Determining pacing efficacy using representative morphology of external cardiac signal

Abstract

Systems and methods for detecting pacing efficiency using an external cardiac signal are described herein. A representative electrical signal morphology of a cardiac signal can be determined based on a plurality of electrical signals, and efficacy of left bundle branch (LBB) engagement is determined based on the representative electrical signal morphology.

Description

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 001,867, filed on March 30, 2020, which is incorporated herein by reference in its entirety.

[0002] This disclosure relates to systems and methods for determining pacing efficacy using multiple external electrodes.

[0003] 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 pacing or shock to terminate rapid arrhythmias such as tachycardia or fibrillation. In some cases, the 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.

[0004] 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.

[0005] In addition to the implantable medical device itself, the system used for implanting the medical device may also include a workstation or other instruments. In some cases, these other instruments assist physicians or other technicians in placing the intracardiac lead at a specific location on the heart. In some cases, these instruments provide the physician with information about the electrical activity of the heart and the location of the intracardiac lead. These instruments can perform functions similar to those of the medical device, including delivering electrical stimulation to the heart and sensing cardiac depolarization. In some cases, these instruments may include devices for obtaining an electrocardiogram (ECG) via electrodes on the patient's surface or skin. More specifically, the patient may have multiple electrodes on an ECG belt or vest around the patient's torso. After the belt or vest has been secured to the torso, the physician can perform a series of tests to assess the patient's cardiac response. The assessment process may include detecting a baseline rhythm in which no electrical stimulation is delivered to the cardiac tissue and another rhythm following the delivery of electrical stimulation to the cardiac tissue.

[0006] ECG electrodes placed on a patient's body surface can be used for a variety of therapeutic purposes (e.g., cardiac resynchronization therapy), including optimizing lead placement, pacing parameters, etc., based on one or more metrics derived from signals captured by the ECG electrodes. For example, electrical heterogeneity information can come from electrical activation times calculated from multiple electrodes on the body surface. Summary of the Invention

[0007] The exemplary systems and methods described herein can be configured to assist users (e.g., physicians) in configuring cardiac treatments (e.g., cardiac treatments performed on a patient during and / or after implantation of a cardiac treatment device). The systems and methods can be described as non-invasive. For example, the systems and methods may not require implantable devices such as leads, probes, sensors, catheters, etc., to assess and configure cardiac treatments. Instead, the systems and methods can utilize non-invasive electrical measurements taken using, for example, multiple external electrodes attached to the patient's skin around the torso.

[0008] An exemplary system for cardiac assessment may include an electrode device comprising a plurality of external electrodes to be placed proximal to the patient's skin. A computing device includes a processing circuitry system. The computing device is operatively coupled to the electrode device. The computing device is configured to use the plurality of external electrodes to monitor electrical activity from the patient's tissue to generate a plurality of electrical signals. A representative electrical signal morphology is determined based on the plurality of electrical signals. The efficacy of left bundle branch (LBB) engagement is determined based on the aforementioned representative electrical signal morphology.

[0009] An exemplary method for cardiac assessment includes using multiple external electrodes to monitor electrical activity from patient tissues to generate multiple electrical signals. A representative electrical signal morphology is determined based on these multiple signals. The efficacy of left bundle branch (LBB) conjunctival articulation is then determined based on the aforementioned representative electrical signal morphology.

[0010] Furthermore, pacing originating from the atrium in the ventricular (VfA) and / or left bundle branch (LBB) regions targets the left bundle branch for pacing delivery to provide effective electrical excitation. Multiple external ECG electrodes can be used as surface mapping tools to “map out” ventricular excitation. Monitoring posterior excitation of ECG electrodes may help determine the effectiveness of pacing originating from the LBB region, VfA pacing, and / or left bundle excitation by pushing the His bundle lead further to engage the left bundle.

[0011] The above overview is not intended to describe every embodiment or every type of 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

[0012] Figure 1 A diagram of an exemplary system including an electrode device, a display device, and a computing device.

[0013] Figure 2-3 A diagram of an exemplary external electrode device for measuring the surface potential of the torso.

[0014] Figure 4 This is a block diagram of an exemplary method for determining pacing efficiency using representative morphologies of external cardiac signals.

[0015] Figure 5 for Figure 4 A detailed block diagram of the process of an exemplary method.

[0016] Figure 6 The illustration shows multiple post-external electrical signals and median post-morphology.

[0017] Figure 7 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.

[0018] Figure 8 yes Figure 7 An enlarged conceptual diagram of the anatomy of an intracardiac medical device and a patient's heart.

[0019] Figure 9 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.

[0020] Figure 10 It is possible to enclose, for example Figure 7-8 A block diagram of an illustrative circuit system within the housing of a medical device to provide the functions and therapies described herein. Detailed Implementation

[0021] In the following detailed description of illustrative embodiments, reference is made to the accompanying drawings, which form a part of the detailed description, and specific embodiments that can be practiced are illustrated by way of illustration in the drawings. It should be understood that other embodiments may be utilized and structural changes may be made without departing from (e.g., still falling within) the scope of this disclosure herein.

[0022] Reference Figure 1-10 Describing illustrative systems and methods. It will be apparent to those skilled in the art that elements or processes of one embodiment can be combined with elements or processes of other embodiments, and that 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.

[0023] Multiple external electrodes positioned on or around the patient's surface or skin can be used to measure or monitor multiple electrocardiogram (ECG) signals (e.g., trunk surface potential). ECG signals can be used to evaluate and configure cardiac therapies, such as those provided by implantable medical devices performing cardiac resynchronization therapy (CRT). As described herein, ECG signals can be acquired or obtained non-invasively because, for example, implantable electrodes can be avoided when measuring ECG signals. Furthermore, ECG signals can be used to determine cardiac electrical activation time, which can be used to generate various metrics (e.g., electrical heterogeneity information) that can be used by a user (e.g., a physician) to optimize one or more settings or parameters of a cardiac therapy (e.g., pacing therapy) (such as CRT).

[0024] Various illustrative systems, methods, and graphical user interfaces can be configured to noninvasively assist users (e.g., physicians) in assessing cardiac health and / or configuring (e.g., optimizing) cardiac therapies using electrode devices, display devices, and computing devices, including external electrodes. Figure 1 An illustrative system 100 is described, comprising an electrode device 110, a computing device 140, and a remote computing device 160.

