Patent Description:
IMDs may also provide cardiac resynchronization therapy (CRT), which is a form of pacing. CRT involves the delivery of pacing to the left ventricle, or both the left and right ventricles. The timing and location of the delivery of pacing pulses to the ventricle(s) may be selected to improve the coordination and efficiency of ventricular contraction. <CIT> discloses a system where cardiac electrical heterogeneity information is used to determine whether one or more ventricle from atrium (VfA) paced settings for VfA pacing therapy are acceptable.

Systems for implanting medical devices may include workstations or other equipment in addition to the implantable medical device itself. In some cases, these other pieces of equipment assist the physician or other technician with placing the intracardiac leads at particular locations on or in the heart. In some cases, the equipment provides information to the physician about the electrical activity of the heart and the location of the intracardiac lead.

The illustrative systems and methods described herein may be configured to assist a user (e.g., a physician) in evaluating and configuring cardiac therapy (e.g., cardiac therapy being performed on a patient during and/or after implantation of cardiac therapy apparatus). In one or more embodiments, the systems and methods may be described as being noninvasive. For example, in some embodiments, the systems and methods may not need, or include, implantable devices such as leads, probes, sensors, catheters, implantable electrodes, etc. to monitor, or acquire, a plurality of cardiac signals from tissue of the patient for use in evaluating and configuring the cardiac therapy being delivered to the patient. Instead, the systems and methods may use electrical measurements taken noninvasively using, e.g., a plurality of external electrodes attached to the skin of a patient about the patient's torso.

It may be described that the illustrative systems and methods may utilize, or include, an electrocardiogram (ECG) belt as a tool to aid in the optimization of resynchronization pacing parameters based on minimization of electrical heterogeneity. Two or more metrics of electrical heterogeneity may be derived from the belt such as, e.g., standard deviation of activation times (SDAT) and average left ventricular activation times (LVAT). Such metrics may be used for measuring electrical heterogeneity at patient's baseline rhythm or intrinsic rhythm and changes during pacing with different parameters. There may be scenarios where more than one set of parameters provide equivalent changes in SDAT/LVAT. The illustrative systems and methods may be described as providing ways of arriving at an optimal parameter based on concurrent ECG parameters from the belt. For example, the illustrative systems and methods may combine multiple ECG-based metrics with ECG belt parameters of electrical heterogeneity for choosing optimal cardiac therapy parameters.

Further, traditional ECG leads (such as, e.g., precordial leads, limb leads, etc.) may be selected from the set of electrodes in the ECG belt using the illustrative systems and methods. Although there may be a default selection, an operator may have the flexibility to change selection of one or more electrodes based on variability in placement of the belt. Traditional ECG signals (e.g., precordial <NUM>-lead or full <NUM>-lead signals) may be shown corresponding to each setting evaluated in addition to changes in SDAT/LVAT. Metrics of changes in morphology in leads V1/V2 (e.g., morphology changes, amplitude changes, etc.) along with QRS duration changes may be measured and quantified in terms of the changes being desirable or not in terms of a favorable resynchronization.

For example, a QS morphology in V1 with QRS narrowing by a certain threshold (e.g., <NUM> milliseconds (ms)) may be a desirable change. Further, for example, a R-wave morphology in V1 without QRS widening by more than a certain threshold (e.g., <NUM>) may be a desirable change. Still further, for example, vectorcardiographic (VCG) metrics derived from the monitored electrical activity from the ECG belt may be quantified for each setting. For instance, VCG metrics may include changes in QRS area and T-wave area on one or more axes. Percent changes in VCG metrics may be recorded. A three-dimensional QRS area reduction by a certain threshold (e.g., greater than <NUM>%) may be a desirable change. If there are multiple optimal settings that are determined based on SDAT/LVAT, changes in these additional ECG metrics may be "factored in" to decide on an optimal setting. For example. if there are certain settings from among the initial list of optimal settings that do not show desirable changes in terms of V1/V2 morphology and/or VCG metrics, then those settings may be filtered out automatically from the list of potential optimal settings to be considered. If all settings in the initial list show desirable changes in terms of the other ECG-based measurements, then all settings may be retained in the final "'optimal" list or subset. Thus, the illustrative systems and methods may be described as making recommendations using monitored electrical activity from a plurality of external electrodes more robust.

One illustrative system for use in configuring cardiac therapy may include electrode apparatus comprising a plurality of external electrodes to monitor electrical activity from tissue of a patient and a computing apparatus comprising processing circuitry and operably coupled to the electrode apparatus. The computing apparatus may be configured to monitor electrical activity using the plurality of external electrodes during the delivery of cardiac pacing therapy at a plurality of different paced settings, generate paced electrical heterogeneity information (EHI) based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, and determine a first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the paced EHI. The computing apparatus may be further configured to generate one or more single-electrode cardiac metrics and vectorcardiographic metrics based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, and determine a second subset of the first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the one or more single-electrode cardiac metrics and vectorcardiographic metrics if the first subset of paced settings comprises more than one paced setting.

One illustrative method for use in configuring cardiac therapy may include monitoring electrical activity using a plurality of external electrodes from tissue of a patient during the delivery of cardiac pacing therapy at a plurality of different paced settings, generating paced electrical heterogeneity information (EHI) based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, and determining a first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the paced EHI. The method may further include generating one or more single-electrode cardiac metrics and vectorcardiographic metrics based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings and determining a second subset of the first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the one or more single-electrode cardiac metrics and vectorcardiographic metrics if the first subset of paced settings comprises more than one paced setting.

One illustrative system for use in configuring cardiac therapy may include electrode apparatus comprising a plurality of external electrodes to monitor electrical activity from tissue of a patient, a display, and a computing apparatus comprising processing circuitry and operably coupled to the electrode apparatus and the display. The computing apparatus may be configured to monitor electrical activity using the plurality of external electrodes during the delivery of cardiac pacing therapy at a plurality of different paced settings, generate one or more multiple-electrode cardiac metrics based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, and determine a first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the one or more generated multiple-electrode cardiac metrics. The computing apparatus may be further configured to generate one or more single-electrode cardiac metrics and vectorcardiographic metrics based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, determine a second subset of the first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the one or more single-electrode cardiac metrics and vectorcardiographic metrics if the first subset of paced settings comprises more than one paced setting, and display the first subset of paced settings and the one or more single-electrode cardiac metrics and vectorcardiographic metrics corresponding to each paced setting of the first subset of paced settings.

The above summary is not intended to describe each embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings.

In the following detailed description of illustrative embodiments, reference is made to the accompanying figures of the drawing which form a part hereof, and in which are shown, by way of illustration, specific embodiments which may be practiced. It is to 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 the disclosure presented hereby.

Illustrative systems and methods shall be described with reference to <FIG>. It will be apparent to one skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of the other embodiments, and that the possible embodiments of such systems and methods using combinations of features set forth herein is not limited to the specific embodiments shown in the Figures and/or described herein. Further, it will be recognized that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be recognized that timing of the processes and the size and shape of various elements herein may be modified but still fall within the scope of the present disclosure, although certain timings, one or more shapes and/or sizes, or types of elements, may be advantageous over others.

A plurality of electrocardiogram (ECG) signals (e.g., torso-surface potentials) may be measured, or monitored, using a plurality of external electrodes positioned about the surface, or skin, of a patient. The ECG signals may be used to evaluate and configure cardiac therapy such as, e.g., cardiac therapy provide by an implantable medical device performing cardiac resynchronization therapy (CRT). As described herein, the ECG signals may be gathered or obtained noninvasively since, e.g., implantable electrodes may not be used to measure the ECG signals. Further, the ECG signals may be used to determine cardiac electrical activation times, which may be used to generate various metrics (e.g., electrical heterogeneity information) that may be used by a user (e.g., physician) to optimize one or more settings, or parameters, of cardiac therapy (e.g., pacing therapy) such as CRT.

Various illustrative systems, methods, and graphical user interfaces may be configured to use electrode apparatus including external electrodes, display apparatus, and computing apparatus to noninvasively assist a user (e.g., a physician) in the evaluation of cardiac health and/or the configuration (e.g., optimization) of cardiac therapy. An illustrative system <NUM> including electrode apparatus <NUM>, computing apparatus <NUM>, and a remote computing device <NUM> is depicted in <FIG>.

The electrode apparatus <NUM> as shown includes a plurality of electrodes incorporated, or included, within a band wrapped around the chest, or torso, of a patient <NUM>. The electrode apparatus <NUM> is operatively coupled to the computing apparatus <NUM> (e.g., through one or wired electrical connections, wirelessly, etc.) to provide electrical signals from each of the electrodes to the computing apparatus <NUM> for analysis, evaluation, etc. Illustrative electrode apparatus may be described in <CIT> and issued on March <NUM>, <NUM>. Further, illustrative electrode apparatus <NUM> will be described in more detail in reference to <FIG>.

Although not described herein, the illustrative system <NUM> may further include imaging apparatus. The imaging apparatus may be any type of imaging apparatus configured to image, or provide images of, at least a portion of the patient in a noninvasive manner. For example, the imaging apparatus may not use any components or parts that may be located within the patient to provide images of the patient except noninvasive tools such as contrast solution. It is to be understood that the illustrative systems, methods, and interfaces described herein may further use imaging apparatus to provide noninvasive assistance to a user (e.g., a physician) to locate, or place, one or more pacing electrodes proximate the patient's heart in conjunction with the configuration of cardiac therapy.

For example, the illustrative systems and methods may provide image guided navigation that may be used to navigate leads including electrodes, leadless electrodes, wireless electrodes, catheters, etc., within the patient's body while also providing noninvasive cardiac therapy configuration including determining an effective, or optimal, pre-excitation intervals such as A-V and V-V intervals, etc. Illustrative systems and methods that use imaging apparatus and/or electrode apparatus may be described in <CIT>, <CIT>, <CIT>, <CIT>.

Illustrative imaging apparatus may be configured to capture x-ray images and/or any other alternative imaging modality. For example, the imaging apparatus may be configured to capture images, or image data, using isocentric fluoroscopy, bi-plane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high frequency ultrasound (HIFU), optical coherence tomography (OCT), intra-vascular ultrasound (IVUS), two dimensional (2D) ultrasound, three dimensional (3D) ultrasound, four dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Further, it is to be understood that the imaging apparatus may be configured to capture a plurality of consecutive images (e.g., continuously) to provide video frame data. In other words, a plurality of images taken over time using the imaging apparatus may provide video frame, or motion picture, data. Additionally, the images may also be obtained and displayed in two, three, or four dimensions. In more advanced forms, four-dimensional surface rendering of the heart or other regions of the body may also be achieved by incorporating heart data or other soft tissue data from a map or from pre-operative image data captured by MRI, CT, or echocardiography modalities. Image datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computer tomography (SPECT) combined with CT, could also provide functional image data superimposed onto anatomical data, e.g., to be used to navigate implantable apparatus to target locations within the heart or other areas of interest.

