System for assessing cardiac therapy

Abstract

This article describes a system and method for evaluating and adjusting cardiac therapy. The system and method can initially evaluate a first pacing parameter while other pacing parameters are fixed to, for example, nominal values, and determine an effective setting for the first pacing parameter. A second pacing parameter can then be evaluated while the first pacing parameter is fixed to the previously determined effective setting. Each evaluation may not test all possible settings of the pacing parameter, but rather various procedures can be used to limit the settings to a subset to be tested.

Description

[0001] The disclosure herein relates to systems and methods for evaluating and configuring cardiac therapies using external electrode devices.

[0002] Implantable medical devices (IMDs), such as implantable pacemakers, cardioverter-defibrillators, or pacemaker-cardioverter-defibrillators, deliver therapeutic electrical stimulation to the heart. IMDs can provide pacing to address 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 control the delivery of electrical stimulation to the heart based on inherent depolarization.

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

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

[0005] For example, systems and devices for performing CRT can offer many different pacing parameters or programming options, including different pacing electrodes and vectors (e.g., quadrupole leads), different pacing configurations (e.g., biventricular, left ventricular only), different pacing times (e.g., AV time, VV time for biventricular pacing), etc. External electrode devices can measure the resynchronization effect of a given set of parameters and help to customize cardiac therapy device programming to maximize the degree of resynchronization. However, there can be hundreds of permutations of pacing parameters; therefore, an efficient method for obtaining the optimal set of pacing parameters in a given patient may be important for improving clinical efficiency. Summary of the Invention

[0006] The illustrative systems and methods described herein can be configured to assist users (e.g., physicians) in assessing and configuring cardiac therapies (e.g., administering cardiac therapy to a patient during and / or after implantation of a cardiac therapy device). In one or more embodiments, the systems and methods can be described as non-invasive. For example, in some embodiments, the systems and methods may not require or include implantable devices (e.g., leads, probes, sensors, catheters, implantable electrodes, etc.) to monitor or acquire multiple cardiac signals from the patient's tissues for assessing and configuring the cardiac therapy being delivered to the patient. Instead, the systems and methods can utilize non-invasive electrical measurements using multiple external electrodes attached to the patient's skin, for example, around the patient's torso. The illustrative systems and methods may include the use of an external electrode device or ECG band applied to the patient's torso to determine optimal synchronization during biventricular and left ventricular pacing. Exemplary systems and methods can be described as providing an efficient search for optimal parameters for programming pacing therapies guided by an ECG band. An efficient parameter search for ECG band-based cardiac resynchronization therapy (CRT) optimization can be important for clinical efficiency and adoption.

[0007] In one or more embodiments, an efficient search for optimal parameters can begin by limiting the parameter set based on the patient’s inherent physiology and other device measurements related to the pacing capture threshold or phrenic nerve stimulation (PNS) threshold of the pacing option / available electrode. For example, the pacing AV time (e.g., the time between intrinsic or pacing atrial depolarization or contraction and ventricular pacing) can be tested between 40% and 80% of the patient’s inherent AV time (e.g., the time between intrinsic or pacing atrial depolarization or contraction and intrinsic ventricular depolarization or contraction). If the patient has AV block, the AV time can be set to a nominal value (e.g., the AV time may not be based on the patient’s inherent AV time). Similarly, pacing electrodes, or particularly pacing electrodes used as cathodes, can be excluded based on considerations of capture thresholds and phrenic nerve stimulation (PNS) thresholds. Furthermore, pacing electrodes, or particularly pacing electrodes used as cathodes, can be excluded manually by the user (e.g., a physician) or can be excluded based on cohort studies of similar patients.

[0008] In one or more embodiments, testing can be performed in a phased manner, wherein biventricular pacing and left ventricular pacing alone are evaluated across available pacing electrodes at AV times set to nominal values ​​or percentiles of the patient’s intrinsic AV time (e.g., 70% of previously measured intrinsic AV time), which is the optimal choice for the majority of patients in population studies. Electrodes or pacing vectors with optimal resynchronization may be included for further testing to find optimal AV time and VV time (e.g., the time interval between intrinsic or pacing left ventricular depolarization and right ventricular pacing). For example, initially, a limited set of AV delays may be tested at, for example, 70%, 50%, and 80% of the patient’s intrinsic AV time. If one of the AV times provides more effective resynchronization than the others (e.g., exceeding a certain threshold), more AV times can be tested around that AV time to reach the optimal AV time. If all three AV times in the limited set show similar degrees of resynchronization, 70% of the AV time can be selected (e.g., chosen as optimal).

[0009] In another embodiment, the assessment or testing of AV time for cardiac pacing therapy can begin with 40% of the patient's inherent AV time, and the pacing AV time can be gradually varied, based on the degree of resynchronization achieved between consecutive pacing AV times (e.g., a larger step if the change in resynchronization is no greater than a pre-specified threshold). In one or more embodiments, a similar strategy can be applied to VV time as well as various other pacing settings. In another embodiment, if the current pacing parameter set produces a degree of resynchronization exceeding a threshold derived from previous cohort studies, indicating a greater likelihood of better outcomes, further testing may be omitted, and the current pacing parameter set can be selected.

[0010] An illustrative system for evaluating cardiac therapy may include an electrode device comprising multiple external electrodes for monitoring electrical activity from a patient's tissues; and a computing device including a processing circuitry system and operatively coupled to the electrode device. The computing device may be configured to monitor electrical activity using the multiple external electrodes, generate electrical heterogeneity information (EHI) based on the monitored electrical activity, and initiate the delivery of pacing therapy using multiple different pacing vectors. Each different pacing vector may use a combination of pacing electrodes different from the other different pacing vectors. The computing device may be further configured to select one or more of the multiple different pacing vectors based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the multiple different pacing vectors, initiate the implementation of pacing therapy using the one or more selected different pacing vectors and multiple different settings of pacing parameters, and identify one or more of the multiple different settings of pacing parameters based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the one or more selected different pacing vectors and multiple different settings of pacing parameters.

[0011] An illustrative method for evaluating cardiac therapy may include monitoring electrical activity using multiple external electrodes from patient tissue, generating electrical heterogeneity information (EHI) based on the monitored electrical activity, and initiating the delivery of pacing therapy using multiple different pacing vectors. Each different pacing vector may use a combination of pacing electrodes different from the other different pacing vectors. The illustrative method may further include selecting one or more of the multiple different pacing vectors based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the multiple different pacing vectors, initiating the implementation of pacing therapy using the one or more selected different pacing vectors and multiple different settings of pacing parameters, and identifying one or more of the multiple different settings of pacing parameters based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the one or more selected different pacing vectors and multiple different settings of pacing parameters.

[0012] An illustrative system for evaluating cardiac therapy may include an electrode device comprising a plurality of external electrodes for monitoring electrical activity from a patient's tissues; and a computing device including a processing circuitry system and operatively coupled to the electrode device. The computing device may be configured to monitor electrical activity using the plurality of external electrodes, generate electrical heterogeneity information (EHI) based on the monitored electrical activity, and initiate the delivery of pacing therapy using a first parameter at a plurality of different first settings. The computing device may be further configured to select one or more of the plurality of different first settings for a first parameter based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the plurality of different first settings, initiate the implementation of pacing therapy using the one or more selected different first parameters and second parameters at a plurality of different second settings, and identify one or more of the plurality of different second setting values ​​based on the EHI generated from the electrical activity monitored during the delivery of pacing therapy using the one or more selected different first settings and a plurality of different second settings.

[0013] The above overview is not intended to describe every embodiment or every implementation of this disclosure. A more complete understanding will become apparent and understood by taking into account the accompanying drawings and the following detailed description and claims. Attached Figure Description

[0014] Figure 1 It is a diagram of an illustrative system that includes electrode devices, display devices, and computing devices.

[0015] Figure 2-3 This is a diagram illustrating an external electrode apparatus used to measure the surface potential of the torso.

[0016] Figure 4 It is a flowchart illustrating the methods for evaluating and configuring cardiac therapies.

[0017] Figure 5A It is a flowchart illustrating an effective method for evaluating cardiac therapy parameters.

[0018] Figure 5B Depicting according to Figure 5A The method effectively evaluated a series of AV time instances.

[0019] Figure 6A This is another block diagram illustrating an effective method for assessing cardiac therapy parameters.

[0020] Figure 6B Depicting according to Figure 6A The method effectively evaluated a series of AV time instances.

[0021] Figure 7 This is a diagram of an illustrative system that includes an illustrative implantable medical device (IMD).

[0022] Figure 8A yes Figure 7 An illustrative diagram of the IMD.

[0023] Figure 8B It is placed in Figure 8A A magnified view of the distal end of the electrical leads in the left ventricle.

[0024] Figure 9A For example Figure 7 A block diagram of the illustrative IMD for the -8 system.

[0025] Figure 9B yes Figure 7 Another block diagram of the illustrative IMD (e.g., implantable pulse generator) circuitry and associated leads used in the -8 system.

[0026] Detailed Implementation of Illustrative Examples

[0027] 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.

[0028] Reference Figure 1 -9 Describes illustrative systems and methods. It will be apparent to those skilled in the art that elements or processes of one embodiment may be used in combination with elements or processes of other embodiments, and that possible embodiments of such systems, methods, and apparatuses using combinations of features set forth herein are not limited to the specific embodiments shown in the figures and / or 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.

[0029] 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, as implantable electrodes may not be used to measure 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).

[0030] Various illustrative systems, methods, and graphical user interfaces can be configured to non-invasively 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 that include external electrodes. Figure 1 The illustration depicts a system 100 including an electrode device 110, a computing device 140, and a remote computing device 160.

[0031] The electrode device 110 shown in the figure includes a plurality of electrodes incorporated into or contained 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 the computing device 140 with electrical signals from each of the electrodes for analysis, evaluation, etc. An illustrative electrode device can be described in U.S. Patent No. 9,320,446, entitled “Bioelectric Sensor Device and Methods,” filed March 27, 2014, and published March 26, 2016. Further reference will be made to… Figure 2-3 A more detailed description of the illustrative electrode device 110.

[0032] 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 may 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.

[0033] For example, illustrative systems and methods can provide image-guided navigation for navigating leads, including electrodes, leadless electrodes, wireless 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 No. 2014 / 0371832, published December 18, 2014 by Ghosh; U.S. Patent Application No. 2014 / 0371833, published December 18, 2014 by Ghosh et al.; U.S. Patent Application No. 2014 / 0323892, published October 30, 2014 by Ghosh et al.; and U.S. Patent Application No. 2014 / 0323882, published October 20, 2014 by Ghosh et al.

[0034] The illustrative imaging device can be configured to capture X-ray images and / or any other alternative imaging modality. 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. An exemplary system employing ultrasound can be found in U.S. Patent Application Serial No. 15 / 643,172 entitled “Non-invasive evaluation of cardiac resynchronization therapy” by Stadler et al., which is incorporated herein by reference in its entirety. Additionally, images can be acquired and displayed in two-dimensional, three-dimensional, or four-dimensional form. In more advanced forms, four-dimensional surface rendering of the heart or other areas of the body can be achieved by incorporating cardiac data or other soft tissue data from images 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, to guide implanted devices to target locations within the heart or other areas of interest.

