Cardiac conduction system assessment

Abstract

This article describes a system, interface, and method related to the assessment of a patient's cardiac conduction system and the assessment of cardiac conduction system pacing therapy delivered to the patient's cardiac conduction system. The assessment of the patient's cardiac conduction system utilizes multiple penetration maps to determine where cardiac conduction blockages may be located. The assessment of the cardiac conduction system pacing therapy utilizes various electrical heterogeneity information monitored before and during delivery of the cardiac conduction system pacing therapy.

Description

[0001] This disclosure relates herein to systems and methods for evaluating cardiac conduction system pacing therapy and cardiac conduction system block location.

[0002] Implantable medical devices (IMDs), such as implantable pacemakers, cardioverter-defibrillators, or pacemaker-cardioverter-defibrillators, deliver therapeutic electrical stimulation to the heart. IMDs can provide pacing to resolve bradycardia, or provide pacing or electric shocks to terminate rapid arrhythmias such as tachycardia or fibrillation. In some cases, the medical device can sense the heart's inherent depolarization, detect arrhythmias based on (or the absence of) inherent depolarization, and, if an arrhythmia is detected based on inherent depolarization, control the delivery of electrical stimulation to the heart.

[0003] IMD can also offer cardiac resynchronization therapy (CRT), a form of pacing. CRT involves delivering pacing pulses to the left ventricle or both the left and right ventricles. The timing and location of the pacing pulses delivered to the ventricles can be selected to improve the coordination and efficiency of ventricular contractions.

[0004] In addition to the implantable medical device itself, the system used for implanting the medical device may also include a workstation or other equipment. In some cases, these other devices assist physicians or other technicians in placing the intracardiac lead at a specific location on or within the heart. In other cases, the equipment provides the physician with information about the heart's electrical activity and the location of the intracardiac lead. Summary of the Invention

[0005] The illustrative systems and methods described herein can be configured to assist a user (e.g., a physician) in assessing a patient's cardiac conduction system and evaluating cardiac conduction pacing therapy being delivered to the patient. Specifically, the illustrative systems and methods can determine the location of cardiac conduction block based on a penetration map generated by monitoring the patient's cardiac electrical activity using multiple external electrodes placed proximal to the patient's skin. Further, the illustrative systems and methods can evaluate cardiac conduction pacing therapy being delivered to the patient by comparing electrical heterogeneity information (EHI) obtained prior to delivery with EHI obtained during delivery of cardiac conduction pacing therapy.

[0006] In one or more embodiments, the system and method can be described as non-invasive. For example, in some embodiments, the system and method may not require or include implantable devices (such as leads, probes, sensors, catheters, implantable electrodes, etc.) to monitor or acquire electrical activity (e.g., multiple cardiac signals) from the patient's tissues for evaluation of the patient's cardiac conduction system and cardiac conduction pacing therapy delivered to the patient's cardiac conduction system. Instead, the system and method can use electrical measurements obtained non-invasively using multiple external electrodes attached to the patient's skin, for example, around the patient's torso. Additionally, it should be understood that in some embodiments, both invasive and non-invasive devices and procedures can be used simultaneously or concurrently.

[0007] This illustrative system and method (e.g., including electrode devices or ECG straps) can be used with cardiac conduction system pacing, and various CRT procedures involve pacing with or without a conventional coronary sinus left ventricular pacing conduction system. Additionally, this illustrative system and method can be used for in-procedure planning and guidance regarding the selection of conduction system pacing / devices / leads to personalize therapy and provide optimal resynchronization in each patient. Further, this illustrative system and method can be described as providing a multi-electrode ECG that provides a combination of activation time, measures of electrical asynchrony (such as the standard deviation of activation times (SDAT)), deviation of left ventricular activation time, mean left ventricular activation time, with or without other measures derived from ECG morphology.

[0008] This illustrative system and method can analyze or evaluate cardiac conduction system pacing leads implanted in locations near the left bundle branch region, the left ventricular septum, the Koch triangle in the right atrium, or the His bundle. Cardiac conduction system pacing can be delivered from those locations with varying pacing positions / parameters, and this illustrative system and method can determine the effectiveness of resynchronization and engagement of the cardiac conduction system or portions of the cardiac conduction system (e.g., left bundle, right bundle, etc.) based on changes in at least one metric derived from electrical activity monitored by multiple external electrodes as described herein (e.g., from baseline to cardiac conduction system pacing) and absolute values ​​(e.g., during cardiac conduction system pacing). If the cardiac conduction system or portions of the cardiac conduction system do not achieve sufficient resynchronization and / or engagement, a conventional pacing lead (e.g., a coronary sinus left ventricular lead) can be implanted, and the effectiveness of resynchronization and engagement of the cardiac conduction system can be reassessed using separate pacing from that lead in conjunction with the cardiac conduction system pacing lead. A decision on which lead to implant is made based on activation time maps and / or baseline / intrinsic activation maps during pacing from individual pacing leads in the cardiac conduction system. Specifically, the location of delays in both the intrinsic and pacing rhythms can be identified on the anterior map. If a significant and persistent delay is identified in right ventricular activation indicating right bundle branch block, a conventional right ventricular pacing lead can be implanted in the right ventricle. If a significant and persistent delay is identified in left ventricular activation indicating left bundle branch block, a conventional left ventricular pacing lead can be implanted in the coronary sinus. Furthermore, the final implantation decision is made based on the resynchronization and engagement effectiveness of the conduction systems from two leads with different parameters, which also feeds into post-implantation optimization.

[0009] An illustrative system may include an electrode device comprising multiple external electrodes to be placed proximal to the patient's skin, and a computing device comprising a processing circuitry system coupled to the electrode device. The computing device may be configured to: monitor the patient's intrinsic electrical activity using the multiple external electrodes of the electrode device; generate baseline electrical heterogeneity information (EHI) based on the monitored intrinsic electrical activity; monitor the patient's pacing electrical activity using the multiple external electrodes of the electrode device during delivery of cardiac conduction system pacing therapy; generate pacing EHI based on the monitored pacing electrical activity; and determine the effectiveness of cardiac conduction system pacing therapy based on the baseline and pacing EHI.

[0010] An illustrative method may include: monitoring a patient’s intrinsic electrical activity using multiple external electrodes placed proximal to the patient’s skin; generating baseline electrical heterogeneity information (EHI) based on the monitored intrinsic electrical activity; monitoring a patient’s pacing electrical activity using multiple external electrodes of an electrode device during delivery of cardiac conduction system pacing therapy; generating pacing EHI based on the monitored pacing electrical activity; and determining whether cardiac conduction system pacing therapy is effective based on the baseline and pacing EHI.

[0011] This illustrative system and method can be described as surface mapping potential penetration for determining the location of conduction blocks in cardiac conduction system diseases. Proximal His bundle pacing or more distal left bundle branch region pacing has been shown to be effective for resynchronization in patients with proximal conduction system disease (PCSD). However, not all patients with left bundle block have proximal block. Instead, there are patients where the block may be located more distally. This illustrative system and method utilizes ECG surface mapping, which provides simultaneous measurements of depolarization groups on multiple electrodes on the body surface covering the anterior and site locations. While the primary output is typically the activation time, alternative visualizations of electrical activity may include spatial maps of potential or voltage per millisecond on multiple electrodes during the depolarization process. The location of left-sided penetration during the intrinsic rhythm can help identify whether the block in a left bundle block patient is proximal or more distal. Therefore, patients can receive therapy using leads that target the His bundle or left bundle branch pacing (in the case of PCSD) or more distal pacing (e.g., septal or parietal septal pacing or even conventional lateral wall pacing) (where the block is located more distally). This illustrative system and method can determine the location of the conduction block in the left bundle branch using the location of the left potential penetration from the ECG band map, and thus select therapy options for the patient.

[0012] In one or more embodiments, the illustrative system and method can provide a spatial map of potentials on the anterior and posterior surfaces per millisecond (ms) from QRS initiation to QRS offset. The left side of the trunk may be defined by the region posterior to the left side of the sternum and the left side of the spine. The location of the first potential penetration on the left side can be recorded on the map. The first potential penetration can be defined by a negative gradient of -0.5 mV on a given electrode within one ms during the depolarization process. The first potential penetration identifies the location where electrical activity first appears on the patient's surface. If the earliest left-side penetration occurs in the left anterior region of the trunk, it will be determined that the patient has a more distal cardiac conduction system disorder and may not be suitable for pacing the His bundle or left bundle branch region for correction of the left bundle. Conversely, if the penetration occurs on the left posterior side of the trunk, the block in the cardiac conduction system may be more proximal, and the patient can receive correction of the left bundle branch block by pacing from the His bundle or left bundle branch region. Thus, it can be described that non-invasive mapping of cardiac conduction system block can aid in the planning of therapies for correcting cardiac conduction system disorders.

[0013] An illustrative system may include an electrode device comprising a plurality of external electrodes to be placed proximal to the skin of a patient, and a computing device comprising a processing circuitry system operatively coupled to the electrode device. The computing device may be configured to: monitor the patient's intrinsic electrical activity using the plurality of external electrodes of the electrode device; and generate a plurality of cardiac penetration maps based on the monitored intrinsic activity over a time period, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential. The computing device may be further configured to: determine the location of cardiac conduction blockage based on the generated plurality of cardiac penetration maps.

[0014] An illustrative method may include: monitoring the patient’s intrinsic electrical activity using multiple external electrodes placed proximal to the patient’s skin; generating multiple cardiac penetration maps based on the intrinsic activity monitored over a time period, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential; and determining the location of cardiac conduction blockage based on the generated multiple cardiac penetration maps.

[0015] An illustrative system may include an electrode device, a display, and a computing device. The electrode device includes multiple external electrodes to be placed proximal to the patient's skin. The display includes a graphical user interface. The computing device includes a processing circuitry system and is operatively coupled to the electrode device and the display. The computing device may be configured to: monitor the patient's intrinsic electrical activity using the multiple external electrodes of the electrode device; generate multiple cardiac penetration maps based on the monitored intrinsic activity over a time period, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential; and display the generated multiple cardiac penetration maps on the graphical user interface.

[0016] The above overview is not intended to describe every embodiment or every implementation of this disclosure. A more complete understanding will become apparent and understood by taking into account the accompanying drawings and the following detailed description and claims. Attached Figure Description

[0017] Figure 1 It is a diagram illustrating a system that includes electrode devices, display devices, and computing devices.

[0018] Figures 2 to 3 This is a diagram illustrating an external electrode apparatus used to measure the surface potential of the torso.

[0019] Figure 4A The cardiac conduction network of a patient with cardiac conduction system block located between the atrioventricular node and His bundle is depicted.

[0020] Figure 4B The cardiac conduction network of a patient with cardiac conduction system block located in the left branch is depicted.

[0021] Figure 5This is a flowchart illustrating a method for assessing a patient's cardiac conduction system.

[0022] Figures 6A to 6B Illustrative anterior and posterior cardiac penetration diagrams are depicted.

[0023] Figure 6C Depicting including Figure 6B An illustrative graphical user interface for the anterior and posterior cardiac penetration diagrams.

[0024] Figure 7 This is a flowchart illustrating an illustrative approach to evaluating pacing therapy for the cardiac conduction system.

[0025] Figure 8 This is a conceptual diagram of an illustrative cardiac therapy system that includes an intracardiac medical device implanted in the patient's heart and a separate medical device positioned outside the patient's heart.

[0026] Figure 9 yes Figure 8 An enlarged conceptual diagram of the anatomy of an intracardiac medical device and a patient's heart.

[0027] Figure 10 This is a conceptual diagram of a patient's heart in a standard 17-segment view showing various electrode implantation sites, intended for use with the illustrative systems and devices described herein.

[0028] Figure 11 It is possible to enclose, for example Figures 8 to 9 A block diagram of an illustrative circuit system within the housing of a medical device to provide the functions and therapies described herein.

[0029] Detailed Implementation of the Illustrative Scheme

[0030] In the following detailed description of illustrative embodiments, reference is made to the accompanying drawings, which form part of this embodiment, and which illustrate specific embodiments that can be practiced by way of illustration. It should be understood that other embodiments may be utilized, and the structural scope may be changed, without departing from (e.g., still falling within) the scope of this disclosure presented herein.

[0031] Reference Figures 1 to 11Describing illustrative systems and methods. It will be apparent to those skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes from other embodiments, and possible embodiments of such systems and methods using combinations of features set forth herein are not limited to those shown in the figures and / or the specific embodiments described herein. Furthermore, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be appreciated that the timing of the processes and the size and shape of the various elements herein may be modified but still fall within the scope of this disclosure; however, certain timings, one or more shapes and / or sizes, or element types may be preferred over others.

[0032] Various illustrative systems, methods, and graphical user interfaces can be configured to use electrode devices, display devices, and computing devices, including external electrodes, and potentially in conjunction with conventional cardiac pacing therapies, to noninvasively assist users (e.g., physicians) in assessing a patient’s cardiac conduction system and evaluating the configuration (e.g., optimization) of cardiac conduction system pacing therapy and / or the complementary cardiac pacing therapy. Figure 1 An illustrative system 100 is described, comprising an electrode device 110, a computing device 140, and a remote computing device 160.

