Mapping electrical activity on a model heart

Abstract

Exemplary systems and methods may be configured to monitor electrical activity from a patient using a plurality of body surface electrodes. Exemplary systems and methods may be further configured to provide a model heart representing the patient's heart based on at least one of a plurality of patient characteristics. The model heart may include a plurality of segments. Exemplary systems and methods may be further configured to determine an electrical activity value for each of a plurality of anatomical regions of the model heart based on the mapped electrical activity. Each of the plurality of anatomical regions may include a subset of the plurality of segments.

Description

[0001] The disclosure herein relates to systems and methods for use in mapping electrical activity on a model heart. Summary of the invention

[0002] The exemplary systems, methods, and interfaces described herein may be configured to assist a user (e.g., a physician) in evaluating a patient and / or evaluating a cardiac therapy (e.g., a cardiac therapy performed on a patient during implantation of a cardiac therapy device and / or after implantation of a cardiac therapy device). In one or more embodiments, the systems, methods, and interfaces may be described as non-invasive. For example, in some embodiments, the systems, methods, and interfaces may not require or include implantable devices (such as leads, probes, sensors, catheters, implanted electrodes, etc.) to monitor or acquire multiple cardiac signals from a patient's tissue for use in evaluating the patient and / or cardiac therapy. Alternatively, the systems, methods, and interfaces may use electrical measurements obtained non-invasively using multiple external electrodes attached to the patient's skin, for example, around the patient's torso.

[0003] An exemplary system may include an electrode device. The electrode device may include multiple extracorporeal electrodes to monitor electrical activity from tissue of a patient. The exemplary system may include a computing device, which includes a processing circuit system and is coupled to the electrode device. The computing device may be configured to monitor electrical activity from a patient using multiple extracorporeal electrodes. The computing device may be further configured to provide a model heart representing the patient's heart based on at least one of multiple patient characteristics. The model heart may include multiple segments. The computing device may be further configured to map the monitored electrical activity onto the multiple segments of the model heart. The computing device may be further configured to determine an electrical activity value for each of multiple anatomical regions of the model heart based on the mapped electrical activity. Each of the multiple anatomical regions includes a subset of the multiple segments.

[0004] In at least one embodiment, the exemplary method may include monitoring electrical activity from the patient using a plurality of external electrodes on the patient's torso. The exemplary method may further include providing a model heart representing the patient's heart based on at least one patient characteristic of a plurality of patient characteristics. The model heart includes a plurality of segments. The exemplary method may further include mapping the monitored electrical activity onto the plurality of segments of the model heart. The exemplary method may further include determining an electrical activity value for each of a plurality of anatomical regions of the model heart based on the mapped electrical activity. Each of the plurality of anatomical regions includes a subset of the plurality of segments.

[0005] In at least one embodiment, an exemplary system may include an electrode device. The electrode device may include a plurality of extracorporeal electrodes to monitor electrical activity from tissue of a patient. The exemplary system may include a computing device including a processing circuit system and coupled to the electrode device. The computing device may be configured to monitor electrical activity from a patient using a plurality of extracorporeal electrodes. The computing device may be further configured to provide a model heart representing a heart of the patient based on at least one of a plurality of patient characteristics. The model heart includes a plurality of anatomical regions. The computing device may be further configured to map the monitored electrical activity onto the plurality of anatomical regions of the model heart. The computing device may be further configured to determine an indication of scar risk based on the monitored electrical activity mapped onto the plurality of anatomical regions. The exemplary system may further include a display. The display may include a graphical user interface configured to assist a user in assessing the heart health of a patient. The computing device may be further configured to display the model heart on the display. The computing device may be further configured to display the mapped electrical activity on the display. The computing device may be further configured to display an indication of a determined scar risk on the model heart on the display.

[0006] The above summary of the invention is not intended to describe every embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and understandable by referring to the following detailed description obtained in conjunction with the accompanying drawings and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Figure 1 is a diagram of an exemplary system including an electrode device, a display device, and a computing device.

[0008] Figure 2 is a diagram of an exemplary in vitro electrode arrangement for measuring electrical potential on the surface of the torso.

[0009] Figure 3 is a diagram of an exemplary in vitro electrode arrangement for measuring electrical potential on the surface of the torso.

[0010] Figure 4 is a block diagram of an exemplary method for use in mapping electrical activity on a model heart.

[0011] Figure 5 is provided for use in e.g. Figure 4 Block diagram of an exemplary method of a model heart used in the method.

[0012] Figure 6 For example, in Figure 4 Block diagram of an exemplary method for mapping electrical activity on a model heart used in the methods.

[0013] Figure 7 is a block diagram of an exemplary method of determining a conduction condition.

[0014] Figure 8 An exemplary model heart including multiple anatomical regions is depicted.

[0015] Fig.9A An exemplary model heart showing several conduction conditions is depicted.

[0016] Fig. 9B An exemplary model heart showing multiple anatomical regions and cardiac electrical activation times mapped to the multiple anatomical regions is depicted.

[0017] Fig. 9C Depicting a conductive condition indicator including a conductive condition Fig.9A Model heart.

[0018] Fig.9D An exemplary model heart showing multiple anatomical regions and cardiac electrical activation times mapped to the multiple anatomical regions is depicted.

[0019] Fig.10 An exemplary model heart including multiple anatomical regions and peak-to-peak values ​​mapped to the multiple anatomical regions is depicted.

[0020] Fig.11A An exemplary model heart showing peak-to-peak voltage values ​​is depicted.

[0021] Fig. 11B An exemplary model heart showing peak-to-peak voltage values ​​including a scar risk indicator identifying increased risk of scarring is depicted.

[0022] Fig.12 is a diagram of an exemplary system including an exemplary implantable medical device (IMD).

[0023] Fig.13 yes Fig.12 FIG. 5 is a diagram of an exemplary IMD of FIG.

[0024] Fig.14 Is set in Fig.13 Figure 3 is an enlarged view of the distal end of the electrical lead in the left ventricle.

[0025] Fig.15 is an exemplary IMD (e.g., Figure 12-14 Block diagram of an exemplary IMD) for a system.

[0026] Fig.16 is Figure 12-Figure 15 Another block diagram of an exemplary IMD (e.g., implantable pulse generator) circuit system and associated leads employed in a system of FIG. DETAILED DESCRIPTION

[0027] In the following detailed description of the illustrative embodiments, reference is made to the accompanying drawings, which form a part of the embodiments and in which are shown by way of illustration specific embodiments that can be practiced. It should be understood that other embodiments can be used and structural changes can be made without departing from (e.g., still falling within) the scope of the present disclosure presented herein.

[0028] Will refer to Figure 1-Figure 16 to describe exemplary systems and methods. It will be apparent to those skilled in the art that elements or processes from one embodiment may be used in combination with elements or processes of other embodiments, and possible embodiments of such methods and systems using the combinations of features set forth herein are not limited to the specific embodiments shown in the drawings and / or described herein. Further, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be appreciated that the timing of the processes herein and the sizes and shapes of the various elements may be modified and still fall within the scope of the present disclosure, but certain timings, one or more shapes and / or sizes or types of elements may be advantageous relative to other timings, shapes and / or size types of elements.

[0029] Various exemplary systems, methods, and interfaces described herein may be configured to non-invasively assist a user (e.g., a physician) in assessing a patient's cardiac condition using an electrode device, a display device, and a computing device including an extracorporeal electrode. Extracorporeal electrodes may be used to monitor and / or detect cardiac electrical activity using a unipolar electrocardiogram (ECG) recording. Electrical activity may be mapped to a model heart by selecting a specific model heart from a plurality of model hearts based on at least one characteristic of the patient. The patient's characteristics may include at least one of the following: age, sex, height, chest circumference, heart chamber size, ventricular ejection fraction, type of cardiomyopathy, and duration of QRS complex on a 12-lead ECG, and the like. The model heart may be divided into a plurality of anatomical regions, and electrical activity may be analyzed on each of the plurality of anatomical regions. For example, the electrical activity on the anatomical region may be averaged for the anatomical region. Adjacent and / or other anatomical regions may be compared and / or analyzed to facilitate determining the condition of the patient's heart. As an example, two adjacent anatomical regions with a particular electrical activity may be determined to have a conduction slowness or conduction block condition. Such electrical activity can be measured by a system that acquires the ECG signal and generates various measures of electrical activation time (e.g., depolarization) and / or peak-to-peak voltage values ​​measured from various ECG locations and displayed or communicated to someone assisting the patient. The electrical activation time can represent the depolarization of the cardiac tissue that propagates through the patient's torso.

[0030] exist Figure 1An exemplary system 100 including an electrode device 110, a display device 130, and a computing device 140 is depicted in the figure. The electrode device 110 shown includes a plurality of electrodes that are incorporated into, or included in, a belt that is wrapped around the chest or torso of a patient 14. The electrode device 110 is operatively coupled to the computing device 140 (e.g., via one or wired electrical connection, wirelessly, etc.) to provide an electrical signal from each of the electrodes to the computing device 140 for analysis, evaluation, etc. The exemplary electrode device may be described in U.S. Patent No. 9,320,446, issued on April 26, 2016, entitled “Bioelectric Sensor Device and Methods,” which is incorporated herein by reference in its entirety. Further, the exemplary electrode device 110 will be referred to Figure 2-3 is described in more detail.

[0031] Although not described herein, the exemplary system 100 may further include an imaging device. The imaging device may be any type of imaging device configured to image or provide an image of at least a portion of the patient in a non-invasive manner. For example, the imaging device may not use any components or parts that may be located within the patient to provide an image of the patient, other than non-invasive tools such as contrast agents. It is to be understood that the exemplary systems, methods, and interfaces described herein may further use the imaging device to provide a user (e.g., a physician) with non-invasive assistance in pre-procedural and intra-procedural planning for implantation of left ventricular (LV) leads or leadless LV pacemakers, as well as other types of implantations. Exemplary leadless LV pacemakers include MICRI TM , which is available from Medtronic, Inc. located in Minneapolis, Minnesota.

[0032] For example, exemplary systems, methods, and interfaces can provide image-guided navigation that can be used to navigate leads (including electrodes, leadless electrodes, wireless electrodes, catheters, etc.) within a patient's body, while also providing non-invasive cardiac therapy evaluation, including pre-procedural and / or intra-procedural planning for cardiac implantation of leads or leadless pacemakers. No. 2014 / 0371832, filed on June 12, 2013, entitled “Implantable Electrode Location Selection,” No. 2014 / 0371833, filed on June 12, 2013, entitled “Implantable Electrode Location Selection,” No. 2014 / 0323892, filed on March 27, 2014, entitled “Systems, Methods, and Interfaces for Identifying Effective Electrodes,” and No. 2014 / 0323893, filed on March 27, 2014, entitled “Systems, Methods, and Interfaces for Identifying Optical Electrical Exemplary systems and methods for using imaging devices and / or electrode devices are described in U.S. Patent Publication No. 2014 / 0323882 entitled "Systems, Methods, and Interfaces for Identifying Optical Electric Vectors," each of which is incorporated herein by reference in its entirety.

[0033] Exemplary imaging devices may be configured to capture X-ray images and / or any other alternative imaging modes. For example, the imaging device may be configured to capture images or image data using concentric fluoroscopy, biplane fluoroscopy, ultrasound, computed tomography (CT), multi-slice computed tomography (MSCT), magnetic resonance imaging (MRI), high frequency ultrasound (HIFU), optical coherence tomography (OCT), intravascular ultrasound (IVUS), two-dimensional (2D) ultrasound, three-dimensional (3D) ultrasound, four-dimensional (4D) ultrasound, intraoperative CT, intraoperative MRI, etc. Further, it is to be understood that the imaging device may be configured to (e.g., continuously) capture multiple continuous images to provide video frame data. That is, multiple images taken over time using the imaging device may provide video frames, or dynamic movies, data. Additionally, images may also be obtained and displayed in two, three or four dimensions. In a more advanced form, a four-dimensional surface presentation of the heart or other regions of the body may also be achieved by combining cardiac data or other soft tissue data from a map or from preoperative image data captured by an MRI, CT or echocardiography modality. Image datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computed tomography (SPECT) combined with CT, can also provide functional image data superimposed on anatomical data, for example, to be used to navigate a cardiac implant device within the heart or other region of interest.