[0035] 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 No. 2005 / 0008210, published January 13, 2005, by Evron et al.; U.S. Patent Application 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 Okerlund et al. U.S. Patent No. 7,286,866, issued October 23, 2007; 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. 7,454,248, issued November 18, 2008, by Vass et al. in 2009... 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, Evron et al., issued August 17, 2010; U.S. Patent No. 7,778,685, issued August 17, 2010, Vass et al.; U.S. Patent No. 7,778,686, issued August 17, 2010, Okerlund et al.; U.S. Patent No. 7,813,785, issued October 12, 2010, Vass et al.; U.S. Patent No. 7,996,063, issued August 9, 2011, Vass et al.; U.S. Patent No. 8,060,185, issued November 15, 2011, Hunter et al.; and U.S. Patent No. 8,401,616, issued March 19, 2013, Verard et al.

[0036] 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. For example, one cardiac cycle or heartbeat 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, which may be related to the therapeutic nature of one or more parameters involving cardiac therapy, 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 known as the earliest activation time, left ventricular or chest standard deviation (LVED) of the electrical activation time, standard deviation of activation time (SDAT), mean left ventricular or chest alternative electrical activation time (LVAT) referenced to the earliest activation time, QRS duration (e.g., the interval between QRS onset and QRS deviation), the difference between the mean left alternative activation time and the mean right alternative 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), other statistical measures of deviation (e.g., mean deviation, standard deviation, variance, interquartile deviation, range), etc. Furthermore, each of the 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.).

[0037] 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 activation time, and for driving a graphical user interface configured to non-invasively 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.

[0038] Computing device 140 can be operatively coupled to input device 142 and display device 130 to transmit data to and from each of the input devices 142 and 130, for example, and remote computing device 160 can be operatively coupled to input device 162 and display device 170 to transmit data to and from each of the input devices 162 and 170, for example,. For example, computing device 140 and remote computing device 160 can be electrically coupled to input devices 142, 162 and display devices 130, 170 using, for example, analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc. As further described herein, a user can provide input to input devices 142, 162 to view and / or select one or more configuration information related to cardiac therapy delivered by a cardiac therapy device, such as, for example, an implantable medical device.

[0039] 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.). Similarly, display devices 130 and 170 may include any device capable of displaying information to the user, such as graphical user interfaces 132 and 172, including electrode status information, graphical representations of electrical activation, multiple signals from external electrodes on one or more heartbeats, QRS complex waves, 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 the patient's heart, graphical depictions of the locations of one or more electrodes, graphical depictions of the human torso, images or graphical depictions of the 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.

[0040] 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. The data stored and / or used by the computing device 140 and the remote computing device 160 may include, for example, electrical signal / waveform data (e.g., multiple QRS complex waves) from the electrode device 110, electrical activation time from the electrode device 110, heart sound / signal / waveform data from the acoustic sensor, graphics (e.g., graphic elements, icons, buttons, windows, dialog boxes, drop-down menus, graphics areas, graphics regions, 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.

[0041] In one or more embodiments, the illustrative systems, methods, and interfaces may be implemented using one or more computer programs that execute on a programmable computer (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 produce 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.

[0042] 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., containing 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, the logic containing 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.

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

[0044] 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).

[0045] 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.

[0046] 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 2As shown, the illustrative electrode device 110 may include an array or collection of acoustic sensors 120 attached to or coupled to the 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.

[0047] Furthermore, electrode 112 and acoustic sensor 120 can be electrically connected to interface / amplifier circuitry 116 via wired connection 118. Interface / amplifier circuitry 116 can be configured to amplify signals from electrode 112 and acoustic sensor 120 and provide the signals to one or both of computing device 140 and remote computing device 160. Other illustrative systems may use 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.

[0048] Despite Figure 2In one example, electrode device 110 includes a strip 113, but in other examples, any of a variety of mechanisms, such as tape or adhesive, can be used to assist in the spacing and placement of electrodes 112 and acoustic sensors 120. In some examples, strip 113 may comprise elastic bands, tape strips, or cloth. Further, in some examples, strip 113 may be part of or integrated with a garment (e.g., a T-shirt). In other examples, electrodes 112 and acoustic sensors 120 may be placed separately on the torso of patient 14. Further, in other examples, one or both of electrodes 112 (e.g., arranged in an array) and acoustic sensors 120 (e.g., also arranged in an array) may be part of or located within patches, vests, and / or other means of securing electrodes 112 and acoustic sensors 120 to the torso of patient 14. Still further, in other examples, one or both of electrodes 112 and acoustic sensors 120 may be two parts of a material or part of two patches or positioned therein. One of the two patches may be located on the anterior side of the patient 14's torso (to monitor, for example, electrical signals representing the anterior side of the patient's heart, measure the electrical activation time of an alternative heart representing the anterior side of the patient's heart, monitor or measure sound in the anterior side of the patient, etc.), and the other patch may be located on the posterior side of the patient 14's torso (to monitor, for example, electrical signals representing the posterior side of the patient's heart, measure the electrical activation time of an alternative heart representing the posterior side of the patient's heart, monitor or measure sound in the posterior side 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 anterior side of the patient 14 across the left side of the patient 14 to the posterior side 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 curve around the axillary region, and the electrode / sensor density on the right chest may be lower than the density in the other remaining areas.

[0049] 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 the 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.

[0050] In some instances, there may be approximately 12 to approximately 50 electrodes 112 spatially distributed around the patient's torso, and approximately 12 to approximately 50 acoustic sensors 120. Other configurations may have more or fewer electrodes 112 and more or fewer acoustic sensors 120. It should be understood that the electrodes 112 and acoustic sensors 120 may not be arranged or may be distributed in an array that extends all the way around or completely around the patient 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).

[0051] The computing device 140 can record and analyze trunk 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).

[0052] Additionally, computing device 140 and telecomputing device 160 can be configured to provide graphical user interfaces 132 and 172 that depict various information related to electrode device 110 and data collected or sensed using electrode device 110. For example, graphical user interfaces 132 and 172 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 non-invasively use electrical information collected using electrode device 110 and 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.

[0053] Furthermore, the electrode device 110 may further include, for example, reference electrodes and / or drive electrodes positioned around the lower torso of the patient 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” monopolar signal with less noise by averaging the three tail-end positioned reference signals.

[0054] 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 comprise 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 activation time. Similar to... Figure 2 Electrode equipment 110, Figure 3 The electrode device 110 may include an interface / amplifier circuitry 116 electrically coupled to each of the electrodes 112 and acoustic sensors 120 via a wired connection 118 and configured to transmit signals from the electrodes 112 and acoustic sensors 120 to a computing device 140. As shown, the electrodes 112 and acoustic sensors 120 may be distributed on the torso of the patient 14, including, for example, posterior, lateral, posterolateral, anterolateral, and anterior positions of the patient 14's torso.

[0055] Vest 114 may be formed of fabric, with electrodes 112 and acoustic sensors 120 attached to the fabric. Vest 114 may be configured to maintain the positioning and spacing of electrodes 112 and acoustic sensors 120 on the torso of patient 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 instances, approximately 25 to approximately 256 electrodes 112 and approximately 25 to approximately 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.

[0056] Illustrative systems and methods can be used to provide non-invasive assistance to users in assessing a patient’s cardiac health status and / or assessing and configuring cardiac therapies currently delivered to the patient (e.g., via implantable medical devices, via LVADs, etc.). For example, illustrative systems and methods can be used to assist users in configuring and / or adjusting one or more cardiac therapy settings, such as, for example, selecting pacing electrodes, selecting pacing vectors, optimizing the AV interval or delay of pacing therapies (e.g., left ventricular only or left univentricular pacing therapy), and the VV interval or delay of pacing therapies (e.g., biventricular pacing therapy).

[0057] 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 embodiment, computing device 140 can be operatively wirelessly coupled to remote computing device 160, as depicted by the wireless signal lines emitted 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 one or a wired electrical connection.

[0058] Figure 4 The illustrative method 200 for evaluating and configuring cardiac therapy is described herein. Illustrative method 200 can generally be described as an effective, non-invasive evaluation and configuration (e.g., optimization) of cardiac therapy. Illustrative method 200 can be described as non-invasive because the method does not use invasive devices to perform the evaluation of the cardiac therapy. However, the delivered cardiac therapy can be described as invasive, such as one or more pacing electrodes that can be implanted near the patient's heart. Therefore, illustrative method 200 can be used to evaluate and configure such invasive cardiac therapy.

[0059] The illustrative method 200 can generally be described as effectively determining the pacing settings or values ​​of multiple pacing parameters for cardiac pacing therapies such as left ventricular pacing only, biventricular pacing, etc. Method 200 can utilize various techniques and processes that enable such determination or selection of pacing settings or values.

[0060] It should be understood that pacing therapy can have multiple different pacing parameters, such as AV time, VV time, selection of pacing electrode or pacing vector (e.g., multi-site pacing), selection of multiple pacing electrodes or multi-point pacing vectors, pacing pulse width, pacing pulse amplitude (e.g., voltage), ventricular pacing rate, pacing configuration (e.g., biventricular pacing, right ventricular pacing only, left ventricular pacing only, etc.), and rate-adaptive pacing settings. Each of these different pacing parameters can include multiple different settings or values. Some different pacing parameters can be extended to the entire value range.

[0061] For example, one pacing parameter that will be frequently described herein can be a pacing vector, which is an identifier for one or more pacing electrodes used to deliver pacing to a patient's heart. Depending on the number of pacing electrodes positioned near the patient's heart to deliver cardiac pacing therapy, multiple pacing vectors may exist. Multiple pacing vectors can include each different combination using one or more pacing electrodes positioned in or around the patient's heart. For example, if four pacing electrodes are configured to pace the patient's heart, sixteen different pacing vectors can be derived from these four pacing electrodes. In other words, when there are four pacing electrodes, sixteen different combinations of pacing electrodes can be used to pace the patient's heart. Pacing vectors can be described based on the identity or name of the electrodes used to deliver pacing therapy.

[0062] Furthermore, for example, one pacing parameter that will be frequently described in this article is the pacing AV time, which is the time interval between the intrinsic or pacing depolarization of the atrium and the delivery of ventricular pacing. The pacing AV time can be described in terms of time values. For example, the pacing AV time can be between approximately 40 ms and approximately 300 ms. The pacing AV time can also be described as a percentage of the patient's intrinsic AV time. For example, the pacing AV time can be between approximately 30% and approximately 90% of the patient's intrinsic AV time. Other times (e.g., VV time) can be described similarly but with different values.

[0063] The illustrative method 200 can be configured to effectively evaluate or test each of a plurality of different pacing parameters, such as pacing vector, AV time, etc. Typically, the illustrative method 200 can be described as testing or evaluating a first pacing parameter while isolating the remaining pacing parameters (e.g., fixing the remaining pacing parameters so that their values ​​or settings do not change during the testing of the first pacing parameter), and once the value or setting of the first pacing parameter has been selected (e.g., optimized), a second pacing parameter can be evaluated while isolating the first pacing parameter (e.g., the first pacing parameter can be fixed or remain unchanged at the selected settings or values).