Systems and/or imaging apparatus that may be used in conjunction with the illustrative systems and method described herein are described in <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, <CIT>, and <CIT>.

The computing apparatus <NUM> and the remote computing device <NUM> may each include display apparatus <NUM>, <NUM>, respectively, that may be configured to display and analyze data such as, e.g., electrical signals (e.g., electrocardiogram data), electrical activation times, electrical heterogeneity information, etc. For example, one cardiac cycle, or one heartbeat, of a plurality of cardiac cycles, or heartbeats, represented by the electrical signals collected or monitored by the electrode apparatus <NUM> may be analyzed and evaluated for one or more metrics including activation times and electrical heterogeneity information that may be pertinent to the therapeutic nature of one or more parameters related to cardiac therapy such as, e.g., pacing parameters, lead location, etc. More specifically, for example, the QRS complex of a single cardiac cycle may be evaluated for one or more metrics such as, e.g., QRS onset, QRS offset, QRS peak, electrical heterogeneity information (EHI), electrical activation times referenced to the earliest activation time, left ventricular or thoracic standard deviation of electrical activation times (LVED), standard deviation of activation times (SDAT), average left ventricular or thoracic surrogate electrical activation times (LVAT), QRS duration (e.g., interval between QRS onset to QRS offset), difference between average left surrogate and average right surrogate activation times, relative or absolute QRS morphology, difference between a higher percentile and a lower percentile of activation times (higher percentile may be <NUM>%, <NUM>%, <NUM>%, <NUM>%, etc. and lower percentile may be <NUM>%, <NUM>%, <NUM>%, <NUM>% and <NUM>%, etc.), other statistical measures of central tendency (e.g., median or mode), dispersion (e.g., mean deviation, standard deviation, variance, interquartile deviations, range), etc. Further, each of the one or more metrics may be location specific. For example, some metrics may be computed from signals recorded, or monitored, from electrodes positioned about a selected area of the patient such as, e.g., the left side of the patient, the right side of the patient, etc..

It may be described that one or more metrics generated based on the electrical activity monitored by the plurality of external electrodes provided by the illustrative electrode apparatus <NUM> may be based on a plurality of electrical signals from more than two external electrodes or based on a single electrical signal from a single external electrode. Thus, the illustrative systems and methods may be described as being able to generate multiple-electrode cardiac metrics and single-electrode cardiac metrics that may be used to evaluate cardiac therapy being delivered to a patient, to evaluate the cardiac condition of a patient, etc. In one or more embodiments, the multiple-electrode cardiac metrics may include electrical heterogeneity information such as, e.g., SDAT or LVAT, and vectorcardiographic metrics such as, e.g., three-dimensional QRS area changes. In one or more embodiments, the single-electrode metrics may include, e.g., QRS duration changes, various morphology changes, etc..

In at least one embodiment, one or both of the computing apparatus <NUM> and the remote computing device <NUM> may be a server, a personal computer, or a tablet computer. The computing apparatus <NUM> may be configured to receive input from input apparatus <NUM> (e.g., a keyboard) and transmit output to the display apparatus <NUM>, and the remote computing device <NUM> may be configured to receive input from input apparatus <NUM> (e.g., a touchscreen) and transmit output to the display apparatus <NUM>. One or both of the computing apparatus <NUM> and the remote computing device <NUM> may include data storage that may allow for access to processing programs or routines and/or one or more other types of data, e.g., for analyzing a plurality of electrical signals captured by the electrode apparatus <NUM>, for determining QRS onsets, QRS offsets, medians, modes, averages, peaks or maximum values, valleys or minimum values, for determining electrical activation times, for driving a graphical user interface configured to noninvasively assist a user in configuring one or more pacing parameters, or settings, such as, e.g., pacing rate, ventricular pacing rate, A-V interval, V-V interval, pacing pulse width, pacing vector, multipoint pacing vector (e.g., left ventricular vector quad lead), pacing voltage, pacing configuration (e.g., biventricular pacing, right ventricle only pacing, left ventricle only pacing, etc.), and arrhythmia detection and treatment, rate adaptive settings and performance, etc..

The computing apparatus <NUM> may be operatively coupled to the input apparatus <NUM> and the display apparatus <NUM> to, e.g., transmit data to and from each of the input apparatus <NUM> and the display apparatus <NUM>, and the remote computing device <NUM> may be operatively coupled to the input apparatus <NUM> and the display apparatus <NUM> to, e.g., transmit data to and from each of the input apparatus <NUM> and the display apparatus <NUM>. For example, the computing apparatus <NUM> and the remote computing device <NUM> may be electrically coupled to the input apparatus <NUM>, <NUM> and the display apparatus <NUM>, <NUM> using, e.g., analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc. As described further herein, a user may provide input to the input apparatus <NUM>, <NUM> to view and/or select one or more pieces of configuration information related to the cardiac therapy delivered by cardiac therapy apparatus such as, e.g., an implantable medical device.

Although as depicted the input apparatus <NUM> is a keyboard and the input apparatus <NUM> is a touchscreen, it is to be understood that the input apparatus <NUM>, <NUM> may include any apparatus capable of providing input to the computing apparatus <NUM> and the computing device <NUM> to perform the functionality, methods, and/or logic described herein. For example, the input apparatus <NUM>, <NUM> may include a keyboard, a mouse, a trackball, a touchscreen (e.g., capacitive touchscreen, a resistive touchscreen, a multi-touch touchscreen, etc.), etc. Likewise, the display apparatus <NUM>, <NUM> may include any apparatus capable of displaying information to a user, such as a graphical user interface <NUM>, <NUM> including electrode status information, graphical maps of electrical activation, a plurality of signals for the external electrodes over one or more heartbeats, QRS complexes, various cardiac therapy scenario selection regions, various rankings of cardiac therapy scenarios, various pacing parameters, electrical heterogeneity information (EHI), textual instructions, graphical depictions of anatomy of a human heart, images or graphical depictions of the patient's heart, graphical depictions of locations of one or more electrodes, graphical depictions of a human torso, images or graphical depictions of the patient's torso, graphical depictions or actual images of implanted electrodes and/or leads, etc. Further, the display apparatus <NUM>, <NUM> may include a liquid crystal display, an organic light-emitting diode screen, a touchscreen, a cathode ray tube display, etc..

The processing programs or routines stored and/or executed by the computing apparatus <NUM> and the remote computing device <NUM> 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 transforms, fast Fourier transforms, etc.), standardization algorithms, comparison algorithms, vector mathematics, or any other processing used to implement one or more illustrative methods and/or processes described herein. Data stored and/or used by the computing apparatus <NUM> and the remote computing device <NUM> may include, for example, electrical signal/waveform data from the electrode apparatus <NUM> (e.g., a plurality of QRS complexes), electrical activation times from the electrode apparatus <NUM>, cardiac sound/signal/waveform data from acoustic sensors, graphics (e.g., graphical elements, icons, buttons, windows, dialogs, pull-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results from one or more processing programs or routines employed according to the disclosure herein (e.g., electrical signals, electrical heterogeneity information, etc.), or any other data that may be used for carrying out the one and/or more processes or methods described herein.

In one or more embodiments, the illustrative systems, methods, and interfaces may be implemented using one or more computer programs executed on programmable computers, such as computers that include, for example, processing capabilities, data storage (e.g., volatile or non-volatile memory and/or storage elements), input devices, and output devices. Program code and/or logic described herein may be applied to input data to perform functionality described herein and generate desired output information. The output information may be applied as input to one or more other devices and/or methods as described herein or as would be applied in a known fashion.

The one or more programs used to implement the systems, methods, and/or interfaces described herein may be provided using any programmable language, e.g., a high-level procedural and/or object orientated programming language that is suitable for communicating with a computer system. Any such programs may, for example, be stored on any suitable device, e.g., a storage media, that is readable by a general or special purpose program running on a computer system (e.g., including processing apparatus) for configuring and operating the computer system when the suitable device is read for performing the procedures described herein. In other words, at least in one embodiment, the illustrative systems, methods, and interfaces may be implemented using a computer readable storage medium, configured with a computer program, where the storage medium so configured causes the computer to operate in a specific and predefined manner to perform functions described herein. Further, in at least one embodiment, the illustrative systems, methods, and interfaces may be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media that includes code for execution and, when executed by a processor or processing circuitry, is operable to perform operations such as the methods, processes, and/or functionality described herein.

The computing apparatus <NUM> and the remote computing device <NUM> may be, for example, any fixed or mobile computer system (e.g., a controller, a microcontroller, a personal computer, minicomputer, tablet computer, etc.). The exact configurations of the computing apparatus <NUM> and the remote computing device <NUM> are not limiting, and essentially any device capable of providing suitable computing capabilities and control capabilities (e.g., signal analysis, mathematical functions such as medians, modes, averages, maximum value determination, minimum value determination, slope determination, minimum slope determination, maximum slope determination, graphics processing, etc.) may be used. As described herein, a digital file may be any medium (e.g., volatile or non-volatile memory, a CD-ROM, a punch card, magnetic recordable tape, etc.) containing digital bits (e.g., encoded in binary, trinary, etc.) that may be readable and/or writeable by the computing apparatus <NUM> and the remote computing device <NUM> described herein. Also, as described herein, a file in user-readable format may be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphically, etc.) presentable on any medium (e.g., paper, a display, etc.) readable and/or understandable by a user.

In view of the above, it will be readily apparent that the functionality as described in one or more embodiments according to the present disclosure may be implemented in any manner as would be known to one skilled in the art. As such, the computer language, the computer system, or any other software/hardware which is to be used to implement the processes described herein shall not be limiting on the scope of the systems, processes, or programs (e.g., the functionality provided by such systems, processes, or programs) described herein.

The illustrative electrode apparatus <NUM> may be configured to measure body-surface potentials of a patient <NUM> and, more particularly, torso-surface potentials of a patient <NUM>. As shown in <FIG>, the illustrative electrode apparatus <NUM> may include a set, or array, of external electrodes <NUM>, a strap <NUM>, and interface/amplifier circuitry <NUM>. The electrodes <NUM> may be attached, or coupled, to the strap <NUM> and the strap <NUM> may be configured to be wrapped around the torso of a patient <NUM> such that the electrodes <NUM> surround the patient's heart. As further illustrated, the electrodes <NUM> may be positioned around the circumference of a patient <NUM>, including the posterior, lateral, posterolateral, anterolateral, and anterior locations of the torso of a patient <NUM>.

