Systems and methods for optimizing implantable medical device characteristics using data structures and graphical representations

Abstract

In some instances, a computing device can determine information corresponding to a data structure and indicating delays associated with atrial leads, left ventricular (LV) leads, and right ventricular (RV) leads, based on one or more input variables. The computing device can determine multiple personalized characteristics based on the information corresponding to the data structure. The computing device can receive multiple second sets of electrical measurements from multiple measuring electrodes, based on the multiple personalized characteristics, indicating a second electrical signal applied to the patient's heart. The computing device can use a first set of electrical measurements (e.g., raw measurements) and the multiple second sets of electrical measurements to determine a cardiac resynchronization index (CRI) value. The computing device can generate a graphical representation based on the populated data structure and display the graphical representation.

Description

Technical Field

[0001] Embodiments of this disclosure generally relate to systems and methods for improving and / or optimizing the performance of implantable medical devices. For example, some embodiments of this disclosure relate to systems and methods for determining parameters of an implantable medical device and applying cardiac resynchronization therapy using said parameters. Background Technology

[0002] Heart failure can occur when the primary signal (e.g., a signal instructing the heart muscle to beat or contract) fails to propagate properly around a patient's heart. For example, blocks such as right bundle branch block (RBBB) or left bundle branch block (LBBB) can cause the primary signal to be delayed and / or blocked as it travels through the heart. This can lead to asynchronous heartbeats (e.g., electrical asynchrony). For instance, in an LBBB event, the left ventricle may receive the primary signal later than the right ventricle, potentially causing the left ventricular muscle to beat after the right ventricular muscle.

[0003] Implantable medical devices (IMDs), such as pacemakers, can be used to correct electrical asynchrony in a patient's heart. For example, a pacemaker can contain multiple different leads, such as a left ventricular lead, a right ventricular lead, and / or a right atrial lead. These leads can contain one or more electrodes that provide electrical signals to cause different parts of the heart to beat. By using these leads, the pacemaker can mimic the original signals to correct electrical asynchrony.

[0004] However, each patient's electrical asynchrony may be different. Traditionally, due to the difficulty in measuring a patient's electrical asynchrony, IMDs are implanted with baseline or standard device settings (e.g., cardiac resynchronization therapy (CRT) settings). In some cases, these baseline settings may not be optimal for the patient and may not significantly improve the patient's cardiac electrical asynchrony.

[0005] For example, CRT works by improving both electrical and mechanical asynchrony. Extensive studies in animals and humans with LBBB have shown that this improvement in electrical asynchrony results from the fusion of the forward and rightward-shifted wavefronts of left ventricular pacing (LV pacing) with those of right ventricular pacing (RV pacing) and / or the original backward and leftward-shifted wavefronts. This fusion can be identified by changes in QRS duration, amplitude, and morphology caused by disruptive interference from opposing wavefronts canceling each other out. Variations in atrial-ventricular (AV) delay, ventricular-ventricular (VV) delay, and pacing patterns (biventricular (BiV) vs. left ventricular only (LV)) affect the contribution of different wavefronts to fusion and elimination. Although 12-lead ECGs have been used to detect wavefront fusion and elimination and to assist in programming CRT settings, no method for determining personalized CRT settings has been accepted and widely used in routine clinical care. In fact, the vast majority of CRT patients do not even undergo optimization procedures but remain with the device settings programmed at implantation. Therefore, one or more improved methods and / or systems are needed to address one or more of the aforementioned deficiencies. Summary of the Invention

[0006] The exemplary systems, methods, and interfaces described herein can be configured to assist users (e.g., physicians) in assessing patients and / or evaluating cardiac therapies (e.g., administering cardiac therapy to patients during and / or after implantation of a cardiac therapy device). In one or more embodiments, the systems, methods, and interfaces can be used to determine novel ways of measuring wavefront fusion and elimination, referred to as the Cardiac Resynchronization Index (CRI). CRI values ​​indicate wavefront fusion and elimination by measuring a single variable using measuring electrodes, reflecting changes in morphology, width, and dominant wavefront direction compared to the original conduction at any IMD characteristic / setting. Comparison of electrogram morphology and CRI under different device settings allows assessment of the relative contributions of the original, RV, and LV wavefronts to electrical fusion during CRT. By using this, the systems and methods can provide non-invasive, practical, and physiological pathways that can be used for personalized (e.g., for a specific patient) and optimized CRT device programming.

[0007] In Example 1, a system for cardiac resynchronization of a patient is provided. The system includes one or more processors communicating with a plurality of measuring electrodes operatively coupled to the patient, and a tangible, non-transitory storage medium. The tangible, non-transitory storage medium includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive from the plurality of measuring electrodes a first set of electrical measurement results indicative of a first electrical signal applied to the patient's heart; receive one or more input variables; determine, based on the one or more input variables, information corresponding to a data structure and indicative of delays associated with atrial leads, left ventricular (LV) leads, and right ventricular (RV) leads; determine a plurality of personalized characteristics based on the information corresponding to the data structure; receive, based on the plurality of personalized characteristics, a plurality of second sets of electrical measurement results indicative of a second electrical signal applied to the patient's heart from the plurality of measuring electrodes; determine a cardiac resynchronization index (CRI) value using the first set of electrical measurement results and the plurality of second sets of electrical measurement results; populate the data structure based on the CRI value and the information indicative of the delays; generate a graphical representation based on the populated data structure; and display the graphical representation corresponding to the populated data structure on a display device.

[0008] In Example 2, according to the system described in Example 1, information corresponding to the data structure indicates multiple entries, wherein each of the multiple entries is associated with a first delay characteristic of the right atrial (RA) lead of the IMD to the left ventricular (LV) lead of the IMD and a second delay characteristic of the RA lead of the IMD to the right ventricular (RV) lead of the IMD.

[0009] In Example 3, according to the system described in Example 2, a first subset of the plurality of entries is associated with a plurality of LV-only lead delay characteristics, and a second subset of the plurality of entries is associated with a plurality of biventricular (BiV) lead characteristics that do not have ventricular-ventricular (VV) delay characteristics.

[0010] In Example 4, according to the system described in Example 2, a first subset of the plurality of entries is associated with a first priority, and the determination of the plurality of personalization features includes filtering the plurality of entries based on the first priority.

[0011] In Example 5, according to the system described in Example 4, a second subset of the plurality of entries is associated with a second priority, and the determination of the plurality of personalization features further includes: receiving user input indicating the second priority; and including the second subset of the plurality of entries corresponding to the second priority into the plurality of personalization features.

[0012] In Example 6, according to the system described in Example 4, wherein determining the plurality of personalization features further includes: receiving user input indicating one or more entries from the plurality of entries; and including the one or more entries from the plurality of entries into the plurality of personalization features.

[0013] In Example 7, according to the system described in Example 2, generating a graphical representation based on a filled data structure includes generating a heatmap based on a determined CRI value, the first delay characteristic, and the second delay characteristic.

[0014] In Example 8, according to the system described in Example 7, wherein displaying the graphical representation includes displaying the heatmap and one or more visual markers, wherein the one or more visual markers indicate at least one optimal cardiac resynchronization therapy (CRT) treatment corresponding to a personalized characteristic from multiple personalized characteristics.

[0015] In Example 9, according to the system described in Example 1, wherein one or more input variables indicate a patient category corresponding to the patient's cardiac condition, and wherein the information determining the data structure corresponding to the delay is based on the patient category.

[0016] In Example 10, according to the system described in Example 1, wherein one or more input variables indicate the device type of the IMD, and wherein the information for determining the data structure corresponding to the delay is based on the device type of the IMD.

[0017] In Example 11, according to the system of Example 1, the tangible non-transitory storage medium further includes instructions that, when executed by the one or more processors, cause the one or more processors to: determine new information corresponding to the data structure and indicating the delay, wherein the new information indicates operating the IMD in a different mode; receive from the plurality of measuring electrodes and based on the new information indicating operating the IMD in the different mode, a plurality of third sets of electrical measurement results indicating a third electrical signal applied to the patient's heart; determine a new CRI value using the first set of electrical measurement results and the plurality of third sets of electrical measurement results; populate the data structure based on the new CRI value and the new information; generate a new graphical representation based on the populated data structure; and display the new graphical representation on the display device.

[0018] In Example 12, according to the system described in Example 11, new information indicates a new delay corresponding to the atrial lead, the LV lead, and the RV lead.

[0019] In Example 13, according to the system described in Example 11, the new information indicating that the IMD is operated in the different modes includes switching the IMD from atrial sensing mode to atrial pacing mode.

[0020] In Example 14, according to the system described in Example 11, the new information indicating that the IMD is operated in the different modes includes switching the IMD from atrial pacing mode to atrial sensing mode.

[0021] In Example 15, according to the system described in Example 11, the new information indicating the operation of the IMD in the different modes includes switching the IMD from a first electrode vector corresponding to a first electrode of the left ventricle (LV) lead to a second electrode vector corresponding to a second electrode of the LV lead.

[0022] In Example 16, according to the system of Example 11, the tangible non-transitory storage medium further includes instructions that, when executed by the one or more processors, cause the one or more processors to: determine the CRI value and that the new CRI value is below a threshold; and, based on the CRI value and the fact that the new CRI value is below the threshold, cause a prompt indicating that the LV lead is in a suboptimal position to be displayed.

[0023] In Example 17, a method for cardiac resynchronization in a patient is provided. The method includes: receiving from a plurality of measuring electrodes a first set of electrical measurement results indicating a first electrical signal applied to the patient's heart; receiving one or more input variables; determining, based on the one or more input variables, information corresponding to a data structure and indicating a delay associated with an atrial lead, a left ventricular (LV) lead, and a right ventricular (RV) lead; determining, based on the information corresponding to the data structure, a plurality of personalized characteristics; receiving, based on the plurality of personalized characteristics, from the plurality of measuring electrodes a plurality of second sets of electrical measurement results indicating a second electrical signal applied to the patient's heart; determining a cardiac resynchronization index (CRI) value using the first set of electrical measurement results and the plurality of second sets of electrical measurement results; populating the data structure based on the CRI value and the information indicating the delay; generating a graphical representation based on the populated data structure; and displaying the graphical representation corresponding to the populated data structure on a display device.

[0024] In Example 18, according to the method of Example 17, the information corresponding to the data structure indicates a plurality of entries, wherein each of the plurality of entries is associated with a first delay characteristic of the right atrial (RA) lead of the IMD to the left ventricular (LV) lead of the IMD and a second delay characteristic of the RA lead of the IMD to the right ventricular (RV) lead of the IMD.

[0025] In Example 19, a non-transitory computer-readable medium is provided. The non-transitory computer-readable medium stores instructions executable by one or more processors incorporated into a system, wherein executing the instructions by the one or more processors causes the one or more processors to: receive from a plurality of measuring electrodes a first set of electrical measurement results indicating a first electrical signal applied to the patient's heart; receive one or more input variables; determine, based on the one or more input variables, information corresponding to a data structure and indicating a delay associated with an atrial lead, a left ventricular (LV) lead, and a right ventricular (RV) lead; determine, based on the information corresponding to the data structure, a plurality of personalized characteristics; receive, based on the plurality of personalized characteristics, from the plurality of measuring electrodes a plurality of second sets of electrical measurement results indicating a second electrical signal applied to the patient's heart; determine a cardiac resynchronization index (CRI) value using the first set of electrical measurement results and the plurality of second sets of electrical measurement results; populate the data structure based on the CRI value and the information indicating the delay; generate a graphical representation based on the populated data structure; and display the graphical representation corresponding to the populated data structure on a display device.

[0026] In Example 20, according to the non-transitory computer-readable medium of Example 19, the information corresponding to the data structure indicates a plurality of entries, each of which is associated with a first delay characteristic of the right atrial (RA) lead of the IMD to the left ventricular (LV) lead of the IMD and a second delay characteristic of the RA lead of the IMD to the right ventricular (RV) lead of the IMD.

[0027] The exemplary systems, methods, and interfaces described herein can be configured to assist users (e.g., physicians) in assessing patients and / or evaluating cardiac therapies (e.g., administering cardiac therapy to patients during and / or after implantation of a cardiac therapy device). In one or more embodiments, the systems, methods, and interfaces can be used to determine novel ways of measuring wavefront fusion and elimination, referred to as the Cardiac Resynchronization Index (CRI). CRI values ​​indicate wavefront fusion and elimination by measuring a single variable using measuring electrodes, reflecting changes in morphology, width, and dominant wavefront direction compared to the original conduction at any IMD characteristic / setting. Comparison of electrogram morphology and CRI under different device settings allows assessment of the relative contributions of the original, RV, and LV wavefronts to electrical fusion during CRT. By using this, the systems and methods can provide non-invasive, practical, and physiological pathways that can be used for personalized (e.g., for a specific patient) and optimized CRT device programming.

[0028] In Example 21, a system for cardiac resynchronization of a patient is provided. The system includes one or more processors communicating with a plurality of measuring electrodes operatively coupled to the patient, and a tangible, non-transitory storage medium. The tangible, non-transitory storage medium includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive from the plurality of measuring electrodes a first set of electrical measurements indicating raw electrical energy applied to the patient's heart; receive from the plurality of measuring electrodes a plurality of second sets of electrical measurements indicating the raw electrical energy applied to the patient's heart and electrical energy applied to the patient's heart by at least one lead, each of the plurality of second sets of electrical measurements corresponding to a different characteristic; determine a first electrical asynchrony value based on the first set of electrical measurements; determine a plurality of second electrical asynchrony values ​​based on the plurality of second sets of electrical measurements; determine a plurality of cardiac resynchronization index values ​​based on a comparison of the first set of electrical measurements with the plurality of second sets of electrical measurements; and provide information on administering cardiac resynchronization therapy (CRT) based on the plurality of cardiac resynchronization index values.

[0029] In Example 22, according to the system of Example 21, the system further includes a display device, and wherein the provision of information includes providing one or more instructions to display at least one of the plurality of cardiac resynchronization index values ​​on the display device.

[0030] In Example 23, according to the system of Example 21, wherein the at least one lead includes a left lead operatively coupled to the left side of the patient’s heart, and wherein receiving the first set of electrical measurements includes receiving the first set of electrical measurements indicative of the electrical characteristics of the patient’s heart without the left lead supplying electrical power to the patient’s heart.

[0031] In Example 24, according to the system of Example 23, receiving the plurality of second sets of electrical measurements includes receiving the plurality of second sets of electrical measurements indicative of the electrical characteristics of the patient's heart while the left lead provides electrical energy to the patient's heart.

[0032] In Example 25, according to the system of Example 21, wherein the at least one lead includes a left lead operatively coupled to a left portion of the patient's heart and a right lead operatively coupled to a right portion of the patient's heart, and wherein receiving the plurality of second sets of electrical measurements includes receiving the plurality of second sets of electrical measurements indicative of the electrical characteristics of the patient's heart while the left lead and the right lead provide electrical energy to the patient's heart.

[0033] In Example 26, according to the system of Example 21, the tangible non-transitory storage medium further includes instructions that, when executed by the one or more processors, cause the one or more processors to: determine, based on the first set of electrical measurement results, a plurality of characteristics applied to the at least one lead based on the first set of electrical measurement results, wherein the plurality of characteristics includes each of the different characteristics, and wherein receiving the plurality of second sets of electrical measurement results is based on the plurality of characteristics.

[0034] In Example 27, according to the system of Example 26, the at least one lead includes a left lead operatively coupled to a left portion of the patient's heart and a right lead operatively coupled to a right portion of the patient's heart, and the plurality of features include a plurality of atrial-ventricular (AV) delays.

[0035] In Example 28, in the system according to Example 27, the plurality of AV delays correspond to the plurality of left ventricular (LV) delays in which the left lead applies the electrical energy to the patient's heart.

[0036] In Example 29, according to the system of Example 27, the plurality of AV delays correspond to the plurality of biventricular (BiV) delays in which the left and right leads apply the electrical energy to the patient's heart.

[0037] In Example 30, according to the system of Example 26, the at least one lead includes a left lead operatively coupled to a left portion of the patient's heart and a right lead operatively coupled to a right portion of the patient's heart, and the plurality of features include a plurality of ventricle-ventricular (VV) delays.

[0038] In Example 31, according to the system of Example 21, the plurality of measuring electrodes are fewer than 40 electrodes.

[0039] In Example 32, according to the system of Example 31, the plurality of measuring electrodes are fewer than 20 electrodes.

[0040] In Example 33, according to the system of Example 31, the plurality of measuring electrodes includes a plurality of front electrodes and a plurality of rear electrodes, wherein the plurality of front electrodes are fewer than ten electrodes and the plurality of rear electrodes are fewer than ten electrodes.

[0041] In Example 34, a system for cardiac resynchronization of a patient is provided. The system includes one or more processors communicating with a plurality of measuring electrodes operatively coupled to the patient, and a tangible, non-transitory storage medium. The tangible, non-transitory storage medium includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive from the plurality of measuring electrodes a first set of electrical measurement results indicating a first electrical signal applied to the patient's heart; and, in response to one or more first instructions to provide an implantable medical device with a plurality of parameters indicating at least one lead, receive from the plurality of measuring electrodes a plurality of second sets of electrical measurement results indicating a second electrical signal applied to the patient's heart; determine a plurality of cardiac resynchronization index values ​​based on comparing the first set of electrical measurement results with the plurality of second sets of electrical measurement results; determine optimized parameters from the plurality of parameters based on the plurality of cardiac resynchronization index values; and provide the implantable medical device with one or more second instructions to administer cardiac resynchronization therapy (CRT) based on the optimized parameters.

[0042] In Example 35, according to the system of Example 34, wherein the at least one lead includes a left ventricular lead operatively coupled to the left ventricle of the patient's heart and a right ventricular lead operatively coupled to the right ventricle of the patient's heart, and wherein the tangible, non-transitory storage medium further includes instructions that, when executed by the one or more processors, cause the one or more processors to: provide the implantable medical device with one or more third instructions to prevent the implantable medical device from supplying electrical power to the left ventricular lead and the right ventricular lead, and wherein receiving the first set of electrical measurement results is based on providing the one or more third instructions.

[0043] In Example 36, according to the system described in Example 34, each of the plurality of second sets of electrical measurement results is associated with a different parameter from the plurality of parameters.

[0044] In Example 37, according to the system of Example 36, the at least one lead includes a left ventricular lead operatively coupled to the left ventricle of the patient's heart, and the plurality of parameters include a plurality of atrioventricular (AV) time delays of the left ventricular lead.

[0045] In Example 38, according to the system of Example 36, wherein the at least one lead includes a left ventricular lead operatively coupled to the left ventricle of the patient's heart and a right ventricular lead operatively coupled to the right ventricle of the patient's heart, and wherein the plurality of parameters includes a plurality of atrioventricular (AV) time delays of the left ventricular lead and the right ventricular lead.

[0046] In Example 39, according to the system of Example 36, the at least one lead includes a left ventricular lead operatively coupled to the left ventricle of the patient's heart and a right ventricular lead operatively coupled to the right ventricle of the patient's heart, and the plurality of parameters include atrioventricular time delays and plurality of ventricle-ventricular (VV) time delays of the left ventricular lead and the right ventricular lead.

[0047] In Example 40, according to the system of Example 36, determining the plurality of cardiac resynchronization index values ​​includes determining a first asynchronous measurement result of the first set of electrical measurements, determining a plurality of second asynchronous measurement results for each of the plurality of second sets of electrical measurements, and determining the plurality of cardiac resynchronization index values ​​based on comparing the first asynchronous measurement result with each of the plurality of second asynchronous measurement results.

[0048] In Example 41, according to the system of Example 40, wherein the plurality of measuring electrodes includes a plurality of front electrodes and a plurality of rear electrodes, wherein the first set of electrical measurement results includes a plurality of front measurement results from the plurality of front electrodes and a plurality of rear measurement results from the plurality of rear electrodes, and wherein determining the first asynchronous measurement result is based on comparing the plurality of front measurement results with the plurality of rear measurement results.

[0049] In Example 42, according to the system of Example 40, wherein the plurality of measuring electrodes includes a plurality of front electrodes and a plurality of rear electrodes, wherein each of the plurality of second sets of electrical measurement results includes a plurality of front measurement results from the plurality of front electrodes and a plurality of rear measurement results from the plurality of rear electrodes, and wherein determining each of the plurality of second asynchronous measurement results is based on comparing the corresponding second asynchronous measurement result with the first asynchronous measurement result.