[0064] The illustrative method 200 may include monitoring or measuring electrical activity 202 using multiple external electrodes. The multiple external electrodes may be similar to those described herein. Figure 1-3 The described electrode device 110 provides external electrodes. For example, the plurality of external electrodes may be part of or incorporated into a vest or bandage located around the patient's torso. More specifically, the plurality of electrodes may be described as surface electrodes positioned in an array near the skin of the patient's torso. The electrical activity monitored prior to the delivery of cardiac therapy may be referred to as "baseline" electrical activity because no therapy is delivered to the patient, allowing the patient's heart to be in its natural or inherent rhythm.

[0065] Although monitoring electrical activity 202 is the first procedure mentioned in method 200, it should be understood that monitoring electrical activity 202 can occur or be performed at any time within method 200, but primarily during the delivery of pacing therapy for evaluation or testing. Various different pacing parameters will be further described in this document.

[0066] Before evaluating multiple different pacing parameters, some settings or values ​​of these different pacing parameters may have been determined to be undesirable or unnecessary for use in delivering cardiac pacing therapy. For example, some pacing vectors and their electrodes may be known to stimulate the patient's phrenic nerve (e.g., based on previous clinical data) or are highly likely to stimulate the patient's phrenic nerve (e.g., based on cohort studies and / or other indicators). Furthermore, for example, some pacing vectors and their electrodes may be known to have high capture thresholds (e.g., based on previous clinical data) or a high probability of having high capture thresholds (e.g., based on cohort studies and / or other indicators). In one or more embodiments, the capture threshold is the amplitude and pulse width of electrical pacing delivered by the pacing electrode or more than one pacing electrode in a multi-point or multi-site pacing vector required to electrically capture and effectively depolarize myocardial tissue. If a pacing vector has a high capture threshold, the battery life of the cardiac therapy device may be shortened and less desirable. Therefore, pacing vectors with high capture thresholds are less desirable.

[0067] The illustrative method 200 may include removing settings or values ​​that may be undesirable or unnecessary 204. For example, any pacing electrode used to provide stimulation or potentially stimulate the patient's phrenic nerve with multiple different pacing vectors, or a pacing electrode specifically used as a cathode, may be dequalified or removed from the multiple different pacing vectors to be evaluated or tested. Furthermore, for example, pacing electrodes exceeding a selected capture threshold (e.g., used to provide multiple different pacing vectors) may be dequalified or removed from the multiple different pacing vectors to be evaluated or tested. The selected capture threshold may be between approximately 4 volts (V) and approximately 6V. In at least one embodiment, the selected capture threshold is 5V. Additionally, for example, a user (e.g., a physician using a graphical user interface) may manually remove or exclude various settings or values.

[0068] For example, if four different pacing electrodes can be used to deliver cardiac pacing therapy, this provides sixteen different or unique pacing vectors, and one of the four pacing electrodes is known or identified as stimulating the phrenic nerve or having too high a pacing threshold when used as a cathode, such electrode can be removed as a potential cathode to deliver pacing therapy, thus limiting the number of different pacing vectors to twelve different or unique pacing vectors.

[0069] Additionally, for example, the range of values ​​for one or more pacing parameters can be limited, thereby removing value 204. For example, instead of testing a larger percentage range or a wider range of time values ​​without using the patient's inherent value as a baseline, AV time can be limited to approximately 40% to approximately 80% of the patient's inherent AV time. Furthermore, if the patient has AV block, the AV time can be initially set to a selected nominal value, rather than testing or evaluating a range of values. In this way, fewer time values ​​of the AV time parameter can be tested, thereby improving the efficiency of configuring the AV time for the patient's cardiac therapy. Furthermore, if the patient has atrial fibrillation and / or atrial tachycardia, AV time may not be tested (e.g., implementation of AV time-based pacing therapy is not helpful in this case). In at least one embodiment, the user (e.g., a physician) can determine that the patient is experiencing atrial fibrillation and / or atrial tachycardia and can manually remove the AV time from the pool of available settings. In another embodiment, in response to a patient experiencing atrial fibrillation and / or atrial tachycardia (e.g., AF / AT detected by the system, AF / AT entered by the user, etc.), the AV time can be automatically removed from the available settings pool.

[0070] In other words, the efficient search for the optimal parameters described in this article can begin by limiting the set of values ​​or settings of certain parameters based on the patient’s inherent physiology and other device measurements related to the pacing capture threshold or phrenic nerve stimulation (PNS) threshold of the pacing options / available electrodes.

[0071] During or simultaneously with monitoring or collecting electrical activity 202, the illustrative method 200 may also include delivery of cardiac pacing therapy 206. In at least one embodiment, each electrode in the electrodes may be coupled to one or more leads implanted in or near the patient's heart. Further, in at least one embodiment, cardiac therapy 206 may be delivered via leadless electrodes. Illustrative cardiac therapies using implantable electrodes and leads can be further described herein with reference to Figures 6-8. Although the system and apparatus of Figures 6-8 contain three leads, it should be understood that the illustrative systems and methods described herein can be used with any type of cardiac pacing system, including leadless, fewer than three, and more than three leads. As described herein, although cardiac therapy delivery may be described as invasive, the illustrative methods and systems may be described as non-invasive because the illustrative methods and systems may only initiate the delivery and configuration of cardiac therapy, and the illustrative methods and systems may further utilize electrical signals non-invasively monitored or acquired from the patient. Furthermore, illustrative cardiac therapies may utilize leaded or leadless implantable cardiac devices comprising tissue-piercing electrodes implantable through the right atrial endocardium and central fibrous body from the Koch triangle region of the right atrium to deliver cardiac therapy to or sense electrical activity in the left ventricle in the basal and / or septal region of the left ventricular myocardium of a patient's heart, as described in U.S. Provisional Patent Application Serial No. 62 / 647,414 entitled "VfA Cardiac Therapy" filed March 23, 2018, and U.S. Provisional Patent Application Serial No. 62 / 725,763 entitled "Adaptive VfA Cardiac Therapy" filed August 31, 2018, each of which is incorporated herein by reference in its entirety.

[0072] Cardiac pacing therapy can be delivered using specific, unique configurations of multiple different cardiac pacing parameters. For example, cardiac pacing therapy could be left ventricular pacing only, with a pacing vector using a single pacing electrode (LV1) at 55% of the patient's inherent AV time, a pacing amplitude of 3.5 volts, and a pulse width of 0.8 milliseconds (ms). For the specific, unique configuration of cardiac pacing parameters, monitored electrical activity can be used to generate electrical heterogeneity information (EHI)208. EHI can be described as information or data representing at least one of mechanical cardiac function and electrical cardiac function. Information on EHI and other cardiac therapies can be described in U.S. Provisional Patent Application No. 61 / 834,133, filed June 12, 2013, entitled “Metrics of Electrical Dyssynchrony and Electrical Activation Patterns from Surface ECG Electrodes,” which is incorporated herein by reference in its entirety.

[0073] Electrical heterogeneity information (e.g., data) can be defined as information indicating at least one of mechanical or asynchronicity of the heart and / or electrical or asynchronicity of the heart. In other words, electrical heterogeneity information can represent alternatives to the actual mechanical and / or electrical function of a patient's heart. In at least one embodiment, relative changes in electrical heterogeneity information (e.g., from baseline heterogeneity information to therapeutic heterogeneity information, from a first set of heterogeneity information to a second set of therapeutic heterogeneity information, etc.) can be used to determine alternative values ​​representing changes in hemodynamic response (e.g., abrupt changes in the LV pressure gradient). Left ventricular pressure can typically be invasively monitored using a pressure sensor positioned in the left ventricle of a patient's heart. Thus, using electrical heterogeneity information to determine alternative values ​​representing left ventricular pressure avoids the invasive monitoring required by left ventricular pressure sensors.

[0074] In at least one embodiment, the electrical heterogeneity information may include the standard deviation of ventricular activation time measured using some or all of the external electrodes, such as those in electrode device 110. Further, local or regional electrical heterogeneity information may include the standard deviation and / or mean of activation time measured using electrodes located in certain anatomical regions of the trunk. For example, external electrodes on the left side of the patient's trunk may be used to calculate local or regional left-sided electrical heterogeneity information.

[0075] Electrical heterogeneity information can be generated using one or more different systems and / or methods. For example, electrical heterogeneity information can be generated using arrays or multiple surface electrodes and / or imaging systems as described below: U.S. Patent Application Publication No. 2012 / 0283587A1, published November 8, 2012, entitled "Assessing Intracardiac Activation Patterns and Electrical Dyssynergy"; U.S. Patent Application Publication No. 2012 / 0284003A1, published November 8, 2012, entitled "Assessing Intracardiac Activation Patterns"; and U.S. Patent No. 8,180,428B2, published May 15, 2012, entitled "Methods and Systems for Using in Selecting Cardiac Pacing Sites".

[0076] Electrical heterogeneity information may include one or more measures or metrics. For example, one measure or metric of electrical heterogeneity may be the standard deviation of activation time (SDAT) measured using some or all electrodes on the surface of a patient's torso. In some instances, SDAT may be calculated using estimated cardiac activation time on the surface of a model heart.

[0077] Another measure or indicator of electrical heterogeneity can be the left standard deviation of the surrogate electrical activation time (LVED) monitored by external electrodes located near the patient's left side. Further, another measure or indicator of electrical heterogeneity can include the average of the surrogate electrical activation time (LVAT) monitored by external electrodes located near the patient's left side. LVED and LVAT can be determined (e.g., calculated, estimated, etc.) based solely on electrical activity measured by electrodes located only near the patient's left side, which may be referred to as "left" electrodes. A left electrode can be defined as any surface electrode located near the left ventricle, which comprises the region on the left side of the patient's sternum and spine. In one embodiment, a left electrode may comprise all anterior electrodes on the left side of the sternum and all posterior electrodes on the left side of the spine. In another embodiment, a left electrode may comprise all anterior and all posterior electrodes on the left side of the sternum. In yet another embodiment, a left electrode may be designated based on the contours of the left and right sides of the heart determined using imaging equipment such as X-rays, fluoroscopy, etc.

[0078] Another illustrative measure or index of asynchrony can be the range of activation time (RAT), which can be calculated as the difference between the maximum and minimum activation times on the trunk surface or heart, for example, overall or for a region. RAT reflects the span of activation time, while SDAT gives an estimate of the deviation of activation time from the mean. SDAT also provides an estimate of the heterogeneity of activation time, because if activation time is spatially heterogeneous, individual activation times will be further away from the mean activation time, indicating activation delays in one or more regions of the heart. In some instances, RAT can be calculated using estimated cardiac activation times on the surface of a model heart.

