
この問題を克服するため、そして、血管を通る流体の流量の信頼できる測定を提供するため、本発明の1つの態様は、図2および図3に図示するように、心臓ポンプ(図示せず)もまた含むカテーテル202の遠位端またはその近くにタービン200を含む。
いくつかの態様において、ブレード204は、放射方向に、すなわち軸206に向かう方向に折りたたみ可能である。そうしたいくつかの態様において、ブレード204は、少なくともカテーテルが血管内に挿入されている間はブレード204の外径216(図2)を低減させるために、折り重ね、収縮、または圧縮できる可撓性材料で作られる。いくつかの態様において、ブレード204は弾力性である。いくつかの態様において、ブレード204は、人体内を循環している血液の温度に等しいかまたはそれよりやや低い温度まで加温されると記憶形状に戻る、形状記憶材料で作られる。いくつかの態様において、各ブレード204は、ブレード204のモード(折りたたみモードまたは伸展モード)に応じて折りたたみまたは伸展する複数のストラットを含む。その結果として、カテーテルが所定のポジションになると、ブレード204は、開くかまたはその他元に戻って、血管内を流れる流体によって駆動されるための効率的な形状になる。
Claims (13)
- ある長さを有し、かつ生物の血管内に挿入されるよう構成されている、カテーテル(202)と;
該カテーテル(202)の遠位端の近傍にありかつ少なくとも1つのブレード(204)を具備するタービン(200)であって、該血管を通る流体の流れに応答して、かつ該血管を通る該流体の流れの速度に少なくとも部分的に依存する回転速度で、該カテーテルに対して回転するよう、該少なくとも1つのブレード(204)が構成されている、該タービン(200)と;
該タービン(200)に機械的に連結され、かつ、該少なくとも1つのブレード(204)の該回転速度の指標となる信号(404)を発生させるよう構成された、信号発生器(400)と;
該少なくとも1つのブレード(204)の該回転速度の指標となる該信号(404)を搬送するよう構成された信号リード(406)であって、該信号発生器(400)に接続されかつ該カテーテル(202)に沿って延在している、該信号リード(406)と
を具備する血流量測定システム。 - 信号発生器(400)が発電機を具備する、請求項1記載の血流量測定システム。
- 信号発生器が磁石(500)を具備する、前記請求項のいずれか記載の血流量測定システム。
- コイル(504)をさらに具備し、磁石(500)が、前記少なくとも1つのブレード(204)の回転に応答して該コイル(504)に対して回転するよう構成されている、請求項3記載の血流量測定システム。
- ホール効果センサー(600)をさらに具備し、磁石(500)が、前記少なくとも1つのブレード(204)の回転に応答して該ホール効果センサー(600)に対して回転するよう構成されている、請求項3記載の血流量測定システム。
- 信号リード(406)が第一および第二の導電性リード(408, 410)を含む、前記請求項のいずれか記載の血流量測定システム。
- 信号リード(406)が光ファイバー(702)を含む、前記請求項のいずれか記載の血流量測定システム。
- 信号リード(406)に連結され、かつ、前記少なくとも1つのブレード(204)の回転速度の指標となる信号(404)に基づいて、血管を通る流体の流れの速度を測定するよう構成された、血流速度計(412)
をさらに具備する、前記請求項のいずれか記載の血流量測定システム。 - 前記少なくとも1つのブレード(204)が放射方向に折りたたみ可能である、前記請求項のいずれか記載の血流量測定システム。
- 信号リード(406)が、生物の体外の位置までカテーテル(202)に沿って延在するよう構成されている、前記請求項のいずれか記載の血流量測定システム。
- 血管を通る流体の流れの少なくとも一部分を前記少なくとも1つのブレード(204)に向かって方向付けるよう構成されたダクト(210)をさらに具備し;該少なくとも1つのブレード(204)が、該ダクト(210)の形状とサイズとに少なくとも部分的に依存する回転速度でカテーテル(202)に対して回転するよう構成されている、前記請求項のいずれか記載の血流量測定システム。
- ダクト(210)が放射方向に折りたたみ可能である、請求項11記載の血流量測定システム。
- ダクト(210)が先細である、請求項11または12記載の血流量測定システム。
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US16/353,132 US20200288988A1 (en) | 2019-03-14 | 2019-03-14 | Blood Flow Rate Measurement System |
PCT/US2019/062764 WO2020185265A1 (en) | 2019-03-14 | 2019-11-22 | Blood flow rate measurement system |
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