[0033] The electrode device 110 shown in the figure includes a plurality of electrodes incorporated into or included within a band wrapped around the chest or torso of a patient 114. The electrode device 110 is operatively coupled to a computing device 140 (e.g., via a wired or wired connection, wirelessly, etc.) to provide the computing device 140 with electrical signals from each of the electrodes for analysis, evaluation, etc. An illustrative electrode device can be described in U.S. Patent No. 9,320,446, entitled “Bioelectric Sensor Device and Methods,” filed March 27, 2014, and published March 26, 2016. Further reference will be made to… Figures 2 to 3 A more detailed description of the illustrative electrode device 110.

[0034] The computing device 140 and the remote computing device 160 may each include display devices 130 and 170, respectively, which can be configured to display data such as, for example, electrical signals (e.g., electrocardiogram data), cardiac penetration maps, surface electrocardiogram potential maps, electrical activation time, electrical heterogeneity information, etc. For example, one or more measures of a cardiac cycle or a single heartbeat represented by electrical signals collected or monitored by the electrode device 110 can be analyzed and evaluated, including activation time and electrical heterogeneity information that can be related to the evaluation and assessment of cardiac conduction system pacing therapy delivered to the patient's cardiac conduction system and / or the cardiac conduction system pacing therapy delivered to that cardiac conduction system. More specifically, for example, one or more measures of the QRS complex in a single cardiac cycle can be assessed, such as QRS onset, QRS deviation, QRS peak, various electrical heterogeneity information (EHI) such as electrical activation time, standard deviation of left ventricular or thoracic electrical activation time (LVED), left ventricular deviation, standard deviation of activation time (SDAT), mean left ventricular or thoracic alternative electrical activation time (LVAT), and reference to the earliest activation time, QRS duration (e.g., the interval between QRS onset and QRS deviation), the difference between mean left alternative activation time and mean right alternative activation time, relative or absolute QRS morphology, the difference between higher and lower percentiles of activation time (higher percentiles may be 90%, 80%, 75%, 70%, etc. and lower percentiles may be 10%, 15%, 20%, 25%, and 30%, etc.), other statistical measures of central tendency (e.g., median or mode), deviations (e.g., mean deviation, standard deviation, variance, interquartile range), etc. Furthermore, each of these one or more measures can be location-specific. For example, some measures can be calculated based on signals recorded or monitored from electrodes located around selected areas of the patient (such as, for example, the patient's left side, the patient's right side, etc.).

[0035] In at least one embodiment, one or both of the computing device 140 and the remote computing device 160 may be a server, a personal computer, or a tablet computer. The computing device 140 may be configured to receive input from an input device 142 (e.g., a keyboard) and transmit output to a display device 130, and the remote computing device 160 may be configured to receive input from an input device 162 (e.g., a touchscreen) and transmit output to a display device 170. One or both of the computing device 140 and the remote computing device 160 may include a data storage device that allows access to processing programs or routines and / or one or more other types of data, such as for analyzing multiple electrical signals captured by the electrode device 110, for determining cardiac penetration maps, spatial representation of electrocardiographic potentials, EHI, QRS initiation, QRS offset, median, mode, mean, peak or maximum, trough or minimum, electrical activation time, location of cardiac conduction pacing along the cardiac conduction system (e.g., more proximal, more distal, etc.), whether the patient has left or right ventricular delay or block, and whether one or more adjustments to the pacing settings for cardiac therapy are available. Effective therapies (e.g., providing improvements in cardiac resynchronization, providing improvements in cardiac heterogeneity) are used to drive a graphical user interface (which is configured to noninvasively assist the user in configuring cardiac conduction system pacing therapies with or without conventional pacing, one or more pacing parameters or settings associated with such cardiac conduction system pacing therapies and / or conventional pacing therapies, such as, for example, pacing rate, ventricular pacing rate, AV interval, VV interval, pacing pulse width, pacing vector, multi-point pacing vector (e.g., left ventricular vector four-lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricular pacing only, left ventricular pacing only, etc.)), and for arrhythmia detection and treatment, etc.

[0036] Computing device 140 can be operatively coupled to input device 142 and display device 130 to transmit data to and from each of the input device 142 and display device 130, for example, and remote computing device 160 can be operatively coupled to input device 162 and display device 170 to transmit data to and from each of the input device 162 and display device 170, for example,. For example, computing device 140 and remote computing device 160 can be electrically coupled to input devices 142, 162 and display devices 130, 170 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc. As further described herein, a user can provide input to input devices 142, 162 to view and / or select one or more cardiac penetration maps and electrical heterogeneity information from a plurality of cardiac penetration maps.

[0037] Although input device 142 is a keyboard and input device 162 is a touchscreen as depicted, it should be understood that input devices 142 and 162 may include any device capable of providing input to computing device 140 and computing device 160 to perform the functions, methods, and / or logic described herein. For example, input devices 142 and 162 may include a keyboard, mouse, trackball, touchscreen (e.g., capacitive touchscreen, resistive touchscreen, multi-touch touchscreen, etc.), etc. Similarly, display devices 130 and 170 may include any device capable of displaying information to a user, such as graphical user interfaces 132 and 172 including: electrode status information, graphical representations of cardiac penetration, graphical representations of electrocardiogram potentials, graphical representations of electrical activation, indications of the location of cardiac conduction system blockades (e.g., along the proximal side of the cardiac conduction system, along the distal side of the cardiac conduction system, etc.), multiple signals from external electrodes on one or more heartbeats, QRS complexes, selection areas for various cardiac therapy options, rankings of various cardiac therapy options, various pacing parameters, electrical heterogeneity information (EHI), text commands, graphical depictions of the anatomical structure of the human heart, images or graphical representations of the patient's heart, graphical depictions of the location of one or more electrodes, graphical depictions of the human torso, images or graphical representations of the patient's torso, graphical depictions or actual images of implanted electrodes and / or leads, etc. Further, display devices 130 and 170 may include liquid crystal displays, organic light-emitting diode screens, touch screens, cathode ray tube displays, etc.

[0038] It should be understood that computing device 140 and remote computing device 160 can be operatively coupled to each other in a variety of different ways to perform or execute the functions described herein. For example, in the depicted embodiments, computing device 140 can be operatively wirelessly coupled to remote computing device 160, as depicted by a wireless signal line emanating therebetween. Alternatively, in contrast to a wireless connection, one or more of computing device 140 and remote computing device 160 can be operatively coupled via a single or wired electrical connection.

[0039] The processing programs or routines stored and / or executed by computing device 140 and remote computing device 160 may include programs or routines for computational mathematics, matrix mathematics, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, image construction algorithms, signal processing algorithms (e.g., various filtering algorithms, Fourier transform, fast Fourier transform, etc.), normalization algorithms, comparison algorithms, vector mathematics, or any other processing used to implement one or more of the illustrative methods and / or processes described herein. The data stored and / or used by computing device 140 and remote computing device 160 may include, for example, electrical signal / waveform data from electrode device 110 (e.g., time-varying waveforms).

[0040] Electrically recorded potential or voltage, multiple QRS groups, etc.; electrical activation time from electrode device 110; heart sound / signal / waveform data from acoustic sensors; graphics (e.g., graphic elements, icons, buttons, windows, dialog boxes, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.); graphical user interface; results of one or more processing procedures or routines adopted according to this disclosure (e.g., electrical signals, electrical heterogeneity information, etc.); or any other data used to perform or conduct one or more processes or methods described herein.

[0041] In one or more embodiments, the illustrative systems, methods, and interfaces may be implemented using one or more computer programs that execute on a programmable computer, such as a computer including, for example, processing power, data storage devices (e.g., volatile or non-volatile memory and / or storage elements), input devices, and output devices. The program code and / or logic described herein may be applied to input data to perform the functions described herein and generate desired output information. The output information may be applied as input to one or more other means and / or methods as described herein or to be applied in a known manner.

[0042] One or more programs for implementing the systems, methods, and / or interfaces described herein can be provided using any programmable language (e.g., high-level programs and / or object-oriented programming languages ​​suitable for communicating with computer systems). Any such program can be stored, for example, on any suitable means (e.g., storage media) that can be read by a general-purpose or special-purpose program running on a computer system (e.g., including a processing device) for configuring and operating the computer system when that suitable means is read to execute the programs described herein. In other words, at least in one embodiment, the illustrative systems, methods, and interfaces can be implemented using a computer-readable storage medium configured with computer programs, wherein such a storage medium causes a computer to operate in a specific and predefined manner to perform the functions described herein. Further, in at least one embodiment, the illustrative systems, methods, and / or interfaces can be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media, which includes code for execution and, when executed by a processor or processing circuitry system, is operable to perform operations such as the methods, processes, and / or functions described herein.

[0043] Computing device 140 and remote computing device 160 can be, for example, any fixed or mobile computer system (e.g., controller, microcontroller, personal computer, microcomputer, tablet computer, etc.). The exact configuration of computing device 140 and remote computing device 160 is not limiting, and any device capable of providing suitable computing and control capabilities (e.g., signal analysis, mathematical functions such as median, mode, average, maximum value determination, minimum value determination, slope determination, minimum slope determination, maximum slope determination, graphics processing, etc.) can be used. As described herein, digital files can be any medium (e.g., volatile or non-volatile memory, CD-ROM, punched card, magnetically recordable magnetic tape, etc.) containing digital bits (e.g., encoded in binary or ternary) that can be read and / or written by computing device 140 and remote computing device 160 as described herein. Moreover, as described herein, a user-readable format file can be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphics, etc.) that can be presented on any medium (e.g., paper, monitor, etc.) that is readable and / or understandable to the user.

[0044] In view of the foregoing, it will be apparent that the functions described in one or more embodiments according to this disclosure can be implemented in any manner as known to those skilled in the art. Thus, the computer language, computer system, or any other software / hardware intended for implementing the processes described herein should not be limited to the scope of the systems, processes, or programs described herein (e.g., the functions provided by such systems, processes, or programs).

[0045] The illustrative electrode device 110 can be configured to measure the surface potential of the patient 114's body and, more specifically, the surface potential of the patient 114's torso. For example... Figure 2 As shown, the illustrative electrode device 110 may include an assembly or array of external electrodes 112, a strip 113, and an interface / amplifier circuitry system 116. The electrodes 112 may be attached to or coupled to the strip 113, and the strip 113 may be configured to wrap around the torso of the patient 114 such that the electrodes 112 surround the patient's heart. As further shown, the electrodes 112 may be positioned around the circumference of the patient 114, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 114's torso.

[0046] The illustrative electrode device 110 can be further configured to measure or monitor sounds from the patient 114 (e.g., heart sounds from the patient's torso). Figure 2As shown, the illustrative electrode device 110 may include an array or collection of acoustic sensors 120 attached to or coupled to a strip 113. The strip 113 may be configured to wrap around the torso of the patient 114 such that the acoustic sensors 120 surround the patient's heart. As further shown, the acoustic sensors 120 may be positioned around the circumference of the patient 114, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 114's torso.

[0047] Furthermore, electrode 112 and acoustic sensor 120 can be electrically connected to interface / amplifier circuitry 116 via wired connection 118. Interface / amplifier circuitry 116 can be configured to amplify signals from electrode 112 and acoustic sensor 120 and provide the signals to one or both of computing device 140 and remote computing device 160. Other illustrative systems may use a wireless connection (e.g., as a data channel) to transmit signals sensed by electrode 112 and acoustic sensor 120 to interface / amplifier circuitry 116, and further to one or both of computing device 140 and remote computing device 160. In one or more embodiments, interface / amplifier circuitry 116 can be electrically coupled to one or both of computing device 140 and remote computing device 160 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc.

[0048] Despite Figure 2In one example, electrode device 110 includes a strip 113; however, in other examples, any of a variety of mechanisms (e.g., tape or adhesive) may be used to assist in the spacing and placement of electrodes 112 and acoustic sensors 120. In some examples, strip 113 may include elastic band, tape strip, or cloth. Further, in some examples, strip 113 may be part of or integrated with a garment (e.g., a t-shirt). In other examples, electrodes 112 and acoustic sensors 120 may be placed separately on the torso of patient 114. Further, in other examples, one or both of electrodes 112 (e.g., arranged in an array) and acoustic sensors 120 (e.g., also arranged in an array) may be part of or located within a patch, vest, and / or other means of securing electrodes 112 and acoustic sensors 120 to the torso of patient 114. Still further, in other examples, one or both of electrodes 112 and acoustic sensors 120 may be part of or located within two material portions or two patches. One of the two patches may be located on the front of the patient 114's torso (to monitor, for example, electrical signals representing the front of the patient's heart, measure the electrical activation time of an alternative heart representing the front of the patient's heart, monitor or measure sound in the front of the patient, etc.), and the other patch may be located on the back of the patient 114's torso (to monitor, for example, electrical signals representing the back of the patient's heart, measure the electrical activation time of an alternative heart representing the back of the patient's heart, monitor or measure sound in the back of the patient, etc.). Furthermore, in other examples, one or both of the electrode 112 and the acoustic sensor 120 may be arranged in top and bottom rows extending from the front of the patient 114, across the left side of the patient 114, to the back of the patient 114. Furthermore, in other examples, one or both of the electrode 112 and the acoustic sensor 120 may be arranged in a curve around the axillary region, and the electrode / sensor density on the right chest may be lower than the density in other remaining areas.

