JP5601892B2 - 自発的な房室伝導に適した刺激モードに対する患者の耐性を分析する装置および方法 - Google Patents
自発的な房室伝導に適した刺激モードに対する患者の耐性を分析する装置および方法 Download PDFInfo
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- A61N1/365—Heart stimulators controlled by a physiological parameter, e.g. heart potential
- A61N1/36514—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure
- A61N1/36578—Heart stimulators controlled by a physiological parameter, e.g. heart potential controlled by a physiological quantity other than heart potential, e.g. blood pressure controlled by mechanical motion of the heart wall, e.g. measured by an accelerometer or microphone
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Description
図1を参照すると、上方のタイミング図は、各心拍周期について、刺激性の心房波A、そして後続する自発性の心室脱分極波Rを含む心内膜心電図(ECG)を示す。第1の周期において、刺激Aと検出R間の遅延AR1は、後の周期における遅延AR2より短く、真性伝導AV遅延の増加を示す。下方のタイミング図は血行動態信号、典型的には上方の図のECG信号と対応する心内膜加速度(EA)信号を示す。ここに示した例では、選ばれた典型的なパラメータは、QRS群の時点におけるEA信号の振幅EA1、EA2…、すなわち、等容性心室収縮の段階の始期における第一の主要な雑音に対応する第一最大心内膜加速度(PEA1)である。第一最大値(PEA1)の振幅の変動が心室内の圧力変化に密接に関連していることは公知であり、それゆえ心筋収縮性を表示するパラメータである。破線は、良好な血行動態的耐性(例えばEA1>EAref)と不良な血行動態的耐性(例えばEA2<EAref)を区別するための基準振幅(EAref)を示す。
(a)第一度AVBすなわちAVB1(存在はするが遅延した伝導):心室検出が後続する心房事象の数が、一定の心拍周期数、例えば連続する6回の心拍周期)を超過し、例えば(自発性の心房事象の場合)350msまたは(刺激性の心房事象の場合)450ms以上の期間の後に発生する;
(b)第二度AVBすなわちAVB2(伝導が不完全で、PR間隔またはAR間隔が徐々に長期化し、その結果P波の一部がもはや伝導されなくなる):心室検出が後続していない心房事象の数が、モニタウィンドウの期間にわたって心房事象の所定回数を超えて一定の回数上回る場合:例えば装置が、3回の連続しないブロックされたP波を、最後の12心拍周期中で検出するとき;そして、
c)完全房室ブロック、第三度房室ブロック、すなわちAVB3(刺激性のまたは自発性の、完全にブロックされた、すなわち心室脱分極が後続していない心房波):例えば、検出されあるいは刺激された連続した2つの心房波が3秒より長い時間にわたりブロックされ心室検出がない場合(心室休止の状態)。
図3乃至5を参照しつつ上記に記載された手順は、患者が発作性ABV1を罹患している場合、特に基準値を知り得るという点において有効である。しかし永久性AVB1の場合には、指標値EArefを更新することは不可能である。
Claims (17)
- 自発的な心房事象および心室事象を検出する手段と、心室刺激および心房刺激を付加する手段と、心房ペーシング(A)の後、自発的な心室脱分極(R)を検出する手段と、前記心房ペーシング(A)とそれに対応する前記心室脱分極(R)との間の房室遅延(AVD)を測定する手段と、房室遅延(AVD)の後に検出された自発的な心室脱分極が存在しない場合において、心室センシングおよび心室ペーシングによってデュアルチャンバモードで前記装置を作動させる手段と、所定の基準に基づき、デュアルチャンバモードと自発的な房室伝導に適したペーシングモードとの間での装置の切換を条件付きで制御する、モード切換手段と、拍出量信号を有する血行動態センサと、前記拍出量出力信号から、自発的な房室伝導に対する患者の耐性を表示する血行動態指標(Indice_EA_encours)を得る手段と、前記血行動態指標に基づいて前記装置の前記デュアルチャンバモードへの前記条件付き切換を抑制または強制する手段を備えてなる患者の刺激、再同期および/または除細動のための能動植込み型医療装置。
- 前記デュアルチャンバモードに対する前記自発的な房室伝導に適した前記ペーシングモードは心室検出を有するAAIモードを含む請求項1に記載の装置。
- 前記デュアルチャンバモードに対する前記自発的な房室伝導に適した前記ペーシングモードは、DDDモードと、房室遅延のヒステリシスを有する両室モードとのうちいずれか一方である請求項1に記載の装置。
- 房室ブロックの発生を診断する手段とをさらに備えた請求項1に記載の装置であって、前記装置の前記デュアルチャンバモードへの前記条件付き切換を抑制または強制する手段は、前記診断手段により証明された房室ブロックが存在しない場合において選択的に作動する前記装置。
- 心房ペーシング(A)と連続的な自発的心室脱分極(R)との間の間隔AR(AR1、AR2)の現行値を評価する手段と、前記間隔ARの現行値を第1の閾値(MaxARhemo)と比較する手段であって、前記装置の前記デュアルチャンバモードへの前記条件付き切換を抑制または強制する手段は、間隔ARの現行値が前記第1の閾値を上回るときに選択的に作動してなる比較手段とをさらに備えてなる請求項1に記載の装置。
