JP2013531528A - 流体送達システム及び流体送達システムを監視するための方法 - Google Patents
流体送達システム及び流体送達システムを監視するための方法 Download PDFInfo
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Abstract
Description
関連出願の相互参照
本出願は、参照により本明細書に組み入れるものとする、2010年6月22日に出願された米国特許仮出願第61/357,439号の利益を主張するものである。
流体送達システムは、広範囲に使用されている。流体送達システムの一例は、血液ポンプシステムである。ヒトの心臓は、経時的に損傷された状態又は機能不全になる可能性がある。心臓に対する損傷が十分に重篤になる場合、心臓は血液を正常に汲み上げ循環させることができず、結果的に心不全として知られる病状をもたらす。世界中で数百万人の人々が心不全に苦しんでいる。多くの人々が薬物療法に不応性であり、その場合、心臓移植の恩恵を受ける可能性がある。しかしながら、ドナー心臓の不足が存在する。結果として、移植可能な血液ポンプは、現実的な治療選択肢へと徐々に進化してきた。
本願は、他の生理学的状態の影響を識別し得るような、システム性能を監視するための方法を開示している。この方法は、フローメーター又は圧力変換器の使用を必要としない。実際、この方法は、ポンプシステムに付加されるいかなる追加的なハードウェアも必要としない。このことは、システムの性能、信頼性、及び使用適性を損なうことなく、新しい血液ポンプシステムに容易にかつ安価に実装されるための方法、並びに現行の血液ポンプシステムに容易に改造設置されるための方法を可能にする。
〔図1〕本発明による心室補助装置の概略図である。
図1は、本発明の好ましい実施形態による心室補助装置10の概略図を示している。心室補助装置10は、本発明を例示するために用いられているが、本発明は、任意の好適な流体送達システムで用いられ得る。装置10は、患者の循環系に接続され得る移植可能なポンプ12を含む。ポンプ12は、入口14と出口16とを有する。このポンプは、軸流ポンプ、渦巻きポンプ、能動的変位ポンプ、又は血液ポンプの任意の他のタイプであり得る。入口14は、患者の心臓の左心室のような患者の循環系に次に接続し得る導管(図示せず)に接続することができる。出口16は、大動脈のような第1の導管の下流側の患者の循環系に次に接続し得る別の導管(図示せず)に接続することができる。ポンプ12は、患者の腹部、胸腔、又は別の位置で移植され得る。
工程1:可変の第1のパラメータを流体送達システムの電気モーターに供給すること(この電気モーターは流体送達システムのポンプを駆動する);
工程2:可変の第1のパラメータに対する電気モーターの第2のパラメータの応答を検知すること(例えば、電圧及び電流の形で);
工程3:電気モーターの第2のパラメータの応答についての周波数領域情報を取得すること(一実施形態では、周波数領域情報は、電気モーターの第2のパラメータの位相角度を含む);並びに、
工程4:電気モーターの第2のパラメータの位相角度に基づいて、ポンプ閉塞の程度を決定すること、である。
Claims (30)
- モーターによって駆動される血液ポンプを制御するよう構成された制御システムであり、
前記モーター又は前記血液ポンプに対して非定常成分を有する駆動信号と、前記モーターから受信され応答信号とを解析するように、又は前記非定常成分を有する前記駆動信号から得られた前記モーターから受信された2つの異なる応答信号を解析するように、並びに前記血液ポンプがポンプ事象又は生理学的事象のいずれの下で動作されているかを解析から決定するようにプログラムされているコントローラを含む、制御システム。 - 前記解析が、周波数領域情報と時間領域情報のうちの1つ又はこの組み合わせを含む情報を発生させることと、前記ポンプ事象と前記生理学的事象の1つ又は双方を表すデータと、前記情報を比較することとを含む、請求項1に記載の制御システム。
