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Device and method for monitoring and optimising a temporal trigger stability (WO2023094554A1)
(2023)
The present invention relates to devices for monitoring and optimising a temporal trigger stability of an extracorporeal circulatory support means, and to open-loop and closed-loop control units for the extracorporeal circulatory support means comprising such a device, and to corresponding methods. A device (10) for monitoring a temporal trigger stability of an extracorporeal circulatory support means is accordingly proposed, which device is designed to receive a first dataset (14) of a measurement of an ECG signal of a supported patient over a predefined period of time. The device (10) comprises an evaluation unit (16), which is designed to determine or identify a plurality of R triggers (26) from the first dataset (14), wherein the evaluation unit (16) is also designed to receive or provide a second dataset (20) having evaluated ECG signals and a plurality of R triggers (28) and to selectively map the second dataset (20) on the first dataset (14). The device is also designed to emit a signal (22) that characterises a temporal gap between successive R triggers (26) from the first dataset (14) and successive R triggers (28) from the second dataset (20) which are mapped on the first dataset.
Die vorliegende Erfindung betrifft Vorrichtungen zum Überwachen und Optimieren einer zeitlichen Triggerstabilität einer extrakorporalen Kreislaufunterstützung sowie Steuer- und Regeleinheiten zur extrakorporalen Kreislaufunterstützung, umfassend eine solche Vorrichtung und entsprechende Verfahren. Entsprechend wird eine Vorrichtung (10) zum Überwachen einer zeitlichen Triggerstabilität einer extrakorporalen Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist, einen ersten Datensatz (14) einer Messung eines EKG-Signals eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen. Die Vorrichtung (10) umfasst eine Auswerteeinheit (16), welche dazu eingerichtet ist, mehrere R-Trigger (26) aus dem ersten Datensatz (14) zu bestimmen oder zu identifizieren, wobei die Auswerteeinheit (16) weiterhin dazu eingerichtet ist, einen zweiten Datensatz (20) mit ausgewerteten EKG-Signalen und mehreren R-Triggern (28) zu empfangen oder bereitzustellen und den zweiten Datensatz (20) selektiv auf dem ersten Datensatz (14) abzubilden. Die Vorrichtung ist weiterhin dazu eingerichtet, ein Signal (22) auszugeben, welches kennzeichnend für einen zeitlichen Abstand sukzessiver R-Trigger (26) aus dem ersten Datensatz (14) und darauf abgebildeten sukzessiven R-Trigger (28) aus dem zweiten Datensatz (20) ist.
Electrode modelling and simulation of diagnostic and pulmonary vein isolation in atrial fibrillation
(2022)
Transthoracic impedance cardiography (ICG) is a non-invasive method for determination of hemodynamic parameters. The basic principle of transthoracic ICG is the measurement of electrical conductivity of the thorax over the time. The aim of the study was the analysis of hemodynamic parameters from healthy individuals and the evaluation of various hemodynamic monitoring devices. Fourteen men (mean age 25 ± 4.59 years) and twelve women (mean age 24 ± 3.5 years) were measured during the cardiovascular engineering laboratory at Offenburg University of Applied Sciences, Offenburg, Germany. The ICG recordings were measured with the devices CardioScreen 1000, CardioScreen 2000 and TensoScreen with the corresponding Software Cardiovascular Lab 2.5 (Medis Medizinische Messtechnik GmbH, Illmenau, Germany). In order to create identical frame conditions, all measurements were recorded in the same position and for the same duration. Various positions were simulated from horizontal lying position to vertical standing position. Altogether, more than 30 hemodynamic parameters were measured.
In contrast to conventional aortic valve replacement, the Transcatheter Aortic Valve Implantation (TAVI) is a new highly specialist alternative to surgical valve replacement for patients with symptomatic severe aortic stenosis and high operative risk. The procedure was performed in a minimally invasive way and was introduced at the university heart centre, Freiburg – Bad Krozingen in 2008. The results have been getting better and better over the years. The aim of the investigation is the analysis of electrocardiogram conduction time and the electrocardiography changes recorded hours and days after the procedure depending on artificial heart valve models, which may lead to pacemaker implantation, even the analysis of the effectiveness of treatment.
The present invention relates to open-loop and closed-loop control units for extracorporeal circulatory support, to systems comprising such an open-loop and closed-loop control unit, and to corresponding methods. An open-loop and closed-loop control unit (10) for extracorporeal circulatory support is proposed, which is configured to receive a measurement of an ECG signal (12) of a supported patient over a predefined period of time, wherein the ECG signal (12) comprises multiple data points for each time point within a heart cycle. The open-loop and closed-loop control unit (10) comprises an evaluation unit (100) which is configured to evaluate the data points for at least one time point in a spatial and/or temporal manner and to determine at least one amplitude change (14) within the heart cycle based on the evaluated data points. The open-loop and closed-loop control unit (10) is further configured to output an open-loop and/or closed-loop signal (16) for extracorporeal circulatory support at a predefined point in time after the at least one amplitude change (14).