[0050] In Example 43, according to the system of Example 34, the at least one lead includes one or more electrodes, and all of the one or more electrodes provide the second electrical signal.

[0051] In Example 44, according to the system of Example 34, the at least one lead includes one or more electrodes, and at least one of the one or more electrodes provides the second electrical signal.

[0052] In Example 45, a system for cardiac resynchronization of a patient is provided. The system includes one or more processors communicating with a plurality of measuring electrodes operatively coupled to the patient, a display device communicating with the one or more processors, and a tangible, non-transitory storage medium. The tangible, non-transitory storage medium includes instructions that, when executed by the one or more processors, cause the one or more processors to: receive a first set of electrical measurements indicative of electrical characteristics of the patient's heart from the plurality of measuring electrodes when no electrical power is supplied to the patient's heart from at least one lead of an implantable medical device; receive a plurality of second sets of electrical measurements indicative of electrical characteristics of the patient's heart from the plurality of measuring electrodes when electrical power is supplied to the patient's heart from the at least one lead, each of the plurality of second sets of electrical measurements indicating a different characteristic of the implantable medical device; determine a plurality of cardiac resynchronization index values ​​based on a comparison of the first set of electrical measurements with the plurality of second sets of electrical measurements, wherein the plurality of cardiac resynchronization index values ​​correspond to the different characteristics of the implantable medical device; and display an image on the display device indicating the plurality of cardiac resynchronization index values.

[0053] In Example 46, according to the system of Example 45, the different characteristics include a plurality of atrial-ventricular (AV) delays, the image includes a graphical representation of a plurality of cardiac resynchronization index values ​​having the plurality of AV delays, and each of the plurality of cardiac resynchronization index values ​​has a corresponding AV delay from the plurality of AV delays.

[0054] In Example 47, according to the system of Example 45, the different characteristics include multiple biventricular (BiV) delays and multiple left ventricular lead-only (LV-only) delays, wherein the image includes a graphical representation of the multiple cardiac resynchronization index values ​​having the multiple BiV delays and the multiple LV-only delays, and wherein each of the multiple cardiac resynchronization index values ​​has a corresponding BiV delay from the multiple BiV delays or a corresponding LV-only delay from the multiple LV-only delays.

[0055] In Example 48, according to the system of Example 45, the different characteristics include a plurality of ventricle-ventricular (VV) delays, the image includes a graphical representation of a plurality of cardiac resynchronization index values ​​having the plurality of VV delays, and each of the plurality of cardiac resynchronization index values ​​has a corresponding VV delay from the plurality of VV delays.

[0056] In Example 49, according to the system described in Example 45, the image includes a graphical representation of a first signal from the left lead of the implantable medical device, a second signal from the right lead of the implantable medical device, and a third signal corresponding to the original signal of the patient's heart.

[0057] In Example 50, according to the system of Example 49, wherein displaying the image on the display device includes an animated display of a first wavefront, a second wavefront, and a third wavefront propagating through a second graphic representation of the patient's heart, wherein the first wavefront corresponds to the first signal, wherein the second wavefront corresponds to the second signal, and wherein the third wavefront corresponds to the third signal.

[0058] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description of illustrative embodiments. Therefore, the drawings and detailed descriptions are to be considered illustrative rather than restrictive in nature. Attached Figure Description

[0059] When the following figures are attached, the following described embodiments will be more readily understood, and the same reference numerals denote the same elements, wherein:

[0060] Figure 1 This is a diagram of an exemplary system that includes an electrode device, an implantable medical device (IMD) optimization computing device, and an implantable medical device;

[0061] Figure 2 This is a diagram of an exemplary electrode configuration for an electrode device;

[0062] Figure 3 This is a diagram of an exemplary system that includes an exemplary IMD;

[0063] Figure 4 yes Figure 3 A diagram of an exemplary IMD;

[0064] Figure 5 It is placed in Figure 4 A magnified view of the distal end of the electrical leads in the left ventricle;

[0065] Figure 6 It is an exemplary IMD (e.g., Figure 3-5 A block diagram of the system.

[0066] Figure 7 yes Figure 3-5 Another block diagram of an exemplary IMD (e.g., implantable pulse generator) circuit system and associated leads used in the system;

[0067] Figure 8 This is a block diagram of an exemplary method for optimizing cardiac resynchronization therapy (CRT) treatment;

[0068] Figure 9 This is another block diagram of an exemplary method for optimizing cardiac resynchronization therapy (CRT) treatment;

[0069] Figure 10 This is another block diagram of an exemplary method for optimizing cardiac resynchronization therapy (CRT) treatment;

[0070] Figure 11 This is another block diagram of an exemplary method for optimizing cardiac resynchronization therapy (CRT) treatment;

[0071] Figure 12 It is an exemplary graphical user interface depicting measurement results from the measuring electrodes of the electrode device;

[0072] Figure 13 This is an example diagram of the patient's heart, the lead from the IMD, and the wavefront formed by the lead;

[0073] Figure 14 It is another exemplary graphical user interface that depicts a graphical representation of the cardiac resynchronization index (CRI) of atrial-ventricular (AV) delay;

[0074] Figure 15 This is another exemplary graphical user interface depicting an atrial-ventricular (AV) delay that includes both biventricular (BiV) delay and left ventricular (LV) delay alone;

[0075] Figure 16 This is another exemplary graphical user interface that depicts a CRI graphical representation of ventricle-ventricular (VV) delay;

[0076] Figure 17 This is another exemplary graphical user interface that depicts the CRI graphical representation of AV delay and VV delay;

[0077] Figure 18 This is another exemplary graphical user interface depicting the wavefront of the leads from the IMD propagating through the patient's heart;

[0078] Figure 19 This is another exemplary graphical user interface depicting the wavefront of leads from IMD propagating through the patient's heart for different AV delays;

[0079] Figure 20 It is another exemplary graphical user interface that depicts the measured values ​​from the measuring electrodes and the CRI value of the AV delay;

[0080] Figure 21These are example diagrams of different VV delay methods;

[0081] Figure 22 This is another exemplary graphical user interface depicting another exemplary electrode configuration of the electrode device and the corresponding measurement results from the electrode device;

[0082] Figure 23A -E shows a depiction of electrophysiological and CRI graphical representations of multiple patients with complete cardiac conduction block (CHD) within the VV delay range;

[0083] Figure 24A -E shows a depiction of electrograms and CRI graphical representations of multiple patients during LV pacing only within the AV delay range;

[0084] Figure 25A -D shows a depiction of the electrophysiological and CRI graphical representations of a single patient within the AV and VV delay ranges;

[0085] Figure 26A -D shows a depiction of the electrophysiological and CRI graphical representations of a single patient within the AV and VV delay ranges;

[0086] Figure 27A -D shows a depiction of the electrophysiological and CRI graphical representations of a single patient within the AV and VV delay ranges;

[0087] Figure 28 This is another block diagram of an exemplary method for optimizing cardiac resynchronization therapy (CRT) treatment;

[0088] Figure 29 This is another exemplary graphical user interface depicting the data structure used to determine the optimal CRT treatment;

[0089] Figure 30 This is another exemplary graphical user interface depicting another data structure used to determine the optimal CRT treatment;

[0090] Figure 31 This is another exemplary graphical user interface that depicts a graphical representation of the data structure used to determine the optimal CRT treatment;

[0091] Figure 32 This is another exemplary graphical user interface that depicts a graphical representation of the data structure used to determine the optimal CRT treatment;

[0092] Figure 33 This is another exemplary graphical user interface depicting a graphical representation of the data structure used to determine optimal CRT treatment; and

[0093] Figure 34This is another exemplary graphical user interface that depicts a different graphical representation of the data structure used to determine the optimal CRT treatment.

[0094] While the invention may take various modifications and alternatives, specific embodiments have been illustrated by way of example in the accompanying drawings and are described in detail below. However, the invention is not intended to be limited to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. Detailed Implementation

[0095] Figure 1 An example of an implantable medical device (IMD) optimization system 100 for cardiac resynchronization and / or optimization of IMD characteristics is shown. In some cases, system 100 includes electrode device 110, IMD optimization computing device 140, and IMD 16. Electrode device 110 may include one or more measuring electrodes 112 and / or 114. Measuring electrodes 112, 114, and / or electrode device 110 may be any device, apparatus, or component that detects electrical information of the patient, such as cardiac electrical activation signals and / or electrocardiogram (ECG) signals. In some cases, electrode device 100 may be an ECG sensor that detects, measures, and / or estimates cardiac electrical activation signals near a reference location. Such electrical activation signals may be measured and displayed, or transmitted to a computing device, such as computing device 140. For example, electrode device 110 can acquire ECG signals from measuring electrodes 112, 114 and generate measurements of electrical activation signals (e.g., depolarization and / or repolarization of the patient's heart) measured from various ECG locations (e.g., the locations of measuring electrodes 112, 114). By using electrode device 100, a user (e.g., a physician) can assess a patient's cardiac condition and / or administer cardiac resynchronization therapy to the patient.

[0096] In some cases, electrode device 110 (e.g., via a wired or wireless connection) is operatively coupled to computing device 140 and / or provides information such as electrical signals (e.g., body surface potentials) from each of the measuring electrodes 112, 114 to computing device 140 for analysis, evaluation, etc.

[0097] The IMD 16 is any type of implantable device used to assist in the treatment of electrical asynchrony. In some cases, the IMD 16 is a pacemaker containing one or more leads. Each lead may contain one or more electrodes that deliver pacing therapy (e.g., pacing pulses) to the patient. For example, the electrodes may be operatively coupled to the patient's heart and may deliver pacing pulses to assist in the depolarization and / or repolarization of the heart. In some cases, the IMD 16 (e.g., via a wired or wired electrical connection, wirelessly, etc.) is operatively coupled to a computing device 140. The computing device 140 may provide instructions, commands, and / or other types of information to the IMD 16. Additionally and / or alternatively, the IMD 16 may provide feedback information to the computing device 140. The IMD 16 will be described in more detail below.

[0098] The IMD-optimized computing device 140 is any type of computing device suitable for implementing various aspects of the embodiments of the disclosed subject matter. Examples of the computing device 140 include, but are not limited to, workstations, laptop computers, desktop computers, tablet computers, handheld devices, display devices, servers, cloud computing platforms, etc., and all devices in these devices are contemplated in... Figure 1 Within the range.

[0099] In some embodiments, computing device 140 includes one or more processors 150 that execute instructions 154 (e.g., code) stored in memory 152 (e.g., a non-transitory storage medium). Computing device 140 may also include other components such as one or more buses that interact with one or more components within computing device 140, one or more communication ports (wired and / or wireless), display device 130, display 132, and / or input device 142.

[0100] The processor 150 can be configured to analyze data such as electrical information from the electrode device 110, cardiac information representing at least one of mechanical cardiac function and / or electrical cardiac function. The cardiac information may include electrical heterogeneity information or electrical asynchrony information, surface cardiac activation information, alternative cardiac electrical activation information, or data, which is generated using electrical signals (e.g., surface potentials) aggregated, monitored, or collected by the electrode device 110.

[0101] The computing device 140 can be configured to receive input from the input device 142 and transmit output to the display device 130. For example, based on analyzed data, the processor 150 can provide information to the display device 130. The display device 130 may include a display 132, which can be configured to display data to a user and / or patient.

[0102] Furthermore, the computing device 140 may include a data storage device (e.g., memory 152) that may allow access to processing programs or routines and / or one or more other types of data, such as a graphical user interface configured to non-invasively assist a user in evaluating, selecting, and / or determining cardiac therapy settings (e.g., the location of implantable electrodes for pacing, the location of pacing therapy provided by a specific pacing vector, the type of pacing therapy such as biventricular pacing and left ventricular pacing only, and various timings, pulse widths, and / or voltages of pacing therapies such as atrial-ventricular (AV) delay and ventricular-ventricular (VV) delay).

[0103] Computing device 140 may include input device 142 and / or display device 130. In other words, processor 150 can transmit and / or receive data from input device 142 and / or display device 130. In some instances, computing device 140 may be separate from input device 142 and / or display device 130. In other words, computing device 140 can be electrically coupled to input device 142 and / or display device 130 via one or more analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, Internet-based connections, etc. As further described herein, a user can provide input to input device 142 to manipulate or modify one or more graphical depictions displayed on display device 130, and to view and / or select one or more pieces of information related to cardiac therapy.

[0104] In some variations, input device 142 is a keyboard. However, it should be understood that input device 142 can be any device capable of providing input to computing device 140 to perform the functions, methods, and / or logic described herein. For example, input device 142 can include a mouse, trackball, touchscreen (e.g., capacitive touchscreen, resistive touchscreen, multi-touch touchscreen, etc.), etc. Similarly, display device 130 and / or display 132 can include any device capable of displaying information to a user, including a graphical user interface. The information displayed by display device 130 can include cardiac information, text commands, graphical depictions of electroactivation information, graphical depictions of multiple signals including anterior and posterior electrode signals, graphical depictions of human cardiac anatomy, images or graphical depictions of a patient's heart, graphical depictions of the location of one or more electrodes, graphical depictions of the human torso, images or graphical depictions of a patient's torso, graphical depictions or actual images of implanted electrodes and / or leads, etc. Further, display device 130 can include a liquid crystal display, an organic light-emitting diode screen, a touchscreen, a cathode ray tube display, etc.

[0105] The processing programs or routines stored and / or executed by computing device 140 may include programs or routines for computational mathematics, matrix mathematics, deviation determination (e.g., standard deviation, distance, area under the curve, variance, range, interquartile range, mean absolute difference, mean absolute deviation, etc.), filtering algorithms, maximum value determination, minimum value determination, threshold determination, moving window algorithms, decomposition algorithms, compression algorithms (e.g., data compression algorithms), calibration algorithms, image construction algorithms, signal processing algorithms (e.g., various filtering algorithms, Fourier transform, fast Fourier transform, etc.), normalization algorithms, comparison algorithms, vector mathematics, or any other processing required to implement one or more 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 (e.g., pre- and post-electrode signals over multiple cardiac cycles, within a single cardiac cycle, or over different time slices), locations or portions of various signals, electrical activation times from the electrode device 110, graphics (e.g., graphic elements, icons, buttons, windows, dialog boxes, drop-down menus, graphic areas, graphic regions, 3D graphics, etc.), graphical user interfaces, results of one or more processing procedures or routines adopted according to this disclosure (e.g., electrical signals, cardiac information, etc.), or any other data necessary to perform one or more of the processes or methods described herein.

[0106] In one or more embodiments, exemplary systems, methods, and interfaces may be implemented using one or more computer programs that execute on a programmable computer (e.g., a computer including, for example, processing power, data storage (e.g., volatile or non-volatile memory and / or storage elements), input means, and output means). The program code and / or logic described herein may be applied to input data to perform the functions described herein and produce desired output information. The output information may be applied as input to one or more other means and / or methods described herein or to be applied in a known manner.

[0107] Any programmable language can be used to provide one or more programs for implementing the systems, methods, and / or interfaces described herein, such as high-level programs and / or object-oriented programming languages ​​suitable for communicating with computer systems. For example, any such program can be stored on any suitable means, such as a storage medium, that can be read by a general-purpose or special-purpose program running on a computer system (e.g., containing a processing device) for configuring and operating the computer system, when read by a suitable means to execute the program described herein. In other words, at least in one embodiment, exemplary systems, methods, and / or interfaces can be implemented using a computer-readable storage medium configured with computer programs, wherein such a storage medium causes a computer to operate in a specific and predefined manner to perform the functions described herein. Further, in at least one embodiment, exemplary systems, methods, and / or interfaces can be described as being implemented by logic (e.g., object code) encoded in one or more non-transitory media, the logic containing code for execution and, when executed by a processor, operable to perform operations such as the methods, processes, and / or functions described herein.

[0108] In some cases, computing device 140 can be, for example, any fixed or mobile computer system (e.g., controller, microcontroller, personal computer, microcomputer, tablet computer, etc.) and can generally be described as containing a system of processing circuitry. The exact configuration of computing device 140 is not limiting, and substantially any device capable of providing suitable computing and control capabilities (e.g., graphics processing, etc.) can be used. As described herein, digital files can be any medium containing digital bits (e.g., encoded in binary, ternary, etc.) that can be read and / or written by the computing device 140 described herein (e.g., volatile or non-volatile memory, CD-ROM, punched cards, magnetically recordable media such as disks or magnetic tapes, etc.). Furthermore, as described herein, user-readable format files can be any representation of data (e.g., ASCII text, binary numbers, hexadecimal numbers, decimal numbers, graphics, etc.) that can be presented on any medium that can be read and / or understood by a user (e.g., paper, monitor, etc.).

[0109] In view of the foregoing, it will be readily understood that the functionality described in one or more embodiments of this disclosure may be implemented in any manner known to those skilled in the art. Therefore, computer languages, computer systems, or any other software / hardware used to implement the processes described herein should not limit the scope of the systems, processes, or programs described herein (e.g., the functionality provided by such systems, processes, or programs).

[0110] As described above, electrode device 110 can monitor the electrical signal activity of a patient's heart and may include multiple measuring electrodes 112 and 114. For example, electrode device 110 may be configured to measure electrical information (e.g., electrical signals) representing different regions of a patient's heart and provide the electrical information to computing device 140.

[0111] In some instances, the electrical information may include surface electrocardiogram (ECG) signals measured using measuring electrodes 112 and 114 near a surface region corresponding to the patient and / or the patient's heart. Figure 2 An exemplary electrode configuration of measuring electrodes 112 and 114 of electrode device 100 is shown. As illustrated, electrode device 110 includes two sets of electrodes, such as a first set of electrodes or front electrodes 112 (e.g., electrodes located in front of or in front of patient 14) and a second set of electrodes or rear electrodes 114 (e.g., electrodes located behind or behind patient 14).

[0112] Electrodes 112 and 114 may be attached to or coupled to one or more leads. The leads may be attached to or coupled to electrode device 100. As shown, electrodes 112 and 114 are positioned close to the torso of patient 14, such that electrodes 112 and 114 surround the patient's heart. Electrodes 112 and 114 may be positioned close to the patient's tissue (e.g., skin) to receive electrical signals or activity (e.g., body surface potential). In other words, electrodes 112 and 114 may be positioned near or operatively in contact with the patient's tissue to be able to sense electrical signals or activity (e.g., body surface potential). Further, electrodes 112 and 114 may be described as being "on" and / or fixed to the patient's skin. Further still, conductive adhesives, such as conductive adhesive layers, may be used to attach electrodes 112 and 114 to the patient's tissue. Moreover, the conductive adhesive and / or conductive adhesive layer may contain a conductive gel.

[0113] In some instances, electrode device 110 may include interface / amplifier circuitry 116. Interface / amplifier circuitry 116 may be configured to amplify signals from electrodes 112 and 114. Electrodes 112 and 114 may be electrically connected to interface / amplifier circuitry 116. Interface / amplifier circuitry 116 may be electrically connected and wired to provide signals from electrodes 112 and 114 to computing device 140. Other exemplary systems may use wireless connections to transmit signals sensed by electrodes 112 and 114 to interface / amplifier circuitry 116, and subsequently to computing device 140. Additionally and / or alternatively, interface / amplifier circuitry 116 may be electrically coupled to each of computing device 140 and display device 130 using analog electrical connections, digital electrical connections, wireless connections, bus-based connections, network-based connections, internet-based connections, etc. In some cases, computing device 140 may include interface / amplifier circuitry 116. In some variations, system 100 may not include interface / amplifier circuitry 116. For example, measuring electrodes 112 and 114 can provide signals to processor 150 without amplifying the signals.

[0114] Electrodes 112 and 114 can be configured around the heart of patient 14. Further, electrodes 112 and 114 can record or monitor electrical signals associated with cardiac depolarization and repolarization after a signal has propagated through the torso of patient 14. Each of electrodes 112 and 114 can be used in a unipolar configuration to sense torso surface potentials reflecting cardiac signals. Interface / amplifier circuitry 116 can also be coupled to a return electrode or an unrelated electrode (not shown) that can be used in combination with each of electrodes 112 and / or 114 for unipolar sensing. Figure 2 In an exemplary embodiment, there are nine front electrodes 112 and nine rear electrodes 114. However, in other instances, the electrode device 110 may contain more or fewer than 18 total electrodes 112 and 114. For example, the electrode device 110 may contain between eight and about 100 electrodes 112 and 114 spatially distributed around the patient's torso.