[0025] The electrode device 110 shown in the figure includes a plurality of electrodes incorporated or included within a bandage wrapped around the chest or torso of the patient 14. The electrode device 110 is operatively coupled to a computing device 140 (e.g., via a wired or wired connection, wirelessly, etc.) to provide electrical signals from each of the electrodes to the computing device 140 for analysis, evaluation, etc. Illustrative electrode devices are described in U.S. Patent No. 9,320,446, filed March 27, 2014 and published March 26, 2016, entitled “Bioelectric Sensor Device and Methods,” and in U.S. Provisional Patent Application No. 62 / 957,449, filed January 6, 2020, entitled “Bioelectric Sensor Device and Methods,” which are incorporated herein by reference in their entirety. Further reference will be made to… Figure 2-3 A more detailed description of the illustrative electrode device 110.

[0026] Although not described herein, the illustrative system 100 may further include an imaging device. The imaging device can be any type of imaging device configured to non-invasively image or provide an image of at least a portion of a patient. For example, in addition to non-invasive tools such as contrast solutions, the imaging device may provide an image of the patient without using any components or parts that may be located within the patient's body. It should be understood that the illustrative systems, methods, and interfaces described herein can further utilize the imaging device to provide non-invasive assistance to a user (e.g., a physician) to position or place one or more pacing electrodes near a patient's heart in conjunction with a cardiac therapy configuration.

[0027] For example, illustrative systems and methods can provide image-guided navigation for navigating leads, including electrodes, leadless electrodes, radio electrodes, catheters, etc., within a patient's body, while also providing non-invasive cardiac therapy configurations, including determining effective or optimal pre-excitation intervals, such as the AV interval and VV interval. Illustrative systems and methods using imaging devices and / or electrode devices can be described in U.S. Patent Application Publication No. 2014 / 0371832, published December 18, 2014, by Ghosh et al.; U.S. Patent Application Publication No. 2014 / 0371833, published December 18, 2014, by Ghosh et al.; U.S. Patent Application Publication No. 2014 / 0323892, published October 30, 2014, by Ghosh et al.; and U.S. Patent Application Publication No. 2014 / 0323882, published October 20, 2014, each of which is incorporated herein by reference in its entirety.

[0028] The imaging device can be configured to capture X-ray images and / or any other alternative imaging modalities. For example, the imaging device can be configured to capture images or image data using isocentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high-frequency ultrasound (HIFU), optical coherence tomography (OCT), intravascular ultrasound (IVUS), two-dimensional (2D) ultrasound, three-dimensional (3D) ultrasound, four-dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Furthermore, it should be understood that the imaging device can be configured to capture multiple consecutive images (e.g., sequentially) to provide video frame data. In other words, multiple images captured by the imaging device over time can provide video frame data or motion picture data. Exemplary systems employing ultrasound can be found in U.S. Patent Application Publication No. 2017 / 0303840, entitled "Non-invasive Assessment of Cardiac Resynthesis Therapy," by Stadler et al., which is incorporated herein by reference in its entirety. Additionally, these images can be acquired and displayed in two, three, or four dimensions. In a more advanced form, four-dimensional surface rendering of the heart or other areas of the body can also be achieved by incorporating cardiac data or other soft tissue data from images or from preoperative image data captured via MRI, CT, or echocardiography modalities. Image datasets from mixed modalities, such as positron emission tomography (PET) combined with CT or single-photon emission computed tomography (SPECT) combined with CT, can also provide functional image data overlaid on anatomical data, for example, for navigating implantable devices to target locations within the heart or other areas of interest.

[0029] Systems and / or imaging devices that can be used in conjunction with the illustrative systems and methods described herein are described in U.S. Patent Application Publication No. 2005 / 0008210, published January 13, 2005, by Evron et al.; U.S. Patent Application Publication No. 2006 / 0074285, published April 6, 2006, by Zakh et al.; U.S. Patent No. 8,731,642, published May 20, 2014, by Zakh et al.; U.S. Patent No. 8,861,830, published October 14, 2014, by Brada et al.; U.S. Patent No. 6,980,675, published December 27, 2005, by Evron et al.; and Okerlu et al. U.S. Patent No. 7,286,866, issued October 23, 2007 by nd et al.; U.S. Patent No. 7,308,297, issued December 11, 2011 by Reddy et al.; U.S. Patent No. 7,308,299, issued December 11, 2011 by Burrell et al.; U.S. Patent No. 7,321,677, issued January 22, 2008 by Evron et al.; U.S. Patent No. 7,346,381, issued March 18, 2008 by Okerlund et al.; U.S. Patent No. 7,454,248, issued November 18, 2008 by Burrell et al.; and U.S. Patent No. 2,454,248, issued November 18, 2008 by Vass et al. U.S. Patent No. 7,499,743, issued March 3, 2009; U.S. Patent No. 7,565,190, issued July 21, 2009 by Okerlund et al.; U.S. Patent No. 7,587,074, issued September 8, 2009 by Zakh et al.; U.S. Patent No. 7,599,730, issued October 6, 2009 by Hunter et al.; U.S. Patent No. 7,613,500, issued November 3, 2009 by Vass et al.; U.S. Patent No. 7,742,629, issued June 22, 2010 by Zakh et al.; and U.S. Patent No. 7,742,629, issued June 29, 2010 by Okerlund et al. U.S. Patent No. 7,747,047, U.S. Patent No. 7,778,685 issued by Evron et al. on August 17, 2010, U.S. Patent No. 7,778,686 issued by Vass et al. on August 17, 2010, U.S. Patent No. 7,813,785 issued by Okerlund et al. on October 12, 2010, U.S. Patent No. 7,996,063 issued by Vass et al. on August 9, 2011, U.S. Patent No. 8,060,185 issued by Hunter et al. on November 15, 2011, and U.S. Patent No. 8,401 issued by Verard et al. on March 19, 2013.Number 616, each of which is incorporated herein by full quotation.

[0030] 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 and analyze data, such as electrical signals (e.g., electrocardiogram data), electrical activation time, electrical heterogeneity information, etc. One of multiple cardiac cycles or heartbeats represented by electrical signals collected or monitored by the electrode device 110 can be analyzed and evaluated for one or more metrics, including activation time and electrical heterogeneity information relating to the nature of the treatment with respect to one or more parameters (such as pacing parameters, lead position, etc.). More specifically, for example, the QRS complex of a single cardiac cycle can be evaluated against one or more measures, such as, for example, QRS onset, QRS deviation, QRS peak, electrical heterogeneity information (EHI), electrical activation time referenced to the earliest activation time, standard deviation of left ventricular or chest electrical activation time (LVED), standard deviation of activation time (SDAT), mean left ventricular or chest substitution electrical activation time (LVAT), QRS duration (e.g., the interval between QRS onset and QRS deviation), the difference between the mean left substitution activation time and the mean right substitution activation time, relative or absolute QRS morphology, the difference between the higher and lower percentiles of activation time (the higher percentile can be 90%, 80%, 75%, 70%, etc., and the lower percentile can be 10%, 15%, 20%, 25%, and 30%, etc.), central tendency (e.g., median or mode), dispersion (e.g., mean deviation, standard deviation, variance, interquartile range, range), and other statistical measures. Furthermore, each of 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 (e.g., the patient's left side, the patient's right side, etc.).

