JP2018140249A - 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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Abstract
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 (55)
- 患者に呼吸サイクルを与える人工呼吸器からの呼吸補助を受けている前記患者の横隔膜廃用性萎縮を防止又は逆転するために設計された治療計画を与えるための方法において、
前記人工呼吸器の前記呼吸サイクルを監視する工程と、
事前プログラムされた刺激信号を少なくとも1つの血管内電極を介して前記患者に与えて、前記患者の横隔神経を補助する工程と、
ペーシングされる呼吸サイクルごとに前記患者の横隔膜出力を調節する工程とからなる、方法。 - 前記刺激信号を与えることの開始が、前記患者が前記人工呼吸器から呼吸補助を最初に受ける期間内に行われ、前記期間が、1時間、3時間、6時間、12時間、1日、3日、及び1週間のうちの1つの範囲内にある、請求項1に記載の方法。
- 1つ又は複数の人工呼吸器パラメータ、1つ又は複数のペーシング・パラメータ、及び前記患者に処方された補助レベルのうちの少なくとも1つを表すデータを取得する工程をさらに備える、請求項1に記載の方法。
- 前記1つ又は複数の人工呼吸器パラメータが、人工呼吸される呼吸の持続時間を表すタイミング・データを含んでなる、請求項3に記載の方法。
- 前記刺激信号の送出と前記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さらに備える、請求項1又は3に記載の方法。
- 前記同調を維持する工程が、1つ又は複数のセンサからのデータによって現在の呼吸サイクルを決定する工程と、
前記現在の呼吸サイクルを、少なくとも1つの以前の呼吸サイクルのタイミング・データと比較する工程とを含んでなる、請求項5に記載の方法。 - 前記横隔膜の補助が、前記処方された補助レベルの少なくとも一部分を提供する、請求項1、3又は4に記載の方法。
- 前記刺激信号を与えることによる横隔膜寄与レベルを決定する工程をさらに備え、前記処方された補助レベルが前記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、請求項1,3,4,6のいずれか一項に記載の方法。
- 前記刺激信号は、前記刺激信号が前記患者へ送出されたときに前記横隔膜寄与レベルを満たすことになる刺激信号特性を含む、請求項8に記載の方法。
- 前記横隔膜寄与レベルが、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、請求項9に記載の方法。
- 前記横隔膜寄与レベルが、前記患者の病状及び収縮能力と、前記横隔膜の機能状態とのうちの少なくとも一方に依存する、請求項10に記載の方法。
- 前記収縮能力を決定する工程が、前記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んでなる、請求項11に記載の方法。
- 前記患者の前記病状及び前記横隔膜の収縮能力と、前記横隔神経の機能状態とのうちの少なくとも一方が、前記治療計画を与える前、及び前記治療計画を与えている間のうちの少なくとも一方のときに評価される、請求項11又は12に記載の方法。
- 前記患者の横隔膜の強さ及び耐久性を決定する工程が、前記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んでなる、請求項12に記載の方法。
- 前記呼吸サイクルを監視する工程が、
前記人工呼吸器の呼吸回路及び前記患者気道と別個であるが接続されている呼吸センサによって呼吸サイクル・データを検知する工程と、
前記呼吸サイクルの吸気相及び呼気相、ならびに各相の持続時間を、前記検知された呼吸サイクル・データから決定する工程とを含んでなる、請求項1,3,4,6,9〜12,14のいずれか一項に記載の方法。 - 前記呼吸サイクルを監視する工程がさらに、
人工呼吸器出力信号の振幅及び変化速度のうちの1つを呼吸ごとに決定する工程をさらに含んでなる、請求項15に記載の方法。 - 刺激信号を与える工程が、
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、
前記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んでなる、請求項15に記載の方法。 - 前記患者の前記横隔膜出力を呼吸サイクルごとに調節する前記工程が、
最後に与えた刺激信号に応じて前記横隔膜出力を監視する工程と、
前記最後に与えた刺激信号の前記横隔膜出力を事前設定目標範囲と比較する工程とを含んでなる、請求項1,3,4,6,9〜12,14,16,17のいずれか一項に記載の方法。 - 前記最後に与えた刺激信号に応じて前記横隔膜出力を監視する工程が、
