JP5179584B2 - 電極コンビネーションを選択する心調律管理システム - Google Patents
電極コンビネーションを選択する心調律管理システム Download PDFInfo
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- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/3605—Implantable neurostimulators for stimulating central or peripheral nerve system
- A61N1/36128—Control systems
- A61N1/36146—Control systems specified by the stimulation parameters
- A61N1/36182—Direction of the electrical field, e.g. with sleeve around stimulating electrode
- A61N1/36185—Selection of the electrode configuration
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
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- A—HUMAN NECESSITIES
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
- A61N1/36842—Multi-site stimulation in the same chamber
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3684—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions for stimulating the heart at multiple sites of the ventricle or the atrium
- A61N1/36843—Bi-ventricular stimulation
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- A—HUMAN NECESSITIES
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/368—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
- A61N1/3686—Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions configured for selecting the electrode configuration on a lead
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- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
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- A61N1/37—Monitoring; Protecting
- A61N1/3706—Pacemaker parameters
- A61N1/3708—Pacemaker parameters for power depletion
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/362—Heart stimulators
- A61N1/3627—Heart stimulators for treating a mechanical deficiency of the heart, e.g. congestive heart failure or cardiomyopathy
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- A—HUMAN NECESSITIES
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- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/372—Arrangements in connection with the implantation of stimulators
- A61N1/37211—Means for communicating with stimulators
- A61N1/37235—Aspects of the external programmer
- A61N1/37241—Aspects of the external programmer providing test stimulations
