JP7313723B2 - 経血管横隔膜ペーシング・システム及び使用方法 - Google Patents
経血管横隔膜ペーシング・システム及び使用方法 Download PDFInfo
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- JP7313723B2 JP7313723B2 JP2021195133A JP2021195133A JP7313723B2 JP 7313723 B2 JP7313723 B2 JP 7313723B2 JP 2021195133 A JP2021195133 A JP 2021195133A JP 2021195133 A JP2021195133 A JP 2021195133A JP 7313723 B2 JP7313723 B2 JP 7313723B2
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Description
第4の実施形態によれば、この方法はまた、刺激信号の送出と人工呼吸器呼吸サイクルとの間の同調を維持する工程を含む。
第7の実施形態によれば、この方法は、刺激信号の投与による横隔膜寄与レベルを判定する工程をさらに含み、処方された補助レベルは、横隔膜寄与レベルと人工呼吸器寄与レベルの合計である。
第9の実施形態によれば、横隔膜寄与レベルは、一回呼吸量又は圧力について別個に、一緒に、及び、これらの構成要素を含めて測定される。
第11の実施形態によれば、収縮能力を判定する工程は、横隔膜の反応から強さ及び耐久性を測定して刺激パターンを検査する工程を含む。
第13の実施形態によれば、患者の横隔膜の強さ及び耐久性を判定する工程は、横隔膜の最大横隔膜出力及び疲労特性を測定する工程を含む。
第16の実施形態によれば、刺激信号を投与する工程は、1つ又は複数のペーシング・パラメータに応じて刺激信号を発生する工程と、刺激信号を人工呼吸器呼吸サイクルと関連して送出する工程とを含む。
第21の実施形態によれば、この方法は、最後に投与された刺激信号の横隔膜出力が事前選択目標範囲の外側にある場合、原因を明らかにする工程をさらに含む。
第23の実施形態によれば、この方法は、評価された横隔膜の状態に基づいて刺激信号を再プログラムする工程をさらに含む。
第26の実施形態によれば、人工呼吸器の呼吸サイクルを監視する工程は、人工呼吸器の吸気及び呼気を表す信号を検知する工程と、吸気相、呼気相、吸気休止、呼気休止、のうちの1つ又は複数を計算する工程とを含む。
本開示の別の態様によれば、人工呼吸器から呼吸補助を受ける患者の横隔膜廃用性萎縮を防止又は逆転する経血管横隔膜ペーシング・システムが提供される。このシステムは、供給された刺激信号を送出するように構成された少なくとも1つの血管内電極を備える。刺激信号は、いくつかの実施形態では患者の横隔神経を補助するように構成され、刺激信号は、いくつかの実施形態では1つ又は複数の刺激パラメータを有する。システムはまた、付随する人工呼吸器からの呼吸サイクル信号、及び横隔神経の補助による横隔膜反応を検知するように構成された1つ又は複数のセンサと、少なくとも1つの血管内電極と電気的に接続すべく結合されたパルス発生器と、治療計画の1つ又は複数の態様を表すデータを入力するように構成された少なくとも1つの入力デバイスとを含む。システムはさらに、1つ又は複数のセンサ、少なくとも1つの入力デバイス及びパルス発生器と電気的に接続すべく結合されたコントローラを含む。このコントローラは、いくつかの実施形態では、人工呼吸器動作パラメータ及び1つ又は複数のペーシング・パラメータを表す検知信号を含む、治療計画の1つ又は複数の態様を表す入力データを受け、呼吸サイクル信号を監視し、呼吸サイクルの吸気相及び呼気相を判定し、1つ又は複数のペーシング・パラメータに応じて刺激信号を発生し、発生した刺激信号を少なくとも1つの経血管電極へ、人工呼吸サイクルの事前選択時間に送出し、患者の横隔膜出力を呼吸サイクルごとに調節するように、プログラムされる。
第29の実施形態によれば、コントローラはさらに、刺激信号の送出と人工呼吸器呼吸サイクルとの同調を維持するようにプログラムされる。
第36の実施形態によれば、コントローラはさらに、人工呼吸器呼吸サイクルの流量及び圧力を表すデータを監視して、呼気終末遅延のタイミングを判定すること、人工呼吸器呼吸サイクルの監視されたデータに基づく刺激信号を用いて横隔膜を漸進的に刺激すること、及び横隔膜及び呼吸器系の1つ又は複数の機能特性を判定することによって、横隔膜を評価するようにプログラムされる。いくつかの実施形態では、1つ又は複数の機能特性には、最大静吸気圧、吸気容量、呼吸仕事量、圧力・時間積、圧力・時間指標、EMG、最大緩和速度、及び呼気時定数のうちの1つ又は複数が含まれる。
第38の実施形態によれば、刺激信号は、刺激列の始め、又は刺激列の中間に2つ組パルス又は3つ組パルスを含む。
本開示のさらに別の態様によれば、人工呼吸器から呼吸補助を受ける患者の横隔膜廃用性萎縮を防止する、又はその逆転を速めるための治療計画を投与する方法が提供される。人工呼吸器は患者に呼吸サイクルを与え、患者は処方された補助レベルを有する。この方法は、処方された補助レベルの少なくとも一部分である横隔膜出力の事前選択範囲を表す測定値を格納する工程と、人工呼吸器の呼吸サイクルを監視する工程と、刺激信号を患者に人工呼吸器の呼吸サイクルと同調して投与して、患者の横隔膜に、あるレベルの横隔膜出力を生じさせる補充をする工程と、横隔膜の補充による患者の横隔膜出力を、横隔膜出力の事前選択範囲内に入るように、刺激された呼吸サイクルごとに調節する工程とを含む。