[0115] Additionally and / or alternatively, in some cases, the electrode device 110 includes strips, bands, and / or various mechanisms such as tape or adhesive that can be used to help space and position the electrodes 112 and 114. In some instances, the strips may comprise elastic bands, tape strips, or cloth. Further, in some instances, the electrodes 112 and 114 (e.g., arranged in an array) may be part of or located therein as a patch, vest, and / or other means of securing the electrodes 112 and 114 to or within the torso of the patient 14.

[0116] The computing device 140 can record and analyze electrical information (e.g., trunk-surface potential signals) sensed by electrodes 112, 114 and / or amplified / modulated by the interface / amplifier circuitry system 116. The computing device 140 can be configured to analyze signals from electrodes 112 and 114 to determine anterior and posterior electrode signals (e.g., signals from electrodes 112 and / or 114), surface cardiac electrical activation time, and alternative cardiac electrical activation times, such as those representing the actual or local electrical activation time of one or more regions of the patient's heart as will be further described herein.

[0117] In some instances, the computing device 140 can determine the activation time by measuring the time interval between the onset of cardiac depolarization (e.g., the onset of a QRS complex) and an appropriate reference point such as a peak, minimum, minimum slope, maximum slope, zero crossover, or threshold crossover. In one or more embodiments, the activation time can typically be determined by measuring the earliest start time within the electrical activity of multiple external electrodes within the cardiac cycle (e.g., the depolarization portion of the cardiac cycle, the QRS complex, etc.) to the steepest or maximum negative slope within the electrical activity monitored by the specific external electrode used to calculate the activation time.

[0118] Additionally, the computing device 140 may be configured to provide a graphical user interface depicting the surface cardiac electrical activation time and / or alternative cardiac electrical activation time obtained using the electrode device 110. Exemplary systems, methods, and / or interfaces can be used non-invasively to assess a patient's cardiac condition and / or cardiac therapies being delivered to the patient using electrical information collected by using the electrode device 110.

[0119] Electrode device 110 and / or computing device 140 may be electrically connected (e.g., wirelessly and / or wired) to IMD 16 and / or one or more leads of IMD 16. One or more leads of IMD 16 may be positioned near one or more portions of the patient's heart. For example, computing device 140 may provide information such as instructions or commands to IMD 16. This information may indicate settings or characteristics of one or more IMD 16 (e.g., ventricle-ventricular (VV) delay and / or atrial-ventricular (AV) delay). Additionally and / or alternatively, IMD 16 may provide information to computing device 140 and / or electrode device 110.

[0120] Figure 3-7 An exemplary IMD 16 of system 100 is described in more detail. Figure 3This is a conceptual diagram illustrating an exemplary therapy system 10 that can be used to deliver pacing therapy to a patient 14 and includes an implantable medical device 16 (IMD). The IMD 16 may include and / or be coupled to leads 18, 20, 22. The IMD 16 may be, for example, an implantable pacemaker, cardioverter-defibrillator, and / or defibrillator that delivers, transmits, or provides electrical signals (e.g., pacing, etc.) to the heart 12 of the patient 14 and / or senses electrical signals from the patient's heart via electrodes coupled to one or more of the leads 18, 20, 22.

[0121] Leads 18, 20, and 22 extend into the heart 12 of the patient 14 to sense the electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. Figure 3 In the example shown, the right ventricle (RV) lead 18 extends through one or more veins (not shown), the superior vena cava (not shown), and the right atrium 26, and enters the right ventricle 28. The left ventricle (LV) coronary sinus lead 20 extends through one or more veins, the vena cava, and the right atrium 26, and enters the coronary sinus 30 to reach the region adjacent to the free wall of the left ventricle 32 of the heart 12. The right atrium (RA) lead 22 extends through one or more veins and the vena cava, and enters the right atrium 26 of the heart 12.

[0122] The IMD 16 can sense electrical signals, such as those associated with depolarization and repolarization of the heart 12, via electrodes coupled to at least one of leads 18, 20, and 22. In some instances, the IMD 16 delivers pacing therapy (e.g., pacing pulses) to the heart 12 based on the electrical signals sensed within the heart 12. The IMD 16 can be operated to adjust one or more parameters associated with the pacing therapy, such as AV delay, VV delay, various other timing / delays, pulse width, amplitude, voltage, burst length, etc. Furthermore, the IMD 16 can be operated to deliver pacing therapy using various electrode configurations, which can be monopolar, bipolar, quadripolar, or further multipolar. For example, a multipolar lead system can contain several electrodes that can be used to deliver pacing therapy. Thus, a multipolar lead system can provide or supply multiple electrical vectors for pacing from it. The pacing vector may include at least one cathode and at least one anode, the at least one cathode being at least one electrode positioned on at least one lead, and the at least one anode being at least one electrode positioned on at least one lead (e.g., the same lead or different leads) and / or on the housing or casing of the IMD 16. While improvements in cardiac function as a result of pacing therapy may depend primarily on the cathode, electrical parameters such as impedance, pacing threshold voltage, current consumption, and lifespan may be more dependent on the pacing vector, which includes both a cathode and an anode. The IMD 16 may also provide defibrillation and / or cardioversion therapy via electrodes located on at least one of leads 18, 20, 22. Further, the IMD 16 may detect arrhythmias of heart 12, such as fibrillation of ventricles 28, 32, and provide defibrillation therapy to heart 12 in the form of electrical pulses. In some instances, the IMD 16 may be programmed to deliver a therapeutic process, e.g., pulses with increasing energy levels, until the fibrillation of heart 12 ceases.

[0123] Figure 4 and 5 It shows in more detail Figure 3 A conceptual diagram of the IMD 16 and leads 18, 20, 22 of the therapy system 10. Leads 18, 20, 22 can be electrically coupled to a therapy delivery module (e.g., for delivering pacing therapy), a sensing module (e.g., for sensing one or more signals from one or more electrodes), and / or any other module of the IMD 16 via connector block 34. In some instances, the proximal ends of leads 18, 20, 22 may contain electrical contacts electrically coupled to corresponding electrical contacts within connector block 34 of the IMD 16. Additionally, in some instances, leads 18, 20, 22 may be mechanically coupled to connector block 34 by means of a retaining screw, connecting pin, or other suitable mechanical coupling mechanism.

[0124] Each of leads 18, 20, and 22 includes an elongated insulated lead body capable of carrying multiple conductors (e.g., concentric coil conductors, straight conductors, etc.) separated from each other by insulation (e.g., a tubular insulating sheath). In the illustrated example, bipolar electrodes 40 and 42 are located near the distal end of lead 18. Additionally, bipolar electrodes 44, 45, 46, and 47 are located near the distal end of lead 20, and bipolar electrodes 48 and 50 are located near the distal end of lead 22.

[0125] Electrodes 40, 44, 45, 46, 47, and 48 may be in the form of ring electrodes, and electrodes 42 and 50 may be in the form of extendable spiral-tipped electrodes retractably mounted within insulated electrode heads 52, 54, and 56, respectively. Each of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be electrically coupled to a corresponding conductor (e.g., coil conductor and / or straight conductor) within the lead body of its associated leads 18, 20, and 22, and thereby coupled to a corresponding electrical contact in an electrical contact at the proximal end of leads 18, 20, and 22.

[0126] In addition, the surface area of ​​electrodes 44, 45, 46, and 47 can be approximately 5.3 mm². 2 up to approximately 5.8mm 2 Electrodes 44, 45, 46, and 47 may also be referred to as LV1, LV2, LV3, and LV4, respectively. The LV electrodes on lead 20 (i.e., left ventricular electrode 1 (LV1) 44, left ventricular electrode 2 (LV2) 45, left ventricular electrode 3 (LV3) 46, and left ventricular electrode 4 (LV4) 47, etc.) can be spaced apart at variable distances. For example, electrode 44 may be spaced from electrode 45 by, for example, approximately 21 millimeters (mm), electrodes 45 and 46 may be spaced apart by, for example, approximately 1.3 mm to approximately 1.5 mm, and electrodes 46 and 47 may be spaced apart by, for example, approximately 20 mm to approximately 21 mm.

[0127] Electrodes 40, 42, 44, 45, 46, 47, 48, and 50 can be further used to sense electrical signals (e.g., morphological waveforms within an electrogram (EGM)) accompanying depolarization and repolarization of the heart 12. The electrical signals are conducted to the IMD 16 via corresponding leads 18, 20, and 22. In some instances, the IMD 16 can also deliver pacing pulses via electrodes 40, 42, 44, 45, 46, 47, 48, and 50 to induce depolarization of the cardiac tissue of the patient's heart 12. In some instances, such as... Figure 4As shown, the IMD 16 includes one or more housing electrodes, such as housing electrode 58, which may be integrally formed with or otherwise coupled to the outer surface of the housing 60 (e.g., an hermetically sealed housing) of the IMD 16. Any of electrodes 40, 42, 44, 45, 46, 47, 48, and 50 may be combined with housing electrode 58 for unipolar sensing or pacing. It will be understood by those skilled in the art that other electrodes may also be selected to define or be used for pacing and sensing vectors. Furthermore, any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58, when not used for pacing therapy, may be used to sense electrical activity during pacing therapy.

[0128] For reference Figure 4 In further detail, the housing 60 may encapsulate a therapy delivery module, which may include a stimulation generator for generating cardiac pacing pulses and defibrillation or cardioversion shocks, and a sensing module for monitoring electrical signals of the patient's heart (e.g., the patient's heart rhythm). Leads 18, 20, and 22 may also include elongated electrodes 62, 64, and 66, respectively, which may be in the form of coils. The IMD 16 can deliver defibrillation shocks to the heart 12 via any combination of the elongated electrodes 62, 64, and 66 and the housing electrode 58. Electrodes 58, 62, 64, and 66 may also be used to deliver cardioversion pulses to the heart 12. Furthermore, electrodes 62, 64, and 66 may be made of any suitable conductive material, such as, but not limited to, platinum, platinum alloys, and / or other materials known to be suitable for use in implantable defibrillation electrodes. Since electrodes 62, 64, and 66 are not typically configured for pacing therapy, any one of electrodes 62, 64, and 66 can be used to sense electrical activity and can be used in combination with any of electrodes 40, 42, 44, 45, 46, 47, 48, 50, and 58. In at least one embodiment, the RV elongated electrode 62 can be used to sense the electrical activity of a patient's heart during pacing therapy delivery (e.g., in combination with housing electrode 58 or a defibrillator electrode-to-housing electrode vector).

[0129] Figure 3-7 The exemplary treatment system 10 configuration shown is only one example. In other examples, instead... Figure 3 The illustrated transvenous leads 18, 20, 22, or others, may be used to implant the therapy system in the epicardial leads and / or patch electrodes. Additionally, in other instances, the therapy system 10 may be implanted in / around the cardiac space (other than in the right venous space, such as when placed in the right venous space) without a transvenous lead (e.g., a leadless / wireless pacing system) or with a lead implanted (e.g., transvenous implantation or method of use) into the left venous chamber of the heart. Figure 3The illustrated transvenous lead may be used in addition to or as a substitute for the transvenous lead placed in the right venous chamber of the heart. Further, in one or more embodiments, it is not necessary to implant the IMD 16 into the patient 14. For example, the IMD 16 can be used for various cardiac therapies via a percutaneous lead extending through the skin of the patient 14 to multiple locations within or outside the heart 12. In one or more embodiments, the system 10 may utilize wireless pacing (e.g., transmitting energy to one or more intracardiac pacing components via ultrasound, inductive coupling, RF, etc.) and sense cardiac excitation using electrodes on the housing / shell and / or subcutaneous leads.

[0130] In other instances of therapeutic systems that provide electrical stimulation to the heart 12, such systems may include any suitable number of leads coupled to the IMD 16, and each lead may extend to any location within or near the heart 12. For example, other instances of the therapeutic system may include... Figure 3-7 The three transvenous leads shown are positioned. Further, other therapeutic systems may include a single lead extending from IMD 16 into the right atrium 26 or the right ventricle 28, or two leads extending into one of the corresponding right atrium 26 and right ventricle 28.

[0131] Figure 6 This is a functional block diagram of an exemplary configuration of IMD 16. As shown, IMD 16 may include a control module 81, a therapy delivery module 84 (e.g., which may include a stimulation generator), a sensing module 86, and a power supply 90.

[0132] Control module 81 may include processor 80, memory 82, and telemetry module 88. Memory 82 may contain computer-readable instructions that, when executed by processor 80, cause IMD 16 and / or control module 81 to perform various functions belonging to IMD 16 and / or control module 81 as described herein. Further, memory 82 may contain any volatile, non-volatile, magnetic, optical, and / or electrical media, such as random access memory (RAM), read-only memory (ROM), non-volatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, and / or any other digital media. An exemplary capture management module may be the left ventricular capture management (LVCM) module described in U.S. Patent No. 7,684,863, entitled "LV Threshold Measurement and Capture Management," published March 23, 2010, which is incorporated herein by reference in its entirety.

[0133] The processor 80 of the control module 81 may include any one or more of the following: a microprocessor, a controller, a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a field-programmable gate array (FPGA), and / or an equivalent discrete or integrated logic circuit system. In some instances, the processor 80 may include multiple components, such as any combination of one or more microprocessors, one or more controllers, one or more DSPs, one or more ASICs and / or one or more FPGAs, as well as other discrete or integrated logic circuit systems. The functionality of the processor 80 as described herein may be embodied in software, firmware, hardware, or any combination thereof.

[0134] The control module 81 can control the therapy delivery module 84 to deliver therapy (e.g., electrical stimulation therapy such as pacing) to the heart 12 according to one or more selected therapy programs that can be stored in the memory 82. More specifically, the control module 81 (e.g., processor 80) can control various parameters of the electrical stimulation delivered by the therapy delivery module 84, such as AV delay, VV delay, pacing pulse with amplitude, pulse width, frequency, or electrode polarity, etc., which can be specified by one or more selected therapy programs (e.g., AV and / or VV delay adjustment program, pacing therapy program, pacing recovery program, capture management program, etc.). As shown, the therapy delivery module 84 is electrically coupled to electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66, for example, via conductors of the corresponding leads 18, 20, 22 or, in the case of housing electrodes 58, via electrical conductors disposed within the housing 60 of the IMD 16. The therapy delivery module 84 can be configured to generate an electrical stimulation therapy, such as pacing therapy, using one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, and 66 and deliver the electrical stimulation therapy to the heart 12.

[0135] For example, the therapy delivery module 84 can deliver pacing stimulation (e.g., pacing pulses) via ring electrodes 40, 44, 45, 46, 47, 48 and / or helical tip electrodes 42, 50 of leads 18, 22. Further, for example, the therapy delivery module 84 can deliver defibrillation shocks to the heart 12 via at least two of electrodes 58, 62, 64, 66. In some instances, the therapy delivery module 84 can be configured to deliver pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other instances, the therapy delivery module 84 can be configured to deliver one or more of these types of stimulation in the form of other signals (such as sine waves, square waves, and / or other substantially continuous time signals).

[0136] The IMD 16 may further include a switching module 85, and the control module 81 (e.g., processor 80) may use the switching module 85 to select, for example via a data / address bus, which of the available electrodes are used for delivering therapy, such as pacing pulses for pacing therapy, or which of the available electrodes are used for sensing. The switching module 85 may include a switch array, switch matrix, multiplexer, or any other type of switching device suitable for selectively coupling the sensing module 86 and / or the therapy delivery module 84 to one or more selected electrodes. More specifically, the therapy delivery module 84 may include a plurality of pacing output circuits. Each of the plurality of pacing output circuits may, for example, be selectively coupled using the switching module 85 to one or more of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 (e.g., a pair of electrodes for delivering therapy to a bipolar or multipolar pacing vector). In other words, each electrode may be selectively coupled using the switching module 85 to one of the pacing output circuits of the therapy delivery module.

[0137] The sensing module 86 is coupled (e.g., electrically coupled) to a sensing device, which may include electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66 to monitor the electrical activity of the heart 12, such as electrocardiogram (ECG) / electrogram (EGM) signals. ECG / EGM signals can be used to measure or monitor activation time (e.g., ventricular activation time), heart rate (HR), heart rate variability (HRV), heart rate oscillation (HRT), deceleration / acceleration capacity, deceleration sequence morbidity, T wave alternation (TWA), P wave to P wave interval (also known as PP interval or AA interval), R wave to R wave interval (also known as RR interval or VV interval), P wave to QRS complex interval (also known as PR interval, AV interval or PQ interval), QRS complex morphology, ST segment (i.e., the segment connecting the QRS complex and the T wave), T wave changes, QT interval, electrical vector, etc.

[0138] The switching module 85 can also be used with the sensing module 86 to select which of the available electrodes are used or enabled to, for example, sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66). Similarly, the switching module 85 can also be used with the sensing module 86 to select which of the available electrodes are not used (e.g., disabled) to, for example, sense the electrical activity of a patient's heart (e.g., using one or more electrical vectors of the patient's heart using any combination of electrodes 40, 42, 44, 45, 46, 47, 48, 50, 58, 62, 64, 66), etc. In some instances, the control module 81 can select the electrodes acting as sensing electrodes by providing signals, for example, via a data / address bus, through the switching module within the sensing module 86.

[0139] In some instances, the sensing module 86 includes a channel comprising an amplifier having a relatively wider passband than an R-wave or P-wave amplifier. Signals from selected sensing electrodes can be supplied to a multiplexer and subsequently converted by an analog-to-digital converter into multi-bit digital signals for storage in memory 82, for example, as an electrogram (EGM). In some instances, such storage of an EGM in memory 82 can be under the control of direct memory access circuitry.

[0140] In some instances, the control module 81 can operate as an interrupt-driven device and can respond to interrupts from the pacemaker timing and control module, where the interruption may correspond to the occurrence of sensed P and R waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations can be performed by the processor 80, and any updates to values ​​or intervals controlled by the pacemaker timing and control module can occur after such interruptions. A portion of the memory 82 can be configured as a plurality of recirculation buffers capable of holding one or more series of measurement intervals that can be analyzed by, for example, the processor 80 in response to the occurrence of a pacing or sensing interruption to determine whether the patient's heart 12 is currently exhibiting atrial or ventricular tachyarrhythmias.

[0141] The telemetry module 88 of the control module 81 may contain any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as a programmer. For example, under the control of the processor 80, the telemetry module 88 may receive downlink telemetry from the programmer and send uplink telemetry to the programmer via an antenna (which may be internal and / or external). The processor 80 may, for example, provide data to be uplinked to the programmer and control signals for the telemetry circuitry within the telemetry module 88 via an address / data bus. In some instances, the telemetry module 88 may provide the received data to the processor 80 via a multiplexer.

[0142] The various components of the IMD 16 are further coupled to a power source 90, which may comprise a rechargeable or non-rechargeable battery. A non-rechargeable battery may be selected for use for several years, while a rechargeable battery may be inductively charged from an external device, for example, daily or weekly.

[0143] Figure 7 This is another embodiment of the functional block diagram of IMD 16, depicting a bipolar RA lead 22, a bipolar RV lead 18, and a bipolar LV CS lead 20 coupled to an implantable pulse generator (IPG) circuit 31 without LACS pacing / sensing electrodes. The implantable pulse generator circuit has programmable modes and parameters of the biventricular DDD / R type known in the pacing field. Furthermore, the sensor signal processing circuit 91 is indirectly coupled to the timing circuit 43 and coupled to the microcomputer circuit system 33 via a data and control bus. The IPG circuit 31 is shown in the functional block diagram, which is generally divided into the microcomputer circuit 33 and the pacing circuit 21. The pacing circuit 21 includes a digital controller / timer circuit 43, an output amplifier circuit 51, a sensing amplifier circuit 55, an RF telemetry transceiver 41, an activity sensor circuit 35, and many other circuits and components described below.

[0144] When battery 29 provides power, crystal oscillator circuit 89 provides a basic timing clock to pacing circuit 21. Power-on reset circuit 87 responds to the initial connection of the circuit with the battery to define initial operating conditions, and similarly resets the operating state of the device in response to the detection of a low battery condition. Reference mode circuit 37 generates a stable voltage reference and current for the analog circuitry within pacing circuit 21. Analog-to-digital converter (ADC) and multiplexer circuit 39 digitizes the analog signals and voltages to provide, for example, real-time telemetry of cardiac signals from sensing amplifier 55 for uplink transmission via RF transmitter and receiver circuit 41. Voltage reference and bias circuit 37, ADC and multiplexer 39, power-on reset circuit 87, and crystal oscillator circuit 89 may correspond to any of those used in exemplary implantable cardiac pacemakers.

