WO2023073252A1 - Système pour la mise en oeuvre de la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de his et dans la région du faisceau gauche - Google Patents

Système pour la mise en oeuvre de la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de his et dans la région du faisceau gauche Download PDF

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Publication number
WO2023073252A1
WO2023073252A1 PCT/ES2021/070777 ES2021070777W WO2023073252A1 WO 2023073252 A1 WO2023073252 A1 WO 2023073252A1 ES 2021070777 W ES2021070777 W ES 2021070777W WO 2023073252 A1 WO2023073252 A1 WO 2023073252A1
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WO
WIPO (PCT)
Prior art keywords
bundle
area
pacemakers
signals
during stimulation
Prior art date
Application number
PCT/ES2021/070777
Other languages
English (en)
Spanish (es)
Inventor
Joaquín OSCA ASENSI
José Ignacio RICHARTE PERALTA
Jesús VILA BERNABÉ
Original Assignee
Cardiohis, S.L.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cardiohis, S.L. filed Critical Cardiohis, S.L.
Priority to PCT/ES2021/070777 priority Critical patent/WO2023073252A1/fr
Publication of WO2023073252A1 publication Critical patent/WO2023073252A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • 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
    • A61N1/362—Heart stimulators
    • A61N1/37—Monitoring; Protecting