[0049] Electrodes 112 can be configured to surround the heart of patient 114 and record or monitor electrical signals associated with cardiac depolarization and repolarization after a signal has propagated through the torso of patient 114. Each electrode in the electrodes 112 can be used in a unipolar configuration to sense the torso surface potential reflecting cardiac signals. Interface / amplifier circuitry 116 can also be coupled to a return electrode or an unrelated electrode (not shown) that can be used in combination with each electrode 112 for unipolar sensing.

[0050] In some examples, there may be approximately 12 to approximately 50 electrodes 112 spatially distributed around the patient's torso and approximately 12 to approximately 50 acoustic sensors 120. Other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120. It should be understood that the electrodes 112 and acoustic sensors 120 may not be arranged or may be distributed in an array that extends all the way around or completely around the patient 114. Instead, the electrodes 112 and acoustic sensors 120 may be arranged in an array that extends only around a portion or partially around the patient 114. For example, the electrodes 112 and acoustic sensors 120 may be distributed on the anterior, posterior, and left sides of the patient, with fewer or no electrodes and acoustic sensors on the proximal side of the right side (including the posterior and anterior regions of the patient's right side).

[0051] One or both of computing device 140 and remote computing device 160 can record and analyze torso surface potential signals sensed by electrode 112 and sound signals sensed by acoustic sensor 120, said signals being amplified / modulated by interface / amplifier circuitry system 116. Further, one or both of computing device 140 and remote computing device 160 can be configured to analyze electrical signals from electrode 112 to provide electrocardiogram (ECG) signals from the patient's heart, such as EHI, or other information or data, as will be further described herein. Still further, one or both of computing device 140 and remote computing device 160 can be configured to analyze electrical signals from acoustic sensor 120 to provide sound signals, information, or data from the patient's body and / or implanted devices (such as left ventricular assist devices).

[0052] Additionally, computing device 140 and telecomputing device 160 can be configured to provide graphical user interfaces 132 and 172 that depict various information related to electrode device 110 and data collected or sensed using electrode device 110. For example, graphical user interfaces 132 and 172 may depict cardiac penetration maps, electrocardiogram potential maps, electrical activation maps, and EHI obtained using electrode device 110. For example, graphical user interfaces 132 and 172 may depict ECG data including QRS complexes obtained using electrode device 110 and acoustic data including sound waves obtained using acoustic sensor 120, as well as other related information. The illustrative system and method can noninvasively use the electrical information collected using electrode device 110 and the acoustic information collected using acoustic sensor 120 to assess a patient's cardiac health and to evaluate and configure cardiac therapies delivered to the patient. More specifically, this illustrative system and method can noninvasively use electrical information collected using electrode device 110 to determine the location of cardiac conduction block and / or evaluate cardiac conduction pacing therapy used with or without conventional pacing therapy.

[0053] Furthermore, the electrode device 110 may further include, for example, reference electrodes and / or drive electrodes positioned around the lower torso of the patient 114, which may be further used by the system 100. For example, the electrode device 110 may include three reference electrodes, and signals from the three reference electrodes may be combined to provide a reference signal. Further, the electrode device 110 may use three tail reference electrodes (e.g., instead of the standard reference electrodes used in the Wilson central terminal) to obtain a “true” unipolar signal with less noise by averaging the three tail-positioned reference signals.

[0054] Figure 3 Another illustrative electrode device 110 is shown, comprising a plurality of electrodes 112 and a plurality of acoustic sensors 120. The electrodes are configured to surround the heart of a patient 114 and record or monitor electrical signals associated with the depolarization and repolarization of the heart after the signal has propagated through the torso of the patient 114. The acoustic sensors are configured to surround the heart of the patient 114 and record or monitor sound signals associated with the heart after the signal has propagated through the torso of the patient 114. The electrode device 110 may include a vest 114 to which the plurality of electrodes 112 and the plurality of acoustic sensors 120 may be attached, or the electrodes 112 and the acoustic sensors 120 may be coupled to the vest. In at least one embodiment, the plurality of electrodes 112 or an array of the electrodes may be used to collect electrical information, such as alternative electrical activation time. Similar to... Figure 2 Electrode equipment 110, Figure 3 The electrode device 110 may include an interface / amplifier circuitry 116 electrically coupled to each of the electrodes 112 and acoustic sensors 120 via a wired connection 118 and configured to transmit signals from the electrodes 112 and acoustic sensors 120 to a computing device 140. As shown, the electrodes 112 and acoustic sensors 120 may be distributed on the torso of the patient 114 (including, for example, posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 114's torso).

[0055] Vest 114 may be formed of fabric, with electrodes 112 and acoustic sensors 120 attached to the fabric. Vest 114 may be configured to maintain the positioning and spacing of electrodes 112 and acoustic sensors 120 on the torso of patient 114. Further, vest 114 may be marked to aid in determining the position of electrodes 112 and acoustic sensors 120 on the surface of the torso of patient 114. In some examples, approximately 25 to approximately 256 electrodes 112 and approximately 25 to approximately 256 acoustic sensors 120 may be distributed around the torso of patient 114, but other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120.

[0056] exist Figures 4A to 4B The patient's cardiac conduction network 200 is depicted. As shown, the cardiac conduction network 200 extends from the proximal region 222 to the distal region 224. The cardiac conduction network 200 includes specialized cellular networks comprising the left and right bundle branches, as well as a specialized Purkinje fiber network of high-order branches, which facilitates the rapid propagation of electrical activation across the ventricles, potentially leading to highly synchronized activation of the heart. The cardiac conduction system is part of a natural pathway of electrical conduction extending from the sinoatrial node 230 to the ventricles via the atrioventricular node 232. Furthermore, an electrical impulse that triggers depolarization of the myocardial tissue of the patient's heart to effectively "beat" traverses the cardiac conduction network 200 from the sinoatrial node 230 to the Purkinje fibers 239.

[0057] As described herein, the proximal region 222 of the cardiac conduction network 200 may include the sinoatrial node 230 and the atrioventricular node 232, as well as the connecting pathway between them, and the distal region 224 of the cardiac conduction network 200 may include the right bundle branch 238, the left posterior bundle 236, and the Purkinje fiber 239. Specifically, the most distal region of the cardiac conduction network 200 may be the end of the Purkinje fiber 239, and the most proximal region of the cardiac conduction network 200 may be the sinoatrial node 230. Therefore, the cardiac conduction network 200 can be described as extending from the sinoatrial node 230 to the Purkinje fiber 239.

[0058] exist Figure 4A In this configuration, cardiac conduction block 240 is located precisely distal to the atrioventricular node 232, but before the His bundle 234 branches into the left and right bundles. Therefore, it can be described that cardiac conduction block 240 is located relatively proximally along the cardiac conduction network 220. Using illustrative systems and methods as further described herein, multiple penetration maps can be used to determine the location of cardiac conduction block 240, such as... Figure 4A As shown in the diagram. Because the cardiac conduction block 240 is located relatively proximally (e.g., closer to proximal region 222 than distal region 224), it can be a good candidate for cardiac conduction pacing therapy, since, for example, cardiac conduction pacing therapy can be delivered to a location or position within the cardiac conduction system distal to the cardiac conduction block 240. For example, cardiac conduction pacing therapy can be delivered to His bundle 234 and / or one of the right and left branches.

[0059] exist Figure 4B In this context, cardiac conduction block 241 is located precisely distal to the left posterior bundle along the left branch. Therefore, it can be described that cardiac conduction block 241 is located relatively distally along the cardiac conduction network 220. Using illustrative systems and methods as further described herein, multiple penetration maps can be used to determine the location of cardiac conduction block 241, such as... Figure 4B As shown in the diagram. Because cardiac conduction block 241 is located relatively distally (e.g., closer to distal region 224 than proximal region 222), cardiac conduction block 241 may not be a good candidate for cardiac conduction pacing therapy, because, for example, cardiac conduction pacing therapy may not be able to be located further than cardiac conduction block 241, and if cardiac conduction pacing therapy is located proximal to cardiac conduction block 241 (e.g., at His bundle 234), any such cardiac conduction pacing therapy can be blocked or stopped by cardiac conduction block 241. Therefore, when comparing... Figures 4A to 4B When the cardiac conduction system is blocked at 240 and 241, it is related to Figure 4B Compared to more distal cardiac conduction block 241, cardiac conduction pacing therapy may make more proximal cardiac conduction block 240 more correctable.

[0060] The illustrative systems, methods, and interfaces described herein can provide non-invasive assistance to users in assessing and evaluating the location of cardiac conduction blockages along the cardiac conduction system, particularly in assessing and evaluating the patient's cardiac conduction system. For example, these illustrative systems, methods, and interfaces can utilize multiple cardiac penetration maps to determine the approximate location of a cardiac conduction blockage along the cardiac conduction system.

[0061] Furthermore, the illustrative systems and methods described herein provide users with useful tools for determining where a cardiac conduction block is located, or relatively located, within a patient's cardiac conduction network. For example, these illustrative systems and methods can determine how proximal or distal the cardiac conduction block is along the patient's cardiac conduction network. The location of the cardiac conduction block can help determine whether cardiac conduction pacing therapy and / or another cardiac therapy can successfully treat the patient.

[0062] Figure 5 The document describes an illustrative method 300 for assessing a patient’s cardiac conduction system. Generally, it can be described as follows: the illustrative method 300 can be used to analyze external electrical activity (e.g., electrical activity from the patient’s torso skin) prior to the delivery of any cardiac pacing therapy, and to use such electrical activity to determine where the block is located along the cardiac conduction system and which can guide the clinician in deciding where the therapy will be delivered.

[0063] Method 300 may include monitoring electrical activity 302. In one embodiment, electrical activity can be measured from outside the patient. In other words, electrical activity can be measured from tissues outside the patient's body (e.g., skin). For example, method 300 may include using multiple external electrodes to monitor or measure electrical activity 302, such as regarding... Figures 1 to 3As shown and described. In one embodiment, the multiple external electrodes may be part of or incorporated into a vest or strap positioned around the patient's torso. More specifically, the multiple electrodes may be described as external surface electrodes positioned in an array and configured to be located proximal to the skin of the patient's torso. It may be described that, when using multiple external electrodes, the monitoring process 302 can provide multiple electrocardiograms (ECGs), electrocardiographic potentials or voltages, signals representing depolarization and repolarization of the patient's heart, and / or multiple activation times.

[0064] Specifically, in method 300, multiple cardiac penetration maps 304 can be generated using the monitored electrical activity 302. Each of the multiple cardiac penetration maps is a spatial representation of the electrocardiographic potential of the patient's heart. When viewed or drawn sequentially, the multiple cardiac penetration maps show a spatial representation of the electrocardiographic potential of the patient's heart over time. In this way, the multiple cardiac penetration maps can be described as a video of the spatial representation of the electrocardiographic potential of the patient's heart (e.g., during the cardiac cycle), which can be traversed forward and backward.

[0065] Illustrative anterior and posterior cardiac penetration diagrams are depicted in Figures 6A to 6B Each cardiac penetration map includes an anterior region corresponding to electrical activity (e.g., electrocardiogram potential) measured from the front of the patient's trunk and a posterior region corresponding to electrical activity (e.g., electrocardiogram potential) measured from the back of the patient's trunk. As shown, the anterior region extends from the patient's right side to the patient's left side, and the posterior region extends from the patient's left side to the patient's right side, in order to depict a penetration map surrounding the patient's trunk.

[0066] As described, a cardiac penetration map depicts the electrocardiographic potentials on the patient's skin (corresponding to the patient's heart) at a given or selected time. For example, at 25 milliseconds (ms) after the start of the QRS complex, a cardiac penetration map is depicted. Figures 6A to 6B The illustrative method 230 generates multiple cardiac penetration maps 304 based on the sampling interval. The sampling interval can be between approximately 0.5 ms and 10 ms. In at least one embodiment, the sampling interval is 5 ms. In other embodiments, the sampling interval can be greater than or equal to 0.5 ms, greater than or equal to 0.75 ms, greater than or equal to 1 ms, greater than or equal to 2.5 ms, etc., and / or less than or equal to approximately 10 ms, less than or equal to approximately 7 ms, less than or equal to approximately 5 ms, less than or equal to approximately 3 ms, less than or equal to approximately 2 ms, etc. Thus, for example, if the sampling interval is 5 ms and a penetration map is generated 500 ms after the start of the QRS, 100 penetration maps can be generated.

[0067] Although QRS initiation is described herein as a triggering or initiating event for generating a cardiac penetration map, it should be understood that any triggering or initiating event can be used to begin generating a cardiac penetration map. In at least one embodiment, the triggering or initiating event may be selected such that ventricular depolarization is captured, thereby enabling the identification of cardiac penetration within the cardiac penetration map.

[0068] Furthermore, multiple cardiac penetration maps can be generated and analyzed for an occasional single heartbeat. For example, the illustrative systems and methods described herein can determine the location of cardiac conduction blockages during a single heartbeat. However, it should be understood that while the location of cardiac conduction blockages can be determined for multiple heartbeats, only a single heartbeat can be analyzed at a time.