[0031] 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, a tablet computer, a mobile device, and a cellular phone. 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 data storage devices that allow 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 QRS initiation, QRS offset, median, mode, average, peak or maximum, valley or minimum, for determining electrical excitation time, and for driving a graphical user interface configured to noninvasively assist the user in configuring one or more pacing parameters or settings, 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 quadrupole lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricular pacing only, left ventricular pacing only, etc.), as well as arrhythmia detection and treatment, rate adaptive settings, and performance, etc.

[0032] Computing device 140 can be operatively coupled to input device 142 and display device 130 to transmit data, for example, between each of input device 142 and display device 130, and remote computing device 160 can be operatively coupled to input device 162 and display device 170 to transmit data, for example, between each of input device 162 and display device 170. 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 pieces of configuration information related to cardiac therapy delivered by a cardiac therapy device, such as, for example, an implantable medical device.

[0033] 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 electrical excitation, 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 depictions of a patient's heart, graphical depictions of the locations of one or more electrodes, graphical depictions of the human torso, images or graphical depictions of a patient's torso, graphical depictions or actual images of implanted electrodes and / or leads, etc. Furthermore, display devices 130 and 170 may include liquid crystal displays, organic light-emitting diode screens, touch screens, cathode ray tube displays, etc.

[0034] The processing programs or routines stored and / or executed by the computing device 140 and the 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 that implements one or more of the illustrative methods and / or processes described herein. Data stored and / or used by computing device 140 and remote computing device 160 may include, for example, electrical signal / waveform data (e.g., multiple QRS groups) from electrode device 110, electrical excitation 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, graphics areas, 3D graphics, etc.), graphical user interfaces, 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 one or more processes or methods described herein.

[0035] 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 (e.g., 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 described herein or to be applied in a known manner.

[0036] Any programmable language can be used to provide one or more programs for implementing the systems, methods, and / or interfaces described herein, such as high-level programs and / or object-oriented programming languages ​​suitable for communicating with computer systems. For example, any such program can be stored on any suitable means, such as a storage medium, readable by a general or special program that runs on a computer system (e.g., including a processing device) to configure and operate the computer system to perform the programs described herein when read by a suitable device. 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, said logic including code for execution and operable, when executed by a processor or processing circuitry system, to perform operations such as the methods, processes, and / or functions described herein.

[0037] 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 can be read and / or understood by a user.

[0038] In view of the foregoing, it will be apparent that the functions described in one or more embodiments of this disclosure can be implemented in any manner 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). Furthermore, additional illustrative systems, methods, and apparatus that may be used in conjunction with this disclosure can be described in U.S. Provisional Patent Application Serial No. 62 / 913,002, filed October 9, 2019, entitled "Systems, Methods, and Devices for Determining Cardiac Condition".

[0039] The illustrative electrode device 110 can be configured to measure the surface potential of the patient 14's body and, more specifically, the surface potential of the patient 14's torso. For example... Figure 2 As shown, the illustrative electrode device 110 may include an external electrode 112, an array or collection of strips 113, and an interface / amplifier circuitry system 116. The electrode 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 14 such that the electrode 112 surrounds the patient's heart. As further shown, the electrode 112 may be positioned around the circumference of the patient 14, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0040] The illustrative electrode device 110 can be further configured to measure or monitor at least one or both sounds from the patient 14. For example... Figure 2 As 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 14 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 14, including posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0041] 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 wireless connections (e.g., as data channels) 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 computing device 140 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc.

[0042] Despite Figure 2In one embodiment, the electrode device 110 includes a strip 113, but in other embodiments, any of a variety of mechanisms, such as tape or adhesive, may be used to assist in the spacing and placement of the electrodes 112 and the acoustic sensor 120. In some embodiments, the strip 113 may include elastic bands, tape strips, or cloth. Further, in some embodiments, the strip 113 may be part of or integrated with a garment (e.g., a T-shirt). In other embodiments, the electrodes 112 and the acoustic sensor 120 may be placed separately on the torso of the patient 14. Further, in other embodiments, one or both of the electrodes 112 (e.g., arranged in an array) and the acoustic sensor 120 (e.g., also arranged in an array) may be patches, vests, and / or other means of securing or positioning the electrodes 112 and the acoustic sensor 120 to the torso of the patient 14. Still further, in other embodiments, one or both of the electrodes 112 and the acoustic sensor 120 may be two parts of a material or two patches or located therein. One of the two patches may be positioned on the front of the patient 14's torso (e.g., to monitor 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 from the front of the patient, etc.), and the other patch may be positioned on the back of the patient 14's torso (e.g., to monitor 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 from the back of the patient, etc.). Furthermore, in other embodiments, one or both of the electrodes 112 and acoustic sensors 120 may be arranged in top and bottom rows extending from the front of the patient 14 across the left side of the patient 14 to the back of the patient 14. Still further, in other embodiments, one or both of the electrodes 112 and acoustic sensors 120 may be arranged in a curved pattern around the axillary region and may have a lower electrode / sensor density on the right chest than in the remaining areas.

[0043] Electrodes 112 can be configured to surround the heart of patient 14 and record or monitor electrical signals associated with cardiac depolarization and repolarization after a signal has propagated through the torso of patient 14. Each electrode in 112 can be used in a monopolar 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 monopolar sensing.

[0044] In some embodiments, there may be about 12 to about 50 electrodes 112 spatially distributed around the patient's torso and about 12 to about 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 14. 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 14. For example, the electrodes 112 and acoustic sensors 120 may be distributed on the front, back, and left sides of the patient, with fewer or no electrodes and acoustic sensors near the right side (including the posterior and anterior regions of the patient's right side).

[0045] The computing device 140 can record and analyze torso surface potential signals sensed by electrode 112 and sound signals sensed by acoustic sensor 120, which are amplified / modulated by interface / amplifier circuitry system 116. The computing device 140 can be configured to analyze electrical signals from electrode 112 to provide electrocardiogram (ECG) signals, information, or data from the patient's heart, as will be further described herein. The computing device 140 can also 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).

[0046] Additionally, computing device 140 and telecomputing device 160 can be configured to provide graphical user interfaces 132, 172 that depict various information associated with electrode device 110 and data collected or sensed using electrode device 110. For example, graphical user interfaces 132, 172 can depict ECG data including QRS complexes obtained using electrode device 110 and acoustic data including sound waves obtained using acoustic sensor 120, along with 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.