Definitions

  • the present invention discloses a system that allows users to determine the best position of leads used by pacemakers during pacing in the His bundle or left bundle branch region.
  • the system is made up of a device (40) that incorporates an acquisition module and an electronic processing module; a tablet (50) to display both the signals and the smart support; more sensitive electrocardiograph (ECG) and intracardiac (EGM) signal acquisition circuitry and software, and software to automatically predict lead proximity to the conduction system.
  • ECG electrocardiograph
  • ECM intracardiac
  • the atrioventricular node, the bundle of His, and their branches are part of the electrical system of the heart. These allow the conduction of the electrical signal to the ventricles.
  • Each ventricle has a branch from the bundle of His, called the right or left bundle branch.
  • Atrioventricular block appears when the transmission of the electrical impulse to the ventricles fails and may appear due to a localized problem in the atrioventricular node, the bundle of His, or in the branches of the bundle of His.
  • His bundle branch block is a problem in which one of the branches (right or left) of the heart does not work properly. This causes a delay in the passage of the signal.
  • the main pumping chambers of the heart, the ventricles are activated less than expected and even below what the body needs to maintain vital functions, and synchrony between the atria and ventricles is also lost, which further deteriorates plus the functionality of the heart.
  • the only treatment capable of solving this problem is the implantation of a pacemaker with the implantation of a cable that stimulates the cardiac ventricles.
  • Cardiac pacing is the mainstay of treatment for bradycardia disorders of the heart and the right ventricular (RV) apex has been the traditional site of choice for permanent ventricular pacing. It is mainly due to technical aspects such as the stability of the cable at this anatomical point.
  • chronic pacing from the apex of the right ventricle has shown deleterious effects on hemodynamics, is associated with left ventricular dysfunction and the appearance of cardiomyopathy. New-onset heart failure is seen in 9% of patients receiving right ventricular pacing at 1-year follow-up and up to 39% after a median follow-up of 10 years.
  • the relationship between chronic right ventricular pacing and heart failure has recently been supported by a European registry conducted in Denmark.
  • the primary objective of this study was to compare the risk of heart failure between pacemaker and non-paced patients with a right ventricular pacing lead and no prior heart failure and an age- and sex-matched control cohort with no prior heart failure.
  • the study involved 27,704 patients with pacemakers implanted between 2000 and 2014 and showed how patients with pacemaker implants suffered a higher incidence of heart failure and higher mortality.
  • Physiologic pacing or pacing of the conduction system is obtained by implanting the pacing lead in the region of the bundle of His or in the area of the left bundle.
  • This pacing provides the most physiologic form of pacing, as it preserves physiologic activation of the left ventricle through the intrinsic electrical system of the heart and avoids the deleterious effects of chronic nonphysiologic RV pacing.
  • the main reported benefits of His-is or left bundle-branch pacing are a very significant reduction in the paced QRS width, an increase in left ventricular ejection fraction, a reduction in hospitalizations for heart failure, and even a lower mortality as suggested by a meta-analysis that suggests even lower mortality.
  • His-bundle or left-bundle pacing may also normalize conduction in patients with bundle branch block (BBB) and therefore has a role as an alternative to biventricular pacing as cardiac resynchronization therapy in treatment of patients with heart failure.
  • BBB bundle branch block
  • physiological pacing has significant drawbacks that have reduced the universalization of this modality of cardiac pacing.
  • Physiologic pacing is associated with a lower success rate, higher probability of lead dislocation, induction of His bundle damage, and high and unstable pacing thresholds. Consequently, pacemaker manufacturers are developing new tools to address the limitations of physiologic pacing, such as new pacing leads, new sheaths to guide pacing lead implantation, or even new algorithms for pacemaker automation.
  • the availability of adequate intracavitary detection and 12-lead electrocardiography essential to analyze pacing morphologies to confirm HB or LBBB recruitment are essential factors. for physiological stimulation.
  • Pacemaker programmers and analyzers used in common pacemaker implants, have limited intracavitary sensing capabilities and do not have a 12-lead ECG, making them unusable for physiologic pacing and necessitating the use of an electrophysiologic polygraph.
  • electrophysiological polygraphs are limited to large arrhythmia units and must be handled by experts and is an expensive device with many more functionalities than those necessary for physiological pacing.
  • the American patent application US20200069938 provides methods for the stimulation of the bundle of His and the left branch of the bundle of His.
  • the method comprises selectively delivering an electrical stimulation pulse to one or more individual electrodes of a roughly linear electrode array, wherein the approximately linear electrode array is set to intersect the bundle of His.
  • the approximately linear array of electrodes is affixed to cardiac tissue by a prong, a stretchable coil, or a combination thereof.
  • the approximately linear array of electrodes comprises at least four, preferably eight, electrodes.
  • the approximately linear array of electrodes is set approximately orthogonal.
  • the approximately linear array of electrodes is disposed on a distal section of a pacemaker lead.
  • the approximately linear electrode array is provided in a leadless pacemaker.
  • the present disclosure provides a lead rhythm comprising a distal section having a distal fixation mechanism, a distal section having a plurality of electrodes along the face of the lead, and a proximal section it has a tip fitted with multiple electrodes.
  • the American patent application US20200261731 discloses a medical device system, which incorporates a computer apparatus configured to receive electrical signals from the body surface from an electrode apparatus that includes multiple external electrodes.
  • the medical device comprises: an electrode apparatus comprising a plurality of external electrodes configured to monitor a plurality of electrical signals from a patient's body surface; and a calculating apparatus coupled to the electrode apparatus and comprising processing circuitry configured to generate cardiac electrical asynchrony data from the body surface electrical signals received from the plurality of external electrodes during the delivery of their pulsed stimulation beams, further allowing identify effective His-bundle capture by His-bundle pacing based on electrical dyssynchrony data, where effective His-bundle capture comprises capture of both a left and a right bundle branch of a bundle of His ; and generating an indication of His bundle capture in response to the identification of effective His bundle capture.
  • the present invention provides a satisfactory solution to the implantation problem of the stimulation system by determining the best position of the cables used by the pacemaker during pacing in the region of the bundle of His or the left bundle, since it incorporates 2 good-resolution intracavitary channels and a 12-lead electrocardiogram.
  • the signals are analyzed and processed to facilitate the procedure for users. It is composed of a) a device for data acquisition and electronic processing, b) a tablet to display both signals and smart support, c) a cloud-based back-end for data storage, and d) a system data processing for learning and feedback on implementation and for patient follow-up.
  • the invention is an affordable solution, it brings together all the necessary specifications in a single technology and facilitates implantation procedures for all implant units around the world.
  • Figure 1. Shows a view of the device (40) that incorporates an acquisition module and an electronic processing module and the tablet (50) that allows both the signals and the user interface to be displayed.