[0034] Systems and / or imaging devices that may be used in conjunction with the exemplary systems and methods described herein are described in the following applications: U.S. Patent Application Publication No. 2005 / 0008210 to Evron et al., published on January 13, 2005; U.S. Patent Application Publication No. 2006 / 0074285 to Zarkh et al., published on April 6, 2006; U.S. Patent Application Publication No. 2011 / 0112398 to Zarkh et al., published on May 12, 2011; U.S. Patent Application Publication No. 2013 / 0116739 to Brada et al., published on May 9, 2013; U.S. Patent Application Publication No. 2013 / 0116739 to Evron et al., published on December 27, 2005 No. 6,980,675 issued on October 23, 2007 to Okerlund et al., U.S. Patent No. 7,286,866 issued on October 23, 2007 to Reddy et al., U.S. Patent No. 7,308,297 issued on December 11, 2011 to Burrell et al., U.S. Patent No. 7,308,299 issued on December 11, 2011 to Efron et al., U.S. Patent No. 7,321,677 issued on January 22, 2008 to Okerlund et al., U.S. Patent No. 7,346,381 issued on March 18, 2008 to Burrell et al., U.S. Patent No. 7,456,677 issued on November 18, 2008 to No. 4,248, Vass et al., U.S. Pat. No. 7,499,743, issued March 3, 2009, Okerlund et al., U.S. Pat. No. 7,565,190, issued July 21, 2009, Sack et al., U.S. Pat. No. 7,587,074, issued September 8, 2009, Hunter et al., U.S. Pat. No. 7,599,730, issued October 6, 2009, Vass et al., U.S. Pat. No. 7,613,500, issued November 3, 2009, Sack et al., U.S. Pat. No. 7,742,629, issued June 22, 2010, Okerlund et al., U.S. Pat. No. 7,587,074, issued September 8, 2009, Hunter et al., U.S. Pat. No. 7,599,730, issued October 6, 2009, Vass et al., U.S. Pat. No. 7,613,500, issued November 3, 2009, Sack et al., U.S. Pat. No. 7,742,629, issued June 22, 2010, 7,747,047, U.S. Patent No. 7,778,685 issued on August 17, 2010 to Efron et al., U.S. Patent No. 7,778,686 issued on August 17, 2010 to Vass et al., U.S. Patent No. 7,813,785 issued on October 12, 2010 to Okerlund et al., U.S. Patent No. 7,996,063 issued on August 9, 2011 to Vass et al., U.S. Patent No. 8,060,185 issued on November 15, 2011 to Hunter et al., and U.S. Patent No. 8,401,616 issued on March 19, 2013 to Verard et al., each of which is incorporated herein by reference in its entirety.

[0035] The display device 130 and the computing device 140 can be configured to display and analyze data, such as, for example, electrical signals (e.g., electrocardiogram data), cardiac activation times, peak-to-peak data, cardiac information representing at least one of mechanical cardiac function and electrical cardiac function, etc. The cardiac information may include, for example, electrical heterogeneity information or electrical dyssynchrony information generated using electrical signals acquired, monitored, or collected using the electrode device 110, alternative electrical activation information or data, etc. In at least one embodiment, the computing device 140 can be a server, a personal computer, or a tablet computer. The computing device 140 can be configured to receive input from the input device 142 and transmit output to the display device 130. Further, the computing device 140 can include a data store that can allow access to processing programs or routines and / or one or more other types of data, for example, for driving a graphical user interface configured to non-invasively assist a user in making assessments during pre-procedural and / or intra-procedural planning for cardiac implantation of a lead or leadless pacemaker.

[0036] The computing device 140 may be operably coupled to the input device 142 and the display device 130, for example, to communicate data to and from each of the input device 142 and the display device 130. For example, the computing device 140 may be electrically coupled to each of the input device 142 and the display device 130 using, for example, an analog electrical connection, a digital electrical connection, a wireless connection, a bus-based connection, a network-based connection, an Internet-based connection, etc. As further described herein, a user may provide input to the input device 142 to manipulate or modify one or more graphical depictions displayed on the display device 130, and to view and / or select one or more pieces of information related to cardiac implantation and / or treatment.

[0037] Although the input device 142 is depicted as a keyboard, it should be understood that the input device 142 may include any device capable of providing input to the computing device 140 in order to perform the functions, methods, and / or logic described herein. For example, the input device 142 may include a mouse, a trackball, a touch screen (e.g., a capacitive touch screen, a resistive touch screen, a multi-point touch screen, etc.), etc. Similarly, the display device 130 may include any device capable of displaying information to a user, such as a graphical user interface 132, the information including cardiac information, text instructions, graphical depictions of electrical activation information, graphical depictions of the anatomical structure of a human heart, a plurality of different model human two-dimensional and three-dimensional model hearts, a plurality of model human two-dimensional and three-dimensional model torsos, cardiac conduction indicators, scar risk indicators, an image or graphical depiction of a patient's heart, a graphical depiction of the location of one or more electrodes, a graphical depiction of a human torso, an image or graphical depiction of a patient's torso, a graphical depiction or actual image of implanted electrodes and / or leads, etc. Further, the display device 130 may include a liquid crystal display, an organic light emitting diode screen, a touch screen, a cathode ray tube display, etc.

[0038] The processing programs or routines stored and / or executed by the computing device 140 may include programs or routines for the following: computational mathematics, image construction algorithms, inverse problem processing of images and / or data projections, two-dimensional and three-dimensional image and / or data projection processing, matrix mathematics, dispersion determination (e.g., standard deviation, variance, range, interquartile range, mean absolute difference, mean absolute deviation, etc.), filtering algorithms, maximum determination, minimum determination, threshold determination, moving window algorithms, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, signal processing algorithms (e.g., various filtering algorithms, Fourier transforms, fast Fourier transforms, etc.), normalization algorithms, comparison algorithms, vector mathematics, or any other processing required to implement one or more of the exemplary methods and / or processes described herein. The data stored and / or used by the computing device 140 may include, for example: electrical signal / waveform data from the electrode device 110; one or more metrics generated or derived based on the electrical signal / waveform data from the electrode device 110 (e.g., peak-to-peak value, excitation time, metrics of cardiac electrical heterogeneity and asynchrony, etc.); scatter signals; windowed scatter signals; multiple portions of various signals; electrical excitation time from the electrode device 110; graphics (e.g., graphical elements, icons, buttons, windows, dialogs, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.); a graphical user interface; results from one or more processing programs or routines adopted in accordance with the present disclosure (e.g., electrical signals, cardiac information, etc.); or any other data that may be necessary to perform one and / or more processes or methods described herein.

[0039] In one or more embodiments, exemplary systems, methods, and interfaces may be implemented using one or more computer programs executed on a programmable computer, such as a computer including, for example, processing power, data storage (e.g., volatile or non-volatile memory and / or storage elements), input devices, and output devices. The program code and / or logic described herein may be applied to input data in order to perform the functions 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 will be applied in a known manner.

[0040] Any programmable language can be used to provide one or more programs for implementing the system, method, and / or interface described herein, such as a high-level procedural programming language and / or an object-oriented programming language suitable for communicating with a computer system. Any such program can be, for example, stored on any suitable device (e.g., storage medium) readable by a general-purpose program or a special-purpose program, which runs on a computer system (e.g., including a processing device) for configuring and operating the computer system when reading a suitable device to execute the program described herein. That is, at least in one embodiment, an exemplary system, method, and / or interface can be implemented using a computer-readable storage medium configured with a computer program, wherein the storage medium so configured causes the computer to operate in a specific and predefined manner to perform the functions described herein. Further, in at least one embodiment, the exemplary system, method, and / or interface can be described as being implemented by logic (e.g., object code) encoded in one or more non-transient media, which include codes for executing and operable to perform operations such as methods, processes, and / or functions described herein when executed by a processor.

[0041] The computing device 140 can be, for example, any fixed or mobile computer system (e.g., a controller, a microcontroller, a personal computer, a minicomputer, a tablet computer, etc.) and can be generally described as including a processing circuit system. The exact configuration of the computing device 140 is not limiting, and substantially any device that can provide appropriate computing power and control capabilities (e.g., graphics processing, etc.) can be used. As described herein, a digital file can be any medium (e.g., volatile or non-volatile memory, CD-ROM, punch cards, magnetically readable media such as disks or tapes, etc.) containing digital bits (e.g., encoded in binary, ternary, etc.) that can be read and / or written by the computing device 140 described herein. Similarly, as described herein, a file in a user-readable format can be any data representation (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, diagrams, etc.) that can be presented on any medium (e.g., paper, display, etc.) that is readable and / or understandable by a user.

[0042] In view of the foregoing, it will be apparent that the functionality as described in one or more embodiments according to the present disclosure may be implemented in any manner as will be known to those skilled in the art. Thus, the computer language, computer system, or any other software / hardware used to implement the processes described herein should not be limited to the scope of the systems, processes, or programs described herein (e.g., the functionality provided by such systems, processes, or programs).

[0043] Use as Figure 1 and Figure 2-Figure 3 The data generated by the electrode device 110 shown in the figure may be useful for evaluating pre-procedural and / or intra-procedural planning for cardiac implantation and / or treatment. For example, the electrode device 110 may be used to monitor or determine surrogate electrical activation information or data of one or more regions of the patient's heart. More specifically, the exemplary electrode device 110 may be configured to measure body surface potentials or torso surface potentials of the patient 14. Figure 2 As shown, an exemplary electrode device 110 may include a set of electrodes 112 or an array of electrodes 112, a strap 113, and an interface / amplifier circuit system 116. The electrodes 112 may be attached or coupled to the strap 113 and the strap 113 may be configured to wrap around the torso of the patient 14 so that the electrodes 112 surround the patient's heart. As further shown, the electrodes 112 may be positioned around the periphery of the patient 14, including posterior locations, lateral locations, posterolateral locations, anterolateral locations, and anterior locations of the torso of the patient 14.

[0044] Further, the electrodes 112 may be electrically connected to the interface / amplifier circuitry 116 via a wired connection 118. The interface / amplifier circuitry 116 may be configured to amplify signals from the electrodes 112 and provide these signals to the computing device 140. Other exemplary systems may use a wireless connection to transmit the signals sensed by the electrodes 112 to the interface / amplifier circuitry 116, and in turn to the computing device 140, e.g., as multi-channel data. For example, the interface / amplifier circuitry 116 may be electrically coupled to each of the computing device 140 and the display device 130 using, for example, an analog electrical connection, a digital electrical connection, a wireless connection, a bus-based connection, a network-based connection, an Internet-based connection, etc.

[0045] Despite Figure 2 In the example of the electrode device 110 includes a strap 113, but in other examples, any of a variety of mechanisms (e.g., tape or adhesive) can be used to assist in the spacing and placement of the electrodes 112. In some examples, the strap 113 can include an elastic band, a tape strip, or a cloth. In other examples, the electrodes 112 can be placed individually on the torso of the patient 14. Further, in other examples, the electrodes 112 (e.g., arranged in an array) can be part of or positioned in a patch, a vest, and / or other means of fastening the electrodes 112 to the torso of the patient 14.

[0046] The electrodes 112 can be configured to surround the heart of the patient 14 and record or monitor electrical signals associated with the depolarization and repolarization of the heart after they have propagated through the torso of the patient 14. Each of the electrodes 112 can be used in a unipolar configuration to sense torso surface potentials that reflect cardiac signals. The interface / amplifier circuit system 116 can also be coupled to a return electrode or neutral electrode (not shown) that can be used in combination with each electrode 112 for unipolar sensing. In some examples, there may be about 12 to about 50 electrodes 112 spatially distributed around the patient's torso. Other configurations may have more or fewer electrodes 112.

[0047] The computing device 140 can record and analyze the electrical activity (e.g., torso surface potential signals) sensed by the electrodes 112 and amplified / conditioned by the interface / amplifier circuit system 116. The computing device 140 can be configured to analyze the signals from the electrodes 112 to provide them as anterior electrode signals and posterior electrode signals and surrogate cardiac electrical activation times, which are, for example, representative of actual or local electrical activation times of one or more regions of the patient's heart, as will be further described below. The computing device 140 can be configured to analyze the signals from the electrodes 112 to provide peak-to-peak values, for example, representative of actual or local peak-to-peak values ​​of one or more regions of the patient's heart, as will be further described herein. Further, the electrical signal measured at the left anterior surface location of the patient's torso may represent the electrical signal of the left anterior left ventricular region of the patient's heart, or may be a substitute for the electrical signal of the left anterior left ventricular region of the patient's heart; the electrical signal measured at the left lateral surface location of the patient's torso may represent the electrical signal of the left lateral left ventricular region of the patient's heart, or may be a substitute for the electrical signal of the left lateral left ventricular region of the patient's heart; the electrical signal measured at the left posterior lateral surface location of the patient's torso may represent the electrical signal of the posterior lateral left ventricular region of the patient's heart, or may be a substitute for the electrical signal of the posterior lateral left ventricular region of the patient's heart; and the electrical signal measured at the posterior surface location of the patient's torso may represent the electrical signal of the posterior left ventricular region of the patient's heart, or may be a substitute for the electrical signal of the posterior left ventricular region of the patient's heart. In one or more embodiments, the measurement of the excitation time can be performed by measuring the time period between the start of cardiac depolarization (e.g., the start of the QRS complex) and an appropriate reference point, such as, for example, a peak value, a minimum value, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc.