[0079] Another illustrative measure or index of electrical heterogeneity information may include an estimate of the percentage of surface electrodes located in a specific region of interest in the trunk or heart whose relevant activation time is greater than a certain percentile (e.g., the 70th percentile) of the measured QRS complex duration or the determined activation time of the surface electrodes. The region of interest may be, for example, the posterior, left anterior, and / or left ventricular regions. An illustrative measure or index may be referred to as the percentage of delayed activation (PLAT). PLAT can be described as providing an estimate of the percentage of the region of interest, such as the posterior and left anterior regions associated with the left ventricular region of the heart, which are activated later. A larger PLAT value may indicate delayed activation of a majority of the region (e.g., the left ventricle) and the potential benefit of electrical resynchronization via CRT through pre-excitation of the late region (e.g., the left ventricle). In other instances, PLAT may be determined for other subsets of electrodes in other regions, such as the right anterior region, to assess delayed activation in the right ventricle. In addition, in some instances, the estimated cardiac activation time on the surface of a model heart can be used to calculate PLAT for the entire heart or a specific region of the heart (e.g., the left or right ventricle).

[0080] In one or more embodiments, the electrical heterogeneity information may include indicators of favorable changes in overall cardiac electrical activation, as described in: Sweeney et al., “Analysis of Ventricular Activation Using Surface Electrocardiography to Predict Left Ventricular Reverse Volumetric Remodeling During Cardiac Resynchronization Therapy”, Circulation, 9 February 2010, 121(5):626-34 and / or Van Deursen et al., “Vectorcardiography as a Tool for Easy Optimization of Cardiac Resynchronization Therapy in Canine LBBB Hearts”, Circulation Arrhythmia and Electrophysiology, 1 June 2012, 5(3):544-52.Heterogeneity information may also include measurements of improved cardiac mechanical function, measured by imaging or other systems, to track the movement of implanted leads within the heart, as described in: Ryu et al., “Simultaneous Electrical and Mechanical Mapping Using 3D Cardiac Mapping System: Novel Approach for Optimal Cardiac Resynchronization Therapy”, Journal of Cardiovascular Electrophysiology, February 2010, 21(2):219-22; Sperzel et al., “Intraoperative Characterization of Interventricular Mechanical Dyssynchrony Using Electroanatomic Mapping System—A Feasibility Study”, Journal of Interventional Cardiac Electrophysiology, November 2012, 35(2):189-96 and / or entitled “METHOD FOR The OPTIMIZAING CRT THERAPY is described in U.S. Patent Application No. 2009 / 0099619A1, published on April 16, 2009.

[0081] In addition, although not in Figure 4 The block diagram is depicted, but electrical heterogeneity information 208 can be generated for electrical activity monitored without or before delivery of cardiac therapy, which may be referred to as baseline electrical heterogeneity information.

[0082] Once electrical heterogeneity information (EHI) 208 has been generated for the current unique cardiac pacing configuration, the illustrative method 200 can adjust the first parameter 210 of multiple different cardiac pacing parameters. All other pacing parameters besides the first parameter of the current unique cardiac pacing configuration can remain unchanged. Thus, no other parameter besides the first parameter being adjusted or changed will affect the cardiac treatment outcome; therefore, the first parameter can be isolated for analysis.

[0083] After the first parameter has been adjusted, method 200 can return to the delivery of pacing therapy 206, where the first parameter has been adjusted and an EHI 208 is generated based on the electrical activity monitored during the delivery of such pacing therapy. Method 200 can continue to cycle until the first parameter has been fully and / or successfully evaluated or tested.

[0084] For example, a first parameter may have a range of values ​​or settings that can be tested or evaluated, and if cardiac therapy has been delivered at each of the ranges or values ​​or settings, and electrical activity has been monitored and an EHI has been generated, then it can be determined that the first parameter has been evaluated or tested. It should be understood that although any numerical range of parameter values ​​can mathematically have an infinite number of values ​​within it, each parameter may have a minimum step size or adjustment value by which it can be adjusted, thereby limiting the range of iterations within a specific range.

[0085] For example, if the EHI generated from monitored electrical activity indicates that the cardiac therapy is effective for the patient at each delivery of cardiac therapy with a range, value, or setting, then the first parameter can be determined to have been successfully evaluated or tested. In this case, method 200 can stop at this point because the current configuration has been determined to be effective. The effectiveness of the current configuration can be compared to a threshold, which can be based on a patient population study. More specifically, the EHI can be SDAT, and if the SDAT is less than or equal to a selected SDAT threshold, such as 30 ms, then the current cardiac therapy pacing configuration can be determined to be effective, and cardiac therapy evaluation and testing can stop. In other words, if the degree of resynchronization generated by the current parameter set exceeds a threshold derived from previous population studies, indicating a greater likelihood of better results, further testing may not be completed.

[0086] However, illustrative method 200 may not evaluate or test the first parameter at every possible value or setting. Instead, method 200 may utilize one or more processes, for example, depending on the parameter being evaluated or tested, to improve efficiency. Figure 5AThe document describes an illustrative method 250 for effectively evaluating cardiac therapy parameters. Method 250 may include delivering cardiac pacing therapy 252 within a subset of settings. The subset of settings or values ​​may be less than, and potentially significantly less than, the entire range of possible settings or values. In one or more embodiments, the subset of settings or values ​​may be equidistantly distributed around a range of possible settings or values, for example, if the parameter is a numerical range of possible settings or values ​​in chronological order. In one or more embodiments, the subset of settings or values ​​may be based on patient metrics and cohort studies of similar patients. In other words, the subset of settings or values ​​initially tested may be effective or optimal when used for other patients similar to the current patient. Furthermore, it can be described that different settings are automatically suggested to a user (e.g., a physician) based on data selected from a pool of patients with characteristics similar to the patient and / or data already known about the patient. Thus, process 252 may first evaluate several different settings or values ​​of the parameter, rather than evaluating every possible setting or value of the parameter.

[0087] Method 250 can then select one or more optimal settings or values ​​from a subset based on the effectiveness of the settings or values. In one or more embodiments, the optimal one or more settings or values ​​may be the most effective one or more settings or values ​​(e.g., most effective in increasing cardiac resynchronization of the patient's heart). For example, electrical activity can be monitored using an external electrode device, an EHI can be generated based on the monitored electrical activity, and one or more optimal settings or values ​​of a subset can be selected. In one instance, a single setting of the subset (e.g., the optimal setting) can be selected. In other instances, more settings of the subset can be selected if, for example, an additional setting exceeds a selected threshold indicating an effective cardiac therapy.

[0088] Then, to further fine-tune the parameters, method 250 can deliver pacing therapy 258 within a range of settings or values ​​close to the selected optimal setting. In other words, settings close to or similar to the selected optimal setting can be used to deliver cardiac pacing therapy. Method 250 can then identify setting 258 from the range of settings close to the selected optimal setting based on the effectiveness of the setting (e.g., similar to how EHI was previously used to determine the effectiveness of the delivered cardiac therapy).

[0089] Figure 5B It describes according to Figure 5A The method effectively evaluated a series of AV time instances. Within a first range of 260 pacing AV time percentages of the patient's inherent AV time, three different pacing AV time percentages were used to deliver cardiac therapy and were evaluated: 50%, 70%, and 80%. Each of the three different pacing AV time percentages is a subset of the pacing AV time settings. This can be similar to the methods described in this article regarding... Figure 4Method 200 describes the monitoring and evaluation of the effectiveness of each of three different pacing AV time percentages. One or more of the three different pacing AV time percentages can be determined as optimal or most effective. As shown, a single pacing AV time percentage is determined as optimal or most effective, as indicated by the dashed circle 264 around 50% of the pacing AV time percentage.

[0090] Next, the range 262 of settings approaching 50% of the pacing AV time percentage can be evaluated. As shown, the range of settings approaching 50% of the pacing AV time percentage extends 15% on range 262 to either side of 50% (i.e., from 35% to 65%). Furthermore, tests are performed for every 5% decrease or increase from 50% to 15% of the pacing AV time percentage. In other words, a 5% step size or adjustment is used. Although this embodiment uses a 5% step size or adjustment, it should be understood that step sizes or adjustments greater than or less than 5% can be used. Furthermore, in one or more embodiments, the size of the step size or adjustment can be based on patient metrics and population studies of similar patients. In other words, when evaluating pacing therapy in other patients similar to the current patient, a size of step size or adjustment that has already proven effective or optimal can be used.

[0091] One or more of the different pacing AV time percentages in the range 262 can be determined as optimal or most effective. As shown, a single pacing AV time percentage of 55% is determined to be optimal or most effective, as indicated by the dashed circle 266. Therefore, settings or values ​​for pacing AV times smaller than the entire range can be used. Figures 5A-5B The process shown is evaluated in an effective manner, while generating an effective setting or value for the AV time of pacing.

[0092] Figure 6A Another illustrative method 270 for effectively evaluating cardiac therapy parameters is described herein. Method 270 may include delivering cardiac pacing therapy while changing pacing parameters 272. The settings or values ​​of the pacing parameters may be increased by selected increments to, for example, traverse a range of different settings or values ​​274. For each setting or value, the effectiveness of the setting or value can be monitored and evaluated, similar to the methods described herein. Figure 4Method 200 describes the process. If a setting or value is determined to be less effective than the last evaluated setting or value, method 270 may increase the selected increment 276, and conversely, if a setting or value is determined to be more effective than the last evaluated setting, method 270 may decrease the selected increment 278. In other words, if a previous setting or value of a pacing parameter provides a better result than the current setting or value, the process "accelerates" the evaluation of the remaining settings or values ​​by increasing the increment or step size, and if the current setting or value of a pacing parameter provides a better result than the previous setting or value, the process then "slows down" the evaluation of the remaining settings or values ​​by decreasing the increment or step size. In one or more embodiments, a user (e.g., a physician) may choose whether method 270 can be performed for one or more parameters. For example, a user may want to evaluate or test each setting or value for one or more parameters (e.g., a standard procedure), and therefore instruct the system not to evaluate or test these parameters in the effective manner described in method 270. Instead, these parameters can be tested in a standard incremental manner. Furthermore, in one or more embodiments, the selected increment 278 may be adjusted based on merged patient population data and / or previously known data about the patient.

[0093] Figure 6B It describes according to Figure 6A This method effectively evaluates a series of AV times in an example. In this example, the pacing AV time percentage range 280 extends between 100% and 25% of the patient's inherent AV time, and its testing or evaluation begins at 100%. The current increment or step 282 indicates a value below range 280. In this example, the increment 282 begins at or is initially set to 5% of the patient's inherent AV time. In other embodiments, it should be understood that the increment may be less than 5%. When the pacing AV time percentage of 95% is evaluated and determined to be less effective than the pacing AV time percentage of 100%, the increment may be increased by 5% to 10%. Therefore, the next pacing AV time percentage evaluated is the pacing AV time percentage of 85% (i.e., 95% minus the increased 10% increment). As shown, the pacing AV time percentage of 85% is determined to be less effective than the last pacing AV time percentage of 95%, therefore, the increment is increased by 5% to 15%.

[0094] The next pacing AV time percentage assessed was 70% (i.e., 85% minus the increase of 15%), which was determined to be more effective than the previous pacing AV time percentage of 85%, therefore the increment was reduced by 5% to 10%. Similarly, the next pacing AV time percentage of 60% was determined to be more effective than the previous pacing AV time percentage of 70%, therefore the increment was reduced by 5% to 5%. The next pacing AV time percentage assessed was 55%, which was determined to be similarly effective as the previous pacing AV time percentage of 60%, therefore the increment was neither reduced nor increased.