[0047] Furthermore, the electrode device 110 may further include, for example, reference electrodes and / or drive electrodes positioned around the lower torso of the patient 14, 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-end reference electrodes (e.g., instead of the standard reference used in the Wilson Central Terminal) to obtain a “true” unipolar signal with less noise by averaging the three tail-end positioned reference signals.

[0048] Figure 3 Another illustrative electrode device 110 is shown, comprising multiple electrodes 112 and multiple acoustic sensors 120. The electrodes are configured to surround the heart of a patient 14 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 14. The acoustic sensors are configured to surround the heart of the patient 14 and record or monitor sound signals associated with the heart after the signal has propagated through the torso of the patient 14. The electrode device 110 may include a vest 114 to which the multiple electrodes 112 and multiple acoustic sensors 120 may be attached, or the electrodes 112 and acoustic sensors 120 may be coupled to the vest. In at least one embodiment, the multiple electrodes 112 or an array of the electrodes may be used to collect electrical information, such as alternative electrical excitation times. 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 14, including, for example, posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0049] 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 14. 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 14. In some embodiments, about 25 to about 256 electrodes 112 and about 25 to about 256 acoustic sensors 120 may be distributed around the torso of patient 14, although other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120.

[0050] The illustrative systems and methods can be used to provide noninvasive assistance to users in the assessment of a patient's cardiac health and / or in the assessment and configuration of cardiac treatments currently being delivered to the patient (e.g., via implantable medical devices for pacing therapy, via LVAD, etc.). Furthermore, 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 the wireless signal lines 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.

[0051] The implementations described herein involve measuring the effectiveness of LBB region pacing using metrics related to the morphology of the post-ECG recorded from the ECG band. For example, various implementations involve comparing electrical signals from the ECG band to representative and / or intermediate morphologies of electrical signals. Pacing effectiveness can be determined based on the comparison of the similarity of the electrical signals. Generally, for example, if too many electrical signals differ from the representative morphology, it can be determined that effective pacing has not yet been achieved.

[0052] Figure 4 This document describes an illustrative method 400 for determining the efficacy of LBB engagement. As shown, method 400 includes monitoring electrical activity 410 to generate multiple electrical signals (e.g., ECG or cardiac signals). Electrical activity can be monitored during pacing therapy delivery using VfA pacing therapy. According to various embodiments, multiple electrodes are used to monitor electrical activity. The multiple electrodes may be outer surface electrodes configured in a belt or vest, similar to those described herein. Figure 1-3As 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 excitation of a different part or region of cardiac tissue of the patient's heart. Thus, for example, after a signal has propagated through the patient's torso, multiple electrodes may record or monitor electrical signals associated with depolarization and repolarization at multiple different locations in or around the heart. According to various embodiments, multiple external electrodes may include or comprise multiple posterior electrodes located near the skin of the posterior part of the patient's torso.

[0053] A representative electrical signal pattern 420 can be determined based on multiple monitored electrical signals. According to various embodiments, the representative electrical signal pattern can be based on the median and / or average of at least a portion of all monitored downstream signals. In some cases, the representative electrical signal pattern is based on the median and / or average of all downstream signals.

[0054] The electrical signals monitored that can be used to determine the representative electrical signal morphology can vary. For example, some of the monitored electrical signals that can be used to determine the representative electrical signal morphology may be QRS complexes. Therefore, a representative electrical morphology can be determined by identifying the representative electrical signal morphology of QRS complexes of the same heartbeat for multiple electrical signals. A QRS complex can be defined as the time period between the QRS start point and the QRS end point. The QRS start point and end point can be determined in a variety of different ways. Illustrative systems and methods for determining the QRS start point and end point are described in U.S. Patent Application No. 2018 / 0263522A1, which is incorporated herein by reference in its entirety. In some cases, the representative electrical morphology may be based on the median of all signals between the QRS start point and the QRS end point.

[0055] The effectiveness of the LBB junction can then be determined based on representative electrical signal morphology 430. The effectiveness of the LBB junction can be determined using one or more illustrative procedures further described herein.

[0056] For example, according to various embodiments, the effectiveness of LBB engagement can be determined at least in part based on whether the maximum amplitude of the representative morphology is less than a maximum threshold and / or whether the minimum amplitude of the representative morphology is less than a minimum threshold (e.g., to avoid large bundle branch block, which is typically indicated by a large R wave). If one or both of these conditions are not met, it can be determined that effective LBB engagement has not been achieved. The minimum amplitude threshold can be between approximately -0.1 and -0.25 mV. In at least one embodiment, the minimum amplitude threshold can be -0.1 mV. The maximum amplitude threshold can be between approximately 0.1 mV and 0.25. In at least one embodiment, the maximum amplitude threshold can be 0.1 mV.

[0057] Furthermore, according to various implementations, the effectiveness of LBB bonding can be determined at least in part based on multiple related values ​​calculated or generated for each of a plurality of electrical signals, as will be referenced herein. Figure 5 Described.

[0058] Figure 5 An illustrative process for determining LBB engagement according to an embodiment described herein is shown. Similar to... Figure 4 A representative electrical signal pattern 510 can be determined based on multiple monitored electrical signals (e.g., those monitored in a single heartbeat). Each electrical signal can be compared with the representative electrical signal pattern 520, and multiple correlation values ​​530 corresponding to the multiple electrical signals can be generated from such comparisons. The comparison between each of the multiple electrical signals and the representative pattern can be performed in a variety of different ways. For example, one or more reference points of each signal can be compared with the representative pattern signal.

[0059] An illustrative process may include comparing one or both of the minimum and maximum amplitudes of each electrical signal to a representative pattern. More specifically, the maximum and minimum amplitudes of the representative electrical signal pattern may be determined. The maximum and minimum amplitudes of at least one of a plurality of electrical signals are determined. At least one of the maximum and minimum amplitudes of the at least one electrical signal is compared to the corresponding maximum and / or minimum amplitudes of the representative electrical signal pattern. Depending on various configurations, the maximum amplitude may be determined by determining a signed difference between the maximum peak and the baseline amplitude. The minimum amplitude may be determined based on a signed difference between the minimum peak and / or negative peak and the baseline amplitude. The degree of correlation between the at least one electrical signal and the representative pattern may be determined based on the comparison of the maximum and / or minimum amplitudes.

[0060] Depending on the configuration, the effectiveness of LBB joining can be determined by determining whether a predetermined percentage of multiple relevant values ​​is greater than or equal to a predetermined LBB joining threshold 540. More specifically, each of the multiple relevant values ​​can be compared with the predetermined LBB joining threshold. The percentage of relevant values ​​greater than or equal to the predetermined LBB joining threshold can be determined or generated based on such comparisons. The percentage of relevant values ​​greater than or equal to the predetermined LBB joining threshold can then be compared with the predetermined LBB joining threshold to determine the effectiveness of LBB joining.

