Determination of septum perforation during electrode implantation

Abstract

The present disclosure relates to a system for assisting implantation of an implantable electrode. The system may include an implantable electrode configured to deliver pacing of the cardiac conduction system, and an external electrode configured to sense electrical activity. The system may further include a computing device operably coupled to the implantable electrode and the external electrode, and configured to monitor at least one of internal electrical activity and external electrical activity, and configured to determine cardiac conduction system capture, current impairment, and impedance based on the monitored electrical activity. The computing device may be further configured to determine, based on at least one of the cardiac conduction system capture, the current impairment, and the impedance, that the implantable electrode is proximate to the cardiac conduction system and implanted in a ventricular septum wall prior to perforation into a left ventricular cavity, and to issue a first notification.

Description

[0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63 / 441,684, filed January 27, 2023, which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates to implantable medical devices and their implementations, as well as systems and methods related thereto. Specifically, the present disclosure relates to determining whether an implantable electrode is positioned within the ventricular septum of a patient's heart near or at the cardiac conduction system based on cardiac conduction system capture, current lesion, and impedance. The present disclosure further relates to determining whether an implantable electrode has perforated the ventricular septum into the left ventricular cavity based on cardiac conduction system capture, current lesion, and impedance.

[0003] Implantable medical devices (IMDs), such as pacemakers or implantable cardioverter-defibrillators, deliver therapeutic stimulation to the patient's heart, thereby improving the lives of millions of heart disease patients. Figure 1 As illustrated, conventional pacing techniques involve pacing one or more of the four chambers of a patient's heart 12, including the left atrium 33, right atrium 26, left ventricle 32, and right ventricle 28. A common conventional therapeutic pacing technique for treating a slow heart rate, known as bradycardia, involves delivering electrical pulses to the patient's right ventricular tissue. In response to the electrical pulses, both the right and left ventricles contract. However, because the pulses propagate from the right ventricle through the left ventricle, the heartbeat process can be significantly delayed. The electrical pulses pass through muscle cells called myocytes. Conduction between myocytes can be very slow. The delayed electrical pulses can cause the left ventricle to lose synchronization with the right ventricle.

[0004] Over time, the left ventricle can become very inefficient at pumping blood to the body. For some patients, heart failure can progress to the point where the heart is too weak to pump blood to the body. Heart failure can be a devastating diagnosis because, for example, fifty percent of people with heart failure have a life expectancy of five years or less. Another possible cause of heart failure is due to dyssynchronous ventricular activation, which is irregular or unsynchronized ventricular contractions, or due to atrioventricular dyssynchrony, which is irregular or unsynchronized timing between atrial contractions and ventricular contractions. For example, when the ventricles beat out of sync, or when the heart's atria beat out of sync with the heart's ventricles, blood clots in the heart can form and increase the risk of stroke or heart failure.

[0005] To avoid the potential development of heart failure, some physicians have considered alternative pacing methods involving the heart's conduction system. Pacing the heart's conduction system can conduct electrical impulses quickly (e.g., similar to a car traveling on a highway), while pacing the heart muscle or myocardial tissue can conduct electrical impulses more slowly (e.g., similar to a car traveling on a muddy road).

[0006] The cardiac conduction system includes the sinoatrial node 1, the atrial nodal bundles 2, 4, and 5 (i.e., the anterior nodal bundle 2, the middle nodal bundle 4, and the posterior nodal bundle 5), the atrioventricular node 3, the His bundle 13 (also known as the atrioventricular bundle or the His bundle), the left bundle branch 8a, and the right bundle branch 8b. Figure 1 The aortic arch 6 and Buckman's bundle 7 are also shown. Figure 1 The sinoatrial node 1, located at the junction of the superior vena cava and the right atrium, is considered the heart's natural pacemaker because it continuously and repeatedly emits electrical impulses. The electrical impulses travel through the muscle of the right atrium 26 to the left atrium 33 to cause synchronous contraction of the atria. The electrical impulses are also delivered to the atrioventricular node 3 (the only connection between the atria and ventricles) through the interatrial nodal bundle. Conduction through the atrioventricular node or atrioventricular node tissue takes longer than through atrial tissue, which results in a delay between atrial contraction and the start of ventricular contraction. Atrioventricular delay is a delay between atrial contraction and ventricular contraction that allows the atria to empty blood into the ventricles. Then, as the ventricles contract, the valves between the atria and ventricles close, accompanied by ventricular contraction caused by branches of the His bundle. The bundle of His (bundle of His or His bundle) 13 is located in the membranous atrioventricular septum, near the tricuspid annulus. The bundle of His 13 is divided into a left bundle branch 8a and a right bundle branch 8b and is formed by specialized fibers called "Purkinje fibers" 9. Purkinje fibers 9 can be described as being capable of rapidly conducting action potentials along the ventricular septum (VS), rapidly extending the depolarization wave front through the remaining ventricular myocardium, and producing coordinated contraction of the ventricular myocardium.

[0007] Patients with conduction system abnormalities (such as AV node poor conduction or SA node dysfunction) may receive an IMD (such as a pacemaker) to restore a more normal heart rhythm and AV synchronization. Some types of IMDs, such as pacemakers, implantable cardioverter-defibrillators (ICDs), or cardiac resynchronization therapy (CRT) devices provide therapeutic electrical stimulation to the patient's heart via electrodes positioned in or adjacent to the heart on one or more implantable endocardial, epicardial, or coronary venous leads. Therapeutic electrical stimulation can be delivered to the heart in the form of pulses or shocks for pacing, cardioversion, or defibrillation. In some cases, an IMD can sense intrinsic depolarization of the heart and, based on the sensing, control the delivery of therapeutic stimulation to the heart.

[0008] In addition to cardiac pacing, arrhythmias can be treated by, for example, delivering an electric shock therapy for cardioversion or defibrillation of the heart from an ICD, which can sense the patient's heart rhythm and classify the heart rhythm according to an arrhythmia detection scheme to detect the onset of tachycardia or fibrillation. Detected arrhythmias may include ventricular tachycardia (VT), rapid ventricular tachycardia (FVT), ventricular fibrillation (VF), atrial tachycardia (AT), and atrial fibrillation (AT). Anti-tachycardia pacing (ATP) is a painless treatment that can be used to treat ventricular tachycardia (VT) to essentially terminate many monomorphic rapid rhythms. Although ATP is painless, ATP may not be effective for delivering all types of VT. For example, ATP may not be effective for polymorphic VT with variable morphology. Polymorphic VT and ventricular fibrillation (VF) may be more fatal and may require rapid treatment with electric shock.

[0009] Positioning an implantable electrode (e.g., on a lead, on a small lead device, etc.) to deliver cardiac conduction system pacing as described herein requires implanting the implantable electrode near the cardiac conduction system of the heart (such as, for example, the left bundle branch (LBB) in the ventricular septum). In some cases, during electrode implantation in the ventricular septum, the implantable electrode is advanced "too far" and the electrode or lead (if a lead is being used) perforates the ventricular septum into a ventricular cavity (such as, for example, the left ventricle). Such perforations may result in loss of cardiac conduction system capture and pacing. Further perforations may result in additional adverse effects or possible lead migration. Therefore, avoiding septal perforations is desirable in order to avoid possible negative consequences. Summary of the Invention

[0010] The present disclosure generally relates to determining whether an implantable electrode is positioned within the ventricular septum of a patient's heart near or at the cardiac conduction system, and whether the implantable electrode should be repositioned based on the determination. The present disclosure further relates to determining that the implantable electrode has perforated the ventricular septum into the left ventricular (LV) cavity, and whether the implantable electrode should be repositioned based on the determination. The position of the implantable electrode is determined based on at least cardiac conduction system capture, current damage, and impedance. Each of cardiac conduction system capture, current damage, and impedance can be monitored in real time, and such real-time monitoring can prevent or avoid perforation of the ventricular septum into the LV cavity. In at least one embodiment, the implantable electrode can be positioned at or near the left bundle branch for cardiac conduction system pacing.

[0011] Cardiac conduction system capture can include LBB capture, and positioning the implanted electrode near or at the cardiac conduction system can include positioning the implanted electrode near or at the LBB. Single-chamber, dual-chamber, and / or triple-chamber medical devices or leadless medical devices are available, which can include, for example, a transvenous atrial lead carrying an electrode that can be placed in the right atrium, a transvenous ventricular lead carrying an electrode that can be placed in the right ventricle, or a transvenous ventricular lead carrying an electrode that can be placed in the ventricular septum via the right atrium, a coronary sinus lead that can be placed in the left ventricle via the coronary sinus, a ventriculo-atrial (VfA) lead that can be placed in the right atrial septum between the right atrium and the left ventricle to pace the left ventricle, and leadless devices (e.g., a leadless pacemaker for LBB pacing in the ventricular septum). During implantation of such a device, the present application can determine the positioning of the electrodes of such a device in the ventricular septum.

[0012] It may be difficult to implant electrodes near the LBB in order to effectively pace the LBB. Also, the implanted LBB electrodes may become displaced over time due to natural movement or due to injury, and as a result, LV septal pacing may occur. This is also true for right bundle branch (RBB) pacing that is transferred to right ventricular (RV) septal pacing. On the one hand, for patients whose cardiac conduction system is functioning properly, septal pacing may not be desired in some cases. On the other hand, for patients whose cardiac conduction system is not functioning properly, septal pacing may be desired in some cases (such as, for example, when the patient experiences an LBB block or RBB block that cannot be corrected or bypassed). In other cases of patients whose cardiac conduction system is not functioning properly (such as, for example, when the LBB block or RBB block can be corrected or bypassed), cardiac conduction system pacing is still desired.

[0013] Specifically, exemplary systems, devices, and methods are described herein for determining electrode location in the ventricular septum and electrode perforation through the ventricular septum into the ventricular cavity using electrogram (EGM) and electrocardiogram (ECG) signal analysis, and in response thereto, providing effective electrode positioning for effective pacing therapy. For example, the use of EGM signals can advantageously provide more efficient or more effective analysis, provide timely modifications to pacing parameters based on a patient's changing physiological condition, thereby resulting in more effective pacing, and can eliminate the need for a patient to visit a clinic for measurement of an ECG signal. For example, the use of ECG signals can advantageously provide additional data from one or more surface electrodes.

[0014] Determining the position of implanted electrodes can be accomplished using analysis of various variables in EGM and ECG signals. For example, cardiac conduction system capture, current damage, and impedance can all be used to determine the position of implanted electrodes. Cardiac conduction system capture can be defined as the successful delivery of cardiac conduction system pacing to the cardiac conduction system, rather than pacing to, for example, myocardial tissue. The cardiac conduction system capture threshold can be described or defined as the minimum amount of power required to deliver cardiac conduction system pacing while achieving cardiac conduction system capture and can be measured in volts (V). Current damage can be described or defined as the current generated when a damaged portion of the conduction system, muscle, or other excitable tissue is connected to an undamaged area via a conductor. A voltage difference is generated in the damaged tissue relative to the undamaged tissue. During implantation, the implanted electrode (or lead, etc.) itself may cause less tissue damage, and certain measured current damage levels may correspond to more optimal electrode placement. Current damage can be measured in volts. Impedance can be described or defined as the effective resistance to the pacing current caused by the combined effects of resistance and reactance in the circuit. In other words, impedance can be defined as the opposition to current flow and can be measured in ohms. During implantation of the implantable electrodes, cardiac conduction system capture, current lesions, and impedance can each be monitored in real time.

[0015] In alternative embodiments, during implantation of an implantable electrode, less than all of cardiac conduction system capture, current lesion, and impedance are monitored and / or less than all of cardiac conduction system capture, current lesion, and impedance are used to determine electrode position or perforation through the ventricular septum into an adjacent cardiac chamber. In such alternative embodiments, one or both of cardiac conduction system capture, current lesion, and impedance may be used to determine electrode position or perforation through the ventricular septum.

[0016] In some embodiments, one of cardiac conduction system capture, current lesion, and impedance can be determined before determining the other variables used. For example, cardiac conduction system capture can be determined first, then current lesion can be determined, and then impedance can be determined. In further examples, any combination or order of determinations can be made.

[0017] During implantation of an implantable electrode, or during implantation of an implantable lead, in some examples, if the current lesion decreases, if the cardiac conduction system capture threshold begins to increase, and if the impedance decreases, it can be determined that the implantable electrode or implantable lead is proximate to the LBB and implanted in the interventricular septum wall prior to perforation into the LV cavity. The increase in the cardiac conduction system capture threshold can be any measurable increase equal to or greater than 1.0 volt. The decrease in current lesion from a relatively high amplitude to a relatively low amplitude can be any measurable decrease. The decrease in impedance can be any measurable decrease equal to or greater than 100 ohms. In response to determining that the implantable electrode or implantable lead is proximate to the cardiac conduction system and implanted in the interventricular septum wall prior to perforation of the LV cavity, a first notification (e.g., an audio notification, a visual notification, etc.) can be issued or initiated.

[0018] During continued advancement of the implanted electrode or implanted lead within the ventricular septum, in some examples, if the current lesion further decreases or disappears, if the cardiac conduction system capture threshold further increases or if capture of the cardiac conduction system is lost, and if the impedance further decreases, it can be determined that the implanted electrode or implanted lead has perforated into the LV cavity. As discussed herein, "further" is relative to a value determined at or near the cardiac conduction system, or a value determined at a location that is understood to be at or near the cardiac conduction system. A further increase in the cardiac conduction system capture threshold can be any further measurable increase greater than or equal to 1.0 volt. A further decrease in the current lesion can be any further measurable decrease greater than or equal to 1 millivolt (mV). A further decrease in impedance can be any further measurable decrease greater than or equal to 100 ohms. In response to determining that the implanted electrode or implanted lead has perforated through the ventricular septum into the LV cavity, a second notification can be issued or initiated.

[0019] In one or more embodiments, exemplary systems, devices, and methods are described herein for determining the location of an implanted electrode within the ventricular septum in "real time" to provide effective cardiac conduction system therapy to a patient and avoid electrode perforation into the LV cavity, which could damage cardiac tissue and potentially require electrode repositioning.

[0020] An exemplary system may be used to assist in the implantation of an implantable electrode. The system may include an implantable electrode configured to deliver cardiac conduction system pacing near a portion of a patient's cardiac conduction system. The system may include an external electrode configured to sense at least electrical activity of the patient's heart. The system may include a computing device comprising processing circuitry. The computing device may be operably coupled to the implantable electrode and the external electrode. The computing device may be configured to: monitor internal electrical activity using the implantable electrode during implantation of the implantable electrode. The computing device may be further configured to monitor external electrical activity using the external electrode during implantation of the implantable electrode. The computing device may be further configured to determine cardiac conduction system capture based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the monitored external electrical activity. The computing device may be further configured to determine current lesions based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the monitored external electrical activity. The computing device may be further configured to determine impedance based on at least one of internal electrical activity monitored during implantation of the implantable electrode and external electrical activity monitored. The computing device may be further configured to issue a first notification in response to determining, based on cardiac conduction system capture, current lesion, and impedance, that the implantable electrode is proximate to the cardiac conduction system and implanted in the interventricular septum wall prior to perforation into the left ventricle (LV) cavity.