[0095] In this example, a threshold can be used to determine whether the setting is more effective, less effective, or similar to a previous value. The threshold can be a percentage difference in effectiveness from the previous setting to the current setting, such as 5%. For example, the threshold could be between approximately 2% and approximately 25%. Furthermore, the threshold can be greater than or equal to 2%, greater than or equal to 4%, greater than or equal to 6%, greater than or equal to 10%, etc., and / or less than or equal to 25%, less than or equal to approximately 20%, less than or equal to approximately 17%, less than or equal to approximately 15%, etc. In an illustrative embodiment, if SDAT increases by 5% from the previous setting, it can be determined that the current setting is more effective than the previous setting; conversely, if SDAT deteriorates by 5% from the previous setting, it can be determined that the setting is less effective than the previous setting. If SDAT does not deteriorate or increase by 5% from the previous setting, it can be determined that the setting is similarly effective to the previous setting.

[0096] The next pacing AV time percentage of 50% is determined to be less effective than the last pacing AV time percentage of 55%, therefore, the increment increases by 5% to 10%. Furthermore, the next pacing AV time percentage of 40% is determined to be less effective than the last pacing AV time percentage of 50%, therefore, the increment decreases by 5% to 15%. In other words, changes to AV delay can be made gradually or incrementally, which can be adapted based on changes in the degree of resynchronization achieved between consecutive AVs (e.g., a larger step size if the change in resynchronization does not exceed a pre-specified threshold).

[0097] A 55% percentage of individual pacing AV time can be identified as optimal or most effective, as shown in the dashed circle 284. Therefore, for pacing AV times smaller than the entire range, it is possible to use... Figures 6A-6B The process shown is evaluated in an effective manner, while generating an effective setting or value for the AV time of pacing.

[0098] Furthermore, although the illustrative methods 250 and 270 described herein with respect to Figures 5-6 illustrate the evaluation and adjustment of AV time, it should be understood that the first parameter evaluated and adjusted according to method 200 may include any pacing parameter, such as AV time, VV time, selection of pacing electrode or pacing vector, selection of multiple pacing electrodes or multi-point pacing vectors, pacing pulse width, pacing pulse amplitude (e.g., voltage), ventricular pacing rate, pacing configuration (e.g., biventricular pacing, right ventricular pacing only, left ventricular pacing only, etc.), rate adaptive pacing settings, etc.

[0099] In one illustrative embodiment, the first parameter evaluated and adjusted by method 200 may be a pacing vector. Thus, method 200 may initiate the delivery of pacing therapy using multiple different pacing vectors, each using a combination of pacing electrodes different from the remaining different pacing vectors, and then select one or more of the multiple different pacing vectors, for example, based on an EHI generated from electrical activity monitored during the delivery of pacing therapy using multiple different pacing vectors.

[0100] After the first parameter has been evaluated and adjusted, its setting or value can be identified and fixed. More specifically, for example, the setting or value of the first parameter can be displayed on a graphical user interface, such as the one described in this article. Figure 1 The graphical user interfaces 132 and 172 are shown. In this way, clinicians (e.g., physicians) can be informed of the most effective setting or value of the first parameter determined by method 200.

[0101] Additionally, for example, for the remainder of method 200, the setting or value of the first parameter can be fixed or remain unchanged, so as to isolate the evaluation and adjustment of the first parameter from those of other parameters, for example. In an illustrative example, the first parameter can be a pacing vector, so that the most effective or optimal pacing vector can be identified and fixed 212, allowing the remainder of method 200 to focus on the evaluation and adjustment of other pacing parameters (e.g., different pacing vectors that do not affect the process).

[0102] After the first parameter 212 can be identified and fixed, method 200 can adjust the second parameter 214, generating an EHI 216 based on electrical activity monitored by external electrodes during cardiac therapy delivery with the first fixed pacing parameter and the adjusted second pacing parameter, and continue cycling until the most effective or optimal setting or value of the second pacing parameter is determined. After the second parameter has been evaluated and adjusted, the setting or value of the second parameter 218 can be identified. Similar to the first parameter, for example, the setting or value of the second parameter can be displayed on a graphical user interface, such as as described herein. Figure 1The graphical user interfaces 132 and 172 are shown. In this way, clinicians (e.g., physicians) can be informed of the most effective setting or value of the first parameter determined by method 200. In one illustrative embodiment, the first parameter evaluated and adjusted by method 200 may be the AV time. Thus, method 200 can initiate the delivery of pacing therapy using a fixed first pacing parameter and multiple different AV times, and then select one or more of the multiple different AV times, for example, based on the EHI generated from electrical activity monitored during the delivery of pacing therapy using a fixed first pacing parameter and multiple different AV times.

[0103] Similar to the description already made herein with respect to the first parameter, illustrative method 200 may not evaluate or test the second parameter at every possible value or setting. Instead, method 200 may utilize one or more processes, for example, depending on the parameter being evaluated or tested, to improve efficiency, such as illustrative methods 250 and 270 described herein with respect to Figures 5-6.

[0104] Furthermore, at any point during the evaluation and adjustment of pacing parameters using method 200, if it is determined that the cardiac pacing therapy being delivered is substantially effective, method 200 can stop and simply identify the current pacing settings or values ​​of multiple different pacing parameters. For example, a selected threshold can be used to determine whether the current cardiac pacing settings or values ​​are sufficiently effective to stop method 200. In one case, the generated EHI can be compared to the selected threshold. More specifically, if the SDAT of a particular pacing configuration is less than or equal to 20 ms, and the SDAT decreases by more than 10% from the patient's intrinsic or baseline rhythm (i.e., before or without pacing therapy), method 200 can stop and simply identify the current pacing settings or values ​​of multiple different pacing parameters.

[0105] Therefore, it can be described that if the generated EHI is greater than a selected threshold, the initiation of pacing therapy delivery can be stopped, and the pacing settings or values ​​(e.g., pacing vectors, etc.) used during monitoring of electrical activity that caused the EHI to stop can be identified. In this way, if method 200 finds a substantially effective pacing configuration, method 200 can stop without spending more time searching for other pacing configurations.

[0106] Illustrative cardiac therapy systems and devices can be referenced in this article. Figure 7 -9 further describes that it can be utilized in this paper regarding Figure 1 -5 describes the descriptive systems, interfaces, methods, and processes.

[0107] Figure 7This is a conceptual diagram illustrating a therapeutic system 10 that can be used to deliver pacing therapy to a patient 14. The patient 14 can be, but does not necessarily have to be, a person. The therapeutic system 10 may include an implantable medical device 16 (IMD) that can be coupled to leads 18, 20, 22. The IMD 16 may be, for example, an implantable pacemaker, cardioverter-defibrillator, and / or a defibrillator, which delivers or provides electrical signals (e.g., pacing, etc.) to the heart 12 of the patient 14 via electrodes coupled to one or more of leads 18, 20, 22 and / or senses electrical signals from said heart.

[0108] Leads 18, 20, and 22 extend into the heart 12 of the patient 14 to sense the electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. Figure 7 In the example shown, the right ventricle (RV) lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium 26, and enters the right ventricle 28. The left ventricle (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, and the right atrium 26, and enters the coronary sinus 30 to reach the region adjacent to the free wall of the left ventricle 32 of the heart 12. The right atrium (RA) lead 22 extends through one or more veins and the vena cava, and enters the right atrium 26 of the heart 12.

[0109] The IMD 16 can sense electrical signals, such as those associated with depolarization and repolarization of the heart 12, via electrodes coupled to at least one of leads 18, 20, and 22. In some instances, the IMD 16 delivers pacing therapy (e.g., pacing pulses) to the heart 12 based on electrical signals sensed within the heart 12. The IMD 16 is operable to adjust one or more parameters associated with the pacing therapy, such as AV delay and various other timing, pulse width, amplitude, voltage, burst length, etc. Furthermore, the IMD 16 is operable to deliver pacing therapy using various electrode configurations, which may be monopolar, bipolar, quadrupole, or further multipolar. For example, a multipolar lead may contain several electrodes that can be used to deliver pacing therapy. Thus, a multipolar lead system can provide or supply multiple electrical vectors for pacing from it. The pacing vector may include at least one cathode and at least one anode, the at least one cathode being at least one electrode located on at least one lead, and the at least one anode being at least one electrode located on at least one lead (e.g., the same lead or different leads) and / or on the housing or canister of the IMD. While improvements in cardiac function as a result of pacing therapy may depend primarily on the cathode, electrical parameters such as impedance, pacing threshold voltage, current consumption, and lifespan may be more dependent on the pacing vector, which includes both a cathode and an anode. The IMD 16 may also provide defibrillation and / or cardioversion therapy via electrodes located on at least one of leads 18, 20, 22. Further, the IMD 16 may detect arrhythmias of heart 12, such as fibrillation of ventricles 28, 32, and provide defibrillation therapy to heart 12 in the form of electrical pulses. In some instances, the IMD 16 may be programmed to deliver a therapeutic process, such as pulses with increasing energy levels, until the fibrillation of heart 12 ceases.

[0110] Figures 8A-8B It shows in more detail Figure 7 A conceptual diagram of the IMD 16 and leads 18, 20, 22 of the therapy system 10. Leads 18, 20, 22 can be electrically coupled to a therapy delivery module (e.g., for delivering pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and / or any other module of the IMD 16 via connector block 34. In some instances, the proximal ends of leads 18, 20, 22 may contain electrical contacts electrically coupled to corresponding electrical contacts within connector block 34 of the IMD 16. Additionally, in some instances, leads 18, 20, 22 may be mechanically coupled to connector block 34 by means of a retaining screw, connecting pin, or other suitable mechanical coupling mechanism.

[0111] Each of leads 18, 20, and 22 includes an elongated insulated lead body capable of carrying multiple conductors (e.g., concentric coil conductors, straight conductors, etc.) separated from each other by insulation (e.g., a tubular insulating sheath). In the illustrated example, bipolar electrodes 40 and 42 are located near the distal end of lead 18. Additionally, bipolar electrodes 44, 45, 46, and 47 are located near the distal end of lead 20, and bipolar electrodes 48 and 50 are located near the distal end of lead 22.

[0112] Electrodes 40, 44, 45, 46, 47, and 48 may be in the form of ring electrodes, and electrodes 42 and 50 may be in the form of extendable spiral-tipped electrodes retractably mounted within insulated electrode heads 52, 54, and 56, respectively. Each of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be electrically coupled to a corresponding conductor (e.g., coil conductor and / or straight conductor) within the lead body of its associated leads 18, 20, and 22, and thereby coupled to a corresponding electrical contact in an electrical contact at the proximal end of leads 18, 20, and 22.

[0113] In addition, the surface area of ​​electrodes 44, 45, 46, and 47 can be approximately 5.3 mm². 2 up to approximately 5.8mm 2 Electrodes 44, 45, 46, and 47 may also be referred to as LV1, LV2, LV3, and LV4, respectively. The LV electrodes on lead 20 (i.e., left ventricular electrode 1 (LV1) 44, left ventricular electrode 2 (LV2) 45, left ventricular electrode 3 (LV3) 46, and left ventricular electrode 4 (LV4) 47, etc.) can be spaced apart at variable distances. For example, electrode 44 may be spaced from electrode 45 by, for example, approximately 21 millimeters (mm), electrodes 45 and 46 may be spaced apart by, for example, approximately 1.3 mm to approximately 1.5 mm, and electrodes 46 and 47 may be spaced apart by, for example, approximately 20 mm to approximately 21 mm.