[0061] The LBB bonding threshold can range from approximately 0.7 to approximately 0.9. The percentages mentioned above can range from approximately 60% to approximately 90%. In some cases, the bonding threshold is approximately 0.8, and the percentage is approximately 75%. If the percentage of the relevant value is determined to be greater than the threshold 540, then LBB bonding is determined to have been achieved 542.

[0062] In some cases, the median of the signal with a correlation value greater than the joining threshold is determined. This median can be used to determine the effectiveness of LBB joining, as a supplement to or alternative to other methods described herein. For example, if the median is less than a predetermined threshold, it can be determined that effective LBB joining has not yet been achieved. If the median is determined to be greater than or equal to the threshold, it can be determined that effective LBB joining has been achieved.

[0063] If the percentage of the relevant value is determined to be no greater than the threshold 540, then LBB engagement is determined not to have been achieved 544. If LBB engagement has not yet been achieved, adjustments can be made using one or more of various pacing settings or parameters (such as lead position, pacing vector, pacing amplitude, pacing pulse width, pacing timing (e.g., AV delay, VV delay, etc.)) until LBB engagement is determined to have been achieved. In this way, closed-loop adjustments to pacing settings or parameters can be performed to achieve, for example, effective LBB engagement.

[0064] Figure 6 Multiple external electrical signals 610 and a median rear profile 620 (i.e., a thicker line) are shown. In some cases, the minimum amplitude threshold is approximately -0.1 mV. Figure 6 In this context, the minimum median amplitude of 630 is approximately -0.42 mV. Therefore, it is less than the minimum amplitude threshold of -0.1 mV. In some cases, the maximum amplitude threshold is approximately 0.1 mV. Figure 6 In the range, the maximum median amplitude of 640 is approximately 0.054 mV. This is less than the maximum amplitude threshold of 0.1 mV.

[0065] In this embodiment, the engagement threshold is approximately 0.8 and the percentage is approximately 75%. Figure 6 The percentage of late ECGs with a correlation greater than 0.8 is approximately 78%. Figure 6 The median correlation between all rear electrodes and the median rear morphology is approximately 0.97. Since all correlation thresholds are met, it can be determined that effective LBB bonding has likely been achieved in this embodiment. If one or more thresholds are not met, invalid LBB engagement can be identified.

[0066] 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," each of which is incorporated herein by reference in its entirety.

[0067] Figure 7 The text describes an illustrative atrioventricular (VfA) cardiac therapy system, which can be configured to, for example, be described herein with respect to... Figure 1-6 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 7 The 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" refers to 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 to 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 it can perform one of two things 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 basement and / or interseptal region of the left ventricular myocardium of the patient's heart.

[0068] 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 patient's heart to outside the heart. Some leadless devices can be introduced through a vein, but once implanted, the device has no or may not contain any transvenous leads and can be configured to provide cardiac therapy without the use of any transvenous leads. Further, when the device housing is positioned in the atrium, specifically, the leadless VfA device does not use leads to operatively connect to electrodes in the ventricle. Additionally, leadless electrodes can be coupled to the housing of the medical device without the use of leads between the electrodes and the housing.

[0069] 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 embodiments, 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.

[0070] 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 endocardial or epicardial surface. Additionally, each dart electrode assembly may carry or contain 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).

[0071] The cardiac therapy system 2 may also include a separate medical device 50 (in Figure 7(Illustrated schematically) The individual medical device 50 can be positioned outside (e.g., subcutaneously) the patient's heart 8 and can be operatively coupled to the patient's heart 8 to deliver cardiac therapy thereto. In one embodiment, the individual medical device 50 can be an extravascular ICD. In some embodiments, the extravascular ICD can include a defibrillation lead that includes or carries a defibrillation electrode. A therapy carrier can 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 can also be used to sense electrical signals related to the patient's heart 8. The ICD can be configured to deliver electrical therapy including one or more defibrillation or cardioversion shocks. For example, if an arrhythmia is sensed, the ICD can send pulses through the lead to shock the heart and restore its normal rhythm. In some embodiments, the ICD can deliver electrical 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, which is incorporated herein by reference in its entirety.

[0072] In the case of electrical shock therapy (e.g., defibrillation shock delivered by defibrillation electrodes via defibrillation leads), a 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 of approximately 60-80 joules (J) for subcutaneous defibrillation.

[0073] The individual medical device 50 may further include sensing circuitry. The sensing circuitry may be configured to acquire electrical signals sensed through 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 the 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 the control circuitry.

[0074] Device 10 and a separate medical device 50 can cooperate to provide 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 provide 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 embodiment, wireless communication can use a unique, signaling, or triggering electrical pulse provided by device 10 that conducts through the patient's tissue and is detectable by the separate medical device 50. In another embodiment, wireless communication can use a communication interface (e.g., an antenna) of device 10 to provide electromagnetic radiation that propagates through the patient's tissue and is detectable, for example, using a communication interface (e.g., an antenna) of the separate medical device 50.

[0075] Figure 8 yes Figure 7 An enlarged conceptual diagram of the anatomy of an intracardiac medical device 10 and a patient's heart 8. Specifically, device 10 is configured to sense electrical activity and / or deliver pacing therapy. Intracardiac device 10 may include a housing 30. Housing 30 may define internal components of device 10 (such as...). Figure 10The 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 contain (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 embodiments, the housing 30 may include non-conductive materials (e.g., formed therefrom or derived therefrom), including ceramics, glass, sapphire, silicone, polyurethane, epoxy resins, acetyl copolymer plastics, polyetheretherketone (PEEK), liquid crystal polymers, or other biocompatible polymers.

[0076] 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.

[0077] All or part of the housing 30 may serve as a sensing and / or pacing electrode during cardiac therapy. In the illustrated embodiment, the housing 30 includes a proximal housing-based electrode 24 external to a proximal portion of the housing 30 (e.g., closer to the proximal region 34 than the distal region 32). When the housing 30 (e.g., defined by or formed of a conductive material such as titanium alloy or other embodiments listed above) is partially electrically insulated from a non-conductive material (e.g., a coating of parylene, polyurethane, silicone, epoxy resin, or other biocompatible polymers), one or more discrete regions of the conductive material are exposed to form or define the 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 the proximal housing-based electrode 24. In other embodiments, 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, through the conductive housing 30 or, when the housing 30 is a non-conductive material.

[0078] In the illustrated embodiment, 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 embodiments, the proximal housing-based electrode 24 may be positioned at other locations along the housing 30, for example, further away from the illustrated location.