The illustrative electrode apparatus <NUM> may be further configured to measure, or monitor, sounds from at least one or both the patient <NUM>. As shown in <FIG>, the illustrative electrode apparatus <NUM> may include a set, or array, of acoustic sensors <NUM> attached, or coupled, to the strap <NUM>. The strap <NUM> may be configured to be wrapped around the torso of a patient <NUM> such that the acoustic sensors <NUM> surround the patient's heart. As further illustrated, the acoustic sensors <NUM> may be positioned around the circumference of a patient <NUM>, including the posterior, lateral, posterolateral, anterolateral, and anterior locations of the torso of a patient <NUM>.

Further, the electrodes <NUM> and the acoustic sensors <NUM> may be electrically connected to interface/amplifier circuitry <NUM> via wired connection <NUM>. The interface/amplifier circuitry <NUM> may be configured to amplify the signals from the electrodes <NUM> and the acoustic sensors <NUM> and provide the signals to one or both of the computing apparatus <NUM> and the remote computing device <NUM>. Other illustrative systems may use a wireless connection to transmit the signals sensed by electrodes <NUM> and the acoustic sensors <NUM> to the interface/amplifier circuitry <NUM> and, in turn, to one or both of the computing apparatus <NUM> and the remote computing device <NUM>, e.g., as channels of data. In one or more embodiments, the interface/amplifier circuitry <NUM> may be electrically coupled to the computing apparatus <NUM> using, e.g., analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc..

Although in the example of <FIG> the electrode apparatus <NUM> includes a strap <NUM>, in other examples any of a variety of mechanisms, e.g., tape or adhesives, may be employed to aid in the spacing and placement of electrodes <NUM> and the acoustic sensors <NUM>. In some examples, the strap <NUM> may include an elastic band, strip of tape, or cloth. Further, in some examples, the strap <NUM> may be part of, or integrated with, a piece of clothing such as, e.g., a t-shirt. In other examples, the electrodes <NUM> and the acoustic sensors <NUM> may be placed individually on the torso of a patient <NUM>. Further, in other examples, one or both of the electrodes <NUM> (e.g., arranged in an array) and the acoustic sensors <NUM> (e.g., also arranged in an array) may be part of, or located within, patches, vests, and/or other manners of securing the electrodes <NUM> and the acoustic sensors <NUM> to the torso of the patient <NUM>. Still further, in other examples, one or both of the electrodes <NUM> and the acoustic sensors <NUM> may be part of, or located within, two sections of material or two patches. One of the two patches may be located on the anterior side of the torso of the patient <NUM> (to, e.g., monitor electrical signals representative of the anterior side of the patient's heart, measure surrogate cardiac electrical activation times representative of the anterior side of the patient's heart, monitor or measure sounds of the anterior side of the patient, etc.) and the other patch may be located on the posterior side of the torso of the patient <NUM> (to, e.g., monitor electrical signals representative of the posterior side of the patient's heart, measure surrogate cardiac electrical activation times representative of the posterior side of the patient's heart, monitor or measure sounds of the posterior side of the patient, etc.). And still further, in other examples, one or both of the electrodes <NUM> and the acoustic sensors <NUM> may be arranged in a top row and bottom row that extend from the anterior side of the patient <NUM> across the left side of the patient <NUM> to the posterior side of the patient <NUM>. Yet still further, in other examples, one or both of the electrodes <NUM> and the acoustic sensors <NUM> may be arranged in a curve around the armpit area and may have an electrode/sensor-density that less dense on the right thorax that the other remaining areas.

The electrodes <NUM> may be configured to surround the heart of the patient <NUM> and record, or monitor, the electrical signals associated with the depolarization and repolarization of the heart after the signals have propagated through the torso of a patient <NUM>. Each of the electrodes <NUM> may be used in a unipolar configuration to sense the torso-surface potentials that reflect the cardiac signals. The interface/amplifier circuitry <NUM> may also be coupled to a return or indifferent electrode (not shown) that may be used in combination with each electrode <NUM> for unipolar sensing.

In some examples, there may be about <NUM> to about <NUM> electrodes <NUM> and about <NUM> to about <NUM> acoustic sensors <NUM> spatially distributed around the torso of a patient. Other configurations may have more or fewer electrodes <NUM> and more or fewer acoustic sensors <NUM>. It is to be understood that the electrodes <NUM> and acoustic sensors <NUM> may not be arranged or distributed in an array extending all the way around or completely around the patient <NUM>. Instead, the electrodes <NUM> and acoustic sensors <NUM> may be arranged in an array that extends only part of the way or partially around the patient <NUM>. For example, the electrodes <NUM> and acoustic sensors <NUM> may be distributed on the anterior, posterior, and left sides of the patient with less or no electrodes and acoustic sensors proximate the right side (including posterior and anterior regions of the right side of the patient).

The computing apparatus <NUM> may record and analyze the torso-surface potential signals sensed by electrodes <NUM> and the sound signals sensed by the acoustic sensors <NUM>, which are amplified/conditioned by the interface/amplifier circuitry <NUM>. The computing apparatus <NUM> may be configured to analyze the electrical signals from the electrodes <NUM> to provide electrocardiogram (ECG) signals, information, or data from the patient's heart as will be further described herein. The computing apparatus <NUM> may be configured to analyze the electrical signals from the acoustic sensors <NUM> to provide sound signals, information, or data from the patient's body and/or devices implanted therein (such as a left ventricular assist device).

Additionally, the computing apparatus <NUM> and the remote computing device <NUM> may be configured to provide graphical user interfaces <NUM>, <NUM> depicting various information related to the electrode apparatus <NUM> and the data gathered, or sensed, using the electrode apparatus <NUM>. For example, the graphical user interfaces <NUM>, <NUM> may depict ECGs including QRS complexes obtained using the electrode apparatus <NUM> and sound data including sound waves obtained using the acoustic sensors <NUM> as well as other information related thereto. Illustrative systems and methods may noninvasively use the electrical information collected using the electrode apparatus <NUM> and the sound information collected using the acoustic sensors <NUM> to evaluate a patient's cardiac health and to evaluate and configure cardiac therapy being delivered to the patient.

Further, the electrode apparatus <NUM> may further include reference electrodes and/or drive electrodes to be, e.g. positioned about the lower torso of the patient <NUM>, that may be further used by the system <NUM>. For example, the electrode apparatus <NUM> may include three reference electrodes, and the signals from the three reference electrodes may be combined to provide a reference signal. Further, the electrode apparatus <NUM> may use of three caudal reference electrodes (e.g., instead of standard references used in a Wilson Central Terminal) to get a "true" unipolar signal with less noise from averaging three caudally located reference signals.

<FIG> illustrates another illustrative electrode apparatus <NUM> that includes a plurality of electrodes <NUM> configured to surround the heart of the patient <NUM> and record, or monitor, the electrical signals associated with the depolarization and repolarization of the heart after the signals have propagated through the torso of the patient <NUM> and a plurality of acoustic sensors <NUM> configured to surround the heart of the patient <NUM> and record, or monitor, the sound signals associated with the heart after the signals have propagated through the torso of the patient <NUM>. The electrode apparatus <NUM> may include a vest <NUM> upon which the plurality of electrodes <NUM> and the plurality of acoustic sensors <NUM> may be attached, or to which the electrodes <NUM> and the acoustic sensors <NUM> may be coupled. In at least one embodiment, the plurality, or array, of electrodes <NUM> may be used to collect electrical information such as, e.g., surrogate electrical activation times. Similar to the electrode apparatus <NUM> of <FIG>, the electrode apparatus <NUM> of <FIG> may include interface/amplifier circuitry <NUM> electrically coupled to each of the electrodes <NUM> and the acoustic sensors <NUM> through a wired connection <NUM> and be configured to transmit signals from the electrodes <NUM> and the acoustic sensors <NUM> to computing apparatus <NUM>. As illustrated, the electrodes <NUM> and the acoustic sensors <NUM> may be distributed over the torso of a patient <NUM>, including, for example, the posterior, lateral, posterolateral, anterolateral, and anterior locations of the torso of a patient <NUM>.

The vest <NUM> may be formed of fabric with the electrodes <NUM> and the acoustic sensors <NUM> attached to the fabric. The vest <NUM> may be configured to maintain the position and spacing of electrodes <NUM> and the acoustic sensors <NUM> on the torso of the patient <NUM>. Further, the vest <NUM> may be marked to assist in determining the location of the electrodes <NUM> and the acoustic sensors <NUM> on the surface of the torso of the patient <NUM>. In some examples, there may be about <NUM> to about <NUM> electrodes <NUM> and about <NUM> to about <NUM> acoustic sensors <NUM> distributed around the torso of the patient <NUM>, though other configurations may have more or fewer electrodes <NUM> and more or fewer acoustic sensors <NUM>.

It is to be understood that the computing apparatus <NUM> and the remote computing device <NUM> may be operatively coupled to each other in a plurality of different ways so as to perform, or execute, the functionality described herein. For example, in the embodiment depicted, the computing device <NUM> may be wireless operably coupled to the remote computing device <NUM> as depicted by the wireless signal lines emanating therebetween. Additionally, as opposed to wireless connections, one or more of the computing apparatus <NUM> and the remoting computing device <NUM> may be operably coupled through one or wired electrical connections.

The illustrative systems and methods may be used to provide noninvasive assistance to a user in the evaluation of a patient's cardiac health and/or evaluation and configuration of cardiac therapy being presently delivered to the patient (e.g., by an implantable medical device, by a LVAD, etc.). For example, the illustrative systems and methods may be used to assist a user in the configuration and/or adjustment of one or more cardiac therapy settings such as, e.g., optimization of the A-V interval, or delay, of pacing therapy (e.g., left ventricular-only, or left univentricular, pacing therapy) and the A-V interval, or delay, and the V-V interval, or delay, of pacing therapy (e.g., biventricular pacing therapy).

An illustrative method <NUM> of evaluation and configuration of cardiac therapy is depicted in <FIG>. The illustrative method <NUM> may be generally described to be used in the noninvasive evaluation and configuration (e.g., optimization) of cardiac therapy. The illustrative method <NUM> may be described as being noninvasive because the method does not use invasive apparatus to perform the evaluation and configuration of the cardiac therapy. The cardiac therapy being delivered, however, may be described as being invasive such as when, e.g., one or more pacing electrodes are implanted proximate a patient's heart. Thus, the illustrative method <NUM> may be used to evaluate and configure such invasive cardiac therapy without being invasive itself.

The illustrative method <NUM> may further be generally described as determining a first subset of paced settings based on electrical activity measured by a plurality of external electrodes, and then determining a second subset of the first subset of paced settings based on one or more of single-electrode cardiac metrics from electrical activity measured by a single external electrode and vectorcardiographic metrics from electrical activity measured by a plurality of external electrodes or other technology.