The present invention relates to open-loop and closed-loop control units for extracorporeal circulatory support, to systems comprising such an open-loop and closed-loop control unit, and to corresponding methods. An open-loop and closed-loop control unit (10) for extracorporeal circulatory support is proposed, which is configured to receive a measurement of an ECG signal (12) of a supported patient over a predefined period of time, wherein the ECG signal (12) comprises multiple data points for each time point within a heart cycle. The open-loop and closed-loop control unit (10) comprises an evaluation unit (100) which is configured to evaluate the data points for at least one time point in a spatial and/or temporal manner and to determine at least one amplitude change (14) within the heart cycle based on the evaluated data points. The open-loop and closed-loop control unit (10) is further configured to output an open-loop and/or closed-loop signal (16) for extracorporeal circulatory support at a predefined point in time after the at least one amplitude change (14).
Die vorliegende Erfindung betrifft Steuer- und Regeleinheiten für eine extrakorporale Kreislaufunterstützung sowie Systeme, umfassend eine solche Steuer- und Regeleinheit und entsprechende Verfahren. Entsprechend wird eine Steuer- und Regeleinheit (10) für eine extrakorporale Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist eine Messung eines EKG-Signals (12) eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen und für die extrakorporale Kreislaufunterstützung bereitzustellen, wobei das EKG-Signal (12) für jeden Zeitpunkt innerhalb eines Herzzyklus eine Signalhöhe aus mindestens einer EKG-Ableitung (14A, 14B) umfasst. Die Steuer- und Regeleinheit (10) umfasst eine Auswerteeinheit (16), welche dazu eingerichtet ist, eine Signaldifferenz (18) einer Signalhöhe eines aktuellen Zeitpunkts (12A) und einer Signalhöhe des vorhergehenden Zeitpunkts (12B) zu bestimmen und die Signaldifferenz (18) mit einem vorgegebenen Schwellenwert (20) zu vergleichen. Die Steuer- und Regeleinheit (10) ist weiterhin dazu eingerichtet, das EKG-Signal (22) beim Überschreiten des Schwellenwerts (20) für den aktuellen Zeitpunkt und eine vorgegebene Anzahl von nachfolgenden Zeitpunkten (28) mit einer vorgegebenen Signalhöhe (30) bereitzustellen.
Die vorliegende Erfindung betrifft Steuer- und Regeleinheiten für eine extrakorporale Kreislaufunterstützung sowie Systeme, umfassend eine solche Steuer- und Regeleinheit und entsprechende Verfahren. Entsprechend wird eine Steuer- und Regeleinheit Steuer- und Regeleinheit (10) für eine extrakorporale Kreislaufunterstützung vorgeschlagen, welche dazu eingerichtet ist eine Messung eines EKG-Signals (12) eines unterstützten Patienten über einen vorgegebenen Zeitraum zu empfangen, wobei das EKG-Signal (12) für jeden Zeitpunkt innerhalb eines Herzzyklus mehrere Datenpunkte umfasst. Die Steuer- und Regeleinheit (10) umfasst eine Auswerteeinheit (100), welche dazu eingerichtet ist, die Datenpunkte für mindestens einen Zeitpunkt räumlich und/oder zeitlich auszuwerten und aus den ausgewerteten Datenpunkten mindestens eine Amplitudenänderung (14) innerhalb des Herzzyklus zu bestimmen. Die Steuer- und Regeleinheit (10) ist weiterhin dazu eingerichtet, ein Steuer- und/oder Regelsignal (16) für die extrakorporale Kreislaufunterstützung an einem vorgegebenen Zeitpunkt nach der mindestens einen Amplitudenänderung (14) auszugeben.
Background: A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His bundle pacing.
Methods: Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. This conventional type of biventricular pacing leads to a reduction of the left ventricular ejection fraction. Furthermore, the non-responder rate of the CRT therapy is about one third of the CRT patients.
Results: His bundle pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the His bundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1.5 V in combination with a pacing pulse duration of 1 ms.
Conclusions: Compared to conventional cardiac pacemaker pacing, His bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
Die transösophageale Neurostimulation ist eine neue Therapieform und könnte unter anderem zur Schmerzlinderung während einer transösophagealen Linksherzstimulation angewendet werden. Sie ist in die Kategorie der Rückenmarksstimulation (SCS) einzuordnen, die die meist verwendete Technik der Neurostimulation ist. Die derzeit auf dem Markt vorhandenen Ösophaguskatheter werden bei einer elektrophysiologischen Untersuchung mit Ablation und transösophagealer Echokardiographie zur Temperaturüberwachung eingesetzt. Das Ziel dieser Arbeit war, das vorhandene Offenburger Herzrhythmusmodell, um die Wirbelsäule zu erweitern, einen neuen Ösophagus-Elektroden- Katheter für die transösophageale elektrische Stimulation des Rückenmarks zu modellieren und mittels 3D-Computer-Simulationen auf Ihre Wirksamkeit zu untersuchen.