[0069] The illustrative method 300 may further include determining the location of a cardiac conduction block based on the generated multiple cardiac penetration maps 306. In other words, the generated multiple cardiac penetration maps can be used to determine the location of a cardiac conduction block. Generally, it can be described that if, according to the multiple cardiac penetration maps, the spatial location of the cardiac penetration is in the left anterior region, then the cardiac conduction block can be determined to be distal along the cardiac conduction system; and conversely, if, according to the multiple cardiac penetration maps, the spatial location of the cardiac penetration is not in the left anterior region, then the cardiac conduction block can be determined to be proximal along the cardiac conduction system.

[0070] More specifically, determining the location of cardiac conduction blockage based on the generated multiple cardiac penetration maps 306 may include first determining the spatial location of the cardiac penetration within the multiple cardiac penetration maps 308. Determining the spatial location of the cardiac penetration within the multiple cardiac penetration maps 308 can be done or performed in a variety of different ways. Typically, determining the spatial location of the cardiac penetration within the multiple cardiac penetration maps 308 involves: locating the first surface location where ventricular depolarization substantially occurs, and thus inferring the location of the first myocardial penetration proximal to the first surface location (e.g., below the first surface location on the heart).

[0071] In one example, a penetration threshold can be used to determine the spatial location of cardiac penetration. An illustrative penetration threshold may be between approximately -0.2 millivolts (mV) and approximately -1.5 mV. In at least one embodiment, the penetration threshold may be -1 mV. When using a penetration threshold, the first location or region that produces a cardiac potential less than or equal to the penetration threshold can be identified as the spatial location of cardiac penetration.

[0072] For example, Figures 6A to 6BEach cardiac penetration map depicted in the diagram utilizes a penetration threshold of -1 mV and is correspondingly grayscaled (or color-coded), where any electrocardiographic potential less than or equal to -1 mV is depicted with a first grayscale (or color-coded), and any electrocardiographic potential greater than -1 mV is depicted with a second grayscale (or color-coded) different from the first grayscale (or color-coded). In this way, when traversing multiple cardiac penetration maps, it becomes obvious which cardiac penetration map depicts the cardiac penetration first. Figures 6A to 6B In the two examples depicted, cardiac penetration occurred 25 ms after the start of the QRS.

[0073] Determining the location of cardiac conduction block based on the generated multiple cardiac penetration maps 306 may further include: determining whether the cardiac penetration is located in the left anterior region of the cardiac penetration map 310. The left anterior region of the cardiac penetration map can be captured from a subset of the left anterior portion, typically located in the anterior part of the patient's trunk, between the sternum and the left side. The illustrative left anterior region is defined by... Figures 6A to 6B The dashed box 316 in the text is used to depict this.

[0074] If the heart is penetrated in places such as Figure 6A In the left anterior region shown, it can be determined that the cardiac conduction block is distal along the cardiac conduction system 312. Conversely, if the cardiac conduction is not located in, for example, the blockage is distal. Figure 6B In the left anterior region shown, it can be determined that the cardiac conduction system block is located proximally along the cardiac conduction system 314.

[0075] As described herein, the cardiac conduction network 200 extends from the proximal region 222 to the distal region 224, such as Figures 4A to 4B As shown. When method 300 determines that the cardiac conduction block is located proximally along the cardiac conduction system 314, the cardiac conduction block can be located closer to the proximal region 222 than the distal region 224. Conversely, when method 300 determines that the cardiac conduction block is located distally along the cardiac conduction system 314, the cardiac conduction block can be located closer to the proximal region 224 than the proximal region 222.

[0076] Multiple cardiac penetration images can be further compared with, for example Figure 6CThis is used in conjunction with the illustrated graphical user interface 311. As shown, the graphical user interface 311 includes a graph area 313 and a timeline area 315, the graph area being used to display cardiac penetration maps including anterior and posterior regions. The user can use the timeline area 315 to move through or traverse multiple penetration map times depicted in the graph area 313. The timeline area 315 includes markers 317 indicating positions along the timeline of multiple penetration maps generated over time based on electrical activity monitored over time. The user can select marker 317 and "drag" marker 317 to the left to move to a previous penetration map corresponding to an earlier time period, or "drag" marker 317 to the right to move to a later penetration map corresponding to a later time period. As shown, marker 317 is located 25 ms after the start of the QRS. Figure 6B The penetration map was depicted in Figure 6C The graphical user interface 311 includes a graphical region 313 (as described herein, this graphical region excludes cardiac penetration located in the left anterior region) indicating whether the cardiac conduction system is located proximally along the cardiac conduction system. Therefore, the graphical user interface 311 further includes a cardiac conduction system blockage indicator 301, which indicates whether the location of the cardiac conduction system blockage is proximally or distally along the cardiac conduction system. In this example, the cardiac conduction system blockage indicator 301 indicates that the cardiac conduction system blockage location is proximally.

[0077] The illustrative systems, methods, and interfaces described herein can be used, with or without conventional pacing therapies (e.g., left ventricular pacing leads in the coronary sinus for pacing the left ventricle, right ventricular pacing leads in the right ventricle for pacing the base of the right ventricle, etc.), to provide non-invasive assistance to users in evaluating and assessing cardiac conduction system pacing therapies (e.g., via implantable medical devices such as VfA pacing devices). Furthermore, the illustrative systems, methods, and interfaces described herein can assist users in improving and configuring cardiac conduction system pacing therapies.

[0078] Figure 7This document describes an illustrative method 400 for evaluating pacing therapy of the cardiac conduction system. Method 400 may include monitoring electrical activity 402 to generate multiple electrical signals (e.g., ECG signals or cardiac signals). The electrical activity can be monitored during the patient's inherent heart rhythm without delivering any cardiac therapy. Therefore, monitoring of electrical activity 402 can be performed prior to the implantation of any implantable cardiac therapy device. For example, monitoring 402 can be performed before any invasive procedure used to treat the current condition. Additionally, as described herein, monitoring electrical activity 402 using multiple external electrodes is a non-invasive procedure because, for example, the external electrodes are attached to the patient's skin, which is the opposite of inserting or implanting any electrodes to obtain electrical activity or data. However, additionally, if an implantable cardiac therapy device has already been implanted in the patient, monitoring 402 can be performed while disabling (or "turning off") any cardiac therapy provided by the implantable cardiac therapy device.

[0079] According to various implementation schemes, multiple electrodes are used to monitor the electrical activity of 402. These multiple electrodes can be outer surface electrodes configured in a belt or vest, similar to those described herein. Figures 1 to 3 As described. Each electrode may be positioned or disposed around the patient's torso to monitor electrical activity (e.g., acquire torso potential) from multiple different locations around the patient's torso. Each of the different locations where the electrodes are located may correspond to the electrical activation of a different part or region of the cardiac tissue of the patient's heart. Thus, for example, multiple electrodes may record or monitor electrical signals associated with depolarization and repolarization of the heart or around the heart after the signal has propagated through the patient's torso. According to various embodiments, the multiple external electrodes may include or include multiple anterior electrodes located proximal to the skin on the anterior part of the patient's torso, lateral or left-sided electrodes located proximal to the skin on the left or left side of the patient's torso, and posterior electrodes located proximal to the skin on the posterior part of the patient's torso.

[0080] This can be described as follows: when using multiple external electrodes, monitoring process 402 can provide multiple electrocardiograms (ECGs) representing the depolarization and repolarization of the patient's heart. Multiple ECGs can then be used to generate alternative cardiac electrical activation times representing cardiac depolarization. As described herein, alternative cardiac electrical activation times can, for example, represent the actual or local electrical activation time of one or more regions of the patient's heart. Activation time can be measured by selecting an appropriate reference point (e.g., peak, minimum, minimum slope, maximum slope, zero intersection, threshold intersection, etc. of the near-field or far-field EGM) and measuring the time between the onset of cardiac depolarization (e.g., the onset of a QRS complex) and the appropriate reference point (e.g., within electrical activity). The activation time between the onset of the QRS complex (or peak Q wave) and the reference point can be referred to as the q-LV time. In at least one embodiment, the earliest QRS onset from all electrodes among the multiple electrodes can be used as the starting point for each activation time of each electrode, and the maximum slope after the onset of the QRS complex can be used as the ending point for each activation time of each electrode.

[0081] The monitored electrical activity 402, and consequently the electrical activation time, can be used to generate baseline (or inherent) electrical heterogeneity information (EHI) 404. This EHI (e.g., data) can be defined as information indicating at least one of mechanical or asynchronicity of the heart and / or electrical or asynchronicity of the heart. In other words, the EHI can represent a substitute for the actual mechanical and / or electrical function of the patient's heart. As will be further described herein, relative changes in the EHI (e.g., from baseline heterogeneity to pacing or therapy heterogeneity, from a first set of heterogeneity to a second set of therapy heterogeneity, etc.) can be used to determine substitute values ​​representing changes in hemodynamic response (e.g., abrupt changes in the LV pressure gradient). Left ventricular pressure can typically be invasively monitored using a pressure sensor located in the left ventricle of the patient's heart. Thus, using the EHI to determine substitute values ​​representing left ventricular pressure avoids the need for invasive monitoring using a left ventricular pressure sensor.

[0082] In at least one implementation, EHI may include, for example, the methods described herein. Figures 1 to 3 The standard deviation of ventricular activation time measured by some or all of the external electrodes of the described electrode device 110. Further, local or regional EHI may include the standard deviation and / or mean of activation time measured using electrodes positioned in certain anatomical areas of the trunk. For example, external electrodes on the left side of the patient's trunk may be used to calculate local or regional left EHI.

[0083] An EHI can be generated using one or more different systems and / or methods. For example, an EHI can be generated using an array or multiple surface electrodes and / or imaging systems as described in the following U.S. patents: U.S. Patent Application Publication No. 9,5107,63B2, published December 6, 2016, entitled "Assessing Intra-Cardiac Activation Patterns and Electrical Dyssynergy"; U.S. Patent Application Publication No. 8,972,228B2, published March 3, 2015, entitled "Assessing Intra-Cardiac Activation Patterns"; and U.S. Patent No. 8,180,428B2, published May 15, 2012, entitled "Methods and Systems for Use in Selecting Cardiac Pacing Sites".

[0084] EHI can include one or more measures or metrics. For example, one measure or metric of electrical heterogeneity could be the standard deviation of activation time (SDAT) measured using some or all electrodes on the surface of a patient's torso. In some examples, SDAT can be calculated using alternative or estimated cardiac activation times on the surface of a model heart.

[0085] In this example, the EHI includes one or more left or left-sided measurements generated based on the left-sided activation time, an alternative cardiac electrical activation time measured using multiple left external electrodes. The left external electrodes may include multiple left external electrodes positioned to the left side of the patient's torso.

[0086] A left or left-sided measure or index of electrical heterogeneity or synchrony can be a measure of the left deviation of the alternative cardiac electrical activation time (LVED) monitored by external electrodes positioned proximal to the left side of the patient, such as, for example, the left standard deviation. Further, another left or left-sided measure or index of electrical heterogeneity may include the average of the alternative electrical activation time (LVAT) monitored by external electrodes positioned proximal to the left side of the patient. LVED and LVAT can be determined (e.g., calculated, estimated, etc.) based solely on electrical activity measured by electrodes located proximal to the left side of the patient, which may be referred to as “left” electrodes. The activation time determined or measured from the left electrodes can be described as the left-sided activation time. A left electrode can be defined as any surface electrode positioned proximal to the left ventricle, including the left side of the patient’s sternum and spine (e.g., towards the patient’s left arm, the patient’s left side, etc.). In one embodiment, the left electrode may include all anterior electrodes on the left side of the sternum and all posterior electrodes on the left side of the spine. In another embodiment, the left electrode may include all anterior electrodes and all posterior electrodes on the left side of the sternum. In yet another implementation, the left electrode can be marked based on the contours of the left and right sides of the heart determined using imaging equipment such as X-rays, fluorescence fluoroscopy, etc.

[0087] The illustrative method 400 can then be used to deliver cardiac conduction pacing therapy 406 using a cardiac conduction system pacing device. Cardiac conduction system pacing therapy may include pacing therapies configured to pace the patient's cardiac conduction system. For example, cardiac conduction system pacing therapy may include those described herein. Figures 8 to 11 The description includes atrial-to-ventricular (VfA) pacing. Further, for example, cardiac conduction system pacing therapy may include His bundle pacing therapy as described, for example, U.S. Patent Application Publication No. 2019 / 0111270A1, entitled "His Bundle and Bundle Branch Pacing Adjustment," published April 18, 2019. Even further, for example, cardiac conduction system pacing therapy may include inter-septal left ventricular endocardial pacing as described, for example, U.S. Patent Application Serial No. 16 / 521,000, entitled "AV Synchronous Septal Pacing," filed July 24, 2019.

[0088] Cardiac conduction system pacing therapy can be delivered based on various basic or nominal parameters. For example, cardiac conduction system pacing therapy can be delivered with a pacing AV delay between 40% and 80% of the inherent AV delay. The pacing AV delay is the time interval between the sensed atrial event and the delivery of cardiac conduction system pacing therapy, while the inherent AV delay is the time interval between the sensed atrial event and the inherent ventricular event. The inherent AV delay can be monitored or measured before delivery of cardiac conduction system pacing therapy or during pauses in the delivery of cardiac conduction system pacing therapy.