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- A—HUMAN NECESSITIES
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- A61N1/38—Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
- A61N1/39—Heart defibrillators
- A61N1/3956—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion
- A61N1/3962—Implantable devices for applying electric shocks to the heart, e.g. for cardioversion in combination with another heart therapy
- A61N1/39622—Pacing therapy
Description
極を使用する場合もある。エネルギーが供給されるそれぞれ異なるコンビネーションの電極の間にベクトルが構成される。心腔内の複数の電極ペアを介したペーシングは、たとえば心腔の収縮機能を向上させる協調的なシーケンスで心臓組織を刺激するなど、有益である可能性がある。
様々な方法の実施形態は、1本以上のリード線で支持した複数の心臓電極を患者に埋込むステップ、1本以上のリード線を患者体外分析回路に取付けるステップ、前記複数の心臓電極と分析回路を用いて患者の心臓に電気刺激を提供するステップ、複数の電極コンビネーションのうちの各コンビネーションごとに、電極コンビネーションによって提供した電気刺激によって生じ、処方した治療に合致して心機能を支援する1つ以上の第1パラメータと、処方した治療に合致して心機能を支援しない1つ以上の第2パラメータとを評価するステップ、前記評価に基づき複数の心臓電極コンビネーションから処方した治療に合致して心機能を支援する1つ以上の第1パラメータに関連し、且つ処方した治療に合致して心機能を支援しない1つ以上の第2パラメータとの関連が複数の心臓電極の他のコンビネーションよりも少ないという理由で選択される1つ以上の電極コンビネーションを選択するステップ、複数の心臓電極コンビネーションの他の電極コンビネーションに比較して選択した1つ以上の電極コンビネーションを優先的に使用する心臓ペーシング治療を提供するよう、埋込ペーシング回路をプログラムするステップ、1つ以上のリード線を分析回路から取外すステップ、1つ以上のリード線を埋込ペーシング回路に取付けるステップ、および埋込ペーシング回路を埋込むステップを含むこともできる。
れる、複数の心臓電極;患者体外分析装置に、複数の心臓電極の複数の電極コンビネーションのうちのそれぞれの電極コンビネーションごとに、複数の電極の少なくとも一部を用いて提供した電気刺激によって生じ、処方した治療に合致して心機能を支援する1つ以上の第1パラメータと、処方した治療に合致して心機能を支援しない1つ以上の第2パラメータとを評価させるようにする、保存されたプログラム指示を実行するように構成される、患者体外分析装置に格納される評価回路(評価電気回路);患者体外分析装置に、評価に基づき、1つ以上の第1パラメータに関連し、1つ以上の第2パラメータとの関連が複数の心臓電極の他の電極コンビネーションよりも少ないという理由で複数の心臓電極の1つ以上の電極コンビネーションを選択させるようにする、保存されたプログラム指示を実行させるように構成される、患者体外分析装置内に格納される、電極コンビネーションプロセッサ;ならびに、複数の心臓電極の他の電極コンビネーションに比較して選択した電極コンビネーションを優先的に用いて患者埋込心臓刺激装置が治療を提供するように、プログラマ回路に患者埋込心臓刺激装置をプログラムさせるようにする、保存されたプログラム指示を実行するように構成されるプログラマ回路を備える心調律管理システムを含む。
たは方法は、本明細書で述べられたそれらの1つ以上の特徴、構造、方法または組合せを含むこともできる。たとえば装置またはシステムは、以下に記載した1つ以上の有利な特徴および/または過程を含めて実施できる。本発明による装置またはシステムは、別々の実施例および/または説明で説明および/または考察した複数の特徴および/または態様を含めて実施できる。このような装置またはシステムは、必ずしも本明細書で述べられる全ての特徴を含む必要はないが、有用な構造、システム、および/または機能性を提供する選択した特徴を含めて実施もできることが意図される。
心機能を支援するパラメータは、患者に処方した1つ以上の治療に合致する生理作用の指標となる任意のパラメータである。たとえば心室ペーシングが患者に処方した治療であった場合、心腔の捕捉成功は、血液をポンピングできる心臓収縮の指標となり得る。処方した治療に合致して心機能を支援するパラメータは、意図した治療効果(たとえば捕捉)の指標となり得る場合には、有益パラメータであってもよい。