[0079] 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 embodiment 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 tip electrodes 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.

[0080] 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 said 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.

[0081] 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.

[0082] 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 possessing 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.

[0083] The one or more fixation members 20 may be described as one or more “teeth” having a normal bending positioning. The teeth may be held in a distally extending positioning within the delivery tool. The distal tip of the teeth may penetrate cardiac tissue to a limited depth before being resiliently or elastically bent back to the normal bending positioning (as shown) proximally upon release from the delivery tool. Further, the fixation members 20 may 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.), each of which is incorporated herein by reference in its entirety.

[0084] In some embodiments, 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 embodiments, 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.

[0085] 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 embodiments, the dart electrode assembly 12 may have a total combined height 47 or length of the tip electrode 42 and shaft 40 of about 3 mm to about 8 mm. The diameter of the shaft 40 may be less than about 2 mm and may be about 1 mm or less, or even about 0.6 mm or less.

[0086] Figure 9 This is a two-dimensional (2D) ventricular diagram 300 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. The ventricular diagram 300 defines or includes multiple zones 326 corresponding to different regions of the human heart. As shown, zones 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). Zones 326 of the ventricular diagram 300 may include the anterior basal zone 1, anterior basal septal zone 2, subbasal septal zone 3, subbasal zone 4, subbasal lateral zone 5, anterior basal lateral zone 6, anterior mid-septal zone 7, anterior mid-septal zone 8, inferior mid-septal zone 9, inferior mid-septal zone 10, inferior mid-lateral zone 11, anterior mid-lateral zone 12, anterior vertex zone 13, vertex septal zone 14, inferior vertex zone 15, lateral vertex zone 16, and vertex zone 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.

[0087] 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 via 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. Figure 7-8 (Referring to ventricular diagram 300), the basal region includes one or more of the following: anterior basal region 1, anterior basal septal region 2, subbasal septal region 3, subbasal region 4, anterior mid-septal region 7, anterior mid-septal region 8, inferior mid-septal region 9, and inferior mid-septal region 10. Referring to ventricular diagram 300, the septal region includes one or more of the following: anterior basal septal region 2, anterior basal septal region 3, anterior mid-septal region 8, inferior mid-septal region 9, and apical septal region 14.

[0088] 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 anterior basal septal region 2, the subbasal septal region 3, the anterior mid-septal region 8, and the inferior mid-septal region 9.

[0089] In some implementations, when implanted, the tissue-piercing electrode can be positioned within the superior / posterior basal septum region of the left ventricular myocardium. The superior / posterior basal septum region of the left ventricular myocardium may comprise 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 comprise a region 324 generally illustrated as a dashed boundary. As shown, 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.

[0090] Figure 10 The diagram depicts a circuit system, according to one embodiment, that can be enclosed within a housing 30 of device 10 or the housing of any other medical device described herein to provide the function of sensing cardiac signals, determining capture and / or delivering pacing therapy. A separate medical device 50 (such as...) Figure 7 The device (shown) may contain 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 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 embodiments, 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, sensor 90 may include a patient activity sensor 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 the delivery of electrical stimulation therapy by therapy delivery circuitry 84.

[0091] 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 the overall 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 for charging a holding capacitor included in therapy delivery circuitry 84, which is discharged 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.

[0092] Figure 10 The functional blocks shown represent functions included in device 10 and may include any discrete and / or integrated electronic circuit components implementing analog and / or digital circuitry capable of producing the functions attributed to the medical device 10 described herein. Each component may include a processing circuitry system (such as an application-specific integrated circuit (ASIC), electronic circuitry, a processor (shared, dedicated, or grouped), and memory) executing one or more software or firmware programs, combinational logic circuitry, a state machine, or other suitable components or combinations of components providing 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 used by the medical device.

[0093] Memory 82 may comprise 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 comprise 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, after left 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 comprise any of the media listed above.

[0094] 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.

[0095] Sensing circuit 86 may include an atrial (A) sensing channel 87 and a ventricular (V) sensing channel 89. A distal housing-based electrode 22 and a proximal housing-based electrode 24 may be coupled to the atrial sensing channel 87 to sense atrial signals, such as P waves associated with atrial myocardial depolarization. In embodiments 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 system contained in the 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. A tip electrode 42 and a proximal housing-based electrode 24 may be coupled to the ventricular sensing channel 89 to sense ventricular signals, such as R waves associated with ventricular myocardial depolarization.

[0096] 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. The 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 a timing period 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, determined by the control circuitry 80.

[0097] 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. Depending on the specific programmed pacing mode, the sensed event signals can trigger or suppress pacing pulses. 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.

[0098] In some embodiments, device 10 can be configured to deliver various pacing therapies, including bradycardia pacing, cardiac resynchronization therapy, post-shock pacing, and / or tachycardia-related therapies (such as ATP). For example, device 10 can be configured to detect non-sinus tachycardia and deliver ATP. Control circuitry 80 can 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 can be compared with tachycardia detection intervals to detect non-sinus tachycardia. Tachycardia can be detected in a given cardiac chamber based on a threshold number of detected tachycardia detection intervals.

[0099] 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 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.

[0100] 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 responsive 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).

[0101] 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 circuit 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.

[0102] 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.

[0103] The technologies described in this disclosure, including those 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 these technologies can be implemented within one or more processors (including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuit systems, and any combination of such components), embodied in a programmer, such as a physician or patient programmer, stimulator, image processing device, or other device. The terms “module,” “processor,” or “processing circuit system” generally refer to any circuit system, alone or in combination with other logic circuit systems, or any other equivalent circuit system.

[0104] 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.

[0105] 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 media, optical data storage media, etc. The 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.

[0106] 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.

[0107] 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.

[0108] Unless otherwise stated, all figures used in the specification and claims to indicate the size, quantity, and physical properties of features are to be understood as being modified by the terms “complete” or “about”. Therefore, unless indicated to the contrary, the numerical parameters shown in the foregoing specification and appended claims are approximations that may vary depending on the desired properties sought by those skilled in the art using the teachings disclosed herein or, for example, within typical ranges of experimental error.

[0109] The numerical ranges listed by endpoints include all numbers included within the range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within the range. In this document, the terms "at most" or "not greater than" a number (e.g., at most 50) include that number (e.g., 50), and the terms "not less than" a number (e.g., not less than 5) include that number (e.g., 5).

[0110] The terms “coupled” or “connected” refer to components being directly attached to each other (in direct contact) or indirectly attached (having one or more components between and connecting them). Both terms can be modified by “operationally” and “operably”, 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).