[0114] Electrodes 40, 42, 44, 45, 46, 47, 48, and 50 can be further used to sense electrical signals (e.g., morphological waveforms within an electrogram (EGM)) accompanying depolarization and repolarization of the heart 12. The electrical signals are conducted to the IMD 16 via corresponding leads 18, 20, and 22. In some instances, the IMD 16 can also deliver pacing pulses via electrodes 40, 42, 44, 45, 46, 47, 48, and 50 to induce depolarization of the cardiac tissue of the patient's heart 12. In some instances, such as... Figure 8AAs shown, the IMD 16 includes one or more housing electrodes, such as housing electrode 58, which may be integrally formed with or otherwise coupled to the outer surface of the housing 60 (e.g., an hermetically sealed housing) of the IMD 16. Any of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be combined with housing electrode 58 for unipolar sensing or pacing. It will be understood by those skilled in the art that other electrodes may also be selected to define or be used for pacing and sensing vectors. Further, any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58, when not used for pacing therapy, may be used to sense electrical activity during pacing therapy.

[0115] For reference Figure 8A In further detail, the housing 60 may encapsulate a therapy delivery module, which may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, and a sensing module for monitoring electrical signals of the patient's heart (e.g., the patient's heart rhythm). Leads 18, 20, and 22 may also include elongated electrodes 62, 64, and 66, respectively, which may be in the form of coils. The IMD 16 can deliver defibrillation shocks to the heart 12 via any combination of the elongated electrodes 62, 64, and 66 and the housing electrodes 58. Electrodes 58, 62, 64, and 66 may also be used to deliver cardioversion pulses to the heart 12. Furthermore, electrodes 62, 64, and 66 may be made of any suitable conductive material, such as, but not limited to, platinum, platinum alloys, and / or other materials known to be suitable for implantable defibrillation electrodes. Since electrodes 62, 64, and 66 are not typically configured for pacing therapy, any one of electrodes 62, 64, and 66 can be used to sense electrical activity and can be used in combination with any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58. In at least one embodiment, the RV elongated electrode 62 can be used to sense the electrical activity of a patient's heart during delivery of pacing therapy (e.g., in combination with housing electrode 58 or a defibrillator electrode-to-housing electrode vector).

[0116] Figure 7 The configuration of the illustrative therapy system 10 shown in Figure -9 is only one example. In other examples, instead... Figure 7 The illustrated transvenous leads 18, 20, 22, or others, may be used to implant the therapy system in the epicardial leads and / or patch electrodes. Additionally, in other instances, the therapy system 10 may be implanted in / around the cardiac space (other than in the right venous space, such as when placed in the right venous space) without a transvenous lead (e.g., a leadless / wireless pacing system) or with a lead implanted (e.g., transvenous implantation or method of use) into the left venous chamber of the heart. Figure 7The illustrated transvenous lead may be used in addition to or as a substitute for the transvenous lead placed in the right venous chamber of the heart. Further, in one or more embodiments, it is not necessary to implant the IMD 16 into the patient 14. For example, the IMD 16 can be used for various cardiac therapies via a percutaneous lead extending through the skin of the patient 14 to multiple locations within or outside the heart 12. In one or more embodiments, the system 10 may utilize wireless pacing (e.g., transmitting energy to one or more intracardiac pacing components via ultrasound, inductive coupling, RF, etc.) and sense cardiac excitation using electrodes on the housing / shell and / or subcutaneous leads.

[0117] In other instances of therapeutic systems that provide electrical stimulation to the heart 12, such systems may include any suitable number of leads coupled to the IMD 16, and each lead may extend to any location within or near the heart 12. For example, other instances of the therapeutic system may include... Figure 7 -9 shows the three venous leads located. Further, other therapeutic systems may include a single lead extending from IMD 16 into the right atrium 26 or the right ventricle 28, or two leads extending into one of the corresponding right atrium 26 and right ventricle 28.

[0118] Figure 9A This is a functional block diagram illustrating one configuration of the IMD 16. As shown, the IMD 16 may include a control module 81, a therapy delivery module 84 (e.g., which may include a stimulation generator), a sensing module 86, and a power supply 90.

[0119] The control module or device 81 may include a processor 80, a memory 82, and a telemetry module, or a device 88. The memory 82 may contain computer-readable instructions that, when executed by, for example, the processor 80, cause the IMD 16 and / or control module 81 to perform various functions belonging to the IMD 16 and / or control module 81 described herein. Further, the memory 82 may contain any volatile, non-volatile, magnetic, optical, and / or electrical media, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and / or any other digital media. An illustrative capture management module may be the left ventricular capture management (LVCM) module described in U.S. Patent No. 7,684,863, entitled "LV Threshold Measurement and Capture Management," published March 23, 2010.

[0120] The processor 80 of the control module 81 may include any one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), and / or an equivalent discrete or integrated logic circuit system. In some instances, the processor 80 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs and / or one or more FPGAs, as well as other discrete or integrated logic circuit systems. The functionality of the processor 80 as described herein may be embodied in software, firmware, hardware, or any combination thereof.

[0121] The control module 81 can control the therapy delivery module 84 to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart 12 according to one or more selected therapy programs that can be stored in the memory 82. More specifically, the control module 81 (e.g., processor 80) can control various parameters of the electrical stimulation delivered by the therapy delivery module 84, such as, for example, AV delay, VV delay, pacing pulse with amplitude, pulse width, frequency, or electrode polarity, which can be specified by one or more selected therapy programs (e.g., AV and / or VV delay adjustment program, pacing therapy program, pacing recovery program, capture management program, etc.). As shown, the therapy delivery module 84 is electrically coupled to electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66, for example, via conductors of the corresponding leads 18, 20, 22 or, in the case of housing electrodes 58, via electrical conductors disposed within the housing 60 of the IMD 16. The therapy delivery module 84 can be configured to generate an electrical stimulation therapy, such as pacing therapy, using one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, and 66 and deliver the electrical stimulation therapy to the heart 12.

[0122] For example, the therapy delivery module 84 can deliver pacing stimulation (e.g., pacing pulses) via ring electrodes 40, 44, 45, 46, 47, 48 and / or helical tip electrodes 42, 50 of leads 18, 22. Further, for example, the therapy delivery module 84 can deliver defibrillation shocks to the heart 12 via at least two of electrodes 58, 62, 64, 66. In some instances, the therapy delivery module 84 can be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other instances, the therapy delivery module 84 can be configured to deliver one or more of these types of stimulation in the form of other signals (such as sine waves, square waves, and / or other substantially continuous time signals).

[0123] The IMD 16 may further include a switching module 85, and the control module 81 (e.g., processor 80) may use the switching module 85 to select, for example via a data / address bus, which of the available electrodes are used for delivering therapy, such as pacing pulses for pacing therapy, or which of the available electrodes are used for sensing. The switching module 85 may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable for selectively coupling the sensing module 86 and / or the therapy delivery module 84 to one or more selected electrodes. More specifically, the therapy delivery module 84 may include a plurality of pacing output circuits. Each of the plurality of pacing output circuits may, for example, be selectively coupled using the switching module 85 to one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 (e.g., a pair of electrodes for delivering therapy to a bipolar or multipolar pacing vector). In other words, each electrode may be selectively coupled using the switching module 85 to one of the pacing output circuits of the therapy delivery module.

[0124] The sensing module 86 is coupled (e.g., electrically coupled) to a sensing device, which may include electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 to monitor the electrical activity of the heart 12, such as electrocardiogram (ECG) / electrogram (EGM) signals. ECG / EGM signals can be used to measure or monitor activation time (e.g., ventricular activation time), heart rate (HR), heart rate variability (HRV), heart rate oscillation (HRT), deceleration / acceleration capacity, deceleration sequence morbidity, T wave alternation (TWA), P wave to P wave interval (also known as PP interval or AA interval), R wave to R wave interval (also known as RR interval or VV interval), P wave to QRS complex interval (also known as PR interval, AV interval or PQ interval), QRS complex morphology, ST segment (i.e., the segment connecting the QRS complex and the T wave), T wave changes, QT interval, electrical vector, etc.

[0125] The switching module 85 can also be used with the sensing module 86 to select which of the available electrodes to use or enable, for example, to sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66). Similarly, the switching module 85 can also be used with the sensing module 86 to select which of the available electrodes to not use (e.g., disable), for example, to sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66), etc. In some instances, the control module 81 can select the electrodes acting as sensing electrodes by providing signals, for example, via a data / address bus, through the switching module within the sensing module 86.

[0126] In some instances, the sensing module 86 includes a channel comprising an amplifier having a relatively wider passband than an R-wave or P-wave amplifier. Signals from selected sensing electrodes can be supplied to a multiplexer and subsequently converted by an analog-to-digital converter into multi-bit digital signals for storage in memory 82, for example, as an electrogram (EGM). In some instances, such storage of an EGM in memory 82 can be under the control of direct memory access circuitry.

[0127] In some instances, the control module 81 can operate as an interrupt-driven device and can respond to interrupts from the pacemaker timing and control module, where the interruption may correspond to the occurrence of sensed P and R waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations can be performed by the processor 80, and any updates to values ​​or intervals controlled by the pacemaker timing and control module can occur after such interruptions. A portion of the memory 82 can be configured as a plurality of recirculation buffers capable of holding one or more series of measurement intervals that can be analyzed by, for example, the processor 80 in response to the occurrence of a pacing or sensing interruption to determine whether the patient's heart 12 is currently exhibiting atrial or ventricular tachyarrhythmias.

[0128] The telemetry module 88 of the control module 81 may contain any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as a programmer. For example, under the control of the processor 80, the telemetry module 88 may receive downlink telemetry from the programmer and send uplink telemetry to the programmer via an antenna (which may be internal and / or external). The processor 80 may, for example, provide data to be transmitted uplink to the programmer and control signals for the telemetry circuitry within the telemetry module 88 via an address / data bus. In some instances, the telemetry module 88 may provide the received data to the processor 80 via a multiplexer.

[0129] The various components of the IMD 16 are further coupled to a power source 90, which may comprise a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected to last for several years, while a rechargeable battery may be inductively charged from an external device, for example, on a daily or weekly basis.

[0130] Figure 9B This is another embodiment of the functional block diagram of IMD 16, depicting a bipolar RA lead 22, a bipolar RV lead 18, and a bipolar LV CS lead 20 coupled to an implantable pulse generator (IPG) circuit 31 without LA CS pacing / sensing electrodes. The implantable pulse generator circuit has programmable modes and parameters of the biventricular DDD / R type known in the pacing field. Furthermore, the sensor signal processing circuit 91 is indirectly coupled to the timing circuit 43 and coupled to the microcomputer circuit system 33 via a data and control bus. The IPG circuit 31 is shown in the functional block diagram, which is generally divided into the microcomputer circuit 33 and the pacing circuit 21. The pacing circuit 21 includes a digital controller / timer circuit 43, an output amplifier circuit 51, a sensing amplifier circuit 55, an RF telemetry transceiver 41, an activity sensor circuit 35, and many other circuits and components described below.