表示部258、およびコミュニケーション回路259を備える。評価ユニット249は、更に除細動/電気的除細動回路253、ペーシング回路252、およびスイッチマトリクス251などを備えてもよい。スイッチマトリクス251は、コンビネーションプロセッサ254、ペーシング回路252、および除細動/電気的除細動回路253が優先的に電気的接続/切断できてリード線605〜608の種々の電極が容易に電気刺激を提供し、シグナルを受取れるように(たとえば電気刺激に対する心臓反応の指標となるECGシグナル)、リード線605〜608の電極に電気的接続される。
ユニット249は患者埋込医療装置と同一リード線に取付けることができるため、評価ユニット249は患者埋込医療装置の実際の操作条件を反映する様々なテストを行うことができる。更に、本明細書で検討される種々のテストの実施、および他の機能を実行するための評価ユニット249の利用は、様々な明確な利点を提供する。
ば携帯用の電話装置、コンピュータまたは遠隔システムと合わせて使用される患者情報サーバなど、他の種類の装置も同様に操作可能である。プログラマ回路300は、心調律管理とプログラマ回路300の間の遠隔計測リンクを構築する埋込装置の埋込部位近くの患者の身体上に設置されるプログラミングヘッド310を備える。遠隔計測リンクは、埋込装置によって収集したデータのプログラマ回路300へのダウンロードを可能にする。ダウンロードしたデータは、プログラマ記憶装置365に保存される。
心機能を支援しない横隔神経刺激および/または横隔膜刺激は望ましくなく、意図する治療を妨げる虞がある。
よび/または再分極波の特性、間隔、心臓再同期に対する反応性、電極コンビネーション活性化タイミング、刺激の強度/持続時間の関係、ならびにバッテリ消費に関連する可能性がある。
ションを選択するステップを含む。
または推定するステップは、本明細書で開示される、または当業者に周知の任意の方法にしたがって実施できる。
図5のプロセス500は、電極コンビネーション情報をプログラマ回路上に表示するステップS540を更に含む。プログラマ回路は、LCDスクリーンまたは本明細書で開示されるもしくは当業者に周知の情報を表示するためのその他の手段を備えてもよい。電極コンビネーション情報の一部または全てが表示されてもよい。電極コンビネーション情報は、ランク付け、1つ以上のグループ、1つ以上のカテゴリー、またはその他の情報整理体系にしたがって整理した状態で表示できる。
図5の特定プロセス500は、プログラマ回路が電極コンビネーション情報を表示すると記載しているが、他の実施形態も可能である。たとえば電極コンビネーション情報は、スクリーン情報に表示されても、またはプログラマ回路から離れた装置から印刷されてもよい。
左心室リード線605は、左心室に近接した冠状静脈系内の様々な位置に配置した複合電極654a〜645d,655を組込んでいる。左心室内の多数の位置または選択した一部位での心室の刺激は、たとえば鬱血性心不全(CHF)を患っている患者の心拍出量を増加させるために与えることができ、および/またはその他の利点をもたらすことができる。電気刺激パルスは、心機能を高めるタイミングシーケンスと出力構成にしたがって、選択した電極を介して提供されてもよい。図6は多数の左心室電極を示しているが、別の構成で、複合電極が代わりに、または追加で1つ以上の右心房、左心房、および右心室に提供されてもよい。
にするために、筐体601に収容される。治療装置600は、患者の代謝要求に対応するために、患者の代謝要求感知、および心臓に提供されるペーシングパルスを調節、および/または電極コンビネーションの選択を更新するためのセンサと適切な回路も備えてもよい。
Vth=IthZ …式1 。
初期電極コンビネーションの捕捉閾値電圧と電流の関係は、次のように表すことができる:
Vth−in=Ith−inZin …式2 。
Vth−ex=Ith−exZex …式3 。
Vth−ex=Vth−in/Zin×Zex …式4 。
特定電極コンビネーションごとの捕捉閾値の推定計算の精度は、測定される電極コンビネーションが、捕捉閾値が推定した電極コンビネーションと同じ極性を有する場合に高まる可能性がある。捕捉閾値の推定を含むパラメータ推定のための方法は、その全体を参照することによって本明細書に組込まれる、特許文献22に開示される。
て行うことができる。別の電極コンビネーションの望ましくない興奮閾値を推定するステップS850は、本明細書で検討また参照されるように、捕捉閾値を推定するステップと同様の方法を用いて行うことができる。
きる。たとえば図9に戻ると、強度−時間プロット910、920の交点951の右の部分950は、捕捉を生じる一方で望ましくない刺激を回避する一連のエネルギーパラメータ値を規定する。この影付領域950、またはペーシング961と望ましくない興奮962のための適切な安全域を有するように変更した領域である改良影付領域960の範囲内に収まるエネルギーパラメータ値を選択できる。
図10のフローチャートは、複数の電極コンビネーションごとの捕捉閾値を決定するためのプロセス1000を示す。プロセス1000は、ステップダウン閾値テストを開始し、初期ペーシングエネルギーを構成するステップS1010を含む。プロセス1000は、ペーシングエネルギーでペーシングパルスを電極コンビネーションに提供するステップS1020を更に含む。電極コンビネーションは、初期電極コンビネーションであってもよい。ペーシングエネルギーは、特にステップS1020が事前に実施されていない例では、初期ペーシングエネルギーであってもよい。