[0021] An exemplary method may include assisting in implanting an implantable electrode, the implantable electrode comprising an implantable electrode proximate to a patient's cardiac conduction system. The method may include, during implantation of the implantable electrode: monitoring internal electrical activity using the implantable electrode during implantation of the implantable electrode. The method may further include monitoring external electrical activity using an external electrode during implantation of the implantable electrode. The method may further include determining cardiac conduction system capture based on at least one of the monitored internal electrical activity and the monitored external electrical activity during implantation of the implantable electrode. The method may further include determining current lesion based on at least one of the monitored internal electrical activity and the monitored external electrical activity during implantation of the implantable electrode. The method may further include determining impedance based on at least one of the monitored internal electrical activity and the monitored external electrical activity during implantation of the implantable electrode. The method may further include issuing a first notification in response to determining, based on cardiac conduction system capture, current lesion, and impedance, that the implantable electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall prior to perforation into the left ventricular (LV) cavity.

[0022] Another exemplary system can be used to assist in the implantation of an implantable electrode. The system may include an implantable electrode configured to deliver cardiac conduction system pacing near a portion of a patient's cardiac conduction system. The system may include a computing device comprising processing circuitry. The computing device may be capable of being operably coupled to one or more implantable electrodes. The computing device may be configured to: monitor internal electrical activity using the implantable electrode during implantation of the implantable electrode. The computing device may be further configured to determine cardiac conduction system capture, current damage, and impedance based on the internal electrical activity monitored during implantation of the implantable electrode. The computing device may be further configured to issue a first notification in response to determining that the implantable electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall prior to perforation into the left ventricle (LV) cavity based on at least one of the determined cardiac conduction system capture, current damage, and impedance.

[0023] Another exemplary method may be to assist in implanting an implantable electrode, the implantable electrode comprising an implantable electrode proximate to a patient's cardiac conduction system. The method may include, during implantation of the implantable electrode: monitoring internal electrical activity using the implantable electrode during implantation of the implantable electrode. The method may further include determining cardiac conduction system capture, current damage, and impedance based on the internal electrical activity monitored during implantation of the implantable electrode. The method may further include issuing a first notification in response to determining, based on at least one of cardiac conduction system capture, current damage, and impedance, that the implantable electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall prior to perforation into the left ventricle (LV) cavity.

[0024] The above summary is not intended to describe each embodiment or every implementation of the present disclosure. A more complete understanding will become apparent and appreciated by referring to the following detailed description and claims taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Figure 1 is a schematic diagram of a patient's heart and conduction system.

[0026] Figure 2A is a conceptual diagram illustrating an illustrative therapy system configured to provide cardiac conduction system pacing therapy to the left bundle branch using a single lead placed in the right ventricle.

[0027] Figure 2B yes Figure 2A A close up view of the leads in a patient's heart.

[0028] Figure 3 This is an example Figures 2A to 2B Functional diagram of an example configuration of an implantable medical device, programmer, and external electrode device.

[0029] Figure 4 Is to ensure that the implanted electrodes are close to the cardiac conduction system (such as Figures 2A to 2B A block diagram of an exemplary method of the present invention is provided.

[0030] Figure 5 is a block diagram of an illustrative method for determining changes in current injury during electrode implantation.

[0031] Figure 6 is a block diagram of an illustrative method for determining changes in cardiac conduction system capture threshold during electrode implantation.

[0032] Figure 7 is a block diagram of an illustrative method for determining changes in impedance during electrode implantation.

[0033] Figure 8 The implantation of implantable electrodes (such as Figures 2A to 2B Block diagram of an exemplary method of electrodes).

[0034] Figure 9 Implantable electrodes (such as Figures 2A to 2B Block diagram of an exemplary method of electrodes).

[0035] Figure 10 Implantable electrodes (such as Figures 2A to 2B Block diagram of an exemplary method of electrodes). DETAILED DESCRIPTION

[0036] In the following detailed description of exemplary embodiments, reference is made to the accompanying drawings, which form a part hereof, and in which is shown by way of illustration specific embodiments that may be practiced. It should be understood that other embodiments may be utilized and structural changes may be made without departing from (e.g., still falling within) the scope of the present disclosure as presented here.

[0037] Should refer to Figures 1 to 10 Describe exemplary systems, devices and methods. It will be apparent to those skilled in the art that an element or process from one embodiment may be used in combination with an element or process of other embodiments, and the possible embodiments of such systems, devices and methods using the feature combinations set forth herein are not limited to the specific embodiments shown in the figures and / or described herein. Further, it will be appreciated that the embodiments described herein may include many elements that are not necessarily shown to scale. Still further, it will be appreciated that the timing of the processes herein and the size and shape of the various elements may be modified and still fall within the scope of the present disclosure, but certain timings, one or more shapes and / or sizes or element types may be superior to other timings, one or more shapes and / or sizes or element types.

[0038] Figure 1 depicts a schematic diagram of the heart 12 and the cardiac conduction system, and Figures 2A to 2B A conceptual diagram is depicted showing an exemplary therapy system 71 configured to provide cardiac conduction system pacing therapy to LBB using cardiac conduction pacing therapy leads 18 that can be implanted in a patient's heart 12. In alternative embodiments, a leadless pacing device can be used as described herein. The patient is typically, but not necessarily, a human. The therapy system 71 can include an IMD 16 coupled to the cardiac conduction pacing therapy leads 18 (e.g., a left bundle branch pacing lead, a right bundle branch pacing lead, a His bundle pacing lead, etc.) and a programmer 24. The IMD 16 can be, for example, an implantable pacemaker, cardioverter, and / or defibrillator that provides electrical pulses to the heart 12 via electrodes coupled to the cardiac conduction pacing therapy leads 18. Other non-limiting examples of IMD 16 include: a pacemaker with medical leads, an implantable cardioverter-defibrillator (ICD), an intracardiac device, a leadless pacing device (LPD), a subcutaneous ICD (S-ICD), and a subcutaneous medical device (e.g., a neurostimulator, an insertable monitoring device, etc.).

[0039] Cardiac pacing therapy leads 18 may be extended into the patient's heart 12 to sense the electrical activity of the heart 12 and / or deliver electrical stimulation to the heart 12. Figure 2A In the example shown, the cardiac conduction system pacing therapy lead 18 extends through one or more veins and the vena cava, the right atrium 26, through the tricuspid valve, and into the right ventricle 28 of the heart 12 to pace the cardiac conduction system (e.g., within the wall of the ventricular septum 35, near and / or in direct contact with the left bundle branch 8a, near and / or in direct contact with the right bundle branch 8b, near and / or in direct contact with the His bundle 13, etc.). In some embodiments, the cardiac conduction system pacing therapy lead 18 can be positioned within approximately 1 mm of a portion of the cardiac conduction system (such as, for example, the left bundle branch 8a). The cardiac conduction system pacing therapy lead 18 can be positioned to position electrodes 48, 50 (respectively) near, adjacent to, on, within, or around the RBB, LBB for sensing electrocardiographic signals and pacing the cardiac conduction system. The cardiac conduction system pacing therapy lead 18 is shown having a ring electrode 48 and a helical tip electrode 50, which can be selected from a variety of bipolar pacing electrode pairs for pacing the RBB and LBB (respectively) and for sensing the RBB ECG signal and the LBB ECG signal (respectively). One of the electrodes 48, 50 can be selected in conjunction with the IMD housing 60 or coil electrode 66 for delivering unipolar RBB and LBB pacing and / or sensing unipolar RBB and LBB ECG signals. In an alternative embodiment, the cardiac conduction system pacing therapy lead 18 is also used to pace the RA (at Figure 2A ), or for pacing RA in addition to the cardiac conduction system.

[0040] An example of a cardiac conduction system pacing therapy lead (e.g., a His lead) may be the SELECTSECURE TM 3830. SELECTSECURE TM For a description of the 3830, see Medtronic model SELECTSECURE TM 3830 Manual (2013), which is incorporated herein by reference in its entirety. SELECTSECURE TM 3830 includes two conductors without a lumen.

[0041] As used herein, cardiac conduction system pacing therapy refers to any technology configured to deliver pacing therapy (e.g., pacing pulses, electrical stimulation, etc.) to the cardiac conduction system, which includes, for example, the His bundle 13, the left bundle branch 8a, the right bundle branch 8b, etc., in order to initiate activation. As used herein, the term "activation" refers to a sensed or paced event. For example, atrial activation may refer to an atrial sensing or event (As) or atrial pacing or an atrial pacing artifact (Ap). As will be described herein, atrial sensing may be detected or identified in one or more different signals monitored using one or more different devices or sensors located at one or more different locations. For example, atrial sensing may be detected in a near-field electrical signal using an electrode positioned in the right atrium and a corresponding reference electrode (e.g., an electrode on the housing of an implantable medical device). Further, for example, atrial sensing may be detected in a far-field electrical signal using an electrode positioned outside the right atrium (such as in the right ventricle or ventricular septum) and a corresponding reference electrode. In addition, for example, atrial sensing can be detected in far-field signals using a mechanical cardiac activation sensor, such as an accelerometer or microphone (e.g., a heart sound sensor) positioned outside the right atrium (such as in the right ventricle or ventricular septum) or another part of the patient's body (e.g., within a can or housing of an IMD positioned outside the patient's heart). Similarly, ventricular activation can refer to a ventricular sense or event (Vs) or a ventricular pacing or ventricular pacing artifact (Vp), which can be described as a ventricular stimulation pulse. In some embodiments, activation intervals from As or Ap to Vs or Vp and from Vp to Vs can be detected. Specifically, activation intervals can include a pacing (Ap or Vp) to a ventricular interval (left ventricular or right ventricular sensing) or an atrial sensing (As) to a ventricular sensing interval (left ventricular or right ventricular sensing).

[0042] An exemplary IMD may be described as delivering one or both of conventional pacing therapy and cardiac conduction system pacing therapy. Conventional or traditional pacing therapy may be described as delivering pacing pulses to myocardial tissue that is not part of the cardiac conduction system of the patient's heart, such that, for example, the pacing pulse triggers electrical activation that propagates primarily from one myocardial cell to another myocardial cell (also referred to as "cell to cell"), as opposed to propagating within the cardiac conduction system before the myocardial tissue. For example, conventional pacing therapy may deliver pacing pulses directly to muscular heart tissue (e.g., myocardial tissue) that is to be depolarized to provide cardiac contraction. For example, conventional left ventricular pacing therapy may utilize an implanted left ventricular coronary sinus lead to extend through one or more veins, the vena cava, the right atrium 26 and into the coronary sinus to a region adjacent to the free wall of the left ventricle 32 of the heart 12 to deliver pacing pulses to the myocardial tissue of the free wall of the left ventricle 32.

[0043] Exemplary cardiac conduction system pacing therapies may be described, for example, in U.S. Patent Application Publication No. 2019 / 0111270A1, entitled “His Bundle and Bundle Branch Pacing Adjustment,” published on April 18, 2019, which is incorporated herein by reference in its entirety. Exemplary left ventricular septal pacing may be described, for example, in U.S. Patent Application Serial No. 16 / 521,000, entitled “AV Synchronous Septal Pacing,” filed on July 24, 2019, which is incorporated herein by reference in its entirety.

[0044] One or more elongated conductors of the cardiac pacing therapy lead 18 can extend through the airtight feedthrough assembly and within the insulating tubular member of the corresponding lead, and can electrically connect an electrical pulse generator (contained within the housing) to one or more electrodes, such as, for example, a ring electrode, a tip electrode, a helical electrode, etc. The conductor can be formed from one or more conductive wires in a coiled or cabled configuration, the conductive wire comprising, for example, an MP35N alloy known to those skilled in the art, and the insulating tubular member can be any suitable medical-grade polymer, such as polyurethane, silicone rubber, or blends thereof. According to one or more exemplary embodiments, the flexible lead body can extend from the proximal end to a predetermined length (e.g., about 10 centimeters (cm) to about 20 cm, or about 15 cm to 20 cm) to the distal end. The lead body can be less than about 7 French (FR), but typically ranges from about 3 FR to 4 FR. In one or more embodiments, a lead body of about 2 FR to about 3 FR is used.

[0045] Cardiac conduction system pacing may include at least one of His bundle pacing, LBB pacing, and RBB pacing. Bundle branch pacing may bypass pathological areas and may have a low and stable pacing threshold. In some embodiments, only one of the left bundle branch or the right bundle branch may be paced using one or more pacing leads. In another embodiment, both bundle branches may be paced simultaneously (e.g., dual bundle branch pacing), which may simulate the inherent propagation of activation via the His-Purkinje conduction system, for example, the activation of the pace is propagated to both ventricles via the two bundle branches for synchronous contraction. On the other hand, His bundle pacing typically paces the His bundle located proximal to the bundle branch. In some embodiments, the IMD 16 may be connected to one, two, or more electrodes located on one or more bundle branches configured for bundle branch pacing.

[0046] In some embodiments, the IMD 16 can be an intracardiac pacemaker or a leadless pacing device (LPD) configured to pace one or more portions of the cardiac conduction system, such as one or both of the bundle branches. As used herein, "leadless" refers to a device that has no leads extending beyond the heart 12. In other words, the leads of a leadless device may not extend from the outside of the heart to the inside of the heart. Some leadless devices can be introduced through a vein, but once implanted, the leadless device does not have or may not include any transvenous leads and can be configured to provide cardiac therapy without the use of any transvenous leads. In one or more embodiments, an exemplary LPD for bundle pacing does not use leads to enable operative connection to electrodes positioned proximal to the septum when the housing of the device is positioned in the atrium. The leadless electrodes can be coupled to the housing of the medical device leadlessly without the use of leads between the electrodes and the housing. For example, the cardiac pacing therapy lead 18 of FIG. 2 may not be needed, and instead, electrodes 48 , 50 , 66 , and 75 may be implanted in the illustrated locations without the use of the cardiac pacing therapy lead 18 .

[0047] The IMD 16 can be connected to the cardiac pacing therapy lead 18 via a Figure 2A The various electrodes shown sense electrical signals accompanying depolarization and repolarization of heart 12. In some examples, IMD 16 provides pacing pulses to heart 12 based on the electrical signals sensed within heart 12. The configuration of electrodes used by IMD 16 for sensing and pacing may be unipolar or bipolar.