1つ又は複数のセンサによって、空気流量、一回呼吸量、圧力、及び/又は流量、一回呼吸量及び/又は圧力の組合せから導出されるパラメータのうちの1つ又は複数を表す横隔膜出力データを検知する工程と、
前記検知された横隔膜データを処理して前記横隔膜出力を決定する工程とを含んでなる、請求項18に記載の方法。 - 前記患者の前記横隔膜出力を呼吸サイクルごとに調節する前記工程がさらに、
前記最後に与えた刺激信号の前記横隔膜出力が前記事前選択目標範囲の外側にある場合、次の人工呼吸器呼吸と共に与えるべき前記刺激信号を修正する工程を含んでなる、請求項18に記載の方法。 - 前記事前選択目標範囲が横隔膜寄与レベルを含んでなる、請求項20に記載の方法。
- 前記最後に与えた刺激信号の前記横隔膜出力が前記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備える、請求項20に記載の方法。
- 前記原因が前記患者の呼吸機構の変化による場合、前記治療計画を与えている間に前記患者の横隔膜及び呼吸器系の状態を評価する、請求項22に記載の方法。
- 前記評価された横隔膜の前記状態に基づいて前記刺激信号を再プログラムする工程をさらに備える、請求項23に記載の方法。
- 前記横隔膜を評価する工程が、
前記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、吸気持続時間、又は呼気持続時間を決定する工程と、
前記人工呼吸器呼吸サイクルの前記監視されたデータに基づく刺激信号を用いて前記横隔膜を刺激する工程と、
前記横隔膜及び呼吸器系の1つ又は複数の機能特性を決定する工程とを含み、前記1つ又は複数の機能特性が、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つ又は複数を含んでなる、請求項24に記載の方法。 - 前記横隔膜刺激が、陽圧を低減しVILIの危険を低減するために、各人工呼吸器呼吸中に行われることを目標にする、請求項1,3,4,6,9〜12,14,16,17のいずれか一項に記載の方法。
- 前記人工呼吸器の前記呼吸サイクルを監視する前記工程が、
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んでなる、請求項1に記載の方法。 - 前記刺激信号を与える工程が、吸気相と同時に前記刺激信号を送出することを含んでなる、請求項27に記載の方法。
- 人工呼吸器からの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ための経血管横隔膜ペーシング・システムにおいて、
前記患者の横隔神経を補助するように構成され、1つ又は複数の刺激パラメータを有する刺激信号である、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つの血管内電極と、
付随する人工呼吸器からの呼吸サイクル信号、及び前記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、
前記少なくとも1つの血管内電極と電気的に接続するように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、
前記1つ又は複数のセンサ、前記少なくとも1つの入力デバイス、及び前記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とからなり、前記コントローラが、
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んでなる入力データであって、前記治療計画の1つ又は複数の態様を表す入力データを受信し、
前記呼吸サイクル信号を監視して、前記呼吸サイクルの吸気相及び呼気相を決定し、
前記1つ又は複数のペーシング・パラメータに応じて前記刺激信号を発生し、前記発生した刺激信号を前記少なくとも1つの血管内電極へ、前記人工呼吸器呼吸サイクルの事前選択時間に送出し、
前記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、経血管横隔膜ペーシング・システム。 - 前記コントローラがさらに、前記患者の前記横隔膜出力を調節して前記患者に処方された補助レベルを満たすようにプログラムされる、請求項29に記載のシステム。
- 前記コントローラがさらに、前記刺激信号の前記送出と前記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、請求項29に記載のシステム。
- 前記コントローラがさらに、
最後に与えた刺激信号に応じて前記横隔膜出力を監視し、