[0089] During the delivery of cardiac conduction system pacing therapy 406, method 400 may further include: monitoring the patient's pacing electrical activity using multiple external electrodes 407, and generating a pacing EHI 408 based on the monitored pacing electrical activity. In addition to monitoring during the delivery of cardiac conduction system pacing therapy, the electrical activity may be monitored 407 in the same or similar manner as described herein with respect to process 402. Similarly, in addition to monitoring the electrical activity used to generate the pacing EHI during the delivery of cardiac conduction system pacing therapy, the pacing EHI 408 may be generated 408 in the same or similar manner as described herein with respect to process 404.

[0090] As a result, method 400 can now be described as having baseline EHI and pacing EHI, which can be used to determine whether cardiac conduction system pacing therapy is effective 410. One or more measures of EHI can be used to determine whether cardiac conduction system pacing therapy is effective.

[0091] For example, the effectiveness of cardiac conduction system pacing therapy can be determined using SDAT 410. More specifically, generating a baseline EHI may include generating a baseline SDAT based on monitored intrinsic electrical activity, and generating a pacing EHI may include generating a pacing SDAT based on monitored pacing electrical activity. The effectiveness of cardiac conduction system pacing therapy can then be determined using (e.g., by comparison) the baseline SDAT and the pacing SDAT 412. For example, the decrease in SDAT from baseline to pacing can be analyzed. In at least one embodiment, if the pacing SDAT is less than 90% of the baseline SDAT, the cardiac conduction system pacing therapy can be determined to be effective 412. Conversely, if the pacing SDAT is greater than or equal to 90% of the baseline SDAT, the cardiac conduction system pacing therapy can be determined to be ineffective. In other words, the effectiveness or ineffectiveness of cardiac conduction system pacing therapy can be determined using a threshold SDAT percentage of the pacing SDAT to the baseline SDAT. The threshold SDAT percentage can be between about 70% and about 95%. As mentioned above, the threshold SDAT percentage can be 90%. In other implementations, the threshold SDAT percentage may be greater than or equal to 70%, greater than or equal to 80%, greater than or equal to 85%, etc., and / or less than or equal to 95%, less than or equal to 90%, etc.

[0092] Further, for example, the effectiveness of cardiac conduction system pacing therapy can be determined using an EHI metric of ventricular dispersion 410. More specifically, generating the pacing EHI may include generating a pacing LVED based on monitored pacing electrical activity. The effectiveness of cardiac conduction system pacing therapy can then be determined using (e.g., comparison) the pacing LVED 412. For example, the LVED can be compared to an LVED threshold. In at least one embodiment, if the pacing LVED is greater than 25 ms, the cardiac conduction system pacing therapy can be determined to be effective 412. Conversely, if the pacing LVED is less than or equal to 25 ms, the cardiac conduction system pacing therapy can be determined to be ineffective. In other words, a threshold LVED value can be used to determine whether cardiac conduction system pacing therapy is effective or ineffective. The threshold LVED value can be between approximately 15 ms and approximately 40 ms. As previously mentioned, the threshold LVED value can be 25 ms. In other implementations, the threshold LVED value may be greater than or equal to 15ms, greater than or equal to 20ms, greater than or equal to 30%, etc., and / or less than or equal to 40%, less than or equal to 35%, etc.

[0093] As described herein, one or more metrics of the EHI can be used to determine whether cardiac conduction system pacing therapy is effective 410. In at least one implementation, changes in SDAT and pacing LVED from baseline to pacing (or therapy) can both be used to determine whether cardiac conduction system pacing therapy is effective 412. For example, if the pacing SDAT is less than 90% of the baseline SDAT and if the pacing LVED is more than 25 ms smaller than the inherent LVED, then cardiac conduction system pacing therapy can be determined to be effective 412. Conversely, if the pacing SDAT is greater than or equal to 90% of the baseline SDAT or if the pacing LVED is less than or equal to 25 ms, then cardiac conduction system pacing therapy can be determined to be ineffective. In other words, such tests can rely on two metrics indicating effective cardiac conduction system pacing therapy to move forward and ultimately determine whether cardiac conduction system pacing therapy is effective. If one or both of the metrics do not indicate that cardiac conduction system pacing therapy is effective, then CCS pacing therapy can be ultimately determined to be ineffective.

[0094] It should be understood that when cardiac conduction system pacing therapy is described as effective, it can be accepted to provide cardiac therapy without the need for additional therapies such as conventional myocardial tissue pacing therapy (e.g., pacing left ventricular myocardial tissue using a left ventricular lead in the coronary sinus, or pacing right ventricular myocardial tissue using a right ventricular lead in the right ventricle). Therefore, if cardiac conduction system pacing therapy is not determined to be effective, it may mean that it is partially effective or completely ineffective. In either case, additional cardiac therapy may be necessary to provide the patient with acceptable cardiac care.

[0095] Therefore, if it is determined that cardiac conduction system pacing therapy is ineffective, method 400 can further analyze the location 414 of the cardiac activation delay. Specifically, based on the monitored electrical activity, it can be determined whether the cardiac activation delay is located on the right or left side of the patient's heart (and particularly the left ventricle) 414. In other words, in response to determining that cardiac conduction system pacing therapy is ineffective, based on the monitored pacing electrical activity, it can be determined whether the cardiac activation delay is located on the left or right side of the left ventricle.

[0096] For example, based on monitoring intrinsic electrical activation and / or monitored pacing electrical activity, alternative cardiac activation timemaps can be generated for the anterior and posterior portions of the patient, and the activation time or delay therein can be compared to an activation threshold. If the activation time is later than the activation threshold, the region of the alternative cardiac activation timemap corresponding to such a later activation time can be identified as having a cardiac activation delay. The activation threshold can be between approximately 25 ms and approximately 75 ms. In at least one embodiment, the activation threshold is 50 ms. In other embodiments, the activation threshold can be greater than or equal to 25 ms, greater than or equal to 35 ms, greater than or equal to 45 ms, greater than or equal to 55 ms, etc., and / or less than or equal to 75 ms, less than or equal to 65 ms, less than or equal to 60 ms, less than or equal to 50 ms, etc. For example, if the delayed activation appears more as both intrinsic rhythm and pacing rhythm on the anterior map, a significant and persistent delay can be identified in right ventricular activation (e.g., in patients with right bundle branch block), in which case the implanted conventional pacing lead can be a right ventricular pacing lead.

[0097] Therefore, if the cardiac activation delay is primarily located on the left side, a left ventricular lead 216 of myocardial tissue pacing the left ventricle can be implanted. And, if the cardiac activation delay is primarily located on the right side, a right ventricular lead 218 of myocardial tissue pacing the right ventricle can be implanted.

[0098] Then, method 400 can continue to monitor pacing electrical activity 408 during delivery of cardiac conduction system pacing therapy and conventional pacing therapy using a right ventricular lead or a left ventricular lead. In other words, cardiac conduction system pacing therapy can be delivered in combination with conventional pacing therapy, and electrical activity can be monitored during delivery of such combined therapy. The monitored electrical activity can then be used to configure a right pacing lead or a left pacing lead 420. For example, a combined pacing EHI can be generated based on the monitored combined pacing electrical activity. The combined EHI can then be used to determine the effectiveness of the combined pacing therapy. For example, the SDAT and / or LVED generated from the electrical activity monitored during the combined pacing therapy can be compared with baseline SDAT and / or baseline LVED, and / or with various thresholds similar to those described herein with respect to process 410.

[0099] Additionally, during pacing lead configuration 420, one or more pacing parameters can be adjusted, such as, for example, pacing lead position, pacing amplitude or voltage, pulse number, pacing burst length, pacing frequency, single or multiple electrode pacing vectors, etc. Each different parameter can be adjusted while monitoring the electrical activity of the combined pacing therapy and evaluating the resulting EHI to determine the optimal set of pacing parameters. Further illustrative systems, methods, and processes for optimizing cardiac pacing therapy are described in U.S. Patent Application Serial No. 15 / 934,517, filed March 23, 2019, entitled "Evaluation of Ventricle from Atrium Pacing Therapy," and U.S. Provisional Patent Application Serial No. 62 / 725,763, filed August 31, 2018, entitled "Adaptive VFA Cardiac Therapy."

[0100] Figure 8 The text describes an illustrative atrioventricular (VfA) cardiac therapy system that can be configured to, for example, be described in this article. Figures 1 to 7 The described systems and methods are used together. Although it should be understood that this disclosure can utilize one or both of leadless and leaded implantable medical devices, Figure 8The illustrative cardiac therapy system includes a leadless intracardiac medical device 10, which can be configured for single-chamber or dual-chamber therapy and implanted in a patient's heart 8. In some embodiments, the device 10 can be configured for single-chamber pacing and can be switched, for example, between single-chamber pacing and multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing). As used herein, "intracardiac" means a device configured to be completely implanted within a patient's heart, for example, to provide cardiac therapy. A device 10 is shown implanted in a target implantation region 4 in the right atrium (RA) of a patient's heart 8. The device 10 may include one or more fixation members 20 anchoring the distal end of the device 10 against the atrial endocardium in the target implantation region 4. The target implantation region 4 may be located between the His bundle 5 and the coronary sinus 3 and may be adjacent to or immediately adjacent to the tricuspid valve 6. Device 10 can be described as an atrial-ventricular device because, for example, device 10 can perform one of the following simultaneously while typically placed in the right atrium: sensing electrical activity from one or both ventricles (e.g., the right ventricle, the left ventricle, or both ventricles, as appropriate) and providing therapy thereto. Specifically, device 10 may include a tissue-piercing electrode that can be implanted from the Koch's triangle region of the right atrium through the right atrial endocardium and central fibrous body into the base and / or septal region of the left ventricular myocardium of the patient's heart.

[0101] Device 10 can be described as a leadless implantable medical device. As used herein, "leadless" means a device without leads extending from the patient's heart 8. Further, although a leadless device may have leads, the leads do not extend from outside the patient's heart to inside the heart or from inside the heart to outside the heart. Some leadless devices can be introduced through a vein, but once implanted, the device has no or may not include any transvenous leads and can be configured to deliver cardiac therapy without the use of any transvenous leads. Further, specifically, the leadless VfA device does not use leads to be operatively connected to electrodes in the ventricles when the device housing is positioned in the atrium. Additionally, leadless electrodes can be coupled to the housing of the medical device without the use of leads between the electrodes and the housing.

[0102] Device 10 may include a dart electrode assembly 12 defining or having a straight axis extending from a distal region of device 10. The dart electrode assembly 12 may be placed or at least configured to pass through the atrial myocardium and central fibrous body and enter into the ventricular myocardium 14 or along the interventricular septum without completely penetrating the ventricular endocardium or epicardial surface. The dart electrode assembly 12 may carry or include an electrode at the distal region of the axis, such that the electrode can be positioned within the ventricular myocardium for sensing ventricular signals and delivering ventricular pacing pulses (e.g., depolarizing the left and / or right ventricles to induce contraction of the left and / or right ventricles). In some examples, the electrode at the distal region of the axis is a cathode electrode provided for use in a bipolar electrode pair for pacing and sensing. While the implantation region 4 shown allows one or more electrodes of the dart electrode assembly 12 to be positioned in the ventricular myocardium, it should be recognized that devices having the aspects disclosed herein can be implanted in other locations where appropriate for multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing), single-chamber pacing with multi-chamber sensing, single-chamber pacing and / or sensing, or other clinical therapies and applications.

[0103] It should be understood that although the device 10 is described herein as comprising a single dart electrode assembly, the device 10 may include more than one dart electrode assembly placed or configured to pass through the atrial myocardium and central fibrous body and into the ventricular myocardium 14 or along the interventricular septum, without passing entirely through the ventricular endocardium or epicardial surface. Additionally, each dart electrode assembly may carry or include more than one electrode in a distal region of the axis or in other regions along the axis (e.g., a proximal region or a central region).

[0104] The cardiac therapy system 2 may also include a separate medical device 50 (in Figure 8(Illustrated schematically) A single medical device 50 may be positioned outside (e.g., subcutaneously) the patient's heart 8 and may be operatively coupled to the patient's heart 8 to deliver cardiac therapy thereto. In one example, the single medical device 50 may be an extravascular ICD. In some embodiments, the extravascular ICD may include a defibrillation lead that includes or carries a defibrillation electrode. A therapy carrier may be present between the defibrillation electrode on the defibrillation lead and the housing electrode of the ICD. Further, one or more electrodes of the ICD may also be used to sense electrical signals relating to the patient's heart 8. The ICD may be configured to deliver electrical shock therapy including one or more defibrillation or cardioversion shocks. For example, if an arrhythmia is sensed, the ICD may transmit pulses via the lead to shock the heart and restore its normal rhythm. In some examples, the ICD may deliver electrical shock therapy without placing the lead inside the heart or attaching the wire directly to the heart (subcutaneous ICD). Examples of vascular perivascular subcutaneous ICDs that can be used with System 2 described herein can be described in U.S. Patent No. 9,278,229 (Reinke et al.), published March 8, 2016.