[0048] IMD 16 may also provide defibrillation therapy and / or cardioversion therapy via electrodes located on cardiac pacing leads 18. For example, IMD 16 may detect atrial arrhythmias of heart 12, such as atrial fibrillation of atria 26, 33, and may then deliver defibrillation therapy in the form of electrical pulses to heart 12. IMD 16 may also detect ventricular arrhythmias of heart 12, such as ventricular fibrillation of ventricles 28, 32, and may then deliver defibrillation therapy in the form of electrical pulses to heart 12. In some examples, IMD 16 may be programmed to deliver a course of therapy, e.g., pulses of increasing energy levels, until the fibrillation of heart 12 ceases. IMD 16 may detect fibrillation using one or more fibrillation detection techniques known in the art.

[0049] In some examples, such as Figures 2A to 2B The programmer 24 shown can be a handheld computing device, a computer workstation, or a mobile phone. The programmer 24 can include a user interface for receiving input from a user. The user interface can include, for example, a keypad and a display 47, which can be, for example, a cathode ray tube (CRT) display, a liquid crystal display (LCD), or a light emitting diode (LED) display. The keypad can take the form of an alphanumeric keypad or a reduced set of keys associated with specific functions. The programmer 24 can additionally or alternatively include a peripheral pointing device (such as a mouse) via which the user can interact with the user interface. In some embodiments, the display 47 of the programmer 24 can include a touch screen display, and the user can interact with the programmer 24 via the display 47. The display 47 can be operably connected to a processor as described herein. Through the graphical user interface on the programmer 24, the user can configure one or more pacing therapies, select one or more pacing modes, etc.

[0050] In some embodiments, programmer 24 can include similar processing components 81 as described further herein with respect to IMD 16 (e.g., a sensing module, stimulation generator, processor, telemetry module, memory, and power supply, collectively labeled as reference numeral 81). Processing component 81 can receive EGM signals from one or more of electrodes 48, 50, 58, 66, and 75. Processing component 81 can receive ECG signals from one or more of external electrodes 44. In some embodiments, programmer 24 can communicate with IMD 16 and / or external electrode device 45 in wired or wireless communication, as further described herein.

[0051] Additionally, various pacing settings can be adjusted or configured based on various sensed signals. For example, various near-field signals and far-field signals can be sensed by one or more of the electrodes coupled to IMD 16 and / or other devices operably coupled thereto. For example, the right ventricular depolarization interval and the left ventricular depolarization interval can be monitored or measured within the near-field signal or the far-field signal and can then be used to adjust, configure, and select cardiac conduction system pacing therapy. Further, for example, QRS morphology (e.g., QRS peak, various QRS intervals, ST intervals, amplitude, etc.) can be monitored or measured within the near-field signal or the far-field signal and can then be used to adjust, configure, and select cardiac conduction system pacing therapy. Still further, for example, one or more of right ventricular depolarization interval consistency and left ventricular depolarization interval consistency and QRS morphology consistency can be monitored or measured within the near-field signal or the far-field signal and can then be used to adjust, configure, and select cardiac conduction system pacing therapy.

[0052] The exemplary therapy systems described herein, such as IMD 16, may be used to deliver cardiac conduction system pacing therapy according to a variety of different modes, such as, for example, an inhibition pacing mode, a ventricular fusion pacing mode, an atrioventricular synchronization pacing mode, an atrial fibrillation pacing mode, etc.

[0053] As used herein, the term "far-field" electrical signal refers to the result of measuring cardiac activity using a sensor (such as an electrode) positioned outside the region of interest. For example, a far-field electrical signal representing the electrical activity of the chamber of interest of a patient's heart can be measured from an electrode positioned in an adjacent cavity (i.e., a cavity different from the cavity of interest that is immediately adjacent to or near the cavity of interest). More specifically, for example, atrial electrical activity representing depolarization of one or both atria or electrical activity originating from one or more of the two atria can be monitored in a far-field electrical signal that is measured using an electrode positioned outside the right atrium (such as in the right ventricle or left ventricle) or in the ventricular septum. As used herein, the term "near-field" electrical signal refers to the result of measuring cardiac activity using a sensor (such as an electrode) positioned near the region of interest. For example, an electrical signal measured using an electrode located to the left of the patient's ventricular septum is an example of a near-field electrical signal of a patient's LV.

[0054] A user (such as a physician, technician, or other clinician) may interact with programmer 24 to communicate with IMD 16. For example, the user may interact with programmer 24 to retrieve physiological or diagnostic information from IMD 16. Additionally, the user may also interact with programmer 24 to program IMD 16, e.g., to select values ​​for operating parameters of IMD 16. IMD 16 and programmer 24 may communicate via wireless communication using any technology known in the art. Examples of communication technologies may include, for example, low-frequency or radio frequency (RF) telemetry, although other technologies are also contemplated. In some examples, programmer 24 may include a programming head that may be placed adjacent to the patient's body near the site of implantation of IMD 16 to improve the quality or safety of communication between IMD 16 and programmer 24.

[0055] Cardiac pacing therapy lead 18 can be electrically coupled to a stimulation generator, a sensing module, or other modules of IMD 16 via connector block 34. In some examples, a proximal end of cardiac pacing therapy lead 18 can include electrical contacts that are electrically coupled to corresponding electrical contacts within connector block 34. Additionally, in some examples, cardiac pacing therapy lead 18 can be mechanically coupled to connector block 34 with the aid of a set screw, a connecting pin, or another suitable mechanical coupling mechanism.

[0056] Although cardiac conduction system pacing therapy lead 18 about Figures 2A to 2B While shown and described as being placed in the RV along the ventricular septal wall 35, in other examples, the cardiac conduction system pacing therapy lead 18 may be placed in the right atrium within the triangle of Koch's area (not shown), with corresponding electrodes 48, 50 tunneling through the septal tissue to be positioned proximal to the RBB and LBB, respectively. In such examples, the system may not include leads positioned in the RV, yet still obtain the benefits of LBB pacing and sensing or RBB pacing and sensing as described herein. Additionally or alternatively, the system in such examples may include an additional lead or electrode positioned in the RA that is configured to pace the RA and that may be distinct from the cardiac conduction system pacing therapy lead 18 or the corresponding LBB and RBB electrodes.

[0057] Cardiac conduction pacing therapy lead 18 includes an elongated, insulated lead body that can carry any number of conductors. In the illustrated example, bipolar electrodes 48 and 50 are positioned proximate the distal end of cardiac conduction system pacing therapy lead 18. An optional pressure sensor (not shown) can respond to absolute pressure within the RV or can be positioned elsewhere within heart 12 or within or near the patient's cardiovascular system to monitor cardiovascular pressure associated with the mechanical contraction of the heart. Additionally, in some examples, the optional pressure sensor can be a self-contained device implanted within heart 12 and wirelessly coupled to IMD 16.

[0058] Electrode 48 can take the form of a ring electrode, and electrode 50 can take the form of an extendable and / or fixed helical tip electrode mounted within an insulated electrode head. Each of electrodes 48 and 50 can be electrically coupled to a respective one of the coil conductors within the lead body and, thereby, to a respective one of the electrical contacts on the proximal end of cardiac pacing therapy lead 18.

[0059] Electrodes 48 and 50 can sense electrical signals associated with depolarization and repolarization of heart 12. The electrical signals are conducted to IMD 16 via cardiac conduction pacing lead 18. In some examples, IMD 16 also delivers pacing pulses via electrodes 48, 50 to cause depolarization of cardiac tissue of heart 12, particularly by delivering pacing pulses to the cardiac conduction system. In some examples, such as Figure 2B As illustrated, IMD 16 may include one or more housing electrodes, such as housing electrode 58, which may be integrally formed with an outer surface of an airtight housing 60 of IMD 16 or otherwise coupled to housing 60. In some examples, housing electrode 58 may be defined by a non-insulated portion of an outwardly facing portion of housing 60 of IMD 16. Other separations between the insulated and non-insulated portions of housing 60 may be used to define two or more housing electrodes. In some examples, housing electrode 58 comprises substantially all of housing 60. Either of electrodes 48, 50 may be used in combination with housing electrode 58 for unipolar sensing or pacing, or for bipolar sensing with two electrodes in the same pacing lead. In one or more embodiments, housing 60 may enclose a stimulation generator (see Figure 4 ), and a sensing module for monitoring the patient's heart rhythm.

[0060] The cardiac pacing therapy lead 18 may also include an elongated electrode 66 ( Figure 2A), the elongated electrode can take the form of a coil. IMD 16 can deliver defibrillation shocks to heart 12 via elongated electrode 66 and housing electrode 58. Electrodes 58, 66 can also be used to deliver cardioversion pulses to heart 12. Electrode 66 can be made of any suitable conductive material, such as, but not limited to, platinum, a platinum alloy, or other materials known for use in implantable defibrillation electrodes. In an alternative embodiment, electrodes 48, 50, 58, 66 can be implanted using a leadless pacing device rather than cardiac conduction therapy lead 18.

[0061] The elongated electrodes may be selected in a unipolar electrode vector along with either a lead-based tip or ring electrode to sense unipolar electrocardiogram signals for analysis and determination of ventricular conduction conditions. In some cases, the elongated electrodes may be used with housing 60 to sense far-field electrocardiogram signals for determination of atrial depolarization or activation, etc.

[0062] In other embodiments (not shown), additional examples of dual-chamber and triple-chamber therapy systems may be utilized. Such examples may use two or three or more leads, or various leadless devices and electrodes. In the dual-chamber example, electrodes are implanted in the RV and RA to pace one or more portions of the cardiac conduction system (such as the His bundle or one or both bundle branches) and the RA, respectively.

[0063] The electrode 50 can be in the form of a spiral (also referred to as a spiral electrode) that can be positioned near, adjacent to, adjacent to, or in an area or portion of the cardiac conduction system, such as, for example, the ventricular septum, Koch's triangle, the bundle of His, left bundle branch tissue, and / or right bundle branch tissue. The cardiac conduction system pacing lead 18 can be configured as a bipolar lead that can be used with a pacemaker device, a CRT-P device, or a CRT-ICD. As shown, the cardiac conduction system pacing lead 18 can be advanced into the RV chamber of the heart into the ventricular septum to achieve ideal positioning of the electrode 50. During electrode advancement, the electrode 50 may be advanced too far into the ventricular septum, causing the electrode 50 to perforate through the ventricular septum and into another chamber of the heart (e.g., LV).

[0064] Specifically, Figures 2A to 2B A patient's heart 12 is shown implanted with a cardiac conduction system pacing lead 18 for delivering bundle branch pacing according to one example of a single chamber therapy system 71. The cardiac conduction system therapy lead 18 is positioned through the tricuspid valve or into the RV and implanted in the ventricular septum, for example, about 1 cm to 2 cm distal to the apex of the RA (e.g., Figures 2A to 2B exemplified). Figure 2B yes Figure 2A12 is a close-up view of a cardiac conduction system therapy lead 18 in a patient's heart 12. In some embodiments, the cardiac conduction system therapy lead 18 can be the only lead implanted in the heart 12. In other embodiments, as discussed herein, leads can be present in addition to the cardiac conduction system therapy lead 18 implanted in the heart 12. The one or more implantable electrodes of the cardiac conduction system therapy lead 18 can include a pacing electrode that can be implanted proximate to the cardiac conduction system to deliver cardiac conduction system pacing therapy. In alternative embodiments, a leadless pacing device and electrodes can be used as described herein.

[0065] As illustrated, the cardiac conduction system pacing therapy lead 18 is implanted in the ventricular septum wall 35 or the ventricular septum from the RV toward the LV. The cardiac conduction system pacing therapy lead 18 does not pierce the LV wall or extend into the LV cavity. Electrodes 48 and 50 may be provided on the distal end portion of the cardiac conduction system pacing therapy lead 18, as described herein at least with respect to Figure 2A However, during electrode advancement, electrodes 48, 50 may also be advanced such that one or both electrodes 48, 50 undesirably perforate through the ventricular septum and into another chamber of the heart (e.g., the LV). The present disclosure generally relates to determining whether an implanted electrode is positioned within the ventricular septum of a patient's heart near or at the cardiac conduction system, and whether the implanted electrode should be repositioned based on the determination. The present disclosure further relates to determining that an implanted electrode has perforated the ventricular septum into the LV cavity, and whether the implanted electrode should be repositioned based on the determination.

[0066] Prior to reaching the ventricular septum, implantable electrodes 48, 50 are advanced into the patient's body and electrical activity can be monitored using external electrode device 45 and the resulting ECG signal. Once the ventricular septum is reached, implantable electrodes 48, 50 can be connected to programmer 24 as described herein. Thereafter, the monitored electrical activity can include monitored internal electrical activity and monitored external electrical activity as discussed herein.

[0067] As the user advances the implantable electrode further into the patient, the implantable electrodes 48, 50 advance through the septum. In embodiments having a lead (such as the cardiac conduction system pacing therapy lead 18), the electrodes 48, 50 are advanced into the patient as the lead is advanced into the patient. The cardiac conduction system pacing therapy lead 18 or the implantable electrodes 48, 50 can be advanced into the ventricular septum via rotation, and in embodiments where the electrode 50 is helical, such rotation will rotate the electrode 50 and advance the electrode further into the ventricular septum tissue. Rotation of the implantable electrodes 48, 50 or rotation of the cardiac conduction system pacing therapy lead 18 can be achieved using a rotary coupling connected to the implantable electrode or cardiac conduction system pacing therapy lead 18. The rotary coupling can allow continuous monitoring of electrical signals using the programmer 24 and computing device 81 via the electrodes 48, 50 as the programmer and computing device are rotated and advanced. An exemplary rotary connector may be described, for example, in U.S. patent application publication No. 2022 / 0088395A1, entitled “Rotatable Adapter For Connecting Implantable Medical Leads To Test Devices,” published on March 24, 2022, which is incorporated herein by reference in its entirety.

[0068] The cardiac conduction system pacing therapy lead 18 may also be described as a shaft. Electrodes 48 and 50 may be connected to Figure 2A The illustrated electrodes 48 and 50 are identical or similar, and electrode 48 is configured to sense or pace the right bundle branch and electrode 50 is configured to sense or pace the left bundle branch, for example, during dual-bundle-branch pacing. Thus, electrode 48 may be implanted near the right bundle branch 8b and electrode 50 may be implanted near the left bundle branch 8a. Electrode 50 may be implanted toward the left side of the patient's ventricular septum. Electrode 48 may be implanted toward the right side of the patient's ventricular septum. In one embodiment, electrode 50 may be a helical electrode and electrode 48 may be a ring electrode. As described herein, in alternative embodiments, a leadless pacing device may be used. In such alternative embodiments, electrodes 48, 50 may be implanted in the locations shown and described without cardiac conduction system pacing therapy lead 18.