[0145] If the IPG is programmed into a rate-response mode, signals output from one or more physiological sensors are used as rate control parameters (RCPs) to derive the physiological escape interval. For example, the escape interval is adjusted proportionally to the patient activity level generated in the patient activity sensor (PAS) circuitry 35 within the illustrated exemplary IPG circuitry 31. The patient activity sensor 27 is coupled to the IPG housing and may take the form of a piezoelectric crystal transducer. The output signal of the patient activity sensor 27 can be processed and used as the RCP. The sensor 27 generates an electrical signal in response to sensed body activity, which is processed by the activity circuitry 35 and provided to the digital controller / timer circuitry 43. The active circuitry 35 and associated sensor 27 can correspond to the circuit systems disclosed in U.S. Patent No. 5,052,388, entitled "Method and Apparatus for Implicationing Activity Sensing in a Pulse Generator," published October 1, 1991, and U.S. Patent No. 4,428,378, entitled "Rate Adaptive Pacer," published January 31, 1984, each of which is incorporated herein by reference in its entirety. Similarly, the exemplary systems, apparatus, and methods described herein can be practiced in conjunction with alternative types of sensors (such as oxygenation sensors, pressure sensors, pH sensors, and respiration sensors) to provide rate-responsive pacing capability. Alternatively, the QT time can be used as a rate indication parameter, in which case no additional sensor is required. Similarly, the exemplary embodiments described herein can also be practiced in non-rate-responsive pacemakers.

[0146] Data transmission to and from the external programmer is achieved via telemetry antenna 57 and an associated RF transceiver 41, which demodulates both received downlink telemetry and transmits uplink telemetry. Uplink telemetry capabilities may include the ability to transmit stored digital information, such as operating modes and parameters, EGM histograms and other events, as well as real-time EGM of atrial and / or ventricular electrical activity and marker channel pulses indicating the occurrence of sensed and paced depolarization in the atria and ventricles.

[0147] The microcomputer 33 includes a microprocessor 80 and an associated system clock, as well as on-processor RAM chips 82A and ROM chips 82B. Additionally, the microcomputer circuitry 33 includes a separate RAM / ROM chip 82C to provide additional memory capacity. The microprocessor 80 typically operates in a low-power mode and is interrupt-driven. The microprocessor 80 is awakened in response to defined interrupt events, which may include A-TRIG, RV-TRIG, and LV-TRIG signals generated by timers in the digital timer / controller circuitry 43, and A-EVENT, RV-EVENT, and LV-EVENT signals generated by the sense amplifier circuitry 55, etc. The specific values ​​of the timeout intervals and delays by the digital controller / timer circuitry 43 are controlled by the microcomputer circuitry 33 via data and control buses from programmed parameter values ​​and operating modes. Furthermore, if programmed to operate as a rate-responsive pacemaker, timing interrupts, such as every cycle or every two seconds, can be provided to allow the microprocessor to analyze active sensor data and update the basic AA, VA, or VV escape intervals (if applicable). In addition, the microprocessor 80 can also be used to define variable, operable AV delay intervals, VV delay intervals, and the energy delivered to each ventricle and / or atrium.

[0148] In one embodiment, microprocessor 80 is a custom microprocessor adapted to fetch and execute instructions stored in RAM / ROM unit 82 in a conventional manner. However, other embodiments are contemplated that may be suitable for practicing the invention. For example, readily available commercially available microprocessors or microcontrollers or custom-designed dedicated hardwired logic or state machine type circuitry can perform the functions of microprocessor 80.

[0149] The digital controller / timer circuit 43 operates under the general control of the microcomputer 33 to control timing and other functions within the pacing circuit 21, and includes a set of timing and associated logic circuits, some of which are depicted in relation to 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 the elapsed V-EVENT to V-EVENT interval or V-EVENT to A-EVENT interval or VV conduction interval, an escape interval timer 83D for timing the AA, VA, and / or VV pacing escape interval, an AV delay interval timer 83E for timing the A-LVp delay (or A-RVp delay) from a previous A-EVENT or A-TRIG, a postventricular timer 83F for timing the postventricular time period, and a date / time clock 83G.

[0150] The AV delay interval timer 83E is loaded with an appropriate delay interval (e.g., A-RVp delay or A-LVp) for a ventricular chamber to start the timeout from a previous A-PACE or A-EVENT. The interval timer 83E triggers pacing stimulus delivery and can be based on one or more previous cardiac cycles (or from a dataset derived empirically for a given patient).

[0151] The post-event timer 83F causes the post-ventricular time period following RV-EVENT, LV-EVENT, RV-TRIG, or LV-TRIG, and the post-atrial time period following A-EVENT or A-TRIG, to time out. The duration of the post-event time period can also be selected as a programmable parameter stored in the microcomputer 33. The post-ventricular time period includes PVARP, post-atrial ventricular blanking period (PAVBP), ventricular blanking period (VBP), post-ventricular atrial blanking period (PVARP), and ventricular refractory period (VRP), but other time periods can be appropriately defined, at least in part, according to the operating circuitry used in the pacemaker. The post-atrial time period includes the atrial refractory period (ARP) and atrial blanking period (ABP). During the atrial refractory period, A-EVENT is ignored for the purpose of resetting any AV delays, and during the atrial blanking period, atrial sensing is disabled. It should be noted that the onset of the post-atrial time interval and AV delay may begin substantially simultaneously with the start or end of each A-EVENT or A-TRIG, or in the latter case, at the end of an A-PACE that can follow an A-TRIG. Similarly, the onset of the post-ventricular time interval and VA escape interval may begin substantially simultaneously with the start or end of a V-EVENT or V-TRIG, or in the latter case, at the end of a V-PACE that can follow a V-TRIG. The microprocessor 80 also optionally calculates the AV delay, VV delay, post-ventricular time interval, and post-atrial time interval, which vary with sensor-based escape intervals and / or intrinsic atrial and / or ventricular rates established in response to one or more RCPs.

[0152] Output amplifier circuit 51 includes an RA pacing pulse generator (and an LA pacing pulse generator, if LA pacing is provided), an RV pacing pulse generator, an LV pacing pulse generator, and / or any other pulse generator configured to provide atrial and ventricular pacing. To trigger the generation of an RV-PACE or LV-PACE pulse, digital controller / timer circuit 43 generates an RV-TRIG signal when the A-RVp delay (in the case of RV pre-excitation) provided by AV delay interval timer 83E (or VV delay timer 83B) times out, or generates an LV-TRIG signal when the A-LVp delay (in the case of LV pre-excitation) times out. Similarly, digital controller / timer circuit 43 generates an RA-TRIG signal (or an LA-TRIG signal, if provided) that triggers the output of an RA-PACE pulse at the end of a VA escape interval timed by escape interval timer 83D.

[0153] Output amplifier circuit 51 includes switching circuitry for coupling selected pacing electrode pairs from the lead conductors and IND-CAN electrodes 20 to RA pacing pulse generators (and LA pacing pulse generators, if provided), RV pacing pulse generators, and LV pacing pulse generators. Pacing / sensing electrode pair selection and control circuitry 53 selects the lead conductors and associated pacing electrode pairs for coupling with atrial and ventricular output amplifiers within output amplifier circuitry 51 to implement RA, LA, RV, and LV pacing.

[0154] Sensing amplifier circuit 55 contains sensing amplifiers for atrial and ventricular pacing and sensing. High-impedance P-wave and R-wave sensing amplifiers can be used to amplify the voltage difference signal generated across the sensing electrode pair due to the passage of the cardiac depolarization wavefront. The high-impedance sensing amplifier uses high gain to amplify low-amplitude signals and relies on passband filtering, time-domain filtering, and amplitude threshold comparison to distinguish the P-wave or R-wave from background electrical noise. Digital controller / timer circuit 43 controls the sensitivity settings of atrial and ventricular sensing amplifier 55.

[0155] During the blanking period before, during, and after the delivery of a pacing pulse to any of the pacing electrodes in the pacing system, the sensing amplifier can be decoupled from the sensing electrode to avoid saturation of the sensing amplifier. Sensing amplifier circuit 55 includes a blanking circuit for decoupling selected lead conductor pairs and IND-CAN electrode 20 from the inputs of the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier during ABP, PVABP, and VBP. Sensing amplifier circuit 55 also includes a switching circuit for coupling the selected sensing electrode lead conductors and IND-CAN electrode 20 to the RA sensing amplifier (and LA sensing amplifier, if provided), RV sensing amplifier, and LV sensing amplifier. Similarly, sensing electrode selection and control circuit 53 selects the conductors and associated sensing electrode pairs to be coupled to the atrial and ventricular sensing amplifiers within output amplifier circuit 51 and sensing amplifier circuit 55 for RA, LA, RV, and LV sensing along desired unipolar and bipolar sensing vectors.

[0156] Right atrial depolarization or a P wave in the RA-SENSE signal sensed by the RA sensing amplifier results in an RA-EVENT signal being transmitted to the digital controller / timer circuit 43. Similarly, left atrial depolarization or a P wave in the LA-SENSE signal sensed by the LA sensing amplifier (if provided) results in an LA-EVENT signal being transmitted to the digital controller / timer circuit 43. Ventricular depolarization or an R wave in the RV-SENSE signal sensed by the ventricular sensing amplifier results in an RV-EVENT signal being transmitted to the digital controller / timer circuit 43. Similarly, ventricular depolarization or an R wave in the LV-SENSE signal sensed by the ventricular sensing amplifier results in an LV-EVENT signal being transmitted to the digital controller / timer circuit 43. The RV-EVENT, LV-EVENT, RA-EVENT, and LA-SENSE signals may be unwanted or not unwanted, and may be unintentionally triggered by electrical noise signals or abnormally conducted depolarization waves instead of genuine R or P waves.

[0157] Figure 8 An example of a treatment sequence 200 for determining IMD parameters and applying cardiac resynchronization therapy using those parameters is shown. (Refer to...) Figure 1-7 The system 100 shown in the figure is described Figure 8 However, any suitable structure, system, component, device, and / or equipment may be used.

[0158] In operation, at block 202, computing device 140 can receive one or more first set of measurement results (e.g., raw measurement results or first measurement results) from measuring electrodes 112 and / or 114. Raw measurement results are electrical measurements from electrodes 112 and / or 114, where leads 18, 20, and / or 22 of IMD 16 are disconnected. For example, when leads 18, 20, and / or 22 of IMD 16 are disconnected (e.g., no pacing pulse is being supplied to heart 12), measuring electrodes 112 and / or 114 can measure electrical information such as cardiac activation signals (e.g., depolarization and / or repolarization) of the patient's heart 12. Measuring electrodes 112 and / or 114 can provide electrical information to interface / amplifier circuitry 116. Interface / amplifier circuitry 116 can amplify the signal and then provide the signal to computing device 140.

[0159] In some instances, computing device 140 may display electrical measurement results, including the raw measurement results, on display 132. Figure 12 Exemplary measurement results from measuring electrodes 112 and 114 are shown that can be displayed on display 132. For example, in response to receiving electrical measurement results from electrodes 112 and / or 114, computing device 140 can analyze, determine, and / or display the electrical measurement results on display 132. For example, in response to receiving raw measurement results or a first measurement result, computing device 140 can determine and / or display a screen 602 indicating the raw measurement results. Computing device 140 can receive and / or determine individual electrical measurement results from each of the measuring electrodes 112 and / or 114. Additionally and / or alternatively, computing device 140 can determine whether individual electrical measurement results from electrodes 112 and / or 114 originate from a preceding measuring electrode 112 and / or a following measuring electrode 114.

[0160] As shown on display 602, each measuring electrode 112 and / or 114 can be displayed as a separate measurement result (e.g., a line). Further, the front electrode 112 can be shown graphically differently from the rear electrode 114 (e.g., by using a different color and / or different type of dashed line). In other words, dashed line 608 can indicate the measurement result from the rear electrode 114, while line 610 can indicate the measurement result from the front electrode 112.

[0161] Back Figure 8At box 204, computing device 140 can determine personalized IMD characteristics based on a first measurement result or the original measurement result and apply those characteristics to IMD 16. In some instances, the electrical asynchrony of patient 14 may vary. Thus, IMD characteristics can be personalized for each patient. Therefore, computing device 140 can determine one or more personalized IMD characteristics based on the original measurement results to apply to patient 14. Personalized IMD characteristics may include different delays, such as ventricle-ventricle (VV) delay, atrial-ventricle (AV) delay, left ventricle (LV) delay, biventricular (BiV) delay, and / or other IMD 16 timing delays. Additionally and / or alternatively, personalized IMD characteristics may include one or more instructions for turning on or off different IMD 16 leads (e.g., 18, 20, 22) and / or IMD 16 electrodes (e.g., 40, 42, 44, 45, 46, 47, 48, 50). In other words, based on the personalized IMD characteristics, IMD 16 can turn on (e.g., apply pacing pulses to heart 12) one or more leads / electrodes and / or turn off (e.g., do not apply pacing pulses to heart 12) one or more leads / electrodes.

[0162] At block 206, in response to applying personalized IMD characteristics, computing device 140 can receive a second set of measurement results (e.g., second measurement results) corresponding to the personalized characteristics from measuring electrodes 112 and / or 114. For example, at block 204, computing device 140 can determine multiple different characteristics (e.g., multiple different delays, such as VV delay and / or AV delay). IMD 16 can receive and / or apply personalized IMD characteristics. In response to applying each personalized IMD characteristic, computing device 140 can receive a second set of measurement results from measuring electrodes 112 and / or 114 for the corresponding personalized IMD characteristic. For example, if the personalized IMD characteristic includes an AV delay, such as an AV delay of 120 milliseconds (ms), then computing device 140 can receive a second measurement result indicating an electrical signal of the patient's heart from electrodes 112 and / or 114 in response to IMD 16 setting an AV delay of 120 milliseconds.

[0163] In some cases, computing device 140 can determine multiple different personalized IMD characteristics. Computing device 140 can receive multiple sets of second measurement results from electrodes 112 and / or 114. Each of the multiple sets of second measurement results can correspond to a different personalized IMD characteristic. For example, personalized IMD characteristics can include AV delays of 80 ms, 100 ms, 120 ms, and / or 140 ms. IMD 16 can apply or set the AV delay for each of the personalized IMD characteristics. In response to setting the AV delay, computing device 140 can receive a set of second measurement results corresponding to the AV delay.

[0164] In some variations and reference Figure 12 The computing device 140 can display the second measurement result on the display 132. For example, the computing device 140 can display a screen 604 on the display 132. The screen 604 can indicate multiple different personalized IMD characteristic measurement results. For example, the left portion of the screen 604 can indicate a first personalized characteristic measurement result 606 (e.g., 100 ms AV delay) and the right portion can indicate a second personalized characteristic measurement result 607 (e.g., 120 ms AV delay). The computing device 140 can display individual measurement results for each of the measurement electrodes 112 and / or 114, similar to the original measurement results. Moreover, the front electrode 112 can be shown graphically differently from the rear electrode 114 (e.g., by using different colors and / or different types of dashed lines).

[0165] In some instances, personalized IMD characteristics can be applied automatically. For example, computing device 140 can provide IMD 16 with one or more commands and / or instructions for applying or setting personalized IMD characteristics. In response to providing one or more instructions, computing device 140 can receive measurement results from electrode device 110 (e.g., measuring electrodes 112 and / or 114) indicating the applied personalized IMD characteristics via electrical measurements. If two or more personalized IMD characteristics exist, computing device 140 can provide instructions for applying or setting personalized IMD characteristics sequentially and / or sequentially. Further, computing device 140 can receive measurement results for each of the different personalized IMD characteristics from electrode device 110.

[0166] In some instances, personalized IMD characteristics can be applied manually. For example, a user can provide user input for each personalized IMD characteristic using input device 142. Input device 142 can provide user input to processor 150 and / or IMD 16. Based on the user input, IMD 16 can set or apply personalized characteristics. The computing device 140 can then receive the measurement results of each of the personalized IMD characteristics from electrode device 110.

[0167] At box 208, computing device 140 can determine a cardiac resynchronization index (CRI) value based on a comparison between a first measurement result (e.g., a raw measurement result) and a second measurement result (e.g., a measurement result with corresponding personalized IMD characteristics). For example, computing device 140 can receive multiple second measurement results from electrode device 110. Each second measurement result can have a corresponding personalized IMD characteristic. Computing device 140 can determine multiple CRI values ​​by comparing each of the second measurement results with the raw measurement result. For example, the second measurement results can correspond to personalized IMD characteristics of 60 ms, 80 ms, 100 ms, and 120 ms AV delays. Computing device 140 can determine CRI values ​​for 60 ms, 80 ms, 100 ms, and 120 ms AV delays by comparing each of the second measurement results with the raw measurement result.

[0168] The CRI value can indicate the wavefront fusion and cancellation method of leads 18, 20, and 22 of IMD 16. Figure 13 The diagram illustrates the CRI values ​​of IMD 16 and a graphical representation of the corresponding leads. For example, the right atrial (RA) lead 22 can be operatively coupled to the right atrium of a patient's heart 12. Similarly, the right ventricular (RV) lead 18 can be operatively coupled to the right ventricle, and the left ventricular (LV) lead 20 can be operatively coupled to the left ventricle. Based on the personalized IMD characteristics, IMD 16 can apply pacing therapy (e.g., electrical signals) to leads 18, 20, and / or 22. For example, the LV lead 20 can deliver an LV pulse 654 to the patient's heart 12. Additionally and / or alternatively, the RV lead 18 can deliver an RV pulse 656 to the patient's heart. Pulses 652, 654, and 656 can generate wavefronts (e.g., RV, LV, and the original wavefront) that propagate throughout the patient's heart 12.

[0169] Furthermore, the IMD 16 can operate in atrial sensing (AS) mode and / or atrial pacing (AP) mode. For example, in AS mode, the RA lead 22 (e.g., an atrial sensing lead) can measure the raw pulse 652 and / or the timing of the raw pulse 652. In other words, the patient 14 provides the heart 12 with the raw pulse 652 for depolarization / repolarization, and the RA lead 22 can measure the raw pulse 652. Additionally and / or alternatively, in AP mode, the RA lead 22 (e.g., an atrial pulse lead) provides the heart 12 with the raw pulse 652.

[0170] Image 658 illustrates an exemplary graphical representation of wavefronts propagating through the left ventricle of a patient's heart 12. For example, the original wavefront and the RV wavefront may merge together and move toward the LV wavefront. Ultimately, when the LV wavefront encounters the original / RV wavefront, the wavefronts may cancel each other out. The CRI value indicates where the wavefronts cancel each other out within the left ventricle of the patient's heart 12. For example, a CRI value of 100% may indicate that the LV wavefront cancels out the RV / original wavefront at the center of the left ventricle. Line 653 shows the center of the left ventricle. Higher CRI values ​​(e.g., 90%) may indicate wavefront cancellation or merging near the center 653 of the left ventricle (e.g., slightly to the left or right of the center 653). Lower CRI values ​​(e.g., 50%) may indicate wavefront cancellation or merging further away from the center 653 of the left ventricle. In some instances, computing device 140 may display image 658 on display 132.

[0171] In some cases, personalized IMD characteristics can indicate that RV lead 18 will be disconnected (e.g., LV wavefront only). For example, LV lead 20 may provide LV pulse 654, but RV lead 18 may not provide RV pulse 656. In this case, the CRI value can indicate whether the LV wavefront cancels out or merges with the original wavefront.

[0172] At box 210, computing device 140 can determine an optimal CRI value and / or provide information for administering cardiac resynchronization therapy (CRT) treatment based on the CRI value. For example, based on the determined CRI value (e.g., CRI values ​​for AV delays of 60 ms, 80 ms, 100 ms, and 120 ms), computing device 140 can determine an optimal CRI value. In some variations, the CRI value is a percentage or fraction. Computing device 140 can determine the optimal CRI value as a percentage or fraction of the largest possible magnitude based on the determined CRI value.

[0173] In response to determining the optimal CRI value, computing device 140 can provide information to CRT treatment and / or administer CRT treatment. In some instances, computing device 140 can provide IMD 16 with one or more instructions and / or commands for applying or setting personalized IMD characteristics to IMD 16 to the optimal CRI value. For example, if the optimal CRI value has a personalized IMD characteristic as a 100 ms AV delay, computing device 140 can provide IMD 16 with instructions for setting IMD 16 at a 100 ms AV delay.