  • FIG.- shows a schematic view of the power distribution in the device (40) connected to 5 VDC from the external power supply that is distributed in the main voltages used to power the analog module (10), processing module ( 20) and transmission module (30). It can be seen that these modules receive the signals of the electrocardiogram (ECG) and electrogram (EGM). DESCRIPTION OF THE INVENTION
  • the present invention allows users to determine the best position of leads used by pacemakers during His bundle or left bundle pacing. It is based on the use of electrocardiograph (ECG) and intracardiac signal acquisition circuitry and software using a more sensitive electrogram (EGM) signal and software to automatically predict lead proximity to the conduction system.
  • ECG electrocardiograph
  • EMM electrogram
  • the pacemaker lead is a non-insulated end of the lead that is in direct contact with the heart. It is usually connected to a pulse generator to stimulate the heart in different ways.
  • the electrode can be placed in the upper chamber (atrium) or in the lower chamber (ventricle).
  • the pulse generator must be programmed with a few parameters: voltage, frequency, etc. It depends on the patient's condition and where it is connected.
  • the system of the invention makes it possible to implant the lead in the same conduction system, in the area called the bundle of His and the left bundle branch.
  • the main advantage of this system is that it is a more physiological procedure with corresponding advantages for patients.
  • the device optimizes the signal-to-noise ratio (SNR) of the electrogram (EGM) signal to ensure detection of HIS and left bundle branch signals.
  • SNR signal-to-noise ratio
  • Easy-to-use remote interface allows user to view multi-lead surface electrocardiogram (ECG) and electrogram (EGM) signal on the same screen, change filter gain and resolution, and save data to database .
  • ECG multi-lead surface electrocardiogram
  • EMG electrogram
  • EMG electrogram
  • ECG electrocardiogram
  • ECG electrogram
  • LVAT left ventricular activation time
  • the solution proposed in the present invention is not only a device to collect information, but is composed of 2 main physical components: a device (40) with electronic acquisition and processing and a tablet (50) (based on iPad or Android) to display both signs and intelligent support for predictive location.
  • the System for determining the optimal arrangement of the leads used by pacemakers during stimulation in the region of the bundle of His or in the area of the left bundle comprises a device (40) that incorporates an acquisition module and an electronic processing module; a tablet (50) to display both the signals and the smart support; a cloud-based back-end for data storage; and a data processing system for learning and feedback on implementation and for patient follow-up.
  • the device with the electronic acquisition and processing comprises an analog module (10) where the ECG and EGM signals are amplified, filtered and level adjusted; a processing module (20) that executes the analog to digital conversion of the signals and performs the digital filtering thereof; and a Bluetooth transmission module (30) that receives the data from the processing module and sends it to the wireless device connected to the user interface.
  • the device is connected to 5 V DC from the external power supply which are converted to the main voltages used in the devices on the power supply board, the device incorporates a main switch (1) for power on and off, a power board (2) that allows the distribution of current to feed the analog module (10), processing module (20) and transmission module (30).
  • the amounts of energy are distributed as follows:
  • the analog module (10) is made up of a surface electrocardiogram (ECG) signal acquisition submodule and a pulse signal acquisition submodule. electrograms (EGM).
  • ECG surface electrocardiogram
  • EMG electrograms
  • the ECG submodule includes an amplifier to reduce interference, called the Right Leg Lead (RLD).
  • the superficial ECG acquisition sub-module uses two integrated devices specialized in ECG signal acquisition and interfaced with master/slave configuration.
  • Electrocardiograph, electrocardiogram (ECG) and electrogram (EGM) signals are acquired and processed in the acquisition sub-module.
  • This submodule is connected via Bluetooth to the tablet where the user interface is running.
  • the user can view the multilead surface ECG and EGM signals on the same screen, change the cutoff frequency of the digital low-pass filter, change the amplitude of the waveforms, and perform automatic calculation of the ventricular contraction width (VTW). of QRS), heart rate (HR) and left ventricular activation time (LVAT) using electrogram (EGM) and electrocardiogram (ECG) signals in real time.
  • QRS QRS
  • HR heart rate
  • LVAT left ventricular activation time
  • ECG electrocardiogram
  • the ECG and EGM signals are amplified, filtered and level adjusted using high signal to noise ratio amplifiers and high precision components.
  • the processing module (20) executes the analog to digital conversion of the signals and carries out the digital filtering thereof.
  • the signals are digitally filtered and amplified to be sent to the Bluetooth transmission module (30).
  • a microcontroller is the main component of this module (20) to execute its functions.
  • the parameters used by the device hardware are stored in an internal microprocessor EEPROM (Electrically Erasable Programmable Read-Only Memory) or (electrically erasable programmable ROM). It is a type of internal memory of the microprocessor that can be electrically programmed, erased and reprogrammed.
  • the Bluetooth transmission module (30) receives the data from the processing module (20) and sends it to the wireless device connected to the user interface. In addition, it receives the different parameters set by the user in the user interface to change the hardware configuration.
  • the user interface device is a portable device on which the software for displaying ECG and EGM signals and allowing the user to set all the parameters necessary to detect the intracardiac signal.
  • the EGM signal acquisition submodule amplifies, filters, and levels the intracardiac signal detected on a bipolar catheter.
  • the bipolar EGM signal is obtained by subtracting cardiac electrical activity detected by a pair of nearby electrodes.
  • multi-electrode catheters generally have short electrode gaps (around 2 mm), therefore are less sensitive to far-field electrical sources and have a high signal-to-noise ratio, the design of EGM acquisition bipolar must consider all the details so that you get the best possible signal quality.
  • the filters used in the EGM acquisition submodule it has been considered that the EGM signals are concentrated in the bandwidth between 30 Hz - 500 Hz and the European electrical network uses 50 Hz.
  • the filters used in this stage They are a passive high-pass filter with cut-off frequency equal to 1 Hz to eliminate the DC component of the signal and a low-pass filter centered at 1 KHz to guarantee the subsequent analog-to-digital conversion of the signal (ADC).
  • the filtered signal is amplified and level adjusted before it is delivered to the analog-to-digital conversion (ADC) processing module.
  • ADC analog-to-digital conversion
  • the processing module (20) is made up of a dual-core microprocessor.
  • the microprocessor also performs digital filtering of the acquired signals to improve their signal to noise ratio before sending them to the Bluetooth module.
  • the Bluetooth transmission module (30) allows wireless communication between the user interface device and the acquisition device. It receives the acquired data from the processing module (20) and transmits it to the application running on the user interface device. Likewise, it receives the configuration set by the user in the user interface device and delivers it to the processing module.
  • Bluetooth transmission/reception is done from the dual-core processor itself used in the processing module, which incorporates these wireless transmission functions.
  • the device incorporates a powerful data processing capability for signal filtering and characterization. This is so since the data transferred to the user interface will be fully processed in the processing module (20) to simplify the registration of the medical device.
  • the system will automatically calculate the following measurements and display on the screen in real time:
  • the system will use the ECG and EGM signals detected through the device.
  • the values obtained will define the suitability of the evaluated stimulation site for physiological stimulation.