[0069] During dual bundle branch pacing, both electrodes 48 and 50 can each deliver pulses to achieve synchronized activation or excitation of the right bundle branch 8b and the left bundle branch 8a, which can result in synchronized activation of the RV and LV. In some embodiments, the pulses can be delivered simultaneously to achieve synchronization. In other embodiments, the pulses can be delivered with a delay to achieve synchronization.

[0070] Although cardiac conduction system pacing therapy lead 18 is shown configured for dual bundle branch pacing using electrodes 48, 50, it should be understood that cardiac conduction system pacing therapy lead 18, or a lead similar thereto, may be considered herein to include only one of electrodes 48 and 50 and, therefore, be configured to deliver cardiac conduction system pacing therapy to only one of the right and left bundle branches. In alternative embodiments, both electrodes 48 and 50 may be located on cardiac conduction system pacing therapy lead 18, but IMD 16 may use only one of electrodes 48, 50 to pace only one bundle branch.

[0071] Additionally, the cardiac conduction system pacing therapy lead 18 can include an RA electrode 75 disposed along the cardiac conduction system pacing therapy lead 18 more proximal to the electrodes 48, 50. The RA electrode 75 can be positioned in or near the RA and can serve as an anode for cathodal pulses from the electrodes 48 and / or 50. Further, the RA electrode 75 can provide atrial sensing, for example, to sense atrial depolarization or activation, sense or detect atrial fibrillation, etc. Although the cardiac conduction system pacing therapy lead 18 is shown as including the RA electrode 75, it should be understood that the cardiac conduction system pacing therapy lead 18 may not include the RA electrode 75, but rather only include one or both of the electrodes 48 and 50. In alternative embodiments, the electrode 75 can be implanted using a leadless pacing device rather than the cardiac conduction system pacing therapy lead 18.

[0072] As illustrated in Figure 2, the treatment system 71 may further include an external electrode device 45, which may include one or more external electrodes 44. The external electrode 44 may be configured to sense at least the electrical activity of the patient's heart 12. The external electrode 44 may be further configured to deliver pacing (e.g., cardiac conduction system pacing). The external electrode device 45 may include a surface ECG device (e.g., an ECG belt, an ECG vest, etc.), which may include a standard 12-lead ECG, a 2-lead ECG, a 1-lead ECG, or any other number of leads. The ECG device may include the use of one or more surface electrodes (e.g., external electrodes 44), including, for example, electrodes positioned on the patient's surface near or at standard I, II, III, IV, V, and VI chest leads and / or right upper and left arm and right lower and left leg limb leads.

[0073] In some embodiments, external electrode device 45 may include similar processing components 83 (e.g., a sensing module, stimulation generator, processor, telemetry module, memory, and power supply, collectively labeled as reference numeral 83) as described further herein with respect to IMD 16. Processing component 83 can receive EGM signals from one or more of electrodes 48, 50, 58, 66, and 75. Processing component 83 can receive ECG signals from one or more of external electrodes 44. In some embodiments, external electrode device 45 can communicate with IMD 16 and / or programmer 24 in wired or wireless communication.

[0074] When cardiac conduction system pacing therapy lead 18 is positioned for delivering bundle branch pacing of one or both bundle branches, cardiac conduction system pacing therapy can be combined with conventional ventricular myocardial pacing of the left ventricle using, for example, a coronary sinus lead to correct left ventricular conduction delays and achieve electrical and mechanical synchronization of the left and right ventricles. Thus, in some examples, one or more processors, one or more processing circuits, or computing devices of IMD 16 can select cardiac conduction system pacing therapy plus conventional left ventricular myocardial pacing therapy, which conventional left ventricular myocardial pacing therapy includes, for example, single bundle branch pacing or dual bundle branch pacing (e.g., using cardiac conduction system pacing therapy lead 18) combined with left ventricular myocardial pacing using a coronary sinus lead (not shown).

[0075] The configuration of treatment system 71 illustrated in FIG2 is merely one example. In other examples, the treatment system may include epicardial leads and / or patch electrodes in place of or in addition to cardiac conduction system pacing treatment leads 18, or other configurations shown or described herein or incorporated by reference. Further, IMD 16 need not be implanted in the patient. Thus, it should be understood that the exemplary treatment systems described herein may include any suitable number of leads coupled to IMD 16, and each of these leads may extend to any location within or proximate to heart 12. For example, the exemplary treatment systems may include, for example, Figures 2A to 2B A single transvenous lead positioned as illustrated in , or two or more transvenous leads located in respective lumens.

[0076] Figure 38 is a functional diagram of an example configuration of IMD 16, external electrode device 45, programmer 24, and electrodes 44, 48, 50, 58, 66, and 75. IMD 16 includes computing device 80 (which may include a processor), memory 82, stimulation generator 84 (e.g., an electrical pulse generator or signal generating circuit), sensing module 86 (e.g., sensing circuit), telemetry module 88, and power supply 90. One or more components of IMD 16, such as computing device 80, may be housed within a housing of IMD 16 (e.g., within a housing of a pacemaker). Telemetry module 88, sensing module 86, or both telemetry module 88 and sensing module 86 may be included in a communication interface. Memory 82 includes computer-readable instructions that, when executed by a processor of computing device 80, cause IMD 16 and computing device 80 to perform various functions attributed to IMD 16 and computing device 80 herein. Memory 82 may include any volatile, nonvolatile, magnetic, optical, or electrical medium, such as random access memory (RAM), read-only memory (ROM), nonvolatile RAM (NVRAM), electrically erasable programmable ROM (EEPROM), flash memory, or any other digital medium. In some embodiments, programmer 24 and / or external electrode device 45 include memory similar to memory 82 as described herein.

[0077] The computing device 80 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), or equivalent discrete or integrated logic circuits. In some examples, the computing device 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, or one or more FPGAs, as well as other discrete or integrated logic circuits. The functions attributed to the computing device 80 herein may be embodied as software, firmware, hardware, or any combination thereof. The computing device 80 controls the stimulation generator 84 to select a therapy mode and delivers stimulation therapy to the heart 12 according to the selected pacing mode and various sensing (e.g., atrial depolarization or activation, ventricular atrial depolarization or activation, heart rate, P wave to R wave interval, etc.) that may be stored in the memory 82. Specifically, the computing device 80 may control the stimulation generator 84 to deliver electrical pulses having an amplitude, pulse width, frequency, or electrode polarity specified by the selected one or more therapy programs and therapy modes. Computing device 80 can also monitor EGM signals from implantable electrodes 48, 50, 66, 75, and can also monitor ECG signals from external electrode 44. The monitored ECG and / or EGM signals can be used to determine whether the implantable electrode is close to the cardiac conduction system (e.g., LBB) or positioned within the ventricular septum at the cardiac conduction system, and whether the implantable electrode should be repositioned based on this determination. The monitored ECG and / or EGM signals can be used to determine that the implantable electrode has perforated the ventricular septum into the LV cavity, and that the implantable electrode should be repositioned based on this determination. In some embodiments, programmer 24 and / or external electrode device 45 include a computing device similar to computing device 80 as described herein (81 and 83, respectively).

[0078] In some embodiments, the cardiac conduction system pacing lead 18 can be operably coupled to an electrode 75 that can be used to monitor or pace RA. In some embodiments, a stimulation generator 84 can be electrically coupled to electrodes 48, 50, 66, and 75, for example, via conductors of the cardiac conduction pacing therapy lead 18 (or, in alternative embodiments, via a leadless pacing device), or, in the case of housing electrode 58, via electrical conductors disposed within housing 60 of IMD 16, or, in the case of external electrode 44, via electrical conductors disposed within external electrode device 45. The stimulation generator 84 can be configured to generate and deliver electrical stimulation therapy to the heart 12. For example, the stimulation generator 84 can deliver a defibrillation shock to the heart 12 via electrode 66. The stimulation generator 84 can deliver pacing pulses via the ring electrode 48 coupled to the cardiac conduction pacing therapy lead 18 and / or the helical electrode 50 coupled to the cardiac conduction pacing therapy lead 18. In various embodiments, cardiac conduction system pacing therapy can be delivered via cardiac conduction system pacing leads 18 connected to the atrial, right ventricular, or left ventricular connection ports of connector block 34. In some examples, stimulation generator 84 delivers pacing, cardioversion, or defibrillation stimulation in the form of electrical pulses. In other examples, stimulation generator 84 can deliver one or more of these types of stimulation in the form of other signals, such as sine waves, square waves, or other substantially continuous time signals. In some embodiments, programmer 24 and / or external electrode device 45 includes a stimulation generator similar to stimulation generator 84 as described herein.

[0079] Stimulation generator 84 may include a switch module, and computing device 80 may use the switch module to select which of the available electrodes to use for delivering a defibrillation shock or pacing pulse, for example, via a data / address bus. The switch module may include a switch array, a switch matrix, a multiplexer, or any other type of switching device suitable for selectively coupling stimulation energy to selected electrodes.

[0080] Sensing module 86 monitors signals from at least one of electrodes 44, 48, 50, 58, 66, or 75 to monitor the electrical activity of heart 12, such as via an electrocardiogram (ECG) signal and / or an electrogram (EGM). Sensing module 86 may also include a switch module to select which of the available electrodes is used to sense cardiac activity. In some examples, computing device 80 may select an electrode to serve as a sensing electrode via a switch module within sensing module 86, for example, by providing a signal via a data / address bus. In some examples, sensing module 86 includes one or more sensing channels, each of which may include an amplifier. In response to a signal from computing device 80, the switch module may connect the output from the selected electrode to one of the sensing channels. In some embodiments, programmer 24 and / or external electrode device 45 include a sensing module similar to sensing module 86 as described herein.

[0081] In some examples, one channel of sensing module 86 may include an R-wave amplifier that receives signals from electrodes 48, 50 used for pacing and sensing in the RV of heart 12. In some examples, the R-wave amplifier may take the form of an automatic gain control amplifier that provides an adjustable sensing threshold based on the measured R-wave amplitude of the heart rhythm.

[0082] Additionally, in some examples, one channel of sensing module 86 may include a P-wave amplifier that receives signals from electrodes used for pacing and sensing in the RA of heart 12. In some examples, the P-wave amplifier may take the form of an automatic gain control amplifier that provides an adjustable sensing threshold based on the measured P-wave amplitude of the heart rhythm. Examples of R-wave and P-wave amplifiers are described in U.S. Patent No. 5,117,824, issued to Keimel et al. on June 2, 1992, entitled "APPARATUS FOR MONITORING ELECTRICAL PHYSIOLOGIC SIGNALS," which is incorporated herein by reference in its entirety. Other amplifiers may also be used. In addition, in some examples, one or more of the sensing channels of the sensing module 86 may be selectively connected to the shell electrode 58 or the slender electrode 66 or the RA electrode 75, together with or in place of one or more of the electrodes 48 or 50, for example for unipolar sensing of R waves or P waves in any of the chambers 26, 28 or 32 of the heart 12.

[0083] In some examples, the sensing module 86 includes a channel that includes an amplifier with a relatively wider passband than the R-wave amplifier or the P-wave amplifier or a high-resolution amplifier with a relatively narrow passband for recording the His bundle or bundle branch potential. The signal from the selected sensing electrode selected for connection to this wideband amplifier can be provided to a multiplexer and thereafter converted by an analog-to-digital converter into a multi-bit digital signal for storage in the memory 82 as an electrogram (EGM). In some examples, the storage of such EGM in the memory 82 can be under the control of a direct memory access circuit. The computing devices 80, 81, 83 can use digital signal analysis techniques to characterize the digitized signals stored in the memory 82 to detect and classify the patient's heart rhythm from the electrical signals. The computing devices 80, 81, 83 can detect and classify the patient's heart rhythm by using any of the numerous signal processing methods known in the art. The computing device 81 may determine whether the implanted electrode (e.g., 48, 50) is located proximate to the cardiac conduction system (e.g., LBB) or within the ventricular septum at the cardiac conduction system based on, for example, cardiac conduction system capture, current lesions, impedance, etc., and may determine whether the implanted electrode should be repositioned based on this determination. The computing device 81 may determine that the implanted electrode has perforated the ventricular septum into the LV cavity and may determine that the implanted electrode should be repositioned based on this determination.

[0084] If the IMD 16 is configured to generate and deliver pacing pulses to the heart 12, the computing device 80 may include a pacemaker timing and control module, which may be embodied in hardware, firmware, software, or any combination thereof. The pacemaker timing and control module may include a dedicated hardware circuit (such as an ASIC) separate from other computing device 80 components, such as a microprocessor, or a software module executed by a component of the computing device 80, which may be a microprocessor or ASIC. The pacemaker timing and control module may include a programmable counter that controls the basic time intervals associated with DDD, VVI, DVI, VDD, AAI, DDI, DDDR, VVIR, DVIR, VDDR, AAIR, DDIR, and other single-chamber and dual-chamber pacing modes. In the aforementioned pacing modes, "D" may indicate dual chamber, "V" may indicate ventricle, "I" may indicate inhibited pacing (e.g., no pacing), and "A" may indicate atrial. The first letter in the pacing mode may indicate the lumen that is paced, the second letter may indicate the lumen in which the electrical signal is sensed, and the third letter may indicate the lumen in which the response to the sensing is provided.

[0085] The intervals defined by the pacemaker timing and control module may include atrial and ventricular pacing escape intervals, a refractory period during which sensed P and R waves are ineffective for re-starting the timing of the escape interval, and the pulse width of the pacing pulse. As another example, the pacemaker timing and control module may define blanking periods and provide signals from the sensing module 86 to blank one or more channels, such as amplifiers, for a period of time during and after the delivery of electrical stimulation to the heart 12. The duration of these intervals may be determined by the computing device 80 in response to data stored in the memory 82. The pacemaker timing and control module may also determine the amplitude of the cardiac pacing pulses.

[0086] During pacing, an escape interval counter within the pacemaker timing / control module may be reset when R waves and P waves are sensed. Stimulation generator 84 may include pacemaker output circuitry that is selectively coupled, for example, via a switch module, to any combination of electrodes 44, 48, 50, 58, 66, or 75 suitable for delivering bipolar or unipolar pacing pulses to one of the chambers of heart 12. Computing device 80 may reset the escape interval counter when pacing pulses are generated by stimulation generator 84 and thereby control the basic timing of cardiac pacing functions, including anti-tachyarrhythmia pacing.

[0087] In some examples, computing device 80 may operate as an interrupt-driven device and respond to interrupts from the pacemaker timing and control module, wherein the interrupts may correspond to the occurrence of sensed P and R waves and the generation of cardiac pacing pulses. Any necessary mathematical calculations are performed by computing device 80, and any updates to values ​​or intervals controlled by the pacemaker timing and control module of computing device 80 may occur after such interrupts. A portion of memory 82 may be configured as a plurality of recirculating buffers capable of holding a series of measured intervals that may be analyzed by computing device 80 in response to the occurrence of a pacing or sensing interrupt to determine whether patient heart 12 is currently exhibiting an atrial or ventricular tachyarrhythmia.