[0048] Additionally, computing device 140 may be configured to provide a graphical user interface depicting surrogate electrical activation times obtained using electrode device 110. Exemplary systems, methods, and / or interfaces may non-invasively use electrical information collected using electrode device 110 to evaluate a patient's pre-procedural and / or intra-procedural implantation plan.

[0049] Figure 3 Another exemplary electrode arrangement 110 is shown that includes a plurality of electrodes 112 configured to surround the heart of a patient 14 and record or monitor electrical signals associated with depolarization and repolarization of the heart after they have propagated through the torso of the patient 14. The electrode arrangement 110 may include a vest 114 to which the plurality of electrodes 112 may be attached or to which the electrodes 112 may be coupled. In at least one embodiment, the plurality of electrodes 112 or an array of electrodes 112 may be used to collect electrical information, such as, for example, surrogate electrical activation times. Figure 2 Similar to the electrode device 110, Figure 3The electrode device 110 may include an interface / amplifier circuit system 116 electrically coupled to each of the electrodes 112 via a wired connection 118 and configured to transmit signals from the electrodes 112 to a computing device 140. As shown, the electrodes 112 may be distributed on the torso of the patient 14, including, for example, the anterior surface, the lateral surface, the posterolateral surface, the anterolateral surface, and the posterior surface of the torso of the patient 14.

[0050] The vest 114 may be formed of a braid, wherein the electrodes 112 are attached to the braid. The vest 114 may be configured to maintain the position and spacing of the electrodes 112 on the torso of the patient 14. Further, the vest 114 may be marked to assist in determining the position of the electrodes 112 on the torso surface of the patient 14. In one or more embodiments, the vest 114 may include 17 or more front electrodes that may be positioned proximate to the patient's anterior torso, and may include 39 or more rear electrodes that may be positioned proximate to the patient's anterior torso. In some examples, there may be about 25 electrodes 112 to about 256 electrodes 112 distributed around the torso of the patient 14, but other configurations may have more or fewer electrodes 112.

[0051] As described herein, the electrode arrangement 110 can be configured to measure electrical information (e.g., electrical signals) representative of different regions of the patient's heart. For example, the activation times of different regions of the patient's heart can be roughly estimated based on surface electrocardiogram (ECG) activation times measured using surface electrodes near surface areas corresponding to different regions of the patient's heart. That is, a rough estimate of the activation times of the patient's heart can be based on a mapping of activation times associated with monitored electrical activity of a model heart and solving an inverse problem to determine the approximate activation times of regions and / or locations of the patient's heart, such as in combination with Figure 8-11B Further, for example, the peak-to-peak values ​​of different regions of the patient's heart may be roughly estimated based on surface electrocardiogram (ECG) signals measured using surface electrodes near surface regions corresponding to the different regions of the patient's heart.

[0052] The exemplary systems, methods, and interfaces may be used to provide non-invasive assistance to a user in pre-procedural and / or intra-procedural planning of a cardiac implant for a therapy related to the patient's cardiac health or condition and / or in post-implantation evaluation of a cardiac therapy (e.g., a cardiac therapy currently being delivered to a patient during or after implantation) using the electrode device 110. Further, the exemplary systems, methods, and interfaces may be used to assist a user in planning a cardiac implant in a patient and / or a therapy being delivered to a patient.

[0053] The electrical activity monitored by multiple external electrodes can be used to solve the inverse problem of the electrocardiogram. The solution to the inverse problem can be based on the projection of the position of the trunk surface potential measured and monitored by the external electrodes onto the model trunk. The trunk surface potential can be projected onto the position on the model heart based on the geometric relationship between the model heart and the model trunk. Because the model heart is selected based on at least one characteristic of the patient, the model trunk associated with the model heart can correspond to the patient's body trunk based on at least one characteristic of the patient. As an example, the patient's chest circumference can be used to select the model heart, and therefore, the model trunk associated with the model heart will correspond to the patient's body trunk based on the chest circumference used. In this way, solving the inverse problem may include: estimating the potential and / or activation time of the patient's heart based on the relationship between the heart position of the trunk surface potential and the trunk model and the relationship between the trunk model and the model heart (both of which are used to map the corresponding trunk surface potential to the model heart). The trunk model may include a typical geometric position of each of the multiple external electrodes corresponding to it. The geometric positions of the multiple external electrodes of the trunk model can be associated with the corresponding geometric positions of the model heart.

[0054] A measure of electrical activity can be calculated based on these torso surface potential signals, and the measure of electrical activity can also be mapped to a corresponding position of the model heart. The measure of electrical activity may include any of the following: excitation time, gradient of excitation time, peak-to-peak QRS voltage, etc. A low amplitude peak-to-peak QRS voltage may indicate the presence of scarring in cardiac tissue. The measure of electrical activity may include a measure of electrical heterogeneity. The measure of electrical heterogeneity may include a measure of the standard deviation of the excitation time (SDAT) of the electrodes on the left side of the patient's torso and / or a measure of the average left ventricular excitation time (LVAT) of the electrodes on the left side of the patient's torso. The measure of LVAT can be determined based on the electrodes on both the front and rear surfaces. The measure of electrical heterogeneity information may include a measure of the average right ventricular excitation time (RVAT) of the electrodes on the right side of the patient's torso. The measure of RVAT can be determined based on the electrodes on both the front and rear surfaces. The measure of electrical heterogeneity may include a measure of the mean total activation time (mTAT) obtained from signals from multiple electrodes on both sides of the patient's torso, or it may include other measures reflecting the range or dispersion of activation times at multiple electrodes located on the left side of the patient's torso or the right side of the patient's torso, or a combination of both the left and right sides of the patient's torso (e.g., standard deviation, interquartile deviation, difference between the latest activation time and the earliest activation time).

[0055] Figure 4 The block diagram of FIG. 4 is an exemplary method 440 for mapping or partitioning electrical activity on a model heart. The method 440 may include monitoring electrical activity (442) using a plurality of external electrodes, such as those described herein with reference to Figure 1-Figure 3Electrode 112 of electrode device 110 described. The monitored electrical activity may include trunk surface potential signals monitored at multiple locations associated with each of multiple extracorporeal electrodes. The monitored electrical activity may be used to determine or generate cardiac excitation time and / or peak-to-peak QRS voltage. As used herein, peak-to-peak voltage may refer to the difference between the maximum voltage and the minimum voltage at each position on the model during the QRS wave that occurs simultaneously with the depolarization of the heart and is generated by the depolarization of the heart. As an example, for a typical unipolar electrogram, the maximum voltage may occur at the top of the upward deflection of the R wave within the QRS complex, the minimum voltage may occur at the bottom of the downward deflection of the S wave in the QRS complex, and the difference in amplitude between the maximum and minimum values ​​represents the peak-to-peak voltage.

[0056] Method 440 may further include providing a model heart (444). The model heart may be a two-dimensional or three-dimensional representation of the patient's heart and may include a plurality of segments. In one or more embodiments, the plurality of segments may be defined as a surface portion of the model heart. Further, in one or more embodiments, each segment may be separated from each other. Further, it may be described that each of the plurality of segments may be a polygon, such as, for example, a triangle. The model heart may be described as being defined by or composed of a plurality of vertices for representing or roughly estimating the outer surface of the heart. Three of these vertices may be connected via lines or edges to define a planar triangular surface (e.g., a polygon). A plurality of planar triangular surfaces may be used to form a complex shape of the heart. That is, the model heart may be described as a model heart modeled using polygons, which use linked multiple vertices to provide multiple edges (e.g., lines between vertices) and multiple polygons (e.g., triangles, quadrilaterals, etc.), which may form multiple non-self-intersecting meshes. In one embodiment, each segment may correspond to one of the plurality of polygons. For example, each triangle formed by three vertices (or a polygon formed by more than three vertices) may be or define a segment. In another embodiment, each segment may correspond to more than one of the plurality of polygons. For example, two or more triangles each formed by three vertices (or a plurality of polygons each formed by more than three vertices) may be or define a segment. In this way, the resolution of the anatomical region may be the same as or lower than the polygonal modeling of the model heart. In at least one example, the segment may be defined by existing clinical standards (e.g., according to the American Heart Association (AHA) model).

[0057] Method 440 may further include mapping the monitored electrical activity onto a plurality of segments of the model heart (446). Figure 6Further details are described regarding at least one embodiment of mapping or projecting monitored electrical activity onto multiple segments of a model heart (446). In one example, a model heart may be provided that has defined or divided segments, and the monitored electrical activity may be projected onto the segments based on the locations of electrodes from which the electrical activity is monitored (locations on the surface of the patient's torso). In another example, a model heart may be provided that has no defined or "divide out" segments. When a model heart is provided that has no defined segments, the model heart may be segmented before or after the electrical activity is mapped onto the model heart. That is, a model heart divided into multiple segments may be provided, and the electrical activity may then be mapped onto those segments.

[0058] Method 440 may further include determining an electrical activity value for each of a plurality of anatomical regions of the model heart based on the mapped electrical activity (448). The plurality of anatomical regions of the model heart may each include a plurality of segments. That is, a first anatomical region may include a first plurality of segments of the model heart, and a second anatomical region may include a second plurality of segments of the model heart. When determining the electrical activity value of an anatomical region, the value may incorporate the value of the electrical activity of each of the segments within the anatomical region. As an example, each of the first plurality of segments of the model heart in the first anatomical region may have electrical activity including an excitation time. The excitation times of the first plurality of segments may be averaged, or combined in some manner (e.g., median, maximum, mean, etc.), and the first anatomical region may be associated with the average excitation time of the region.

[0059] exist Figure 5 A detailed block diagram of providing a model heart 444 is depicted in FIG. Figure 5 The method 444 is described as combining Figure 4 An exemplary embodiment of method step 444 in method 440 is described. That is, providing a model heart 444 of method 440 may include Figure 5 In general, providing the model heart 444 may include one or both of selecting the model heart from a plurality of model hearts based on one or more patient characteristics, and generating the model heart based on the one or more patient characteristics.

[0060] Method 444 may include providing one or more patient characteristics (550). One or more patient characteristics may be used to select, generate, and modify a model heart for the patient. That is, a model heart may be "picked" or "created" based on one or more characteristics of the patient, thereby making the model heart ultimately provided by method 444 approximate the patient's heart without the need to obtain a model of the patient's heart with the aid of a time-consuming and potentially expensive imaging procedure. The patient's characteristics may include at least one of the following: age, gender, height, weight, chest circumference, heart chamber size (e.g., end-systolic and end-diastolic diameters of at least one of the left and right ventricles), ventricular ejection fraction, type of cardiomyopathy, and duration of a QRS complex on a 12-lead ECG, among others. Further, it is understood that the exemplary methods and processes described herein may be configured to use one or more of the patient characteristics to select, generate, and / or modify a model heart for the patient.

[0061] The patient characteristics may then be used to provide a model heart. For example, method 444 may further include providing a plurality of model hearts (552). As described above, a plurality of model hearts may be provided from a library and / or catalog of model hearts that have been generated, for example, based on one or more various patients (different from the patient currently being evaluated) and / or based on one or more known heart models that approximate the size, shape, and structure of a human heart. Each of the plurality of model hearts may be associated with or correspond to a patient characteristic, and the model heart is derived or generated based on the patient characteristic. For example, if each model heart is acquired based on imaging of a patient (different from the patient being evaluated), each model heart may be associated with a plurality of patient characteristics of the patient. Further, if each model heart is acquired based on imaging of a plurality of patients, each model heart may be associated with a plurality of patient characteristics that may be compiled from the plurality of patients. That is, each of the model hearts may be accompanied by or associated with a plurality of patient characteristics, and the plurality of patient characteristics are generated or derived from the patient whose heart is used to model the model heart.

[0062] Further, the plurality of model hearts of the library may be described as having been generated or pre-generated, thereby eliminating, for example, the need to image a patient or scan the patient using computed tomography (CT), magnetic resonance imaging (MRI), etc. In this manner, the exemplary systems and methods described herein may be less complex and more cost-effective.