The illustrative method <NUM> may include monitoring, or measuring, electrical activity using a plurality of external electrodes <NUM>. The plurality of external electrodes may be similar to the external electrodes provided by the electrode apparatus <NUM> as described herein with respect to <FIG>. For example, the plurality of external electrodes may be part, or incorporated into, a vest or band that is located about a patient's torso. More specifically, the plurality of electrodes may be described as being surface electrodes positioned in an array configured to be located proximate the skin of the torso of a patient. The electrical activity monitored during process <NUM> prior to the delivery of cardiac therapy may be referred to as "baseline" electrical activity because no therapy is delivered to the patient such that the patient's heart is in its natural, or intrinsic, rhythm.

During, or simultaneous with, the monitoring, or collecting, of electrical activity <NUM>, the illustrative method <NUM> may include delivering cardiac therapy <NUM> such as, e.g., left ventricular-only, or left univentricular, pacing therapy or biventricular pacing therapy, at a plurality of different paced settings. The cardiac therapy <NUM> may be delivered by at least one electrode configured to electrically stimulate (e.g., depolarize, pace, etc.) the patient's left ventricle after either an atrial sense or atrial pace in left ventricular-only pacing or the patient's left ventricle and right ventricle after either an atrial sense or atrial pace in biventricular pacing.

The cardiac therapy may be delivered to the patient at a plurality of difference paced settings. As an example, a paced setting can be any one parameter or a combination of parameters including, but not limited to, electrode position, pacing polarity, pacing voltage, pacing output, pacing pulse width, timing at which pacing is delivered to the ventricles (e.g., left ventricle) relative to atria activity (e.g., A-V delay), timing at which pacing is delivered to the right ventricle relative to left ventricle activity (e.g., V-V delay), pacing rate, number of electrodes utilized, location, etc. Further, as an example, the location of a leadless device or a pacing lead can include a location in the left ventricle, accessed through the right atrium within, or in close proximity to, the high posterior basal and/or septal (HPBS) area of the left ventricular cavity. Moreover, pacing of, or in close proximity to, the HPBS area can be selective (e.g., involving stimulation of a particular area of the HPBS alone) or non-selective (e.g., combined pacing at the location of the HPBS and other atrial and/or ventricular septum areas).

For example, the A-V and/or V-V intervals may be adjusted (e.g., increased or decreased) by a step size value from previous values. It may be described that the A-V and/or V-V intervals may be "swept" from an initial, short A-V and/or V-V interval until an intrinsic ventricular event (e.g., depolarization) is sensed, e.g., due to the A-V interval being adjusted to be too "long. " In at least one embodiment, the first, or initial, A-V interval may be about <NUM> milliseconds (ms). The first, or initial, A-V interval may be greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, etc. Further, the first, or initial, A-V interval may be less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, etc..

The A-V interval may be increased by a step size until an intrinsic ventricular event is sensed. As used herein, an "intrinsic" ventricular event or conduction is one that occurs or is conducted (e.g., across the A-V node of the heart, from the atria to the ventricles, etc.) naturally. In at least one embodiment, the step size, or increment, may be about <NUM>. The step size, or increment, may be greater than or about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, greater than or equal to about <NUM>, etc. Further, the step size, or increment, may be less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, less than or equal to about <NUM>, etc..

In at least one embodiment, each of the electrodes may be coupled to one or more leads implanted in, or proximate to, the patient's heart. Further, in at least one embodiment, the cardiac therapy <NUM> may be delivered by a lead-less electrode. Illustrative cardiac therapy using an implantable electrode and lead may be further described herein with reference to <FIG>. Although the systems and devices of <FIG> include three leads, it is to be understood that the illustrative systems and methods described herein may be used with any type of cardiac pacing systems including no leads, less than three leads, and more than three leads. As described herein, although the cardiac therapy delivery may be described as being invasive, the illustrative methods and systems may be described as being noninvasive because the illustrative methods and systems may only initiate the delivery of and configure the cardiac therapy, and the illustrative methods and systems may further use electrical signals that are monitored, or taken, from the patient noninvasively. Further, illustrative cardiac therapy may utilize an leaded or leadless implantable cardiac device that includes a tissue-piercing electrode implantable from the triangle of Koch region of the right atrium through the right atrial endocardium and central fibrous body to deliver cardiac therapy to or sense electrical activity of the left ventricle in the basal and/or septal region of the left ventricular myocardium of a patient's heart as described in <CIT>, and <CIT>.

The method <NUM> further includes generating one or more multiple-electrode cardiac metrics for each of the plurality of different paced settings based on the monitored electrical activity <NUM>. A multiple-electrode cardiac metric may be described as a cardiac metric derived from, or generated from, a plurality of external electrodes.

One set illustrative multiple-electrode metrics may be referred to as electrical heterogeneity information (EHI). EHI may be described as information, or data, representative of at least one of mechanical cardiac functionality and electrical cardiac functionality. The EHI and other cardiac therapy information may be described in <CIT>.

Electrical heterogeneity information (e.g., data) may be defined as information indicative of at least one of mechanical synchrony or dyssynchrony of the heart and/or electrical synchrony or dyssynchrony of the heart. In other words, electrical heterogeneity information may represent a surrogate of actual mechanical and/or electrical functionality of a patient's heart. In at least one embodiment, relative changes in electrical heterogeneity information (e.g., from baseline heterogeneity information to therapy heterogeneity information, from a first set of heterogeneity information to a second set of therapy heterogeneity information, etc.) may be used to determine a surrogate value representative of the changes in hemodynamic response (e.g., acute changes in LV pressure gradients). The left ventricular pressure may be typically monitored invasively with a pressure sensor located in the left ventricular of a patient's heart. As such, the use of electrical heterogeneity information to determine a surrogate value representative of the left ventricular pressure may avoid invasive monitoring using a left ventricular pressure sensor.

In at least one embodiment, the electrical heterogeneity information may include a standard deviation of ventricular activation times measured using some or all of the external electrodes, e.g., of the electrode apparatus <NUM>. Further, local, or regional, electrical heterogeneity information may include standard deviations and/or averages of activation times measured using electrodes located in certain anatomic areas of the torso. For example, external electrodes on the left side of the torso of a patient may be used to compute local, or regional, left electrical heterogeneity information.

The electrical heterogeneity information may be generated using one or more various systems and/or methods. For example, electrical heterogeneity information may be generated using an array, or a plurality, of surface electrodes and/or imaging systems as described in <CIT> and entitled "ASSESSING INRA-CARDIAC ACTIVATION PATTERNS AND ELECTRICAL DYSSYNCHRONY," <CIT> and entitled "ASSESSING INTRA-CARDIAC ACTIVATION PATTERNS", and <CIT> and entitled "METHODS AND SYSTEMS FOR USE IN SELECTING CARDIAC PACING SITES".

Electrical heterogeneity information may include one or more metrics or indices. For example, one of the metrics, or indices, of electrical heterogeneity may be a standard deviation of activation times (SDAT) measured using some or all of the electrodes on the surface of the torso of a patient. In some examples, the SDAT may be calculated using the estimated cardiac activation times over the surface of a model heart.

Another metric, or index, of electrical heterogeneity may be a left standard deviation of surrogate electrical activation times (LVED) monitored by external electrodes located proximate the left side of a patient. Further, another metric, or index, of electrical heterogeneity may include an average of surrogate electrical activation times (LVAT) monitored by external electrodes located proximate the left side of a patient. The LVED and LVAT may be determined (e.g., calculated, computed, etc.) from electrical activity measured only by electrodes proximate the left side of the patient, which may be referred to as "left" electrodes. The left electrodes may be defined as any surface electrodes located proximate the left ventricle, which includes region to left of the patient's sternum and spine. In one embodiment, the left electrodes may include all anterior electrodes on the left of the sternum and all posterior electrodes to the left of the spine. In another embodiment, the left electrodes may include all anterior electrodes on the left of the sternum and all posterior electrodes. In yet another embodiment, the left electrodes may be designated based on the contour of the left and right sides of the heart as determined using imaging apparatus (e.g., x-ray, fluoroscopy, etc.).

Another illustrative metric, or index, of dyssynchrony may be a range of activation times (RAT) that may be computed as the difference between the maximum and the minimum torso-surface or cardiac activation times, e.g., overall, or for a region. The RAT reflects the span of activation times while the SDAT gives an estimate of the dispersion of the activation times from a mean. The SDAT also provides an estimate of the heterogeneity of the activation times, because if activation times are spatially heterogeneous, the individual activation times will be further away from the mean activation time, indicating that one or more regions of heart have been delayed in activation. In some examples, the RAT may be calculated using the estimated cardiac activation times over the surface of a model heart.

Another illustrative metric, or index, of electrical heterogeneity information may include estimates of a percentage of surface electrodes located within a particular region of interest for the torso or heart whose associated activation times are greater than a certain percentile, such as, for example the 70th percentile, of measured QRS complex duration or the determined activation times for surface electrodes. The region of interest may, e.g., be a posterior, left anterior, and/or left-ventricular region. The illustrative metric, or index, may be referred to as a percentage of late activation (PLAT). The PLAT may be described as providing an estimate of percentage of the region of interest, e.g., posterior and left-anterior area associated with the left ventricular area of heart, which activates late. A large value for PLAT may imply delayed activation of a substantial portion of the region, e.g., the left ventricle, and the potential benefit of electrical resynchronization through CRT by pre-exciting the late region, e.g., of left ventricle. In other examples, the PLAT may be determined for other subsets of electrodes in other regions, such as a right anterior region to evaluate delayed activation in the right ventricle. Furthermore, in some examples, the PLAT may be calculated using the estimated cardiac activation times over the surface of a model heart for either the whole heart or for a particular region, e.g., left or right ventricle, of the heart.

In one or more embodiments, the electrical heterogeneity information may include indicators of favorable changes in global cardiac electrical activation such as, e.g., described in <NPL> and/or <NPL>. Heterogeneity information may also include measurements of improved cardiac mechanical function measured by imaging or other systems to track motion of implanted leads within the heart as, e.g., described in <NPL>, <NPL>, and/or <CIT>.

Additionally, although not depicted in the block diagram of <FIG>, one or more multiple-electrode cardiac metrics may be generated <NUM> for electrical activity monitored without, or before the delivery of, cardiac therapy, which may be referred to as baseline multiple-electrode cardiac metrics.

Thus, it may be described that the illustrative method <NUM> may deliver left ventricular-only or biventricular pacing therapy <NUM>, monitor electrical activity <NUM>, and generate one or more multiple-electrode cardiac metrics <NUM> for a plurality of different paced settings (such as, e.g., a plurality of different A-V intervals, a plurality of different V-V intervals, a plurality of different pacing thresholds, a plurality of different pacing pulse widths, a plurality of different pacing vectors including single point and multipoint vectors, etc.).