[0105] In the case of electrical shock therapy (e.g., defibrillation shock delivered by defibrillation electrodes via a defibrillation lead), the standalone medical device 50 (e.g., an extravascular ICD) may include control circuitry that uses a therapy delivery circuit to generate a defibrillation shock with any of a variety of waveform characteristics, including leading-edge voltage, slope, delivered energy, pulse phase, etc. The therapy delivery circuitry may, for example, generate monophasic, biphasic, or multiphasic waveforms. Additionally, the therapy delivery circuitry may generate defibrillation waveforms with varying amounts of energy. For example, the therapy delivery circuitry may generate a defibrillation waveform delivering a total energy between approximately 60 and 80 joules (J) for subcutaneous defibrillation.

[0106] The individual medical device 50 may further include sensing circuitry. The sensing circuitry may be configured to acquire electrical signals sensed by one or more combinations of electrodes and to process the acquired signals. Components of the sensing circuitry may include analog components, digital components, or combinations thereof. The sensing circuitry may, for example, include one or more sense amplifiers, filters, rectifiers, threshold detectors, analog-to-digital converters (ADCs), etc. The sensing circuitry may convert the sensed signals into digital form and provide the digital signals to control circuitry for processing and / or analysis. For example, the sensing circuitry may amplify the signal from the sensing electrodes and convert the amplified signal into a multi-bit digital signal via an ADC, and then provide the digital signal to control circuitry. In one or more embodiments, the sensing circuitry may also compare the processed signal with a threshold to detect the presence of atrial or ventricular depolarization (e.g., P wave or R wave) and indicate the presence of atrial depolarization (e.g., P wave) or ventricular depolarization (e.g., R wave) to control circuitry.

[0107] Device 10 and a separate medical device 50 can collaborate to deliver cardiac therapy to a patient's heart 8. For example, device 10 and the separate medical device 50 can be used to detect tachycardia, monitor tachycardia, and / or deliver tachycardia-related therapy. For example, device 10 can wirelessly communicate with the separate medical device 50 to trigger an electric shock therapy using the separate medical device 50. As used herein, "wireless" means an operative coupling or connection between device 10 and the separate medical device 50 that does not use a metallic conductor. In one example, wireless communication can use a unique, signal-conducting, or triggered electrical pulse provided by device 10 that travels through the patient's tissue and can be detected by the separate medical device 50. In another example, wireless communication can use the communication interface (e.g., an antenna) of device 10 to provide electromagnetic radiation that propagates through the patient's tissue and can be detected, for example, using the communication interface (e.g., an antenna) of the separate medical device 50.

[0108] Figure 9 yes Figure 8 An enlarged conceptual diagram of the anatomy of an intracardiac medical device 10 and a patient's heart 8. Specifically, the device 10 is configured to sense electrical activity and / or deliver pacing therapy. The intracardiac device 10 may include a housing 30. The housing 30 may define internal components of the device 10 (such as those used in conjunction with...). Figure 11The generally described sensing circuitry, therapy delivery circuitry, control circuitry, memory, telemetry circuitry, other optional sensors, and power supply reside in a hermetically sealed internal cavity. The housing 30 may include (e.g., formed therefrom or derived therefrom) conductive materials such as titanium or titanium alloys, stainless steel, MP35N (a non-magnetic nickel-cobalt-chromium-molybdenum alloy), platinum alloys, or other biocompatible metals or metal alloys. In other examples, the housing 30 may include (e.g., formed therefrom or derived therefrom) non-conductive materials, including ceramics, glass, sapphire, silicone, polyurethane, epoxy resin, acetyl copolymer plastics, polyetheretherketone (PEEK), liquid crystal polymers, or other biocompatible polymers.

[0109] In at least one embodiment, the housing 30 may be described as extending between the distal region 32 and the proximal region 34 and as defining a generally cylindrical shape, for example, to facilitate catheter delivery. In other embodiments, the housing 30 may be prismatic or any other shape to perform the functions and utilities described herein. The housing 30 may include, for example, a delivery tool interface member 26 defined or positioned at the proximal region 34 for engagement with a delivery tool during implantation of the device 10.

[0110] All or part of the housing 30 may serve as a sensing and / or pacing electrode during cardiac therapy. In the example shown, the housing 30 includes a proximal housing-based electrode 24 that is external to a proximal portion of the housing 30 (e.g., closer to the proximal region 34 than to the distal region 32). When the housing 30 (e.g., defined by or formed of a conductive material such as titanium alloy or other examples listed above) is partially electrically insulated from a non-conductive material (such as a coating of parylene, polyurethane, silicone, epoxy, or other biocompatible polymers), one or more discrete regions of the conductive material are exposed to form or define a proximal housing-based electrode 24. When the housing 30 (e.g., defined by or formed of a non-conductive material such as ceramic, glass, or polymeric material) is present, a conductive coating or layer, such as titanium, platinum, stainless steel, or alloys thereof, can be applied to one or more discrete regions of the housing 30 to form or define a proximal housing-based electrode 24. In other examples, the proximal housing-based electrode 24 may be a component mounted or assembled onto the housing 30, such as a ring electrode. The proximal housing-based electrode 24 may be electrically coupled to the internal circuitry of the device 10, for example, via a conductive housing 30 or, when the housing 30 is a non-conductive material.

[0111] In the example shown, the proximal housing-based electrode 24 is positioned closer to the proximal housing region 34 than the distal housing region 32, and can therefore be referred to as the proximal housing-based electrode 24. However, in other examples, the proximal housing-based electrode 24 may be positioned at other locations along the housing 30, for example, further away from the position shown.

[0112] At the distal region 32, the device 10 may include a distal fixation and electrode assembly 36, which may include one or more fixation members 20 and one or more dart electrode assemblies 12 of equal or unequal length. In one such example as shown, a single dart electrode assembly 12 includes a shaft 40 extending distally away from the distal region 32 of the housing, and one or more electrode elements, such as a tip electrode 42, at or near the free distal region of the shaft 40. The tip electrode 42 may have a conical or hemispherical distal tip with a relatively narrow tip diameter (e.g., less than about 1 mm) for penetration and through tissue layers without the need for sharp or beveled tips or needle-like tips.

[0113] The dart electrode assembly 12 can be configured to pierce one or more tissue layers to position the tip electrode 42 within a desired tissue layer (e.g., ventricular myocardium). Thus, the height 47 or length of the shaft 40 can correspond to the intended pacing site depth, and the shaft 40 can have relatively high compressive strength along its longitudinal axis to resist bending in the lateral or radial directions when pressed and inserted into the implantation region 4. If a second dart electrode assembly 12 is used, its length may not be equal to the intended pacing site depth and can be configured to act as an independent electrode for delivering pacing energy to and / or sensing signals from the tissue. In one embodiment, a longitudinal axial force can be applied to the tip electrode 42, for example, by applying a longitudinal thrust to the proximal region 34 of the housing 30, to advance the dart electrode assembly 12 into the tissue within the target implantation region.

[0114] Shaft 40 can be described as longitudinally non-compressible and / or elastically deformable in the transverse or radial direction when subjected to transverse or radial forces, allowing for temporary bending, for example, with tissue movement, but returning to its normal straight positioning when the transverse force decreases. Therefore, the dart electrode assembly 12 including shaft 40 can be described as elastic. When shaft 40 is not exposed to any external force or is only exposed to a force along its longitudinal central axis, shaft 40 can maintain a straight, linear positioning as shown.

[0115] In other words, the shaft 40 of the dart electrode assembly 12 can normally be a straight member and can be rigid. In other embodiments, the shaft 40 can be described as relatively rigid, but still having limited flexibility in the lateral direction. Further, the shaft 40 can be non-rigid to allow some lateral bending with heart movement. However, in a relaxed state, when not subjected to any external force, the shaft 40 can maintain a straight positioning as shown to space the tip electrode 42 from the distal region 32 of the housing by at least the height or length 47 of the shaft 40.

[0116] The one or more fixation members 20 can be described as one or more “teeth” having a normal bending position. The teeth can be held in a distally extended position within the delivery tool. The distal tip of the teeth can penetrate cardiac tissue to a limited depth before being elastically or resiliently bent back to the normal bending position proximally (as shown) upon release from the delivery tool. Further, the fixation member 20 can include one or more aspects described, for example, in U.S. Patent No. 9,675,579, issued June 13, 2017 (Grubac et al.) and U.S. Patent No. 9,119,959, issued September 1, 2015 (Rys et al.).

[0117] In some examples, the distal fixation and electrode assembly 36 includes a distal housing-based electrode 22. When using the device 10 as a pacemaker for multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing) and sensing, the tip electrode 42 can serve as a cathode electrode paired with the proximal housing-based electrode 24, which acts as a return anode electrode. Alternatively, the distal housing-based electrode 22 can serve as a return anode electrode paired with the tip electrode 42 for sensing ventricular signals and delivering ventricular pacing pulses. In other examples, the distal housing-based electrode 22 can be a cathode electrode for sensing atrial signals and delivering pacing pulses to the atrial myocardium in the target implantation region 4. When the distal housing-based electrode 22 acts as an atrial cathode electrode, the proximal housing-based electrode 24 can serve as a return anode paired with the tip electrode 42 for ventricular pacing and sensing, and can also serve as a return anode paired with the distal housing-based electrode 22 for atrial pacing and sensing.

[0118] As illustrated in the diagram, in some pacing applications, the target implantation region 4 is along the atrial endocardium 18, typically below the AV node 15 and His bundle 5. The dart electrode assembly 12 may at least partially define the height 47 or length of the shaft 40 to penetrate the atrial endocardium 18 in the target implantation region 4, through the central fibrous body 16, and into the ventricular myocardium 14 without penetrating the ventricular endocardial surface 17. When the height 47 or length of the dart electrode assembly 12 is fully advanced into the target implantation region 4, the tip electrode 42 may be positioned within the ventricular myocardium 14, and the distal housing-based electrode 22 may be positioned in close contact with or very close to the atrial endocardium 18. In various examples, the dart electrode assembly 12 may have a total combined height 47 or length of the tip electrode 42 and shaft 40 of approximately 3 mm to approximately 8 mm. The diameter of the shaft 40 may be less than approximately 2 mm and may be approximately 1 mm or less, or even approximately 0.6 mm or less.

[0119] Figure 10 Figure 319 is a two-dimensional (2D) ventricular diagram of a patient's heart (e.g., a top-down view), showing the left ventricle 320 and right ventricle 322 in a standard 17-segment view. Figure 319 defines or includes multiple regions 326 corresponding to different areas of the human heart. As shown, regions 326 are numbered from 1 to 17 (e.g., corresponding to 17 segments of a standard 17-segment human heart model, corresponding to 17 segments of the left ventricle of the human heart). Regions 326 of Figure 319 may include the anterior basal region 1, the anterior basal septum region 2, the subbasal septum region 3, the subbasal region 4, the subbasal lateral region 5, the anterior basal lateral region 6, the mid-anterior region 7, the mid-anterior septum region 8, the mid-inferior septum region 9, the mid-inferior region 10, the mid-inferior lateral region 11, the mid-anterior lateral region 12, the anterior vertex region 13, the vertex septum region 14, the vertex inferior region 15, the vertex lateral region 16, and the apex region 17. The inferior and anterior septal regions of the right ventricle 322, as well as the right bundle branch (RBB) 25 and the left bundle branch (LBB) 27, are also shown.

[0120] In some embodiments, any tissue-piercing electrode of this disclosure can be implanted in the base and / or septal region of the left ventricular myocardium of a patient's heart. Specifically, the tissue-piercing electrode can be implanted through the right atrial endocardium and central fibrous body from the Koch's triangle region of the right atrium. Once implanted, the tissue-piercing electrode can be positioned in a target implantation area such as the base and / or septal region of the left ventricular myocardium. Figures 8 to 9 Referring to Figure 319, the basal region includes one or more of the following: anterior basal region 1, anterior basal septum 2, subbasal septum 3, subbasal region 4, mid-anterior region 7, mid-anterior septum 8, mid-inferior septum 9, and mid-inferior region 10. Referring to Figure 319, the septal region includes one or more of the following: anterior basal septum 2, anterior basal septum 3, mid-anterior septum 8, mid-inferior septum 9, and apical septum 14.

[0121] In some implementations, when implanted, the tissue-puncturing electrode can be positioned in the basal-septal region of the left ventricular myocardium. The basal septal region may include one or more of the following: anterior basal septal region 2, subbasal septal region 3, anterior mid-septal region 8, and inferior mid-septal region 9.

[0122] In some implementations, upon implantation, the tissue-piercing electrode can be positioned in the superior / posterior basal septum region of the left ventricular myocardium. The superior / posterior basal septum region of the left ventricular myocardium may include a portion of one or more of the subbasal septum region 3 and the mid-inferior septum region 9 (e.g., only the subbasal septum region, only the mid-inferior septum region, or both the subbasal septum region and the mid-inferior septum region). For example, the superior / posterior basal septum region may include a region 324 generally illustrated as having a dashed boundary. As illustrated, the dashed boundary indicates the approximate location of the superior / posterior basal septum region, and its shape or size may vary slightly depending on the specific application.