[0063] Method 444 may further include selecting a model heart from a plurality of model hearts (554) based on one or more provided patient characteristics without using imaging or scanning (MRI, CT, etc.) of the patient's heart. That is, an attempt may be made to approximately "match" the provided patient characteristics of the current patient with the patient characteristics of the corresponding model heart. In this way, the selected model heart, although not generated based on the imaging of the current patient, may also be described as representing the heart of the current patient. For example, a model heart may be selected based on age, gender, and chest circumference, and thus a model heart in a model heart library and / or catalog that best corresponds to or is associated with the patient's age, gender, and chest circumference may be selected. Further, for example, a model heart may be selected based on height, age, and ventricular ejection, and thus a model heart in a model heart library and / or catalog that best corresponds to or is associated with the patient's height, age, weight, chest circumference, and heart size (e.g., left ventricular end-systolic and end-diastolic diameters) may be selected, and thus a model heart in a model heart library and / or catalog that best corresponds to or is associated with the patient's height, age, and size may be selected.

[0064] Further, method 444 may further include (in conjunction with or in lieu of processes 552, 554) generating a model heart (556) based on one or more patient characteristics without using imaging or scanning (MRI, CT, etc.) of the patient's heart. For example, the patient characteristics may be input into a model heart generation process (e.g., a three-dimensional model heart generation process), which then generates a model heart based on such patient characteristics. The model heart generation process may utilize the known size, shape, and locations of various parts, regions, and structures of the human heart associated with the patient characteristics, and then generate the model heart using the input patient characteristics. For example, the size of the patient's heart may be roughly estimated based on the width and / or length of the patient's heart and / or torso, ejection fraction, heart size (e.g., left ventricular end-systolic and / or end-diastolic diameter), coronary artery anatomy from an venogram, and chest circumference. Thus, the model heart generation process may include a calculation or algorithm that determines the size of the model heart based on the width and / or length of the patient's heart and / or torso, the input ejection fraction, heart size, and chest circumference.

[0065] Further, method 444 may include modifying the selected model heart (555) using input or provided patient characteristics. For example, a model heart may be provided by using a model heart (554) from a plurality of model hearts as a guide, and using a modification process (555) to modify the model heart to be more consistent with the patient's characteristics. As an example, a model heart in the plurality of model hearts may be from a previous patient whose characteristics may be relatively close to the patient's characteristics, but in order to obtain a more accurate model heart, the model heart may be modified to compensate for any differences between the characteristics of the previous patient and the patient. That is, the selected model heart may be modified to be consistent with the differences in the patient's characteristics. If the selected model heart is derived from a previous patient having characteristics different from those of the current patient (such as chest circumference), the selected model heart may be modified to account for the difference (e.g., a smaller or larger chest circumference). In this way, a combination of a model heart library and modifications to the selected model heart for the current patient may be used.

[0066] Figure 6 is a detailed block diagram of mapping electrical activity onto multiple anatomical regions of a model heart (446). Figure 6 The method 446 is described as combining Figure 4 An exemplary embodiment of method step 446 in method 440 is described. That is, mapping electrical activity onto multiple anatomical regions of the model heart (446) in method 440 may include Figure 6 The method 446 may include projecting the location of the monitored torso surface potential signal onto a corresponding location on the model torso (661). The model torso may be associated with the provided and / or selected model heart. That is, a model torso of a previous patient associated with the model heart may be used to project the location of the torso surface potential signal onto the model torso.

[0067] Figure 6 The method 446 may further include projecting the torso surface potential signal onto a segment on the model heart (663). The torso surface potential signal may be projected onto the segment on the model heart based on a geometric relationship between the model heart and the model torso. As an example, the patient's torso is associated with the location of the segment on the model torso, and the model torso has a geometric relationship with the location of the segment on the model heart. In this way, the location of the torso surface potential signal may be associated with the location of the segment on the model heart.

[0068] Figure 6Method 448 may further include generating a value for each anatomical region based on the corresponding trunk surface potential signal of the segment (665). Generating the value for each anatomical region may include: combining the values ​​of each segment from multiple segments within each anatomical region. For example, the generated value may include at least one of the following: the excitation time and / or peak-to-peak voltage associated with the trunk surface potential signal projected onto the multiple segments within each anatomical region. In at least one example, the generated value may include averaging the excitation times of these multiple segments within the anatomical region and / or within a threshold proximity to the anatomical region. In at least one example, the generated value may include averaging the peak-to-peak voltage within the anatomical region and / or within a threshold proximity to the anatomical region. Figure 6 The method 448 may further include mapping the values ​​onto the anatomical region (667). The values ​​may be projected onto the anatomical region by numerical display, graphical display, color matching or gray shading display, etc., in combination with Figure 8-11B These methods are further described.

[0069] Figure 6 The method 448 may further optionally include determining an indication of scar risk (669). In at least one example, scar risk may be determined based on a peak-to-peak value below a particular threshold. In at least one example, in response to an anatomical region including an average peak-to-peak value below a threshold, it may be determined that the anatomical region includes scar risk. An indicator indicating that the anatomical region has a higher risk of scarring may be used to mark the anatomical region with scar risk. An implanter of a lead or leadless pacemaker may wish to target a region of delayed electrical excitation that does not have the scar risk indicator as a preliminary implantation target region.

[0070] Figure 7 The block diagram of FIG. 7 is an exemplary method 770 for determining and mapping conduction conditions (such as slow conduction activity, conduction block, etc.). More specifically, the method 770 may include comparing (775) monitored electrical activity mapped to adjacent anatomical regions, and then determining the conduction condition (776) based on the compared adjacent anatomical regions. As an example, a first anatomical region may be adjacent to a second anatomical region. The electrical activity of the first anatomical region may be compared to the electrical activity of the second anatomical region. The compared electrical activity may include excitation time, peak-to-peak voltage value, etc.

[0071] That is, a conduction condition may be determined in response to a high gradient between electrical activity of adjacent first and second anatomical regions. Adjacent anatomical regions having a high gradient difference in electrical activity indicates that conduction is having difficulty passing from one anatomical region to the next adjacent anatomical region. For example, a percentage difference between values ​​(e.g., peak to peak) of mapped anatomical regions may be calculated, and if the percentage difference exceeds a selected threshold indicative of a conduction condition (e.g., such as a block), then a conduction condition may be determined to exist between such anatomical regions.

[0072] The method 770 may further include displaying the conduction status (778), such as Fig. 9B For example, a graphical element (e.g., a line) indicating the location of a determined conduction slowness or conduction block condition can be depicted or displayed on the model heart, e.g., between adjacent anatomical regions determined to have the conduction condition. In response to electrical heterogeneity during pacing not decreasing beyond a selected threshold at the intersection of these adjacent anatomical regions, the implanter can use electrical activity information from the pacing period to target lead position (e.g., target an anatomical region that avoids the line of conduction block, etc.).

[0073] Figure 8 Describes the use of this article reference Figure 1-Figure 7 An exemplary model heart 1011 including multiple anatomical regions 1020 of the described exemplary systems and methods. Thus, without imaging the patient's heart, and instead using one or more patient characteristics to provide the model heart 1011 and map electrical activity onto the model heart 1011, an exemplary model heart 1011 including multiple anatomical regions 1020 and electrical activity mapped onto the multiple anatomical regions 1020 may have been generated or created. As shown, a marker region indicator 1012 may be depicted near the model heart 1011, and the marker region indicator 1012 may be used to indicate a specific anatomical region of the model heart 1011. As shown in FIG. Figure 8 As shown in FIG. 1 , anatomical region 1020-5 corresponds to the color / shading of labeled region indicator 1012 indicating “heart valve.” This region of the heart may not have electrically active myocardium, but may be included in the figure in order to fully capture the geometry of the heart, in order to properly illustrate other electrically active portions of the myocardium and to properly map and / or project their corresponding electrical activity.

[0074] Further, as further described herein with reference to process 444, the model heart 1011 may be described as a three-dimensional (3D) representation extending in the x, y, and z planes (indicated by axes 1016 (x plane), 1014 (y plane), and 1018 (z plane)), and as including a plurality of anatomical regions, several of which are labeled 1020-1, 1020-2, 1020-3, 1020-4, 1020-5, 1020-6, 1020-7, and 1020-8 (hereinafter collectively referred to as 1020). Each of the anatomical regions 1020 may include a plurality of segments (e.g., the triangles shown) that constitute the corresponding anatomical region. In other words, each of the anatomical regions 1020 may include a subset of the plurality of segments that cover the entire heart model 1011. Each of the anatomical regions 1020 may be indicated by a corresponding shading / color of the labeled region indicator 1012 of the model heart 1011. As an example, anatomical region 1020-7 may correspond to a shading / color on marker region indicator 1012 corresponding to the posterolateral base of the left ventricle (LV posterolateral base). That is, all segments in anatomical region 1020-7 have the same shading / color from marker region indicator 1012. Further, anatomical region 1020-3 may correspond to a shading / color on marker region indicator 1012 corresponding to the anterior apex of the right ventricle (RV anterior apex). As will be seen in conjunction with Fig.9A As further described, anatomical regions 1020 may each exhibit different levels or values ​​of electrical activity. In at least one example, at least one segment of a particular region (e.g., a triangular segment) may be discontinuous with other segments of the particular region due to mapping artifacts. Figure 8 As shown in , a thick line may indicate a boundary between two marking regions. However, in at least one example, the thick line may be omitted, and the thick line is used here only for illustrative purposes.

[0075] like Fig.9A As shown in , the model heart 1111 may include multiple segments, several of which are adjacent to other segment boundaries at different activation times and are labeled as 1110-1, 1110-2, 1110-3, 1110-4 (hereinafter collectively referred to as 1110). The segments 1110 may each exhibit different levels or values ​​of electrical activity, as indicated by the correspondence between the shading / color of the electrical activity indicator 1119 and the shading / color on the model heart 1111. The electrical activity may be mapped to the segments 1110 of the model heart 1111. Fig.9A The model heart 1111 shown in FIG. 1 shows segments that have not yet been combined and / or divided into anatomical regions, such as will be combined Figure 9B-9D Further described.

[0076] In this embodiment, the electrical activity mapped around or onto the model heart 1111 within segment 1110 is the cardiac activation time. As described herein, the cardiac activation time can be described as representing the timing of depolarization of cardiac tissue. In one or more embodiments, the measurement of activation time can be performed by measuring the time period between the start of cardiac depolarization (e.g., the start of the QRS complex) and an appropriate reference point, such as, for example, a peak, a minimum, a minimum slope, a maximum slope, a zero crossing, a threshold crossing, etc.

[0077] That is, the first segment 1110-1 is shown as having an electrical activity value or an excitation time corresponding to approximately twelve (12) on the indicator 1119. The second segment 1110-2 is shown as having an electrical activity value or an excitation time corresponding to approximately eighty (80) on the indicator 1119. The third segment 1110-3 and the fourth segment 1110-4 also each have electrical activity values ​​or excitation times corresponding to eighty (80) and approximately twelve (12), respectively. The fifth segment 1110-5 has an electrical activity value or an excitation time corresponding to approximately seventy (70) on the electrical activity indicator 1119. The sixth segment 1110-6 has an electrical activity value or an excitation time corresponding to approximately fifty (50) on the electrical activity indicator 1119. In this embodiment, each of the mentioned segments may be surrounded by further segments having approximately the same or substantially different electrical activity values.

[0078] Further, Fig.9A An exemplary model heart 1111 is depicted showing or having several possible conduction conditions. As shown, the first segment 1110-1 and the fourth segment 1110-4 have similar electrical activities, and the second segment 1110-2 and the third segment 1110-3 have similar electrical activities. However, the adjacent first segment 1110-1 and the second segment 1110-2 include electrical activities that can be described as significantly different or having significantly different electrical activities. That is, there is a gradient at the boundary 1112 between the first segment 1110-1 and the second segment 1110-2, which can indicate a conduction condition, such as a slow conduction condition or a conduction block condition. Further, another example gradient of electrical activity is shown at the boundary 1114 between the third segment 1110-3 and the fourth segment 1110-4, which also indicates a conduction condition.

[0079] Fig. 9B An exemplary model heart showing multiple anatomical regions and cardiac electrical activation times mapped to the multiple anatomical regions is depicted. The model heart 1120 may include multiple anatomical regions 1130, wherein each labeled region or group of regions 1130-1, 1130-2, 1130-3, 1130-4, 1130-5, 1130-6, 1130-7 indicates at least one region for which a median activation time has been determined. That is, the labeled regions, such as Fig. 9B 1130-3 of this section may include Figure 8 Both regions 1020-2 and 1020-6 are shown in FIG. 1 because both regions 1020-2 and 1020-6 have the same median activation time (e.g., approximately 10 ms), as shown in FIG. Fig. 9B As shown in Fig. 9B As shown in , a bold line may indicate a boundary between at least two marking regions. However, in at least one example, the bold line may be omitted, and the bold line is used here only for illustrative purposes.