The method <NUM> may then determine a first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the generated multiple-electrode metrics <NUM>. The first subset may include one or more of the different paced settings that satisfy one or more conditions indicative of successful pacing, improvement in the patient's cardiac functionality, etc. The first subset may be described as including the best paced settings of the plurality of different paced settings based on the multiple-electrode cardiac metrics. For example, if thirty-two different paced settings were tried, a first subset of the thirty-two different paced settings may selected by evaluating the generated multiple-electrode cardiac metrics associated therewith. The first subset may, e.g., include the best six paced settings out of the thirty-two different paced settings.

In at least one embodiment, one or more multiple-electrode cardiac metrics may be compared to threshold values to indicate whether the paced settings associated therewith are acceptable. For example, a paced setting may be determined to be acceptable if the multiple-electrode cardiac metric is less than or equal to a threshold or if the multiple-electrode cardiac metric changed (e.g., improved) a selected percentage from an intrinsic multiple-electrode cardiac metric generated from electrical activity monitored during no delivery of cardiac pacing therapy. Any paced settings associated with multiple-electrode cardiac metrics that exceed the threshold or the selected percentage may be determined to be acceptable, and thus, may be included in the first subset.

More specifically, in at least one embodiment, the multiple-electrode metrics may include EHI such, e.g., SDAT or LVAT. In such an embodiment, any paced settings resulting in an SDAT that is less than or equal to <NUM> milliseconds (ms) or resulting in an LVAT that is less than or equal to <NUM> may be determined to be acceptable, and thus, included in the first subset. Additionally, in such an embodiment, any paced settings resulting in an SDAT that has been reduced from intrinsic activity by <NUM> percent or resulting in an LVAT that has been reduced from intrinsic activity by <NUM> percent may be determined to be acceptable, and thus, included in the first subset.

The illustrative method <NUM> may further differentiate between the different paced settings of the first subset by generating single-electrode and/or vectorcardiographic metrics <NUM> for each of the first subset of paced settings. The single-electrode metrics may include one or more of morphology changes, amplitude changes, QRS duration, various other ECG-segment durations, etc. Examples of favorable, or desirable, morphology changes (e.g., indicative of acceptable pacing) may include QS morphology with QRS narrowing and/or R-wave morphology without QRS widening on signals measured from electrodes close to where right precordial leads V1/V2 are placed for the standard <NUM>-lead ECG in clinical practice. The vectorcardiographic metrics may include one or more of three-dimensional QRS area changes, t-wave areas change based on one or more axes, etc..

The method <NUM> may then determine a second, or final, subset of the first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on one or more of the generated single-electrode metrics and vectorcardiographic metrics <NUM>. The second subset may include one or more of the different paced settings from the first subset that satisfy one or more conditions indicative of successful pacing, improvement in the patient's cardiac functionality, etc. The second subset may be described as including the best paced settings of the first subset of the plurality of different paced settings. For example, if the first subset included six different paced settings, a second subset of the first subset may selected by evaluating the one or more of the generated single-electrode metrics and vectorcardiographic metrics associated with each of the six different paced settings of the first subset. The second subset may, e.g., include the best one or more paced settings out of the six paced settings of the first subset.

In at least one embodiment, one or more of the generated single-electrode metrics and vectorcardiographic metrics may be compared to threshold values to indicate whether the paced settings associated therewith are acceptable and may be included the second subset. For example, a paced setting may be determined to be acceptable if the single-electrode metrics and vectorcardiographic metrics are less than or equal to a threshold or if the single-electrode metrics and vectorcardiographic metrics are greater than or equal to a threshold. For example, QRS duration may be compared to a threshold value, such as, e.g., <NUM> milliseconds, which will be described further herein.

Further, the single-electrode cardiac metrics may be associated with a single electrode corresponding to a standard <NUM>-lead ECG. For example, each single-electrode cardiac metric may be associated with one of the three limb leads, namely, I, II, and III, one of the three augmented limb leads, namely aVR, aVL, and aVF, and one of the three precordial leads, namely, V1, V2, V3, V4, V5, and V6. When utilizing single-electrode cardiac metrics, it is to be understood that an operator or physician may be able to select which of the electrodes to be used including electrodes corresponding to a standard <NUM>-lead ECG.

Additionally, one or more of the generated single-electrode metrics and vectorcardiographic metrics may be simply evaluated for detection thereof. For example, various morphologies may be detected in monitored single-electrode signals, and the detection of such morphologies may be used to indicate acceptability of a paced setting related thereto.

In one or more embodiments, the detection of various morphologies may be used in conjunction with other metrics such as QRS duration. For example, a single-electrode cardiac metric may correspond to electrical activity monitored from a single electrode of the plurality of external electrodes proximate the fourth intercostal space to the right of the patient's sternum. This location may be referred to as V1 because such single electrode may be positioned to correspond to V1 according to a <NUM>-lead ECG. A paced setting may be determined to be acceptable if QS morphology is detected and QRS duration has decreased by a selected threshold (e.g., decreased by more than the selected threshold) in the electrical activity monitored by the single electrode at location V1or if R-wave morphology is detected and QRS duration has not increased by the selected threshold in the electrical activity monitored by the single electrode at location V1. In at least one embodiment, the selected threshold may be <NUM> or <NUM>.

Further, for example, a vectorcardiographic metric may include a three-dimensional QRS area change. Paced settings may be determined to be acceptable if a three-dimensional QRS area decreases by a selected percentage from an intrinsic three-dimensional QRS area generated from electrical activity monitored during no delivery of cardiac pacing therapy. In at least one embodiment, the selected percentage may be <NUM>%.

Illustrative graphical user interfaces for use in configuring cardiac therapy are depicted in <FIG>. Generally, the graphical user interfaces may be used to depict the paced settings of the first subset and the paced settings of the second subset along with the multiple-electrode cardiac metrics and single-electrode cardiac metrics.

The illustrative graphical user interface <NUM> show in <FIG> depicts six different paced settings and multiple-electrode cardiac metrics and single-electrode cardiac metrics associated therewith arranged about five columns. The first column <NUM> depicts the paced settings for each of the six different paced settings. The second column <NUM> depicts SDAT, the third column depicts V1 QS morphology, the fourth column depicts V1 R-wave morphology, and the fifth column depicts QRS duration change.

As shown in the graphical user interface <NUM> of <FIG>, the first subset of paced settings may have been selected, or determined, from a plurality of different paced settings as described herein with respect to the illustrative method <NUM>. The first subset is depicted in the first column <NUM> ranked one through six based on the multiple-electrode cardiac metric, namely SDAT. More specifically, the first ranked paced setting (i.e., biventricular pacing having a V-V timing of <NUM> and A-V timing of <NUM> and utilizing pacing vector LV2) of the first subset generated a SDAT of <NUM>, the second ranked paced setting (i.e., biventricular pacing having a V-V timing of <NUM> and A-V timing of <NUM> and utilizing pacing vector LV3) of the first subset generated a SDAT of <NUM>, the third ranked paced setting (i.e., biventricular pacing having a V-V timing of <NUM> and A-V timing of <NUM> and utilizing pacing vector LV2) of the first subset generated a SDAT of <NUM>, the fourth ranked paced setting (i.e., biventricular pacing having a V-V timing of <NUM> and A-V timing of <NUM> and utilizing pacing vector LV1) of the first subset generated a SDAT of <NUM>, the fifth ranked paced setting (i.e., biventricular pacing having a V-V timing of <NUM> and A-V timing of <NUM> and utilizing pacing vector LV1) of the first subset generated a SDAT of <NUM>, and the last ranked paced setting (i.e., biventricular pacing having a V-V timing of -<NUM> and A-V timing of <NUM> and utilizing pacing vector LV1) of the first subset generated a SDAT of <NUM>.

To determine the second subset of paced settings from the first subset of paced settings, the single-electrode cardiac metrics may be utilized. For example, a paced setting may be determined to be acceptable if QS morphology is detected and QRS duration has decreased by <NUM> or if R-wave morphology is detected and QRS duration has not increased by <NUM>. The paced settings that are determined to not be acceptable are lined through in the graphical user interface <NUM> of <FIG> resulting in a second subset of paced settings. In other words, the second, or final, subset of paced settings are not lined through in the graphical user interface <NUM> of <FIG>.

As shown, the second ranked paced settings and the fourth ranked paced settings remain from the first subset, and thus, form the second subset. The first ranked, the fifth ranked, and the sixth ranked paced setting were eliminated because no V1 QS or R-wave morphology was detected. The third ranked paced setting was eliminated because, despite having V1 or R-wave morphology, the QRS duration increased by more than <NUM>, namely, by <NUM>.

The second ranked paced setting was deemed acceptable because V1 QS morphology was detected and the QRS duration decreased by more than <NUM>, namely, by <NUM>. The fourth ranked paced setting was deemed acceptable because V1 R-wave morphology was detected and the QRS duration increased by less than <NUM>, namely, by <NUM>.

Therefore, despite the first and second ranked paced settings having equal multiple-electrode cardiac metric, namely SDAT, the second ranked paced setting was ultimately determined to be more acceptable based on the single-electrode cardiac metrics.

The illustrative graphical user interface <NUM> show in <FIG> depicts six different paced settings and generated multiple-electrode cardiac metrics and vectorcardiographic cardiac metrics associated therewith arranged about three columns. The first column <NUM> depicts the paced settings for each of the six different paced settings. The second column <NUM> depicts change in LVAT from intrinsic rhythm, and the third column <NUM> depicts three-dimensional QRS area change from intrinsic rhythm.

As shown in <FIG>, the first subset of paced settings may have been selected, or determined, from a plurality of different paced settings as described herein with respect to illustrative method <NUM>. The first subset is depicted in the first column <NUM> ranked one through six based on the multiple-electrode cardiac metric, namely change in LVAT from intrinsic rhythm. More specifically, the first ranked paced setting (i.e., left-ventricle only pacing having A-V timing of <NUM> and a pulse width of <NUM> and utilizing pacing vector LV2) of the first subset generated a change in LVAT of -<NUM>%, the second ranked paced setting (i.e., biventricular pacing having V-V timing of <NUM>, A-V timing of <NUM>, and a pulse width of <NUM> and utilizing pacing vector LV3) of the first subset generated a change in LVAT of -<NUM>%, the third ranked paced setting (i.e., left-ventricle only pacing having A-V timing of <NUM> and a pulse width of <NUM> and utilizing pacing vector LV2) of the first subset generated a change in LVAT of -<NUM>%, the fourth ranked paced setting (i.e., biventricular pacing having V-V timing of <NUM>, A-V timing of <NUM>, and a pulse width of <NUM> and utilizing pacing vector LV3) of the first subset generated a change in LVAT of -<NUM>%, the fifth ranked paced setting (i.e., biventricular pacing having V-V timing of <NUM>, A-V timing of <NUM>, and a pulse width of <NUM> and utilizing pacing vector LV1) of the first subset generated a change in LVAT of -<NUM>%, and the last ranked paced setting (i.e., biventricular pacing having V-V timing of -<NUM>, A-V timing of <NUM>, and a pulse width of <NUM> and utilizing pacing vector LV1) of the first subset generated a change in LVAT of -<NUM>%.