[0174] In other instances, computing device 140 may display CRI values ​​on display 132. Figure 14An exemplary display 132 is shown, illustrating multiple different CRI values ​​with corresponding personalized IMD characteristics (e.g., AV latency). For example, computing device 140 can display the CRI value for each of the AV latencies from 60 to 180 milliseconds. Using input device 142, a user can provide user input indicating the optimal personalized IMD characteristics (e.g., 100 milliseconds AV latency). Input device 142 can provide information to processor 150 and / or IMD 16 to set IMD 16 under the optimal personalized IMD characteristics (e.g., 100 milliseconds AV latency).

[0175] Figure 9-11 The box for processing sequence 200 will be described in more detail. For example, Figure 9 A more detailed version of boxes 202 and 204 from processing sequence 200 is shown. In operation, at box 302, computing device 140 may receive one or more input variables. For example, computing device 140 may receive from input device 142 the patient's name, the patient's date of birth, the date the IMD 16 was implanted in the patient, the cause of heart failure (HF) (e.g., ischemic cardiomyopathy (ICM), non-ischemic cardiomyopathy (NICM), and / or others), and the type of IMD 16 (e.g., the manufacturer of the IMD 16).

[0176] At block 306, computing device 140 can receive raw measurement results from measuring electrodes 112 and / or 114. As described above, the raw measurement results can be measurements from electrodes 112 and / or 114 with one or more leads of IMD 16 disconnected. In some instances, electrode device 110 can be a 12-lead ECG-CRT device. Computing device 140 can provide one or more instructions or commands for shutting down IMD 16. Alternatively and / or as an alternative, a user can manually shut down IMD 16. After shutting down IMD 16, computing device 140 can receive raw measurement results from measuring electrodes 112 and / or 114 of the 12-lead ECG-CRT device. Based on the original measurements, the computing device 140 can determine the PR interval, QRS interval, QRS morphology (e.g., LBBB, RBBB, interventricular conduction delay (IVCD), right ventricular pacing (RVP), stenosis), complete cardiac conduction block (CHB) of the patient's heart 12, and / or atrial fibrillation / flutter (AF) of the patient's heart 12.

[0177] At box 308, computing device 140 can determine whether it has received user input indicating atrial sensing (AS) mode or atrial pacing (AP) mode. For example, computing device 140 can display a prompt (e.g., a report) indicating whether IMD 16 is operating in AS mode or AP mode. Then, computing device 140 can receive user input indicating whether to operate in AS mode or AP mode. Computing device 140 can apply personalized IMD characteristics to IMD 16 based on user input.

[0178] In some cases, if IMD 16 operates in a specific mode, such as AS mode, less than 90% of the time, computing device 140 may display a prompt instructing the user to select a mode (e.g., the delay type determined at step 204) for which personalized IMD features are applied. Computing device 140 may receive user input indicating the mode and use that mode when applying personalized IMD features. If IMD 16 operates in a specific mode, such as a specific mode, more than 90% of the time, computing device 140 may not display the prompt and may automatically use the specific mode when applying personalized IMD features.

[0179] At box 310, computing device 140 can determine whether the patient's heart 12 has AF and / or CHB. If so, processing sequence 300 can move to box 312. If not, processing sequence 300 can move to box 314. At box 314, computing device 140 can determine whether the patient's heart 12 has RBBB. If so, processing sequence 300 can move to box 314. If not, processing sequence 300 can move to box 316. In other words, if the patient's heart 12 has LBBB, IVCD, RVP, or stenosis, processing sequence 300 can move to box 316.

[0180] In some instances, the determination of boxes 310 and 314 is not sequential but parallel. For example, if computing device 140 determines AF or CHB, processing sequence 300 moves to box 312. If computing device 140 determines LBBB, IVCD, RVP, or narrowing, processing sequence 300 moves to box 316. If computing device 140 determines RBBB, processing sequence 300 moves to box 318.

[0181] At block 312, computing device 140 determines one or more personalized IMD characteristics, such as a first VV delay scan with an AV delay setting, a second VV delay scan with a second vector, and / or a third VV delay scan with a third vector. Additionally and / or alternatively, computing device 140 may determine that one or more leads (e.g., leads 18, 20, and / or 22) from LV lead 20 and electrodes (e.g., electrodes 40, 42, 44, 45, 46, 47, 48, 50) are switched on to apply AV and / or VV delay pacing pulses. For example, for a first VV delay scan with an AV delay setting, computing device 140 may determine an AV delay characteristic and multiple different VV delay characteristics (e.g., the scan is multiple different delay characteristics). Additionally and / or alternatively, computing device 140 may determine that LV lead 20 and electrode 44 are switched on to apply pacing pulses.

[0182] For a second VV delay scan with a second vector, computing device 140 can determine AV delay characteristics and multiple different VV delay characteristics. Additionally and / or alternatively, for the second vector, computing device 140 can determine to activate LV lead 20 and an electrode different from LV lead 20, or a second electrode (e.g., electrode 45), to apply a pacing pulse. In some instances, the second VV delay scan may contain the same VV delay and the same AV delay as a first VV delay scan with AV delay settings.

[0183] In other instances, these may differ. For example, for a first VV delay scan with an AV delay setting, computing device 140 may determine the AV delay characteristic and multiple different VV delay characteristics (e.g., the scan has multiple different delay characteristics). Additionally and / or alternatively, computing device 140 may determine to turn on the LV lead 20 and a different electrode or a third electrode (e.g., electrode 46) to apply a pacing pulse. In some instances, the third VV delay scan may contain the same VV delay and the same AV delay as the first and second VV delay scans. In other instances, these may differ.

[0184] refer to Figure 13 The AV delay characteristic can indicate the delay between the original pulse 652 and the RV / LV lead pulses 654 / 656. For example, in response to detecting and / or providing the original pulse 652, the IMD 16 can delay the RV / LV lead pulses by the AV delay characteristic before providing the RV / LV pulses 654 / 656. The AV delay characteristic can also indicate whether the characteristic is biventricular (BiV) or LV only. For example, the BiV characteristic indicates that the IMD 16 provides both the RV pulse 656 and the LV pulse 654. LV only indicates that the IMD 16 provides only the LV pulse 654.

[0185] The VV delay characteristic can indicate the VV delay between RV pulse 656 and LV pulse 654 (e.g., RV lead 18 can provide RV pulse 656 before LV lead 20 provides LV pulse 654, or LV lead 20 can provide LV pulse 654 before RV lead 18 provides RV pulse 656). In some instances, the type of IMD 16 can indicate which pulse (RV or LV pulse 656, 654) is provided first and which pulse is delayed and provided second. Figure 21 This is illustrated in more detail. For example, Figure 810 shows the first IMD characteristic with a 130 ms AV delay and a 0VV delay. With only a 130 ms AV delay, both RV lead 18 and LV lead 20 provide an electrical pulse of 130 ms (e.g., AV delay).

[0186] Figures 820 and 830 illustrate the characteristics of a second IMD with a 130 ms AV delay and a -20 ms VV delay. However, Figure 820 pertains to a first-type IMD device 16, while Figure 830 pertains to a second-type IMD device 16. In Figure 820, the first-type IMD device 16 directs the RV lead 18 to provide a pulse at 130 ms (e.g., with an AV delay), but based on the -20 ms VV delay, IMD 16 directs the LV lead 20 to provide a pulse at 110 ms (e.g., 20 seconds before the RV delay). In other words, for the first-type IMD device 16, IMD 16 provides an electrical pulse to the RV lead with an AV delay and varies the pulse to the LV lead based on the VV delay (e.g., for a positive +20VV delay, the RV lead pulse would be 130 ms and the LV lead pulse would be 150 ms).

[0187] In Figure 830, the second type of IMD device 16 directs the LV lead 20 to provide a pulse at 130 milliseconds (e.g., with an AV delay), but based on a -20 millisecond VV delay, the IMD 16 directs the RV lead 18 to provide a pulse at 150 milliseconds. In other words, for the second type of IMD device 16, the IMD 16 provides an electrical pulse to either the LV or RV lead based on either of the preceding pulses (e.g., if the VV delay is negative, the LV lead is in an AV delay; if the VV delay is positive, the RV lead is in an AV delay), and then the other lead is canceled out by the VV delay.

[0188] Back Figure 9 IMD 16 can delay RV / LV pulses 654 / 656 based on AV delay characteristics and VV delay characteristics. After applying each of the VV delay characteristics, processing sequence 300 can move to box 206, and computing device 140 can receive these second measurement results from measurement electrodes 112 and / or 114.

[0189] At box 316, computing device 140 determines one or more personalized IMD characteristics, such as an AV scan for BiV, an AV scan for LV only, a VV scan for a baseline AV delay of pulse 656 provided by RV lead 18 before pulse 654 provided by LV lead 20, a VV scan for a baseline AV delay of pulse 654 provided by LV lead 20 before pulse 656 provided by RV lead 18, a VV scan with a baseline AV delay under a second vector, and / or a VV scan with a baseline AV delay under a third vector. Additionally and / or alternatively, computing device 140 may determine that one or more leads (e.g., leads 18, 20, and / or 22) and electrodes (e.g., electrodes 40, 42, 44, 45, 46, 47, 48, 50) from LV lead 20 are switched on to apply AV and / or VV delayed pacing pulses. In other words, IMD 16 may delay RV / LV pulses 654 / 656 based on AV and / or VV delay characteristics. Furthermore, the computing device 140 can (e.g., based on a second / third vector) determine one or more leads and / or electrodes connected. Then, the processing sequence 300 can move to block 206, where the computing device 140 can receive these second measurement results from the measuring electrodes 112 and / or 114.

[0190] At box 318, computing device 140 determines one or more personalized IMD characteristics, such as an AV scan for BiV, a VV scan for an AV delay of pulse 656 provided by RV lead 18 before pulse 654 provided by LV lead 20, a VV scan for an AV delay of pulse 654 provided by LV lead 20 before pulse 656 provided by RV lead 18, a VV scan with a baseline AV delay under a second vector, and / or a VV scan with a baseline AV delay under a third vector. Additionally and / or alternatively, computing device 140 may determine that one or more leads (e.g., leads 18, 20, and / or 22) and electrodes (e.g., electrodes 40, 42, 44, 45, 46, 47, 48, 50) from LV lead 20 are switched on to apply AV and / or VV delayed pacing pulses. In other words, IMD 16 may delay RV / LV pulses 654 / 656 based on AV and / or VV delay characteristics. Furthermore, the computing device 140 can (e.g., based on a second / third vector) determine one or more leads and / or electrodes connected. Then, the processing sequence 300 can move to block 206, where the computing device 140 can receive these second measurement results from the measuring electrodes 112 and / or 114.

[0191] Additionally and / or alternatively, the determined delay characteristics (e.g., AV / VV) can be based on the PR interval and / or QRS interval. For example, based on the PR interval and / or QRS interval, the computing device 140 can determine different delay times (e.g., 60 ms, 80 ms, 100 ms, etc.). Thus, these delay characteristics can be personalized for patient 14 based on the patient's own QRS or PR interval.

[0192] Processing sequence 300 is only an exemplary processing sequence for determining personalized IMD characteristics. In other instances, computing device 140 may use other inputs, parameters, and / or determinations to determine personalized IMD characteristics. Additionally and / or alternatively, computing device 140 may determine additional or different latency characteristics and / or the type of latency characteristics (e.g., AV, VV, BiV, or LV only) for blocks 312, 316, and / or 318.

[0193] Figure 10 A more detailed version of block 208 from processing sequence 200 is shown. For example, computing device 140 can use processing sequence 400 to determine the CRI value. At block 402, computing device 140 can determine a first asynchronous value based on (e.g., from block 202) a first set of measurements or the original measurements. In some cases, computing device 140 can use area under the curve calculation to determine the first asynchronous value. For example, refer to... Figure 12 The computing device 140 can determine the first asynchronous value based on the area under the curve between lines 608 and 610 from individual measuring electrodes 112 and / or 114.

[0194] In some instances, computing device 140 can determine the area under the curve (AUC) of a first set of measuring electrodes (e.g., front electrode 112 or rear electrode 114) compared to another set of measuring electrodes (e.g., another of front electrode 112 or rear electrode 114). In other words, computing device 140 can determine the AUC between said sets of measuring electrodes. For example, electrode device 110 may include nine front electrodes 112 and nine rear electrodes 114. Computing device 140 can calculate the AUC between the first front electrode measurement and the nine rear electrode measurements. Computing device 140 can determine this for all nine front electrodes 112. Computing device 140 can determine a first asynchrony value based on a total AUC of 81 (e.g., nine front electrode measurements multiplied by nine rear electrode measurements). In other words, computing device 140 can sum all 81 AUC calculations to determine the first asynchrony value.

[0195] In some cases, electrode device 110 may contain more or fewer than nine electrodes. Thus, computing device 140 may perform more or fewer than 81 total area under the curve calculations to determine a first asynchronous value. In some variations, computing device 140 may use one or more matrices (e.g., a 9×9 matrix of nine front electrodes 112 and nine rear electrodes 114) to determine the area under the curve calculations and / or the first asynchronous value.

[0196] At box 404, computing device 140 can determine one or more second asynchronous values ​​based on one or more second sets of measurement results (e.g., from box 206). Each of the second asynchronous values ​​may correspond to a different personalized IMD characteristic. In some cases, computing device 140 can use area under the curve (AUC) calculation to determine the second asynchronous value. For example, similar to box 402, computing device 140 can determine the AUC of a first set of measuring electrodes (e.g., front electrode 112 or rear electrode 114) compared to another set of measuring electrodes (e.g., another of front electrode 112 or rear electrode 114). Computing device 140 can use AUC calculation to determine the second asynchronous value. Computing device 140 can repeat box 404 multiple times to determine the second measurement results for each of the personalized IMD characteristics. In some variations, computing device 140 can use one or more matrices (e.g., a 9×9 matrix of 9 front electrodes 112 and 9 rear electrodes 114) to determine the AUC calculation and / or the second asynchronous value.

[0197] In some instances, instead of using the area under the curve, the computing device 140 may use different methods, procedures, or algorithms to determine the first dyssynchrony value and / or the second dyssynchrony value. Exemplary methods, procedures, or algorithms for determining the first dyssynchrony value and / or the second dyssynchrony value are described in U.S. Patent Application No. 62 / 609935, filed December 22, 2017, entitled “Anterior and Posterore Electrode Signals,” which includes area under the curve measures and other measures such as inter-activation event distance measures, composite height measures based on the maximum height of measuring electrodes 112 and 114, and / or ventricular electrical decoupling (VEU) measures, which are incorporated herein by reference in their entirety.

[0198] At box 406, computing device 140 can determine a CRI value based on a comparison between a first asynchronous value and one or more second asynchronous values. For example, computing device 140 can compare the first asynchronous value with the second asynchronous value to determine a CRI value (e.g., the location where the left ventricular wavefronts (LV wavefront and RV / original wavefront) of the patient's heart 12 cancel each other out).

[0199] For example, the computing device 140 can use the area under the curve (AUC) to calculate the amount of electrical dyssynchrony within the heart 12 (e.g., the more extreme the electrical dyssynchrony, the larger the AUC value). In patients with electrical dyssynchrony, the heart 12 may beat asynchronously, which may result in a larger AUC value between measurements from the anterior electrode 112 and measurements from the posterior electrode 114. In patients without electrical dyssynchrony, the heart 12 may beat synchronously, which may result in a smaller AUC value between measurements from the anterior electrode 112 and measurements from the posterior electrode 114 (inclusive, essentially zero). The computing device 140 can use the following calculations to determine the CRI value for one or more second dyssynchrony values ​​of a personalized IMD characteristic:

[0200] CRI value (percentage) = Abs[(first asynchronous value - second asynchronous value) / first asynchronous value * 100]

[0201] The first and second asynchronous values ​​are as described above, and Abs is the calculated absolute value.

[0202] In some instances, the computing device 140 can determine the optimal personalized IMD characteristic for CRT treatment as the characteristic with the largest magnitude of CRI value or percentage (e.g., the value closest to 1 or 100%). For example, the CRI value may decrease as the second dyssynchrony value increases. However, the CRI value may increase as the second dyssynchrony value decreases. The optimal IMD characteristic can be the characteristic with the largest magnitude of CRI value.

[0203] Additionally and / or alternatively, a first asynchrony value (e.g., a value corresponding to the original measurement result) can further personalize the IMD characteristics of patient 14. For example, the original measurement result indicates that the patient's heart 12 did not provide electrical impulses to leads 18, 20, 22 (e.g., the original or natural measurement result of the heart). Each patient can have different original measurement results and different asynchrony values. In other words, each patient can be unique, and some patients may have larger electrical asynchrony while others may have smaller electrical asynchrony. Thus, by using the above equation, the computing device 140 considers the original measurement result (e.g., natural heartbeat) of a particular patient when determining the validity of personalized IMD characteristics.

[0204] Alternatively and / or alternatively, fewer measurement electrodes 112 and / or 114 can be used to determine the optimized IMD characteristics of the IMD 16 by using the CRI value. For example, conventional methods may require substantially more measurement electrodes due to outlier measurements and other faults. However, by using the area under the curve (AUC) to determine the CRI value, fewer measurement electrodes, comprising 18 non-invasive measurement electrodes, can be used to determine the optimized IMD characteristics.

[0205] Figure 11 A more detailed version of box 210 from processing sequence 200 is shown. For example, computing device 140 can use processing sequence 500 to manage CRT therapy. At box 502, computing device 140 can determine an optimal CRI value. As previously described, the optimal CRI value can be a CRI value of the largest magnitude or a percentage (e.g., a value closest to 1 or 100%). At box 504, computing device 140 can provide one or more instructions for setting IMD 16 to the optimal IMD characteristic corresponding to the optimal CRI value. For example, if computing device 140 determines that a personalized IMD characteristic with a 120 ms AV delay has a CRI value of the largest magnitude, computing device 140 can provide one or more instructions for setting IMD 16 to a 120 ms AV delay.

[0206] Additionally and / or alternatively, at box 506, computing device 140 may display CRI information, including one or more of the CRI values, as an image and / or visual marker. In some instances, as previously described, a user may manually input optimized CRI values ​​based on the CRI information displayed on display 132. Based on user input, computing device 140 may set IMD 16 to the optimized CRI value. In other instances, box 506 may be concatenated with boxes 502 and 504. In other words, computing device 140 may determine optimized CRI values, provide one or more instructions for setting IMD 16 with optimized IMD characteristics based on the optimized CRI values, and cause the CRI information to be displayed on display 132.

[0207] Figure 14-20 The computing device 140 is shown to be able to display various images and / or visual markers on the display 132. (Source: [Original Source Name]) Figure 14-19 The image shown is exemplary, and additional images indicating CRI information may be displayed on display 132. (Reference) Figure 14 The computing device 140 can display image 710 on display 132. Image 710 shows different AV delays (e.g., AV delay of LV only) and their corresponding CRI values. Furthermore, image 710 can also show whether the AV delay produces the dominant LV lead wavefront or the dominant RV / primary lead wavefront. For example, shading can indicate the dominant LV lead wavefront (e.g., the LV wavefront and RV / primary lead wavefront meet on the right side of the center 653 of the left ventricle). White can indicate the dominant RV / primary lead wavefront (e.g., the LV wavefront and RV / primary lead wavefront meet on the left side of the center 653 of the left ventricle).

[0208] refer to Figure 15The computing device 140 can display image 720 on display 132. Image 720 shows different AV delays and their corresponding CRI values. Additionally, image 720 shows AV delay for LV only and BiV AV delay. Furthermore, image 720 can also show whether the AV delay produces the dominant LV lead wavefront or the dominant RV / original lead wavefront.

[0209] refer to Figure 16 The computing device 140 can display image 730 on display 132. Image 730 shows different VV delays and their corresponding CRI values. Furthermore, image 710 can also show whether the VV delay generates the dominant LV lead wavefront or the dominant RV / original lead wavefront. Additionally, image 730 shows the CRI values ​​for different electrodes 44, 45, 46, 47 of LV lead 20 being open or closed (e.g., LV 4 to CAN indicates the measurement result when the LV 4 electrode from LV lead 20 is on as the cathode and IMD 16 is on as the anode; LV 1 to CAN indicates the measurement result when the LV 1 electrode from LV lead 20 is on as the cathode and IMD 16 is on as the anode; LV tip to LV ring indicates the measurement result when the first electrode from LV lead 20 is on as the cathode and the second electrode from LV lead 20 is on as the anode; LV ring to CAN indicates the measurement result when the first electrode from LV lead 20 is on as the cathode and IMD 16 is on as the anode).