[0080] Each of the anatomical regions 1130 may include a subset of a plurality of segments spanning the entire heart model 1120, wherein a segment of the plurality of segments is illustrated by the triangular shape of the model heart 1120. Fig.9A The electrical activity maps for each segment are shown in Fig. 9B , thereby showing a plurality of anatomical regions 1130. That is, as an example, Fig.9A The electrical activity of the segments corresponding to the anatomical regions shown in FIG. 1 is averaged for the anatomical regions. Fig. 9B In other words, Fig.9A The electrical activity shown in the figure is on a segment-by-segment basis and is averaged across anatomical regions (in Fig. 9B ) so that electrical activity is on a zone-by-zone basis. Figure 8 As described, some anatomical regions may be associated with electrically inactive myocardium (such as Figure 8 To compensate for this, these electrically inactive portions of the heart's myocardium may be assigned an electrical activity value of -1 ms to indicate that these portions are not regions of interest, as will be described below in conjunction with Figure 9B-9D Further described.

[0081] A median activation time indicator 1012 for a zone is shown, depicting a color / shading diagram corresponding to the median activation time for each zone. That is, anatomical zone 1130-1 has a median activation time corresponding to approximately ten (10) ms (shown in white in 1130-1) on the electrical activity indicator 1012 (e.g., the median activation time of all segments within anatomical zone 1130-1). Anatomical zone 1130-2 is assigned a median activation time of negative one (-1) ms on the median activation time indicator 1012 for the zone, indicating that the anatomical zone is not activating the myocardium, i.e., not activating valves and blood vessels. Anatomical zone 1130-3 has a median activation time corresponding to approximately ten (10) ms, anatomical zone 1130-4 has a median activation time corresponding to approximately eighty (80) ms (shown in black in 1130-4), and so on.

[0082] Fig. 9CAn exemplary model heart 1120 is depicted showing several conduction conditions indicated by conduction condition indicators. Fig. 9B As described, there may be a gradient of electrical activity between two adjacent anatomical regions, such as between a first anatomical region 1210-1 and a second anatomical region 1210-2. That is, the anatomical region 1210-1 has a median activation time corresponding to approximately ten (10) ms on the region median activation time indicator 1012, and the anatomical region 1210-2 adjacent to the anatomical region 1210-1 has a median activation time corresponding to approximately eighty (80) ms. This gradient between adjacent anatomical regions may indicate a conduction condition. The conduction condition may be visually illustrated by a conduction condition indicator, such as a graphical element (e.g., a line) between the first anatomical region 1210-1 and the second anatomical region 1210-2. Although graphical elements are described, any number of elements (such as arrows, displayed letters, etc.) may be used to indicate a conduction condition.

[0083] Fig.9D An exemplary model heart showing multiple anatomical regions and cardiac electrical activation times mapped to the multiple anatomical regions is depicted. The model heart 1140 may include multiple anatomical regions, several of which are labeled 1142-1, 1142-2, 1142-3, 1142-4, 1142-5, 1142-6, 1142-7. Fig.9A The electrical activity maps for each segment are shown in Fig.9D , thereby showing a plurality of anatomical regions 1140. That is, as an example, Fig.9A The electrical activity of the segments corresponding to the anatomical regions shown in FIG. 1 can be used to determine the maximum activation time of the anatomical regions. Fig.9D In other words, Fig.9A The electrical activity shown in the Fig.9D The maximum values ​​of electrical activity in those segments of each anatomical region are shown in order to facilitate the electrical activity on a region-by-region basis.

[0084] A maximum activation time indicator 1150 for the zone is shown, depicting a color / shading diagram corresponding to the maximum activation time of each zone. That is, anatomical zone 1142-1 has a maximum activation time corresponding to approximately twenty (20) ms on the electrical activity indicator 1150 (e.g., the maximum activation time of all segments within anatomical zone 1142-1). Anatomical zone 1142-2 has a maximum activation time corresponding to approximately negative one (-1) ms on the median activation time indicator 1150 for the zone, indicating that the anatomical zone is not activated myocardium, i.e., valves and blood vessels are not activated. Further, anatomical zone 1142-3 has a maximum activation time corresponding to approximately eighty (80) ms, anatomical zone 1142-4 has a maximum activation time corresponding to approximately eighty (80) ms, and so on.

[0085] Fig.10 Describes the use of this article reference Figure 1-Figure 7 An exemplary model heart 1313 of the described exemplary systems and methods includes a plurality of anatomical regions 1310 and peak-to-peak voltage values ​​mapped to the plurality of anatomical regions 1310. Thus, without imaging the patient's heart, and instead using one or more patient characteristics to provide the model heart 1313 and map the peak-to-peak voltage values ​​onto the model heart 1313, an exemplary model heart 1313 including a plurality of segments 1310 and peak-to-peak voltage values ​​mapped to the plurality of segments 1310 may have been generated or created. The segments 1310 may each exhibit different levels or values ​​of peak-to-peak voltage, as indicated by the correspondence between the shading / color of the peak-to-peak voltage indicator 1321 and the shading / color on the model heart 1313.

[0086] Further, as further described herein with reference to process 444, the model heart 1313 may be described as a three-dimensional (3D) representation extending in x, y, and z planes (indicated by axes 1316 (x plane), 1314 (y plane), and 1318 (z plane)) and as including multiple segments, several of which are labeled 1310-1, 1310-2, 1310-3, 1310-4, and 1310-5 (hereinafter collectively referred to as 1310).

[0087] The first segment 1310-1 is shown as having a peak-to-peak voltage value corresponding to approximately twelve (12) millivolts (mV) at indicator 1321. The second segment 1310-2 is shown as having a peak-to-peak voltage value corresponding to approximately nine (9) mV at indicator 1321. The third segment 1310-3 has a peak-to-peak voltage value corresponding to five (5) mV, the fourth segment 1310-4 corresponds to two (2) mV, and the fifth segment 1310-5 corresponds to three (3) mV. In this embodiment, each of the mentioned segments may be surrounded by further segments having approximately the same or substantially different peak-to-peak voltage values.

[0088] Although not in Fig.10 , but the peak-to-peak voltages may be averaged and / or combined across anatomical regions, such as in combination with Figure 9A-9D In this example, the peak-to-peak voltage value may be an average of the peak-to-peak voltages across the anatomical region, and not necessarily a specific location within the anatomical region having that value. When traversing away from the referenced anatomical region, the boundary extends between anatomical regions having different peak-to-peak voltages (as described above in conjunction with Fig. 9B and electrical activation time).

[0089] Fig.11AAn exemplary model heart showing peak-to-peak voltage values ​​is depicted. Model heart 1414 shows a plurality of peak-to-peak voltage values ​​indicated by peak-to-peak indicator 1416. The peak-to-peak voltage values ​​of model heart 1414 are between 3.8 mV and 6.1 mV, approximately close to 5 mV, on peak-to-peak indicator 1416. The peak-to-peak voltage value of approximately 5 mV is above a threshold indicating that there is no risk of scarring in the model heart tissue.

[0090] Fig. 11B An exemplary model heart showing peak-to-peak voltage values ​​including a scar risk indicator identifying an increased risk of scarring is depicted. The model heart 1418 shows a plurality of peak-to-peak voltage values ​​indicated by peak-to-peak indicators 1416. The peak-to-peak voltage values ​​of the model heart 1416 (indicated by arrows 1420) are between 3.8 mV and 6.1 mV on the peak-to-peak indicator 1416, approximately close to 5 mV. The peak-to-peak voltage values ​​of approximately 5 mV are above a threshold indicating that there is no risk of scarring at these locations in the model heart tissue. However, some portions 1422 of the model heart 1418 are below the threshold, at 1.4 mV on the peak-to-peak indicator 1416. This indicates a risk of scarring in the model heart tissue. In response to a portion of the model heart tissue having a peak-to-peak voltage value below the threshold, a scar risk indicator 1424 may be displayed on the model heart 1418.

[0091] The exemplary systems, methods, and graphical user interfaces described herein may be used with respect to implantation and configuration of an implantable medical device (IMD) and / or one or more leads configured to be positioned proximate to one or more portions of a patient's heart. Figure 12-16 The exemplary treatment system 10 described uses exemplary systems, methods, and interfaces.

[0092] Fig.12 is a conceptual diagram illustrating an exemplary therapy system 10 that can be used to deliver pacing therapy to a patient 14. Patient 14 can be, but is not necessarily, a human. Therapy system 10 can include an implantable medical device 16 (IMD) that can be coupled to leads 18, 20, 22. IMD 16 can be, for example, an implantable pacemaker, cardioverter, and / or defibrillator that delivers or provides electrical signals (e.g., pacing, etc.) to and / or senses electrical signals from heart 12 of patient 14 via electrodes coupled to one or more of leads 18, 20, 22.

[0093] Leads 18, 20, 22 extend into heart 12 of patient 14 to sense electrical activity of heart 12 and / or deliver electrical stimulation to heart 12. Fig.12In the example shown in FIG, a right ventricular (RV) lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium 26, and into the right ventricle 28. A left ventricular (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, the right atrium 26, and into the coronary sinus 30 to a region adjacent to the free wall of the left ventricle 32 of the heart 12. A right atrial (RA) lead 22 extends through one or more veins and the vena cava, and into the right atrium 26 of the heart 12.

[0094] The IMD 16 may sense electrical signals associated with depolarization and repolarization of the heart 12, etc., via electrodes coupled to at least one of the leads 18, 20, 22. In some examples, the IMD 16 provides pacing therapy (e.g., pacing pulses) to the heart 12 based on the electrical signals sensed within the heart 12. The IMD 16 is operable to adjust one or more parameters associated with the pacing therapy, such as, for example, AV delay and other various timings, pulse width, amplitude, voltage, pulse train length, etc. Further, the IMD 16 is operable to deliver pacing therapy using various electrode configurations, which may be unipolar, bipolar, quadripolar, or more multipolar. For example, a multipolar lead may include several electrodes that may be used to deliver pacing therapy. Thus, a multipolar lead system may provide or supply multiple electrical vectors from which to pace.

[0095] The pacing vector may include: at least one cathode, which may be at least one electrode positioned on at least one lead; and at least one anode, which may be at least one electrode positioned on at least one lead (e.g., the same lead or different leads) and / or on the housing or can of the IMD. Although the improvement in cardiac function due to pacing therapy may be primarily dependent on the cathode, electrical parameters such as impedance, pacing threshold voltage, current consumption, life span, etc. may be more dependent on the pacing vector including both the cathode and the anode. The IMD 16 may also provide defibrillation therapy and / or cardioversion therapy via electrodes located on at least one of the leads 18, 20, 22. Further, the IMD 16 may detect arrhythmias of the heart 12 (e.g., fibrillation of the ventricles 28, 32) and deliver defibrillation therapy to the heart 12 in the form of electrical pulses. In some examples, the IMD 16 may be programmed to deliver progressive therapy (e.g., pulses with increasing energy levels) until the fibrillation of the heart 12 ceases.

[0096] Figure 13-Figure 14 is shown in more detail Fig.121 and 2. Conceptual diagram of IMD 16 and leads 18, 20, 22 of therapy system 10 of FIG. Leads 18, 20, 22 may be electrically coupled to a therapy delivery module (e.g., for delivering pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and / or any other module of IMD 16 via connector block 34. In some examples, proximal ends of leads 18, 20, 22 may include electrical contacts that are electrically coupled to corresponding electrical contacts in connector block 34 of IMD 16. Additionally, in some examples, leads 18, 20, 22 may be mechanically coupled to connector block 34 by means of set screws, connecting pins, or another suitable mechanical coupling mechanism.

[0097] Each of leads 18, 20, 22 includes an elongated insulated lead body that can carry a plurality of conductors (e.g., concentrically coiled conductors, straight conductors, etc.) separated from one another by a separator (e.g., a tubular insulating sheath). In the example shown, bipolar electrodes 40, 42 are positioned near the distal end of lead 18. In addition, bipolar electrodes 44, 45, 46, 47 are positioned near the distal end of lead 20, and bipolar electrodes 48, 50 are positioned near the distal end of lead 22.

[0098] Electrodes 40, 44, 45, 46, 47, 48 may take the form of ring electrodes, and electrodes 42, 50 may take the form of extendable spiral tip electrodes telescopically mounted within insulating electrode heads 52, 54, 56, respectively. Each of electrodes 40, 42, 44, 45, 46, 47, 48, 50 may be electrically coupled to a respective one of the conductors (e.g., wound and / or straight) within the lead body of its associated lead 18, 20, 22, and thereby coupled to a respective one of the electrical contacts on the proximal end of leads 18, 20, 22.