[0131] When battery 29 provides power, crystal oscillator circuit 89 provides a basic timing clock to pacing circuit 21. Power-on reset circuit 87 responds to the initial connection of the circuit with the battery to define initial operating conditions, and similarly resets the operating state of the device in response to the detection of a low battery condition. Reference mode circuit 37 generates a stable voltage reference and current for the analog circuitry within pacing circuit 21. Analog-to-digital converter (ADC) and multiplexer circuit 39 digitizes the analog signals and voltages to provide, for example, real-time telemetry of cardiac signals from sensing amplifier 55 for uplink transmission via RF transmitter and receiver circuit 41. Voltage reference and bias circuit 37, ADC and multiplexer 39, power-on reset circuit 87, and crystal oscillator circuit 89 may correspond to any of those used in illustrative implantable cardiac pacemakers. If the IPG is programmed to rate response mode, the signal output by one or more physiological sensors is used as a rate control parameter (RCP) to derive the physiological escape interval. For example, the escape interval is adjusted proportionally to the level of patient activity generated in the patient activity sensor (PAS) circuit 35 within the illustrated IPG circuit 31. The patient activity sensor 27 is coupled to the IPG housing and may take the form of a piezoelectric crystal transducer. The output signal of the patient activity sensor 27 can be processed and used as an RCP. The sensor 27 generates an electrical signal in response to sensed body activity, which is processed by the activity circuit 35 and provided to the digital controller / timer circuit 43. The active circuit 35 and associated sensor 27 can correspond to the circuit systems disclosed in U.S. Patent No. 5,052,388, entitled "Method and Apparatus for Improving Activity Sensing in a Pulse Generator," published October 1, 1991, and U.S. Patent No. 4,428,378, entitled "Rate Adaptive Pacer," published January 31, 1984. Similarly, the illustrative systems, apparatus, and methods described herein can be practiced in conjunction with alternative types of sensors (such as oxygenation sensors, pressure sensors, pH sensors, and respiration sensors) to provide rate-responsive pacing capability. Alternatively, the QT time can be used as a rate indication parameter, in which case no additional sensor is required. Similarly, the illustrative embodiments described herein can also be practiced in non-rate-responsive pacemakers.

[0132] Data transmission to and from the external programmer is achieved via telemetry antenna 57 and an associated RF transceiver 41, which demodulates both received downlink telemetry and transmits uplink telemetry. Uplink telemetry capabilities may include the ability to transmit stored digital information, such as operating modes and parameters, EGM histograms and other events, as well as real-time EGM of atrial and / or ventricular electrical activity and marker channel pulses indicating the occurrence of sensed and paced depolarization in the atria and ventricles.

[0133] The microcomputer 33 includes a microprocessor 80 and an associated system clock, as well as on-processor RAM chips 82A and ROM chips 82B. Additionally, the microcomputer circuitry 33 includes a separate RAM / ROM chip 82C to provide additional memory capacity. The microprocessor 80 typically operates in a low-power mode and is interrupt-driven. The microprocessor 80 is awakened in response to defined interrupt events, which may include A-TRIG, RV-TRIG, and LV-TRIG signals generated by timers in the digital timer / controller circuitry 43, and A-EVENT, RV-EVENT, and LV-EVENT signals generated by the sense amplifier circuitry 55, etc. The specific values ​​of the timeout intervals and delays by the digital controller / timer circuitry 43 are controlled by the microcomputer circuitry 33 via data and control buses from programmed parameter values ​​and operating modes. Furthermore, if programmed to operate as a rate-responsive pacemaker, timing interrupts, such as every cycle or every two seconds, can be provided to allow the microprocessor to analyze active sensor data and update the basic AA, VA, or VV escape intervals (if applicable). In addition, the microprocessor 80 can also be used to define variable, operable AV delay intervals, VV delay intervals, and the energy delivered to each ventricle and / or atrium.

[0134] In one embodiment, microprocessor 80 is a custom microprocessor adapted to fetch and execute instructions stored in RAM / ROM unit 82 in a conventional manner. However, other embodiments are contemplated that may be suitable for practicing this disclosure. For example, readily available commercially available microprocessors or microcontrollers or custom-designed dedicated hardwired logic or state machine type circuitry can perform the functions of microprocessor 80.

[0135] The digital controller / timer circuit 43 operates under the general control of the microcomputer 33 to control timing and other functions within the pacing circuit 21, and includes a set of timing and associated logic circuits, some of which are depicted in relation to this disclosure. The depicted timing circuits include a URI / LRI timer 83A, a VV delay timer 83B, an intrinsic interval timer 83C for timing the elapsed V-EVENT to V-EVENT interval or V-EVENT to A-EVENT interval or VV conduction interval, an escape interval timer 83D for timing the AA, VA, and / or VV pacing escape interval, an AV delay interval timer 83E for timing the A-LVp delay (or A-RVp delay) from a previous A-EVENT or A-TRIG, a postventricular timer 83F for timing the postventricular time period, and a date / time clock 83G. The AV delay interval timer 83E is loaded with an appropriate delay interval (e.g., A-RVp delay or A-LVp) for a ventricular chamber to time out from a previous A-PACE or A-EVENT. The interval timer 83E triggers pacing stimulus delivery and can be based on one or more previous cardiac cycles (or on a dataset derived empirically for a given patient).

[0136] The post-event timer 83F causes the post-ventricular time period following RV-EVENT, LV-EVENT, RV-TRIG, or LV-TRIG, and the post-atrial time period following A-EVENT or A-TRIG, to time out. The duration of the post-event time period can also be selected as a programmable parameter stored in the microcomputer 33. The post-ventricular time period includes PVARP, post-atrial ventricular blanking period (PAVBP), ventricular blanking period (VBP), post-ventricular atrial blanking period (PVARP), and ventricular refractory period (VRP), but other time periods can be appropriately defined, at least in part, according to the operating circuitry used in the pacemaker. The post-atrial time period includes the atrial refractory period (ARP) and atrial blanking period (ABP). During the atrial refractory period, A-EVENT is ignored for the purpose of resetting any AV delays, and during the atrial blanking period, atrial sensing is disabled. It should be noted that the onset of the post-atrial time interval and AV delay may begin substantially simultaneously with the start or end of each A-EVENT or A-TRIG, or in the latter case, at the end of an A-PACE that can follow an A-TRIG. Similarly, the onset of the post-ventricular time interval and VA escape interval may begin substantially simultaneously with the start or end of a V-EVENT or V-TRIG, or in the latter case, at the end of a V-PACE that can follow a V-TRIG. The microprocessor 80 also optionally calculates the AV delay, VV delay, post-ventricular time interval, and post-atrial time interval, which vary with sensor-based escape intervals and / or intrinsic atrial and / or ventricular rates established in response to one or more RCPs.

[0137] Output amplifier circuit 51 includes an RA pacing pulse generator (and an LA pacing pulse generator, if LA pacing is provided), an RV pacing pulse generator, an LV pacing pulse generator, and / or any other pulse generator configured to provide atrial and ventricular pacing. To trigger the generation of an RV-PACE or LV-PACE pulse, digital controller / timer circuit 43 generates an RV-TRIG signal when the A-RVp delay (in the case of RV pre-excitation) provided by AV delay interval timer 83E (or VV delay timer 83B) times out, or generates an LV-TRIG signal when the A-LVp delay (in the case of LV pre-excitation) times out. Similarly, digital controller / timer circuit 43 generates an RA-TRIG signal (or an LA-TRIG signal, if provided) that triggers the output of an RA-PACE pulse at the end of a VA escape interval timed by escape interval timer 83D.

[0138] Output amplifier circuit 51 includes switching circuitry for coupling selected pacing electrode pairs from the lead conductors and IND-CAN electrodes 21 to RA pacing pulse generators (and LA pacing pulse generators, if provided), RV pacing pulse generators, and LV pacing pulse generators. Pacing / sensing electrode pair selection and control circuitry 53 selects the lead conductors and associated pacing electrode pairs for coupling with atrial and ventricular output amplifiers within output amplifier circuitry 51 to implement RA, LA, RV, and LV pacing.

[0139] Sensing amplifier circuit 55 contains sensing amplifiers for atrial and ventricular pacing and sensing. High-impedance P-wave and R-wave sensing amplifiers can be used to amplify the voltage difference signal generated across the sensing electrode pair due to the passage of the cardiac depolarization wavefront. The high-impedance sensing amplifier uses high gain to amplify low-amplitude signals and relies on passband filtering, time-domain filtering, and amplitude threshold comparison to distinguish the P-wave or R-wave from background electrical noise. Digital controller / timer circuit 43 controls the sensitivity settings of atrial and ventricular sensing amplifier 55.

[0140] During the blanking period before, during, and after the delivery of a pacing pulse to any of the pacing electrodes in the pacing system, the sensing amplifier can be decoupled from the sensing electrode to avoid saturation of the sensing amplifier. Sensing amplifier circuit 55 includes a blanking circuit for decoupling selected lead conductor pairs and IND-CAN electrode 21 from the inputs of the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier during ABP, PVABP, and VBP. Sensing amplifier circuit 55 also includes a switching circuit for coupling the selected sensing electrode lead conductors and IND-CAN electrode 21 to the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier. Similarly, sensing electrode selection and control circuit 53 selects the conductors and associated sensing electrode pairs to be coupled to the atrial and ventricular sensing amplifiers within output amplifier circuit 51 and sensing amplifier circuit 55 for RA, LA, RV, and LV sensing along desired unipolar and bipolar sensing vectors.

[0141] Right atrial depolarization or a P wave in the RA-SENSE signal sensed by the RA sensing amplifier results in an RA-EVENT signal being transmitted to the digital controller / timer circuit 43. Similarly, left atrial depolarization or a P wave in the LA-SENSE signal sensed by the LA sensing amplifier (if provided) results in an LA-EVENT signal being transmitted to the digital controller / timer circuit 43. Ventricular depolarization or an R wave in the RV-SENSE signal sensed by the ventricular sensing amplifier results in an RV-EVENT signal being transmitted to the digital controller / timer circuit 43. Similarly, ventricular depolarization or an R wave in the LV-SENSE signal sensed by the ventricular sensing amplifier results in an LV-EVENT signal being transmitted to the digital controller / timer circuit 43. The RV-EVENT, LV-EVENT, RA-EVENT, and LA-SENSE signals may be unwanted or not unwanted, and may be unintentionally triggered by electrical noise signals or abnormally conducted depolarization waves instead of genuine R or P waves. The techniques described in this disclosure (including those attributable to IMD 16, computing device 140, and / or various constituent components) can be implemented at least in part in the form of hardware, software, firmware, or any combination thereof. For example, aspects of the techniques can be implemented within one or more processors embodied in a programmer, stimulator, image processing device, or other apparatus, such as a physician or patient programmer, which includes one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuit systems, and any combination of such components. The terms “module,” “processor,” or “processing circuit system” generally refer to any circuit system, alone or in combination with other logic circuit systems, or any other equivalent circuit system.