- 前記ポンプ事象と前記生理学的事象の1つ又は双方を表すデータを記憶するメモリデバイスを更に含み、前記メモリデバイスが、前記コントローラと連結されている、請求項1に記載の制御システム。
- 前記ポンプ事象が、閉塞、前記血液ポンプ内の付加的摩擦、前記血液ポンプ内の血栓形成、前記血液ポンプに接続されたグラフト又は人工導管でのねじれ、前記血液ポンプのローター上への増大した抗力、前記血液ポンプの羽根車上への増大した抗力、前記血液ポンプの内部軸受上への増大した抗力、及びこれらの組み合わせからなる群から選択される、請求項1に記載の制御システム。
- 前記生理学的事象が、末梢血管抵抗における変化である、請求項1に記載の制御システム。
- 前記生理学的事象が、高血圧、低血圧、血液過多、頻脈、不整脈、及びタンポナーデからなる群から選択される状態である、請求項1に記載の制御システム。
- 前記コントローラが、前記解析に従って、前記血液ポンプの動作状況を、閉塞、前記血液ポンプ内の付加的摩擦、前記血液ポンプ内の血栓形成、前記血液ポンプに接続されたグラフト又は人工導管でのねじれ、前記血液ポンプのローター上への増大した抗力、前記血液ポンプの羽根車上への増大した抗力、前記血液ポンプの内部軸受上への増大した抗力、及びこれらの組み合わせが挙げられる複数のポンプ事象からの特定のポンプ事象に合致させるようにプログラムされている、請求項1に記載の制御システム。
- 前記解析が、位相及び電力解析、振幅及び電力解析、又はこれらの組み合わせを含む、請求項7に記載の制御システム。
- 前記コントローラが、前記解析に従って、高血圧、低血圧、血液過多、頻脈、不整脈、及びタンポナーデが挙げられる複数の生理学的事象から特定のポンプ事象を識別するようにプログラムされている、請求項7に記載の制御システム。
- 前記解析が、位相及び電力解析、振幅及び電力解析、ピーク振幅周波数解析、周波数−領域解析、時間−領域解析、及び時間−周波数−領域解析のうちのいずれか1つ又はこれらの組み合わせを含む、請求項9に記載の制御システム。
- 前記駆動信号が、患者の心臓に基づく、請求項1に記載の制御システム。
- 前記コントローラが、前記モーターへ前記駆動信号を供給するよう構成されている、請求項1に記載の制御システム。
- 前記解析が、前記応答信号に対する前記駆動信号の伝達関数と、2つの異なる応答信号の第2の信号に対する前記2つの異なる応答信号の第1の信号の伝達関数のうちの1つ以上を含む周波数領域情報を発生させることを含む、請求項1に記載の制御システム。
- 前記解析が、信号の対の伝達関数を含む周波数領域情報を発生させることを含み、前記信号の対が、モーター電圧及びモーター電流、モーター電圧及びローター速度、モーター電圧及びモーター電力、速度コマンド信号及びモーター電流、速度コマンド信号及びローター速度、速度コマンド信号及びモーター電力、モーター電流及びローター速度、並びにモーター電力及びローター速度からなる群から選択される、請求項1に記載の制御システム。
- 前記伝達関数が、選択された周波数での前記対の信号の第1の信号の振幅を、前記選択された周波数での前記対の信号の第2の信号の振幅で割ったものである、請求項14に記載の制御システム。
- 前記コントローラが、少なくとも前記伝達関数に基づいて、ポンプ閉塞の程度を決定するようプログラムされている、請求項14に記載の制御システム。
- 前記解析が、選択された周波数での前記応答信号の位相角度を含む周波数領域情報を発生させることを含む、請求項1に記載の制御システム。
- 前記周波数領域情報が位相差を含み、前記位相差が、選択された周波数での前記駆動信号の位相角度から、所定の周波数での前記応答信号の前記位相角度を減じたものである、請求項17に記載の制御システム。
- 前記コントローラが、少なくとも前記位相差に基づいて、ポンプ閉塞の程度を決定するようプログラムされている、請求項18に記載の制御システム。
- 前記コントローラが、
(a)選択された周波数での前記駆動信号と前記応答信号との間の位相差と、
(b)ポンプ閉塞の程度と、前記駆動信号と前記応答信号との間の位相差との間の予め決められた関連性と、