Um medizinische Behandlungsverfahren in der Praxis besser verstehen und anwenden zu können, gewinnt die Visualisierung der Prozesse an immer größerer Bedeutung. Durch Anwendung der Computer-Simulationssoftware CST können elektromagnetische und thermische Simulationen zur Analyse verschiedener Herzrhythmusstörungen durchgeführt werden. Eine weitere Form der Visualisierung erfolgt durch haptische, dreidimensionale Druckmodelle. Diese Modelle können mit einem generativen Herstellungsverfahren, wie z. B. einem 3D-Drucker, in kürzester Zeit hergestellt werden.
A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients with reduction of the left ventricular ejection fraction, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His-bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His-Bundle-Pacing. Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. The non-responder rate of the CRT therapy is about one third of the CRT patients. His- Bundle-Pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His-bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the Hisbundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1,5 V in combination with a pacing pulse duration of 1 ms. Compared to conventional pacemaker pacing, His-bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His-bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
本发明涉及一种用于生物阻抗测量和/或用于神经刺激的食道电极探针(10);用于经食道心脏病治疗和/或心脏病诊断的设备(100);以及一种用于控制或调节用于心脏导管消融装置和/或心脏、循环和/或肺支持装置的方法。食道电极探针包括生物阻抗测量装置,用于测量围绕食道电极探针的组织中的至少一部分组织的生物阻抗。生物阻抗装置包括至少一个第一电极和至少一个第二电极,其中至少一个第一电极(12A)布置在食道电极探针的面向心脏的一侧(14)上,并且至少一个第二电极(12B)布置在食道电极探针背离心脏的一侧(16)上。装置(100)包括食道电极探针(10)和控制和/或评估装置(30),其被配置用于从至少一个第一电极(12A)接收第一生物阻抗测量信号并从至少一个第二电极(12B)接收第二生物阻抗测量信号,并对这些信号进行比较,并且在比较的基础上产生控制信号。该控制信号可以是用于控制或调节心脏导管消融装置和/或心脏、循环和/或肺支持装置的信号。
Oesophageal Electrode Probe and Device for Cardiological Treatment and/or Diagnosis (US20200261024)
(2020)
An oesophageal electrode probe for bioimpedance measurement and/or for neurostimulation is provided; a device for transoesophageal cardiological treatment and/or cardiological diagnosis is also provided; a method for the open-loop or closed-loop control of a cardiological catheter ablation device and/or a cardiological, circulatory and/or respiratory support device is also provided. The oesophageal electrode probe comprises a bioimpedance measuring device for measuring the bioimpedance of at least one part of tissue surrounding the oesophageal electrode probe. The bioimpedance device comprises at least one first and one second electrode. The at least one first electrode is arranged on a side of the oesophageal electrode probe facing towards the heart. The at least one second electrode is arranged on a side of the oesophageal electrode probe facing away from the heart. The device comprises the oesophageal electrode probe and a control and/or evaluation device.
Introduction: Patient selection for cardiac resynchronization therapy (CRT) requires quantification of left ventricular conduction delay (LVCD). After implantation of biventricular pacing systems, individual AV delay (AVD) programming is essential to ensure hemodynamic response. To exclude adverse effects, AVD should exceed individual implant-related interatrial conduction times (IACT). As result of a pilot study, we proposed the development of a programmer-based transoesophageal left heart electrogram (LHE) recording to simplify both, LVCD and IACT measurement. This feature was implemented into the Biotronik ICS3000 programmer simultaneously with 3-channel surface ECG.
Methods: A 5F oesophageal electrode was perorally applied in 44 heart failure CRT-D patients (34m, 10f, 65±8 yrs., QRS=162±21ms). In position of maximum left ventricular deflection, oesophageal LVCD was measured between onsets of QRS in surface ECG and oesophageal left ventricular deflection. Then, in position of maximum left atrial deflection (LA), IACT in VDD operation (As-LA) was calculated by difference between programmed AV delay and the measured interval from onset of left atrial deflection to ventricular stimulus in the oesophageal electrogram. IACT in DDD operation (Ap-LA) was measured between atrial stimulus and LA..
Results: LVCD of the CRT patients was characterized by a minimum of 47ms with mean of 69±23ms. As-LA and Ap-LA were found to be 41±23ms and 125±25ms, resp., at mean. In 7 patients (15,9%), IACT measurement in DDD operation uncovered adverse AVD if left in factory settings. In this cases, Ap-LA exceeded the factory AVD. In 6 patients (13,6%), IACT in VDD operation was less than or equal 10ms indicating the need for short AVD.
Conclusion: Response to CRT requires distinct LVCD and AVD optimization. The ICS3000 oesophageal LHE feature can be utilized to measure LVCD in order to justify selection for CRT. IACT measurement simplifies AV delay optimization in patients with CRT systems irrespective of their make and model.