To determine the second subset of paced settings from the first subset of paced settings, the vectorcardiographic cardiac metric, namely, three-dimensional QRS area change from intrinsic rhythm may be utilized. For example, a paced setting may be determined to be acceptable if the three-dimensional QRS area from intrinsic morphology decreases by more than <NUM>%. The paced settings that are not determined to be acceptable are lined through in the graphical user interface <NUM> of <FIG> resulting in a second subset of paced settings. In other words, the second, or final, subset of paced settings are not lined through in the graphical user interface <NUM> of <FIG>.

As shown, the third ranked paced settings and the fourth ranked paced settings remain from the first subset, and thus, form the second subset. The first ranked, the second ranked, the fifth ranked and the sixth ranked paced settings were eliminated because three-dimensional QRS area change from intrinsic was not greater than -<NUM>%. The second ranked and third ranked paced settings were deemed acceptable because their three-dimensional QRS area changes from intrinsic were greater than -<NUM>%.

Therefore, despite the first, second, third, and fourth ranked paced settings having a substantially equivale multiple-electrode cardiac metric, namely LVAT change from intrinsic with <NUM>% of each other, the third ranked and fourth ranked paced settings were ultimately determined to be more acceptable based on the vectorcardiographic cardiac metric.

Illustrative cardiac therapy systems and devices may be further described herein with reference to <FIG>. Such cardiac therapy systems and devices may deliver therapy that may be configured using the illustrative systems, interfaces, methods, and processes described herein with respect to <FIG>.

<FIG> is a conceptual diagram illustrating an illustrative therapy system <NUM> that may be used to deliver pacing therapy to a patient <NUM>. Patient <NUM> may, but not necessarily, be a human. The therapy system <NUM> may include an implantable medical device <NUM> (IMD), which may be coupled to leads <NUM>, <NUM>, <NUM>. The IMD <NUM> may be, e.g., an implantable pacemaker, cardioverter, and/or defibrillator, that delivers, or provides, electrical signals (e.g., paces, etc.) to and/or senses electrical signals from the heart <NUM> of the patient <NUM> via electrodes coupled to one or more of the leads <NUM>, <NUM>, <NUM>.

The leads <NUM>, <NUM>, <NUM> extend into the heart <NUM> of the patient <NUM> to sense electrical activity of the heart <NUM> and/or to deliver electrical stimulation to the heart <NUM>. In the example shown in <FIG>, the right ventricular (RV) lead <NUM> extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium <NUM>, and into the right ventricle <NUM>. The left ventricular (LV) coronary sinus lead <NUM> extends through one or more veins, the vena cava, the right atrium <NUM>, and into the coronary sinus <NUM> to a region adjacent to the free wall of the left ventricle <NUM> of the heart <NUM>. The right atrial (RA) lead <NUM> extends through one or more veins and the vena cava, and into the right atrium <NUM> of the heart <NUM>.

The IMD <NUM> may sense, among other things, electrical signals attendant to the depolarization and repolarization of the heart <NUM> via electrodes coupled to at least one of the leads <NUM>, <NUM>, <NUM>. In some examples, the IMD <NUM> provides pacing therapy (e.g., pacing pulses) to the heart <NUM> based on the electrical signals sensed within the heart <NUM>. The IMD <NUM> may be operable to adjust one or more parameters associated with the pacing therapy such as, e.g., A-V delay and other various timings, pulse wide, amplitude, voltage, burst length, etc. Further, the IMD <NUM> may be operable to use various electrode configurations to deliver pacing therapy, which may be unipolar, bipolar, quadripoloar, or further multipolar. For example, a multipolar lead may include several electrodes that can be used for delivering pacing therapy. Hence, a multipolar lead system may provide, or offer, multiple electrical vectors to pace from. A pacing vector may include at least one cathode, which may be at least one electrode located on at least one lead, and at least one anode, which may be at least one electrode located on at least one lead (e.g., the same lead, or a different lead) and/or on the casing, or can, of the IMD. While improvement in cardiac function as a result of the pacing therapy may primarily depend on the cathode, the electrical parameters like impedance, pacing threshold voltage, current drain, longevity, etc. may be more dependent on the pacing vector, which includes both the cathode and the anode. The IMD <NUM> may also provide defibrillation therapy and/or cardioversion therapy via electrodes located on at least one of the leads <NUM>, <NUM>, <NUM>. Further, the IMD <NUM> may detect arrhythmia of the heart <NUM>, such as fibrillation of the ventricles <NUM>, <NUM>, and deliver defibrillation therapy to the heart <NUM> in the form of electrical pulses. In some examples, IMD <NUM> may be programmed to deliver a progression of therapies, e.g., pulses with increasing energy levels, until a fibrillation of heart <NUM> is stopped.

<FIG> are conceptual diagrams illustrating the IMD <NUM> and the leads <NUM>, <NUM>, <NUM> of therapy system <NUM> of <FIG> in more detail. The leads <NUM>, <NUM>, <NUM> may be electrically coupled to a therapy delivery module (e.g., for delivery of pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and/or any other modules of the IMD <NUM> via a connector block <NUM>. In some examples, the proximal ends of the leads <NUM>, <NUM>, <NUM> may include electrical contacts that electrically couple to respective electrical contacts within the connector block <NUM> of the IMD <NUM>. In addition, in some examples, the leads <NUM>, <NUM>, <NUM> may be mechanically coupled to the connector block <NUM> with the aid of set screws, connection pins, or another suitable mechanical coupling mechanism.

Each of the leads <NUM>, <NUM>, <NUM> includes an elongated insulative lead body, which may carry a number of conductors (e.g., concentric coiled conductors, straight conductors, etc.) separated from one another by insulation (e.g., tubular insulative sheaths). In the illustrated example, bipolar electrodes <NUM>, <NUM> are located proximate to a distal end of the lead <NUM>. In addition, bipolar electrodes <NUM>, <NUM>, <NUM>, <NUM> are located proximate to a distal end of the lead <NUM> and bipolar electrodes <NUM>, <NUM> are located proximate to a distal end of the lead <NUM>.

The electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may take the form of ring electrodes, and the electrodes <NUM>, <NUM> may take the form of extendable helix tip electrodes mounted retractably within the insulative electrode heads <NUM>, <NUM>, <NUM>, respectively. Each of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be electrically coupled to a respective one of the conductors (e.g., coiled and/or straight) within the lead body of its associated lead <NUM>, <NUM>, <NUM>, and thereby coupled to a respective one of the electrical contacts on the proximal end of the leads <NUM>, <NUM>, <NUM>.

Additionally, electrodes <NUM>, <NUM>, <NUM> and <NUM> may have an electrode surface area of about <NUM><NUM> to about <NUM><NUM>. Electrodes <NUM>, <NUM>, <NUM>, and <NUM> may also be referred to as LV1, LV2, LV3, and LV4, respectively. The LV electrodes (i.e., left ventricle electrode <NUM> (LV1) <NUM>, left ventricle electrode <NUM> (LV2) <NUM>, left ventricle electrode <NUM> (LV3) <NUM>, and left ventricle <NUM> (LV4) <NUM> etc.) on the lead <NUM> can be spaced apart at variable distances. For example, electrode <NUM> may be a distance of, e.g., about <NUM> millimeters (mm), away from electrode <NUM>, electrodes <NUM> and <NUM> may be spaced a distance of, e.g. about <NUM> to about <NUM>, away from each other, and electrodes <NUM> and <NUM> may be spaced a distance of, e.g. <NUM> to about <NUM>, away from each other.

The electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may further be used to sense electrical signals (e.g., morphological waveforms within electrograms (EGM)) attendant to the depolarization and repolarization of the heart <NUM>. The electrical signals are conducted to the IMD <NUM> via the respective leads <NUM>, <NUM>, <NUM>. In some examples, the IMD <NUM> may also deliver pacing pulses via the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to cause depolarization of cardiac tissue of the patient's heart <NUM>. In some examples, as illustrated in <FIG>, the IMD <NUM> includes one or more housing electrodes, such as housing electrode <NUM>, which may be formed integrally with an outer surface of a housing <NUM> (e.g., hermetically-sealed housing) of the IMD <NUM> or otherwise coupled to the housing <NUM>. Any of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> may be used for unipolar sensing or pacing in combination with the housing electrode <NUM>. It is generally understood by those skilled in the art that other electrodes can also be selected to define, or be used for, pacing and sensing vectors. Further, any of electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, when not being used to deliver pacing therapy, may be used to sense electrical activity during pacing therapy.

As described in further detail with reference to <FIG>, the housing <NUM> may enclose a therapy delivery module that may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, as well as a sensing module for monitoring the electrical signals of the patient's heart (e.g., the patient's heart rhythm). The leads <NUM>, <NUM>, <NUM> may also include elongated electrodes <NUM>, <NUM>, <NUM>, respectively, which may take the form of a coil. The IMD <NUM> may deliver defibrillation shocks to the heart <NUM> via any combination of the elongated electrodes <NUM>, <NUM>, <NUM> and the housing electrode <NUM>. The electrodes <NUM>, <NUM>, <NUM>, <NUM> may also be used to deliver cardioversion pulses to the heart <NUM>. Further, the electrodes <NUM>, <NUM>, <NUM> may be fabricated from any suitable electrically conductive material, such as, but not limited to, platinum, platinum alloy, and/or other materials known to be usable in implantable defibrillation electrodes. Since electrodes <NUM>, <NUM>, <NUM> are not generally configured to deliver pacing therapy, any of electrodes <NUM>, <NUM>, <NUM> may be used to sense electrical activity and may be used in combination with any of electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>. In at least one embodiment, the RV elongated electrode <NUM> may be used to sense electrical activity of a patient's heart during the delivery of pacing therapy (e.g., in combination with the housing electrode <NUM>, or defibrillation electrode-to-housing electrode vector).