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  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

La présente invention concerne un système qui permet de mettre en oeuvre la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de His et dans la région du faisceau gauche. Le système est composé d'un dispositif (40) qui comprend un module d'acquisition et un module de traitement électronique; d'une tablette (50) pour montrer tant les signaux que le support intelligent; d'un logiciel et d'un circuit d'acquisition de signaux électrocardiographiques (ECG) et intracardiaques (EGM) plus sensible et d'un logiciel pour prédire automatiquement la proximité du fil par rapport au système de conduction . Le dispositif (40) avec l'acquisition et le traitement électronique comprend un module analogique (10) dans lequel les signaux d'électrocardiogramme (ECG) et d'électrogramme (EGM) sont amplifiés, filtrés et ajustés relativement à leur niveau; un module de traitement (20) qui exécute la conversion analogique-numérique des signaux et réalise le filtrage numérique de ceux-ci; et un module de transmission Bluetooth (30) qui reçoit les données du module de traitement (20) et les envoie au dispositif sans fil connecté à l'interface utilisateur.
PCT/ES2021/070777 2021-10-27 2021-10-27 Système pour la mise en oeuvre de la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de his et dans la région du faisceau gauche WO2023073252A1 (fr)

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PCT/ES2021/070777 WO2023073252A1 (fr) 2021-10-27 2021-10-27 Système pour la mise en oeuvre de la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de his et dans la région du faisceau gauche

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PCT/ES2021/070777 WO2023073252A1 (fr) 2021-10-27 2021-10-27 Système pour la mise en oeuvre de la pose optimale des fils utilisés pour les stimulateurs cardiaques pendant la stimulation dans la région du faisceau de his et dans la région du faisceau gauche

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080319501A1 (en) * 2004-12-20 2008-12-25 Qingsheng Zhu Systems, Devices and Methods for Monitoring Efficiency of Pacing
WO2009078751A1 (fr) * 2007-12-18 2009-06-25 St Jude Medical Ab Dispositif médical pour la stimulation du faisceau de his
WO2012040487A1 (fr) * 2010-09-23 2012-03-29 C.R. Bard, Inc. Appareil et procédé destinés à assister la navigation d'un cathéter en utilisant la cartographie de l'énergie endovasculaire
EP3381509A1 (fr) * 2017-03-30 2018-10-03 NewStim, Inc. Système de traitement du syndrome de brugada

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080319501A1 (en) * 2004-12-20 2008-12-25 Qingsheng Zhu Systems, Devices and Methods for Monitoring Efficiency of Pacing
WO2009078751A1 (fr) * 2007-12-18 2009-06-25 St Jude Medical Ab Dispositif médical pour la stimulation du faisceau de his
WO2012040487A1 (fr) * 2010-09-23 2012-03-29 C.R. Bard, Inc. Appareil et procédé destinés à assister la navigation d'un cathéter en utilisant la cartographie de l'énergie endovasculaire
EP3381509A1 (fr) * 2017-03-30 2018-10-03 NewStim, Inc. Système de traitement du syndrome de brugada

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