前記最後に与えた刺激信号の前記横隔膜出力を事前選択目標範囲と比較する、ようにプログラムされる、請求項29に記載のシステム。 - 前記コントローラが、前記1つ又は複数のセンサの1つによって横隔膜出力データを検知し、前記検知された横隔膜データを処理して前記横隔膜出力を判定することによって、前記横隔膜出力を監視するようにプログラムされ、前記横隔膜出力が、流量、一回呼吸量及び/又は圧力、及び/又は流量、一回呼吸量及び/又は圧力の組合せから導出されるパラメータを含む、請求項32に記載のシステム。
- 前記コントローラがさらに、前記最後に与えた刺激信号の前記横隔膜出力が事前選択範囲の外側にあった場合、次の人工呼吸器呼吸と共に与えるべき刺激信号を修正するようにプログラムされる、請求項32に記載のシステム。
- 前記コントローラがさらに、
前記最後に与えた刺激信号の前記横隔膜出力が前記事前選択目標範囲の外側にあった場合、原因を明らかにするようにプログラムされる、請求項32に記載のシステム。 - 前記コントローラが、前記原因が前記患者の呼吸機構の変化によると判定する場合に、前記コントローラがさらに、前記治療計画を与えている間に前記患者の横隔膜及び呼吸器系の状態を評価するようにプログラムされる、請求項35に記載のシステム。
- 前記評価された横隔膜の前記状態に基づいて前記刺激信号を再プログラムする工程をさらに含む、請求項36に記載のシステム。
- 前記コントローラがさらに、
前記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、
前記人工呼吸器呼吸サイクルの前記監視されたデータに基づく刺激信号を用いて前記横隔膜を刺激すること、及び
前記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、前記横隔膜を評価するようにプログラムされ、前記1つ又は複数の機能特性に、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、請求項35に記載のシステム。 - 前記コントローラがさらに、前記横隔膜の前記評価に基づいて、前記人工呼吸器からの離脱しやすさを判定するようにプログラムされる、請求項35に記載のシステム。
- 前記刺激信号が、刺激列の始め、又は前記刺激列の中間に2つ組パルス又は3つ組パルスを含む、請求項29に記載のシステム。
- 機械式人工呼吸器からの人工呼吸補助を受ける患者の呼吸器廃用性萎縮を防止するための方法において、
呼吸サイクルを有する人工呼吸器によって前記患者に呼吸補助を行う工程と、
前記患者の左横隔神経に近い脈管構造内に第1の電極を配置する工程と、
前記患者の右横隔神経に近い脈管構造内に第2の電極を配置する工程と、
前記患者に前記人工呼吸器が付けられている数時間以内に、前記人工呼吸器呼吸サイクルと同調して横隔膜を刺激するために、事前プログラムされた刺激信号を前記第1及び第2の電極へ送出する工程とからなる、方法。 - 前記数時間以内との時間には、24時間以内、12時間以内、6時間以内、5時間以内、4時間以内、3時間以内、2時間以内及び1時間以内のうちの1つが含まれる、請求項41に記載の方法。
- 患者に呼吸サイクルを与える人工呼吸器からの呼吸補助を受ける、処方された補助レベルを有する前記患者の横隔膜廃用性萎縮を防止又は低減するための治療計画を与えるための方法において、
前記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、
前記人工呼吸器の前記呼吸サイクルを監視する工程と、
刺激信号を前記患者に前記人工呼吸器の前記呼吸サイクルと同調して与えて、前記患者の横隔膜に、あるレベルの横隔膜出力を生じさせる補助をする工程と、
横隔膜の補助による前記患者の横隔膜出力を、横隔膜出力の前記事前選択範囲内に入るように、呼吸サイクルごとに調節する工程とからなる、方法。 - 前記患者の前記横隔膜出力を呼吸サイクルごとに調節する前記工程が、
最後に与えた刺激信号に応じて前記横隔膜出力を監視する工程と、
前記最後に与えた刺激信号の横隔膜出力を横隔膜出力の前記事前選択範囲と比較する工程とを含む、請求項43に記載の方法。 - 前記最後に与えた刺激信号に応じて前記横隔膜出力を監視する工程が、
1つ又は複数のセンサによって横隔膜出力データを検知する工程と、
前記検知された横隔膜出力データを処理して前記横隔膜出力を判定する工程とを含んでなり、前記横隔膜出力が、空気流量、一回呼吸量、圧力、及び/又は流量、一回呼吸量及び/又は圧力の組合せから導出されるパラメータのうちの1つ又は複数を含む、請求項44に記載の方法。 - 前記患者の前記横隔膜出力を呼吸サイクルごとに調節する前記工程がさらに、
前記判定された横隔膜出力を横隔膜出力の前記事前選択範囲と比較する工程と、
最後に与えた刺激信号からの前記横隔膜出力が横隔膜出力の前記事前選択範囲から外れる場合、次の人工呼吸器呼吸と共に与えるべき前記刺激信号を修正する工程とを含んでなる、請求項43に記載の方法。 - 前記刺激信号を修正する前記工程が、前記刺激信号の強度を増大させる工程を含んでなる、請求項46に記載の方法。