[0111] Orientation-related terms, such as “top,” “bottom,” “side,” and “end,” are used to describe the relative positioning of components and do not imply limitation on the orientation of the embodiments under consideration. For example, embodiments described as having a “top” and a “bottom” also include embodiments in which they rotate in various directions, unless otherwise clearly indicated.

[0112] The references to "one embodiment," "implementation," "certain embodiments," or "some embodiments," etc., mean that a particular feature, configuration, composition, or characteristic described in connection with an embodiment is included in at least one embodiment of this disclosure. Therefore, the appearance of these phrases in various places throughout the text does not necessarily refer to the same embodiment of this disclosure. Furthermore, in one or more embodiments, a particular feature, configuration, composition, or characteristic may be combined in any suitable manner.

[0113] As used in this specification and the appended claims, unless otherwise expressly stated herein, the singular forms “a,” “an,” and “the” include embodiments having multiple referents. Unless otherwise expressly stated herein, as used in this specification and the appended claims, the term “or” is generally used in its sense to include “and / or.”

[0114] As used in this article, words such as “have,” “possess,” “include,” and “contain” are used in their open-ended sense and generally refer to “including but not limited to.” It will be understood that phrases such as “consistent with…” and “comprises from…” are included within words such as “contains.”

[0115] The term “and / or” refers to one or all of the listed elements or a combination of at least two of the listed elements. The phrases “at least one,” “including at least one,” and “one or more” that follow the list refer to any item in the list and any combination of two or more items in the list.

[0116] Illustrative Implementation

[0117] Implementation 1. A system for cardiac assessment, comprising: 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, the computing device being operatively coupled to the electrode device and configured to: The plurality of external electrodes are used to monitor electrical activity from patient tissues to generate a plurality of electrical signals; Based on the multiple electrical signals, a representative electrical signal pattern is determined; and The effectiveness of left bundle branch (LBB) junction is determined based on the representative electrical signal morphology.

[0118] Implementation Method 2. A method for cardiac assessment, comprising: Multiple external electrodes are used to monitor electrical activity from the patient's tissues to generate multiple electrical signals; Based on the multiple electrical signals, a representative electrical signal pattern is determined; and The effectiveness of left bundle branch (LBB) junction is determined based on the representative electrical signal morphology.

[0119] Implementation 3. The system or method according to any one of Implementation 1 and 2, wherein the plurality of external electrodes comprises a plurality of surface electrodes to be positioned proximal to the patient's torso skin.

[0120] Embodiment 4. The system or method according to any one of Embodiments 1-3, wherein the plurality of external electrodes comprises a plurality of posterior electrodes to be positioned proximal to the skin of the patient's torso.

[0121] Implementation 5. The system or method according to any one of Implementations 1-4, wherein the representative electrical signal form is a median electrical signal.

[0122] Implementation 6. The system or method according to any one of Implementations 1-5, wherein determining the effectiveness of the LBB junction based on the representative electrical signal morphology includes: Each of the plurality of electrical signals is compared with the representative electrical signal pattern to generate a plurality of correlation values ​​corresponding to the plurality of electrical signals; and The effectiveness of LBB bonding is determined based on the aforementioned multiple relevant values.

[0123] Implementation 7. The system or method according to Implementation 6, wherein determining the effectiveness of LBB bonding based on the plurality of relevant values ​​includes determining the percentage of the plurality of relevant values ​​that are greater than or equal to a predetermined LBB bonding threshold.

[0124] Implementation 8. The system or method according to Implementation 7, wherein the computing device is configured to perform, or the method further includes: determining that LBB bonding has been achieved if the percentage is greater than a predetermined percentage.

[0125] Implementation 9. The system or method according to Implementation 8, wherein the predetermined percentage is approximately 75%.

[0126] Implementation 10. The system or method according to any one of claims 1-9, wherein the computing device is configured to perform, or the method further comprises: Determine the maximum and minimum amplitudes of the representative electrical signal pattern; Determine the maximum and minimum amplitude of at least one of the plurality of electrical signals; The maximum amplitude of each of the plurality of electrical signals is compared with the maximum amplitude of the representative electrical signal pattern, and the minimum amplitude of each of the plurality of electrical signals is compared with the minimum amplitude of the representative electrical signal pattern; and Based on the comparison between the maximum amplitude and the minimum amplitude, the correlation value of each of the plurality of electrical signals is determined.

[0127] Embodiment 11. The system or method according to any one of Embodiments 1-10, wherein during pacing therapy to deliver the ventricle from atrial (VfA) pacing therapy, the plurality of external electrodes are used to monitor electrical activity from the patient's tissues to generate the plurality of electrical signals.

[0128] Implementation 12. The system or method according to any one of Implementations 1-11, wherein determining the representative electrical signal morphology based on the plurality of electrical signals includes determining the representative electrical signal morphology of the QRS complex wave of the same heartbeat of the plurality of electrical signals.

[0129] Implementation Method 13. The system or method according to any one of claims 1-12, wherein the computing device is further configured to perform, or the method further comprises: The maximum amplitude of the representative pattern is compared with the maximum threshold, and the minimum amplitude of the representative pattern is compared with the minimum threshold; and The effectiveness of the left bundle branch (LBB) junction is determined based on the comparison.

[0130] Implementation 14. The system or method according to Implementation 13, wherein the minimum threshold is in the range of about -0.1 mV to about -0.25 mV and the maximum threshold is in the range of about 0.1 mV to about 0.25 mV.

Claims

1. A system for cardiac assessment, comprising: An electrode device comprising a plurality of external electrodes for placement proximal to the patient's skin; and A computing device comprising a processing circuitry system, the computing device being operatively coupled to the electrode device and configured to: The plurality of external electrodes are used to monitor electrical activity from patient tissues to generate a plurality of electrical signals; Based on the multiple electrical signals, a representative electrical signal morphology of the patient is determined; and The pacing efficacy of the left bundle branch (LBB) junction is determined based on the representative electrical signal morphology. in, The computing device is configured to determine the pacing efficacy of the LBB junction based on whether the maximum amplitude of the representative electrical signal morphology is less than a maximum threshold and / or whether the minimum amplitude of the representative electrical signal morphology is less than a minimum threshold.

2. The system according to claim 1, wherein, The plurality of external electrodes comprises a plurality of surface electrodes to be positioned proximal to the patient’s torso skin.

3. The system according to claim 1, wherein, The plurality of external electrodes includes a plurality of posterior electrodes to be positioned proximal to the patient's torso skin.

4. The system according to claim 1, wherein, The representative electrical signal form is the median electrical signal.

5. The system according to claim 1, wherein, Determining the pacing efficacy of the LBB junction based on the representative electrical signal morphology includes: Each of the plurality of electrical signals is compared with the representative electrical signal pattern to generate a plurality of correlation values ​​corresponding to the plurality of electrical signals; and The pacing efficacy of LBB combination is determined based on the aforementioned multiple correlation values.