(c)前記駆動信号と前記応答信号との間の位相差が負であるか正であるかと、
(d)前記駆動信号と前記応答信号との間の位相差の履歴記録と、
(e)前記駆動信号と前記応答信号との間の位相差での変化、とのうちの少なくとも1つ以上に基づいて、ポンプ閉塞の程度を決定するようプログラムされている、請求項1に記載の制御システム。 - 心室補助装置として機能するポンプシステムであり、
モーターにより駆動される血液ポンプと、
請求項1によるコントローラとを含む、ポンプシステム。 - モーターによって駆動される血液ポンプを制御するための方法であり、
前記モーター又は前記血液ポンプに対して非定常成分を有する駆動信号と、前記モーターから受信された対応する応答信号とを解析すること、又は前記非定常成分を有する前記駆動信号から得られた前記モーターからの2つの異なる応答信号を解析することと、
前記解析から、前記血液ポンプが、ポンプ事象又は生理学的事象のいずれの下で動作状態にあるかを決定することとを含む方法。 - 前記解析工程が、周波数領域情報及び時間領域情報のうちの1つ又はこの組み合わせを含む情報を発生させることと、前記情報を、前記ポンプ事象と前記生理学的事象の1つ又は双方を表すデータと比較することを含む、請求項22に記載の方法。
- 前記ポンプ事象が、閉塞、前記血液ポンプ内の付加的摩擦、前記血液ポンプ内の血栓形成、前記血液ポンプに接続されたグラフト又は人工導管でのねじれ、前記血液ポンプのローター上への増大した抗力、前記血液ポンプの羽根車上への増大した抗力、前記血液ポンプの内部軸受上への増大した抗力、及びこれらの組み合わせからなる群から選択される状態である、請求項22に記載の方法。
- 前記生理学的事象が、末梢血管抵抗における変化である、請求項22に記載の方法。
- 前記生理学的事象が、高血圧、低血圧、血液過多、頻脈、不整脈、及びタンポナーデからなる群から選択される状態である、請求項22に記載の方法。
- 前記決定する工程が、前記血液ポンプの動作状況を、閉塞、前記血液ポンプ内の付加的摩擦、前記血液ポンプ内の血栓形成、前記血液ポンプに接続されたグラフト又は人工導管でのねじれ、前記血液ポンプのローター上への増大した抗力、前記血液ポンプの羽根車上への増大した抗力、前記血液ポンプの内部軸受上への増大した抗力、及びこれらの組み合わせが挙げられる複数のポンプ事象からの特定のポンプ事象に合致させることを含む、請求項22に記載の方法。
- 前記解析工程が、位相及び電力解析、振幅及び電力解析、又はこれらの組み合わせを含む、請求項27に記載の方法。
- 前記決定する工程が、高血圧、低血圧、血液過多、頻脈、不整脈、及びタンポナーデが挙げられる複数の生理学的事象から特定のポンプ事象を識別することを含む、請求項27に記載の方法。
- 前記解析工程が、位相及び電力解析、振幅及び電力解析、ピーク振幅周波数解析、周波数−領域解析、時間−領域解析、及び時間−周波数−領域解析のうちのいずれか1つ又はこれらの組み合わせを含む、請求項29に記載の方法。
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AU2011270881B2 (en) | 2015-10-29 |
WO2011163421A1 (en) | 2011-12-29 |
EP2585129B1 (en) | 2017-03-08 |
US8905910B2 (en) | 2014-12-09 |
EP2585129A1 (en) | 2013-05-01 |
JP5898190B2 (ja) | 2016-04-06 |
AU2011270881A1 (en) | 2012-12-13 |
TW201212959A (en) | 2012-04-01 |
US20110313238A1 (en) | 2011-12-22 |
CA2802217A1 (en) | 2011-12-29 |
EP2585129B8 (en) | 2017-07-12 |
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