[0088] During implantation of the implantable electrodes, each of cardiac conduction system capture, current impairment, and impedance can be monitored by computing devices 80, 81, 83. Cardiac conduction system capture can be determined based on EGM or ECG signal analysis (e.g., based on left ventricular activation time, maximum rate of change after a pacing pulse, etc.). Current impairment can be determined based on EGM or ECG signal analysis (e.g., based on the "ST" segment, or the interval between ventricular depolarization and repolarization, etc.). Impedance can be determined based on EGM or ECG signal analysis (e.g., based on the potential difference measured between the electrodes, etc.). Computing device 81 can use EGM and ECG signal analysis of cardiac conduction system capture, current impairment, and impedance to determine the position of the implantable electrodes.

[0089] Telemetry module 88 includes any suitable hardware, firmware, software, or any combination thereof for communicating with another device, such as programmer 24 and / or external electrode device 45. Under the control of computing device 80, telemetry module 88 can receive downlink telemetry from programmer 24 and send uplink telemetry to the programmer via an antenna, which can be internal and / or external. Computing device 80 can, for example, provide data to be uplinked to programmer 24 and control signals for telemetry circuitry within telemetry module 88 via an address / data bus. In some examples, telemetry module 88 can provide received data to computing device 80 via a multiplexer. In some embodiments, programmer 24 and / or external electrode device 45 include a telemetry module similar to telemetry module 88 as described herein.

[0090] The various components of IMD 16 are coupled to power source 90, which may include a rechargeable or non-rechargeable battery. Non-rechargeable batteries may be selected to last for several years, while rechargeable batteries may be inductively charged from an external device, for example, on a daily or weekly basis. In some embodiments, programmer 24 and / or external electrode device 45 include a power source similar to power source 90 as described herein.

[0091] The exemplary systems, devices, and methods described herein can provide an effective and efficient way to implant electrodes in a patient's body near a portion of the cardiac conduction system (e.g., LBB) using implantable electrodes (e.g., electrodes 48, 50). The implantable electrodes may include one or more implantable electrodes, as described herein. The exemplary systems, devices, and methods described herein can provide and use monitored electrical activity (e.g., using internal and / or external electrodes to obtain EGM and / or ECG signals, respectively) to determine cardiac conduction system capture, current damage, and impedance, and further determine that the electrode is implanted near a portion of the cardiac conduction system based on cardiac conduction system capture, current damage, and impedance during electrode implantation. Monitoring of electrical activity can be used to help reduce the incidence of ventricular septal wall perforation during electrode implantation (e.g., in real time) during electrode advancement.

[0092] In at least one embodiment, and as Figures 4 to 7As illustrated, the therapy system 71 can be used to assist in the implantation of implantable electrodes (e.g., electrodes 48, 50). The therapy system 71 can include an implantable lead (e.g., cardiac conduction system pacing therapy lead 18) having one or more implantable electrodes 48, 50. In an alternative embodiment, a leadless pacing device can be used as described herein. Throughout this application, an implantable electrode can be described, which can be understood as one or both of the implantable electrodes 48, 50. The implantable electrodes 48, 50 can be configured to deliver cardiac conduction system pacing near a portion of the patient's cardiac conduction system. The implantable electrodes 48, 50 can be configured to deliver cardiac conduction system pacing near a portion of the patient's LBB. Cardiac conduction system pacing can include LBB pacing or LBB regional pacing. LBB pacing can be defined as direct pacing of the LBB, and LBB regional pacing can be defined as pacing near or at the LBB. In an alternative embodiment, other parts of the cardiac conduction system can be paced (e.g., the RBB, the His bundle, Purkinje fibers, etc.). Implantable electrodes 48 , 50 may be further configured to sense electrical activity of the patient's heart 12 .

[0093] like Figure 3 As illustrated, external electrode device 45 (including external electrodes 44 and processing component 83) can communicate with IMD 16 in wired or wireless communication, and can additionally or alternatively communicate with programmer 24 in wired or wireless communication. External electrodes 44 can be configured to sense at least electrical activity of patient's heart 12, as described herein. Programmer 24 (including display 47 and processing component 81) can communicate with IMD 16 in wired or wireless communication, and can additionally or alternatively communicate with external electrode device 45 in wired or wireless communication. Display 47 can include, for example, a Medtronic SMARTSYNC TM Portable monitor. Trademark SMARTSYNC TM The use of has been indicated in this application.

[0094] As described herein, computing devices 80, 81, 83 may include processing circuitry and may be operably coupled to implanted electrodes 48, 50 and external electrode 44. Computing devices 81, 83 may be configured to monitor internal electrical activity during implantation of the implanted electrodes using implanted electrodes 48, 50. Computing devices 81, 83 may be further configured to monitor external electrical activity during implantation of the implanted electrodes using external electrode 44.

[0095] The computing device 81 may be further configured to determine cardiac conduction system capture 117A based on at least one of the monitored internal electrical activity and the monitored external electrical activity during implantation of the implantable electrode. Figure 4). Cardiac conduction system capture 117A can be defined as the successful delivery of intended cardiac conduction system pacing (rather than pacing, e.g., myocardial tissue). Cardiac conduction system capture threshold 118A ( Figure 6 ) can be used to define a minimum amount of power for delivering cardiac conduction system pacing while achieving capture of the cardiac conduction system 117A and can be measured in volts. The cardiac conduction system capture threshold 118A can be monitored in real time during implantation of the implanted electrode using at least one of the implanted electrodes 48, 50 and the external electrode 44.

[0096] The computing device 81 may be further configured to determine the current lesion 112A based on at least one of the internal electrical activity monitored and the external electrical activity monitored during implantation of the implantable electrode. Figure 4 、 Figure 5 ). Current injury 112A can be defined as the current generated when a damaged portion of a nerve (e.g., a nerve bundle), muscle, or other excitable tissue is connected to an undamaged area by a conductor. Damaged tissue will have a negative voltage compared to undamaged tissue. During implantation, the implanted electrode itself may produce less tissue damage, and some measured current injury levels may correspond to more optimized electrode placement. If leads are used, the leads themselves may produce slight tissue damage, and some measured current injury levels may correspond to more optimized lead placement. Current injury 112A can be measured in millivolts. Current injury 112A can be monitored in real time during implantation of the implantable electrode using at least one of the implanted electrodes 48, 50 and the external electrode 44.

[0097] The computing device 81 may be further configured to determine the impedance 124A based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the external electrical activity monitored. Figure 4 、 Figure 7 Impedance 124A can be defined as the effective resistance to pacing current caused by the combined effects of resistance and reactance in the circuit. In other words, impedance can be defined as the opposition to current flow and can be measured in ohms. Impedance 124A can be monitored in real time during implantation of the implantable electrode using at least one of implantable electrodes 48, 50 and external electrode 44.

[0098] The computing device 81 can be further configured to determine, during implantation of the implanted electrode, that the implanted electrode is proximate to the cardiac conduction system and implanted in the interventricular septal wall 35 prior to perforation into the LV cavity 32 based on at least one of cardiac conduction system capture 117A, current lesion 112A, and impedance 124A. Such determination is discussed further herein. Determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the interventricular septal wall 35 prior to perforation into the LV cavity 32 based on at least one of cardiac conduction system capture 117A, current lesion 112A, and impedance 124A can include determining that the implanted electrode is implanted in the interventricular septal wall 35 proximate to the LBB 8a. Such implantation proximate to the LBB can allow for LBB pacing and / or LBB regional pacing.

[0099] Computing device 81 may be further configured to issue or initiate a first notification 110 in response to determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall 35 prior to perforation of the LV cavity 32. First notification 110 may be audible, visual, or in any other format to notify the user having the implanted electrode implanted that the implanted electrode is implanted proximate to the cardiac conduction system. As described herein, first notification 110 may be displayed (audibly, visually, etc.) on or by display 47.

[0100] Computing device 81 may be further configured to determine that the implanted electrode has perforated into LV cavity 32 based on at least one of cardiac conduction system capture threshold 118A, current lesion 112A, and impedance 124A. Computing device 81 may be further configured to issue a second notification 111 in response to determining that the implanted electrode has perforated into LV cavity 32. Second notification 111 may be audible, visual, or in any other format to notify a user who is implanting the implanted electrode that the implanted electrode has perforated into LV cavity 32. As described herein, second notification 111 may be displayed (audibly, visually, etc.) on or by display 47.

[0101] Computing device 81 may be further configured to display first notification 110 during implantation of the implantable electrode, for example, using display 47. Computing device 81 may be further configured to display second notification 111 during implantation of the implantable electrode, for example, using display 47.

[0102] In at least one embodiment, and as Figures 4 to 7As illustrated, treatment system 71 can perform method 100 to assist in implanting an implantable electrode as described herein. Method 100 can include monitoring internal electrical activity using one or more of implantable electrodes 48, 50 during implantation of implantable electrode 102. Method 100 can further include monitoring external electrical activity using one or more external electrodes 44 during implantation of implantable electrode 104. Monitoring of internal and external electrical activity can include monitoring EGM signals generated by implantable electrodes 48, 50 and / or monitoring ECG signals generated by external electrodes 44.

[0103] The method 100 may further include determining cardiac conduction system capture 117A based on at least one of the internal electrical activity monitored and the monitored external electrical activity during implantation of the implanted electrode 106. The method 100 may further include determining current lesion 112A based on at least one of the internal electrical activity monitored and the monitored external electrical activity during implantation of the implanted electrode 106. The method 100 may further include determining impedance 124A based on at least one of the internal electrical activity monitored and the monitored external electrical activity during implantation of the implanted electrode 106.

[0104] The method 100 may further include determining during implantation of the implantable electrode that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 (at a location within the ventricular septum wall 35) prior to perforation into the LV cavity 32 based on at least one of cardiac conduction system capture 117A, current lesion 112A, and impedance 124A. Figure 4 The method 100 may further include issuing a first notification 110 in response to determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall 35 prior to perforation of the LV cavity 32 (such issuance being in the Figure 4 The method 100 may further include determining that the implanted electrode has perforated the LV cavity 32 based on at least one of a cardiac conduction system capture threshold 118A, a current lesion 112A, and an impedance 124A, as further described herein. The method 100 may further include issuing a second notification 111 in response to determining that the implanted electrode has perforated the LV cavity 32 (such issuance being in the Figure 4 111 in the figure and further as an optional step of method 100).

[0105] Figure 51A is illustrated in FIG. 101A for determining a change in current lesion 112A during electrode implantation for use in method 100. Determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 prior to perforation into the LV cavity 32 based on the current lesion 112A may include determining the current lesion 112 during electrode implantation. Determining the current lesion 112 during electrode implantation may include determining the current lesion based on at least one of an EGM or ECG signal analysis (e.g., based on an "ST" segment, understood as the interval between ventricular depolarization and repolarization, the amplitude of the signal, the amplitude of the ST segment of the signal, the amplitude of the ST segment relative to the R wave of the signal, etc., and any combination thereof). The signal analysis may be based on signals obtained from at least one of the one or more implanted electrodes 48, 50 and the external electrode 44. The computing device 81 may use the monitored electrical activity of the implanted electrode (e.g., ECG and EGM signals) to determine the location of the implanted electrode to determine the current lesion.

[0106] Method 101A may further include, in response to determining a decrease in monitored current lesion 112A as the implanted electrode moves through the ventricular septum 35 toward the LV cavity 32 during implantation of the implanted electrode, determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 prior to perforating into the LV cavity 32. Determining the decrease in monitored current lesion 112A may include determining the decrease in monitored current lesion 112A via a current lesion (IOC) implant change value 114.

[0107] The IOC implant change value 114 can be between about 0 mV and about 20 mV. In at least one embodiment, the IOC implant change value 114 can be greater than 0 mV. In other embodiments, the IOC implant change value 114 can be greater than or equal to 0.1 mV, greater than or equal to 1 mV, greater than or equal to 2 mV, greater than or equal to 3 mV, greater than or equal to 4 mV, greater than or equal to 5 mV, greater than or equal to 6 mV, etc., and / or less than or equal to 20 mV, 6.5 mV, 5.5 mV, 4.5 mV, 3.5 mV, 2.5 mV, 1.5 mV, 0.5 mV, etc. In alternative embodiments, the IOC implant change value 114 can be a set percentage of the patient's current injury being monitored at or near the ventricular septum.

[0108] Therefore, if the IOC implant change value 114 is 0.1 mV and the IOC decreases to 0.2 mV during monitoring 112, it can be determined that an IOC decrease has occurred, indicating that the implanted electrode is close to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32. If the IOC implant change value 114 is 5 mV and the IOC decreases to 2 mV during monitoring 112, it can be determined that an IOC decrease has not occurred, indicating that the implanted electrode is not close to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32.

[0109] In an alternative embodiment, determining a reduction in the monitored current impairment 112A may include determining that the monitored current impairment 112A is reduced to an IOC implant target value. The IOC implant target value may be between approximately 0 mV and approximately 5 mV. In at least one embodiment, the IOC implant target value may be approximately equal to or greater than 2 mV. In other embodiments, the IOC implant target value may be greater than 0 mV and / or greater than or equal to 0.1 mV, greater than or equal to 1 mV, greater than or equal to 2 mV, greater than or equal to 3 mV, greater than or equal to 4 mV, greater than or equal to 5 mV, etc. and / or less than or equal to 5.5 mV, 4.5 mV, 3.5 mV, 2.5 mV, 1.5 mV, 0.5 mV, etc. In an alternative embodiment, the IOC implant target value may be a set percentage of the patient's current impairment monitored at or near the ventricular septum.

[0110] Thus, if the IOC implant target value is 2 mV, and the IOC is monitored 112 to decrease to 2 mV, it can be determined that an IOC decrease has occurred, indicating that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 before perforating into the LV cavity 32. If the IOC implant target value is 2 mV, and the IOC is monitored 112 to decrease to 2.5 mV, it can be determined that an IOC decrease has not occurred, indicating that one or more implanted electrodes are not proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 before perforating into the LV cavity 32.

[0111] Method 101A may further include determining that the implanted electrode has perforated into the LV cavity 32 based on the current lesion 112A. Such determination may include determining that the implanted electrode has perforated into the LV cavity 32 in response to determining a further decrease in the monitored current lesion 112A as the implanted electrode 48, 50 moves from an implantation location proximate to the cardiac conduction system through the ventricular septum 35 into the LV cavity 32 during implantation of the implanted electrode. Determining a further decrease in the monitored current lesion 112A may include determining a further decrease IOC perforation change value 116 of the monitored current lesion 112A. As discussed herein, a "further decrease" in the monitored current lesion is relative to a current lesion value monitored at or near the cardiac conduction system, or relative to an IOC value monitored at a location understood to be at or near the cardiac conduction system.