ネーションエネルギーを減少させるステップS1070に進む。電極コンビネーションエネルギーを減少(ステップS1070)させた後、減少したエネルギーレベルで電極コンビネーションを用いてペーシングパルスが提供される(ステップS1020)。この方法では、1020、1030、1040、1060、および1070のステップを反復してもよく、捕捉の喪失が検出(ステップS1030)されるまで電極コンビネーションのペーシングエネルギーを減少させる(ステップS1070)。このように、1010、1020、1030、1040、1060、および1070のステップは、電極コンビネーションのスキャンを行うことができ、捕捉の喪失の検出(ステップS1030)によって特定した時点で、電極コンビネーションごとの捕捉閾値が記憶装置に保存(ステップS1050)される。
ランク付けするステップは、パラメータに基づき複数の電極コンビネーションの関係を構築する階層的ステップを含むこともできる。一部の実施形態では、最も上位にランク付けした電極コンビネーションは、同様にランクに従って順序づけられる他の電極コンビネーションに比較して最も好ましい有益パラメータと非有益パラメータを有する電極コンビネーションとしてもよい。
選択した電極コンビネーションを用いて治療を提供(ステップS1240)した後、プロセス1200は、患者の状態変化の指標となる1つ以上の条件を感知する(ステップS1250)。本発明の一部の実施形態では、感知される患者状態の変化は、特に、活動レベル、姿勢、呼吸、電極位置、体液の化学的性質、血液または気道の酸素濃度、血圧、水分過剰、血行動態、または電極コンビネーションインピーダンスを含む場合もある。
ンのうちの電極コンビネーションは、各カテゴリーが、検出される様々な種類の望ましくない刺激(たとえば横隔神経刺激、陽極刺激、過剰インピーダンス)および/または心機能を支援しないパラメータ(たとえば低捕捉閾値、低インピーダンス)に関連する、様々なカテゴリーでグループ分けできる。
援しない1つ以上の第2パラメータを評価する手段;第1パラメータと第2パラメータの評価に基づき、複数の電極コンビネーションのうちの電極コンビネーションの少なくとも一部の順序を決定する手段;順序に基づき1つ以上の電極コンビネーションを選択する手段;ならびに選択した1つ以上の電極コンビネーションを用いて電気刺激治療を提供する手段を含むこともできる。また治療提供のために、第1パラメータと第2パラメータを評価するステップ、電極コンビネーションを順序づけするステップ、および電極コンビネーションを選択するステップの少なくとも1つを心調律管理(CRM)システムによって自動的に実施できる。前記実施形態において、第1パラメータを評価する手段は、捕捉閾値を評価するための手段を含むこともできる。前記実施形態において、第1パラメータを評価する手段は、心臓再同期に対する反応性を評価するための手段を含むこともできる。前記実施形態において、第1パラメータを評価する手段は、複数の電極コンビネーションの少なくとも1つごとに第1パラメータを測定するための手段、および複数の電極コンビネーションの少なくとも1つごとに第1パラメータを推定するための手段を含むこともできる。前記実施形態において、第2パラメータを評価する手段は、意図しない神経刺激と、意図しない筋肉刺激とのうちの少なくとも1つを検出するための手段を含むこともできる。前記実施形態において、順序を決定する手段は、1つの電極コンビネーションに関連する第1パラメータと第2パラメータの少なくとも1つを、少なくとも1つの他の電極コンビネーションの第1パラメータと第2パラメータの少なくとも1つと比較するための手段を含むこともできる。前記実施形態において、順序を決定する手段は、予め決定した基準に従って、電極コンビネーションをグループ分けするための手段を含むこともできる。前記実施形態において、電極コンビネーションの少なくとも一部の順序を決定する手段は、1つ以上の捕捉閾値、治療エネルギー消費、神経または筋肉組織の望ましくない興奮、陽極心臓刺激、心臓再同期療法に対する反応の程度、インピーダンス、心臓収縮性、電極コンビネーションの活性化タイミング、心拍出量、1回拍出量、dP/dt、血行動態、および電極コンビネーションを用いる治療の過去の奏功に基づき、少なくとも一部の電極コンビネーションをランク付けするための手段を含むこともできる。前記実施形態において、電極コンビネーションの少なくとも一部の順序を決定するための手段は、電極コンビネーションの少なくとも一部をランク付けするための手段を含むこともでき、ランク付けは、望ましい第1パラメータレベルと第2パラメータレベルを備える電極コンビネーションに優先順位をつけることもできる。前記実施形態は、1つ以上の推奨した電極構成を決定するための手段;および1つ以上の推奨した電極コンビネーションを表示するための手段を更に含むこともできる。前記実施形態において、第1パラメータを評価する手段は、複数の電極コンビネーションのそれぞれごとに捕捉閾値を評価するための手段を含んでもよく;第2パラメータを評価する手段は、心臓外刺激を感知するための手段を含んでもよく;および順序を決定するための手段は、心臓外刺激を引起こさない最低の捕捉閾値を備える複数の電極コンビネーションの少なくとも1つの電極コンビネーションを特定するための手段を含んでもよい。