[0099] Additionally, electrodes 44, 45, 46, and 47 may have a width of approximately 5.3 mm. 2 To approximately 5.8mm 2 Electrode surface area. Electrodes 44, 45, 46, and 47 may also be referred to as LV1, LV2, LV3, and LV4, respectively. The LV electrodes on lead 20 (i.e., left ventricular electrode 1 (LV1) 44, left ventricular electrode 2 (LV2) 45, left ventricular electrode 3 (LV3) 46, left ventricular 4 (LV4) 47, etc.) may be spaced apart at variable distances. For example, electrode 44 may be spaced apart from electrode 45, for example, by about 21 millimeters (mm), electrodes 45 and 46 may be spaced apart from each other, for example, by a distance of about 1.3 mm to about 1.5 mm, and electrodes 46 and 47 may be spaced apart from each other, for example, by a distance of 20 mm to about 21 mm.

[0100] Electrodes 40, 42, 44, 45, 46, 47, 48, 50 may further be used to sense electrical signals (e.g., morphological waveforms within an electrogram (EGM)) accompanying depolarization and repolarization of heart 12. These electrical signals are conducted to IMD 16 via corresponding leads 18, 20, 22. In some examples, IMD 16 may also deliver pacing pulses via electrodes 40, 42, 44, 45, 46, 47, 48, 50 to cause depolarization of cardiac tissue of the patient's heart 12. In some examples, such as Fig.13 , IMD 16 includes one or more housing electrodes, such as housing electrode 58, which may be integrally formed with or otherwise coupled to an outer surface of a housing 60 (e.g., a hermetically sealed housing) of IMD 16. Any of electrodes 40, 42, 44, 45, 46, 47, 48, 50 may be used for unipolar sensing or pacing in combination with housing electrode 58. It is generally understood by those skilled in the art that other electrodes may also be selected to define or be used for pacing and sensing vectors. Further, when not being used to deliver pacing therapy, any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58 may be used to sense electrical activity during pacing therapy.

[0101] As reference Fig.13 As further described in detail, housing 60 may enclose a therapy delivery module that may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, and a sensing module for monitoring electrical signals of a patient's heart (e.g., the patient's heart rhythm). Leads 18, 20, 22 may also include elongated electrodes 62, 64, 66, respectively, which may take the form of coils. IMD 16 may deliver defibrillation shocks to heart 12 via any combination of elongated electrodes 62, 64, 66 and housing electrodes 58. Electrodes 58, 62, 64, 66 may also be used to deliver cardioversion pulses to heart 12. Further, electrodes 62, 64, 66 may be made of any suitable conductive material, such as, but not limited to, platinum, platinum alloys, and / or other materials known to be useful for implantable defibrillation electrodes. Because electrodes 62, 64, 66 are generally not configured to deliver pacing therapy, any of electrodes 62, 64, 66 may be used to sense electrical activity and may be used in combination with any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58. In at least one embodiment, RV elongated electrode 62 may be used to sense electrical activity of the patient's heart during delivery of pacing therapy (e.g., in combination with housing electrode 58, or in combination with a defibrillation electrode-to-housing electrode vector).

[0102] Figure 12-14The configuration of the exemplary treatment system 10 shown in is only one example. In other examples, instead of Fig.12 The transvenous leads 18, 20, 22 shown in the Fig.12 In addition to the transvenous leads 18, 20, 22 shown in FIG. 1 , the therapy system may include epicardial leads and / or patch electrodes. Additionally, in other examples, the therapy system 10 may be implanted in / around the cardiac space without employing a transvenous lead (e.g., a leadless / or wireless pacing system), or with a lead implanted (e.g., implanted transvenously or using an approach) into the left chamber of the heart (in addition to, for example, a pacing system). Fig.12 In addition to or in place of a transvenous line placed into the right chamber of the heart as shown Figure 7 14). Further, in one or more embodiments, IMD 16 need not be implanted in patient 14. For example, IMD 16 may deliver various cardiac therapies to heart 12 via percutaneous leads extending through the skin of patient 14 to a plurality of locations within or outside of heart 12. In one or more embodiments, system 10 may employ wireless pacing (e.g., using energy transmission to pacing component(s) within the heart via ultrasound, inductive coupling, RF, etc.) and sensing of cardiac activation using electrodes on the can / housing and / or on subcutaneous leads.

[0103] In other examples of therapy systems that provide electrical stimulation therapy to heart 12, such therapy systems may include any suitable number of leads coupled to IMD 16, and each of the leads may extend to any location within or near heart 12. For example, other examples of therapy systems may include, for example, Figure 12-14 Still further, other therapy systems may include a single lead extending from IMD 16 into right atrium 26 or right ventricle 28, or two leads extending into a respective one of right atrium 26 and right ventricle 28.

[0104] Fig.15 is a functional block diagram of one exemplary configuration of IMD 16. As shown, IMD 16 may include a control module 81, a therapy delivery module 84 (eg, which may include a stimulation generator), a sensing module 86, and a power source 90.

[0105] Control module 81 may include processor 80, memory 82, and telemetry module 88. Memory 82 may include computer-readable instructions that, when executed, for example, by processor 80, cause IMD 16 and / or control module 81 to perform various functions described herein and attributed to IMD 16 and / or control module 81. Further, memory 82 may include any volatile, nonvolatile, magnetic, optical, and / or electrical media, such as random access memory (RAM), read-only memory (ROM), nonvolatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and / or any other digital media. An exemplary capture management module may be a left ventricular capture management (LVCM) module described in U.S. Pat. No. 7,684,863, issued Mar. 23, 2010, entitled “LV THRESHOLD MEASUREMENT AND CAPTURE MANAGEMENT,” which is incorporated herein by reference in its entirety.

[0106] The processor 80 of the control module 81 may include any one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), and / or an equivalent discrete or integrated logic circuit system. In some examples, the processor 80 may include multiple components, such as any combination of the following: one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs, and / or one or more FPGAs, and other discrete or integrated logic circuit systems. The functions attributed to the processor 80 herein may be embodied as software, firmware, hardware, or any combination thereof.

[0107] The control module 81 may control the therapy delivery module 84 to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart 12 according to one or more selected therapy programs that may be stored in the memory 82. More specifically, the control module 81 (e.g., the processor 80) may control various parameters of the electrical stimulation delivered by the therapy delivery module 84, such as, for example, AV delay, VV delay, pacing pulses having amplitude, pulse width, frequency, or polarity of electrodes, etc., which may be specified by one or more selected therapy programs (e.g., AV and / or VV delay adjustment programs, pacing therapy programs, pacing restoration programs, capture management programs, etc.). As shown, the therapy delivery module 84 is electrically coupled to the electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66, for example, via conductors of the corresponding leads 18, 20, 22 or, in the case of the housing electrode 58, via electrical conductors disposed within the housing 60 of the IMD 16. Therapy delivery module 84 may be configured to generate and deliver electrical stimulation therapy, such as pacing therapy, to heart 12 using one or more of electrodes 40 , 42 , 44 , 45 , 46 , 47 , 48 , 50 , 58 , 62 , 64 , 66 .

[0108] For example, therapy delivery module 84 may deliver pacing stimulation (e.g., pacing pulses) via ring electrodes 40, 44, 45, 46, 47, 48 coupled to leads 18, 20, 22 and / or via helical tip electrodes 42, 50 of leads 18, 22. Further, for example, therapy delivery module 84 may deliver a defibrillation shock to heart 12 via at least two of electrodes 58, 62, 64, 66. In some examples, therapy delivery module 84 may be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, therapy delivery module 84 may be configured to deliver one or more of these types of stimulation in the form of other signals (e.g., sine waves, square waves, and / or other substantially continuous time signals).

[0109] The IMD 16 may further include a switch module 85, and the control module 81 (e.g., the processor 80) may use the switch module 85 to select, for example, 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 85 may include a switch array, a switch matrix, a multiplexer, or any other type of switch device suitable for selectively coupling the sensing module 86 and / or the therapy delivery module 84 to one or more selected electrodes. More specifically, the therapy delivery module 84 may include a plurality of pacing output circuits. The switch module 85 may be used, for example, to selectively couple each of the plurality of pacing output circuits to one or more of the electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 (e.g., a pair of electrodes for delivering therapy to a bipolar or multipolar pacing vector). That is, the switch module 85 may be used to selectively couple each electrode to one of the pacing output circuits of the therapy delivery module.

[0110] The sensing module 86 is coupled (e.g., electrically coupled) to a sensing device, which, as well as additional sensing devices, may include electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 for monitoring electrical activity of the heart 12, such as electrocardiogram (ECG) / electrogram (EGM) signals, etc. ECG / EGM signals can be used to measure or monitor activation time (e.g., ventricular activation time, etc.), heart rate (HR), heart rate variability (HRV), heart rate oscillations (HRT), deceleration / acceleration ability, deceleration sequence incidence, T wave alternans (TWA), P wave to P wave interval (also known as PP interval or AA interval), R wave to R wave interval (also known as RR interval or VV interval), P wave to QRS complex interval (also known as PR interval, AV interval or PQ interval), QRS complex morphology, ST segment (i.e., the segment connecting the QRS complex and T wave), T wave changes, QT interval, electrical vector, etc.

[0111] The switch module 85 can also be used with the sensing module 86 to select which of the available electrodes to use or enable, for example, to sense electrical activity of the patient's heart (e.g., using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 to sense one or more electrical vectors of the patient's heart). Similarly, the switch module 85 can also be used with the sensing module 86 to select which of the available electrodes to not use (e.g., disable) to, for example, sense electrical activity of the patient's heart (e.g., using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 to sense one or more electrical vectors of the patient's heart), etc. In some examples, the control module 81 can select the electrodes to be used as sensing electrodes via the switch module within the sensing module 86 (e.g., by providing a signal via a data / address bus).

[0112] In some examples, the sensing module 86 includes a channel including an amplifier having a relatively wider passband than an R-wave or P-wave amplifier. The signal from the selected sensing electrode can be provided to a multiplexer and then converted by an analog-to-digital converter into a multi-bit digital signal for storage in the memory 82, for example, as an electrogram (EGM). In some examples, the storage of such an EGM in the memory 82 can be under the control of a direct memory access circuit.

[0113] In some examples, the control module 81 may operate as an interrupt driven device and may respond to interrupts from the pacemaker timing and control module, wherein the interrupts may correspond to the occurrence of sensed P and R waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations may be performed by the processor 80, and any updates to values ​​or intervals controlled by the pacemaker timing and control module may occur following such interrupts. A portion of the memory 82 may be configured as a plurality of recirculating buffers capable of retaining one or more series of measured intervals that may be analyzed by, for example, the processor 80 in response to the occurrence of a pacing or sensing interruption to determine whether the patient's heart 12 is currently exhibiting an atrial or ventricular tachyarrhythmia.

[0114] Telemetry module 88 of control module 81 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 processor 80, telemetry module 88 may receive downlink telemetry from a programmer and send uplink telemetry to the programmer via an antenna (which may be an internal and / or external antenna). Processor 80 may provide telemetry circuitry within telemetry module 88 with data to be transmitted to the programmer via an uplink, as well as control signals, for example via an address / data bus. In some examples, telemetry module 88 may provide the received data to processor 80 via a multiplexer.

[0115] The various components of IMD 16 are further coupled to a power source 90, which may include rechargeable and non-rechargeable batteries. Non-rechargeable batteries may be selected to last for several years, while rechargeable batteries may be inductively charged from an external device, for example, daily or weekly.

[0116] Fig.16 is another embodiment of a functional block diagram of IMD 16 . Fig.16 A bipolar RA lead 22, a bipolar RV lead 18, and a bipolar LV CS lead 20 are depicted, without LA CS pacing / sensing electrodes, and coupled to an implantable pulse generator (IPG) circuit 31 having programmable modes and parameters of a biventricular DDD / R type as is well known in the art of pacing. In turn, a sensor signal processing circuit 91 is indirectly coupled to a timing circuit 43 and to a microcomputer circuit system 33 via a data and control bus. The IPG circuit 31 is shown in a functional block diagram generally divided into a microcomputer circuit 33 and a pacing circuit 21. The pacing circuit 21 includes a digital controller / timer circuit 43, an output amplifier circuit 51, a sense amplifier circuit 55, an RF telemetry transceiver 41, an activity sensor circuit 35, and a number of other circuits and components described below.

