PFA implant trigger

Abstract

Synchronization unit (120) designed to receive telemetry signals from an implantable cardiac pulse generator (130) and to control a PFA generator (110) such that the PFA pulse sequences are delivered synchronously to selected rhythm events of the cardiac pulse generator (130).

Description

[0001] The present invention relates to a device for synchronizing pulsed-field ablation (PFA) pulses with the ventricular events of an implantable cardiac pulse generator. The aim is to reduce the proarrhythmic risk of PFA in patients with implanted cardiac devices such as pacemakers or implantable cardioverter-defibrillators (ICDs).

[0002] In medical practice, cases have been documented in which PFA procedures in patients with implanted cardiac devices led to the induction of ventricular tachycardias (VT) or ventricular fibrillation (VF).

[0003] One possible mechanism for this induction could be the transmission of PFA currents via the implant's input protection circuitry. The input protection circuitry includes, as shown in Fig. Figure 1 shows EMI protection capacitors C1, C2, which, however, play a subordinate role at the frequencies used for PFA, as well as Zener diodes (D1 to D3) which limit the maximum voltage on the implant circuit to 12-15 V.

[0004] If the voltage difference induced by PFA exceeds this threshold, a current path is activated, represented by the black dashed current path. This current path runs between the electrodes. Depending on the type of device, the current path runs, for example, between the casing electrode (Can) 10 and a coil electrode (Coil) 30 of the shock lead in the case of a cardioverter-defibrillator, or between a ring electrode (instead of coil) 30 and a tip electrode (Tip) 20 of the ventricular lead in the case of a pacemaker. This mechanism could contribute to the induction of VT or VF. This is in the Fig. 1 schematically represented.

[0005] However, it should be noted that other mechanisms for the induction of VF without implant involvement have also been described. Some PFA systems offer the option of synchronizing pulse delivery to the R-wave of a surface ECG. However, this method is prone to error due to the challenges of accurately detecting the R-wave and ventricular activation. This can either significantly restrict the safe time window for PFA pulse delivery or keep the risk of VT / VF induction relatively high in patients with implants.

[0006] The object of the invention is, therefore, to provide a solution to the technical problem of how to reduce the risk of proarrhythmic events in patients with implanted cardiac devices during the application of pulsed-field ablation pulses.

[0007] This problem is solved by a synchronization unit with the features of claim 1. Advantageous embodiments of the invention are described below.

[0008] According to claim 1, a synchronization unit is disclosed, designed to receive telemetry signals from an implantable cardiac pulse generator and to control a pulsed-field ablation generator (PFA generator) such that PFA pulse sequences generated by the PFA ablation generator are delivered synchronously to selected rhythm events of the cardiac pulse generator.

[0009] According to a preferred embodiment, the implantable cardiac pulse generator is one of the following devices: an implantable pulse generator (IPG), an implantable cardioverter defibrillator (ICD), a cardiac resynchronization therapy defibrillator (CRT-D), a cardiac resynchronization therapy pacemaker (CRT-P), or a non-transvenous ICD.

[0010] According to another preferred embodiment, the synchronization unit for controlling the PFA ablation generator is configured such that high-frequency pulse sequences generated by the PFA ablation generator are delivered synchronously to selected rhythm events of the cardiac pulse generator.

[0011] In particular, the pulses of the pulse sequences can have a voltage of 2000 V to 3500 V, advantageously 3000 V. The pulse duration can preferably be 0.5 ms to 3 ms, more particularly 1 ms to 2 ms.

[0012] Furthermore, according to a preferred embodiment of the invention, the rhythm events include ventricular events selected from the group consisting of ventricular stimulation (V-Pace) and ventricular detection (V-Sense).

[0013] In a further preferred embodiment, telemetry between the synchronization unit and the implantable cardiac pulse generator is performed in one of the following ways: in the MICS band, via BLE, via ZigBee, in the MEDS band, in the ISM band, or by means of coil telemetry. In particular, the synchronization unit is configured to receive the telemetry signals from a distance of 0 to 4 m, especially 3 m, from the cardiac pulse generator.

[0014] According to a further preferred embodiment of the invention, the duration of the ventricular synchronous PFA pulse sequence is adjustable and / or limited to the duration of the absolute refractory period after a ventricular event.

[0015] Furthermore, according to a preferred embodiment of the invention, the synchronization unit is part of a programming device for the implantable cardiac pulse generator, or is configured to be implantable in such a programming device. According to another aspect of the invention, a programming device comprising a synchronization unit according to the invention is disclosed.

[0016] Furthermore, according to a preferred embodiment, the synchronization unit is connectable to the PFA generator or is designed as an integral component of the PFA generator, in particular being arrangable in the housing of the PFA ablation generator. According to a further aspect of the invention, a PFA generator is disclosed which includes a synchronization unit according to the invention.

[0017] Another aspect of the present invention relates to a method for controlling a pulsed-field ablation generator (PFA generator), comprising the steps of: - Receiving telemetry signals from an implantable cardiac pulse generator by means of a synchronization unit (in particular the synchronization unit according to the invention), - Control of the PFA generator by the synchronization unit in such a way that PFA pulse sequences generated by the PFA generator are delivered synchronously to selected rhythm events of the cardiac pulse generator.

[0018] The following section will explain embodiments and variants of the invention, as well as further features and advantages of the invention, with reference to the figures. The figures show: Fig. 1 a schematic representation of a cardiac implant with input protection circuitry and a possible introduction of PFA currents according to the state of the art, and Fig. 2 a schematic representation of a synchronization unit according to the invention in connection with a PFA pulse generator and a cardiac implant.

[0019] In the Fig. Figure 2 shows a block diagram of the overall system. This consists of the PFA ablation generator 110, the synchronization unit 120 according to the invention, and the cardiac implant 130.

[0020] The implant 130 is shown here connected to the synchronization unit 120 via MICS telemetry as an example and receives at least the ventricular marker channel.

[0021] The synchronization unit 120 is connected to the PFA ablation generator 110, in particular via cable or wirelessly, and signals ventricular events of the implant 130 to the PFA ablation generator 110 as a trigger for the delivery of a PFA pulse sequence.

[0022] The duration of the PFA pulse sequence can be set on the PFA ablation generator 110 or specified via the synchronization unit 120 and should in particular not be longer than the absolute refractory period of the heart minus a safety margin (e.g. 150ms).

[0023] The invention advantageously increases patient safety during an ablation procedure, particularly PFA, to a significant degree.

Claims

[1] Synchronization unit (120) designed to receive telemetry signals from an implantable cardiac pulse generator (130) and to control a PFA generator (110) such that the PFA pulse sequences are delivered synchronously to selected rhythm events of the cardiac pulse generator (130).

Images