The configuration of the illustrative therapy system <NUM> illustrated in <FIG> is merely one example. In other examples, the therapy system may include epicardial leads and/or patch electrodes instead of or in addition to the transvenous leads <NUM>, <NUM>, <NUM> illustrated in <FIG>. Additionally, in other examples, the therapy system <NUM> may be implanted in/around the cardiac space without transvenous leads (e.g., leadless/wireless pacing systems) or with leads implanted (e.g., implanted transvenously or using approaches) into the left chambers of the heart (in addition to or replacing the transvenous leads placed into the right chambers of the heart as illustrated in <FIG>). Further, in one or more embodiments, the IMD <NUM> need not be implanted within the patient <NUM>. For example, the IMD <NUM> may deliver various cardiac therapies to the heart <NUM> via percutaneous leads that extend through the skin of the patient <NUM> to a variety of positions within or outside of the heart <NUM>. In one or more embodiments, the system <NUM> may utilize wireless pacing (e.g., using energy transmission to the intracardiac pacing component(s) via ultrasound, inductive coupling, RF, etc.) and sensing cardiac activation using electrodes on the can/housing and/or on subcutaneous leads.

In other examples of therapy systems that provide electrical stimulation therapy to the heart <NUM>, such therapy systems may include any suitable number of leads coupled to the IMD <NUM>, and each of the leads may extend to any location within or proximate to the heart <NUM>. For example, other examples of therapy systems may include three transvenous leads located as illustrated in <FIG>. Still further, other therapy systems may include a single lead that extends from the IMD <NUM> into the right atrium <NUM> or the right ventricle <NUM>, or two leads that extend into a respective one of the right atrium <NUM> and the right ventricle <NUM>.

<FIG> is a functional block diagram of one illustrative configuration of the IMD <NUM>. As shown, the IMD <NUM> may include a control module <NUM>, a therapy delivery module <NUM> (e.g., which may include a stimulation generator), a sensing module <NUM>, and a power source <NUM>.

The control module, or apparatus, <NUM> may include a processor <NUM>, memory <NUM>, and a telemetry module, or apparatus, <NUM>. The memory <NUM> may include computer-readable instructions that, when executed, e.g., by the processor <NUM>, cause the IMD <NUM> and/or the control module <NUM> to perform various functions attributed to the IMD <NUM> and/or the control module <NUM> described herein. Further, the memory <NUM> may include any volatile, non-volatile, magnetic, optical, and/or electrical media, such as a 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 <CIT>.

The processor <NUM> of the control module <NUM> may include any one or more of a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field-programmable gate array (FPGA), and/or equivalent discrete or integrated logic circuitry. In some examples, the processor <NUM> 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 circuitry. The functions attributed to the processor <NUM> herein may be embodied as software, firmware, hardware, or any combination thereof.

The control module <NUM> may control the therapy delivery module <NUM> to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart <NUM> according to a selected one or more therapy programs, which may be stored in the memory <NUM>. More, specifically, the control module <NUM> (e.g., the processor <NUM>) may control various parameters of the electrical stimulus delivered by the therapy delivery module <NUM> such as, e.g., A-V delays, V-V delays, pacing pulses with the amplitudes, pulse widths, frequency, or electrode polarities, etc., which may be specified by one or more selected therapy programs (e.g., A-V and/or V-V delay adjustment programs, pacing therapy programs, pacing recovery programs, capture management programs, etc.). As shown, the therapy delivery module <NUM> is electrically coupled to electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, e.g., via conductors of the respective lead <NUM>, <NUM>, <NUM>, or, in the case of housing electrode <NUM>, via an electrical conductor disposed within housing <NUM> of IMD <NUM>. Therapy delivery module <NUM> may be configured to generate and deliver electrical stimulation therapy such as pacing therapy to the heart <NUM> using one or more of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>.

For example, therapy delivery module <NUM> may deliver pacing stimulus (e.g., pacing pulses) via ring electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> coupled to leads <NUM>, <NUM>, <NUM> and/or helical tip electrodes <NUM>, <NUM> of leads <NUM>, <NUM>. Further, for example, therapy delivery module <NUM> may deliver defibrillation shocks to heart <NUM> via at least two of electrodes <NUM>, <NUM>, <NUM>, <NUM>. In some examples, therapy delivery module <NUM> may be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, therapy delivery module <NUM> may be configured 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.

The IMD <NUM> may further include a switch module <NUM> and the control module <NUM> (e.g., the processor <NUM>) may use the switch module <NUM> to select, e.g., via a data/address bus, which of the available electrodes are used to deliver therapy such as pacing pulses for pacing therapy, or which of the available electrodes are used for sensing. The switch module <NUM> may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable to selectively couple the sensing module <NUM> and/or the therapy delivery module <NUM> to one or more selected electrodes. More specifically, the therapy delivery module <NUM> may include a plurality of pacing output circuits. Each pacing output circuit of the plurality of pacing output circuits may be selectively coupled, e.g., using the switch module <NUM>, to one or more of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> (e.g., a pair of electrodes for delivery of therapy to a bipolar or multipolar pacing vector). In other words, each electrode can be selectively coupled to one of the pacing output circuits of the therapy delivery module using the switching module <NUM>.

The sensing module <NUM> is coupled (e.g., electrically coupled) to sensing apparatus, which may include, among additional sensing apparatus, the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> to monitor electrical activity of the heart <NUM>, e.g., electrocardiogram (ECG)/electrogram (EGM) signals, etc. The ECG/EGM signals may be used to measure or monitor activation times (e.g., ventricular activations times, etc.), heart rate (HR), heart rate variability (HRV), heart rate turbulence (HRT), deceleration/acceleration capacity, deceleration sequence incidence, T-wave alternans (TWA), P-wave to P-wave intervals (also referred to as the P-P intervals or A-A intervals), R-wave to R-wave intervals (also referred to as the R-R intervals or V-V intervals), P-wave to QRS complex intervals (also referred to as the P-R intervals, A-V intervals, or P-Q intervals), QRS-complex morphology, ST segment (i.e., the segment that connects the QRS complex and the T-wave), T-wave changes, QT intervals, electrical vectors, etc..

The switch module <NUM> may also be used with the sensing module <NUM> to select which of the available electrodes are used, or enabled, to, e.g., sense electrical activity of the patient's heart (e.g., one or more electrical vectors of the patient's heart using any combination of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>). Likewise, the switch module <NUM> may also be used with the sensing module <NUM> to select which of the available electrodes are not to be used (e.g., disabled) to, e.g., sense electrical activity of the patient's heart (e.g., one or more electrical vectors of the patient's heart using any combination of the electrodes <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>), etc. In some examples, the control module <NUM> may select the electrodes that function as sensing electrodes via the switch module within the sensing module <NUM>, e.g., by providing signals via a data/address bus.

In some examples, sensing module <NUM> includes a channel that includes an amplifier with a relatively wider pass band than the R-wave or P-wave amplifiers. Signals from the selected sensing electrodes may be provided to a multiplexer, and thereafter converted to multi-bit digital signals by an analog-to-digital converter for storage in memory <NUM>, e.g., as an electrogram (EGM). In some examples, the storage of such EGMs in memory <NUM> may be under the control of a direct memory access circuit.

In some examples, the control module <NUM> may operate as an interrupt-driven device, and may be responsive to interrupts from pacer timing and control module, where the interrupts may correspond to the occurrences of sensed P-waves and R-waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations may be performed by the processor <NUM> and any updating of the values or intervals controlled by the pacer timing and control module may take place following such interrupts. A portion of memory <NUM> may be configured as a plurality of recirculating buffers, capable of holding one or more series of measured intervals, which may be analyzed by, e.g., the processor <NUM> in response to the occurrence of a pace or sense interrupt to determine whether the patient's heart <NUM> is presently exhibiting atrial or ventricular tachyarrhythmia.

The telemetry module <NUM> of the control module <NUM> may include 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 <NUM>, the telemetry module <NUM> may receive downlink telemetry from and send uplink telemetry to a programmer with the aid of an antenna, which may be internal and/or external. The processor <NUM> may provide the data to be uplinked to a programmer and the control signals for the telemetry circuit within the telemetry module <NUM>, e.g., via an address/data bus. In some examples, the telemetry module <NUM> may provide received data to the processor <NUM> via a multiplexer.

The various components of the IMD <NUM> are further coupled to a power source <NUM>, which may include 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, e.g., on a daily or weekly basis.

<FIG> is another embodiment of a functional block diagram for IMD <NUM> that depicts bipolar RA lead <NUM>, bipolar RV lead <NUM>, and bipolar LV CS lead <NUM> without the LA CS pace/sense electrodes and coupled with an implantable pulse generator (IPG) circuit <NUM> having programmable modes and parameters of a bi-ventricular DDD/R type known in the pacing art. In turn, the sensor signal processing circuit <NUM> indirectly couples to the timing circuit <NUM> and via data and control bus to microcomputer circuitry <NUM>. The IPG circuit <NUM> is illustrated in a functional block diagram divided generally into a microcomputer circuit <NUM> and a pacing circuit <NUM>. The pacing circuit <NUM> includes the digital controller/timer circuit <NUM>, the output amplifiers circuit <NUM>, the sense amplifiers circuit <NUM>, the RF telemetry transceiver <NUM>, the activity sensor circuit <NUM> as well as a number of other circuits and components described below.

Crystal oscillator circuit <NUM> provides the basic timing clock for the pacing circuit <NUM> while battery <NUM> provides power. Power-on-reset circuit <NUM> responds to initial connection of the circuit to the battery for defining an initial operating condition and similarly, resets the operative state of the device in response to detection of a low battery condition. Reference mode circuit <NUM> generates stable voltage reference and currents for the analog circuits within the pacing circuit <NUM>. Analog-to-digital converter (ADC) and multiplexer circuit <NUM> digitize analog signals and voltage to provide, e.g., real time telemetry of cardiac signals from sense amplifiers <NUM> for uplink transmission via RF transmitter and receiver circuit <NUM>. Voltage reference and bias circuit <NUM>, ADC and multiplexer <NUM>, power-on-reset circuit <NUM>, and crystal oscillator circuit <NUM> may correspond to any of those used in illustrative implantable cardiac pacemakers.

If the IPG is programmed to a rate responsive mode, the signals output by one or more physiologic sensors are employed as a rate control parameter (RCP) to derive a physiologic escape interval. For example, the escape interval is adjusted proportionally to the patient's activity level developed in the patient activity sensor (PAS) circuit <NUM> in the depicted, illustrative IPG circuit <NUM>. The patient activity sensor <NUM> is coupled to the IPG housing and may take the form of a piezoelectric crystal transducer. The output signal of the patient activity sensor <NUM> may be processed and used as an RCP. Sensor <NUM> generates electrical signals in response to sensed physical activity that are processed by activity circuit <NUM> and provided to digital controller/timer circuit <NUM>. Activity circuit <NUM> and associated sensor <NUM> may correspond to the circuitry disclosed in <CIT> and <CIT>. Similarly, the illustrative systems, apparatus, and methods described herein may be practiced in conjunction with alternate types of sensors such as oxygenation sensors, pressure sensors, pH sensors, and respiration sensors, for use in providing rate responsive pacing capabilities. Alternately, QT time may be used as a rate indicating parameter, in which case no extra sensor is required. Similarly, the illustrative embodiments described herein may also be practiced in non-rate responsive pacemakers.