[0117] Crystal oscillator circuit 89 provides a basic timing clock for pacing circuit 21, while battery 29 provides power. Power-on reset circuit 87 responds to initial connection of the circuit to the battery for defining initial operating conditions, and similarly responds to detecting a low battery condition to reset the operating state of the device. Reference mode circuit 37 generates a stable voltage reference and current for analog circuits within pacing circuit 21. Analog-to-digital converter (ADC) and multiplexer circuit 39 digitize analog signals and voltages to provide real-time telemetry of cardiac signals, such as from sense amplifier 55, for uplink transmission via RF transmitter and receiver circuit 41. Voltage reference and bias circuit 37, ADC and multiplexer 39, power-on reset circuit 87, and crystal oscillator circuit 89 may correspond to any of those used in exemplary implantable cardiac pacemakers.

[0118] If the IPG is programmed for rate responsive mode, the signals output by one or more physiological sensors are used as a rate control parameter (RCP) to derive the physiological escape interval. For example, the escape interval is adjusted in proportion to the patient's activity level generated in the patient activity sensor (PAS) circuit 35 in the depicted, exemplary IPG circuit 31. The patient activity sensor 27 is coupled to the IPG housing and can take the form of a piezoelectric crystal transducer. The output signal of the patient activity sensor 27 can be processed and used as the RCP. The sensor 27 generates electrical signals in response to the sensed physical activity, which are processed by the activity circuit 35 and provided to the digital controller / timer circuit 43. The activity circuit 35 and associated sensor 27 may correspond to the circuit systems disclosed in U.S. Pat. No. 5,052,388, issued on Oct. 1, 1991, entitled “METHOD AND APPARATUS FORIMPLEMENTING ACTIVITY SENSING IN A PULSE GENERATOR” and U.S. Pat. No. 4,428,378, issued on Jan. 31, 1984, and entitled “RATE ADAPTIVE PACER”, each of which is incorporated herein by reference in its entirety. Similarly, the exemplary systems, apparatus, and methods described herein may be practiced in conjunction with alternative types of sensors, such as oxygenation sensors, pressure sensors, pH sensors, and respiration sensors, for providing rate-responsive pacing functionality. Alternatively, the QT time may be used as a rate-indicating parameter, in which case no additional sensor is required. Similarly, the exemplary embodiments described herein may also be practiced in a non-rate-responsive pacemaker.

[0119] Data transmission to and from an external programmer is accomplished through telemetry antenna 57 and associated RF transceiver 41 for both demodulating received downlink telemetry and for transmitting uplink telemetry. The uplink telemetry capability may include the ability to transmit stored digital information (e.g., operating modes and parameters, EGM histograms and other events, and real-time EGMs of atrial and / or ventricular electrical activity and marker channel pulses indicating the occurrence of sensed and paced depolarizations in the atria and ventricles).

[0120] The microcomputer 33 includes a microprocessor 80 and an associated system clock, and includes on-processor RAM and ROM chips 82A and 82B, respectively. In addition, the microcomputer circuit 33 includes a separate RAM / ROM chip 82C to provide additional memory capacity. The microprocessor 80 is usually operated in a reduced power consumption mode and is interrupt driven. The microprocessor 80 is awakened in response to a defined interrupt event, which may include an A-trigger (TIRG) signal, an RV-trigger signal, a LV-trigger signal generated by a timer in the digital timer / controller circuit 43, and an A-event signal, an RV-event signal, and a LV-event signal generated by the sense amplifier circuit 55, etc. The specific value of the interval and delay of the countdown (timeout) performed by the digital controller / timer circuit 43 is controlled by the microcomputer circuit 33 through the data and control bus according to the parameter values ​​and operating modes programmed into the microcomputer circuit 33. Furthermore, if programmed to operate as a rate-responsive pacemaker, a timed interrupt may be provided, for example, every cycle or every two seconds, to allow the microprocessor to analyze the activity sensor data and update the basic AA, VA, or VV escape intervals, as applicable. In addition, the microprocessor 80 may also be used to define variable, operational AV delay intervals, VV delay intervals, and the energy delivered to each ventricle and / or atrium.

[0121] In one embodiment, microprocessor 80 is a custom microprocessor adapted to fetch and execute instructions stored in RAM / ROM unit 82 in a conventional manner. However, it is contemplated that other implementations may be suitable for practicing the present invention. For example, an off-the-shelf commercially available microprocessor or microcontroller, or a custom dedicated hard-wired logic or state machine type circuit may perform the functions of microprocessor 80.

[0122] The digital controller / timer circuit 43 operates under the overall control of the microcomputer 33 to control timing and other functions within the pacing circuit 21 and includes a set of timing circuits and associated logic circuits, certain of which are depicted that are relevant to the present invention. The depicted timing circuits include a URI / LRI timer 83A, a VV delay timer 83B, an intrinsic interval timer 83C for timing past V-event to V-event intervals or V-event to A-event intervals or VV conduction intervals, an escape interval timer 83D for timing AA, VA and / or VV pacing escape intervals, an AV delay interval timer 83E for timing the A-LVp delay (or A-RVp delay) from a preceding A-event or A-trigger, a post-ventricular timer 83F for timing post-ventricular time periods, and a date / time clock 83G.

[0123] The AV delay interval timer 83E is loaded with the appropriate delay interval for a ventricular chamber (e.g., A-RVp Delay or A-LVp Delay) to count down from a preceding A-Pace or A-Event. The interval timer 83E triggers the delivery of the pacing stimulus and may be based on one or more previous cardiac cycles (or from an empirically derived data set for a given patient).

[0124] The post-event timer 83F counts down the post-ventricular time period after an RV-event or LV-event or RV-trigger or LV-trigger, and the post-atrial time period after an A-event or A-trigger. The duration of the post-event time period may also be selected as a programmable parameter stored in the microcomputer 33. The post-ventricular time period includes the PVARP, the post-atrial ventricular blanking period (PAVBP), the ventricular blanking period (VBP), the post-ventricular atrial blanking period (PVARP), and the ventricular refractory period (VRP), although other time periods may also be appropriately defined based at least in part on the operating circuitry employed in the pacing engine. The post-atrial time period includes the atrial refractory period (ARP) (during which the A-event is ignored for the purpose of resetting any AV delay) and the atrial blanking period (ABP) (during which atrial sensing is disabled). It should be noted that the start of the post-atrial time period and AV delay may begin substantially simultaneously with the start or end of each A-event or A-trigger, or in the case of an A-trigger, may begin at the end of the A-pacing following the A-trigger. Similarly, the start of the post-ventricular time period and VA escape interval may begin substantially simultaneously with the start or end of a V-event or V-trigger, or in the case of a V-trigger, at the end of the V-pacing following the V-trigger. The microprocessor 80 also optionally calculates the AV delay, VV delay, post-ventricular time period, and post-atrial time period as a function of sensor-based escape intervals established in response to one or more RCPs and / or with intrinsic atrial and / or ventricular rates.

[0125] The output amplifier circuit 51 includes an RA pacing pulse generator (and a LA pacing pulse generator, if LA pacing is provided), an RV pacing pulse generator, an LV pacing pulse generator, and / or any other pulse generator configured to provide atrial and ventricular pacing. To trigger the generation of RV-pacing or LV-pacing pulses, the digital controller / timer circuit 43 generates an RV-trigger signal upon timeout of the A-RVp delay (in the case of RV preexcitation) or generates an LV-trigger upon timeout of the A-LVp delay (in the case of LV preexcitation), the timeout of the A-RVp delay and the timeout of the A-LVp delay being provided by the AV delay interval timer 83E (or the VV delay timer 83B). Similarly, at the end of the VA escape interval timed by the escape interval timer 83D, the digital controller / timer circuit 43 generates an RA-trigger signal that triggers the output of an RA-pacing pulse (or an LA-trigger signal that triggers the output of an LA-pacing pulse, if provided).

[0126] The output amplifier circuit 51 includes switching circuitry for coupling selected pacing electrode pairs from between the lead conductors and the IND-can electrode 20 to the RA pacing pulse generator (and LA pacing pulse generator, if provided), the RV pacing pulse generator, and the LV pacing pulse generator. The pacing / sense electrode pair selection and control circuit 53 selects the lead conductors and associated pacing electrode pairs to be coupled to the atrial and ventricular output amplifiers within the output amplifier circuit 51 for accomplishing RA, LA, RV, and LV pacing.

[0127] The sense amplifier circuit 55 contains sense amplifiers for atrial and ventricular pacing and sensing. High impedance P-wave and R-wave sense amplifiers can be used to amplify the differential pressure signal generated across the sensing electrode pair by the passage of the cardiac depolarization wavefront. The high impedance sense amplifier uses high gain to amplify low amplitude signals and relies on passband filters, time domain filtering, and amplitude threshold comparison to distinguish the P wave or R wave from background electrical noise. The digital controller / timer circuit 43 controls the sensitivity setting of the atrial and ventricular sense amplifiers 55.

[0128] The sense amplifier is typically decoupled from the sense electrode during blanking periods before, during, and after delivery of a pacing pulse to any of the pacing electrodes of the pacing system to avoid saturation of the sense amplifier. The sense amplifier circuit 55 includes a blanking circuit for decoupling the selected lead conductor pairs and the IND-can electrode 20 from the inputs of the RA sense amplifier (and the LA sense amplifier if provided), the RV sense amplifier, and the LV sense amplifier during ABP, PVABP, and VBP. The sense amplifier circuit 55 also includes a switching circuit for coupling the selected sensing electrode lead conductors and the IND-can electrode 20 to the RA sense amplifier (and the LA sense amplifier if provided), the RV sense amplifier, and the LV sense amplifier. Similarly, the sense electrode selection and control circuit 53 selects conductors and associated sensing electrode pairs for coupling with the output amplifier circuit 51 and the atrial and ventricular sense amplifiers within the sense amplifier circuit 55 for accomplishing RA, LA, RV, and LV sensing along the desired unipolar and bipolar sensing vectors.

[0129] A right atrial depolarization or P wave in the RA-sense signal sensed by the RA sense amplifier results in an RA-event signal transmitted to the digital controller / timer circuit 43. Similarly, a left atrial depolarization or P wave in the LA-sense signal sensed by the LA sense amplifier (if provided) results in an LA-event signal transmitted to the digital controller / timer circuit 43. A ventricular depolarization or R wave in the RV-sense signal sensed by the ventricular sense amplifier results in an RV-event signal transmitted to the digital controller / timer circuit 43. Similarly, a ventricular depolarization or R wave in the LV-sense signal sensed by the ventricular sense amplifier results in an LV-event signal transmitted to the digital controller / timer circuit 43. The RV event signal, the LV event signal, as well as the RA event signal, the LA sense signal may be responsive or responsive, and may be inadvertently triggered by an electrical noise signal or an abnormally conducted depolarization wave, rather than a true R wave or P wave.

[0130] The techniques described in the present disclosure, including those attributed to IMD 16, computing device 140, and / or various component parts, may be implemented, at least in part, in hardware, software, firmware, or any combination thereof. For example, aspects of these 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, and any combination of such components embodied in a programmer (such as a physician programmer or patient programmer, stimulator, image processing device, or other device). The terms "module," "processor," or "processing circuitry" may generally refer to any of the foregoing logic circuitry, either independently or in combination with other logic circuitry, or any other equivalent circuitry.

[0131] Such hardware, software and / or firmware may be implemented in the same device or in separate devices to support the various operations and functions described in the present disclosure. In addition, any of the described units, modules or components may be implemented together, or may be implemented separately as discrete but interoperable logical devices. Depicting different features as modules or units is intended to emphasize different functional aspects, and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Instead, the functions associated with one or more modules or units may be performed by separate hardware or software components, or may be integrated in common or separate hardware or software components.

[0132] When implemented in software, the functionality attributed to the systems, devices, and techniques described in this disclosure may be embodied as instructions on a computer-readable medium (such as RAM, ROM, NVRAM, EEPROM, flash memory, magnetic data storage media, optical data storage media, etc.). These instructions may be executed by one or more processors to support one or more aspects of the functionality described in this disclosure.

[0133] The present disclosure has been provided with reference to illustrative embodiments, and the disclosure is not intended to be interpreted in a limiting sense. As previously stated, those skilled in the art will recognize that various other illustrative applications can use the techniques described herein to take advantage of the beneficial properties of the apparatus and methods described herein. Various modifications of the illustrative embodiments and additional embodiments of the present disclosure will be apparent when referring to this specification.

[0134] Illustrative Embodiments

[0135] Embodiment 1: A system comprising:

[0136] an electrode assembly comprising a plurality of extracorporeal electrodes for monitoring electrical activity from tissue of a patient; and

[0137] a computing device including processing circuitry and coupled to the electrode device, the computing device being configured to:

[0138] monitoring electrical activity from a patient using multiple external electrodes;

[0139] providing a model heart representing a heart of the patient based on at least one patient characteristic of the plurality of patient characteristics, wherein the model heart comprises a plurality of segments;

[0140] mapping the monitored electrical activity onto multiple segments of the model heart; and

[0141] Based on the mapped electrical activity, an electrical activity value is determined for each of a plurality of anatomical regions of the model heart, wherein each of the plurality of anatomical regions comprises a subset of the plurality of segments.