[0123] Figure 11 The diagram depicts a block diagram of a circuit system, according to one example, that can be enclosed within a housing 30 of device 10 or the housing of any other medical device described herein to provide the functions of sensing cardiac signals, determining capture and / or delivering pacing therapy. A separate medical device 50 (such as...) Figure 8 The device (shown) may include some or all of the same components that can be configured in a similar manner. The electronic circuitry enclosed within housing 30 may include software, firmware, and hardware that collaboratively monitor atrioventricular and ventricular electrocardiographic signals, determine if cardiac system capture has occurred, determine when cardiac therapy is needed, and / or deliver electrical pulses to the patient's heart according to programmed therapy patterns and pulse control parameters. The electronic circuitry may include control circuitry 80 (e.g., including processing circuitry), memory 82, therapy delivery circuitry 84, sensing circuitry 86, and / or telemetry circuitry 88. In some examples, device 10 includes one or more sensors 90 for generating signals related to one or more physiological functions, states, or symptoms of the patient. For example, one or more sensors 90 may include patient activity sensors for determining the need for pacing therapy and / or controlling the pacing rate. In other words, device 10 may include additional sensors 90 for sensing signals from the patient to determine whether and / or control electrical stimulation therapy delivered by therapy delivery circuitry 84.

[0124] Power source 98 can provide power as needed to the circuitry of device 10, which includes each of components 80, 82, 84, 86, 88, and 90. Power source 98 may include one or more energy storage devices, such as one or more rechargeable or non-rechargeable batteries. The connections between power source 98 and each of components 80, 82, 84, 86, 88, and 90 (not shown) can be understood from a general block diagram shown to a person skilled in the art. For example, power source 98 may be coupled to one or more charging circuits included in therapy delivery circuitry 84 to provide power to charge a holding capacitor included in therapy delivery circuitry 84, which discharges at appropriate times under the control of control circuitry 80 to deliver pacing pulses, for example, according to a dual-chamber pacing mode (such as DDI(R)). Power source 98 may also be coupled to components of sensing circuitry 86 (such as sensing amplifiers, analog-to-digital converters, switching circuitry, etc.), sensor 90, telemetry circuitry 88, and memory 82 to provide power to various circuits.

[0125] Figure 11 The functional blocks shown represent the functions included in device 10 and may include any discrete and / or integrated electronic circuit components that implement analog and / or digital circuitry capable of producing the functions attributed to the medical device 10 described herein. Individual components may include processing circuitry systems (such as application-specific integrated circuits (ASICs), electronic circuitry, processors (shared, dedicated, or grouped), and memory) that execute one or more software or firmware programs, combinational logic circuitry, state machines, or other suitable components or combinations of components that provide the described functions. The specific form of software, hardware, and / or firmware used to implement the functions disclosed herein will be determined primarily by the specific system architecture employed in the medical device and the specific detection and therapy delivery methods employed by the medical device.

[0126] Memory 82 may include any volatile, non-volatile, magnetic, or electrically non-transitory computer-readable storage medium, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other memory device. Furthermore, memory 82 may include a non-transitory computer-readable medium storing instructions that, when executed by one or more processing circuits, cause control circuitry 80 and / or other processing circuitry systems to determine left posterior bundle branch engagement and / or perform single-chamber, dual-chamber, or triple-chamber calibrated pacing therapy (e.g., single-chamber or multi-chamber pacing) or other cardiac therapeutic functions attributed to device 10 (e.g., sensing or delivery therapy). The non-transitory computer-readable medium storing instructions may include any of the media listed above.

[0127] The control circuit 80 can communicate, for example, via a data bus with the therapy delivery circuit 84 and the sensing circuit 86 to sense cardiac electrical signals and control the delivery of cardiac electrical stimulation therapy in response to sensed cardiac events (e.g., P waves and R waves, or their absence). The tip electrode 42, the distal housing-based electrode 22, and the proximal housing-based electrode 24 can be electrically coupled to the therapy delivery circuit 84 for delivering electrical stimulation pulses to the patient's heart, and electrically coupled to the sensing circuit 86 for sensing cardiac electrical signals.

[0128] Sensing circuit 86 may include an atrial (A) sensing channel 87 and a ventricular (V) sensing channel 89. Distal housing-based electrode 22 and proximal housing-based electrode 24 may be coupled to atrial sensing channel 87 to sense atrial signals, such as P waves associated with atrial myocardial depolarization. In an example including two or more selectable distal housing-based electrodes, sensing circuit 86 may include a switching circuit system for selectively coupling one or more of the available distal housing-based electrodes to a cardiac event detection circuitry included in atrial sensing channel 87. The switching circuit system may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable for selectively coupling components of sensing circuit 86 to selected electrodes. Tip electrode 42 and proximal housing-based electrode 24 may be coupled to ventricular sensing channel 89 to sense ventricular signals, such as R waves associated with ventricular myocardial depolarization.

[0129] Each of the atrial sensing channel 87 and the ventricular sensing channel 89 may include a cardiac event detection circuitry for detecting P waves and R waves, respectively, from cardiac electrical signals received by the respective sensing channel. The cardiac event detection circuitry included in each of channels 87 and 89 may be configured to amplify, filter, digitize, and rectify the cardiac electrical signals received from selected electrodes to improve signal quality for detecting cardiac electrical events. The cardiac event detection circuitry within each channel 87 and 89 may include one or more sensing amplifiers, filters, rectifiers, threshold detectors, comparators, analog-to-digital converters (ADCs), timers, or other analog or digital components. Cardiac event sensing thresholds, such as P-wave and R-wave sensing thresholds, may be automatically adjusted by each respective sensing channel 87 and 89 under the control of the control circuitry 80, for example, based on timing periods and sensing thresholds stored in memory 82 and / or controlled by the hardware, firmware, and / or software of the control circuitry 80 and / or the sensing circuitry 86, as determined by the control circuitry 80.

[0130] When a cardiac electrical event is detected based on a sensing threshold crossing, sensing circuit 86 can generate a sensed event signal that is transmitted to control circuit 80. For example, atrial sensing channel 87 can generate a P-wave sensed event signal in response to a P-wave sensed threshold crossing. Ventricular sensing channel 89 can generate an R-wave sensed event signal in response to an R-wave sensed threshold crossing. Control circuit 80 can use the sensed event signals to set a pacing escape interval timer that controls the basic time interval used to schedule cardiac pacing pulses. The sensed event signals can trigger or suppress pacing pulses, depending on the specific programmed pacing mode. For example, a P-wave sensed event signal received from atrial sensing channel 87 can cause control circuit 80 to suppress scheduled atrial pacing pulses and schedule ventricular pacing pulses with a programmed atrioventricular (AV) pacing interval. If an R-wave is sensed before the AV pacing interval expires, the ventricular pacing pulse can be suppressed. If the AV pacing interval is terminated before the control circuit 80 receives the R-wave sensing event signal from the ventricular sensing channel 89, the control circuit 80 can use the therapy delivery circuit 84 to deliver a scheduled ventricular pacing pulse synchronized with the sensed P wave.

[0131] In some examples, device 10 may be configured to deliver a variety of pacing therapies, including bradycardia pacing, cardiac resynchronization therapy, post-shock pacing, and / or tachycardia-related therapies (such as ATP). For example, device 10 may be configured to detect non-sinus tachycardia and deliver ATP. Control circuitry 80 may determine cardiac event time intervals, such as the PP interval between consecutive P-wave sensed event signals received from atrial sensing channel 87, the RR interval between consecutive R-wave sensed event signals received from ventricular sensing channel 89, and the PR and / or RP intervals received between P-wave sensed event signals and R-wave sensed event signals. These intervals may be compared with tachycardia detection intervals to detect non-sinus tachycardia. Tachycardia may be detected in a given cardiac chamber based on a threshold number of detected tachycardia detection intervals.

[0132] The therapy delivery circuit 84 may include an atrial pacing circuit 83 and a ventricular pacing circuit 85. Each pacing circuit 83, 85 may include a charging circuit system, one or more charge storage devices (such as one or more low-voltage holding capacitors), an output capacitor, and / or a switching circuit system that controls when the holding capacitor is charged and discharged across the output capacitor to deliver pacing pulses to the pacing electrode vector coupled to the respective pacing circuit 83, 85. The tip electrode 42 and the proximal housing-based electrode 24 may be coupled as a bipolar cathode and anode pair to the ventricular pacing circuit 85 to deliver ventricular pacing pulses, for example, upon the expiration of the AV or VV pacing interval set by the control circuit 80 for providing atrial synchronizing ventricular pacing and a basic lower ventricular pacing rate.

[0133] Atrial pacing circuit 83 can be coupled to distal housing-based electrode 22 and proximal housing-based electrode 24 to deliver atrial pacing pulses. Control circuit 80 can set one or more atrial pacing intervals based on a programmed lower pacing rate or a temporarily lower rate set according to a pacing rate indicated by a rate responsiveness sensor. If the atrial pacing interval is cut off before a P-wave sensed event signal is received from atrial sensing channel 87, the atrial pacing circuit can be controlled to deliver atrial pacing pulses. Control circuit 80 initiates an AV pacing interval in response to the delivered atrial pacing pulses to provide synchronized multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing).

[0134] The therapy delivery circuit 84 can charge the holding capacitors of the atrial or ventricular pacing circuits 83, 85 to a programmed pacing voltage amplitude and discharge the capacitors for a programmed pacing pulse width, based on control signals received from the control circuit 80. For example, the pacing timing circuitry included in the control circuit 80 may include a programmable digital counter, set by the microprocessor of the control circuit 80, to control the basic pacing interval associated with various single-chamber or multi-chamber pacing (e.g., dual-chamber or triple-chamber pacing) modes or anti-tachycardia pacing sequences. The microprocessor of the control circuit 80 can also set the amplitude, pulse width, polarity, or other characteristics of the cardiac pacing pulses based on programmed values ​​stored in memory 82.

[0135] Control parameters for sensing cardiac events and controlling the delivery of pacing therapy, utilized by control circuitry 80, can be programmed into memory 82 via telemetry circuitry 88, which can also be described as a communication interface. Telemetry circuitry 88 includes a transceiver and antenna for communicating with external devices such as programmers or home monitors using radio frequency communication or other communication protocols. Control circuitry 80 can use telemetry circuitry 88 to receive downlink telemetry from external devices and transmit uplink telemetry to external devices. In some cases, telemetry circuitry 88 can be used to transmit and receive communication signals to and from another medical device implanted in the patient.

[0136] The technology described in this disclosure, including technology belonging to IMD 10, device 50, computing device 140 and computing device 160 and / or various constituent components, can be implemented at least in part in hardware, software, firmware or any combination thereof. For example, aspects of this technology can be implemented within one or more processors embodied as programmers, stimulators, image processing devices or other devices such as physician or patient programmers, including one or more microprocessors, DSPs, ASICs, FPGAs or any other equivalent integrated or discrete logic circuit systems and any combination of such components. The terms “module,” “processor,” or “processing circuit system” can generally refer to the individual aforementioned logic circuit system or a combination of the aforementioned logic circuit system with other logic circuit systems, or any circuit system in any other equivalent circuit system.

[0137] Such hardware, software, and / or firmware may be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any described unit, module, or component may be implemented together or individually as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated into common or separate hardware or software components.

[0138] When implemented in software, the functionality attributable to the systems, apparatus, and techniques described herein can be embodied in instructions on a computer-readable medium such as RAM, ROM, NVRAM, EEPROM, flash memory, magnetic data storage medium, optical data storage medium, etc. These instructions can be executed by a processing circuit system and / or one or more processors to support one or more aspects of the functionality described herein.

[0139] For all purposes, all references and publications cited herein are expressly incorporated herein by reference in their entirety, unless any incorporated aspect directly contradicts this disclosure.

[0140] Unless otherwise stated, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of this disclosure.

[0141] Unless otherwise specified, all numerical values ​​used in the specification and claims to represent characteristic dimensions, quantities, and physical properties are to be understood as being modified by the terms “precisely” or “about”. Therefore, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and appended claims are approximate values ​​that may vary within typical ranges of experimental error, depending on the desired properties sought by a person skilled in the art using the teachings disclosed herein.

[0142] The numerical range described by the endpoints includes all values ​​contained within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within that range. In this document, the terms "at most" or "not greater than" a value (e.g., at most 50) include that value (e.g., 50), and the terms "not less than" a value (e.g., not less than 5) include that value (e.g., 5).

[0143] The terms “coupled” or “connected” refer to components being directly attached to each other (in direct contact with each other) or indirectly attached (having one or more elements between and attached to two components). Both terms can be modified by “operationally” and “operationally capable”, and they are used interchangeably to describe a coupling or connection configured to allow components to interact to perform at least some functions (e.g., a first medical device can be operably coupled to another medical device to send or receive information in the form of data).

[0144] Orientation-related terms, such as “top,” “bottom,” “side,” and “end,” are used to describe the relative positioning of components and do not imply a limitation on the orientation of the considered implementation. For example, an implementation described as having a “top” and a “bottom” also includes implementations that rotate in various directions, unless otherwise clearly indicated.

[0145] The references to "one embodiment," "an embodiment," "certain embodiments," or "some embodiments" mean that a particular feature, configuration, composition, or characteristic described in connection with the embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of such references throughout the document does not necessarily refer to the same embodiment of this disclosure. Furthermore, a particular feature, configuration, composition, or characteristic may be combined in any suitable manner in one or more embodiments.