[0210] refer to Figure 17 The computing device 140 can display image 740 on the display 132. Image 740 shows different AV delays and their corresponding CRI values, and different VV delays and their corresponding CRI values. Furthermore, image 740 can show whether the AV delay produces the dominant LV lead wavefront or the dominant RV / original lead wavefront.

[0211] refer to Figure 18 The computing device 140 can be from Figure 13 Image 658 is displayed on display 132. As described above, image 658 shows an exemplary graphical representation of the wavefronts from leads 18, 20, and 22 propagating through the left ventricle of the patient's heart 12. In some cases, image 658 may be animated. For example, display 132 may show the wavefronts propagating from leads 18, 20, and / or 22 through the left ventricle until they cancel each other out between the LV wavefront and the RV / original wavefront.

[0212] In some instances, a user can use input device 142 to select personalized IMD characteristics from images 710-740. Based on the user's selection, computing device 140 can display image 658 or an animation of image 658 corresponding to the selected personalized IMD characteristics on display 132.

[0213] refer to Figure 19 The computing device 140 can display image 750 on display 132. Image 750 may resemble image 658 and shows an exemplary graphical representation of wavefronts with multiple different IMD characteristics propagating from leads 18, 20, and 22 through the left ventricle of the patient's heart 12. In some cases, image 750 may be animated. For example, display 132 may show wavefronts propagating from leads 18, 20, and / or 22 through the left ventricle until the LV wavefront with different IMD characteristics (e.g., AV delay) cancels out the original wavefront.

[0214] In some instances, computing device 140 can determine the timing of each wavefront within a wavefront (e.g., the time it takes for each wavefront to begin propagating through the left ventricle). For example, computing device 140 can determine the delay time between RA lead 22 (e.g., a right atrial sensing or right atrial pulse lead and / or electrode) and RV lead 18, which can be the PR interval determined based on the original measurement. The LV lead 20 pulse (e.g., the original pulse preceding the LV pulse) can be determined by subtracting the AV delay at the LV-only CRI optimization value as described above from the PR interval. The RV lead 18 pulse preceding the LV lead 20 pulse can be determined by 100% - (CRI at BiV short AVD / 2).

[0215] In other words, if the patient's PR interval is 260 milliseconds, the optimal AV delay at the LV CRI is 180 milliseconds, and the CRI at the BIV short AV delay is 30%, then the original pulse leads the LV pulse by 80 milliseconds (260 milliseconds - 180 milliseconds), the RV pulse leads the LV pulse by 35 milliseconds, and the original pulse leads the RV pulse by 45 milliseconds. In response to determining these timings, the computing device 140 can enable an animated display showing the wavefronts of pulses that propagate through the patient's left ventricle and converge (e.g., cancel out) at specific locations.

[0216] refer to Figure 20 The computing device 140 can display image 760 on display 132. Image 760 shows different AV delays (e.g., LV and BiV delays only) and their corresponding CRI values. Furthermore, image 760 shows the measurement results from measuring electrodes 112 and / or 114 used to determine the CRI values ​​for different AV delays.

[0217] Studies were conducted using the methods and procedures described above (e.g., processing sequences 200-500). During the study, patients underwent routine device questioning to assess lead threshold and atrial RV sensing time (A-RV). Standard 12-lead ECG measurements were performed with the CRT off (e.g., lead disconnected from IMD 16) to confirm the presence of LBBB and to measure QRS and PR intervals. For patients with underlying complete cardiac conduction block (CHB), RV pacing (e.g., using RV lead 18) was used instead of the original approach. Data were acquired via biventricular (BiV) and LV-only pacing across a wide range of AVD (typically 40-90% of the intrinsic PR interval in a 20 ms step) and VV delay (typically LV pre-activation with VV = 0 to 60 ms in a 20 ms step) ranges. All data were acquired at pacing vectors and electrodes selected by the implantation electrophysiologist, and VV delay was assessed at the presented AV delay (typically approximately 70% of the intrinsic PR interval).

[0218] Do not use Figure 2 Instead of using the traditional electrode configuration, a 53-electrode ECG band was used to acquire research data. The ECG band used 17 anterior electrodes and 36 posterior electrodes on the upper torso to measure unipolar ECGs. Figure 22 ECG electrophoresis images of LBBB patients with CRT off at standard and optimal CRT settings are shown. The maximum slope and the time between the earliest and latest maximum slopes were calibrated for each electrophoresis image. Each of the 17 anterior electrophoresis images was matched with one of the 36 posterior electrophoresis images to generate 612 pairs, and the area under each pair (shaded area) was calculated. The start and end of each region were defined based on the earliest and latest maximum slopes, rather than the start and end of the QRS complex, as these time points are more consistent and reproducible. The mean area under all paired curves (AUC) is negative if the major wavefront is anterior to posterior and positive if posterior to anterior. The cardiac resynchronization index (CRI) is calculated as the percentage change of AUC relative to the original at any setting.

[0219] Twelve patients with chronic heart disease (CHB) and two patients with atrial fibrillation participated in the study. Figure 23A-E shows ECG electrophoresis and CRI in CHB patients within the VV delay range (A) and similar CRI in 6 other patients within the VV delay range (B). Due to LV pre-activation from 0 to -80 ms (2A), the waveform morphology changes with the gradual decrease in pre- and post-amplitude amplitudes and the eventual “flip” of many individual electrophoresis patterns. During LV pre-activation, AUC decreases and CRI increases to peak. Dose-response curves were observed in the 6 patients shown (2B) and in all 14 patients studied. The mean VV offset with optimal CRI leads RVp LVp by 40 + / - 18 ms. The mean CRI at the optimal VV offset (90 + / - 8.5%) was significantly (p < 0.001) greater than the CRI at VV = 0 (54.2 + / - 23.3%).

[0220] Figure 24A -E illustrates the electrophysiological and CRI graphical representations of multiple patients during LV-only pacing within the AV delay range. For example, LV-only pacing was studied in 70 patients. Figure 24A and 24B In the first case, compared to the original, a shorter AVD (60 ms) resulted in a flip of the preceding and following electrograms, with the LVp wavefront significantly ahead of the original wavefront and a low CRI of 15.9%. As AVD increased, the amplitude of the preceding and following electrograms decreased, the AUC decreased, and the CRI increased to a peak of 88.9% at an AVD of 100 ms. With further increases in AVD, the electrogram morphology gradually approached the original LBBB electrogram morphology, and the CRI decreased. Figure 24C In the -E group, a similar dose-response relationship was observed between AVD and CRI, where the LVp wavefront always led the original wavefront at short AVDs, and the original wavefront always led the LVp wavefront at relatively long AVDs. Similar dose-response responses were observed in all 70 patients studied. The optimal CRI (mean 89.6% ± 8%) occurred at a mean AV delay of 116 ms ± 44 ms (61.8% ± 12% of the As-RVs interval), which was 68 ms ± 22 ms shorter than the As-RVs interval.

[0221] Of the 70 patients with LV-only data, 61 (87.1%) also had data collected during synchronous and continuous BiV pacing. Due to wavefront fusion of RVp and LVp, there was little contribution from the original wavefront at the short AVD; therefore, patients were divided into three relatively equivalent subgroups using CRI at the short AVD with BiV pacing. 21 patients (34.4%) had CRI <50%, 21 patients (34.4%) had CRI <50-75%, and 19 patients (31.2%) had CRI >75%. Figure 25A-D shows the patient's ECG electrogram and CRI map, where when BiV pacing is performed at a short AVD, the RVp wavefront significantly leads the LVp wavefront (CRI 30%). With increasing AVD, the electrogram morphology or CRI changes little. In contrast, with LV pacing only at a short AVD, the pre-electrogram flip is consistent with the LVp wavefront significantly leading the original wavefront. The CRI is lower, but gradually increases to a peak of 99% at 180 ms AVD. With further increases in AVD, the original wavefront gradually moves to significantly lead the LVp wavefront and the CRI decreases. In the case of sequential BiV pacing at a 150 ms pacing AVD, pre-activation of the LV lead gradually flattens the electrogram and increases the CRI, where the optimal CRT setting is likely at VV-50 (halfway between VV-40 ms and VV-60 ms).

[0222] Figure 26A -D illustrates the depiction of electrocardiograms and CRI graphical representations for individual patients within the AV and VV delay ranges. For example, during BiV pacing at short AVD (CRI 70%), the RVp wavefront slightly leads the LVp wavefront. As AVD increases, CRI gradually decreases due to increased pre- and post-wavefront electrical activity generated by the original wavefront. At AVD of 140 ms, the electrocardiograms of BiV pacing and LV-only pacing are nearly identical, consistent with the fusion of the original wavefront and the LVp wavefront, while the contribution of the RVp wavefront is minimal. LV-only pacing results in a dose-dependent increase in CRI, peaking at AVD of 100 ms and then gradually decreasing. With increased LV pre-activation, continuous BiV pacing at AVD of 120 ms indicates a sustained and steady increase in CRI.

[0223] Figure 27A -D shows the patient's data where the RVp and LVp wavefronts were fairly timely (CRI of 80% at 100 ms AVD). Increasing AVD resulted in a gradual decrease in CRI as the combined RVp and original wavefronts significantly preceded the LVp wavefront. As with previous patients, only LV pacing produced peak CRI, which gradually decreased with further increases in AVD (due to the original wavefront increasingly moving ahead of the LVp wavefront). Continuous BiV pacing was performed on this patient by keeping the A-LVp interval constant at 160 ms and sequentially lengthening the A-RVp interval. This resulted in only minor changes in electrogram morphology and CRI, as the RVp wavefront contributed little to the fusion at 160 ms AVD (the electrogram morphology during BiV pacing was almost identical to that of only LV pacing at 160 ms AVD). Therefore, delaying the RVp wavefront by 20 to 60 ms did not significantly alter the fusion of the original and LVp wavefronts.

[0224] During BiV pacing at short AVD, only 5 patients (8.2%) had a positive AUC (LVp wave preceding RVp wave), and all patients had a CRI >75%. The mean CRI for BiV pacing at short AVD was 57.2 ± 30%. The mean optimal CRI during BiV pacing was only 7.3 ± 14.7% higher. In continuous BiV pacing, only 3 patients (5%) achieved optimal CRI at VV=0. Optimal CRI was found in 20 patients (33%) with LV preactivation at 20 ms, 19 patients (31%) with 40 ms, and 19 patients (31%) with 60 ms. The optimal CRI during continuous BiV pacing was 83.9 ± 13%, and occurred at LV preactivation at 40.2 ± 20 ms. The CRI in the standard device setting (VV=0 and AVD is approximately 70% of the PR interval) was 49.9 ± 23.2%. The CRI in the optimal overall device setting was significantly better, at 91.6 ± 7.8% (p<0.001).

[0225] On average, the RVp wavefront leads the LVp wavefront by approximately 40 ms, and the original wavefront leads the LVp wavefront by approximately 70 ms. CRI of BiV pacing at a short AVD helps determine whether the RVp and LVp wavefronts are synchronized. Changes in the AVD of BiV pacing generally do not produce a substantial improvement in electrical synchronization. In contrast, in all patients studied, starting at a short AVD and gradually increasing the AVD with LV-only pacing produced a dose-dependent increase in CRI with a peak, which then gradually decreased. Continuous BiV pacing with LV pre-activation generally increases CRI by moving the LVp wavefront (usually delayed) well ahead of the RVp and / or original wavefront. BiV pacing at standard settings (VV=0, AVD at approximately 70% of the PR interval) produces an approximately 50% increase in CRI compared to the original LBBB, which can be significantly improved to approximately 92% CRI with optimal programming using ECG bands.

[0226] In patients with atrial fibrillation or chronic heart disease (CHB), there is no fusion of the original wavefront with the LVp and RVp wavefronts, thus allowing for the investigation of the effects of pure BiV pacing. The degree of wavefront fusion during simultaneous BiV pacing in these patients is determined by the location of the LV and RV leads and the conduction properties of the LV myocardium (latency, block, wavefront conduction velocity). Wavefront fusion and cancellation during simultaneous BiV pacing, as measured by CRI, ranged from -3.1% to 89.2% in these patients, with a mean of 54%. In all these patients, the RVp wavefront leads the LVp wavefront in cases of simultaneous RV and LV pacing. The only programming option to improve wavefront fusion and electrical synchronization in these patients is to alter the VV delay. An average LV pre-activation of approximately 40 ms resulted in an increase in CRI from 54% to 90%.

[0227] In patients with intact AV junction conduction, LV pacing alone was used to investigate the effects of LVp wavefront fusion and cancellation on the original wavefront. In all 70 patients studied, LV pacing had a consistent effect on wavefront fusion and cancellation. At very short AV delays, the LVp wavefront always led the original wavefront. As the AV delay gradually lengthened, CRI improved due to increased electrofusion and cancellation, and was considered to be primarily a decrease in post-QRS amplitude, followed by a decrease in pre-QRS amplitude, while QRSd shortened. Most (90%) patients reached >80% of peak CRI when AV delay was assessed in 20-millisecond increments. Once peak CRI was reached, further increases in AV delay led to a gradual decrease in CRI as the original wavefront increasingly moved ahead of the LVp wavefront, exemplified by a gradual increase in pre- and post-electrograph amplitude. On average, peak CRI occurred at an AV delay approximately 70 m shorter than the PR interval. Although peak CRI occurred at 62% of the mean AV delay of the original PR interval, considerable variation exists, requiring individual optimization to achieve optimal wavefront fusion.

[0228] At a constant VV delay of 0, variations in AV delay lead to varying degrees of fusion among the original wavefront, RVp wavefront, and LVp wavefront. With shorter AV delays, the RVp wavefront consistently precedes the original wavefront, and the patient receives BiV pacing, with the original wavefront making no significant contribution. As AV delay increases, the contribution of the original wavefront to LV depolarization becomes increasingly larger. The contribution of the original wavefront to LV depolarization can be determined by changes in waveform morphology and CRI, with a typical response being an increase in the amplitude of the preceding waveform and a decrease in CRI due to the combination of the original wavefront and RVp wavefront providing a more dominant preceding and following wavefront. Once the AV delay is within the original PR interval of approximately 20–30 ms, the RVp wavefront makes almost no contribution to LV depolarization, as shown by the lack of change in morphology or CRI between electrograms obtained with and without RV pacing at the same longer AV delay. At these longer AV delays during BiV pacing, the patient effectively receives LV-only pacing fused with the original conduction, but the AV delay is too long, resulting in the original wavefront having a greater advantage over the LVp wavefront.

[0229] During simultaneous BiV pacing, the mean peak CRI within the AV delay range was significantly lower (p<0.001) than the mean peak CRI during LV pacing alone within the same AV delay range (63.4% vs. 89.6%). This is likely because the RVp wavefront is dominant in almost all patients and significantly leads the LVp wavefront. In the absence of pre-activation of the LV lead in these patients, the RVp wavefront (or a combination of right-sided RVp and the original wavefront) typically remains ahead of the LVp wavefront throughout the AV delay range. In patients with relatively high CRI during BiV pacing at short AV delays, LV pre-activation requires only about 20 ms to optimize electrical synchronization because the RVp wavefront only slightly leads the LVp wavefront. In patients with low CRI during BiV pacing at short AV delays, LV pre-activation requires 40–60 ms to optimize LV electrical synchronization because the RVp wavefront significantly leads the LVp wavefront.

[0230] As mentioned above, there is no standard, widely accepted method for optimizing CRT programming, and the vast majority of patients remain in their initial CRT device settings. While 12-lead ECG optimization can be performed and has proven valuable, the systems and methods described above offer numerous benefits. For example, due to the increased number of leads and the presence of a posterior lead, these systems and methods can detect changes in wavefront fusion and cancellation better than 12-lead ECGs. Since the lower ventricle (LV) is largely located in the posterior chest, the posterior electrode provides a wealth of information that the anterior lead cannot obtain. The ECG banding method described herein offers many potential benefits for optimizing CRT: it is non-invasive, practical, rapid (30 settings can be tested in approximately 30 minutes), and unaffected by observer bias (all measurements are automated).

[0231] Figure 28 This is a block diagram of another exemplary treatment sequence 900 for optimizing cardiac resynchronization therapy (CRT) treatment (e.g., determining one or more personalized IMD characteristics, CRI values, and / or optimal CRT treatment). (Refer to...) Figure 1-7 The system 100 shown herein describes the processing sequence 900. However, any suitable structure, system, component, device, and / or apparatus may be employed.

[0232] Furthermore, the functionality of one or more boxes from processing sequence 900 can be similar to that of the boxes from processing sequences 200-500 described above. For example, similar to processing sequence 200, computing device 140 can receive raw measurement results (first measurement results) and second measurement results of personalized IMD characteristics (e.g., IMD delay characteristics such as AV, BiV, and / or VV delays). Computing device 140 can then determine the CRI value and optimal CRT processing (e.g., optimal delay applied to IMD 16 based on wavefront cancellation between leads 18, 20, and / or 22).

[0233] Additionally and / or alternatively, the computing device 140 can determine information from a data structure, such as a matrix. This information can indicate different delays applied to IMD 16 for the second measurement result and CRI value. Furthermore, additionally and / or alternatively, the computing device 140 can generate and display a heatmap representing the CRI values. In some cases, using a data structure with CRI values ​​and / or a heatmap can make it easier for users, such as physicians, to determine optimal CRT treatment. For example, a heatmap generated based on CRI values ​​can help physicians determine the optimal settings for IMD 16 (e.g., physicians can easily see the portion of the optimal CRT settings used for CRT programming). In other cases, using a data structure with CRI values ​​and / or a heatmap can allow the process of determining optimal CRT treatment to be more robust and standardized. For example, as mentioned above, there is no standard, widely accepted method for optimizing CRT programming. Thus, information from the data structure can indicate priorities, such as always acquired, usually acquired, and / or sometimes acquired, which can help standardize the process used to optimize CRT programming.

[0234] In operation, at box 902, computing device 140 can receive one or more input variables corresponding to patient 14 (e.g., patient category and / or IMD device type) and / or one or more first set of measurements (e.g., raw measurements). For example, similar to box 202 above, computing device 140 can receive one or more raw measurements from measuring electrodes 112 and / or 114. For example, when leads 18, 20, and / or 22 of IMD 16 are disconnected, measuring electrodes 112 and / or 114 can measure electrical information such as cardiac activation signals (e.g., depolarization and / or repolarization) of the patient's heart 12. Measuring electrodes 112 and / or 114 can provide electrical information to interface / amplifier circuitry 116. Interface / amplifier circuitry 116 can amplify the signal and then provide the signal to computing device 140.

[0235] Additionally and / or alternatively, similar to box 302 above, computing device 140 may receive one or more input variables (e.g., user input) corresponding to a patient such as patient 14. For example, computing device 140 may receive from input device 142 patient 14's name, patient 14's date of birth, date IMD 16 implanted in patient 14, cause of heart failure (HF) (e.g., ischemic cardiomyopathy (ICM), non-ischemic cardiomyopathy (NICM), and / or others), patient category, and / or IMD device type (e.g., IMD 16 manufacturer). Patient category may include, but is not limited to, atrial fibrillation / flutter (AF), complete cardiac conduction block (CHB), left bundle branch block (LBBB), interventricular conduction delay (IVCD), right ventricular pacing (RVP), stenosis, and / or right bundle branch block (RBBB). In some cases, as described in box 306 above, the computing device 140 can determine the patient category (e.g., LBBB, RBBB, IVCD, RVP, stenosis, CHB, and / or AF) based on the received raw measurements.

[0236] At box 904, based on input variables and / or raw measurement results, computing device 140 can determine information related to and indicating delays corresponding to atrial leads (e.g., RA lead 22), LV lead 20, and / or RV lead 18, as well as data structures (e.g., templates, tables, matrices, and / or another type of data type or structure). For example, the delays of RA lead 22, LV lead 20, and RV lead 18 may include, but are not limited to, the delay from RA lead 22 to RV lead 18 (A-RV delay) and / or the delay from RA lead 22 to LV lead 20 (A-LV delay).