[0142] Embodiment 2: The system of embodiment 1, wherein providing a model heart representing the patient's heart based on at least one patient characteristic of a plurality of patient characteristics comprises:

[0143] Providing multiple model hearts; and

[0144] A model heart representing a heart of the patient is selected from a plurality of model hearts using at least one patient characteristic of the plurality of patient characteristics.

[0145] Embodiment 3: A system according to any one of embodiments 1 to 2, wherein providing a model heart representing the patient's heart based on at least one patient characteristic among a plurality of patient characteristics comprises: generating the model heart based on at least one patient characteristic among the plurality of patient characteristics.

[0146] Embodiment 4: The system of any one of embodiments 1 to 3, wherein the plurality of extracorporeal electrodes comprises body surface electrodes positioned in an array and configured to be located proximate to the skin of the patient's torso.

[0147] Embodiment 5: According to any one of embodiments 1 to 4, wherein the system further includes a display, wherein the display includes a graphical user interface configured to assist a user in assessing a patient's heart health, wherein the computing device is further configured to display a model heart and mapped electrical activity.

[0148] Embodiment 6: A system according to any one of embodiments 1 to 5, wherein the plurality of patient characteristics include age, gender, height, chest circumference, heart chamber size, ventricular ejection fraction, type of cardiomyopathy, and duration of a QRS complex on a 12-lead ECG.

[0149] Embodiment 7: The system of any one of embodiments 1 to 6, wherein the monitored electrical activity comprises a plurality of torso surface potential signals, wherein mapping the monitored electrical activity onto a plurality of segments of the model heart comprises:

[0150] Projecting the position of the monitored potential signal on the surface of the torso onto the corresponding position of the torso of the model;

[0151] Projecting the torso surface potential signal onto the position on the model heart based on the geometric relationship between the model heart and the model torso; and

[0152] A value for each of the plurality of segments of the model heart is generated based on one or more of the plurality of torso surface potential signals corresponding to each of the plurality of segments of the model heart.

[0153] Embodiment 8: A system according to any one of embodiments 1 to 7, wherein mapping the monitored electrical activity onto multiple anatomical regions of the model heart further comprises: calculating a measure of the electrical activity based on a trunk surface potential signal projected at each location of a segment of the model heart within the corresponding anatomical region.

[0154] Embodiment 9: The system according to any one of embodiments 1 to 8, wherein the computing device is further configured to:

[0155] comparing values ​​of adjacent anatomical regions in the plurality of anatomical regions; and

[0156] Based on the compared values, a conduction slowness or conduction block condition is determined between the compared adjacent anatomical regions.

[0157] Embodiment 10: The system of embodiment 9, wherein the system further comprises a display, wherein the display comprises a graphical user interface configured to assist a user in assessing the patient's cardiac health, wherein the computing device is further configured to display the model heart and the mapped electrical activity,

[0158] Therein, the computing device is further configured to display a graphical element on the model heart indicating the location of the determined conduction slowness or conduction block condition.

[0159] Embodiment 11: The system of any one of embodiments 1 to 10, wherein mapping the monitored electrical activity onto multiple segments of the model heart comprises mapping peak-to-peak voltage values ​​onto multiple segments of the model heart.

[0160] Embodiment 12: The system according to embodiment 11, wherein determining the electrical activity value of each of the plurality of anatomical regions of the model heart comprises:

[0161] determining an indication of scar risk based on the peak-to-peak voltage values ​​determined for each of a plurality of anatomical regions of the model heart; and

[0162] An indication of the determined scar risk is identified on the model heart.

[0163] Embodiment 13: A system according to any one of embodiments 1 to 12, wherein determining the electrical activity value of each of the multiple anatomical regions of the model heart comprises: determining the excitation time of each of the multiple anatomical regions of the model heart.

[0164] Embodiment 14: A method comprising:

[0165] monitoring electrical activity from the patient using a plurality of external electrodes on the patient's torso;

[0166] providing a model heart representing a heart of the patient based on at least one patient characteristic of the plurality of patient characteristics, wherein the model heart comprises a plurality of segments;

[0167] mapping the monitored electrical activity onto multiple segments of a model heart; and

[0168] Based on the mapped electrical activity, an electrical activity value is determined for each of a plurality of anatomical regions of the model heart, wherein each of the plurality of anatomical regions comprises a subset of the plurality of segments.

[0169] Embodiment 15: The method according to Embodiment 14, wherein providing a model heart representing the patient's heart based on at least one patient characteristic among a plurality of patient characteristics comprises: generating the model heart based on at least one patient characteristic among the plurality of patient characteristics.

[0170] Embodiment 16: The method according to any one of embodiments 14 to 15, further comprising displaying the model heart and the mapped electrical activity on a graphical user interface of the display for assisting a user in assessing the patient's heart health.

[0171] Example 17: A method according to any one of Examples 14 to 16, wherein the plurality of patient characteristics include age, gender, height, chest circumference, heart chamber size, ventricular ejection fraction, type of cardiomyopathy, and duration of a QRS complex on a clinical 12-lead ECG.

[0172] Embodiment 18: The method of any one of Embodiments 14 to 17, wherein the monitored electrical activity comprises a plurality of torso surface potential signals, and wherein mapping the monitored electrical activity onto a plurality of segments of the model heart comprises:

[0173] Projecting the position of the monitored potential signal on the surface of the torso onto the corresponding position of the torso of the model;

[0174] Based on the geometric relationship between the model heart and the model torso, the torso surface potential signal is projected onto the position on the model heart;

[0175] calculating a measure of electrical activity from the projected torso surface potential signal at each of the locations of the segments of the model heart; and

[0176] A value for each of the plurality of anatomical regions of the model heart is generated based on one or more of the plurality of torso surface potential signals corresponding to each of the plurality of anatomical regions of the model heart.

[0177] Embodiment 19: The method according to any one of embodiments 14 to 18, further comprising:

[0178] comparing the determined values ​​of adjacent anatomical regions in the plurality of anatomical regions; and

[0179] Based on the compared values, a conduction slowness or conduction block condition is determined between the compared adjacent anatomical regions.

[0180] Embodiment 20: The method according to embodiment 19 further comprises:

[0181] displaying the model heart, the mapped electrical activity, and the determined values ​​on a graphical user interface of the display for assisting a user in assessing the patient's heart health; and

[0182] Graphical elements are displayed on the model heart indicating the location of identified slow or block conditions.

[0183] Embodiment 21: The method of any one of embodiments 14 to 20, wherein the monitored electrical activity comprises a peak-to-peak voltage value, and the determined value is a peak-to-peak voltage value, and the method further comprises:

[0184] determining an indication of scar risk based on the determined peak-to-peak voltage values ​​for each of a plurality of anatomical regions of the model heart; and

[0185] An indication of the determined scar risk is identified on the model heart.

[0186] Embodiment 22: A system comprising:

[0187] an electrode assembly comprising a plurality of extracorporeal electrodes for monitoring electrical activity from tissue of a patient;

[0188] a computing device including processing circuitry and coupled to the electrode device, the computing device being configured to:

[0189] monitoring electrical activity from a patient using multiple external electrodes;

[0190] providing a model heart representing a heart of the patient based on at least one patient characteristic of the plurality of patient characteristics, wherein the model heart includes a plurality of anatomical regions;

[0191] mapping the monitored electrical activity onto multiple anatomical regions of the model heart; and

[0192] determining an indication of scarring risk based on monitored electrical activity mapped over multiple anatomical regions;

[0193] A display, wherein the display includes a graphical user interface configured to assist a user in assessing a patient's cardiac health, wherein the computing device is further configured to display on the display:

[0194] Model heart;

[0195] mapped electrical activity; and

[0196] Indications of the determined scar risk are marked on a model heart.

[0197] Embodiment 23: The system according to embodiment 22, wherein the computing device is further configured to:

[0198] comparing monitored electrical activity mapped to adjacent anatomical regions of the plurality of anatomical regions; and

[0199] Based on the compared monitored electrical activities, conduction conditions between the compared adjacent anatomical regions are determined.

[0200] Embodiment 24: The system of any one of embodiments 22 to 23, further comprising a display, wherein the display comprises a graphical user interface configured to assist a user in assessing a patient's cardiac health,

[0201] Wherein the computing device is further configured to display an indicator of a conduction condition on a display of the model heart, and the conduction condition includes at least one of a conduction block and a scar risk.

[0202] Embodiment 25: The system of any one of embodiments 22 to 24, wherein the computing device is further configured to map activation times onto a plurality of anatomical regions of the model heart.

Claims

1. A system for mapping electrical activity on a model heart, the system comprising: a display, wherein the display includes a graphical user interface configured to assist a user in assessing a patient's cardiac health; an electrode assembly comprising a plurality of extracorporeal electrodes for monitoring electrical activity from tissue of a patient; as well as a computing device including processing circuitry and coupled to the electrode device and the display, the computing device being configured to: monitoring electrical activity from the patient using the plurality of external electrodes; providing a model heart representing a heart of the patient based on at least one patient characteristic of a plurality of patient characteristics, wherein the model heart includes a plurality of segments and is divided into a plurality of anatomical regions, wherein each of the plurality of anatomical regions includes two or more of the plurality of segments that are different from other remaining segments of the plurality of segments, wherein each anatomical region represents an area that is smaller than an entire chamber of the heart; mapping the monitored electrical activity onto the plurality of segments of the model heart; determining a value of electrical activity for each of the plurality of anatomical regions of the model heart based on the mapped electrical activity of the two or more segments corresponding to each of the plurality of anatomical regions; comparing values ​​of adjacent anatomical regions among the plurality of anatomical regions; and determining a conduction slowness or conduction block condition between the compared adjacent anatomical regions based on the compared values; displaying the model heart and the mapped electrical activity on the model heart on the graphical user interface; and A graphical element is displayed on the model heart indicating the location of the determined conduction slowing or conduction block condition.

2. The system according to claim 1, characterized in that Providing a model heart representing the patient's heart based on at least one patient characteristic of a plurality of patient characteristics comprises: Providing multiple model hearts; and The model heart representing the patient's heart is selected from the plurality of model hearts using the at least one patient characteristic of a plurality of patient characteristics.

3. The system according to claim 1, characterized in that Providing a model heart representing the patient's heart based on at least one patient characteristic of a plurality of patient characteristics comprises generating the model heart based on the at least one patient characteristic of the plurality of patient characteristics.

4. The system according to any one of claims 1 to 3, characterized in that: The plurality of extracorporeal electrodes include body surface electrodes positioned in an array and configured to be located proximate to the skin of the patient's torso.

5. The system according to any one of claims 1 to 3, characterized in that: The plurality of patient characteristics include age, sex, height, chest circumference, heart chamber size, ventricular ejection fraction, type of cardiomyopathy, and duration of a QRS complex on a 12-lead ECG.

6. The system according to any one of claims 1 to 3, characterized in that: The monitored electrical activity includes a plurality of trunk surface potential signals, wherein mapping the monitored electrical activity onto the plurality of segments of the model heart includes: Projecting the position of the trunk surface potential signal monitored onto a corresponding position on the model trunk; Based on the geometric relationship between the model heart and the model torso, projecting the torso surface potential signal onto a position on the model heart; and A value for each of the plurality of segments of the model heart is generated based on one or more of the plurality of torso surface potential signals corresponding to each of the plurality of segments of the model heart.

7. The system according to any one of claims 1 to 3, characterized in that: Mapping the monitored electrical activity onto the multiple anatomical regions of the model heart further includes calculating a measure of electrical activity based on a trunk surface potential signal projected at each location within a corresponding anatomical region of a segment of the model heart.

8. The system according to any one of claims 1 to 3, characterized in that: Mapping the monitored electrical activity onto the multiple segments of the model heart includes mapping peak-to-peak voltage values ​​onto the multiple segments of the model heart.

9. The system according to claim 8, characterized in that Determining the electrical activity value of each of the plurality of anatomical regions of the model heart comprises: determining an indication of scar risk based on the peak-to-peak voltage values ​​determined for each of the plurality of anatomical regions of the model heart; and An indication of the determined scar risk is identified on the model heart.

10. The system according to any one of claims 1 to 3, characterized in that: Determining the electrical activity value for each of the plurality of anatomical regions of the model heart includes determining an activation time for each of the plurality of anatomical regions of the model heart.

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