6. The system according to claim 5, wherein, Determining the pacing efficacy of LBB engagement based on the plurality of relevant values ​​includes determining the percentage of the plurality of relevant values ​​that are greater than or equal to a predetermined LBB engagement threshold.

7. The system according to claim 6, wherein, The computing device is configured to determine if the percentage is greater than a predetermined percentage, then determine that LBB bonding has been achieved.

8. The system according to claim 7, wherein, The predetermined percentage is 75%.

9. The system according to claim 1, wherein, The computing device is configured as follows: Determine the maximum and minimum amplitudes of the representative electrical signal pattern; Determine the maximum and minimum amplitude of each of the plurality of electrical signals; The maximum amplitude of each of the plurality of electrical signals is compared with the maximum amplitude of the representative electrical signal pattern, and the minimum amplitude of each of the plurality of electrical signals is compared with the minimum amplitude of the representative electrical signal pattern; as well as Based on the comparison of the maximum amplitude and the comparison of the minimum amplitude, the correlation value of each of the plurality of electrical signals is determined.

10. The system according to claim 1, wherein, The system is further configured such that the operation of using the plurality of external electrodes to monitor electrical activity from the patient’s tissues to generate the plurality of electrical signals occurs during atrial-ventricular VfA pacing therapy.

11. The system according to claim 1, wherein, Determining the representative electrical signal morphology based on the plurality of electrical signals includes determining the representative electrical signal morphology of the QRS complex wave of the same heartbeat of the plurality of electrical signals.

12. The system according to claim 1, wherein, Determining the representative electrical signal morphology based on the plurality of electrical signals includes: determining the representative electrical signal morphology of at least a portion of a single heartbeat based on the plurality of electrical signals, wherein the plurality of electrical signals are all located on the same at least a portion of a single heartbeat.

13. The system according to claim 12, wherein, The minimum threshold is in the range of -0.1 mV to -0.25 mV and the maximum threshold is in the range of 0.1 mV to 0.25 mV.

14. A computer-readable storage medium including instructions stored thereon, the instructions, when executed by a processor, causing the processor to perform a method for cardiac assessment, the method comprising: Multiple external electrodes are used to monitor electrical activity from the patient's tissues to generate multiple electrical signals; Based on the multiple electrical signals, a representative electrical signal morphology of the patient is determined; and The pacing efficacy of the left bundle branch (LBB) junction is determined based on the representative electrical signal morphology. The pacing efficacy of left bundle branch (LBB) junction is determined based on the representative electrical signal morphology, including: The pacing efficacy of the LBB junction is determined based on whether the maximum amplitude of the representative electrical signal morphology is less than a maximum threshold and / or whether the minimum amplitude of the representative electrical signal morphology is less than a minimum threshold.

15. The computer-readable storage medium according to claim 14, wherein, The plurality of external electrodes comprises a plurality of surface electrodes to be positioned proximal to the patient’s torso skin.

16. The computer-readable storage medium according to claim 14, wherein, The plurality of external electrodes includes a plurality of posterior electrodes to be positioned proximal to the patient's torso skin.

17. The computer-readable storage medium according to claim 14, wherein, The representative electrical signal form is the median electrical signal.

18. The computer-readable storage medium according to claim 14, wherein, Determining the effectiveness of the LBB junction based on the representative electrical signal morphology includes: Each of the plurality of electrical signals is compared with the representative electrical signal pattern to generate a plurality of correlation values ​​corresponding to the plurality of electrical signals; and The effectiveness of the LBB bonding is determined based on the aforementioned multiple relevant values.

19. The computer-readable storage medium according to claim 18, wherein, Determining the pacing efficacy of the LBB engagement based on the plurality of relevant values ​​includes determining the percentage of the plurality of relevant values ​​that are greater than or equal to a predetermined LBB engagement threshold.

20. The computer-readable storage medium of claim 19, further comprising: If the percentage is greater than the predetermined percentage, then the LBB engagement is determined to have been achieved.

21. The computer-readable storage medium according to claim 20, wherein, The predetermined percentage is 75%.

22. The computer-readable storage medium of claim 14, wherein the method further comprises: Determine the maximum and minimum amplitudes of the representative electrical signal pattern; Determine the maximum and minimum amplitude of each of the plurality of electrical signals; The maximum amplitude of each of the plurality of electrical signals is compared with the maximum amplitude of the representative electrical signal pattern, and the minimum amplitude of each of the plurality of electrical signals is compared with the minimum amplitude of the representative electrical signal pattern; as well as Based on the comparison of the maximum amplitude and the comparison of the minimum amplitude, the correlation value of each of the plurality of electrical signals is determined.

23. The computer-readable storage medium according to claim 14, wherein, The operation of using the plurality of external electrodes to monitor electrical activity from the patient’s tissues to generate the plurality of electrical signals occurs during atrial-ventricular VfA pacing therapy.

24. The computer-readable storage medium of claim 14, wherein, Determining the representative electrical signal morphology based on the plurality of electrical signals includes: determining the representative electrical signal morphology of the QRS complex wave of the same heartbeat of the plurality of electrical signals.

25. The computer-readable storage medium according to claim 14, wherein, Determining the representative electrical signal morphology based on the plurality of electrical signals includes: determining the representative electrical signal morphology of at least a portion of a single heartbeat based on the plurality of electrical signals, wherein the plurality of electrical signals are all located on the same at least a portion of a single heartbeat.

26. A system for cardiac assessment, comprising: An electrode device comprising a plurality of external electrodes for placement proximal to the patient's skin; and A computing device comprising a processing circuitry system, the computing device being operatively coupled to the electrode device and configured to: During cardiac conduction system pacing, the multiple external electrodes are used to monitor electrical activity from patient tissues to generate multiple electrical signals; Based on the multiple electrical signals, the representative electrical signal morphology of the patient is determined; as well as The pacing efficacy of the left bundle branch (LBB) junction is determined by pacing the cardiac conduction system based on the representative electrical signal morphology. The computing device is further configured to determine the pacing efficacy of the LBB junction based on whether the maximum amplitude of the representative electrical signal morphology is less than a maximum threshold and / or whether the minimum amplitude of the representative electrical signal morphology is less than a minimum threshold.

27. The system according to claim 26, wherein, Determining the representative electrical signal morphology based on the plurality of electrical signals includes: determining the representative electrical signal morphology of at least a portion of a single heartbeat based on the plurality of electrical signals, wherein the plurality of electrical signals are all located on the same at least a portion of a single heartbeat.

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