[0237] Figure 29 and 30 An exemplary data structure for two patients using two different input variables is shown. For example, in data structure 1000, the patient uses a first device type where VV-20 ms at an atrial pacing AV delay (PAV) of 160 ms (e.g., from atrial pacing or RA lead 18 pacing) means A-RV is 180 ms and A-LV is 160 ms. In matrix 1010, the patient uses a second device type where VV-20 ms at an atrial sensing AV delay (SAV) of 100 ms (e.g., from atrial sensing, RA lead 18 sensing) means A-RV is 100 ms and A-LV is 80 ms. In other words, Figure 29Matrix 1000 is shown, where x-axis 1002 indicates the A-LV delay and y-axis 1004 indicates the delay from the A-RV delay. The A-LV delay can be the delay or time difference between the original pulse (IMD 16 operating in AS mode) / the pulse generated by RA lead 22 (IMD 16 operating in AP mode) and the pulse generated by LV lead 20 (e.g., the LV pulse). The A-RV delay can be the delay or time difference between the original pulse (IMD 16 operating in AS mode) / the pulse generated by RA lead 22 (IMD 16 operating in AP mode) and the pulse generated by RA lead 18 (e.g., the RA pulse). If the A-LV delay is the same as the A-RV delay (e.g., the lower left entry shows an A-LV delay of 140 ms and an A-RV delay of 140 ms), then it is the simultaneous BiV delay described above (e.g., a BiV delay of 140 ms). If they are different, it is a BiV delay with a VV delay. For example, entries showing an A-LV of 140 ms and an A-RV of 160 ms indicate a PAV latency of 140 ms and a VV latency of -20 ms. Similarly, entries showing an A-LV of 200 ms and an A-RV of 240 ms indicate a PAV latency of 200 ms and a VV latency of -40 ms. The top entries show only LV latency characteristics (e.g., an entry showing an A-LV of 200 ms is an LV latency of 200 ms only). The right-hand entries show only RV latency characteristics (e.g., an entry showing an A-RV of 200 ms is an RV latency of 200 ms only). Figure 30 Another matrix 1010 is shown for the second patient 14, where the x-axis 1002 indicates A-LV delay and the y-axis 1004 indicates A-RV delay.

[0238] In some instances, the information indicating delay may include priority information such as always acquired, usually acquired, and / or sometimes acquired. The computing device 140 may use patient category, device type, and / or raw measurement results to determine the priority information.

[0239] In some variations, computing device 140 may determine information indicating delays in the data structure based on patient category, IMD device type, and / or raw measurement results. For example, computing device 140 may determine different A-LV delays and / or A-RV delays for patient 14 based on patient category, IMD device type, and / or a first set of measurement results. For example, refer to... Figure 29 The computing device 140 can determine the A-LV and / or A-RV delay and / or generation matrix 1000 based on determining that IMD 16 is the first IMD device type. (Reference) Figure 30The computing device 140 can determine the A-LV and / or A-RV delay and / or generation matrix 1010 based on determining that the IMD 16 is a second IMD device type.

[0240] Additionally and / or alternatively, the computing device 140 may vary the increment between each entry based on patient category, IMD device type, and / or original measurement results (e.g., Figure 29 and 30 (The 10-millisecond increments are shown versus the 20-millisecond increments). Additionally and / or alternatively, the computing device 140 may determine the maximum delay (e.g., A-RV delay and / or A-LV delay) based on the PR interval of the patient 14. For example, refer to... Figure 29 If computing device 140 determines that the PR interval of patient 14 is 300 milliseconds, then computing device 140 may determine the maximum A-RV delay and / or A-LV delay as 280 milliseconds. Computing device 140 may use the maximum delay and / or the increment between each entry to determine different A-LV delays and / or A-RV delays for patient 14.

[0241] Additionally and / or alternatively, the computing device 140 may determine the size of the data structure (e.g., a 9×9 matrix, an 8×8 matrix, a 7×7 matrix, etc.) based on the patient category, the IMD device type, and / or the first set of measurement results.

[0242] Additionally and / or alternatively, if the input variables and / or raw measurement results indicate AF and / or CHB, the computing device 140 can generate a first data structure type (e.g., a first matrix). If the input variables and / or raw measurement results indicate LBBB, IVCD, RVp, or narrow QRS, the computing device 140 can generate a second data structure type or a different data structure type. Furthermore, if the input variables and / or raw measurement results indicate RBBB, the computing device 140 can generate a third data structure type different from the first or second data structure.

[0243] In some cases, information containing different data structures with varying delays and priorities can be stored in memory 152. For example, memory 152 can store different information for each patient category, for each type of device. This different information can include the size of the data structure, A-LV and A-RV delays, and different priorities. For example, computing device 140 can determine that IMD 16 is a first-type device and the patient category is LBBB. Computing device 140 can retrieve information from memory 152 for the first-type device and the patient category LBBB, which may indicate the size of the data structure (e.g., an 8×8 matrix) and entries with different priorities, such as... Figure 29 The priorities shown are always 1020, usually 1022, and sometimes 1024. Then, based on the measured PR interval, computing device 140 can determine the maximum A-RV and A-LV latency (e.g., if the PR interval is 300 milliseconds, then the maximum A-RV and A-LV latency is 280 milliseconds). Computing device 140 can then use intervals such as pre-programmed, predefined, and / or user-defined intervals to fill in other portions of the A-RV and A-LV latency (e.g., reducing the 280-millisecond latency by 20 milliseconds, down to 140 milliseconds).

[0244] Furthermore, if the computing device 140 determines that IMD 16 is a first-type device and the patient category is RBBB, the computing device 140 can retrieve different information for the first-type device and the patient category from the memory 152. For example, the computing device 140 can retrieve information corresponding to... Figure 30 The data structure 1010 shown contains information such as a 7×7 matrix size and entries with priorities of always acquiring 1020, usually acquiring 1022, sometimes acquiring 1024, and 1026 being unavailable. Then, based on the measured PR interval, the computing device 140 can determine the maximum A-RV and A-LV latency (e.g., if the PR interval is 200 milliseconds, then the maximum A-RV and A-LV latency is 180 milliseconds). The computing device 140 can then use intervals such as pre-programmed, predefined, and / or user-defined intervals to fill in other portions of the A-RV and A-LV latency (e.g., reducing the 180-millisecond latency by 20 milliseconds, down to 60 milliseconds).

[0245] At box 906, computing device 140 may determine personalized IMD characteristics based on filtering entries indicating delays in a data structure and / or prioritizing them. For example, entries from the generated data structure may have different priorities (e.g., first, second, third, etc., rankings or priorities). Based on the corresponding priorities, computing device 140 may determine the personalized IMD characteristics to use. As previously described and will be further described in detail below, computing device 140 provides (e.g., directly and / or through displaying and providing user input to IMD 16) personalized IMD characteristics to IMD 16. Then, based on the personalized IMD characteristics, computing device 140 receives a second set of measurements, determines a CRI value based on the measurements, and determines the optimal CRT treatment.

[0246] refer to Figure 29 The data structure or matrix 1000 can have a first priority or higher priority, such as always getting 1020; a second priority, such as usually getting 1022; and a third priority, such as sometimes getting 1024. (See reference) Figure 30 The data structure or matrix 1010 can have a first priority or high priority, such as always getting 1020, a second priority, such as usually getting 1022, a third priority, such as sometimes getting 1024, and a fourth priority, such as not being available 1026.

[0247] In some instances, computing device 140 may receive user input indicating priorities or selections for filtering entries and determining personalized IMD characteristics. For example, computing device 140 may display a data structure on display 132. Computing device 140 may then receive user input indicating selections such as always getting 1020 and usually getting 1022. Computing device 140 may determine entries within a data structure, such as data structure 1000 or 1010, that have corresponding priorities indicating always getting 1020 and usually getting 1022.

[0248] In some cases, data structures can be pre-programmed and / or predefined to filter entries. For example, computing device 140 can determine personalized IMD characteristics to have entries with a first priority, such as always getting 1020. Additionally and / or alternatively, computing device 140 can receive user input indicating a second priority, such as usually getting 1022. Based on the user input, computing device 140 can add entries corresponding to usually getting 1022 to the personalized IMD characteristics.

[0249] Additionally and / or alternatively, computing device 140 may receive user input indicating additional entries to be selected and / or entries to be removed. For example, computing device 140 may receive user input indicating that one or more entries corresponding to a value of 1024 (e.g., A-LV for 160 milliseconds and A-RV for 140 milliseconds) should be added to the personalized IMD feature. Computing device 140 may add the A-LV for 160 milliseconds and A-RV for 140 milliseconds to the personalized IMD feature. Additionally and / or alternatively, computing device 140 may receive user input indicating that one or more entries corresponding to a value of 1022 (e.g., A-LV for 140 milliseconds and A-RV for 200 milliseconds) should be removed from the personalized IMD feature.

[0250] At block 910, based on the personalized IMD characteristics determined according to block 906, computing device 140 can receive a second set of measurement results (e.g., second measurement results) corresponding to the determined IMD characteristics from measurement electrodes 112 and / or 114. The function of block 910 can be similar to that of block 206 described above. For example, at block 908, computing device 140 can determine multiple different characteristics (e.g., multiple different delays from data structures such as structure 1000). IMD 16 can receive and / or apply personalized IMD characteristics. In response to applying each personalized IMD characteristic, computing device 140 can receive a second set of measurement results for the corresponding personalized IMD characteristic from measurement electrodes 112 and / or 114.

[0251] In some instances, computing device 140 can categorize the personalized IMD characteristics to be applied to IMD 16. For example, computing device 140 can initially apply only LV personalized IMD characteristics (e.g., top row entries from data structure 1000). Then, computing device 140 can apply entries with the same A-LV latency (e.g., moving column-by-column within data structure 1000).

[0252] At box 912, computing device 140 can determine the CRI value of the measurement result and / or populate a data structure using the CRI value and information indicating delay. Box 912 functions similarly to box 208 above. For example, computing device 140 can determine the CRI value based on a comparison between a first measurement result (e.g., the original measurement result) and a second measurement result (e.g., a measurement result with corresponding personalized IMD characteristics). After determining the CRI value, computing device 140 can populate the CRI value for each corresponding entry in a data structure such as structure 1000. For example, computing device 140 can determine the CRI value as described above using the second measurement result corresponding to 140 milliseconds A-LV and 140 milliseconds A-RV, as well as the original measurement result. Then, computing device 140 can populate the 140 milliseconds A-LV and 140 milliseconds A-RV entries with the determined CRI value. For each of the determined IMD characteristics, computing device 140 can populate the corresponding entry in a data structure such as structure 1000 with its CRI value.

[0253] At box 914, computing device 140 can generate and / or display a graphical representation of a data structure such as structure 1000 on a display device such as display 132. The graphical representation can be any type of graphical representation, such as a graph, chart, heatmap, etc. In some cases, computing device 140 may not receive the CRI value for each entry within an entry of a data structure such as data structure 1010. In this case, computing device 140 can use best-fit calculations (e.g., best-fit curve, best-fit line, average, etc.) to populate the data structure and generate a graphical representation. For example, for entries with an unavailable priority of 1026, computing device 140 may not receive their CRI values. In this case, computing device 140 uses best-fit calculations on these entries and generates a graphical representation based on the best-fit calculations.

[0254] Figures 31-33 An exemplary graphical representation of the populated data structure is shown. Figure 31 A 3-D heatmap 1020 of a populated data structure, such as structure 1000, is shown. For example, computing device 140 can display the 3-D heatmap 1020 on display 132. The 3-D heatmap 1020 includes A-LV intervals 1002 on the x-axis, A-RV intervals 1004 on the y-axis, and CRI (%) 1006 on the z-axis. Furthermore, illustration 1008 shows the corresponding CRI values ​​from different entries of data structure 1000.

[0255] Figure 32Another heatmap 1030 of a populated data structure, such as structure 1000, which the computing device 140 can display on the display 132, is shown. Furthermore, the computing device 140 can generate and / or display various other markers on the display 132. For example, the computing device 140 can display markers 1032 and 1034. Marker 1032 can represent a BiV entry without VV delay (e.g., A-RV and A-LV have the same delay). Marker 1034 can represent only LV entries (e.g., from the top row of data structure 1000).

[0256] The computing device 140 can also display markers 1036 (e.g., optimal CRI curve) and 1050. Marker 1050 represents the programming window used by the user / doctor when programming the IMD 16. In other words, marker 1050 shows areas where the CRI value is higher than a certain CRI threshold (e.g., 80%). These areas can be used for optimal CRT treatment settings to be programmed in the IMD 16. For example, according to data structure 1000, the computing device 140 can determine entries where the CRI value exceeds a predefined, predetermined, and / or user-defined threshold (e.g., 80%). The computing device 140 can then generate and display markers such as 1036 indicating entries exceeding the threshold. In other words, the computing device 140 can display a curve passing through the center of a portion of the graphical representation of the data structure (e.g., heatmap 1030). Marker 1036 can contain three distinct segments 1044, 1046, and 1048. Section 1044 represents the optimal fusion and / or cancellation between the original pulse and the LV lead 20 pulse. Section 1046 represents the optimal fusion and / or cancellation between the original pulse, the LV lead 20 pulse, and the RV lead 18 pulse. Section 1048 represents the optimal fusion and / or cancellation between the RV lead 18 pulse and the LV lead 20 pulse.

[0257] Additionally and / or alternatively, the computing device 140 may display labels 1038, 1040, and 1042 (e.g., A, B, and C). Label 1038 indicates the optimal IMD characteristic between RV and LV delay (e.g., the optimal VV delay setting for IMD 16). Label 1040 indicates the optimal IMD characteristic between the raw measurement and the optimal LV delay (during LV pacing only). Label 1042 indicates the optimal IMD characteristic between the raw measurement and the optimal RV delay.

[0258] At box 916, computing device 140 can determine whether to generate a new data structure and / or graphical representation. In some variations, computing device 140 can determine to generate a new data structure and / or graphical representation based on the CRI value from the data structure being below a threshold (e.g., below 80%). Processing sequence 900 can then move back to box 904. For example, if all personalized IMD characteristics of entries from the data structure are below the threshold, computing device 140 can determine to generate a new data structure. Otherwise, processing sequence can move to box 918.

[0259] Additionally and / or alternatively, based on received user input indicating a need for new data structures and / or graphical representations, computing device 140 may determine to generate new data structures and / or graphical representations. Furthermore, as discussed below, user input may indicate new types of information, such as different IMD 16 configurations (e.g., atrial sensing, atrial pacing, different cathode / anode pairs). Processing sequence 900 may then return to block 904.

[0260] At box 918, computing device 140 can determine one or more optimal CRT treatments and / or provide information for administering CRT treatments based on the generated graphical representation and / or filled data structure. The function of box 918 can be similar to that of box 210 described above and... Figure 11 Further description is provided below. For example, computing device 140 can display a graphical representation of the generated data structure on display device 132. Based on the generated graphical representation, computing device 140 can receive user input indicating optimal CRT treatment. Computing device 140 can provide information indicating optimal CRT treatment to IMD 16. In other words, computing device 140 can set IMD 16 to the determined optimal CRT treatment (e.g., the delay between RA lead 22, LV lead 20, and RV lead 18). Then, processing sequence 900 can end.

[0261] If processing sequence 900 moves back to box 904, computing device 140 can determine new information related to the data structure and indicating delays corresponding to RA lead 22, LV lead 20, and / or RV lead 18. For example, the new information may include operating IMD 16 in a different mode (e.g., changing the electrode vector used for CRI values ​​and / or changing the mode from AS to AP or vice versa) and / or determining new delays (e.g., A-RV and / or A-LV delays). Computing device 140 can determine the new information automatically and / or based on user input. For example, computing device 140 may retrieve instructions from memory such as memory 152 and / or indicate new information. Additionally and / or alternatively, computing device 140 may receive user input indicating new information.

[0262] In some cases, the new information may include instructions to operate IMD 16 in a different mode. For example, if IMD 16 operated in a first mode (e.g., AS mode) in a previous iteration, computing device 140 may (e.g., directly and / or via display 132 and user input to IMD 16) provide instructions to IMD 16 to operate in a new mode or a second mode (e.g., AP mode). Computing device 140 may apply personalized IMD characteristics based on IMD 16 operating in the new mode and receive a second set of measurement results.

[0263] In other words, if initially, when IMD 16 is in AS mode (e.g., RA lead 22 is sensing the raw signal of the wavefront), personalized IMD characteristics applied to IMD 16 to obtain CRI values ​​are executed, then for the next iteration (e.g., back to box 904), computing device 140 can apply personalized IMD characteristics in AP mode (e.g., RA lead 22 is providing a signal to the wavefront). If the original second set of measurements were when IMD 16 was in AP mode, computing device 140 can apply personalized IMD characteristics in AS mode. Additionally and / or alternatively, computing device 140 can determine new A-LV and / or A-RV delays, intervals, magnitudes, etc., for IMD 16 in the second iteration.

[0264] In some cases, if the IMD 16 uses the first electrode vector in previous iterations, the computing device 140 can (e.g., directly and / or via the display 132 and user input to the IMD 16) provide instructions to the IMD 16 to use the second electrode vector. The computing device 140 can then apply personalized IMD characteristics based on the IMD 16 using the second electrode vector and receive a second set of measurement results.

[0265] In other words, in the first iteration, computing device 140 determines a first vector (e.g., from one or more pacing electrodes, such as electrodes 40, 42, 44, 45, 46, 47, 48, 50, from leads such as LV lead 20) to apply personalized IMD characteristics from the data structure. For example, for the first iteration, computing device 140 may determine to turn on electrode 44 of LV lead 20 to apply a pacing pulse. For the second iteration, computing device 140 may determine a new vector or a second vector (e.g., from electrode 47 of LV lead 20) to apply a pacing pulse. Processing sequence 900 may be repeated continuously and different vectors may be applied to IMD 16 to determine different CRI values ​​for personalized IMD characteristics. 140 may generate new data structures (e.g., new matrices containing new A-LV and / or A-RV delays, intervals, sizes, etc.) for IMD 16 operating in a second mode.

[0266] In some cases, computing device 140 can (e.g., directly and / or via display 132 and user input to IMD 16) provide instructions to IMD 16 to apply different multi-point pacing configurations. For multi-point pacing, two different LV electrodes (e.g., 44, 45, 46, 47) are used as cathodes, where the time delay between pacing stimulations of each electrode is variable. For example, computing device 140 can adjust the timing of two or more cathodes, such as electrodes 44 and 46, from LV lead 20 and instruct these two leads when to emit their LV pulses to rendezvous with the RV lead / origin. Compared to single-point pacing (e.g., using a single LV lead electrode), computing device 140 can use data structures and / or information specific to multi-point pacing.

[0267] Figure 33 A 3-D heatmap 1060 with a filled data structure, such as structure 1010, is shown. For example, computing device 140 can display the 3-D heatmap 1060 on display 132. The 3-D heatmap 1060 includes the A-LV interval 1002 on the x-axis, the A-RV interval 1004 on the y-axis, and the CRI (%) 1006 on the z-axis. As shown, the graphical representation 1060 does not contain any CRI values ​​higher than 60%. This may be because the electrode lead (LV lead 20) is in a suboptimal (typically anterior) position, making sufficient wavefront fusion and cancellation impossible. For example, referring back to reference 13, if the LV lead 20 were positioned closer to the bottom or anterior, the LV lead 20 pulse would begin to be closer to the centerline 653. Thus, the pulse from lead 20 may never optimally cancel the pulse from RV lead 18 and / or the original pulse at the center 653 of the left ventricle.

[0268] If similar data structures are obtained when pacing with different LV electrodes, such as electrodes 44-48, and no CRI value is above a certain threshold (e.g., 60%), then LV lead 20 may be poorly positioned, and possible LV lead replacement needs to be considered. In other words, computing device 140 can process several iterations of sequence 900 and generate new information for new data structures and new graphical representations. If computing device 140 determines that there is no optimal CRT treatment setting that can be used (e.g., CRI value below a threshold such as 60%), then computing device 140 can determine that LV lead 20 is poorly positioned. Then, computing device 140 can display a prompt indicating poor LV lead 20 positioning. By displaying the prompt, the physician can move the patient's LV lead 20 to a better position and obtain a better CRI value / optimal CRT treatment setting.