前記実施形態において、1つ以上の電極コンビネーションを選択する方法は、1つ以上の電極コンビネーションに関連する情報を表示するための手段を含んでもよく、また前記実施形態は、人間である分析者から1つ以上の電極コンビネーションの選択を示すインプットを受取るための手段を含むこともできる。前記実施形態は、患者の状態変化を検出するための手段;患者の状態変化が検出した場合に電気刺激治療の提供を、複数の電極コンビネーションのうちの選択した1つ以上の電極コンビネーションから複数の電極コンビネーションのうち別の1つ以上の電極コンビネーションに切換えるための手段であって、別の1つ以上の電極コンビネーションに切換えを行うステップが順序に基づく手段を更に含むこともできる。前記実施形態において、1つ以上の第1パラメータを評価する手段は、電極コンビネーションを用いて提供される電気刺激によって生じた、処方した治療に合致して心機能を支援する2つ以上の別の第1パラメータを評価するための手段を含むこともできる。
成すべく電気的接続される複数の心臓電極;複数の電極コンビネーションのうちのそれぞれの電極コンビネーションごとに、電極コンビネーションを用いて提供した電気刺激によって生じた、処方した治療に合致して心機能を支援する1つ以上の第1パラメータを評価するように構成される回路;複数の電極コンビネーションのうちのそれぞれの電極コンビネーションごとに、電極コンビネーションを用いて提供した電気刺激によって生じた、処方した治療に合致して心機能を支援しない1つ以上の第2パラメータを評価するように構成される回路;第1パラメータと第2パラメータの評価に基づき、複数の電極コンビネーションのうちの少なくとも一部の電極コンビネーションの順序を決定するように構成される電極コンビネーションプロセッサ;ならびに、電極コンビネーションを用いて電気刺激治療を提供するように構成される治療回路を含むこともできる。前記システムにおいて、1つ以上の第1パラメータを評価する回路と、1つ以上の第2パラメータを評価する回路とは、少なくとも部分的に埋込筐体に収容され、複数の心臓電極の各心臓電極は埋込筐体に接続されてもよい。前記システムにおいて、電極コンビネーションプロセッサは、埋込筐体に収容されてもよい。前記システムは、埋込筐体の内容物と、電極コンビネーションプロセッサを備える患者体外装置との間のワイヤレスデータ送信を容易にするように構成されるコミュニケーション回路を更に含むこともできる。前記システムは、埋込装置と患者体外プログラマ回路の間のワイヤレスデータ送信を容易にするように構成されるコミュニケーション回路を備える、患者体外プログラマ回路;および1つ以上の第1パラメータ、1つ以上の第2パラメータ、および電極コンビネーションの少なくとも一部の順序に関連する情報を表示するように構成される表示部を更に含むこともできる。前記システムにおいて、電気刺激治療の提供に用いられる電極コンビネーションは、人間によって選択されてもよく、選択は患者体外プログラマ回路から埋込装置に送信されてもよい。前記システムにおいて、1つ以上の第1パラメータを評価するように構成される回路は、複数の電極コンビネーションのうちのそれぞれの各電極コンビネーションを用いて提供される電気治療が、心機能または心機能に関連する心拍出量またはそれぞれの電極コンビネーションを用いる電気治療無しの心拍出量を改善するか否かを検出するように構成されてもよい。前記システムにおいて、1つ以上の第2パラメータを評価するように構成される回路は、複数の電極コンビネーションのうちのそれぞれの各電極コンビネーションを用いて提供される電気治療が、神経または組織を刺激する否かを検出するように構成されてもよい。神経または組織の刺激は、各電極コンビネーションを用いて提供される電気治療無しの心機能に比較して、処方した治療に合致して心機能を改善しない神経または細胞の刺激であってもよい。前記システムは、電極コンビネーションプロセッサが、人間によって患者体外プログラマ回路にインプットした1つ以上の電極コンビネーション基準に基づき、複数の電極コンビネーションのうちの少なくとも一部の電極コンビネーションの順序を決定するように構成される患者体外プログラマ回路を更に含んでもよい。前記システムは、電気刺激治療が提供される電極コンビネーションを選択するように構成され且つ前記選択が電極コンビネーションの少なくとも一部の順序に基づく電極コンビネーション選択プロセッサを更に含んでもよい。前記システムにおいて、電極コンビネーション選択プロセッサは、電気刺激治療が提供される別の電極コンビネーションを、電極コンビネーションの少なくとも一部の順序に基づき選択するように構成されてもよい。電極コンビネーションを用いる電気刺激の提供を、別の電極コンビネーションを用いる提供に切換えるよう治療回路にコマンドを出してもよい。前記システムにおいて、第1パラメータの1つは、捕捉閾値であってもよい。第2パラメータの1つは、心臓外刺激であってもよい。前記システムにおいて、電極コンビネーションプロセッサは、複数の電極コンビネーションのうちの少なくとも一部の電極コンビネーションの順序を、少なくとも2つの別の第1パラメータと、1つ以上の第2パラメータとの評価に基づき決定するよう更に構成されてもよい。