[0146] As used in this specification and the appended claims, the singular forms “a,” “an,” and “the” cover embodiments having multiple indicators, unless otherwise expressly specified. As used in this specification and the appended claims, the term “or” is used in its usual sense, including “and / or,” unless otherwise expressly specified herein.

[0147] As used in this article, "have," "having," "include," "including," "comprise," and "comprising" are used in their open-ended sense and usually mean "including but not limited to." It should be understood that phrases such as "basically composed of" or "composed of" are categorized under "comprising."

[0148] The term “and / or” means one or all of the listed elements or a combination of at least two of the listed elements. The phrases accompanying the list, such as “at least one of…”, “including at least one of…”, and “one or more of…”, refer to any one item in the list or any combination of two or more items in the list.

[0149] Illustrative Examples

[0150] Example 1: A system comprising:

[0151] Electrode device, the electrode device comprising a plurality of external electrodes to be placed proximal to the patient's skin; and

[0152] A computing device, comprising a processing circuitry system and operatively coupled to the electrode device, is configured to:

[0153] The patient's intrinsic electrical activity is monitored using the plurality of external electrodes of the electrode device.

[0154] Multiple cardiac penetration maps are generated based on intrinsic activity monitored over a period of time, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential; and

[0155] The location of the cardiac conduction system blockage is determined based on the generated multiple cardiac penetration maps.

[0156] Example 2: A method, the method comprising:

[0157] The patient's intrinsic electrical activity was monitored using multiple external electrodes placed proximal to the patient's skin.

[0158] Multiple cardiac penetration maps are generated based on intrinsic activity monitored over a period of time, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential; and

[0159] The location of the cardiac conduction system blockage is determined based on the generated multiple cardiac penetration maps.

[0160] Example 3: According to the system described in Example 1 or the method described in Example 2, each of the plurality of cardiac penetration maps is generated based on the sampling interval after the QRS initiation of a single heartbeat.

[0161] Example 4: The system or method according to Example 3, wherein the sampling interval is less than or equal to 5 milliseconds.

[0162] Example 5: The system or method according to any one of Examples 1 to 4, wherein determining the location of the cardiac conduction system blockage based on the generated cardiac penetration map includes: determining the spatial location of the penetration within the plurality of cardiac penetration maps, wherein the cardiac potential is less than or equal to a penetration threshold.

[0163] Example 6: The system or method according to Example 5, wherein the penetration threshold is less than or equal to -1 millivolt.

[0164] Example 7: The system or method according to any one of Examples 5 to 6, wherein determining the location of the cardiac conduction system blockage based on the generated cardiac penetration map includes: if the spatial location of the penetration is located in the left anterior region of the generated cardiac penetration map, then determining that the location of the cardiac conduction system blockage is distal along the cardiac conduction system.

[0165] Example 8: The system or method according to any one of Examples 1 to 7, wherein determining the location of the cardiac conduction system blockage based on the generated cardiac penetration map includes: if the spatial location of the penetration is not located in the left anterior region of the generated cardiac penetration map, then determining that the location of the cardiac conduction system blockage is proximal along the cardiac conduction system.

[0166] Example 9: A system or method according to any one of Examples 1 to 8, wherein the system is further configured to perform or the method further includes: displaying the plurality of cardiac penetration maps on a graphical user interface.

[0167] Example 10: The system or method according to any one of Examples 1 to 9, wherein the plurality of cardiac penetration maps include:

[0168] Anterior region, which spatially represents the cardiac electrical potential of the anterior portion of the patient's heart; and

[0169] The posterior region, which spatially represents the cardiac electrical potential at the posterior part of the patient's heart.

[0170] Example 11: A system comprising:

[0171] An electrode device comprising a plurality of external electrodes to be placed proximal to the patient's skin;

[0172] The display includes a graphical user interface; and

[0173] A computing device, comprising a processing circuitry system and operatively coupled to the electrode device and the display, is configured to:

[0174] The patient's intrinsic electrical activity is monitored using the plurality of external electrodes of the electrode device.

[0175] Multiple cardiac penetration maps are generated based on intrinsic activity monitored over a period of time, wherein each cardiac penetration map is a spatial representation of an electrocardiogram potential; and

[0176] The generated multiple cardiac penetration images are displayed on the graphical user interface.

[0177] Example 12: According to the system of Example 11, displaying the plurality of cardiac penetration images on the graphical user interface includes: sequentially displaying each of the plurality of cardiac penetration images on the graphical user interface.

[0178] Example 13: According to the system of Example 12, the computing device is further configured to allow a user to interact with the graphical user interface to selectively traverse the sequentially displayed plurality of cardiac penetration maps on the graphical user interface.

[0179] Example 14: The system according to any one of Examples 11 to 13, wherein the plurality of cardiac penetration maps include:

[0180] Anterior region, which spatially represents the cardiac electrical potential of the anterior portion of the patient's heart; and

[0181] The posterior region, which spatially represents the cardiac electrical potential at the posterior part of the patient's heart.

[0182] Example 15: The system according to any one of Examples 11 to 14, wherein the computing device is further configured to: determine the spatial location of the penetration based on the plurality of cardiac penetration maps, wherein displaying the plurality of cardiac penetration maps on the graphical user interface includes: displaying at least one cardiac penetration map including the spatial location of the penetration.

[0183] Example 16: The system according to any one of Examples 11 to 15, wherein the computing device is further configured as follows:

[0184] Based on multiple cardiac penetration maps generated on the graphical user interface, determine whether the location of the cardiac conduction system blockage is proximal or distal along the cardiac conduction system; and

[0185] The graphical user interface displays an indication of whether the blockage in the cardiac conduction system is located proximally or distally along the cardiac conduction system.

[0186] Example 17: A system comprising:

[0187] Electrode device, the electrode device comprising a plurality of external electrodes to be placed proximal to the patient's skin; and

[0188] A computing device, comprising a processing circuitry system coupled to an electrode device, is configured to:

[0189] The patient's intrinsic electrical activity is monitored using the plurality of external electrodes of the electrode device;

[0190] Limiting electrical heterogeneity information (EHI) is generated based on the monitored intrinsic electrical activity;

[0191] During delivery of cardiac conduction system pacing therapy, the patient's pacing electrical activity is monitored using the plurality of external electrodes of the electrode device;

[0192] The pacing EHI is generated based on the monitored pacing electrical activity; and

[0193] The effectiveness of cardiac conduction system pacing therapy is determined based on baseline and the pacing EHI.

[0194] Example 18: A method comprising:

[0195] The patient's intrinsic electrical activity was monitored using multiple external electrodes placed proximal to the patient's skin.

[0196] Limiting electrical heterogeneity information (EHI) is generated based on the monitored intrinsic electrical activity;

[0197] During delivery of cardiac conduction system pacing therapy, the patient's pacing electrical activity is monitored using the plurality of external electrodes of the electrode device;

[0198] A pacing EHI is generated based on the monitored pacing electrical activity; and

[0199] The effectiveness of cardiac conduction system pacing therapy is determined based on baseline and the pacing EHI.

[0200] Example 19: The system according to Example 17 or the method according to Example 18, wherein the cardiac conduction system pacing therapy is delivered with a pacing AV delay, the pacing AV delay being between 40% and 80% of the inherent AV delay, wherein the pacing AV delay is the time period between a sensed atrial event and the delivery of the cardiac conduction system pacing therapy, and wherein the inherent AV delay is the time period between a sensed atrial event and an inherent ventricular event.

[0201] Example 20: A system or method according to any one of Examples 17 to 19, wherein generating a baseline EHI includes: generating a baseline standard deviation of the alternative cardiac electrical activation time (SDAT) based on the monitored intrinsic electrical activity, wherein generating a pacing EHI includes: generating a pacing SDAT based on the monitored pacing electrical activity.

[0202] Example 22: According to the system or method of Example 21, determining whether the cardiac conduction system pacing therapy is effective based on the baseline and the pacing EHI includes: if the pacing SDAT is less than 90% of the baseline SDAT, then the cardiac conduction system pacing therapy is determined to be effective.

[0203] Example 22: The system or method according to any one of Examples 17 to 21, wherein the plurality of external electrodes includes a plurality of left external electrodes positioned to the left side of the patient’s torso, wherein generating pacing EHI includes: using the plurality of left external electrodes to generate a pacing left standard deviation of the alternative cardiac electrical activation time (LVED) based on the monitored pacing electrical activity.

[0204] Example 23: According to the system or method of Example 22, determining whether the cardiac conduction system pacing therapy is effective based on the baseline and the pacing EHI includes: if the pacing LVED is less than 25 milliseconds, then the cardiac conduction system pacing therapy is determined to be effective.

[0205] Example 24: A system or method according to any one of Examples 17 to 21, wherein the computing device is further configured to perform, or the method further comprises:

[0206] In response to determining that the cardiac conduction system pacing therapy is ineffective, based on the monitored pacing electrical activity, it is determined whether the cardiac activation delay is located on the left or right side of the left ventricle;

[0207] If the cardiac activation delay is located on the left side of the left ventricle, then the left ventricular lead is instructed to assist in cardiac conduction system pacing therapy; and

[0208] If the cardiac activation delay is located on the right side of the left ventricle, the right ventricular lead is indicated to assist in cardiac conduction system pacing therapy.

[0209] Example 25: The system or method according to Example 24, wherein the computing device is further configured to perform, or the method further includes:

[0210] During the delivery of the cardiac conduction system pacing therapy and pacing therapy using a right ventricular lead or a left ventricular lead, the patient’s combined pacing electrical activity is monitored using the plurality of external electrodes of the electrode device;

[0211] Combined pacing EHI is generated based on the monitored combined pacing electrical activity; and

[0212] The effectiveness of the position of the right ventricular lead or left ventricular lead is determined based on the combined pacing EHI and the baseline EHI.

[0213] Example 26: The system or method according to any one of Examples 17 to 25, wherein the cardiac conduction system pacing therapy includes one or more of the following therapies: atrial-to-ventricular (VfA) pacing therapy, His bundle pacing therapy, and septal left ventricular endocardial pacing.

[0214] This disclosure has been provided with reference to illustrative embodiments and examples, and is not intended to be interpreted in a limiting sense. As previously described, those skilled in the art will recognize that various other illustrative applications can utilize the beneficial features of the systems, apparatus, and methods described herein using the techniques described herein. Various modifications to the illustrative embodiments and examples will become apparent upon reference to this specification.

Claims

1. A system comprising: An electrode device comprising a plurality of external electrodes to be placed proximal to the patient's skin; and A computing device, comprising a processing circuitry system and operatively coupled to the electrode device, is configured to: The patient's intrinsic electrical activity is monitored using the plurality of external electrodes of the electrode device. Multiple cardiac penetration maps are generated based on intrinsic activity monitored over a period of time, wherein each cardiac penetration map is a spatial representation of electrocardiographic potential, and the multiple cardiac penetration maps sequentially display the spatial representation of the patient's cardiac electrocardiographic potential over time. as well as The location of cardiac conduction blockage was determined based on multiple generated cardiac penetration maps. If, based on the multiple cardiac penetration maps, the spatial location of the cardiac penetration is within the left anterior region, then it is determined that the cardiac conduction system block is distal along the cardiac conduction system. If, according to the plurality of cardiac penetration maps, the spatial location of the cardiac penetration is not located in the left anterior region, then it is determined that the cardiac conduction system block is located proximally along the cardiac conduction system.

2. The system of claim 1, wherein each of the plurality of cardiac penetration maps is generated based on the sampling interval following the initiation of the QRS complex of a single heartbeat.

3. The system according to claim 2, wherein the sampling interval is less than or equal to 5 milliseconds.

4. The system according to any one of claims 1 or 2, wherein determining the location of the cardiac conduction system blockage based on the generated cardiac penetration map comprises: Determine the spatial location of the penetration within the plurality of cardiac penetration maps, wherein the cardiac potential is less than or equal to the penetration threshold.

5. The system of claim 4, wherein the penetration threshold is less than or equal to -1 millivolt.

6. The system according to any one of claims 1 to 5, the system further comprising a display depicting a graphical user interface, wherein the computing device is further operatively coupled to the display and configured to display the plurality of cardiac penetration maps.

7. The system according to any one of claims 1 to 6, wherein the plurality of cardiac penetration maps comprises: Anterior region, which spatially represents the cardiac electrical potential of the anterior part of the patient's heart; and The posterior region, which spatially represents the cardiac electrical potential at the posterior part of the patient's heart.

8. The system according to any one of claims 1 to 7, wherein the computing device is further configured to monitor the patient's pacing electrical activity using the plurality of external electrodes of the electrode device during delivery of cardiac conduction system pacing therapy; Pacing electrical heterogeneity information (EHI) is generated based on the monitored pacing electrical activity; and The effectiveness of cardiac conduction system pacing therapy is determined based on baseline and the aforementioned pacing electrical heterogeneity information (EHI).

9. The system of claim 8, wherein the cardiac conduction system pacing therapy comprises one or more of the following: atrial-to-ventricular (VfA) pacing therapy, His bundle pacing therapy, and septal left ventricular endocardial pacing.

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