- 請求項5に記載の装置であって、前記第1の閾値(MaxARhemo)は患者の心拍数(Fc)に基づく可変閾値をさらに含み、また前記装置は、現時点の心拍数が増加した際に前記第1の閾値を動的に低減させる手段をさらに備えてなる装置。
- 患者の労作時の状態を検出する手段をさらに備える請求項1に記載の装置であって、前記装置の前記デュアルチャンバモードへの前記条件付き切換を抑制または強制する手段は、デュアルチャンバモードへの切換を強制する手段と、前記装置が患者の労作時の状態を検出するまで自発的な房室伝導に適したペーシングモードへの回帰を抑制する手段をさらに備えてなる前記装置。
- 請求項1に記載の装置であって、前記装置の前記デュアルチャンバモードへの前記条件付き切換を抑制または強制する手段は、前記血行動態指標の現行値(Indice_EA_encours)を基準血行動態指標(Indice_EA_ref_encours)と比較する手段をさらに備え、前記強制手段は、前記血行動態指標の現行値が基準血行動態指標を下回ったときに前記装置を前記デュアルチャンバモードに切換えてなる前記装置。
- 前記基準血行動態指標(EAref)の値は患者の心拍数(Fc)に基づく可変値であり、また前記装置は現時点の心拍数が増加したときに前記基準血行動態指標を動的に増加させる手段をさらに備える請求項8に記載の装置。
- 前記基準血行動態指標(EAref)の値は、最小限度(Indice_EA_ref_repos)と最大限度(Indice_EA_ref_exer)との間の可変値であり、また前記装置は前記最小限度と最大限度とを動的に更新する手段をさらに備える請求項9に記載の装置。
- 永久房室ブロックの発生を判定する手段と、前記判定された永久房室ブロックが前記基準血行動態指標(EAref)を心拍数に依存しない値に強制設定する手段とをさらに備える請求項8に記載の装置。
- 前記血行動態センサは、心内膜加速度センサ、心外膜加速度センサ、心筋壁運動センサ、心臓内圧力センサ、心臓内生体インピーダンスセンサ、酸素飽和度を測定する光学センサ、超音波によって体積変化を測定するセンサからなる群から選択されるセンサをさらに備える請求項1に記載の装置。
- 前記血行動態センサは、心筋の循環収縮によって生じる運動を表示する拍出量信号を付加する血行動態心内膜加速度センサである請求項12に記載の装置。
- 心室収縮に関連する最大心内膜加速度に対応する要素を拍出量信号において認識し且つ分離する手段と、前記要素から前記血行動態指標を得る手段とをさらに備える請求項13に記載の装置。
- 心室収縮に関連するそれぞれ二つの最大心内膜加速度に対応する少なくとも二つの要素(T1EA,T2EA)を前記血行動態センサにより付加された拍出量信号において認識し且つ分離する手段と、前記少なくとも二つの要素を区別する時間間隔(ΔTx、)から前記血行動態指標を得る手段とをさらに含む請求項13に記載の装置。
- 前記デュアルチャンバモードはDDDモードを含む請求項1に記載の装置。
- 前記デュアルチャンバモードは両室モードを含む請求項1に記載の装置。
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EP2357020B1 (fr) * | 2010-02-17 | 2012-08-29 | Sorin CRM SAS | Dispositif médical actif de type stimulateur cardiaque, défibrillateur et/ou resynchroniseur, à optimisation automatique du délai atrioventriculaire |
CA2840084C (en) | 2011-06-21 | 2019-11-05 | Foundry Newco Xii, Inc. | Prosthetic heart valve devices and associated systems and methods |
US9039757B2 (en) | 2011-10-19 | 2015-05-26 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
CN103889369B (zh) | 2011-10-19 | 2016-09-14 | 托尔福公司 | 用于心脏瓣膜置换术的装置 |
US11202704B2 (en) | 2011-10-19 | 2021-12-21 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
CA2849030C (en) | 2011-10-19 | 2020-10-27 | Twelve, Inc. | Prosthetic heart valve devices, prosthetic mitral valves and associated systems and methods |
EP2684515B1 (fr) | 2012-07-13 | 2014-12-17 | Sorin CRM SAS | Dispositif médical actif comprenant des moyens de suivi de l'état d'un patient souffrant d'un risque d'insuffisance cardiaque |
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US8874210B2 (en) | 2014-10-28 |
JP2011005250A (ja) | 2011-01-13 |
EP2263747A1 (fr) | 2010-12-22 |
US20140379040A1 (en) | 2014-12-25 |
EP2263747B1 (fr) | 2015-08-26 |
US20100318150A1 (en) | 2010-12-16 |
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