[0142] 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.

[0143] When implemented in software, the functionality attributable to the systems, apparatus, and techniques described in this disclosure 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 circuitry system and / or one or more processors to support one or more aspects of the functionality described in this disclosure.

[0144] Illustrative Examples

[0145] Example 1. A system for evaluating cardiac therapy, comprising:

[0146] Electrode devices comprising multiple external electrodes for monitoring electrical activity from a patient's tissues; and

[0147] A computing device, comprising a processing circuitry system and operatively coupled to the electrode device, the computing device being configured to:

[0148] The plurality of external electrodes are used to sense electrical activity.

[0149] Electrical heterogeneity information (EHI) is generated based on the monitored electrical activity.

[0150] The delivery of pacing therapy is initiated using multiple different pacing vectors, each using a combination of pacing electrodes that differs from the rest of the different pacing vectors.

[0151] Based on the EHI generated by monitoring electrical activity during pacing therapy using multiple different pacing vectors, one or more of the multiple different pacing vectors are selected.

[0152] The delivery of pacing therapy can be initiated using one or more different settings of different pacing vectors and pacing parameters, and

[0153] EHI, generated based on electrical activity monitored during pacing therapy using one or more different settings of different pacing vectors and pacing parameters, identifies one or more different settings of pacing parameters.

[0154] Example 2. A method for evaluating cardiac therapy, comprising:

[0155] Electrical activity was monitored using multiple external electrodes from the patient's tissue.

[0156] Electrical heterogeneity information (EHI) is generated based on the monitored electrical activity;

[0157] The delivery of pacing therapy is initiated using multiple different pacing vectors, each of which uses a combination of pacing electrodes that are different from the rest of the different pacing vectors;

[0158] Based on the EHI generated by monitoring electrical activity during pacing therapy using multiple different pacing vectors, one or more of the multiple different pacing vectors are selected;

[0159] The delivery of pacing therapy is initiated using one or more different settings of different pacing vectors and pacing parameters; and

[0160] EHI, generated based on electrical activity monitored during pacing therapy using one or more different settings of different pacing vectors and pacing parameters, identifies one or more different settings of pacing parameters.

[0161] Example 3: The system or method according to any one of Examples 1-2, wherein the EHI includes the standard deviation of the electroactivation time monitored by the plurality of external electrodes.

[0162] Example 4: The system or method according to any one of Examples 1-3, wherein a plurality of different pacing settings include a plurality of different AV and / or VV times.

[0163] Example 5: The system or method according to Example 4, wherein the plurality of different AV times are between 40% and 80% of the patient's inherent AV delay.

[0164] Example 6: A system or method according to any one of Examples 1-5, wherein the pacing parameters include one of AV time and VV time, wherein the delivery of pacing therapy is initiated using one or more selected different pacing vectors and multiple different settings of the pacing parameters, and one or more of the multiple different settings of the pacing parameters identified by EHI based on electrical activity monitored during the delivery of pacing therapy using one or more selected different pacing vectors and multiple different settings of the pacing parameters include:

[0165] The delivery of pacing therapy is initiated using one or more selected pacing vectors and subsets of multiple different time values ​​of pacing parameters;

[0166] EHI, generated based on the time values ​​of a subset of different time values ​​of pacing parameters, is used to identify the time values ​​of a subset of different time values ​​of pacing parameters during the delivery of electrical activity monitored during pacing therapy using one or more different selected pacing vectors and pacing parameters.

[0167] The delivery of pacing therapy is initiated using one or more selected pacing vectors and a set of closely spaced different time values ​​of pacing parameters within a selected range of time values; and

[0168] EHI, generated based on electrical activity monitored during pacing therapy using one or more selected different pacing vectors and a set of close different time values ​​of pacing parameters within a selected range of time values, identifies one or more of the set of close different time values ​​of pacing parameters.

[0169] Example 7: A system or method according to any one of Examples 1-6, wherein the pacing parameters include one of AV time and VV time, wherein initiating the delivery of pacing parameters based on multiple different settings using one or more selected different pacing vectors and pacing parameters includes:

[0170] The delivery of pacing therapy is initiated using one or more selected pacing vectors and time values ​​of pacing parameters;

[0171] Increase the time value by the selected increment;

[0172] If the monitored electrical activity indicates that the time value is less effective than previous monitoring, then increase the selected increment; and

[0173] If the monitored electrical activity indicates that the time value is more effective than previously monitored, then the selected increment is reduced.

[0174] Example 8: The system or method according to any one of Examples 1-7, wherein the computing device is further configured to perform, or the method further includes:

[0175] Disqualify any pacing electrode used to provide multiple different pacing vectors for stimulating the phrenic nerve.

[0176] Example 9: The system or method according to any one of Examples 1-8, wherein the computing device is further configured to perform, or the method further includes:

[0177] Disqualify any pacing electrode used to provide multiple different pacing vectors exceeding the selected capture threshold.

[0178] Example 10: A system or method according to any one of Examples 1-9, wherein delivering pacing therapy using multiple different pacing vectors includes delivering pacing therapy using a selected AV time if the patient has atrioventricular block. Example 11: A system or method according to any one of Examples 1-10, wherein selecting one or more of multiple different pacing vectors based on the EHI generated from electrical activity monitored during delivery of pacing therapy using multiple different pacing vectors includes selecting a single different pacing vector.

[0179] Example 12: The system or method according to any one of Examples 1-11, wherein the computing device is further configured to perform, or the method further includes:

[0180] If the generated EHI is greater than the selected threshold, then pacing therapy is stopped; and

[0181] Identify the pacing vectors and pacing settings used during monitoring of electrical activity that leads to EHI cessation.

[0182] Example 13: A system or method according to any one of Examples 1-12, wherein the computing device is further configured to perform or the method further includes removing AV time from the plurality of different pacing settings in response to an indication of atrial fibrillation or atrial tachycardia.

[0183] Example 14: A system for evaluating cardiac therapy, comprising:

[0184] Electrode devices comprising multiple external electrodes for monitoring electrical activity from a patient's tissues; and

[0185] A computing device, comprising a processing circuitry system and operatively coupled to the electrode device, the computing device being configured to:

[0186] The plurality of external electrodes are used to sense electrical activity.

[0187] Electrical heterogeneity information (EHI) is generated based on the monitored electrical activity.

[0188] The delivery of pacing therapy was initiated using the first parameter under several different first settings.

[0189] Based on the EHI generated from electrical activity monitored during pacing therapy using multiple different first settings, one or more of the multiple different first settings are selected for the first parameter.

[0190] The delivery of pacing therapy is initiated using one or more selected different first settings and second parameters under multiple different second settings, and

[0191] EHI generated based on electrical activity monitored during pacing therapy using one or more different first settings and multiple different second settings identifies one or more of the multiple different second setting values.

[0192] This disclosure is provided with reference to illustrative embodiments and is not intended to be limiting. As previously described, those skilled in the art will recognize that various other illustrative applications can utilize the beneficial features of the devices and methods described herein using the techniques described herein. Various modifications to the illustrative embodiments and further embodiments of this disclosure will become apparent in this specification.

Claims

1. A system for evaluating cardiac therapy, comprising: An electrode device comprising multiple external electrodes for monitoring electrical activity from a patient’s tissues; as well as A computing device, comprising a processing circuitry system and operatively coupled to the electrode device, the computing device being configured to: The plurality of external electrodes are used to sense electrical activity. Electrical heterogeneity information (EHI) is generated based on the monitored electrical activity. The delivery of pacing therapy is initiated using multiple different pacing vectors, each using a combination of pacing electrodes that differ from the other different pacing vectors. Based on the EHI generated by monitoring electrical activity during pacing therapy using multiple different pacing vectors, one or more of the multiple different pacing vectors are selected. The delivery of pacing therapy can be initiated using one or more different settings of different pacing vectors and pacing parameters, and EHI, generated based on electrical activity monitored during pacing therapy using one or more different settings of different pacing vectors and pacing parameters, identifies one or more different settings of pacing parameters.

2. The system of claim 1, wherein the EHI includes the standard deviation of the electrical activation time monitored by the plurality of external electrodes.

3. The system according to any one of claims 1-2, wherein the multiple different settings of the pacing parameters include multiple different AV and / or VV times.

4. The system of claim 3, wherein the plurality of different AV times are between 40% and 80% of the patient-inherent AV delay.

5. The system according to any one of claims 1-2, wherein the pacing parameters include one of AV time and VV time, wherein initiating the delivery of pacing therapy using one or more selected different pacing vectors and multiple different settings of the pacing parameters, and generating an EHI based on electrical activity monitored during the delivery of pacing therapy using one or more selected different pacing vectors and multiple different settings of the pacing parameters, one or more of the multiple different settings of the pacing parameters include: The delivery of pacing therapy is initiated using one or more selected pacing vectors and subsets of multiple different time values ​​of pacing parameters; EHI, generated based on the time values ​​of a subset of different time values ​​of pacing parameters, is generated by delivering electrical activity monitored during pacing therapy using a subset of multiple different time values ​​of one or more selected pacing vectors and pacing parameters. The delivery of pacing therapy is initiated using one or more selected pacing vectors and a set of close, different time values ​​of pacing parameters within a selected range of time values; and EHI, generated based on electrical activity monitored during pacing therapy using one or more selected different pacing vectors and a set of close different time values ​​of pacing parameters within a selected range of time values, identifies one or more of the set of close different time values ​​of pacing parameters.

6. The system according to any one of claims 1-2, wherein the pacing parameters include one of AV time and VV time, wherein initiating the delivery of the pacing parameters based on multiple different settings using one or more selected different pacing vectors and pacing parameters comprises: The delivery of pacing therapy is initiated using one or more selected pacing vectors and time values ​​of pacing parameters; Increase the time value by the selected increment; If the monitored electrical activity indicates that the time value is less effective than previous monitoring, then increase the selected increment; and If the monitored electrical activity indicates that the time value is more effective than previously monitored, then the selected increment is reduced.

7. The system according to any one of claims 1-2, wherein the computing device is further configured to: Disqualify any pacing electrode used to provide multiple different pacing vectors for stimulating the phrenic nerve.

8. The system according to any one of claims 1-2, wherein the computing device is further configured to: Disqualify any pacing electrode used to provide multiple different pacing vectors exceeding the selected capture threshold.

9. The system according to any one of claims 1-2, wherein delivering pacing therapy using multiple different pacing vectors includes delivering pacing therapy using a selected AV time if the patient has atrioventricular block.

10. The system according to any one of claims 1-2, wherein selecting one or more of the plurality of different pacing vectors based on the EHI generated from electrical activity monitored during pacing therapy using a plurality of different pacing vectors includes selecting a single different pacing vector.

11. The system according to any one of claims 1-2, wherein the computing device is further configured to: If the generated EHI is greater than the selected threshold, then pacing therapy is stopped; and Identify the pacing vectors and pacing settings used during monitoring of electrical activity that leads to EHI cessation.

12. The system according to any one of claims 1-2, wherein the computing device is further configured to remove the AV time from a plurality of different settings of the pacing parameters in response to an indication of atrial fibrillation or atrial tachycardia.

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