第44の実施形態によれば、刺激信号の強度を増大させる工程が、刺激信号パルスの周波数を高くする工程、刺激信号パルスの振幅を増大させる工程、及び/又は刺激信号パルスの持続時間を増やす工程のうちの1つ又は複数を含む。
本開示のさらに別の態様によれば、重病患者の横隔膜廃用性萎縮を防止する方法が提供される。この方法は、患者に人工呼吸器を付ける工程と、人工呼吸器の呼吸サイクルを監視する工程と、患者に人工呼吸器が付けられている12時間又は6時間の一方の時間以内に、事前プログラムされた刺激信号を患者に投与して、あるレベルの横隔膜出力を出力するように患者の横隔膜を補充する工程と、刺激信号の投与に基づいて、患者の横隔膜出力のレベルを、事前選択閾値に一致させるか又は超えるように、呼吸サイクルごとに調節する工程とを含む。
システム20はさらに、患者の横隔神経刺激に対する反応及び/又は他の生理的特性を監視するように構成された1つ又は複数のセンサ48を含む。以下でより詳細に説明するように、1つ又は複数のセンサ48は、患者に与えられる刺激を調節するためのフィードバック制御系統の一部とすることができる。複数のセンサ48は、以下のうちの1つ又は複数を示すデータを刺激装置24へ送信することができる:筋電図活動(筋肉内、表面、及び/又は食道内で監視)、中心静脈圧(この信号の任意の特定の成分)、心拍数、胸壁加速、血液酸素飽和度、二酸化炭素濃度、静脈内のカテーテルの位置/深さ、機械的動き(すなわち、加速度計、長さゲージ、及び/又は歪みゲージから)、抵抗(すなわち、インピーダンス呼吸曲線記録器、及び/又は圧電抵抗センサから)、及び/又は他の生理的もしくは機械的諸パラメータである。これらの情報は、刺激装置24で使用する前に適切に処理できることを理解されたい(例えば、フィルタリング、条件付け、増幅など)。
ータ」)、又は上述のブロック108で修正された刺激パラメータにより生成される。刺激傾斜列の送出タイミングもまた、ブロック110で決定される。例えば、このルーチンでは、横隔神経刺激の適切なタイミングを人工呼吸器32の実際の呼吸サイクルとの相関から決定することができる。一般的に説明すると、ルーチンでは、呼吸検出アルゴリズムなどからのパラメータ推定値に基づき、事前定義された規則に従って刺激のタイミングを制御する。事前定義される規則には、図11及び図12に示されている、人工呼吸器32の吸気相の開始前、開始中、もしくは開始後の任意の時間に刺激が始まるかどうか、又は、図24に示されているように、呼気相中に刺激が始まるかどうかを含むことができる。
Claims (12)
- 刺激システムにおいて、
患者の1つの呼吸の間に刺激信号で横隔神経を刺激するための刺激装置と、
横隔膜出力データを取得するためのセンサと、
前記刺激システムを制御するための命令を格納する電子記憶装置と、
プロセッサであって、
前記センサから前記横隔膜出力データを受信するステップと、
前記横隔膜出力データを処理し、前記患者の横隔膜が行う呼吸仕事量を決定するステップと、
前記呼吸仕事量が選択した範囲外にあることを判定するステップと、
前記呼吸仕事量が選択した範囲外にあることに応答して前記刺激信号を変更するステップと、を行う命令を実行するための前記プロセッサとを備える、前記刺激システム。 - 前記刺激装置は前記刺激信号をカテーテル上に支持した複数の電極に送達することにより前記横隔神経を刺激する、請求項1に記載の刺激システム。
- 前記複数の電極は、左横隔神経に近接して配置される第1の群の電極と、右横隔神経に近接して配置される第2の群の電極とを含む、請求項2に記載の刺激システム。
- 前記呼吸は前記患者が人工呼吸器からの呼吸補助を受けている間の呼吸である、請求項1に記載の刺激システム。
- 前記プロセッサはさらに、前記患者の呼吸サイクルの属性を取得するための命令を実行する、請求項1に記載の刺激システム。
- 前記プロセッサはさらに、前記患者の呼吸サイクルに関連して前記横隔神経を刺激するタイミングを判定するための命令を実行する、請求項1に記載の刺激システム。
- 前記呼吸仕事量には、1つの呼吸サイクルの1つ以上の相の間に前記患者が行う仕事量が含まれる、請求項1に記載の刺激システム。
- 前記呼吸仕事量には、前記患者の前記横隔膜によりなされる仕事量が含まれる、請求項1に記載の刺激システム。
- 前記センサは、前記患者によって生成される気流を感知することにより前記横隔膜出力データを取得する、請求項1に記載の刺激システム。
- 前記刺激システムは、
前記センサを用いて、前記患者が行った複数の呼吸について横隔膜出力データを取得すること、
前記横隔膜出力データを平均化し、平均化された横隔膜出力データを生成すること、及び、
前記平均化された横隔膜出力データに基づいて、前記複数の呼吸にわたり行われた呼吸仕事量の平均を決定することによって前記呼吸仕事量を決定する、請求項1に記載の刺激システム。 - 前記横隔膜出力データは、気道圧と一回換気量を含む、請求項1に記載の刺激システム。
- 前記呼吸仕事量は、気道圧と一回換気量の積を含む、請求項11に記載の刺激システム。
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