Data transmission to and from the external programmer is accomplished by way of the telemetry antenna <NUM> and an associated RF transceiver <NUM>, which serves both to demodulate received downlink telemetry and to transmit uplink telemetry. Uplink telemetry capabilities may include the ability to transmit stored digital information, e.g., operating modes and parameters, EGM histograms, and other events, as well as real time EGMs of atrial and/or ventricular electrical activity and marker channel pulses indicating the occurrence of sensed and paced depolarizations in the atrium and ventricle.

Microcomputer <NUM> contains a microprocessor <NUM> and associated system clock and on-processor RAM and ROM chips 82A and 82B, respectively. In addition, microcomputer circuit <NUM> includes a separate RAM/ROM chip 82C to provide additional memory capacity. Microprocessor <NUM> normally operates in a reduced power consumption mode and is interrupt driven. Microprocessor <NUM> is awakened in response to defined interrupt events, which may include A-TRIG, RV-TRIG, LV-TRIG signals generated by timers in digital timer/controller circuit <NUM> and A-EVENT, RV-EVENT, and LV-EVENT signals generated by sense amplifiers circuit <NUM>, among others. The specific values of the intervals and delays timed out by digital controller/timer circuit <NUM> are controlled by the microcomputer circuit <NUM> by way of data and control bus from programmed-in parameter values and operating modes. In addition, if programmed to operate as a rate responsive pacemaker, a timed interrupt, e.g., every cycle or every two seconds, may be provided in order to allow the microprocessor to analyze the activity sensor data and update the basic A-A, V-A, or V-V escape interval, as applicable. In addition, the microprocessor <NUM> may also serve to define variable, operative A-V delay intervals, V-V delay intervals, and the energy delivered to each ventricle and/or atrium.

In one embodiment, microprocessor <NUM> is a custom microprocessor adapted to fetch and execute instructions stored in RAM/ROM unit <NUM> in a conventional manner. It is contemplated, however, that other implementations may be suitable to practice the present disclosure. For example, an off-the-shelf, commercially available microprocessor or microcontroller, or custom application-specific, hardwired logic, or state-machine type circuit may perform the functions of microprocessor <NUM>.

Digital controller/timer circuit <NUM> operates under the general control of the microcomputer <NUM> to control timing and other functions within the pacing circuit <NUM> and includes a set of timing and associated logic circuits of which certain ones pertinent to the present disclosure are depicted. The depicted timing circuits include URI/LRI timers 83A, V-V delay timer 83B, intrinsic interval timers 83C for timing elapsed V-EVENT to V-EVENT intervals or V-EVENT to A-EVENT intervals or the V-V conduction interval, escape interval timers 83D for timing A-A, V-A, and/or V-V pacing escape intervals, an A-V delay interval timer 83E for timing the A-LVp delay (or A-RVp delay) from a preceding A-EVENT or A-TRIG, a post-ventricular timer 83F for timing post-ventricular time periods, and a date/time clock <NUM>.

The A-V delay interval timer 83E is loaded with an appropriate delay interval for one ventricular chamber (e.g., either an A-RVp delay or an A-LVp) to time-out starting from a preceding A-PACE or A-EVENT. The interval timer 83E triggers pacing stimulus delivery and can be based on one or more prior cardiac cycles (or from a data set empirically derived for a given patient).

The post-event timer 83F times out the post-ventricular time period following an RV-EVENT or LV-EVENT or a RV-TRIG or LV-TRIG and post-atrial time periods following an A-EVENT or A-TRIG. The durations of the post-event time periods may also be selected as programmable parameters stored in the microcomputer <NUM>. The post-ventricular time periods include the PVARP, a post-atrial ventricular blanking period (PAVBP), a ventricular blanking period (VBP), a post-ventricular atrial blanking period (PVARP) and a ventricular refractory period (VRP) although other periods can be suitably defined depending, at least in part, on the operative circuitry employed in the pacing engine. The post-atrial time periods include an atrial refractory period (ARP) during which an A-EVENT is ignored for the purpose of resetting any A-V delay, and an atrial blanking period (ABP) during which atrial sensing is disabled. It should be noted that the starting of the post-atrial time periods and the A-V delays can be commenced substantially simultaneously with the start or end of each A-EVENT or A-TRIG or, in the latter case, upon the end of the A-PACE which may follow the A-TRIG. Similarly, the starting of the post-ventricular time periods and the V-A escape interval can be commenced substantially simultaneously with the start or end of the V-EVENT or V-TRIG or, in the latter case, upon the end of the V-PACE which may follow the V-TRIG. The microprocessor <NUM> also optionally calculates A-V delays, V-V delays, post-ventricular time periods, and post-atrial time periods that vary with the sensor-based escape interval established in response to the RCP(s) and/or with the intrinsic atrial and/or ventricular rate.

The output amplifiers circuit <NUM> contains a RA pace pulse generator (and a LA pace pulse generator if LA pacing is provided), a RV pace pulse generator, a LV pace pulse generator, and/or any other pulse generator configured to provide atrial and ventricular pacing. In order to trigger generation of an RV-PACE or LV-PACE pulse, digital controller/timer circuit <NUM> generates the RV-TRIG signal at the time-out of the A-RVp delay (in the case of RV pre-excitation) or the LV-TRIG at the time-out of the A-LVp delay (in the case of LV pre-excitation) provided by A-V delay interval timer 83E (or the V-V delay timer 83B). Similarly, digital controller/timer circuit <NUM> generates an RA-TRIG signal that triggers output of an RA-PACE pulse (or an LA-TRIG signal that triggers output of an LA-PACE pulse, if provided) at the end of the V-A escape interval timed by escape interval timers 83D.

The output amplifiers circuit <NUM> includes switching circuits for coupling selected pace electrode pairs from among the lead conductors and the IND-CAN electrode <NUM> to the RA pace pulse generator (and LA pace pulse generator if provided), RV pace pulse generator and LV pace pulse generator. Pace/sense electrode pair selection and control circuit <NUM> selects lead conductors and associated pace electrode pairs to be coupled with the atrial and ventricular output amplifiers within output amplifiers circuit <NUM> for accomplishing RA, LA, RV and LV pacing.

The sense amplifiers circuit <NUM> contains sense amplifiers for atrial and ventricular pacing and sensing. High impedance P-wave and R-wave sense amplifiers may be used to amplify a voltage difference signal that is generated across the sense electrode pairs by the passage of cardiac depolarization wavefronts. The high impedance sense amplifiers use high gain to amplify the low amplitude signals and rely on pass band filters, time domain filtering and amplitude threshold comparison to discriminate a P-wave or R-wave from background electrical noise. Digital controller/timer circuit <NUM> controls sensitivity settings of the atrial and ventricular sense amplifiers <NUM>.

The sense amplifiers may be uncoupled from the sense electrodes during the blanking periods before, during, and after delivery of a pace pulse to any of the pace electrodes of the pacing system to avoid saturation of the sense amplifiers. The sense amplifiers circuit <NUM> includes blanking circuits for uncoupling the selected pairs of the lead conductors and the IND-CAN electrode <NUM> from the inputs of the RA sense amplifier (and LA sense amplifier if provided), RV sense amplifier and LV sense amplifier during the ABP, PVABP and VBP. The sense amplifiers circuit <NUM> also includes switching circuits for coupling selected sense electrode lead conductors and the IND-CAN electrode <NUM> to the RA sense amplifier (and LA sense amplifier if provided), RV sense amplifier and LV sense amplifier. Again, sense electrode selection and control circuit <NUM> selects conductors and associated sense electrode pairs to be coupled with the atrial and ventricular sense amplifiers within the output amplifiers circuit <NUM> and sense amplifiers circuit <NUM> for accomplishing RA, LA, RV, and LV sensing along desired unipolar and bipolar sensing vectors.

Right atrial depolarizations or P-waves in the RA-SENSE signal that are sensed by the RA sense amplifier result in a RA-EVENT signal that is communicated to the digital controller/timer circuit <NUM>. Similarly, left atrial depolarizations or P-waves in the LA-SENSE signal that are sensed by the LA sense amplifier, if provided, result in a LA-EVENT signal that is communicated to the digital controller/timer circuit <NUM>. Ventricular depolarizations or R-waves in the RV-SENSE signal are sensed by a ventricular sense amplifier result in an RV-EVENT signal that is communicated to the digital controller/timer circuit <NUM>. Similarly, ventricular depolarizations or R-waves in the LV-SENSE signal are sensed by a ventricular sense amplifier result in an LV-EVENT signal that is communicated to the digital controller/timer circuit <NUM>. The RV-EVENT, LV-EVENT, and RA-EVENT, LA-SENSE signals may be refractory or non-refractory and can inadvertently be triggered by electrical noise signals or aberrantly conducted depolarization waves rather than true R-waves or P-waves.

The techniques described in this disclosure, including those attributed to the IMD <NUM>, the computing apparatus <NUM>, and/or various constituent components, may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as physician or patient programmers, stimulators, image processing devices, or other devices. The term "module," "processor," or "processing circuitry" may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.

Such hardware, software, and/or firmware may be implemented within the same device or within separate devices to support the various operations and functions described in this disclosure. In addition, any of the described units, modules, or components may be implemented together or separately as discrete but interoperable logic devices. Rather, functionality associated with one or more modules or units may be performed by separate hardware or software components or integrated within common or separate hardware or software components.

Claim 1:
A system (<NUM>) for use in configuring cardiac therapy comprising:
electrode apparatus (<NUM>) comprising a plurality of external electrodes (<NUM>) to monitor electrical activity from tissue of a patient (<NUM>); and
a computing apparatus (<NUM>) comprising processing circuitry and operably coupled to the electrode apparatus (<NUM>), the computing apparatus (<NUM>) configured to:
monitor electrical activity using the plurality of external electrodes (<NUM>) during the delivery of cardiac pacing therapy at a plurality of different paced settings,
generate paced electrical heterogeneity information (EHI) based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings,
determine a first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the paced EHI,
generate one or more single-electrode cardiac metrics and vectorcardiographic metrics based on the monitored electrical activity during delivery of cardiac pacing therapy at the plurality of different paced settings, and
determine a second subset of the first subset of the plurality of different paced settings for the cardiac pacing therapy that are acceptable based on the one or more single-electrode cardiac metrics and vectorcardiographic metrics if the first subset of paced settings comprises more than one paced setting.