- 前記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つ又は複数を含んでなる、請求項47に記載の方法。
- 横隔膜出力を測定する工程が、一回呼吸量、圧力、又はこれらの組合せを測定する工程を含んでなる、請求項43に記載の方法。
- 陽圧機械式人工呼吸器が付けられた重病患者の横隔膜廃用性萎縮を防止する方法において、
前記人工呼吸器の呼吸サイクルを監視する工程と、
前記患者に前記人工呼吸器が付けられている、24時間、12時間、6時間、5時間、4時間、3時間、2時間及び1時間のうちから選択された一定の時間以内に、事前プログラムされた刺激信号を前記患者に与えて、あるレベルの横隔膜出力を出力するように前記患者の横隔膜を補助する工程と、
前記刺激信号を与えることに基づいて、前記患者の横隔膜出力の前記レベルを、事前選択閾値範囲に入るように呼吸サイクルごとに調節する工程とからなる、方法。 - 廃用性萎縮を防止する、又は患者の横隔膜を回復させる、前記患者のための治療計画を構築する方法において、
最大横隔膜出力及び疲労特性について前記横隔膜を評価する工程と、
横隔膜出力を前記最大横隔膜出力の事前選択百分率にする1つ又は複数の刺激信号を判定する工程とからなる、方法。 - 一連の個別刺激信号を含む刺激を与える計画を作成する工程をさらに備え、前記一連の刺激信号が、速度、持続時間、パルス幅、周波数、及び振幅について変化しうる、請求項51に記載の方法。
- 横隔膜を評価するための方法において、
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する工程と、
前記人工呼吸器呼吸サイクルの前記監視されたデータに基づく刺激信号を用いて横隔膜を刺激する工程と、
前記刺激信号を用いて前記横隔膜を刺激することにより引き起こされた反応から前記横隔膜の1つ又は複数の機能特性を判定する工程とからなり、
前記1つ又は複数の機能特性に、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、方法。 - 横隔膜廃用性萎縮を防止する、又は患者の横隔膜を回復させる前記患者の治療計画を構築するための経血管横隔膜ペーシング・システムにおいて、
前記患者の横隔神経を補助するように構成され、1つ又は複数の刺激パラメータを有する刺激信号である、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つの血管内電極と、
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基づく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、
前記少なくとも1つの血管内電極と電気的に接続するように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、
前記1つ又は複数のセンサ、前記少なくとも1つの入力デバイス及び前記パルス発生器と電気的に結合されたコントローラとからなり、前記コントローラが、
最大横隔膜出力及び疲労特性について前記横隔膜を評価し、及び、
横隔膜出力を前記最大横隔膜出力の事前選択百分率にする1つ又は複数の刺激信号を判定する、ようにプログラムされている、経血管横隔膜ペーシング・システム。 - 横隔膜を評価するための経血管横隔膜ペーシング・システムにおいて、
患者の横隔神経を補助するように構成され、1つ又は複数の刺激パラメータを有する刺激信号である、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つの血管内電極と、
陽圧機械式人工呼吸器からの呼吸サイクル信号、及び前記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、
前記少なくとも1つの血管内電極と電気的に接続するように結合されたパルス発生器と、
評価計画の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、
前記1つ又は複数のセンサ、前記少なくとも1つの入力デバイス、及び前記パルス発生器と電気的に接続するように結合されたコントローラとからなり、前記コントローラが、
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、
前記人工呼吸器呼吸サイクルの前記監視データに基づく刺激信号を用いて前記横隔膜を刺激し、
前記刺激信号を用いて前記横隔膜を刺激することにより引き起こされた反応から、前記横隔膜の1つ又は複数の機能特性を判定する、ようにプログラムされ、前記1つ又は複数の機能特性に、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、経血管横隔膜ペーシング・システム。
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