[0112] The IOC perforation variation value 116 can be between about 0.1 mV and about 20 mV. In at least one embodiment, the IOC perforation variation value 116 can be greater than 1 mV. In other embodiments, the IOC perforation variation value 116 can be greater than 0 mV and / or greater than or equal to 1 mV, greater than or equal to 2 mV, greater than or equal to 3 mV, greater than or equal to 4 mV, greater than or equal to 5 mV, greater than or equal to 10 mV, etc., and / or less than or equal to 20.5 mV, 6.5 mV, 5.5 mV, 4.5 mV, 3.5 mV, 2.5 mV, 1.5 mV, etc. In alternative embodiments, the IOC perforation variation value 116 can be a set percentage of the patient's IOC implant variation value 114, or can be a set percentage of the patient's current injury monitored at or near the cardiac conduction system.

[0113] Thus, if the IOC perforation change value 116 is 1 mV, and monitoring 112 is performed to a further IOC decrease of 1.2 mV, it can be determined that a further IOC decrease has occurred to indicate that the implanted electrode has perforated into the LV cavity 32. If the IOC perforation change value 116 is 1 mV, and monitoring 112 is performed to a further IOC decrease of 0.7 mV, it can be determined that no further IOC decrease has occurred to indicate that the implanted electrode has not perforated into the LV cavity 32.

[0114] In an alternative embodiment, determining a further reduction in the monitored current impairment 112A may include determining a further reduction in the monitored current impairment 112A to the IOC perforation target value. In yet another alternative embodiment, if the monitored current impairment 112A disappears or is no longer monitorable, such disappearance may be equated with a further reduction in the monitored current impairment 112A to the IOC perforation target value.

[0115] The IOC perforation target value can be between about 0mV and about 2mV. In at least one embodiment, the IOC perforation target value can be approximately equal to or greater than 1mV. In other embodiments, the IOC perforation target value can be greater than 0mV and / or greater than or equal to 2mV, greater than or equal to 1mV, greater than or equal to 0.5mV, greater than or equal to 0.25mV, greater than or equal to 0.2mV, greater than or equal to 0.1mV, greater than or equal to 0mV, etc. and / or less than or equal to 0.3mV, 0.6mV, 0.9mV, 1.1mV, 1.6mV, 1.9mV, etc. In alternative embodiments, the IOC perforation target value can be a set percentage of the patient's IOC implant target value, or can be a set percentage of the patient's current injury monitored at or near the cardiac conduction system.

[0116] Thus, if the IOC perforation target value is 1 mV, and the IOC is monitored 112 to decrease to 1 mV, it can be determined that a decrease in the IOC has occurred to indicate that the implanted electrode has perforated into the LV cavity 32. If the IOC perforation target value is 1 mV, and the IOC is monitored 112 to decrease to 1.5 mV, it can be determined that a decrease in the IOC has not occurred to indicate that the implanted electrode has perforated into the LV cavity 32.

[0117] Figure 6 1. A method 118B for determining a cardiac conduction system capture threshold 101A during electrode implantation for use in method 100 is illustrated in FIG. As discussed herein, the cardiac conduction system capture threshold 118A may be a threshold value for determining a cardiac conduction system capture threshold 101A during electrode implantation. Figure 4 The invention also provides a method for delivering a minimum amount of power (e.g., voltage) for cardiac conduction system pacing while simultaneously capturing the cardiac conduction system 117A (as shown). Thus, capture of the cardiac conduction system 117A can be established before determining the cardiac conduction system capture threshold 118A. Exemplary establishment of cardiac conduction system capture can be described, for example, in U.S. Patent No. 11,007,369 B2, entitled “Implantable medical device and method for determining His bundlepacing capture,” published on May 9, 2019, and issued on May 18, 2021, which is incorporated herein by reference in its entirety, and in U.S. Patent Application No. 2022 / 0080210 A1, entitled “His Bundle and Bundle Branch Pacing Adjustment,” published on March 17, 2022, which is incorporated herein by reference in its entirety.

[0118] Determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 prior to perforation into the LV cavity 32 based on the cardiac conduction system capture threshold 118A may include determining the cardiac conduction system capture threshold 118 during electrode implantation. Determining the cardiac conduction system capture threshold 118 during electrode implantation may include determining the cardiac conduction system capture threshold 118A based on at least one of an EGM or ECG signal analysis (e.g., based on left ventricular activation time, maximum rate of change after a pacing pulse, a specific QRS morphology, etc., and any combination thereof). An exemplary determination of cardiac conduction system capture may be described, for example, in U.S. Patent Application Publication No. 2020 / 0306546A1, entitled “Cardiac Conduction System Capture,” published on October 1, 2020, which is incorporated herein by reference in its entirety. The signal analysis may be based on signals obtained from at least one of the one or more implanted electrodes 48, 50 and the external electrode 44. Computing device 81 may determine the location of the implanted electrodes using the monitored electrical activity of the implanted electrodes (eg, ECG and EGM signals) to determine a cardiac conduction system capture threshold 118A.

[0119] Method 101B may further include determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall 35 prior to perforating into the LV cavity 32 in response to determining an increase in the cardiac conduction system capture threshold 118A as the implanted electrode moves through the ventricular septum 35 toward the LV cavity 32 during implantation of the implanted electrode.

[0120] Determining an increase in cardiac conduction system capture threshold 118A may include determining that cardiac conduction system capture threshold 118A has increased by implantation threshold 120. Implantation threshold 120 may be between approximately 0V and approximately 2V. In at least one embodiment, implantation threshold 120 may be approximately equal to or greater than 1V. In other embodiments, implantation threshold 120 may be less than or equal to 2V, less than or equal to 1.75V, less than or equal to 1.5V, less than or equal to 1V, less than or equal to 0.75V, less than or equal to 0.5V, less than or equal to 0.2V, etc., and / or greater than 0V and / or greater than or equal to 0.1V, 0.6V, 0.9V, 1.1V, 1.6V, 1.9V, 2.1V, etc. In another embodiment, implantation threshold 120 may be a set percentage of the patient's intrinsic cardiac conduction system capture threshold 118A.

[0121] Thus, if the implantation threshold 120 is 1 V and the conduction system capture threshold increase is monitored 118 to 1.2 V, it can be determined that a conduction system capture threshold increase has occurred, indicating that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32. If the implantation threshold 120 is 1 V and the conduction system capture threshold increase is monitored 118 to 0.8 V, it can be determined that a conduction system capture threshold increase has not occurred, indicating that the implanted electrode is not proximate to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32.

[0122] In an alternative embodiment, method 101B may further include determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall 35 prior to perforating into the LV cavity 32 in response to determining a decrease in the cardiac conduction system capture threshold 118A as the implanted electrode moves through the ventricular septum 35 toward the LV cavity 32 during implantation of the implanted electrode.

[0123] Determining a decrease in cardiac conduction system capture threshold 118A can include determining that cardiac conduction system capture threshold 118A has decreased by an initial implant threshold. The initial implant threshold can be between approximately 0V and approximately 2V. In at least one embodiment, the initial implant threshold can be approximately equal to or greater than 1V. In other embodiments, the initial implant threshold can be less than or equal to 2V, less than or equal to 1.75V, less than or equal to 1.5V, less than or equal to 1V, less than or equal to 0.75V, less than or equal to 0.5V, less than or equal to 0.2V, etc., and / or greater than 0V and / or greater than or equal to 0.1V, 0.6V, 0.9V, 1.1V, 1.6V, 1.9V, 2.1V, etc. In another embodiment, the initial implant threshold can be a set percentage of the patient's intrinsic cardiac conduction system capture threshold 118A.

[0124] Thus, if the initial implantation threshold is 1 V, and a conduction system capture threshold decrease is monitored 118 to 1.2 V, it can be determined that a conduction system capture threshold decrease has occurred, indicating that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32. If the initial implantation threshold is 1 V, and a conduction system capture threshold decrease is monitored 118 to 0.8 V, it can be determined that a conduction system capture threshold decrease has not occurred, indicating that the implanted electrode is not proximate to the cardiac conduction system and implanted in the ventricular septum membrane wall 35 before perforating into the LV cavity 32.

[0125] Method 101B may further include determining that the implanted electrode has perforated into the LV cavity 32 based on the cardiac conduction system capture threshold 118A. Such a determination may include determining that the implanted electrode has perforated into the LV cavity 32 in response to determining a further increase in the cardiac conduction system capture threshold 118A as the implanted electrode 48, 50 moves from an implantation location proximate to the cardiac conduction system through the ventricular septum 35 into the LV cavity 32 during implantation of the implanted electrode. Determining the further increase in the cardiac conduction system capture threshold 118A may include determining that the cardiac conduction system capture threshold 118A has further increased by the perforation threshold 122. As discussed herein, "further" is relative to a capture threshold determined at or near the cardiac conduction system, or at a location that is understood to be at or near the cardiac conduction system.

[0126] The breakdown threshold 122 can be between about 0.1 V and about 5 V. In at least one embodiment, the breakdown threshold 122 can be about equal to or greater than 1 V. In other embodiments, the breakdown threshold 122 can be greater than 0 V, greater than or equal to 0.1 V, greater than or equal to 0.15 V, greater than or equal to 0.5 V, greater than or equal to 1 V, greater than or equal to 2 V, greater than or equal to 5 V, etc., and / or less than or equal to 4.5 V, 3.5 V, 2.5 V, 1.5 V, 0.4 V, 0.2 V, 0.1 V, etc. In alternative embodiments, the breakdown threshold 122 can be a set percentage of the patient's implant threshold 120, or can be a set percentage of the patient's intrinsic cardiac conduction system capture threshold 118A, or can be a set percentage of the patient's cardiac conduction system capture threshold determined at or near the cardiac conduction system.

[0127] Thus, if perforation threshold 122 is 1 V, and monitoring 118 for a conduction system capture threshold increase of 1.1 V, it can be determined that a further conduction system capture threshold increase has occurred to indicate that the implanted electrode has perforated into LV cavity 32. If perforation threshold 122 is 1 V, and monitoring 118 for a conduction system capture threshold increase of 0.9 V, it can be determined that no further conduction system capture threshold increase has occurred to indicate that the implanted electrode has not perforated into LV cavity 32.

[0128] In an alternative embodiment, determining a further increase in cardiac conduction system capture threshold 118A can include determining that cardiac conduction system capture threshold 118A has further increased to at least a capture perforation target value. In yet another alternative embodiment, if cardiac conduction system capture threshold 118A disappears, or the cardiac conduction system is no longer captured at all, such loss of capture can be equated with cardiac conduction system capture threshold 118A reaching the perforation target value.

[0129] Determining a further increase in the cardiac conduction system capture threshold 118A may include determining that the cardiac conduction system capture threshold 118A has further increased to a capture perforation target value. The capture perforation target value may be between approximately 0.1 V and approximately 5.0 V. In at least one embodiment, the capture perforation target value may be approximately equal to or greater than 1.0 V. In other embodiments, the capture perforation target value can be less than or equal to 5 V, less than or equal to 4.0 V, less than or equal to 3.0 V, less than or equal to 2.0 V, less than or equal to 1.0 V, less than or equal to 0.5 V, less than or equal to 0.4 V, less than or equal to 0.3 V, less than or equal to 0.2 V, less than or equal to 0.1 V, etc., and / or greater than 0 V, greater than or equal to 0.15 V, 0.25 V, 0.35 V, 0.45 V, 0.55 V, 0.65 V, 0.75 V, 0.85 V, 0.95 V, 1.05 V, 1.5 V, 2.5 V, 3.5 V, 4.5 V, etc. In another embodiment, the capture perforation target value can be a set percentage of the patient's native cardiac conduction system capture threshold 118A, or can be a set percentage of an implanted target value, or can be a set percentage of the patient's cardiac conduction system capture threshold determined at or near the cardiac conduction system.

[0130] Thus, if the capture perforation target value is 1.0 V, and the conduction system capture threshold is monitored 118 to increase to 1.1 V, it can be determined that an increase in the conduction system capture threshold has occurred, indicating that the implanted electrode has perforated into the LV cavity 32. If the capture perforation target value is 1.0 V, and the conduction system capture threshold is monitored 118 to increase to 0.5 V, it can be determined that an increase in the conduction system capture threshold has not occurred, indicating that the implanted electrode has perforated into the LV cavity 32.

[0131] Figure 7 , a method 101C for determining impedance 124A during electrode implantation for use in method 100 is illustrated in FIG. Determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall 35 prior to perforation into the LV cavity 32 based on impedance 124A may include determining impedance 124 during electrode implantation. Determining impedance 124 during electrode implantation may include determining impedance based on at least one of EGM or ECG signal analysis (e.g., based on a measured potential difference between the implanted electrode and the pulse generator in a unipolar configuration as discussed herein, based on a measured potential difference between the implanted electrodes in a bipolar configuration as discussed herein, etc.). The signal analysis may be based on signals obtained from at least one of the one or more implanted electrodes 48, 50 and the external electrode 44. The computing device 81 may determine the position of the implanted electrode using the monitored electrical activity of the implanted electrode (e.g., ECG and EGM signals) to determine the impedance.

[0132] Method 101C may further include, in response to determining a decrease in monitored impedance 124A as the implanted electrode moves through the ventricular septum 35 toward the LV cavity 32 during implantation of the implanted electrode, determining based on the impedance that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall 35 prior to perforating into the LV cavity 32.

[0133] Determining a decrease in the monitored impedance 124A can include determining that the monitored impedance 124A has decreased by an impedance implant change value 126. The impedance implant change value 126 can be between approximately 10 ohms and approximately 200 ohms. In at least one embodiment, the impedance implant change value 126 can be approximately equal to or greater than 100 ohms. In other embodiments, the impedance implant change value 126 can be less than or equal to 200 ohms, less than or equal to 175 ohms, less than or equal to 150 ohms, less than or equal to 125 ohms, less than or equal to 100 ohms, less than or equal to 75 ohms, less than or equal to 50 ohms, etc., and / or greater than 0 ohms, greater than or equal to 10 ohms, 25 ohms, 80 ohms, 110 ohms, 125 ohms, 145 ohms, 180 ohms, 195 ohms, etc. In alternative embodiments, the impedance implant change value 126 can be a set percentage of the patient's impedance monitored at or near the ventricular septum.

[0134] Thus, if the impedance implant change value 126 is 100 ohms and an impedance decrease 124 of 125 ohms is monitored, it can be determined that an impedance decrease has occurred, indicating that the implanted electrode is proximate to the cardiac conduction system and implanted in the interventricular septal membrane wall 35 before perforating into the LV cavity 32. If the impedance implant change value 126 is 100 ohms and an impedance decrease 124 to 85 ohms is monitored, it can be determined that an impedance decrease has not occurred, indicating that the implanted electrode is not proximate to the cardiac conduction system and implanted in the interventricular septal membrane wall 35 before perforating into the LV cavity 32.