ネーションを用いて提供される電気刺激によって生じた、処方した治療に合致して心機能を支援する1つ以上の第1パラメータを評価するように構成した回路;複数の電極コンビネーションのうちのそれぞれの電極コンビネーションごとに、電極コンビネーションを用いて提供される電気刺激によって生じた、処方した治療に合致して心機能を支援しない1つ以上の第2パラメータを評価するように構成した回路;第1パラメータと第2パラメータの評価に基づき、複数の電極コンビネーションのうちの少なくとも一部の電極コンビネーションの順序を決定するための手段;ならびに、複数の電極コンビネーションのうちの少なくとも1つの電極コンビネーションを用いて電気刺激治療を提供するように構成される治療回路を含んでもよい。前記システムは、電気刺激治療を提供する電極コンビネーションを、順序に基づき選択するための手段を更に含んでもよい。
めの手段;複数の心臓電極の少なくとも一部の電極コンビネーションごとに、第1パラメータと第2パラメータの評価に基づくランク付けを決定するための手段;ならびに条件の変化を検出するための手段を更に含むこともできる。心臓ペーシング治療を提供するよう埋込ペーシング回路をプログラムするステップは、検出した条件の変化に対応して、心臓ペーシング治療の提供を、ランク付けで第1優先順位とした電極コンビネーションから、ランク付けがより低い優先順位とした電極コンビネーションに切換えるよう埋込ペーシング回路をプログラムするステップを更に含むこともできる。前記システムは、埋込ペーシング回路のための電極を格納する筐体を埋込むための位置を特定するための手段;および電極を備えるカテーテルをその位置に留置するための手段を更に含んでもよい。複数の心臓電極と分析回路を用いて電気刺激を提供するための手段は、複数の心臓電極と、カテーテル電極の1つ以上との間に、電気刺激を提供するステップを更に含んでもよい。評価するための手段は、カテーテル電極を使用する電極コンビネーションごとに、第1パラメータと第2パラメータを評価するステップを更に含んでもよい。選択するための手段は、筐体電極を使用する1つ以上の電極コンビネーションを、カテーテル電極を使用する電極コンビネーションごとに第1パラメータと第2パラメータの評価に基づき選択するステップを更に含んでもよい。
よく、また電極コンビネーションプロセッサは、インプットモジュールを通じてインプットした指示に基づき、患者体外分析装置に、複数の心臓電極から1つ以上の電極コンビネーションを選択させるように、保存されたプログラム指示を実行するよう更に構成されてもよい。前記システムでは、電極コンビネーションプロセッサは、インプットモジュールを通じてインプットした指示に基づき、患者体外分析装置に複数の心臓電極から1つ以上の電極コンビネーションを選択させるようにする、保存されたプログラム指示を実行するよう更に構成されてもよい。指示は、複数の別のパラメータから1つ以上の第1パラメータと1つ以上の第2パラメータを特定し、これに基づき1つ以上の電極コンビネーションが選択される。前記システムでは、インプット指示の実行は、最大パルス振幅、最小パルス振幅、最大パルス幅、最小パルス幅、および複数の電極のうちのどの電極コンビネーションが電気刺激の提供に使用され、電極コンビネーションプロセッサによって評価されるかを含む複数のパルスパラメータ境界を用いて、電極コンビネーションプロセッサによって分析される複数の心臓電極を用いて患者体外分析装置に電気刺激を提供させてもよい。前記システムでは、プログラマ回路は、患者体外分析装置内に格納してもよい。前記システムでは、電極コンビネーションプロセッサは、患者体外分析装置が、どの電極コンビネーションを直接測定し、どの電極コンビネーションを推定するかを特定するインプット指示に基づき、電気刺激の提供に基づき1つ以上の電極コンビネーションの第1パラメータを直接測定し、1つ以上の他の電極コンビネーションの第1パラメータを推定し、1つ以上の他の電極コンビネーションの第1パラメータを直接測定しないようにする、保存されたプログラム指示を実行するよう更に構成されてもよい。前記システムでは、電極コンビネーションプロセッサが評価し選択する1つ以上の電極コンビネーションを構成する複数の電極の一部である電極を備える非埋込カテーテルが、患者体外分析装置に接続されてもよい。また患者埋込心臓刺激装置は、筐体電極を備えてもよい。患者体外分析装置は、カテーテル電極を含む電極コンビネーションを選択した場合に、筐体電極を使用しない電極コンビネーションに比較して、筐体電極を治療の提供に優先的に使用するように患者埋込心臓刺激装置がプログラミング回路によってプログラムされるようにプログラムされてもよい。
できる。したがって、本発明の範囲は、上述の特定実施形態によって限定されるべきではなく、下に説明される特許請求の範囲とその同等物によってのみ規定されるべきである。
Claims (5)
- 複数の心臓電極と、これら複数の心臓電極に接続される電極コンビネーションユニットと、治療回路とを有する心調律管理システムであって、
前記複数の心臓電極は、心臓に電気刺激を送達するために複数の電極コンビネーションを構成するように電気的接続され、