[0269] The techniques described in this disclosure (including those attributable to IMD 16, computing device 140, and / or various constituent components) can be implemented at least in part in the form of hardware, software, firmware, or any combination thereof. For example, aspects of the techniques can be implemented within one or more processors embodied in a programmer, stimulator, image processing device, or other apparatus, such as a physician or patient programmer, which includes one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuit systems, and any combination of such components. The terms “module,” “processor,” or “processing circuit system” generally refer to any circuit system, alone or in combination with other logic circuit systems, or any other equivalent circuit system.

[0270] Such hardware, software, and / or firmware may be implemented within the same device or in separate devices to support the various operations and functions described in this disclosure. Furthermore, any described unit, module, or component may be implemented together or individually as discrete but interoperable logical devices. Describing different features as modules or units is intended to highlight different functional aspects and does not necessarily imply that such modules or units must be implemented by separate hardware or software components. Rather, the functionality associated with one or more modules or units may be performed by separate hardware or software components, or integrated into shared or separate hardware or software components.

[0271] When implemented in software, the functionality attributable to the systems, apparatus, and techniques described herein can be embodied in instructions on a computer-readable medium such as RAM, ROM, NVRAM, EEPROM, flash memory, magnetic data storage media, optical data storage media, etc. The instructions can be executed by a processing circuit system and / or one or more processors to support one or more aspects of the functionality described herein.

[0272] As described herein, exemplary systems, methods, and interfaces can be used to provide non-invasive assistance to users when assessing a patient's cardiac health or condition and / or evaluating cardiac therapies (e.g., cardiac therapies currently delivered to the patient during or after implantation). Further, exemplary systems, methods, and interfaces can be used to assist users in configuring cardiac therapies being delivered to patients. For example, exemplary systems, methods, and interfaces can be used to test multiple different cardiac therapy settings and present the results of these settings to a user via a graphical user interface. Further, for example, exemplary systems, methods, and interfaces can test multiple different cardiac therapy settings and present one or more effective cardiac therapy settings to a user. In at least one embodiment, exemplary systems, methods, and interfaces can automatically program a cardiac therapy device to use effective cardiac therapy settings.

[0273] The specific embodiments and examples described herein are presented for illustrative and descriptive purposes only and are not intended to be limiting. Therefore, this disclosure is contemplated to cover any and all modifications, variations, or equivalents falling within the spirit and scope of the fundamental principles of the foregoing disclosure and claims herein.

Claims

1. A system for cardiac resynchronization of a patient, the system comprising: one or more processors configured to communicate with a plurality of measurement electrodes operatively coupled to the patient; and a tangible, non-transitory storage medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to: receive, from the plurality of measurement electrodes, a first set of electrical measurements indicative of a first electrical signal applied to a heart of the patient; receive one or more input variables comprising a patient category corresponding to a cardiac condition of the patient; determine, based on the one or more input variables, information corresponding to a data structure and indicative of delays associated with an atrial lead, a left ventricular (LV) lead, and a right ventricular (RV) lead, the information indicative of a plurality of entries each associated with a first delay characteristic from the atrial lead to the LV lead and a second delay characteristic from the atrial lead to the RV lead; determine, based on the information corresponding to the data structure, a plurality of individualized characteristics each comprising at least one delay characteristic selected from an atrio-ventricular (AV) delay characteristic and a ventricular-ventricular (VV) delay characteristic of the atrial lead, the LV lead, and / or the RV lead; receive, based on the plurality of individualized characteristics, a plurality of second sets of electrical measurements indicative of a second electrical signal applied to the heart of the patient from the plurality of measurement electrodes; determine a cardiac resynchronization index (CRI) value calculated as a % change in area under the curve (AUC) based on a comparison between the first set of electrical measurements and the plurality of second sets of electrical measurements; populate the data structure based on the CRI value and the information indicative of the delays; generate a graphical representation based on the populated data structure; and cause the graphical representation corresponding to the populated data structure to be displayed on a display device.

2. The system of claim 1, wherein the information corresponding to the data structure is indicative of a plurality of entries, wherein each of the plurality of entries is associated with a first delay characteristic of a right atrial (RA) lead of an IMD to a left ventricular (LV) lead of the IMD and a second delay characteristic of the RA lead of the IMD to a right ventricular (RV) lead of the IMD.

3. The system of claim 2, wherein a first subset of the plurality of entries is associated with a plurality of LV-only lead delay characteristics, and wherein a second subset of the plurality of entries is associated with a plurality of biventricular (BiV) lead characteristics without ventricular-ventricular (VV) delay characteristics.

4. The system of claim 2, wherein a first subset of the plurality of entries is associated with a first priority, and wherein the determining the plurality of individualized characteristics comprises filtering the plurality of entries based on the first priority. ​ 5. The system of claim 4, wherein a second subset of the plurality of entries is associated with a second priority, and wherein the determining the plurality of personalization characteristics further comprises: receiving user input indicating the second priority; and including the second subset of the plurality of entries corresponding to the second priority into the plurality of personalization characteristics.

6. The system of claim 4, wherein the determining the plurality of personalization characteristics further comprises: receiving user input indicating one or more entries from the plurality of entries; and including the one or more entries from the plurality of entries into the plurality of personalization characteristics.

7. The system of claim 2, wherein the generating the graphical representation based on the populated data structure comprises generating a heat map based on the determined CRI value, the first latency characteristic, and the second latency characteristic.

8. The system of claim 7, wherein the causing the graphical representation to be displayed comprises causing the heat map and one or more visual markers to be displayed, wherein the one or more visual markers indicate at least one optimal cardiac resynchronization therapy (CRT) treatment corresponding to a personalization characteristic from the plurality of personalization characteristics.

9. The system of claim 1, wherein the one or more input variables indicate a patient class corresponding to a cardiac condition of the patient, and wherein the determining the information corresponding to the data structure and indicative of the latency is based on the patient class.

10. The system of claim 1, wherein the one or more input variables indicate a device type of an IMD, and wherein the determining the information corresponding to the data structure and indicative of the latency is based on the device type of the IMD.

11. The system of claim 1, wherein the tangible, non-transitory storage medium further comprises instructions that, when executed by the one or more processors, cause the one or more processors to: determine new information corresponding to the data structure and indicative of the latency, wherein the new information indicates operating an IMD in a different mode; receive, from the plurality of measurement electrodes and based on the new information indicating operating the IMD in the different mode, a plurality of third sets of electrical measurements indicative of a third electrical signal applied to a heart of the patient; determine a new CRI value using the first set of electrical measurements and the plurality of third sets of electrical measurements; populate the data structure based on the new CRI value and the new information; generate a new graphical representation based on the populated data structure; and cause the new graphical representation to be displayed on the display device.

12. The system of claim 11, wherein new information indicates new latencies corresponding to the atrial lead, the LV lead, and the RV lead.

13. The system of claim 11, wherein the new information indicating operating the IMD in the different mode comprises switching the IMD from an atrial sensing mode to an atrial pacing mode.

14. The system of claim 11, wherein the new information indicative of operating the IMD in the different mode comprises switching the IMD from an atrial pacing mode to an atrial sensing mode.

15. The system of claim 11, wherein the new information indicative of operating the IMD in the different mode comprises switching the IMD from a first electrode vector corresponding to a first electrode of a left ventricular (LV) lead to a second electrode vector corresponding to a second electrode of the LV lead.

16. The system of claim 11, wherein the tangible, non-transitory storage medium further comprises instructions that, when executed by the one or more processors, cause the one or more processors to: determine the CRI value, and the new CRI value is below a threshold value; and based on the CRI value and the new CRI value being below the threshold value, cause a prompt indicative of the LV lead being in a suboptimal position to be displayed.

17. A non-transitory computer readable medium storing instructions for execution by one or more processors incorporated into a system for cardiac resynchronization of a patient, wherein execution of the instructions by the one or more processors causes the one or more processors to: receive, from a plurality of measurement electrodes, a first set of electrical measurements indicative of a first electrical signal applied to a heart of the patient; receive one or more input variables comprising a patient category corresponding to a cardiac condition of the patient; based on the one or more input variables, determine information corresponding to a data structure and indicative of delays associated with an atrial lead, a left ventricular (LV) lead, and a right ventricular (RV) lead, the information indicative of a plurality of entries each associated with a first delay characteristic from the atrial lead to the LV lead and a second delay characteristic from the atrial lead to the RV lead; based on the information corresponding to the data structure, determine a plurality of individualized characteristics, each individualized characteristic comprising at least one delay characteristic selected from an atrial-ventricular (AV) delay characteristic and a ventricular-ventricular (VV) delay characteristic of the atrial lead, LV lead, and / or RV lead; based on the plurality of individualized characteristics, receive, from the plurality of measurement electrodes, a plurality of second sets of electrical measurements indicative of a second electrical signal applied to the heart of the patient; determine a cardiac resynchronization index (CRI) value calculated as a % change in area under the curve (AUC) based on a comparison between the first set of electrical measurements and the plurality of second sets of electrical measurements; populate the data structure based on the CRI value and the information indicative of the delays; generate a graphical representation based on the populated data structure; and cause the graphical representation corresponding to the populated data structure to be displayed on a display device. ​ 18. The non-transitory computer-readable medium of claim 17, wherein the information corresponding to the data structure indicates a plurality of entries, wherein each entry of the plurality of entries is associated with a first delay characteristic of a right atrial (RA) lead of an IMD to a left ventricular (LV) lead of the IMD and a second delay characteristic of the RA lead of the IMD to a right ventricular (RV) lead of the IMD.

19. A system for cardiac resynchronization of a patient, the system comprising: one or more processors in communication with a plurality of measurement electrodes operatively coupled to the patient; and a tangible non-transitory storage medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to: receive, from the plurality of measurement electrodes, a first set of electrical measurements indicative of raw electrical energy applied to a heart of the patient; receive, from the plurality of measurement electrodes, a plurality of second sets of electrical measurements indicative of the raw electrical energy applied to the heart of the patient and electrical energy applied to the heart of the patient by at least one lead, each electrical measurement of the plurality of second sets of electrical measurements corresponding to a different characteristic; determine a first electrical dyssynchrony value based on the first set of electrical measurements; determine a plurality of second electrical dyssynchrony values based on the plurality of second sets of electrical measurements; determine a plurality of cardiac resynchronization index values based on a comparison of the first set of electrical measurements and the plurality of second sets of electrical measurements, the plurality of cardiac resynchronization index values calculated as a % change in area under the curve (AUC); and provide information to administer cardiac resynchronization therapy (CRT) based on the plurality of cardiac resynchronization index values.

20. The system of claim 19, further comprising: a display device, and wherein the providing the information comprises providing one or more instructions that cause at least one of the plurality of cardiac resynchronization index values to be displayed on the display device.

21. The system of claim 19, wherein the at least one lead comprises a left lead operatively coupled to a left side portion of the heart of the patient, and wherein receiving the first set of electrical measurements comprises receiving the first set of electrical measurements indicative of electrical characteristics of the heart of the patient with the left lead not providing electrical energy to the heart of the patient.

22. The system of claim 21, wherein receiving the plurality of second sets of electrical measurements comprises receiving the plurality of second sets of electrical measurements indicative of the electrical characteristics of the heart of the patient with the left lead providing electrical energy to the heart of the patient.

23. The system of claim 19, wherein the at least one lead includes a left lead operatively coupled to a left side portion of the patient’s heart and a right lead operatively coupled to a right side portion of the patient’s heart, and wherein receiving the second plurality of sets of electrical measurements includes receiving the second plurality of sets of electrical measurements indicative of electrical characteristics of the patient’s heart with the left lead and the right lead providing electrical energy to the patient’s heart.

24. The system of claim 19, wherein the tangible, non-transitory storage medium further includes instructions that, when executed by the one or more processors, cause the one or more processors to: determine, based on the first set of electrical measurements, a plurality of characteristics applied to the at least one lead based on the first set of electrical measurements, wherein the plurality of characteristics includes each of the different characteristics, and wherein receiving the second plurality of sets of electrical measurements is based on the plurality of characteristics.

25. The system of claim 24, wherein the at least one lead includes a left lead operatively coupled to a left side portion of the patient’s heart and a right lead operatively coupled to a right side portion of the patient’s heart, and wherein the plurality of characteristics includes a plurality of atrial-ventricular (AV) delays.

26. The system of claim 25, wherein the plurality of AV delays corresponds to a plurality of left ventricular (LV) delays with the left lead imposing the electrical energy to the patient’s heart.

27. The system of claim 25, wherein the plurality of AV delays corresponds to a plurality of biventricular (BiV) delays with the left lead and the right lead imposing the electrical energy to the patient’s heart.

28. The system of claim 24, wherein the at least one lead includes a left lead operatively coupled to a left side portion of the patient’s heart and a right lead operatively coupled to a right side portion of the patient’s heart, and wherein the plurality of characteristics includes a plurality of ventricular-ventricular (VV) delays.

29. The system of claim 19, wherein the plurality of measurement electrodes is fewer than 40 electrodes.

30. The system of claim 29, wherein the plurality of measurement electrodes is fewer than 20 electrodes.

31. The system of claim 29, wherein the plurality of measurement electrodes includes a plurality of anterior electrodes and a plurality of posterior electrodes, and wherein the plurality of anterior electrodes is fewer than ten electrodes and the plurality of posterior electrodes is fewer than 10 electrodes.

32. A system for cardiac resynchronization of a patient, the system comprising: one or more processors in communication with a plurality of measurement electrodes operatively coupled to the patient; and a tangible, non-transitory storage medium including instructions that, when executed by the one or more processors, cause the one or more processors to: receive, from the plurality of measurement electrodes, a first set of electrical measurements indicative of a first electrical signal imposed to the patient’s heart; receive, from the plurality of measurement electrodes, a second set of electrical measurements indicative of a second electrical signal imposed to the patient’s heart; and determine, based on the first set of electrical measurements and the second set of electrical measurements, a plurality of characteristics applied to the at least one lead based on the first set of electrical measurements and the second set of electrical measurements. receiving, from the plurality of measurement electrodes, a plurality of second sets of electrical measurements indicative of a second electrical signal applied to a heart of the patient in response to providing one or more first instructions to the implantable medical device indicative of a plurality of parameters of at least one lead; determining a plurality of cardiac resynchronization index values based on comparing the first set of electrical measurements to the plurality of second sets of electrical measurements, the plurality of cardiac resynchronization index values calculated as a % change in area under the curve (AUC); determining an optimized parameter from the plurality of parameters based on the plurality of cardiac resynchronization index values; and providing one or more second instructions to the implantable medical device to administer cardiac resynchronization therapy (CRT) based on the optimized parameter.

33. The system of claim 32, wherein the at least one lead comprises a left ventricular lead operatively coupled to a left ventricle of a heart of the patient and a right ventricular lead operatively coupled to a right ventricle of the heart of the patient, and wherein the tangible, non-transitory storage medium further comprises instructions that, when executed by the one or more processors, cause the one or more processors to: provide one or more third instructions to the implantable medical device to cause the implantable medical device to not provide electrical energy to the left ventricular lead and the right ventricular lead, and wherein receiving the first set of electrical measurements is based on providing the one or more third instructions.

34. The system of claim 32, wherein each electrical measurement of the plurality of second sets of electrical measurements is associated with a different parameter from the plurality of parameters.

35. The system of claim 34, wherein the at least one lead comprises a left ventricular lead operatively coupled to a left ventricle of a heart of the patient, and wherein the plurality of parameters comprises a plurality of atrio-ventricular (AV) timing delays of the left ventricular lead.

36. The system of claim 34, wherein the at least one lead comprises a left ventricular lead operatively coupled to a left ventricle of a heart of the patient and a right ventricular lead operatively coupled to a right ventricle of the heart of the patient, and wherein the plurality of parameters comprises a plurality of atrio-ventricular (AV) timing delays of the left ventricular lead and the right ventricular lead.

37. The system of claim 34, wherein the at least one lead comprises a left ventricular lead operatively coupled to a left ventricle of a heart of the patient and a right ventricular lead operatively coupled to a right ventricle of the heart of the patient, and wherein the plurality of parameters comprises atrio-ventricular timing delays and a plurality of ventricular-ventricular (VV) timing delays of the left ventricular lead and the right ventricular lead.

38. The system of claim 34, wherein determining the plurality of cardiac resynchronization index values comprises: determining a first dyssynchrony measurement of the first set of electrical measurements; determining a plurality of second dyssynchrony measurements of each electrical measurement of the plurality of second sets of electrical measurements; and determining the plurality of cardiac resynchronization index values based on comparing the first dyssynchrony measurement to each dyssynchrony measurement of the plurality of second dyssynchrony measurements.

39. The system of claim 38, wherein the plurality of measurement electrodes comprises a plurality of anterior electrodes and a plurality of posterior electrodes, wherein the first set of electrical measurements comprises a plurality of anterior measurements from the plurality of anterior electrodes and a plurality of posterior measurements from the plurality of posterior electrodes, and wherein determining the first dyssynchrony measurement is based on comparing the plurality of anterior measurements to the plurality of posterior measurements.

40. The system of claim 38, wherein the plurality of measurement electrodes comprises a plurality of anterior electrodes and a plurality of posterior electrodes, wherein each electrical measurement of the plurality of second sets of electrical measurements comprises a plurality of anterior measurements from the plurality of anterior electrodes and a plurality of posterior measurements from the plurality of posterior electrodes, and wherein determining each dyssynchrony measurement of the plurality of second dyssynchrony measurements is based on comparing the corresponding second dyssynchrony measurement to the first dyssynchrony measurement.

41. The system of claim 32, wherein the at least one lead comprises one or more electrodes, and wherein all of the one or more electrodes provide the second electrical signal.

42. The system of claim 32, wherein the at least one lead comprises one or more electrodes, and wherein at least one electrode of the one or more electrodes provides the second electrical signal.

43. A system for cardiac resynchronization of a patient, the system comprising: one or more processors in communication with a plurality of measurement electrodes operatively coupled to the patient; a display device in communication with the one or more processors; and a tangible, non-transitory storage medium comprising instructions that, when executed by the one or more processors, cause the one or more processors to: receive a first set of electrical measurements indicative of electrical characteristics of the patient’s heart from the plurality of measurement electrodes in a condition in which at least one lead of an implantable medical device does not provide electrical energy to the patient’s heart; receive a plurality of second sets of electrical measurements indicative of electrical characteristics of the patient’s heart from the plurality of measurement electrodes in a condition in which the at least one lead of the implantable medical device provides electrical energy to the patient’s heart, each electrical measurement of the plurality of second sets of electrical measurements being indicative of a different characteristic of the implantable medical device; determine a plurality of cardiac resynchronization index values based on comparing the first set of electrical measurements to the plurality of second sets of electrical measurements, the plurality of cardiac resynchronization index values being calculated as a % change in area under the curve (AUC), wherein the plurality of cardiac resynchronization index values correspond to the different characteristics of the implantable medical device; and cause an image to be displayed on the display device, the image being indicative of the plurality of cardiac resynchronization index values.

44. The system of claim 43, wherein the different characteristics comprise a plurality of atrio-ventricular (AV) delays, wherein the image comprises a graphical representation of the plurality of cardiac resynchronization index values with the plurality of AV delays, and wherein each of the plurality of cardiac resynchronization index values has a corresponding AV delay from the plurality of AV delays.

45. The system of claim 43, wherein the different characteristics comprise a plurality of biventricular (BiV) delays and a plurality of left-ventricular-only (LV-only) delays, wherein the image comprises a graphical representation of the plurality of cardiac resynchronization index values with the plurality of Bi-V delays and the plurality of LV-only delays, and wherein each of the plurality of cardiac resynchronization index values has a corresponding Bi-V delay from the plurality of Bi-V delays or a corresponding LV-only delay from the plurality of LV-only delays.

46. The system of claim 43, wherein the different characteristics comprise a plurality of ventricular-ventricular (VV) delays, wherein the image comprises a graphical representation of the plurality of cardiac resynchronization index values with the plurality of VV delays, and wherein each of the plurality of cardiac resynchronization index values has a corresponding VV delay from the plurality of VV delays.

47. The system of claim 43, wherein the image comprises a graphical representation of a first signal from a left lead of the implantable medical device, a second signal from a right lead of the implantable medical device, and a third signal corresponding to a native signal of a heart of the patient.

48. The system of claim 47, wherein the causing the image to be displayed on the display device comprises causing an animation of a first wavefront, a second wavefront, and a third wavefront of a second graphical representation propagating through the heart of the patient to be displayed, wherein the first wavefront corresponds to the first signal, wherein the second wavefront corresponds to the second signal, and wherein the third wavefront corresponds to the third signal.

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