[0135] Method 101C may further include determining that the implanted electrode has perforated into the LV cavity 32 based on the determined impedance 124A. Such a determination may include determining that the implanted electrode has perforated into the LV cavity 32 in response to determining a further decrease in the monitored impedance 124A as the implanted electrode 48, 50 moves from an implantation location proximate to the cardiac conduction system through the ventricular septum 35 into the LV cavity 32 during implantation. Determining that the monitored impedance 124A has further decreased may include determining that the impedance 124A has further decreased by an impedance perforation change value 128. As discussed herein, a "further decrease" in the monitored impedance is relative to an impedance monitored at or near the cardiac conduction system, or an impedance monitored at a location understood to be at or near the cardiac conduction system.

[0136] The impedance perforation variation 128 may be between about 10 ohms and about 600 ohms. In at least one embodiment, the impedance perforation variation 128 may be about equal to or greater than 100 ohms. In other embodiments, the impedance perforation variation 128 may be greater than or equal to 10 ohms, 25 ohms, 50 ohms, 75 ohms, 150 ohms, 200 ohms, greater than or equal to 250 ohms, greater than or equal to 300 ohms, greater than or equal to 350 ohms, greater than or equal to 400 ohms, greater than or equal to 450 ohms, greater than or equal to 500 ohms, greater than or equal to 550 ohms, greater than or equal to 600 ohms, and / or less than or equal to 590 ohms, 540 ohms, 490 ohms, 440 ohms, 390 ohms, 340 ohms, 290 ohms, 240 ohms, 190 ohms, 140 ohms, 30 ohms, and the like. In another embodiment, the impedance perforation change value 128 may be a set percentage of the impedance implant change value 126, or may be a set percentage of the patient's impedance monitored at or near the cardiac conduction system.

[0137] Thus, if the impedance perforation change value 128 is 100 ohms, and an impedance decrease of 124 to 115 ohms is monitored, it can be determined that a further impedance decrease has occurred to indicate that the implanted electrode has perforated into the LV cavity 32. If the impedance perforation change value 128 is 100 ohms, and an impedance decrease of 124 to 190 ohms is monitored, it can be determined that no further impedance decrease has occurred to indicate that the implanted electrode has not perforated into the LV cavity 32.

[0138] During implantation of the implantable electrode, in some examples, if current lesion 112A decreases by IOC implant change value 114 or decreases to an IOC implant target value, and if cardiac conduction system capture threshold 118A increases by implant threshold 120 or increases to a capture implant target value, and if impedance 124A decreases by impedance implant change value 126, it can be determined that the implantable electrode is proximate to LBB 8a and implanted in the ventricular septal membrane wall 35 before perforation into the LV cavity 32. A first notification 110 can be issued in response to determining that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septal membrane wall 35 before perforation of the LV cavity 32.

[0139] During continued advancement of the implanted electrode from its implantation position adjacent the cardiac conduction system within the ventricular septum 35, in some examples, if current lesion 112A further decreases by IOC perforation change value 116 or further decreases to an IOC perforation target value, and if cardiac conduction system capture threshold 118A further increases by perforation threshold 122 or further increases to a capture perforation target value, and if impedance 124A further decreases by impedance perforation change value 128, then it can be determined that the implanted electrode has perforated into the LV cavity 32. A second notification 111 can be issued in response to determining that the implanted electrode has perforated into the LV cavity 32.

[0140] In some embodiments, all of cardiac conduction system capture, current injury, and impedance are monitored during implantation of the implantable electrode, and all of cardiac conduction system capture, current injury, and impedance are used to determine electrode position or perforation through the ventricular septum into an adjacent cardiac chamber. In alternative embodiments, during implantation of the implantable electrode, less than all of cardiac conduction system capture, current injury, and impedance are monitored, and / or less than all of cardiac conduction system capture, current injury, and impedance are used to determine electrode position or perforation through the ventricular septum into an adjacent cardiac chamber. In such alternative embodiments, one or both of cardiac conduction system capture, current injury, and impedance may be used to determine electrode position or perforation through the ventricular septum.

[0141] In at least one embodiment, and as Figure 8 As illustrated, the treatment system 71 can perform method 200 to assist in implanting an implantable electrode as described herein. Method 200 can include continuous ECG and EGM data collection 202 as a beat-to-beat measurement of perforation-related variables (e.g., current damage, cardiac conduction system capture, and impedance) 204. Method 200 can further include evaluating dynamic changes in perforation-related variables 206. Method 200 can further include determining whether a perforation threshold has been reached based on evaluating dynamic changes in perforation-related variables 208. If the perforation threshold has not been reached, method 200 can continue continuous ECG and EGM data collection 202. If the perforation threshold is reached, method 200 can further include issuing a warning to stop lead advancement or reposition the lead (labeled with reference numeral 210).

[0142] In at least one embodiment, and as Figure 9As illustrated, the therapy system 71 can perform a method 300 to assist in implanting an implantable electrode as described herein. The method 300 can include continuous ECG and EGM data collection 302 using a cardiac conduction system pacing threshold while slowly advancing an electrode (labeled as reference numeral 304) within the intraventricular septal wall 35. The method 300 can further include monitoring capture of the LBB 306. Once capture is established, the method 300 can continue with continuous testing 308 of a cardiac conduction system capture threshold (e.g., an LBB cardiac conduction system capture threshold).

[0143] Method 300 may further include determining whether the LBB cardiac conduction system capture threshold decreases as the electrode is advanced 310. If the LBB cardiac conduction system capture threshold does not decrease during electrode advancement, method 300 may continue continuous testing of the LBB cardiac conduction system capture threshold (308). If the LBB cardiac conduction system capture threshold does decrease during electrode advancement, method 300 may further include stopping electrode advancement and evaluating the LBB cardiac conduction system capture threshold and other perforation-related variables (e.g., current lesion and impedance) 312. Method 300 may further include determining whether a significant decrease in the LBB cardiac conduction system capture threshold (e.g., threshold cessation of decrease, increase, or signal loss), current lesion amplitude (e.g., amplitude significant decrease or signal loss), and pacing impedance (e.g., impedance significant decrease or signal loss) has occurred 314. If such a significant decrease has not occurred, method 300 may further include completing electrode implantation at or near the LBB 318. If such a significant decrease has occurred, method 300 may further include repositioning the electrode (labeled as reference numeral 316).

[0144] In at least one embodiment, and as Figure 10 As illustrated, the therapy system 71 may perform a method 400 to assist in implanting an implantable electrode as described herein. The method 400 may include continuous ECG and EGM data collection 402, monitoring and measuring current damage 404 while advancing the electrode. The method 400 may further include recording LBB cardiac conduction system capture (in Figure 10 Electrode advancement 406 is also continued at (labeled as LBB potential).

[0145] The method 400 may further include detecting current injury until a significant current injury amplitude is present 408, and continuously measuring the beat-to-beat amplitude of the current injury 410. The method 400 may further include determining whether a high to low current injury phenomenon occurs 412. If such a high to low current injury phenomenon does not occur, the method 400 may repeat and continue to continuously measure the beat-to-beat amplitude of the current injury 410. If such a high to low current injury phenomenon occurs, the method 400 may further include issuing a warning and stopping electrode advancement and evaluating for potential electrode perforation 414. The method 400 may further include completing electrode placement 416 if perforation is not detected. The method 400 may further include repositioning the electrode 418 if perforation is detected.

[0146] Various embodiments have been described. These and other embodiments are within the scope of the appended claims. For example, single-, dual-, or triple-chamber pacemakers (e.g., CRT-P) or ICDs (e.g., CRT-D) or leadless devices, as well as changes in LBB (or conduction system) capture threshold, current lesion, pacing impedance, or other parameters suggestive of tissue perforation, can be used to implement the exemplary methods described herein.

[0147] Exemplary Embodiments

[0148] Although the present disclosure is not limited thereto, an understanding of various aspects of the present disclosure will be gained through a discussion of the specific exemplary embodiments provided below. Various modifications to the exemplary embodiments as well as additional embodiments of the present disclosure will become apparent herein.

[0149] Embodiment Ex1: A system for assisting in the implantation of an implantable electrode, the system comprising: an implantable electrode configured to deliver cardiac conduction system pacing proximate a portion of a patient's cardiac conduction system; an external electrode configured to sense at least electrical activity of the patient's heart; and a computing device comprising a processing circuit, the computing device being operably coupled to the implantable electrode and the external electrode, wherein the computing device is configured to: monitor internal electrical activity using the implantable electrode during implantation of the implantable electrode; monitor internal electrical activity using the external electrode during implantation of the implantable electrode external electrical activity; determining cardiac conduction system capture based on at least one of the internal electrical activity monitored during implantation of the implanted electrode and the monitored external electrical activity; determining current lesion based on at least one of the internal electrical activity monitored during implantation of the implanted electrode and the monitored external electrical activity; determining impedance based on at least one of the internal electrical activity monitored during implantation of the implanted electrode and the monitored external electrical activity; issuing a first notification in response to determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall prior to perforation into the left ventricle (LV) cavity based on the cardiac conduction system capture, the current lesion, and the impedance.

[0150] Embodiment Ex2: A method for assisting in the implantation of an implantable electrode, the implantable electrode comprising an implantable electrode proximate to a patient's cardiac conduction system, the method comprising, during implantation of the implantable electrode: monitoring internal electrical activity using the implantable electrode during implantation of the implantable electrode; monitoring external electrical activity using an external electrode during implantation of the implantable electrode; determining cardiac conduction system capture based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the monitored external electrical activity; determining current damage based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the monitored external electrical activity; determining impedance based on at least one of the internal electrical activity monitored during implantation of the implantable electrode and the monitored external electrical activity; issuing a first notification in response to determining, based on the cardiac conduction system capture, the current damage, and the impedance, that the implantable electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforation into the left ventricle (LV) cavity.

[0151] Example Ex3: A system according to Example Ex1 or a method according to Example Ex2, wherein issuing a first notification in response to determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall before perforating into the LV cavity based on the cardiac conduction system capture, the current injury, and the impedance includes determining that the implanted electrode is implanted in the ventricular septum wall proximate to a left bundle branch (LBB) for LBB pacing or LBB regional pacing.

[0152] Embodiment Ex4: A system or method according to any one of embodiments Ex1 to Ex3, wherein issuing a first notification in response to determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity based on the current damage includes: in response to determining a reduction in the current damage monitored as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity.

[0153] Embodiment Ex5: The system or method of embodiment Ex4, wherein determining the reduction in the monitored impairment of current comprises determining a reduction in the monitored impairment of current (IOC) by an IOC implant change value, wherein the IOC implant change value is greater than 0 mV.

[0154] Embodiment Ex6: A system or method according to any one of embodiments Ex1 to Ex5, wherein a cardiac conduction system capture threshold is a minimum amount of power for delivering cardiac conduction system pacing while achieving capture of the cardiac conduction system, wherein issuing a first notification in response to determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity based on monitored cardiac conduction system capture comprises: in response to determining an increase in the cardiac conduction system capture threshold as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity.

[0155] Embodiment Ex7: The system or method of Embodiment Ex6, wherein determining the increase in the cardiac conduction system capture threshold comprises determining that the cardiac conduction system capture threshold has increased by an implantation threshold, wherein the implantation threshold is greater than or equal to 1.0 volt.

[0156] Embodiment Ex8: A system or method according to any one of embodiments Ex1 to Ex7, wherein issuing a first notification in response to determining based on the impedance that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity includes: in response to determining a decrease in impedance monitored as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity.

[0157] Embodiment Ex9: The system or method of embodiment Ex8, wherein determining the decrease in the monitored impedance comprises determining a monitored impedance decrease impedance implant change value, wherein the impedance implant change value is greater than or equal to 100 ohms.

[0158] Embodiment Ex10: The system according to embodiment Ex1 or the method according to embodiment Ex2, wherein the computing device is further configured to execute or the method further includes, during implantation of the implantable electrode: issuing a second notification in response to determining that the implantable electrode has perforated the LV cavity based on the cardiac conduction system capture threshold, the current damage and the impedance.

[0159] Embodiment Ex11: A system or method according to embodiment Ex10, wherein issuing a second notification in response to determining that the implanted electrode has perforated the LV cavity based on the current damage includes determining that the implanted electrode has perforated the LV cavity in response to determining that the current damage monitored decreases when the implanted electrode moves from an implantation position near the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode.

[0160] Embodiment Ex12: The system or method of embodiment Ex11, wherein determining the reduction in the monitored current impairment comprises determining a reduction in the monitored current impairment by an IOC perforation change value, wherein the IOC perforation change value is greater than or equal to 1 mV.

[0161] Embodiment Ex13: A system or method according to embodiment Ex10, wherein a cardiac conduction system capture threshold is a minimum amount of power for delivering cardiac conduction system pacing while achieving capture of the cardiac conduction system, and wherein issuing a second notification in response to determining that the implanted electrode has perforated into the LV cavity based on the monitored cardiac conduction system capture includes: determining that the implanted electrode has perforated into the LV cavity in response to determining that the implanted electrode has perforated into the LV cavity in response to an increase in the cardiac conduction system capture threshold when the implanted electrode moves from an implantation position proximal to the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode.

[0162] Embodiment Ex14: The system or method of Embodiment Ex13, wherein determining the increase in the cardiac conduction system capture threshold comprises determining that the cardiac conduction system capture threshold has increased by a perforation threshold, wherein the perforation threshold is greater than or equal to 1.0 volt.

[0163] Example Ex15: A system or method according to Example Ex10, wherein issuing a second notification in response to determining that the implanted electrode has perforated into the LV cavity based on the impedance includes: determining that the implanted electrode has perforated into the LV cavity in response to determining a decrease in impedance monitored when the implanted electrode moves from an implantation position near the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode.

[0164] Embodiment Ex16: The system or method of embodiment Ex15, wherein determining the decrease in the monitored impedance comprises determining a decrease in the monitored impedance by an impedance perforation change value, wherein the impedance perforation change value is greater than or equal to 100 ohms.

[0165] Embodiment Ex17: A system according to embodiment Ex1 or a method according to embodiment Ex2, wherein the computing device is further configured to execute or the method further includes: displaying the first notification using a display during implantation of the implantable electrode, wherein the computing device is capable of being operably connected to the display.

[0166] Example Ex18: According to the system or method of Example Ex10, the system or method further includes a display, wherein the computing device is further configured to execute or the method further includes: displaying the first notification using the display during implantation of the implantable electrode; and displaying the second notification using the display during implantation of the implantable electrode, wherein the computing device can be operably connected to the display.