前記電極コンビネーションユニットは、心臓への電気刺激に対する患者の生理学的反応を示す前記複数の心臓電極からの信号を受信するように構成され、
前記電極コンビネーションユニットは、心臓への電気刺激の結果として生成される1つ以上の第1パラメータと1つ以上の第2パラメータとについての信号を、前記電極コンビネーションごとに評価するように構成され、
前記第1パラメータは、処方した治療に合致して心機能を支援するために用いられ、
前記第2パラメータは、処方した前記治療に合致して心機能を支援するためには用いられず、
前記電極コンビネーションユニットはさらに、記第1パラメータと前記第2パラメータとの評価に基づき、前記電極コンビネーションのランク付けを決定するように構成され、
前記電極コンビネーションユニットはさらに、前記ランクに基づき、心臓への電気刺激による治療としての電気刺激治療を提供するための電極コンビネーションを選択するように構成され、
前記治療回路は、選択された前記電極コンビネーションを用いて、前記電気刺激治療を提供するように構成される、
心調律管理システム。 - 前記電極コンビネーションユニットは、それぞれ前記電極コンビネーションを用いて提供された前記処方した治療が、前記処方した治療に合致して心機能を改善することはない神経または組織を刺激するか否か検出するように構成される、
請求項1記載の心調律管理システム。 - 前記第1パラメータは、捕捉閾値であり、
前記第2パラメータは、心臓外刺激である、
請求項1記載の心調律管理システム。 - 患者埋込リード線に取付けられる複数の心臓電極と、患者体外分析装置と、治療回路とを有する心調律管理システムであって、
前記複数の心臓電極は、心臓に電気刺激を送達するために複数の電極コンビネーションを構成するように電気的接続され、
前記患者体外分析装置は、前記複数の心臓電極に接続される電極コンビネーションユニットを有し、
前記電極コンビネーションユニットは、心臓への電気刺激に対する患者の生理学的反応を示す前記複数の心臓電極からの信号を受信するように構成され、
前記電極コンビネーションユニットは、心臓への電気刺激の結果として生成される1つ以上の第1パラメータと1つ以上の第2パラメータとについての信号を、前記電極コンビネーションごとに評価するように構成され、
前記第1パラメータは、処方した治療に合致して心機能を支援するために用いられ、
前記第2パラメータは、処方した前記治療に合致して心機能を支援するためには用いられず、
前記電極コンビネーションユニットはさらに、記第1パラメータと前記第2パラメータとの評価に基づき、前記電極コンビネーションのランク付けを決定するように構成され、
前記電極コンビネーションユニットはさらに、前記ランクに基づき、心臓への電気刺激による治療としての電気刺激治療を提供するための電極コンビネーションを選択するように構成され、
前記治療回路は、選択された前記電極コンビネーションを用いて電気刺激治療を提供するように構成される、
心調律管理システム。 - 前記電極コンビネーションユニットは、前記第1パラメータとの関連度合いが強くかつ前記第2パラメータとの関連度合いが低い電極コンビネーションほど、他の電極コンビネーションよりも高くランク付けるように構成され、
前記心調律管理システムは、前記治療回路が前記ランク付けに基づき、より高いランクの前記電極コンビネーションを優先的に使用して前記電気刺激治療を提供するようにプログラムするプログラマ回路を有する、
請求項4記載の心調律管理システム。
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CN104874105B (zh) | 2018-04-03 |
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US10022548B2 (en) | 2018-07-17 |
US9539429B2 (en) | 2017-01-10 |
CN101827629B (zh) | 2015-05-20 |
CN104874105A (zh) | 2015-09-02 |
US9037239B2 (en) | 2015-05-19 |
CN101827629A (zh) | 2010-09-08 |
AU2008284265B2 (en) | 2012-01-19 |
US20140005741A1 (en) | 2014-01-02 |
US20130296961A1 (en) | 2013-11-07 |
AU2008284265A1 (en) | 2009-02-12 |
US11857795B2 (en) | 2024-01-02 |
US20180345024A1 (en) | 2018-12-06 |
EP2188012A1 (en) | 2010-05-26 |
JP2010534549A (ja) | 2010-11-11 |
WO2009020639A1 (en) | 2009-02-12 |
US20090043352A1 (en) | 2009-02-12 |
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