[0167] Embodiment Ex19: A system for assisting in the implantation of an implantable electrode, the system comprising: an implantable electrode configured to deliver cardiac conduction system pacing near a portion of a patient's cardiac conduction system; and a computing device comprising a processing circuit, the computing device being operably connected to the implantable electrode, wherein the computing device is configured to: monitor internal electrical activity using the implantable electrode during implantation of the implantable electrode; determine cardiac conduction system capture, current damage, and impedance based on the internal electrical activity monitored during implantation of the implantable electrode; and issue a first notification in response to determining that the implantable electrode is proximate to the cardiac conduction system and is implanted in the interventricular septum wall before perforating into the left ventricle (LV) cavity based on at least one of the determined cardiac conduction system capture, the current damage, and the impedance.

[0168] Example Ex20: A method for assisting in the implantation of an implantable electrode, the implantable electrode comprising an implantable electrode proximate to a patient's cardiac conduction system, the method comprising: during implantation of the implantable electrode: monitoring internal electrical activity using the implantable electrode during implantation of the implantable electrode; determining cardiac conduction system capture, current damage, and impedance based on the internal electrical activity monitored during implantation of the implantable electrode; and issuing a first notification in response to determining that the implantable electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the left ventricle (LV) cavity based on at least one of the cardiac conduction system capture, the current damage, and the impedance.

[0169] Example Ex21: A system according to Example Ex19 or a method according to Example Ex20, wherein issuing a first notification in response to determining that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall before perforating into the LV cavity based on the cardiac conduction system capture, the current injury, and the impedance includes determining that the implanted electrode is implanted in the ventricular septum wall proximate to the left bundle branch (LBB) for LBB pacing or LBB regional pacing.

[0170] Example Ex22: A system or method according to any one of Examples 19 to 21, wherein issuing a first notification in response to determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity based on the current damage includes: determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity in response to determining a reduction in the current damage monitored as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode.

[0171] Embodiment Ex23: According to the system or method of embodiment Ex22, determining the reduction of the monitored impairment of current includes determining that the monitored impairment of current (IOC) is reduced by an IOC implant change value, wherein the IOC implant change value is greater than 0 mV.

[0172] Embodiment Ex24: A system or method according to any one of Embodiments 19 to 23, wherein a cardiac conduction system capture threshold is a minimum amount of power for delivering cardiac conduction system pacing while achieving capture of the cardiac conduction system, wherein issuing a first notification in response to determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity based on monitored cardiac conduction system capture includes: in response to determining an increase in the cardiac conduction system capture threshold as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, determining that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity.

[0173] Embodiment Ex25: The system or method of Embodiment Ex24, wherein determining an increase in the cardiac conduction system capture threshold comprises determining that the cardiac conduction system capture threshold has increased by an implantation threshold, wherein the implantation threshold is greater than or equal to 1.0 volt.

[0174] Example Ex26: A system or method according to any one of Examples 19 to 25, wherein issuing a first notification in response to determining based on the impedance that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity includes: in response to determining a decrease in impedance monitored as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, determining that the implanted electrode is close to the cardiac conduction system and is implanted in the ventricular septum wall before perforating into the LV cavity.

[0175] Embodiment Ex27: The system or method of embodiment Ex26, wherein determining the decrease in the monitored impedance comprises determining a monitored impedance decrease impedance implant change value, wherein the impedance implant change value is greater than or equal to 100 ohms.

[0176] Example Ex28: A system according to Example Ex19 or a method according to Example Ex20, wherein the computing device is further configured to execute or the method further includes, during implantation of the implantable electrode: issuing a second notification in response to determining that the implantable electrode has perforated into the LV cavity based on the cardiac conduction system capture threshold, the current damage and the impedance.

[0177] Example Ex29: A system or method according to Example Ex28, wherein issuing a second notification in response to determining that the implanted electrode has perforated the LV cavity based on the current damage includes: determining that the implanted electrode has perforated the LV cavity in response to determining a decrease in the current damage monitored during implantation of the implanted electrode as the implanted electrode moves from an implantation position near the cardiac conduction system through the ventricular septum into the LV cavity.

[0178] Embodiment Ex30: The system or method of embodiment Ex29, wherein determining the reduction in the monitored current injury comprises determining a monitored current injury reduction IOC perforation change value, wherein the IOC perforation change value is greater than or equal to 1 mV.

[0179] Embodiment Ex31: A system or method according to embodiment Ex28, wherein a cardiac conduction system capture threshold is a minimum amount of power for delivering cardiac conduction system pacing while achieving capture of the cardiac conduction system, and wherein issuing a second notification in response to determining that the implanted electrode has perforated into the LV cavity based on the monitored cardiac conduction system capture includes determining that the implanted electrode has perforated into the LV cavity in response to determining that the implanted electrode has perforated into the LV cavity in response to an increase in the cardiac conduction system capture threshold when the implanted electrode moves from an implantation position proximal to the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode.

[0180] Embodiment Ex32: The system or method of Embodiment Ex31, wherein determining an increase in the cardiac conduction system capture threshold comprises determining that the cardiac conduction system capture threshold has increased by a perforation threshold, wherein the perforation threshold is greater than or equal to 1.0 volt.

[0181] Example Ex33: A system or method according to Example Ex28, wherein issuing a second notification in response to determining that the implanted electrode has perforated into the LV cavity based on the impedance includes: determining that the implanted electrode has perforated into the LV cavity in response to determining that the impedance monitored decreases when the implanted electrode moves from an implantation position near the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode.

[0182] Embodiment Ex34: The system or method of embodiment Ex33, wherein determining the decrease in the monitored impedance comprises determining a decrease in the monitored impedance by an impedance perforation change value, wherein the impedance perforation change value is greater than or equal to 100 ohms.

[0183] Embodiment Ex35: A system according to embodiment Ex19 or a method according to embodiment Ex20, wherein the computing device is further configured to execute or the method further includes: displaying a first notification using a display during implantation of the implantable electrode, wherein the computing device is capable of being operably connected to the display.

[0184] Example Ex36: According to the system or method of Example Ex28, the system or method further includes a display, wherein the computing device is further configured to execute or the method further includes: displaying the first notification using the display during implantation of the implantable electrode; and displaying the second notification using the display during implantation of the implantable electrode, wherein the computing device can be operably connected to the display.

[0185] The present disclosure has been provided with reference to exemplary embodiments and examples, and is not intended to be construed in a limiting sense. As previously mentioned, those skilled in the art will recognize that various other exemplary applications can utilize the beneficial properties of the apparatus and methods described herein using the techniques described herein. Various modifications of the exemplary embodiments and examples will become apparent after reference to this specification.

[0186] In one or more examples, the described techniques may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored as one or more instructions or codes on a computer-readable medium and executed by a hardware-based processing unit. The computer-readable medium may include a non-transitory computer-readable medium that corresponds to a tangible medium such as a data storage medium (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer).

[0187] Instructions may be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable logic arrays (FPGAs), or other equivalent integrated or discrete logic circuits. Thus, the term "processor," as used herein, may refer to any of the aforementioned structures or any other physical structure suitable for implementing the described techniques. Additionally, these techniques may be fully implemented in one or more circuits or logic elements.

[0188] All references and publications cited herein are expressly incorporated by reference in their entirety for all purposes unless in any respect directly inconsistent with this disclosure.

[0189] Unless otherwise specified, all scientific and technical terms used herein have the meanings commonly used in the art. The definitions provided herein are intended to facilitate understanding of certain terms frequently used herein and are not intended to limit the scope of the present disclosure.

[0190] Unless otherwise indicated, all numerical values ​​expressing feature sizes, amounts, and physical properties used in the specification and claims may be understood as being modified by the terms "exactly" or "about." Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and the appended claims are approximations that may vary depending upon the desired properties sought to be obtained by one skilled in the art utilizing the teachings disclosed herein or, for example, within typical ranges of experimental error.

[0191] The recitation of numerical ranges by endpoints includes all numbers within the stated range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5) and any range within the stated range. As used herein, the term "at most" or "not more than" a number (e.g., at most 50) includes that number (e.g., 50), and the term "not less than" a number (e.g., not less than 5) includes that number (e.g., 5).

[0192] The terms "coupled" or "connected" refer to elements being directly attached to one another (in direct contact with one another) or indirectly attached (with one or more elements between and attaching the two elements). Both terms can be modified by the interchangeable use of "operably" and "operably" to describe a coupling or connection configured to allow the components to interact to perform at least some function (e.g., a mobile user device can be operatively coupled to a cellular network to send data to or receive data from it).

[0193] References to "one embodiment," "an embodiment," "certain embodiments," or "some embodiments" mean that a particular feature, configuration, component, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. Thus, the appearance of such phrases in various places throughout the text are not necessarily referring to the same embodiment of the present disclosure. Furthermore, the particular features, configurations, components, or characteristics may be combined in any suitable manner in one or more embodiments.

[0194] As used in this specification and the appended claims, the singular forms "a," "an," and "the" encompass embodiments having plural referents, unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally used in its sense, including "and / or," unless the context clearly dictates otherwise.

[0195] As used herein, “having,” “including,” “comprising,” etc. are used in their open-ended sense and generally mean “including but not limited to.” It should be understood that “consisting essentially of,” “consisting of,” etc. are subsumed under “comprising,” etc.

[0196] The term "and / or" means one or all of the listed elements or a combination of at least two of the listed elements.

[0197] The phrases "at least one of," "including at least one of," and "one or more of" following a list refer to any one of the items in the list and any combination of two or more items in the list.

Claims

1. A system for assisting implantation of an implantable electrode, the system comprising: an implantable electrode configured to deliver cardiac conduction system pacing proximate a portion of a patient's cardiac conduction system; external electrodes configured to sense at least electrical activity of the patient's heart; and a computing device comprising processing circuitry, the computing device being operably coupled to the implantable electrode and the external electrode, wherein the computing device is configured to, during implantation of the implantable electrode: monitoring internal electrical activity using the implantable electrode during implantation of the implantable electrode, monitoring external electrical activity using the external electrode during implantation of the implantable electrode, determining cardiac conduction system capture based on at least one of monitored internal electrical activity and monitored external electrical activity during implantation of the implantable electrode, determining a current injury based on at least one of internal electrical activity monitored and external electrical activity monitored during implantation of the implantable electrode, determining impedance based on at least one of monitored internal electrical activity and monitored external electrical activity during implantation of the implantable electrode, and A first notification is issued in response to determining that the implantable electrode is proximate to the cardiac conduction system and implanted in a ventricular septum wall prior to perforation into a left ventricular (LV) cavity based on at least one of the cardiac conduction system capture, the current lesion, and the impedance.

2. The system of claim 1 , wherein issuing a first notification in response to determining, based on at least one of the cardiac conduction system capture, the current lesion, and the impedance, that the implantable electrode is proximate to the cardiac conduction system and implanted in the interventricular septum wall prior to perforation into the LV cavity comprises: The implantable electrode is determined to be implanted in the ventricular septum wall near a left bundle branch (LBB) for LBB pacing or LBB regional pacing.

3. The system of claim 1 or 2, wherein issuing a first notification in response to determining, based on the current injury, that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall prior to perforation into the LV cavity comprises: In response to determining a reduction in monitored current lesions as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implantable electrode, it is determined that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall prior to perforating into the LV cavity.

4. The system of claim 3, wherein determining the reduction in the monitored impairment current comprises determining that the monitored impairment current (IOC) is reduced by an IOC implant change value, wherein the IOC implant change value is greater than 0 mV.

5. The system of any one of claims 1 to 4, wherein a cardiac conduction system capture threshold is a minimum amount of power used to deliver the cardiac conduction system pacing while achieving capture of the cardiac conduction system. wherein issuing a first notification in response to determining, based on monitored cardiac conduction system capture, that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall prior to perforation into the LV cavity comprises: In response to determining an increase in the cardiac conduction system capture threshold as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, it is determined that the implanted electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall prior to perforating into the LV cavity.

6. The system of claim 5, wherein determining the increase in the cardiac conduction system capture threshold comprises: It is determined that the cardiac conduction system capture threshold has been increased by an implantation threshold, wherein the implantation threshold is greater than or equal to 1.0 volt.

7. The system of any one of claims 1 to 6, wherein issuing a first notification in response to determining, based on the impedance, that the implantable electrode is proximate to the cardiac conduction system and implanted in the ventricular septum wall prior to perforation into the LV cavity comprises: In response to determining a decrease in monitored impedance as the implanted electrode moves through the ventricular septum toward the LV cavity during implantation of the implanted electrode, it is determined that the implanted electrode is proximate to the cardiac conduction system and is implanted in the ventricular septum wall prior to perforating into the LV cavity.

8. The system of claim 7, wherein determining the decrease in the monitored impedance comprises determining a decrease in the monitored impedance by an impedance implant change value, wherein the impedance implant change value is greater than or equal to 100 ohms.

9. The system of any one of claims 1 to 9, wherein the computing device is further configured to perform the following, or the method further comprises the following, during implantation of the implantable electrode: A second notification is issued in response to determining that the implanted electrode has perforated into the LV cavity based on at least one of the cardiac conduction system capture threshold, the current lesion, and the impedance.

10. The system of claim 9, wherein issuing a second notification in response to determining that the implanted electrode has perforated the LV cavity based on the current injury comprises: In response to determining a decrease in monitored current lesions as the implanted electrode moves from an implantation location proximate the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode, it is determined that the implanted electrode has perforated into the LV cavity.

11. The system of claim 10, wherein determining the reduction in the monitored current impairment comprises determining that the monitored current impairment is reduced by an IOC perforation variation value, wherein the IOC perforation variation value is greater than or equal to 1 mV.

12. The system of claim 9, wherein a cardiac conduction system capture threshold is a minimum amount of power used to deliver the cardiac conduction system pacing while achieving capture of the cardiac conduction system. Wherein issuing a second notification in response to determining that the implanted electrode has perforated into the LV cavity based on the monitored cardiac conduction system capture comprises: In response to determining an increase in the cardiac conduction system capture threshold as the implanted electrode moves from an implantation location proximate the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode, it is determined that the implanted electrode has perforated into the LV cavity.

13. The system of claim 12, wherein determining the increase in the cardiac conduction system capture threshold comprises: It is determined that the cardiac conduction system capture threshold has been increased by a perforation threshold, wherein the perforation threshold is greater than or equal to 1.0 volt.

14. The system of claim 9, wherein issuing a second notification in response to determining based on the impedance that the implantable electrode has perforated into the LV cavity comprises: In response to determining a decrease in monitored impedance as the implanted electrode moves from an implantation location proximate the cardiac conduction system through the ventricular septum into the LV cavity during implantation of the implanted electrode, it is determined that the implanted electrode has perforated into the LV cavity.

15. The system of claim 14, wherein determining the decrease in the monitored impedance comprises determining a decrease in the monitored impedance by an impedance perforation change value, wherein the impedance perforation change value is greater than or equal to 100 ohms.

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